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ETICĂ ȘI COMUNICARE
ÎN ANTREPRENORIATUL MEDICAL

Dr. IRINA STĂNCIUGELU

Reader
 CUPRINS

Cuvânt înainte

1. ETICĂ ÎN AFACERI ȘI ETICĂ PROFESIONALĂ PENTRU MEDICII-

ANTREPRENORI
1.1. Etică în publicitatea pentru cabinete medicale
1.2. Integritate profesională și conflicte de interese
1.3. Turismul medical și responsabilitatea față de pacient
2. ETICĂ ÎN COMUNICAREA CU PACIENȚII
2.1. Paternalism în relația medic-pacient
2.2. Dreptul la viață privată și confidențialitatea în cabinetele medicale
2.3. Informarea corectă a pacienților
2.4. Consimțământul informat
2.5. Comunicarea cu pacienții agresivi
2.6. Comunicarea cu pacienții aflați în stadii terminale
3. ETICĂ ÎN RELAȚIA CU FURNIZORII ȘI PRODUCĂTORII DE MEDICAMENTE
3.1. Conflictul de interese
3.2. Cadourile și alte stimulente
Bibliografie
 CUVÂNT ÎNAINTE

Acest reader conține o serie de texte menite să vă însoțească pe parcursul cursului on-
line de Etică și comunicare în antreprenoriatul medical, dar și dincolo de limita de timp
impusă de acesta. Ele au fost selectate nu atât pentru „reprezentativitatea” lor
academică, adică pentru faptul că au însemnat un punct de cotitură în literatura de
specialitate dedicată subiectului S1 sau S2, ci pentru valoarea lor didactică, pentru cât
de bine reușesc autorii să prezinte punctele de tensiune ale temei abordate. Ulterior, cei
interesați să aprofundeze una sau alta din temele acestui reader, o pot face consultând
bibliografia, ca punct de plecare.

Este demn de menționat faptul că în România nu există o literatură de specialitate clar

conturată pe nici una dintre temele incluse aici. Nu ne aflăm în situația de a fi reflectat
în mod serios și consecvent pe aceste teme, chiar dacă, de-a lungul celor 25 de ani de
democrație, toate au fost în atenția presei și autorităților, a specialiștilor din domeniul
medical, a celor specializați în management medical (câți or fi cu adevărat aceștia) și
publicului în genere. Nu avem nici cultura dialogului, astfel încât să fi adus în discuția
academică și să fi studiat fenomenele în cauză înainte ca ele să fi produs efecte
negative, și nu avem nici o tradiție în ceea ce privește cercetarea în domeniul eticii
aplicate. Ca atare, nici unul dintre textele ce urmează nu se referă la experiența
românească. Probabil că acest lucru generează un soi de reticență față de teme în sine,
față de diversele abordări teoretice și practice, dar, la un moment dat, tot trebuie să
purtăm o discuție structurată despre ele. Acesta este un prim pas către o asemenea
discuție.

Temele celor trei secțiuni au fost alese în mod special pentru relevanța lor pentru ideea
de antreprenoriat medical în România. De exemplu, etica publicității pentru cabinetele
medicale este un subiect straniu pentru un bioetician pur-sânge, adică pentru unul
ancorat în mediul academic și care arareori este implicat în zona de consultanță pentru
mediul de afaceri sau în zona medicală, însă ea vine în contextul în care în România
există foarte multă publicitate outdoor, in-print și în audiovizual pentru cabinete
medicale (de la reclamele cabinetelor stomatologice la cele pentru intervențiile
chirurgicale de eliminare a hemoroizilor, de la materialele publicitare on-line ale unor
spitale specializate în medicină bariatrică până la prezența, contra-cost, în studiourile
unor televiziuni de scandal a unor medici care prezintă beneficiile procedurilor de
medicină estetică pe care ei le realizează în propriile cabinete).

Unele teme sunt acoperite cu documente legislative și nu cu o tratare structurată, sub

forma unui articol sau capitol de carte. Pentru aceste teme, ne-a fost imposibil să găsim la
ora actuală un text care să problematizeze într-un mod coerent subiectul.

La finalul fiecărui capitol există un set de două întrebări menit să ajute înțelegerea tematicii
acestui reader și cursului aferent. Este de preferat ca după lectura fiecărui material,
participanții la programul de formare să formuleze pe cont propriu și alte întrebări la care
să încerce să răspundă nu doar în forul interior, ci și în discuții cu colegii.
 SECȚIUNEA 1
ETICĂ ÎN AFACERI ȘI ETICĂ PROFESIONALĂ
PENTRU MEDICII-ANTREPRENORI
SUBTEMA: 1.1
 *** (2012), Codul de deontologie medicală; Colegiul Medicilor din România, 30 martie.
A se vedea în mod special articolele 48-53.

A se vedea și:
 COOTER, Roger & John Pickstone (2003), Companion Encyclopedia of Medicine in the
Twentieth Century, Chapter 31: „Media”; Routledge, New York, pp. 487-502.
 OSTEHRR, Kirsten (2013), Medical Visions: Producing the Patient through Film,
Television, and Imaging Technologies; Oxford University Press, Oxford.

SUBTEMA: 1.2
 *** (2012), Codul de deontologie medicală; Colegiul Medicilor din România, 30 martie.
A se vedea în mod special articolele 5-6, 8, 22, lit. h, și 23.
 SCHACHTER, Steven C. & William Mandell & L. Scott Harshbarger & Randall
Grometstein (2008), Managing Relationships with Industry. A Physician’s Compliance
Manual; Elsevier, Amsterdam, pp. 17-20.

SUBTEMA: 1.3
 LUNT, Neil & Richard Smith & Mark Exworthy & Stephen T. Green & Daniel
Horsfall & Russell Mannion (unk), Medical Tourism: Treatments, Markets and Health
System Implications: A scoping review; OECD, Directorate for Employment, Labour
and Social Affairs, pp. 37-40.
Un document care descrie responsabilitățile medicilor față de pacienții lor, dar și
constrângerile de natură etică implicate în turismul medical.

 TODD, Maria K. (2012), Handbook of Medical Tourism Program Development.

Developing Globally Integrated Health Systems; CRC Press, Boca Raton.
o Capitolul 8 – „Quality and Safety Transparency”, pp. 65-76.
Acest capitol descrie o serie întreagă de riscuri asociate turismului medical și oferă
o perspectivă structurată a lor. El este introdus aici ca preambul la capitolul
următor, dar și la orice discuție viitoare despre riscuri și responsabilități în
turismul medical.

o Capitolul 9 – „Risk Management and Liability Mitigation in the Medical

Travel Industry”, pp. 77-80.
Capitolul de față prezintă problema responsabilității medicilor care sunt implicați
în turismul medical la modul general.
A se vedea și:
 COHEN, I. Glenn (2014), Patients with Passports: Medical Tourism, Law; Oxford
University Press, Oxford, pp. 79-134.
 LUNT, Neil & Stephen T. Green & Russell Mannion & Daniel Horsfall (2013),
Quality, Safety, and Risk in Medical Tourism; în HALL, C. Michael (2013), Medical
Tourism. The Ethics, Regulation, and Marketing of Healh Mobility; Routledge, London,
pp. 31-46.
 COHEN, I. Glenn (2015), Medical Tourism for Services Illegal in Patients’ Home
Country; în LUNT, Neil & Daniel Horsfall & Johanna Hanefeld (2015), Handbook of
Medical Tourism and Patient Mobility; Edward Elgar Pub, pp. 350-359.

ÎNTREBĂRI
Q1. Care sunt rațiunile etice pentru care o reclamă la un cabinet de medicină
estetică nu ar trebui să folosească imagini cu proprii pacienți?

Q2. Spitalul X deține un aparat de RMN, însă acesta este vechi, uzat și nu oferă
claritatea necesară pregătirii unor intervenții medicale. Șeful secției de neurologie este
medic asociat și la un spital privat. Întrucât rezultatele RMN sunt indispensabile, el le
solicită pacienților să meargă și să își facă un RMN, însă nu la spitalul privat cu care
colaborează, ci la un altul, unde prețul este cu circa 20% mai mare. Medicul procedează în
acest fel pentru a nu fi acuzat de conflict de interese. Este corect din punct de vedere
moral?
CODUL DE DEONTOLOGIE MEDICALĂ din 30 martie 2012
al Colegiului Medicilor din România
EMITENT: COLEGIUL MEDICILOR DIN ROMÂNIA
PUBLICAT ÎN: MONITORUL OFICIAL nr. 298 din 7 mai 2012

CAP. I
Principiile fundamentale ale exercitării profesiei de medic

ART. 1
Scopul şi rolul profesiei medicale
Întreaga activitate profesională a medicului este dedicată exclusiv
apărării vieţii, sănătăţii şi integrităţii fizice şi psihice a fiinţei
umane.
ART. 2
Nediscriminarea
Actul profesional şi întreaga activitate a medicului se va
exercita, respectiv desfăşura, fără niciun fel de discriminare inclusiv
în ceea ce priveşte starea de sănătate sau şansele de vindecare ale
pacientului.
ART. 3
Respectul demnităţii fiinţei umane
În toate situaţiile actul profesional, în oricare formă sau
modalitate s-ar desfăşura, se va face cu respectarea strictă a
demnităţii umane ca valoare fundamentală a corpului profesional.
ART. 4
Primordialitatea interesului şi a binelui fiinţei umane
În toate deciziile cu caracter medical, medicul va trebui să se
asigure că interesul şi binele fiinţei umane prevalează interesului
societăţii ori al ştiinţei.
ART. 5
Obligativitatea normelor profesionale şi a celor de conduită
Medicul trebuie să depună toate diligenţele şi să se asigure că
orice intervenţie cu caracter medical pe care o execută sau decizie
profesională pe care o ia respectă normele şi obligaţiile profesionale
şi regulile de conduită specifice cazului respectiv.
ART. 6
Independenţa profesională
Medicul este dator să stăruie şi să îşi apere independenţa
profesională, fiind interzisă orice determinare a actului medical ori a
deciziei profesionale de raţiuni de rentabilitate economică sau de
ordin administrativ.
ART. 7
Caracterul relaţiei medic-pacient
Relaţia medicului cu pacientul va fi una exclusiv profesională şi
se va clădi pe respectul acestuia faţă de demnitatea umană, pe
înţelegere şi compasiune faţă de suferinţă.

1
 ART. 8
Obligaţia diligenţei de mijloace
Medicul îşi va dedica întreaga ştiinţă şi pricepere interesului
pacientului său şi va depune toată diligenţa pentru a se asigura că
decizia luată este corectă, iar pacientul beneficiază de maximum de
garanţii în raport de condiţiile concrete, astfel încât starea sa de
sănătate să nu aibă de suferit.
ART. 9
Principiul specializării profesionale
Cu excepţia unor cazuri de urgenţă vitală, medicul acţionează
potrivit specialităţii, competenţelor şi practicii pe care le are.
ART. 10
Respectul faţă de confraţi
De-a lungul întregii sale activităţi, medicul îşi va respecta
confraţii, ferindu-se şi abţinându-se să-i denigreze ori să aducă
critici cu privire la activitatea profesională a acestora.

CAP. II
Consimţământul

ART. 11
Acordarea şi retragerea consimţământului
(1) Nicio intervenţie în domeniul sănătăţii nu se poate efectua
decât după ce persoana vizată şi-a dat consimţământul liber şi în
cunoştinţă de cauză.
(2) În aceleaşi condiţii, consimţământul se poate retrage în orice
moment de persoana vizată.
(3) Dispoziţiile privind retragerea consimţământului sunt valabile
şi în ceea ce priveşte consimţământul exprimat, în condiţiile legii, de
altă persoană sau instituţie decât persoana respectivă.
ART. 12
Consimţământul în cazul minorilor
(1) Atunci când, conform legii, un minor nu are capacitatea de a
consimţi la o intervenţie, aceasta nu se poate efectua fără acordul
reprezentantului său, autorizarea unei autorităţi sau a unei alte
persoane ori instanţe desemnate prin lege.
(2) Medicul, în funcţie de vârsta şi gradul de maturitate a
minorului şi numai strict în interesul acestuia, poate lua în
considerare şi părerea minorului.
ART. 13
Consimţământul persoanelor fără capacitatea de a consimţi
Atunci când, conform legii, un major nu are, din cauza unui
handicap mintal, a unei boli sau dintr-un motiv similar, capacitatea de
a consimţi la o intervenţie, aceasta nu se poate efectua fără acordul
reprezentantului său ori fără autorizarea unei autorităţi sau a unei
persoane ori instanţe desemnate prin lege.
ART. 14
Informarea prealabilă şi adecvată a persoanei
(1) Medicul va solicita şi va primi consimţământul numai după ce,
în prealabil, persoana respectivă sau cea îndreptăţită să îşi dea
acordul cu privire la intervenţia medicală a primit informaţii adecvate

2
în privinţa scopului şi naturii intervenţiei, precum şi în privinţa
consecinţelor şi a riscurilor previzibile şi în general acceptate de
societatea medicală.
(2) Pe cât posibil, medicul va urmări ca informarea să fie adecvată
şi raportată persoana care urmează să îşi manifeste consimţământul.
ART. 15
Lipsa consimţământului în situaţii de urgenţă
Atunci când, din cauza unei situaţii de urgenţă, nu se poate obţine
consimţământul adecvat, se va putea proceda imediat la orice
intervenţie indispensabilă din punct de vedere medical în folosul
sănătăţii persoanei vizate.
ART. 16
Consimţământul implicit
În interesul pacientului sunt valabile şi vor fi luate în
considerare autorizările şi dorinţele exprimate anterior cu privire la
o intervenţie medicală de către un pacient care, în momentul noii
intervenţii, nu este într-o stare care să îi permită să îşi exprime
voinţa sau dacă prin natura sa actul medical are o succesiune şi o
repetabilitate specifică.

CAP. III
Secretul profesional şi accesul la datele referitoare la starea de
sănătate

ART. 17
Secretul profesional
Medicul va păstra secretul profesional şi va acţiona în acord cu
dreptul legal al fiecărei persoane la respectul vieţii sale private din
punctul de vedere al informaţiilor referitoare la sănătatea sa.
ART. 18
Întinderea obligaţiei de păstrare a secretului profesional
(1) Obligaţia medicului de a păstra secretul profesional este
opozabilă inclusiv faţă de membrii familiei persoanei respective.
(2) Obligaţia medicului să păstreze secretul profesional persistă
şi după ce persoana respectivă a încetat să îi fie pacient sau a
decedat.
ART. 19
Transmiterea datelor referitoare la sănătatea persoanei
Medicul, la solicitarea persoanei în cauză, o va informa pe aceasta
sau pe persoana desemnată de aceasta cu privire la orice informaţie pe
care o deţine referitoare la starea de sănătate a persoanei în cauză.
ART. 20
Derogări de la regula păstrării secretului profesional
Derogările de la dreptul fiecărei persoane la respectul vieţii sale
private din punctul de vedere al informaţiilor referitoare la sănătate
sunt numai cele prevăzute în mod expres de lege.

3
CAP. IV
Reguli generale de comportament în activitatea medicală

ART. 21
Comportamentul profesional şi etic
(1) Medicul trebuie să fie un model de comportament profesional şi
etic, fiind în permanenţă preocupat de creşterea nivelului său
profesional şi moral, a autorităţii şi prestigiului profesiunii
medicale.
(2) Comportamentul profesional implică, fără a se limita la,
preocuparea constantă şi permanentă a medicului pentru aflarea, pe
orice cale, inclusiv prin intermediul formelor de educaţie medicală
continuă, a celor mai noi descoperiri, procedee şi tehnici medicale
asimilate şi agreate de comunitatea medicală.
ART. 22
Fapte şi acte nedeontologice
Sunt contrare principiilor fundamentale ale exercitării profesiei
de medic, în special, următoarele acte:
a) practicarea eutanasiei şi eugeniei;
b) cu excepţia situaţiilor prevăzute de lege sau de normele
profesiei, refuzul acordării serviciilor medicale;
c) abandonarea unui pacient fără asigurarea că acesta a fost
preluat de o altă unitate medicală sau de un alt medic ori că
beneficiază de condiţii adecvate situaţiei în care se află şi stării
sale de sănătate;
d) folosirea unor metode de diagnostic sau tratament nefundamentate
ştiinţific sau neacceptate de comunitatea medicală, cu risc pentru
pacient;
e) cu excepţia urgenţelor vitale, exercitarea profesiei medicale în
condiţii care ar putea compromite actul profesional sau ar putea afecta
calitatea actului medical;
f) emiterea unui document medical de complezenţă sau pentru
obţinerea unui folos nelegal sau imoral;
g) emiterea unui document medical pentru care nu există competenţă
profesională;
h) atragerea clientelei profitând de funcţia ocupată sau prin
intermediul unor promisiuni oneroase şi neconforme cu normele
publicităţii activităţilor medicale;
i) folosirea, invocarea sau lăsarea impresiei deţinerii unor
titluri profesionale, specialităţi ori competenţe profesionale
neconforme cu realitatea;
j) încălcarea principiilor fundamentale ale exercitării profesiei
de medic.
ART. 23
Atingeri ale independenţei profesionale
Constituie o atingere gravă adusă caracterului independent al
profesiei medicale următoarele acte:
a) cu excepţia situaţiilor prevăzute de lege şi cu anunţarea
prealabilă a organelor profesiei, asocierea sau colaborarea, sub orice
formă şi orice modalitate, directă ori indirectă, dintre un medic şi o
persoană care produce sau distribuie medicamente;

4
 b) reclama, în orice mod, la medicamente, aparatură medicală sau
alte produse de uz medical;
c) implicarea, direct sau indirect, în distribuţia de medicamente,
dispozitive medicale, aparatură medicală sau de alte produse de uz
medical;
d) încălcarea principiului transparenţei în relaţia cu producătorii
şi distribuitorii de medicamente şi produse medicale;
e) primirea unor donaţii sub formă de cadouri în bani sau în natură
ori alte avantaje, a căror valoare le face să îşi piardă caracterul
simbolic şi care influenţează actul medical, de la una dintre
entităţile prevăzute la lit. a)-c).
ART. 24
Caracterul nemediat al relaţiei medic-pacient
Cu excepţia unor situaţii obiectiv excepţionale şi imposibil de
înlăturat, orice decizie medicală se va baza în primul rând pe
examinarea personală şi nemediată a pacientului de către medicul
respectiv.
ART. 25
Limitele angajamentului profesional
(1) În orice situaţie, angajamentul profesional al medicului nu
poate depăşi competenţa profesională, capacitatea tehnică şi de dotare
a cabinetului sau a unităţii sanitare ori baza materială afectată,
inclusiv prin convenţii sau colaborări ferme cu alte unităţi sanitare.
(2) Dacă medicul nu are suficiente cunoştinţe ori experienţa
necesară pentru a asigura o asistenţă medicală corespunzătoare, acesta
va solicita un consult adecvat situaţiei sau va îndruma bolnavul către
un astfel de consult la o altă unitate medicală. Aceleaşi dispoziţii se
vor aplica şi în cazul în care dotarea tehnică şi materială a unităţii
în care are loc consultul sau intervenţia medicală nu este adecvată
consultului, stabilirii diagnosticului sau intervenţiei medicale.
ART. 26
Diligenţa de claritate
Medicul care a răspuns unei solicitări cu caracter medical se va
asigura că persoana respectivă a înţeles pe deplin prescripţia,
recomandarea sau orice altă cerinţă a medicului, precum şi cu privire
la faptul că pacientul este, după caz, preluat de o altă unitate
medicală ori în supravegherea altui specialist în domeniu.
ART. 27
Colaborarea cu alţi specialişti
În situaţia în care pacientul a fost preluat sau îndrumat către un
alt specialist, medicul va colabora cu acesta din urmă, punându-i la
dispoziţie orice fel de date sau informaţii cu caracter medical
referitoare la persoana în cauză şi informândul cu privire la orice
altă chestiune legată de starea de sănătate a acesteia.
ART. 28
Consultul în echipă
În situaţia în care este necesar, medicul, cu consimţământul
pacientului sau, după caz, al persoanei respectiv instituţiei
abilitate, va solicita părerea unuia sau mai multor medici, cu care se
poate consulta, pentru luarea celor mai adecvate măsuri în interesul
pacientului.

5
 ART. 29
Luarea deciziei şi comunicarea ei
(1) În cazul unui consult organizat de către medicul curant în
condiţiile art. 27, luarea şi comunicarea deciziei finale aparţine
medicului care l-a organizat.
(2) Dacă opinia majorităţii medicilor participanţi la un consult
organizat în condiţiile art. 27 diferă de a medicului care a organizat
consultul, pacientul ori, după caz, instituţia sau persoana abilitată
vor fi informaţi.
ART. 30
Dreptul la o a doua opinie medicală
În toate situaţiile medicul va respecta dreptul pacientului de a
obţine o a doua opinie medicală.
ART. 31
Actul medical de la distanţă
Investigaţia ori intervenţia medicală la distanţă, în oricare
dintre formele şi modalităţile existente, este permisă numai în
situaţia în care pacientul este asistat nemijlocit de către medicul
său, iar scopul investigaţiei şi procedurilor la care este supus
pacientul este acela de a ajuta medicul să determine diagnosticul, să
stabilească tratamentul sau să întreprindă orice altă măsură medicală
necesară finalizării actului medical sau intervenţiei medicale în cazul
operaţilor. Excepţie fac situaţiile de urgenţă.
ART. 32
Finalizarea obligaţiei asumate
(1) Medicul se va asigura că pacientul a înţeles natura şi
întinderea relaţiei medic-pacient, că are o aşteptare corectă cu
privire la rezultatele actului medical şi la serviciile medicale pe
care acesta urmează să le primească.
(2) Odată încheiată înţelegerea medic-pacient, medicul este ţinut
să ducă la îndeplinire toate obligaţiile asumate, aşa cum rezultă ele
din înţelegerea părţilor sau din obiceiurile şi cutumele profesiei
medicale.
ART. 33
Refuzul acordării serviciilor medicale
(1) Refuzul acordării asistenţei medicale poate avea loc strict în
condiţiile legii sau dacă prin solicitarea formulată persoana în cauză
îi cere medicului acte de natură a-i ştirbi independenţa profesională,
a-i afecta imaginea sau valorile morale ori solicitarea nu este
conformă cu principiile fundamentale ale exercitării profesiei de
medic, cu scopul şi rolul social al profesiei medicale.
(2) În toate cazurile, medicul îi va explica persoanei respective
motivele care au stat la baza refuzului său, se va asigura că prin
refuzul acordării serviciilor medicale viaţa sau sănătatea persoanei în
cauză nu sunt puse în pericol şi, în măsura în care refuzul este bazat
pe încălcarea convingerilor sale morale, va îndruma persoana în cauză
spre un alt coleg sau o altă unitate medicală.

6
 CAP. V
Activităţile conexe actului medical

ART. 34
Legalitatea şi realitatea conţinutului documentelor medicale
Medicul va elibera persoanelor îndreptăţite numai documentele
permise de lege şi care atestă realitatea medicală aşa cum rezultă
aceasta din datele şi informaţiile pe care medicul le deţine în mod
legal ori aşa cum a rezultat ea în urma exercitării profesiei cu
privire la persoana respectivă.
ART. 35
Conformitatea documentului medical cu specialitatea medicală
(1) Documente medicale referitoare la starea de sănătate a
pacientului, întocmite de medic în urma exercitării personale a
profesiei, vor fi în limita specialităţii şi competenţelor profesionale
ale medicului respectiv.
(2) Orice activitate medicală se va consemna în documente adecvate
înregistrării activităţii respective.
ART. 36
Obligaţii referitoare la sănătatea publică
(1) Medicul are obligaţia profesională şi legală să se îngrijească
de respectarea regulilor de igienă şi de profilaxie. În acest scop, ori
de câte ori are ocazia şi este cazul, el va semnala persoanelor
respective responsabilitatea ce le revine acestora faţă de ei înşişi,
dar şi faţă de comunitate şi colectivitate.
(2) Medicul are obligaţia morală de a aduce la cunoştinţă organelor
competente orice situaţie de care află şi care reprezintă un pericol
pentru sănătatea publică.
ART. 37
Semnalarea erorilor profesionale
(1) Medicul care ia cunoştinţă despre fapte care, în opinia lui, ar
putea constitui erori profesionale va informa prin scrisoare medicală
medicul autor al faptei.
(2) Dacă eroarea nu este corectată ori apreciază că nu s-au
întreprins toate măsurile adecvate situaţiei, medicul va informa în mod
cât mai detaliat organismele corpului profesional şi, cu excepţia
situaţiilor prevăzute de lege, nu va face publice datele decât după ce
corpul profesional s-a pronunţat.
ART. 38
Primordialitatea concilierii
În orice situaţie litigioasă ori divergenţă profesională, înaintea
oricărui demers public este obligatorie procedura de conciliere din
cadrul corpului profesional.
ART. 39
Obligaţia de sprijin reciproc şi de loialitate
În toate situaţiile şi împrejurările legate de exercitarea
obligaţiilor profesionale, medicii îşi vor acorda sprijin reciproc şi
vor acţiona cu loialitate unul faţă de celălalt. Obligaţia de sprijin
şi loialitate subzistă şi faţă de corpul profesional şi organismele
sale.

7
 CAP. VI
Cercetarea medicală

ART. 40
Principiul legalităţii şi eticii cercetării medicale
Orice activitate de cercetare medicală va fi efectuată cu
respectarea strictă a principiilor fundamentale ale exercitării
profesiei de medic, în respect deplin faţă de fiinţa şi de specia umană
şi cu respectarea strictă a condiţiilor prevăzute de lege şi normele
profesiei.
ART. 41
Cercetarea pe fiinţa umană
Cercetarea pe fiinţa umană are caracter de excepţie şi poate fi
făcută numai dacă, în mod cumulativ, sunt întrunite următoarele
condiţii:
a) nu există nicio metodă alternativă la cercetarea pe fiinţe
umane, de eficacitate comparabilă;
b) riscurile la care se poate expune persoana nu sunt
disproporţionate în comparaţie cu beneficiile potenţiale ale
cercetării;
c) proiectul de cercetare a fost aprobat de instanţa sau
autoritatea competentă după ce a făcut obiectul unei examinări
independente asupra pertinenţei sale ştiinţifice, inclusiv al unei
evaluări a importanţei obiectivului cercetării, precum şi al unei
examinări pluridisciplinare a acceptabilităţii sale pe plan etic;
d) persoana pe care se fac cercetări este informată asupra
drepturilor sale şi asupra garanţiilor prevăzute prin lege pentru
protecţia sa;
e) consimţământul a fost dat în mod expres, specific şi a fost
consemnat în scris. Acest consimţământ poate fi retras în orice moment,
în mod liber.
ART. 42
Cercetarea pe persoana fără capacitatea de a consimţi
Nu poate fi desfăşurată activitate de cercetare ştiinţifică
medicală pe o persoană care nu are capacitatea de a consimţi decât dacă
sunt întrunite cumulativ condiţiile următoare:
a) sunt îndeplinite condiţiile prevăzute la art. 41 lit. a)-d);
b) rezultatele cercetării au potenţialul de a produce beneficii
reale şi directe pentru sănătatea sa;
c) cercetarea nu se poate efectua cu o eficacitate comparabilă pe
subiecţi capabili să îşi dea consimţământul;
d) autorizarea necesară prevăzută la art. 41 lit. c) a fost dată
specific şi în scris;
e) persoana în cauză nu are obiecţii.
ART. 43
Diligenţa medicului
Medicul este dator să depună toată diligenţa şi să stăruie pentru
lămurirea tuturor împrejurărilor de fapt şi de drept atunci când este
implicat într-o activitate de cercetare medicală. În caz de nevoie,
pentru lămurirea deplină, medicul este dator să solicite sprijinul
organismelor profesiei medicale.

8
 ART. 44
Intervenţia asupra persoanei
Nicio persoană nu va putea fi supusă experienţelor, testelor,
prelevărilor, tratamentelor sau altor intervenţii în scop de cercetare
decât în condiţiile expres şi limitativ prevăzute de lege.
ART. 45
Prelevarea şi transplantul de organe, ţesuturi şi celule de origine
umană de la donatori în viaţă
(1) Prelevarea şi transplantul de organe, ţesuturi şi celule de
origine umană de la donatori în viaţă se fac exclusiv în cazurile şi
condiţiile prevăzute de lege, cu acordul scris, liber, prealabil şi
expres al acestora şi numai după ce persoana respectivă a fost
informată, în prealabil, asupra riscurilor intervenţiei. În toate
cazurile, până în momentul prelevării, donatorul poate reveni asupra
consimţământului dat.
(2) În afara cazurilor expres prevăzute de lege, este interzisă
prelevarea de organe, ţesuturi şi celule de origine umană de la minori,
precum şi de la persoane aflate în viaţă, dar lipsite de discernământ
din cauza unui handicap mintal, unei tulburări mintale grave sau dintr-
un alt motiv similar.
ART. 46
Prelevarea de organe, ţesuturi şi celule umane de la persoane
decedate
Prelevarea de organe, ţesuturi şi celule umane, în scop terapeutic
sau ştiinţific, de la persoane decedate se efectuează numai în
condiţiile prevăzute de lege, cu acordul scris, exprimat în timpul
vieţii, al persoanei decedate sau, în lipsa acestuia, cu acordul scris,
liber, prealabil şi expres dat, în ordine, de soţul supravieţuitor, de
părinţi, de descendenţi ori, în sfârşit, de rudele în linie colaterală
până la gradul al patrulea inclusiv.
ART. 47
Limitări ale cercetării medicale
Sunt contrare scopului şi rolului profesiei de medic următoarele
activităţi în domeniul cercetării medicale:
a) orice intervenţie medicală asupra caracterelor genetice prin
care se urmăreşte modificarea descendenţei unei persoane. Excepţie fac
situaţiile care privesc prevenirea şi tratamentul unor maladii
genetice, situaţie în care se vor obţine toate autorizările adecvate;
b) orice intervenţie prin care se urmăreşte crearea unei fiinţe
umane genetic identică cu altă fiinţă umană vie sau moartă;
c) crearea de embrioni umani în scopuri de cercetare;
d) orice intervenţie de natură a determina sexul viitorului copil.
Excepţie fac situaţiile în care în mod obiectiv este necesară
determinarea sexului în scopul evitării unei boli ereditare grave
legate de sexul viitorului copil;
e) examinarea caracteristicilor genetice ale unei persoane în alt
scop decât medical şi strict în condiţiile şi procedurile legale;
f) orice intervenţie prin care s-ar urmări sau s-ar determina
selecţia persoanelor ori s-ar aduce atingere speciei umane;
g) participarea sau implicarea într-o activitate de identificare a
unei persoane pe baza amprentelor sale genetice altfel decât în cadrul

9
unei proceduri judiciare penale ori civile sau în scopuri strict
medicale ori de cercetare ştiinţifică, ambele efectuate strict în
condiţiile legii;
h) participarea la orice fel de acte care au ca obiect conferirea
unei valori patrimoniale corpului uman, elementelor sau produselor
sale, cu excepţia cazurilor expres prevăzute de lege.

CAP. VII
Publicitatea activităţilor medicale

ART. 48
Scopul publicităţii
(1) Publicitatea formelor de exercitare a profesiei este destinată
să asigure publicului informaţii cu privire la activitatea desfăşurată
de acestea.
(2) Publicitatea trebuie să fie veridică, neînşelătoare, să
respecte secretul profesional şi să fie realizată cu demnitate şi
prudenţă.
(3) Indiferent de mijlocul de publicitate utilizat, toate
menţiunile laudative sau comparative şi toate indicaţiile referitoare
la identitatea pacienţilor sunt interzise.
(4) Mijloacele de publicitate a formelor de exercitare a profesiei
nu pot fi folosite ca reclamă în scopul dobândirii de clientelă.
ART. 49
Mijloacele de publicitate
(1) Formele de exercitare a profesiei de medic pot utiliza unul sau
mai multe mijloace de publicitate, respectiv:
a) plasarea unei firme;
b) anunţuri de publicitate, potrivit prezentului cod de deontologie
medicală;
c) anunţuri şi menţiuni în anuare şi cărţi de telefon;
d) invitaţii, broşuri şi anunţuri de participare la conferinţe,
colocvii etc., profesionale şi de specialitate;
e) corespondenţă profesională şi cărţi de vizită profesionale;
f) adresă de internet.
(2) Nu este permisă utilizarea următoarelor mijloace de
publicitate:
a) oferirea serviciilor prin prezentare proprie sau prin
intermediar la domiciliul ori reşedinţa unei persoane sau într-un loc
public;
b) propunerea personalizată de prestări de servicii efectuată de o
formă de exercitare a profesiei, fără ca aceasta să fi fost în
prealabil solicitată în acest sens, indiferent dacă aceasta este făcută
sau nu în scopul racolării de pacienţi;
c) acordarea de consultaţii medicale realizate pe orice suport
material, precum şi prin orice alt mijloc de comunicare în masă,
inclusiv prin emisiuni radiofonice sau televizate, cu excepţia acelora
avizate de Colegiul Medicilor din România sau de alte organisme
acreditate de acesta în acest scop.
(3) În cadrul apariţiilor în mediile de informare, medicul va putea
prezenta procedee de diagnostic şi tratament, tehnici medicale
specifice ori alte procedee şi mijloace de investigare, dar nu va putea

10
folosi acest prilej pentru a-şi face reclamă pentru sine sau pentru
orice altă firmă implicată în producţia de medicamente ori dispozitive
medicale.
ART. 50
Firma
(1) Firma trebuie să aibă dimensiunile maxime de 40 x 80 cm şi va
fi amplasată la intrarea imobilului şi/sau a spaţiului ocupat în care
forma de exercitare a profesiei îşi are sediul profesional principal
sau secundar ori birou de lucru.
(2) Firma cuprinde următoarele menţiuni:
a) Colegiul Medicilor din România;
b) structura teritorială a Colegiului Medicilor din România;
c) denumirea formei de exercitare a profesiei;
d) menţiuni privind identificarea sediului (etaj, apartament);
e) menţiuni privind titlurile profesionale, academice, ştiinţifice,
specialităţile şi competenţele medicale;
f) menţiuni privind sediul principal şi sediul secundar.
ART. 51
Publicitatea prin mijloacele media
(1) Formele de exercitare a profesiei pot publica anunţuri în mica
sau în marea publicitate.
(2) Anunţurile publicate în anuarele profesionale privesc
activitatea formelor de exercitare a profesiei, numele şi principalele
specialităţi şi competenţe în care medicii îşi desfăşoară activitatea,
precum şi programul de activitate.
ART. 52
Corespondenţa
(1) Corespondenţa formei de exercitare a profesiei poate cuprinde:
a) numărul de telefon, fax, adresa de internet şi adresa
electronică (e-mail);
b) indicarea sediului principal şi, după caz, a sediului secundar
şi/sau a altui loc de muncă;
c) specialităţile şi competenţele medicale;
d) titlurile academice, ştiinţifice sau profesionale;
e) sigla formei respective de exercitare a profesiei.
(2) Cărţile de vizită profesionale ale medicului care îşi
desfăşoară activitatea în cadrul formei respective de exercitare a
profesiei pot cuprinde menţiunile permise corespondenţei, precum şi
calitatea medicului în forma de exercitare a profesiei.
ART. 53
Pagina web
(1) Medicii, precum şi formele de exercitare a profesiei pot avea
un website care poate cuprinde menţiuni referitoare la activitatea
desfăşurată, precum şi pe cele permise corespondenţei ori publicităţii.
(2) Conţinutul şi modul de prezentare a adresei de internet trebuie
să respecte demnitatea şi onoarea profesiei, precum şi secretul
profesional.
(3) Pagina web nu poate cuprinde nicio intercalare cu caracter de
reclamă sau menţiune publicitară pentru un produs sau serviciu diferit
de activităţile pe care are dreptul să le furnizeze medicul sau
respectiva formă de exercitare a profesiei.

11
 (4) Pagina web nu poate conţine legături către alte adrese al căror
conţinut ar fi contrar principiilor esenţiale ale profesiei de medic.
(5) Pentru realizarea cerinţelor menţionate la alin. (4), medicul
sau forma de exercitare a profesiei deţinătoare a paginii web trebuie
să asigure în mod regulat vizitarea şi evaluarea paginilor proprii şi a
paginilor la care este permis accesul pe baza legăturilor realizate
prin intermediul adresei proprii şi trebuie să dispună fără întârziere
eliminarea lor în cazul în care conţinutul şi forma acestora sunt
contrare principiilor esenţiale privind exercitarea profesiei de medic.

CAP. VIII
Judecarea cauzelor deontologice

ART. 54
Celeritatea
(1) Cercetarea şi analiza oricărei sesizări privind existenţa unei
posibile încălcări a dispoziţiilor prezentului cod de deontologie
medicală se fac cu celeritate de către persoanele desemnate cu
cercetarea faptei ori de către cei cărora le-au fost solicitate date în
legătură cu soluţionarea sesizării, fiind obligate să acţioneze cu
maximă diligenţă, netergiversând sau prelungind realizarea
atribuţiilor, respectiv comunicarea datelor solicitate.
(2) În adresa de solicitare a unor date şi informaţii necesare
soluţionării cauzei disciplinare se va indica data până la care urmează
să se facă comunicarea datelor sau informaţiilor solicitate.
ART. 55
Prezumţia de nevinovăţie
(1) Cercetarea şi analiza oricărei sesizări se vor face având în
vedere şi respectând prezumţia de nevinovăţie a medicului.
(2) Persoanele desemnate cu cercetarea sesizării ori membrii
comisiei de disciplină vor acţiona cu tact şi moderaţie, fără a se
antepronunţa sau a emite opinii personale în niciun mod şi în niciun
sens pe timpul soluţionării sesizării.
ART. 56
Imparţialitatea
(1) Persoana desemnată cu cercetarea faptei reclamate ori membrii
comisiei de disciplină care are/au vreun interes personal în cauză, în
orice mod, ori are/au legături de rudenie cu medicul care face obiectul
cercetării sau cu persoana care a făcut reclamaţia îl va/vor informa pe
preşedintele comisiei de disciplină, care va decide, după caz,
menţinerea sau înlocuirea persoanei în cauză.
(2) Dispoziţiile alin. (1) se aplică şi în situaţia existenţei unor
situaţii conflictuale.
(3) Nicio persoană implicată în cercetarea sau soluţionarea cauzei
disciplinare nu va putea face declaraţii publice cu privire la cauza
respectivă până la soluţionarea ei definitivă.
ART. 57
Contradictorialitatea scrisă
(1) Comisia de disciplină va stărui pentru obţinerea în scris a
poziţiei fiecărei părţi implicate în cauza disciplinară.
(2) Contradictorialitatea orală directă se va desfăşura doar în
condiţiile în care pentru soluţionarea cauzei este strict necesară,

12
neputându-se soluţiona cauza altfel. În acest caz, preşedintele
şedinţei va acţiona cu tact şi înţelegere, fiind interzise adresările
directe între persoanele implicate sau emiterea de către membrii
comisiei de disciplină a unor aprecieri ori opinii în legătură cu cauza
respectivă.
ART. 58
Expertiza
(1) În funcţie de cauza supusă cercetării disciplinare, comisia de
disciplină poate solicita o expertiză de specialitate de la medici
specialişti cu reputaţie în domeniu.
(2) Dispoziţiile art. 55 se aplică şi în ceea ce priveşte experţii.
ART. 59
Desfăşurarea audierilor
(1) În cauza supusă soluţionării, membrii comisiei de disciplină se
vor adresa persoanelor audiate exclusiv prin intermediul preşedintelui
comisiei sau solicitându-i acestuia permisiunea şi exclusiv pentru a-i
pune persoanei în cauză întrebări utile şi relevante soluţionării
cauzei.
(2) Pe timpul audierii este interzisă emiterea de către membrii
comisiei de disciplină a unor opinii personale sau aprecieri de orice
natură. În caz de nevoie, preşedintele comisiei poate interveni şi
restabili cadrul decent al audierilor, inclusiv prin suspendarea
şedinţei comisiei.

CAP. IX
Dispoziţii finale

ART. 60
Aplicarea codului de deontologie medicală în timp
Cu excepţia situaţiilor mai favorabile, faptele săvârşite până la
intrarea în vigoare a prezentului cod de deontologie medicală vor fi
supuse prevederilor vechiului cod.
ART. 61
Data intrării în vigoare
Prezentul cod de deontologie medicală intră în vigoare în termen de
30 de zile de la data publicării lui în Monitorul Oficial al României,
Partea I.

___________

13
 Chapter 1 / Background 17

A parallel development over the past two decades is the growing depen-
dence on drug and device companies to fund CME activities, whether
through MECCs or academic centers or medical societies. Commercial sup-
port for CME has more than doubled in the last decade. For example, as
of 2003, funding for 70% of continuing education for physicians came from
drug companies.49 Such support has increasingly facilitated the provision
of CME to physicians by medical specialty societies. Under the voluntary
codes of conduct and OIG Guidelines (to be discussed in detail later in
this book), the provision of unrestricted educational grants to host organi-
zations is permissible. However, because such grants may possibly serve a
marketing purpose in some instances, they have come under scrutiny by
Congress.50

PAYING DOCTORS TO ENROLL PATIENTS

IN CLINICAL TRIALS

Financial inducements from drug companies to physicians can include pay-

ments for enrolling patients in industry-sponsored drug trials. Although
physician referrals are no longer the main source of research subjects,51 drug
companies pay generously for recruiting subjects in some cases. In one trial,
for example, physicians were paid $12,000 for each patient entered, with a
bonus of $30,000 for the sixth patient enrolled.52 Post-marketing research
trials (often called “seeding trials” because some may lack scientific rigor)
may pay particularly well for the amount of work performed.53 According
to Jerome Kassirer, “[I]t is not difficult for a busy physician to bring in tens
of thousands of dollars a year from such patient enrollments.”54 Excessive
study enrollment fees present ethical problems, particularly if the studies
do not have a solid scientific or medical foundation and design, including

49
John Abramson, MD, Overdosed America: The Broken Promise of American Medicine
(New York: Harper Collins, 2005), pp. 118–9.
50
Press Release, U.S. Senate Committee on Finance, January 11, 2006, Grassley, Baucus
Seek More Details of Drug Company Grant Money to Promote Particular Medicines.
51
In the study by Campbell et al. (2007), A National Survey of Physician–Industry Rela-
tionships, only 3% of respondents reported receiving fees for enrolling subjects in industry-
sponsored drug trials. The survey was conducted between November 2003 and June 2004.
52
Marcia Angell, The Truth About the Drug Companies, p. 31, citing the DHHS, OIG,
Recruiting Human Subjects: Pressures in Industry-Sponsored Research, June 2000, OEI-01-97-
00195, 17.
53
Howard Brody, Hooked, p. 189.
54
Jerome Kassirer, On the Take, p. 9.
18 Managing Relationships with Industry

the possibility of compromised clinical judgment about the suitability of a

study for a particular patient.55

OTHER CONFLICTS OF INTEREST

Beyond writing prescriptions and ordering devices, physicians encounter

potential conflicts of interests in their medical decisions every day. As
pointed out by Dr. Jerry Avorn in Powerful Medicines, there are signifi-
cantly more healthcare costs and quality-of-care concerns riding on a physi-
cian’s referral of patients beyond the pharmaceutical and device context.
Throughout these clinical decisions there is a common element.
The issue of self-referrals has been a source of policy debate and uncer-
tain legal standards that pose significant risk to physicians. If a doctor needs
to refer patients for a blood test or a CT scan, why not send them to a lab or
imaging center owned (in whole or in part) by the doctor? Patients could be
assured of high-quality service with no delays and the doctor would benefit
financially. In the 1980s, a host of freestanding clinics, labs and surgical centers
sprang up that were owned by physicians and to which they referred their own
patients. Criticism that these arrangements constituted a conflict of interest
for the referring doctor did not seem to weigh against the utility of the arrange-
ment. The AMA took the position that such an arrangement was acceptable,
provided the financial interest of the doctor was disclosed to the patient.
But some studies showed that self-referrals resulted in a much higher
utilization rate. Patients were referred for MRIs and other diagnostic tests
more often when the referral was to a facility in which the doctor had
a financial interest, and this raised issues for the Medicare and Medicaid
programs that paid for the tests. As later chapters discuss, there are now
federal and state laws that prohibit certain self-referrals and other forms of
remuneration in return for referrals.56

55
Jerry Avorn, Powerful Medicines, waxes eloquent on the beauty of the randomized,
controlled trial as a scientific technique. He points out (p. 54) that such tests are run double-
blind, that is, neither the patient nor the doctor knows whether the patient is receiving the
drug or a placebo. The doctor must be blind to the nature of the dose because the placebo
effect works on doctors as well as patients—especially if the doctor has a financial relationship
with the maker of the drug.
56
The federal anti-kickback statute was first enacted in the 1970s. Subsequently, in 1989,
Congress enacted the original Stark law (now called “Stark I”) to prohibit self-referrals for
clinical laboratory services. Final regulations to implement Stark I were published in 1995. In
the meantime, Congress passed a second bill (Stark II) in 1993 to prohibit referrals to a broad
array of “designated health services.” Regulations to implement Stark II have been issued in
three phases and include expanded exceptions to the prohibition. Currently, federal agencies
are considering further limits to the scope of permissible self-referrals under Stark. These are
discussed in detail in succeeding chapters.
 Chapter 1 / Background 19

Self-referrals and referrals to parties remunerating the doctor consti-

tute a classic conflict of interest for the doctor. The laws drawing the lines
between legal and illegal financial relationships between physicians and
entities benefiting from their referrals are uncertain in many instances and
are subject to continued debate and redrawing by regulators. We present
this issue because there are essential questions that physicians need to ask
themselves that are common to both self-referrals and physician–industry
financial relationships. First and foremost, is the relationship defensible
from a legal standpoint? And, even if it is, is it ethically and otherwise advis-
able for the physician to enter into the relationship? The ultimate question
is whether there is an unmanageable conflict of interest between the doc-
tor’s financial interests and his or her clinical judgment. The important point
is that doctors need to be made aware, as they are with self-referrals, of the
general ethical and legal boundaries related to industry relationships even
if the exact lines are still subject to debate and redrawing.

 The important point is that doctors need to be made aware, as they are
 with self-referrals, of the general ethical and legal boundaries related to
 industry relationships even if the exact lines are still subject to debate and
 redrawing.

Until recently, the medical community felt that ethical standards were
satisfactorily addressed by a physician if he or she disclosed any financial
interest they had with a drug or device company whose product was rel-
evant to a particular activity, such as a CME presentation, and that such
disclosure was sufficient to mitigate the potential bias of the physician.
Many reformers no longer view disclosure alone as an effective means to
prevent a conflict between a physician’s financial self-interest and his or
her professional responsibilities. In their view, financial interests involve the
problem of trying to serve two masters. The Hippocratic oath (“To keep the
good of the patient as the highest priority”) requires the doctor to place
the patient’s interests ahead of his or her own. Most physicians understand
that principle in the context of medical decision-making, but it applies to
financial matters as well. Doctors must also safeguard their patients’ inter-
ests and uphold the integrity of the medical profession over any financial
opportunities they may be offered. While there are instances in which both
interests can be harmonized, and pursuit of a legal financial opportunity will
not be in conflict with patient interests, physicians should carefully consider
whether such a scenario is realistically achievable or simply illusory.
20 Managing Relationships with Industry

 Doctors must safeguard their patients’ interests and uphold the integrity
 of the medical profession over any financial opportunities they may be
 offered.

The enactment of federal and state laws regulating self-referrals and

financial relationships with industry to some extent represents the view of
lawmakers that the medical profession has not sufficiently policed itself.
Voluntary efforts by individual physicians and the profession as a whole
could head off future forms of regulatory action. Physicians should take a
more proactive leadership role by debating these issues within their specialty
societies and AMCs and by developing specialty-centered compliance guide-
lines regarding industry relationships with individual physicians and their
organizations. These codes can use existing trade association guidelines and
OIG compliance guidance, which are detailed in depth in later chapters, as
a starting point. Medical organizations and foundations need to maintain a
separation between their professional activities and the financial support
they receive from drug and device companies to minimize, for example,
the influence of industry on medical education content and practice guide-
lines.57 Physicians and their organizations should also confront these issues
on an individual basis and adopt their own policies governing physician
interaction with drug and device companies. As highlighted in Chapter 6,
physicians who embrace “medical professionalism”—a physician leadership
strategy devised to improve the quality of care and patient safety—in the
management of relationships with industry will be best positioned to stay
on the right side of the legal and ethical divide.
We began this chapter by looking at the history of the collaboration
between the medical profession and the drug and device industries, and in
particular the practice of mutual accommodation between the two parties.
After a century of interactions, drug and other medical technology com-
panies are still enterprises run for the benefit of their shareholders, while
physicians are still members of an ancient and honorable profession with
an important duty, akin to that of a fiduciary, to patients. Accommodation
is never permanently achieved; it is an ongoing tug-of-war. In managing
their relationships with the drug and device industries, physicians should
never forget the best interests of the patient, which may, upon reflection,
not always be consistent with the goals of industry marketing efforts. As
Hippocrates is believed to have stated, “In every house where I come I will
enter only for the good of my patients, keeping myself far from all intentional
ill-doing and all seduction.”

57
Many commentators believe that the independence of many professional organizations
has already been compromised. See, e.g., Kassirer, On the Take, ch. 6; Angell, The Truth
About the Drug Companies, pp. 144ff.; and Brody, Hooked, ch. 12.
 Medical Tourism: Treatments,
Markets and Health System
Implications: A scoping
review

Neil Lunt, Richard Smith, Mark Exworthy, Stephen T.

Green, Daniel Horsfall and Russell Mannion

1University of York
2London School of Hygiene & Tropical Medicine
3Royal Holloway University of London
4Sheffield Teaching Hospitals Foundation NHS Trust
5University of Birmingham

The opinions expressed and arguments employed here are the responsibility
of the author(s) and do not necessarily reflect those of the OECD.

Directorate for Employment,

Labour and Social Affairs
 SUMMARY

1. The global growth in the flow of patients and health professionals as well as medical technology,
capital funding and regulatory regimes across national borders has given rise to new patterns of
consumption and production of healthcare services over recent decades. A significant new element of a
growing trade in healthcare has involved the movement of patients across borders in the pursuit of medical
treatment and health; a phenomenon commonly termed ‗medical tourism‘. Medical tourism occurs when
consumers elect to travel across international borders with the intention of receiving some form of medical
treatment. This treatment may span the full range of medical services, but most commonly includes dental
care, cosmetic surgery, elective surgery, and fertility treatment. There has been a shift towards patients
from richer, more developed nations travelling to less developed countries to access health services, largely
driven by the low-cost treatments available in the latter and helped by cheap flights and internet sources of
information.

2. Despite high-profile media interest and coverage, there is a lack of hard research evidence on the
role and impact of medical tourism for OECD countries. Whilst there is an increasing amount written on
the subject of medical tourism, such material is hardly ever evidence-based. Medical tourism introduces a
range of attendant risks and opportunities for patients. This review identifies the key emerging policy
issues relating to the rise of ‗medical tourism‘.

3. The review details what is currently known about the flow of medical tourists between countries
and discusses the interaction of the demand for, and supply of, medical tourism services. It highlights the
different organisations and groups involved in the industry, including the range of intermediaries and
ancillary services that have grown up to service the industry. Treatment processes (including consideration
of quality, safety and risk) and system-level implications for countries of origin and destination (financial
issues; equity; and the impact on providers and professionals of medical tourism) are highlighted. The
review examines harm, liability and redress in medical tourism services with a particular focus on the
legal, ethical and quality-of-care considerations.

4. In light of this, our broad review outlines key health policy considerations, and draws attention to
significant gaps in the research evidence. The central conclusion from this review is that there is a lack of
systematic data concerning health services trade, both overall and at a disaggregated level in terms of
individual modes of delivery, and of specific countries. This is both in terms of the trade itself, as well as
its implications. Mechanisms are needed that help us track the balance of trade around medical tourism on
a regular basis. The evidence base is scant to enable us to assess who benefits and who loses out at the
level of system, programme, organisation and treatment.

2
 RÉSUMÉ

1. L‘accroissement général de la circulation transfrontières des patients et des professionnels de la

santé ainsi que de la technologie médicale et des capitaux, et l‘extension des régimes réglementaires au-
delà des frontières nationales, ont donné lieu à de nouveaux modes de consommation et de production des
services de santé au cours des dernières décennies. L‘expansion du commerce des soins de santé s‘est en
particulier caractérisée par les mouvements transfrontières de patients à la recherche de traitements
médicaux et de santé, phénomène que l‘on désigne communément à l‘aide de l‘expression « tourisme
médical ». On parle de tourisme médical lorsque des consommateurs choisissent de traverser des frontières
internationales dans l‘intention de recevoir un traitement médical sous une forme ou sous une autre, lequel
peut relever de toutes les spécialités médicales, mais concerne le plus souvent la dentisterie, la chirurgie
esthétique, la chirurgie non vitale et l‘assistance à la procréation. Une évolution s‘est produite en ce sens
que ce sont surtout les patients de nations plus riches et plus développées qui se rendent dans des pays
moins développés pour bénéficier de services de santé, essentiellement en raison du faible coût des
traitements, des possibilités de voyager à bon marché et de la disponibilité d‘informations sur l‘internet.

2. Bien que le tourisme médical soit très médiatisé, rares sont les informations concrètes issues de la
recherche sur son rôle et son impact dans les pays de l‘OCDE. Même si l‘on écrit de plus en plus sur ce
thème, les travaux publiés se fondent rarement sur des données probantes. Le tourisme médical présente à
la fois des risques et des avantages pour les patients. La présente étude identifie les principaux enjeux liés à
l‘expansion du « tourisme médical ».

3. L‘étude fait le point des connaissances actuelles sur la circulation des touristes médicaux entre les
pays et examine les interactions de la demande et de l‘offre de services de tourisme médical. Elle présente
les divers groupes et organisations impliqués dans cette activité, y compris l‘ensemble des intermédiaires et
des services auxiliaires qui sont apparus parallèlement à son développement. L‘accent est mis sur les
modalités des traitements (qualité, sécurité et risques) et sur les conséquences systémiques du phénomène
pour les pays d‘origine et de destination (questions financières, équité et impact sur les prestataires et les
professionnels intervenant dans le tourisme médical). L‘étude envisage les services de tourisme médical
sous l‘angle des dommages, des responsabilités et des possibilités de recours en s‘intéressant
particulièrement aux aspects juridiques et éthiques ainsi qu‘à la qualité des soins.

4. Cette vaste étude présente donc d‘importantes considérations liées à la politique de la santé et
appelle l‘attention sur l‘existence de sérieuses lacunes dans les données disponibles. La principale
conclusion sur laquelle elle débouche est le manque de données systématiques, tant globales que
désagrégées sur le commerce des services de santé au niveau des différents modes de prestation et des
pays, et cela, à la fois sur le plan du commerce proprement dit et sur le plan de ses implications. Il est
nécessaire de mettre au point des mécanismes qui nous aident à suivre régulièrement l‘évolution des
échanges commerciaux liés au tourisme médical. Les données dont on dispose, qui sont insuffisantes, ne
permettent pas de déterminer qui est gagnant et qui est perdant au niveau des systèmes, des programmes,
de l‘organisation des soins et des traitements.

3
 TABLE OF CONTENTS

SUMMARY ....................................................................................................................................................2
RÉSUMÉ .........................................................................................................................................................3
BACKGROUND .............................................................................................................................................6
Globalisation of the health care market .......................................................................................................6
Definitions of medical tourism and health tourism ......................................................................................7
Mobility of patients across international borders .........................................................................................8
Medical tourism or cross-border care?.........................................................................................................8
Globalisation and medical tourism ..............................................................................................................9
Structure of the report ................................................................................................................................10
SECTION ONE THE MEDICAL TOURISM MARKET ............................................................................11
Introduction ................................................................................................................................................11
Established and emerging medical tourism markets ..................................................................................13
Places of consumption and flows of medical tourists ................................................................................13
Demand-side drivers of mass-market medical tourism..............................................................................15
Decision-making ........................................................................................................................................16
Supply side: models of service delivery and funding ................................................................................17
SECTION TWO THE MEDICAL TOURISM INDUSTRY ........................................................................18
Medical tourism and the web .....................................................................................................................18
Quality of information ...............................................................................................................................19
Advertising and marketing.........................................................................................................................19
Brokers .......................................................................................................................................................20
Travel insurance .........................................................................................................................................21
Providers ....................................................................................................................................................21
National strategies......................................................................................................................................22
SECTION THREE TREATMENT PROCESSES ........................................................................................24
Quality, safety and risk ..............................................................................................................................24
Patient satisfaction .....................................................................................................................................24
Clinical outcomes ......................................................................................................................................25
Continuity of care ......................................................................................................................................26
Privacy and confidentiality ........................................................................................................................26
Infection and cross-border spread of antimicrobial resistance and dangerous pathogens .........................27
External Quality Assessment and accreditation .........................................................................................27
Accreditation ..............................................................................................................................................28
SECTION FOUR SYSTEM IMPLICATIONS: COUNTRY OF ORIGIN ..................................................30
Origin and destination ................................................................................................................................30
Financial impacts .......................................................................................................................................30
Exacerbation of a two-tier system..............................................................................................................30
Competitive pressure on local providers....................................................................................................32

4
SECTION FIVE SYSTEM IMPLICATIONS: DESTINATION COUNTRY..............................................33
Economic impacts ......................................................................................................................................33
Trickle down of best practice/technological transfer .................................................................................35
Internal brain drain and reverse brain drain ...............................................................................................35
Two-tier system .........................................................................................................................................36
SECTION SIX HARM, LIABILITY & REDRESS .....................................................................................37
Medico-legal issues (quality of care, redress, liability, litigation) .............................................................37
Issues for providers, ancillary interests and third-party funders ................................................................38
Ethical dimensions .....................................................................................................................................39
Nonmaleficence and beneficence ..............................................................................................................40
SECTION SEVEN CONCLUSIONS AND CONSIDERATIONS FOR FUTURE RESEARCH ...............41
System issues .............................................................................................................................................41
Programme issues ......................................................................................................................................42
Organisation and clinical issues .................................................................................................................43
Summary ....................................................................................................................................................44
REFERENCES ..............................................................................................................................................45

Tables

Table 1: Medical tourism prices (in selected countries) ............................................................................12

Table 2: Cost for patient and one accompanying person travelling ...........................................................31
Table 3: Cost for only patient travelling ....................................................................................................32

Figures

Figure 1: Health and Medical Tourism ........................................................................................................7

Figure 2: The Medical Tourism Industry ...................................................................................................18

5
 BACKGROUND

Globalisation of the health care market

5. The global growth in the flow of patients and health professionals as well as medical technology,
capital funding and regulatory regimes across national borders has given rise to new patterns of
consumption and production of healthcare services over recent decades.

6. The free movement of goods and services under the auspices of the World Trade Organization
and its General Agreement on Trade in Services (Smith, 2004, Smith et al,. 2009b) has accelerated the
liberalisation of the trade in health services, as have developments with regard to the use of regional and
bi-lateral trade agreements. As health care is predominantly a service industry, this has made health
services more tradable, global commodities. A significant new element of this trade has involved the
movement of patients across borders in the pursuit of medical treatment and health care, a phenomenon
commonly termed ‗medical tourism‘.

7. The consumption of health care in a foreign land is not a new phenomenon, and developments
must be situated within the historical context. Individuals have travelled abroad for health benefits since
ancient times, and during the 19th Century in Europe for example there was a fashion for the growing
middle-classes to travel to spa towns to ‗take the waters‘, which were believed to have health-enhancing
qualities. During the 20th Century, wealthy people from less developed areas of the world travelled to
developed nations to access better facilities and highly trained medics. However, the shifts that are
currently underway with regard to medical tourism are quantitatively and qualitatively different from
earlier forms of health-related travel. The key differences are a reversal of this flow from developed to less
developed nations, more regional movements, and the emergence of an ‗international market‘ for patients.
The key features of the new 21st Century style of medical tourism are summarized below:

 The large numbers of people travelling for treatment;

 The shift towards patients from richer, more developed nations travelling to less developed
countries to access health services, largely driven by the low-cost treatments and helped by cheap
flights and internet sources of information;

 ‗New‘ enabling infrastructure – affordable, accessible travel and readily available information
over the internet;

 Industry development: both the private business sector and national governments in both
developed and developing nations have been instrumental in promoting medical tourism as a
potentially lucrative source of foreign revenue.

8. What are the implications of these changes in medical travel for OECD countries?
Fundamentally, such developments point towards a paradigm shift in the understanding and delivery of
health services. The market in medical tourists is set to grow, with potentially far-reaching impacts on
publicly-funded health care including the developing notion of patients as ‗consumers‘ of health care rather
than ‗citizens‘ with rights to health care services. There will of course also be a range of attendant risks and

6
opportunities for patients. Predictions for this emerging global market are difficult but the direction and
speed of its travel is becoming increasing clear. This report identifies the key emerging policy issues
relating to the rise of ‗medical tourism‘. In this introductory section we explore competing definitions and
concepts relating to medical tourism.

Definitions of medical tourism and health tourism

9. It is important to begin by defining what is meant by ‗medical tourism‘. For the purposes of this
report we define medical tourism as when consumers elect to travel across international borders with the
intention of receiving some form of medical treatment. This treatment may span the full range of medical
services, but most commonly includes dental care, cosmetic surgery, elective surgery, and fertility
treatment. Setting the boundary of what is health and counts as medical tourism for the purposes of trade
accounts is not straightforward. Within this range of treatments, not all would be included within health
trade. Cosmetic surgery for aesthetic rather than reconstructive reasons, for example, would be considered
outside the health boundary (OECD, 2010, pp.30-31).

10. Medical tourism is related to the broader notion of health tourism which, in some countries, has
longstanding historical antecedents of spa towns and coastal localities, and other therapeutic landscapes.
Some commentators have considered health and medical tourism as a combined phenomenon but with
different emphases. Carrera and Bridges (2006, p.447), for example, define health tourism as ―the
organised travel outside one‘s local environment for the maintenance, enhancement or restoration of an
individual‘s well-being in mind and body‖. This definition encompasses medical tourism which is
delimited to ―organised travel outside one‘s natural health care jurisdiction for the enhancement or
restoration of the individual‘s health through medical intervention‖.

11. As Figure 1 suggests, medical tourism is distinguished from health tourism by virtue of the
differences with regard to the types of intervention, setting and inputs.

Figure 1: Health and Medical Tourism

Source: Carrera and Lunt (2010).

7
Mobility of patients across international borders

12. Medical tourism can be understood as a subset of the wider notion of patient mobility which itself
may be sub-divided as follows:

13. Temporary visitors abroad: These include those individuals holidaying abroad who use health
services as a result of an accident or a sudden illness. Health services for tourists are funded variously
through the European Health Insurance Card (for EU citizens) for occasional or emergency treatment
within the EU, private insurance and out-of-pocket expenses. These would not be considered as ‗medical
tourists‘, more just ‗unfortunate tourists‘!

14. Long-term residents: There are increasing flows of EU citizens choosing to retire in countries
other than their country of origin, within the EU borders and indeed beyond (Rosenmöller et al., 2006), and
there are growing exchanges of working-age citizens within Europe. Such residents may receive health
services funded variously by the country of residence, the country of origin, private insurance, or through
private contributions. Again, these individuals would not be considered as ‗medical tourists‘.

15. Common borders: countries that share common borders may collaborate in providing cross-
national public funding for health care services from providers in other countries (Rosenmöller et al.,
2006).

16. Outsourced patients: are those patients opting to be sent abroad by health agencies using cross-
national purchasing agreements. Typically, such agreements are driven by long waiting lists and a lack of
available specialists and specialist equipment in the home country. These patients often travel relatively
short distances and contracted services (both public and private) are more likely to be subject to robust
safety audits and quality assurance (Lowson et al., 2002, Burge et al., 2004, Glinos et al., 2006, Muscat et
al., 2006). These individuals could be described as ‗collective‘ medical tourists, albeit they being state or
agency-sponsored rather than acting as individual consumers in the traditional sense.

17. Medical tourism more commonly refers to patients who are mobile through their own volition
and this type of patient mobility is the focus of this report. Such medical tourists do not make use of EU
rights (where the phenomenon is ordinarily known as ‗cross-border care‘) but choose to pay out-of pocket,
and therefore are better cast as consumers rather than as individuals exercising their European citizenship
rights (Lunt and Carrera, 2010).

Medical tourism or cross-border care?

18. Within the European context a medical tourist may be categorised in one of two ways. First, there
are those citizens who use their European citizenship rights to access medical care in EU Member States
and their national purchaser reimburses the costs of their treatment abroad. This is allowed because
European citizens, under specific circumstances, have rights to receive medical care in other EU countries.
Such rights have been established by successive rulings of the European Court of Justice on private cases
regarding consumption of health care in another EU Member State and reimbursement by the (national)
purchasing body in the home country (Bertinato et al., 2005).

19. There is ongoing debate about the most appropriate terminology to describe the movement of
individuals overseas for treatment. A range of nomenclature is used in the health services literature,
including international medical travel (Huat, 2006a, Fedorov et al., 2009, Cormany and Baloglu, 2010,
Crozier and Baylis, 2010), medical outsourcing (Jones and Keith, 2006), medical refugees (Milstein and
Smith, 2006), and even biotech pilgrims (Song, 2010). Although for the purposes of this report we adopt
the term medical tourism, some commentators object to the use of this term (Whittaker, 2008, Glinos et al.,
2010, Kangas, 2010).

8
  ―the industry-driven term ‗medical tourism‘ insinuates leisurely travelling and does not capture
the seriousness of most patient mobility‖ (Glinos et al., 2011, p. 1146).

 ―medical tourism is a misnomer, as it carries connotations of pleasure not always associated with
this travel…‖ (Whittaker, 2008, p.272).

 ―A term that suggests leisure and frivolity. The term promotes a market place model that
disregards the suffering that patients experience‖ (Kangas, 2010, p.350).

20. We believe that the concept of medical tourism does have analytical value. As a concept it
conveys both the willingness to travel and willingness to treat as core processes within the new global
market of health travel. It also captures the health sector element as well as the wider economic impact of
such travel. Such a focus facilitates an understanding of which individuals go where, why and for what,
and what the impact is for whom from this. Whilst we agree medical tourism may have little to do with
general tourism (cf Glinos et al., 2011), the term emphasises the commodification and commercialisation
of health travel. Medical tourism also highlights the role of the industry, issues of advertising, supplier-
induced demand and extends beyond the notion of ‗willingness to travel‘.

Globalisation and medical tourism

21. Health policies and health delivery have traditionally been bounded by the nation state or
between federal tiers of government. Within the UK, for example, the establishment of the National Health
Service in 1948 introduced primary and secondary health care services funded by public taxation and
delivered to the national population free at the point of use. In recent decades significant economic, social
and political changes have encouraged a more trans-national and international role for health policy
development. These national interconnections (political, economic, social and technical) include the
movement of people, products, capital and ideas and this has offered new opportunities and challenges for
health care delivery and regulation. A number of developments support this growth in medical travel:

 Regulatory regimes (such as the General Agreement on Trade in Services and other World Trade
Organization agreements);

 Recognition of transnational disease patterns;

 Growing patient mobility (low-cost airlines, advancements in information-communication

technology, and shifting cultural attitudes among the public about overseas destinations);

 Industry development.

22. The medical tourist industry is dynamic and volatile and a range of factors including the
economic climate, domestic policy changes, political instability, travel restrictions, advertising practices,
geo-political shifts, and innovative and pioneering forms of treatment may all contribute towards shifts in
patterns of consumption and production of domestic and overseas health services. There are, for example,
important bilateral exchanges between OECD members (e.g. United States to Mexico; United States to
Korea; northern Europe to central and eastern Europe). Some OECD countries seek to leverage their own
strengths to become providers in the medical tourism market with all the attendant implications. There are
also flows of patients from OECD countries to Lower and Middle Income Countries (LMIC), in particular
India, Thailand, and Malaysia which will necessarily have potential repercussions for health systems of
OECD countries.

9
Structure of the report

23. The report is not a systematic and comprehensive overview of the literature. Rather, the attempt
is to identify policy issues at the systemic (regulation and finance), programmatic (system-level priorities),
organisation (management of services) and instrumental (clinical interface) levels (Frenk, 1994) (see
Section Seven ). The rest of this report is organised into seven sections:

 Section One explores the market in medical tourists, and considers both established and emerging
medical tourism markets. We detail what is currently known about the flow of medical tourists
between countries and discuss the interaction of the demand for, and supply of, medical tourism
services.

 Section Two provides an overview of the medical tourism industry, and describes the growth of a
range of supporting health information resources, including internet marketing. We also discuss
the different organisations and groups involved in the industry, including the range of
intermediaries and ancillary services that have grown up to service the industry. Alternative
provider models are discussed and we highlight a range of strategies that governments have used
to develop their own facilities for medical tourism.

 Section Three focuses on treatment processes, including consideration of quality, safety and risk,
clinical outcomes, continuity of care and infection rates that are of crucial importance to
protecting the welfare of patients. We also discuss issues relating to the accreditation and
regulation of medical tourism services.

 Sections Four and Five look at system-level implications for countries of origin and destination
for medical tourists. We examine the financial issues; equity; and the impact on providers and
professionals of medical tourism.

 Section Six highlights issues that relate to harm, liability and redress in medical tourism services
with a particular focus on the legal, ethical and quality-of-care considerations.

 Section Seven examines the future development of the medical tourism industry. We present a
conceptual framework for understanding medical tourism and discuss recent developments in
regulation, quality and safety policy.

10
 SECTION ONE
THE MEDICAL TOURISM MARKET

Introduction

24. From marketing materials (both print and web-based sources), it is apparent that the range of
treatments available overseas for prospective medical tourists are wide, including:

 Cosmetic surgery (breast, face, liposuction)

 Dentistry (cosmetic and reconstruction)

 Cardiology/cardiac surgery (by-pass, valve replacement)

 Orthopaedic surgery (hip replacement, resurfacing, knee replacement, joint surgery)

 Bariatric surgery (gastric by-pass, gastric banding)

 Fertility/reproductive system (IVF, gender reassignment)

 Organ, cell and tissue transplantation (organ transplantation; stem cell)

 Eye surgery

 Diagnostics and check-ups.

Collectively, not all of these treatments would be classed as acute and life-threatening and some are
clearly more marginal to mainstream health care. Some forms of plastic surgery would be excluded from
health spending (e.g. for solely cosmetic reasons); other forms of medical tourism (e.g. IVF) would be
counted within the remit of health trade (OECD, 2010).

25. A detailed online search derives a broad ‗menu‘ of available treatments and claims of cost
savings achieved by having treatment abroad compared to the UK private sector (see Table 1).

11
 DELSA/HEA/WD/HWP(2011)3
Table 1: Medical tourism prices (in selected countries)

Procedure US India Thailand Singapore Malaysia Mexico Cuba Poland Hungary UK

Heart bypass (CABG) 113 000 10 000 13 000 20 000 9 000 3 250 7 140 13 921

Heart Valve replacement 150 000 9 500 11 000 13 000 9 000 18 000 9 520

Angioplasty 47 000 11 000 10 000 13 000 11 000 15 000 7 300 8 000

Hip replacement 47 000 9 000 12 000 11 000 10 000 17 300 6 120 7 500 12 000

Knee replacement 48 000 8 500 10 000 13 000 8 000 14 650 6 375 10 162

Gastric bypass 35 000 11 000 15 000 20 000 13 000 8 000 11 069

Hip resurfacing 47 000 8 250 10 000 12 000 12 500 12 500 7 905

Spinal fusion 43 000 5 500 7 000 9 000 15 000

Mastectomy 17 000 7 500 9 000 12 400 7 500

Rhinoplasty 4 500 2 000 2 500 4 375 2 083 3 200 1 535 1 700 2 858 3 500

Tummy Tuck 6 400 2 900 3 500 6 250 3 903 3 000 1 831 3 500 3 136 4 810

Breast reduction 5 200 2 500 3 750 8 000 3 343 3 000 1 668 3 146 3 490 5 075

Breast implants 6 000 2 200 2 600 8 000 3 308 2 500 1 248 5 243 3 871 4 350

Crown 385 180 243 400 250 300 246 322 330

Tooth whitening 289 100 100 400 350 174 350 500

Dental implants 1 188 1 100 1 429 1 500 2 636 950 953 650 1 600

* Costs of surgeries around the world. Costs given in US$

** The price comparisons for surgery take into account hospital and doctor charges, but do not include the costs of flights and hotel bills for the expected length of stay.
Source: Authors, March 2011, compiled from medical tourism providers and brokers online.

12
Established and emerging medical tourism markets

26. Patterns of travel between source and destination countries are well-established. For example,
those accessing medical treatment in Hungary tend to be from Western Europe and some countries exploit
longstanding historical ties, for example between Malta and the UK or the UK and Cyprus (cf. Muscat,
2006). Other Western Europeans take advantage of the growing familiarity with countries as a result of the
opening of Eastern Europe and the former USSR (for example, between the UK and Poland). However,
more accurate data are required about patient flows between different countries and continents.

27. Whilst any global map of medical tourism destinations would include Asia (India, Malaysia,
Singapore, and Thailand); South Africa; South and Central America (including Brazil, Costa Rica, Cuba
and Mexico); the Middle East (particularly Dubai); and a range of European destinations (Western,
Scandinavian, Central and Southern Europe, Mediterranean), estimates rely on industry sources which may
be biased and inaccurate.

28. It would appear that geographical proximity is an important, but not a decisive, factor in shaping
individual decisions to travel to specific destinations for treatment (Exworthy and Peckham, 2006).
Whether this is a reflection of the ‗tourism‘ element, meaning that people are travelling with not just
medical treatment as the sole reason, but also factors related to the wider opportunities for tourism is not
clear. Travel distance is likely also related to cost.

29. The demand for services may also be volatile (MacReady, 2007, Gray and Poland, 2008) with
travel determined by both wider economic and external factors, as well as shifting consumer preferences
and exchange rates. Providers and national governments may seek to challenge existing suppliers, for
example Latin American fertility clinics (Smith et al., 2010). A number of governments are also promoting
their health facilities and emerging consumer markets are stimulated by brokers, websites and trade-fairs.
Exchange-rate fluctuations may also make countries more or less financially attractive, and restrictions on
travel and security concerns may prompt consumers to explore alternative markets. Moreover, an
unanswered question concerns the status of medical tourism as a luxury good or not. That is, do consumers
spend proportionately more on medical tourism treatments as their incomes rises, how use of services
varies with price (price elasticity) and does a worsening of wider economic conditions impact deleteriously
on the demand for medical tourism. It may even be that a declining economic climate has the reverse effect
because reduced public service provision at home prompts patients to look elsewhere to avoid waiting lists
and tighter eligibility criteria.

Places of consumption and flows of medical tourists

30. For some medical tourist destinations, attempts are being made to promote the cultural, heritage
and recreational opportunities. It is likely that for some treatments the vacation and convalescence
functions will be more marginal, for others it could be a significant component of consumer decision-
making. The reputation of places as highly customer-focused service providers is also a prevalent emphasis
in advertising (Turner, 2007). An emphasis on marketing services as high technology and high quality is
common, as well as a focus on clinicians that have overseas experience (training, employment,
registration) is also potentially important. Familiarity and cultural similarity is emphasised when services
are targeted at Diaspora populations, for example Korean health care services to those settled or second-
generation within the United States, Australia and New Zealand. Similarly, the colonial connection
between the UK and India appears to have encouraged a medical market between the two countries. While
Mexican migrants to the US return to Mexico for health services, this may be because they are uninsured,
have problems with accessing services in the US, or have particular preferences to return to Mexico
(Bergmark et al., 2008, Gill et al., 2008, Lee et al., 2010, Smith et al., 2011c).

13
31. Some destinations have marketed themselves as a healthcare city, or more widely as a
Biomedical City. Singapore, for example, from 2001 was promoted as a centre for biomedical and
biotechnological activities (Cyranoski, 2001). High-end medical tourism can be seen as part of this
development. Singapore is not alone in its pursuit of such recognition; the last ten years has also seen the
emergence of the Dubai Health Care City (DHCC). As Crone notes, perhaps unlike the Singaporean
Biopolis, the DHCC represents the product of an intentional programme that ―started from scratch‖ (Crone,
2008, p.119). Whereas the Singapore bio-city is a government supported networking of established and
emerging facilities and organisations, the DHCC represents a planned bio-city. The DHCC is an attempt to
attract the vast numbers of Middle Eastern medical tourists to stay within the Middle East rather than travel
to Asia. However, as Connell highlights, the key selling point of the DHCC is quality, rather than cost
(Connell, 2006). This is perhaps expected given the sheer scale of investment combined with its links with
Harvard Medical International. The DHCC is much more than a destination for medical tourists, hosting
clinics, accident and emergency sites, research units, and teaching sections (Crone, 2008).

32. Despite a number of countries offering relatively low-cost treatments, we currently know very
little about many of the key features of medical tourism. Indeed, there are no authoritative data on the
number and flow of medical tourists between nations and continents. While there is a general consensus
that the medical tourism industry has burgeoned over the past decade and that there is scope for even
further expansion, there remains disagreement as to the current size of the industry. Estimates of the
numbers of medical tourists generally lie on a continuum between statistics published by the Deloitte
management consultancy at one end of the spectrum and a more conservative estimate by McKinsey and
Company at the other. Figures that are regularly reproduced in the literature (Whittaker, 2010) draw on
data collected and projections made by Deloitte, which put the number of US citizens leaving the country
in search of treatment at 750,000 in 2007 (Keckley and Underwood, 2008). This number, Keckley insists,
would reach somewhere between 3 and 5 million by 2010 (Keckley and Underwood, 2008, Keckley and
Eselius, 2009). Given that US tourists are thought to represent roughly 10% of the global number of
medical tourists (Ehrbeck et al., 2008), this would suggest that total worldwide figures would lie
somewhere between 30 and 50 million medical tourists travelling for treatment each year. Even where
commentators avoid placing a figure on the number of medical tourists, the frequent citation of medical
tourism as a $60bn industry can be traced back to Deloitte‘s report (MacReady, 2007, Crone, 2008,
Keckley and Underwood, 2008).

33. The main objection to Deloitte‘s figures come from McKinsey and Co who suggest that, while
the potential for such large numbers exist, a more accurate worldwide figure would be between 60,000 and
85,000 medical tourists per year (Ehrbeck et al., 2008). In large part, this disparity may be due to different
definitions of medical tourism. For Ehrbeck, a medical tourist should only be included where they have
travelled for the purpose of elective surgery. This, he insists, excludes expatriates, those undergoing
emergency unplanned surgery, and outpatients. While Youngman agrees that some estimates are clearly
overstated, he rejects one of Ehrbeck‘s key principles, pointing out that although dental tourists are often
not inpatients, this nevertheless makes them no less a medical tourist (Youngman, 2009).

34. The numbers of medical tourists proffered by McKinsey still appear rather small, particularly
given the context of a US population of 360 million. While the often cited one million foreign visitors to
Thailand (Carabello, 2008, Crozier and Baylis, 2010) encompasses wellness tourists visiting spas, it also
includes a number of medical tourists who meet Ehrbeck‘s definition that far exceeds his estimate. It is
reported, for example, that the Bumrungrad hospital in Bangkok admitted close to 500,000 patients in 2003
(Turner, 2007, McClean, 2008). By 2005, the hospital admitted 93,000 Arab patients alone (MacReady,
2007). Given that even the most conservative estimates of inward medical tourism to India place the
number of tourists at 200,000 (Carabello, 2008, Crone, 2008, Youngman, 2009), alongside figures of
between 200,000 and 350,000 for Singapore (Huat, 2006b, Carabello, 2008, Youngman, 2009), 200,000
for Cuba (Crozier and Baylis, 2010), and between 50,000 and 100,000 for the UK (Youngman, 2009), it

14
would seem that McKinsey‘s numbers are unrealistically low. Youngman for his part stakes his claim at 5
million, based on the lowest estimates of official figures from providing countries (TreatmentAbroad,
2009, Youngman, 2009), though there is no way to assess the accuracy of this figure. In summary,
therefore we can narrow down the number of medical tourists worldwide as lying somewhere between
60,000 and 50 million! This huge gap is a clear pointer for the need to agree parameters and pilot robust
ways of collecting and analysing information on the number of medical tourists travelling for treatment.
Such numbers are important to quantify economic impact and also to assess potential risk to source health
systems. Clarification is required around the sources and surveys used to provide numbers, including the
role of national agencies and private facilities in providing numbers. Extrapolating from a country to a
more global perspective is difficult, as is ensuring ‗the count‘ is appropriate (do we count patients or
treatment episodes; day treatments or in-stay treatment; expatriates and those funded by their multinational
employers; only large and accredited providers?). That many of the flows are confidential to protect
privacy around treatments and choices makes the count further problematic. Such health trade is also not
seen as a priority for measurement by national stakeholders.

35. The patient profile of medical tourists is similarly opaque. Different drivers may exist for higher
and lower income patients groups travelling from North America and Western Europe. But we know
relatively little about socio-demographic profile, age, gender, existing health conditions and status in
attempting to map the composition of the medical tourism market. Medical tourists are likely to come
from certain social and population groups and future research should seek to identify this social patterning,
as it might increase inequality (cf Exworthy and Peckham, 2006).

36. While there is a disagreement over the total number of medical tourists, figures are relatively
consistent with regard to the costs of procedures. Table 1 shows that treatment outside the wealthier OECD
countries is much less expensive in South and Central America, Asia, and Africa. The potential savings
range from a 75% reduction in price compared with US inpatient prices, to a 90% reduction depending on
the type of procedure and the location. Ehrbeck et al (2008) note, however, that cost is not necessarily the
main driver, suggesting that availability and quality are the major factors for many medical tourists.

Demand-side drivers of mass-market medical tourism

37. Drivers of medical tourism include globalisation – economic, social, cultural and technological.
Many domestic health systems are undergoing significant challenges and strain – tightened eligibility
criteria, waiting lists, and shifting priorities for health care may all impact on consumer decision making.
There is also the emergence of patient choice and forms of consumerism, including within countries that
traditionally have had public-funded services. Openness of information and development of diverse
providers competing on quality and price now cater for all demands.

38. Unlike other forms of patient mobility where decisions on behalf of the patient are made by an
expert clinician (the agency relationship), medical tourism involves individuals acting as a consumer and
making their own decisions regarding their health needs, how these can best be treated, and the most
appropriate provider. They are therefore especially prone to well-known problems related to information
asymmetry and provider-induced demand.

39. Glinos et al., (2006) identify five drivers behind the increases in demand for medical services
overseas: familiarity, availability, cost, quality and bioethical legislation (international travel for abortion
services, fertility treatment, and euthanasia services. In terms of familiarity, expatriates often have medical
care on their visits back to their ‗home‘ country, which would also show up as medical tourism, for
example, the large Indian Diaspora in the UK. Some treatments may not be available or may be subject to a
wait in the home country. This may include latest technology and techniques. Some treatments may not be
legal in the country of origin. The desire for privacy and the wish to combine traditional tourist attractions,

15
hotels, climate, food, cultural visits with medical procedures are also thought to be key contributing factors
to the growth in this market (see discussion in Connell, 2006, MacReady, 2007, Ramírez de Arellano,
2007).

40. The Flash Barometer survey (2007) – albeit focussed on the EU market for all forms of patient
mobility – lists the lack of availability of treatment at home; the better quality of treatment abroad; the
provision of services by specialists; faster treatment and the affordability of care as among the key drivers
that motivate citizens of EU member states to seek treatment outside of their home country (although this
includes individuals asserting their EU rights rather than simply paying out of their own pocket). There is,
however, little firm evidence on the relative importance of these different factors in influencing decisions
to seek treatment abroad. There remains a dearth of empirical research; for example, there is little that adds
to knowledge concerning the patient‘s decision to have domestic cosmetic treatments (Brown et al., 2007).
We know relatively little about particular treatments and source/destination countries. If proximity is an
important, but not a decisive, factor in shaping choices given peoples‘ ability and seeming willingness to
travel longer distances there is a need for a greater understanding of how trade-offs are made and how
these differ for different treatments and consumer groups (Exworthy and Peckham, 2006).

Decision-making

41. Important questions remain with regard to how consumers assimilate and synthesise the
information they retrieve from website searches, and how they take into account commercial interests and
bias when making decisions. Again there is no research evidence around this dimension of medical tourism
and this requires research investment, for example to know about patient understanding of risk. There is
some evidence relating to how breast augmentation patients use the internet, with one survey suggesting
that 68% of respondents utilized internet information, and of this subset of patients the information
influenced decision making around the choice of procedures (in 53% of cases), choice of surgeon (36% of
cases) and choice of hospital (25% of cases) (Losken et al., 2005). Elsewhere, Peterson et al., (2003)
suggest that consumers of medicine are aware of bias, commercialization and lack of regulation when they
explore health sites, but suggest that the context of what is being searched is important. They argue that
commercial considerations ―may have an impact on the motives for, and quality of, information‖. What is
unclear, for example, is whether potential consumers purposively seek information that cautions about
possible pitfalls and difficulties (perhaps through professional or regulatory sites), in addition to the more
aesthetic, clinical and cost attractions of medical tourism.

42. We need to know more about how individuals access, process and judge medical tourist
information they retrieve given such information may be confusing, overwhelming, and even
contradictory. An important distinction is likely to exist between how consumers actually conduct searches
and reach decisions from what they say they do. For instance, Bates et al., (2006) note that while
consumers may report that the credibility of the source is important in judging information quality,
observational studies would suggest this is rarely borne out in practice. Retrospective and prospective
studies are thus required. Marshall and Williams (2006) discuss the ways in which health information is
assessed by consumers and recommend improved public awareness of critical appraisal tools, developing
information literacy for health, and health information access points. Underpinning the search and
interpretation of sites is the fundamental issue of how trust and credibility of information are established
and maintained given there are limits of choice, the existence of uncertainty and the possibility of pain
incurred by treatments (Natalier and Willis, 2008). How information is used in supporting intended
cognitive, affective and behavioural shifts and how material is weighed alongside other forms of hard and
soft intelligence (including media reports, professional networks, and friends and family) requires
investigation.

16
43. A systematic review of 50 on-line websites from a UK consumer perspective examined the sites
using 10 key dimensions drawn from guidelines of the British Association for Plastic, Reconstructive and
Aesthetic Surgeons, looking for clear statements on the websites for each of these. Many of the sites
contained details on how long surgeons had been practicing (25 of the 38 provider sites). Qualifications
and affiliations were also frequently listed (25 of 38 provider sites), and the attachment of full CVs, copies
of certification on-line and publication lists were all commonplace. It was less common, however, to find
details of the number of procedures carried out – only 5 of the sites listed surgeon experience of each
procedure performed. For 10 of the provider websites there was a clear statement that pre-operative
consultative was available in the UK and Ireland. Typically, pre-operative consultation was conducted via
email exchange with a surgeon creating, at best, a virtual consulting room. Where UK/Ireland consultation
was available, it was not always conducted by the operating surgeon – in one case, for example, the pre-
operative assessment was carried out by a contracted nurse (Lunt and Carrera, 2011).

Supply side: models of service delivery and funding

44. In terms of medical tourism delivery and funding, a number of private (and public) providers in
LMIC have targeted what they see as a lucrative medical tourism market. In part, the experience of many
UK and American private patient hospitals and hospital wings for wealthy patients has informed the
strategy of emergent medical tourism destinations with emphasis on quality and customer service. In
Thailand, provision for medical tourism developed to support the failing private sector where domestic
private patients were shifting to the publicly funded system.

45. As well as individual out-of-pocket payments for treatment, a potentially more lucrative source of
income would be the private and workplace insurance systems. To date there has been relatively limited
success by medical tourist providers in tapping these potential revenue streams. Examples of more
institutionalised arrangements do exist but are rare. In 2009, following its achieving international
accreditation, a hospital in Mexico arranged a deal with a US-based insurance group which enabled Blue
Cross and Blue Shield members to utilise that hospital‘s services. This arrangement is not just about
proximity but also reflects the close links with US Latino communities, especially on the West coast and in
the Southern states. Some places such as Juárez in Mexico are seeking to target the migrant population
(Bergmark et al., 2008, Cuddehe, 2009). Arguably, the industry is engaged in a process of legitimating and
marketing with an emphasis on promoting service quality and competitiveness and targeting
workplace/private/public health insurance schemes are part of this.

17
 SECTION TWO
THE MEDICAL TOURISM INDUSTRY

46. Medical tourism is an emerging global industry, with a range of key stakeholders with
commercial interests including brokers, health care providers, insurance provision, website providers and
conference and media services. These commercial interests are summarised in Figure 2. This section
explores the role of a number of ancillary and supporting services for medical tourists.

Figure 2: The Medical Tourism Industry

Brokers

Insurance

Websites

Medical
Providers
Tourist

Financial
products

Travel,
Conference accomm., &
and media concièrge

Medical tourism and the web

47. A key driver in the medical tourism phenomenon is the technological platform provided by the
internet for consumers to access healthcare information and advertising from anywhere in the world.
Equally, the internet offers providers vital new avenues for marketing to reach into non-domestic markets.
Commercialisation is at the heart of the growth in medical tourism and in some part this is due to the
availability of web-based resources to provide consumers with information, advertisements and market
destinations, and to connect consumers with an array of healthcare providers and brokers. A review (Lunt
et al., 2010) suggests the following typology of websites:

 portals (focussed on provider and treatment information)

 media sites

18
  consumer-driven sites

 commerce-related sites (providing ancillary services and information)

 professional contributions (from sources such as professional associations and state regulatory
institutions are relatively rare).

48. Medical tourism sites satisfy a range of ends and needs. First and foremost, the scope of such
sites is to introduce and promote services to the consumer. The main services of the sites can be separated
into five main functions: as a gateway to medical and surgical information, connectivity to related health
services, the assessment and/or promotion of services, commerciality and opportunity for communication
(Lunt et al., 2010). The internet offers a range of functionalities and formats including discussion forums,
file sharing, posting information and sharing experience, member only pages, advertisements and online
tours. The internet also facilitates decisions regarding the purchase of treatments.

Quality of information

49. The range of medical tourism sites and related content raise concerns associated with unregulated
on-line health information (Eysenbach, 2001). The internet sites are relatively cheap to set up and run, and
contributors may post information without being subject to clear quality controls or advertising standards.
Selective information may be presented, or presented in a vacuum, ignoring for example issues such as
post-operative care and support. There is always the possibility of unreliable products being marketed via
the internet – poor-quality surgery or inadvisable treatments, unnecessary and even dangerous treatments.
As Mason and Wright (2011) note, medical tourist sites promote benefits and downplay the risks.

50. Given the large amount of material concerning how medical tourism is sourced on line, it raises
questions about the quality and veracity of the information used. Clear evidence from other studies
suggests that the quality of health information online is variable and should be used with caution
(Eysenbach et al., 2002). For example, when the Journal of the American Medical Association standards
for responsible print were used to judge the quality of infertility treatment information resources on the
web, information was found to be, at best variable and at the worst misleading (Okamura et al., 2002).
Similarly, in the area of domestic cosmetic surgery, a study using the search term ‗breast augmentation‘
located 130 sites and concluded that 34% of these sites contained information that was either false or
misleading (Jejurikar et al., 2002). Gordon et al (2001, p.176) examined the quality of plastic surgery
information concluding ―it is difficult for the average lay person to get authoritative information quickly
and easily on at least one aspect of cosmetic surgery‖. Commenting on Stem Cell sites, Murdoch and Scott
(2010) note such sites are thick with therapeutic language.

Advertising and marketing

51. Given the role of advertising in influencing consumer decisions, there are questions relating to
asymmetry of information between provider and consumers where there are differences in access to
availability and quality of information, and issues of safety and informed choice that link to medical
tourism and Internet usage. Many of the sites are primarily adverts and ‗infomercials‘ (with a series of
buttons, banners and popups). It would appear there are relatively few sources that are non-commercial in
nature and provide independent information as opposed to information provided to serve commercial and
marketing ends. While there is some evidence that the presence of advertising on a website reduced its
credibility (Walther et al., 2004), there is no clear evidence for the medical tourism field.

52. The evidence of Direct-to-Consumer sales in other sectors suggests a number of potential
problems which may be present in medical tourism. Gollust et al., (2003) examine the Direct-to-Consumer

19
internet sales of genetic services and note that sites are likely to exaggerate the benefits of such services.
Datta et al., (2008) explore the quality of websites marketing home diagnostic tests and conclude that the
majority of websites provide information that is of inadequate quality. Illes et al., (2004) focus on Direct-
to-Consumer advertising in print and information brochures, concluding that such materials fail to provide
consumers with the sort of comprehensive and balanced information necessary for informed decision-
making. They suggest it is common to identify misinformation, unsubstantiated scientific claims, fear-
provoking threats, and a lack of information on the uncertainties and the risks of particular services – in
their case tomographic and magnetic resonance imaging. With regards to surgery, Salant and Santry (2006)
highlight the growth of web-based advertising of bariatric surgery centres. Bariatric surgery centres in the
US – in common with many medical tourist destinations – rely on patient self-referral and thus need to
stimulate demand for these services, ―constructing the need for bariatric surgery through strategic
advertising approaches‖ (p. 226). The marketing of unproven stem-cell treatments raises particular
concern, encouraging patients with severe diseases to travel to seek ‗unorthodox‘ therapies and cures
(Dedmon, 2009, Murdoch and Scott, 2010).

53. A systematic review of 50 medical tourism websites, marketing treatments and services in
mainland Europe (Lunt and Carrera, 2011) found that the sites were variable. In a small number of sites,
both the grammar and spelling were poor, giving little confidence in a clinic‘s proficiency in the English
language and ability to communicate clearly. Sites contained details on arrival, treatment and travel home
arrangements and itineraries and length of recuperation but little was stated explicitly on arrangements for
follow-up (only 5 of the 50 sites). Surgery was presented as routine and itineraries listed in a vacation-like
fashion from day one of arrival to day of departure. Many sites included photographs, videos and virtual
tours of facilities – and often emphasised the modern and ‗hi-tech‘ features, cleanliness and infection-
control technique of facilities and services. However, few were explicit on the number of staff, size of the
establishment (e.g. bed numbers) and emergency arrangements and facilities (only 3 from 50 sites) (Lunt
and Carrera, 2010).

54. Underpinning the search and interpretation of sites are the fundamental issues of how trust and
credibility of information are established and maintained given there are limits of choice and a great deal of
uncertainty and information asymmetry when potential medical tourists make decisions around treatments,
providers and destinations. The fine line between editorial content and advertising of online sites does not
help assuring informed choice on the part of the patient.

55. Despite a growth in the number of websites dedicated to medical tourism, there is currently little
empirical evidence on the role, use and impact of these websites on the behaviour of health care
consumers. This is a major deficit in evidence. For example, from a consumer perspective there is a need to
understand how medical tourists view advertising and whether this changes with demographic group.

Brokers

56. There has been a steady rise in the number of companies and consultancies offering brokerage
arrangements for services and providing web-based information for prospective patients about available
services and choices, which can be attributed to the transaction costs associated with medical tourism,
where individuals have to assemble their own information and negotiate any treatment. Typically, brokers
and their web-sites tailor surgical packages to individual requirements: flights, treatment, hotel, and
recuperation (Whittaker, 2008, Cormany and Baloglu, 2010, Reddy and Qadeer, 2010, Lunt and Carrera,
2011). Brokers may specialise in particular target markets or procedures (treatments such as dentistry, or
cosmetic surgery), or destination countries (e.g. Poland, Hungary). A series of interrelated issues exist
around the precise role of these intermediaries in arranging overseas surgery: how do they determine their
market, source information, choose providers, and subsequently determine what the most appropriate

20
advice is? What is noteworthy is that website facilitation businesses may disappear as quickly as they
entered the market (Cormany and Baloglu, 2010).

57. Mirrer-Singer (2007) cites one company that is a network of pre-qualified hospitals (i.e. that are
inspected and verified and form a pool from which clients then choose). But it is not clear what these
processes consist of. A number of potential legal issues that arise with regard to brokerage are discussed in
Section Six.

Travel insurance

58. A market in travel insurance for medical tourists is emerging. Purchasing adequate specialist
travel health insurance may be problematic, especially if the intending medical tourist has significant pre-
existing health problems prior to travelling. Traditional insurance policies for travel and accommodation
(delay, loss of baggage) would exclude those individuals travelling for the purposes of planned medical
tourism. Insurance products have been developed that cover medical tourists for such contingencies when
travelling for surgery. Insurance products have also emerged that go beyond insuring travel and loss, and
which seek to cover the costs of further treatments that may be required as a result of complications and
dissatisfaction following surgery abroad. It is extremely unwise to travel outside of one‘s home country
without this type of insurance unless a deal has been negotiated with the provider hospital that they will
cover all possible eventualities.

Providers

59. Within the wide picture of medical tourism there is a diversity of participating providers – or as
Ackerman (2010) notes there are ―cottage industries and transnational enterprises‖. Providers are primarily
from the private sector but are also drawn from some public sectors (e.g. Singapore and within Cuba). The
NHS has some facility for treating foreign patients who pay and for those who do not.

60. Relatively small clinical providers may include solo practices or dual partnerships, offering a full
range of treatments. At the other end of the scale are extremely large medical tourism facilities (e.g.
Bumrungrad in Thailand, Raffles in Singapore, Yonsei Severance Hospital in South Korea) where clinical
specialism is the order of the day. Hospitals may be part of large corporations (the Apollo Group for
example has 50 hospitals within and outside India), and ownership itself may lie primarily in the higher
income countries from where patients mostly originate. We know relatively little about the development of
European and international industries and markets trading in medical tourism. As the review of patient
mobility in Europe4Patients (Rosenmöller et al., 2006, p.6) noted, a lack of data around mobility in general
is compounded in relation to information about the commercial sector.

61. Countries seeking to develop medical tourism have the options of growing their own health
service or inviting partnerships with large multinational players. Individual hospitals may develop relations
with travel agencies or wider brokerage companies (Whittaker, 2008). Securing accreditation from
international programmes may be a part of the development of services. In addition to accreditation, other
approaches to raising the profile of countries and their health facilities have been used. For example,
partnerships and oversight by overseas hospitals and universities, most often from the American private
sector, can fulfil a similar role. Formalised linkages with widely recognised medical providers and
educators (like Harvard Medical International, the Mayo Clinic, the Cleveland Clinic, John Hopkins
Hospital, are becoming increasingly popular among hospitals catering for medical travellers. (As Exworthy
and Peckham (2006, p.282) note, hospital reputation is based on many factors not solely the quality of
clinical services). Medical tourist facilities will often target particular cultural groups – Bumrungrad for
example has a wing for Middle East patients (Cohen, 2009, Reddy and Qadeer, 2010).

21
National strategies

62. A range of national government agencies and policy initiatives have sought to stimulate and
promote medical tourism in their countries. Many countries see significant economic development
potential in the emergent field of medical tourism. The Thai, Indian, Singaporean, Malaysian, Hungarian,
Polish and Maltese governments have all sought to promote their comparative advantage as medical
tourism destinations at large international trade fairs, via advertising within the overseas press, and official
support for activities as part of their economic development and tourism policy (Mudur, 2004, Chee, 2007,
Whittaker, 2008, Reisman, 2010).

63. Since 2003, SingaporeMedicine has been a multi-agency government-industry partnership aiming
to promote Singapore as a medical hub and a destination for advanced patient care. It is led by the Ministry
of Health, and has the support of the Development Board (new investments and healthcare industry
capabilities); International Enterprise Singapore (growth and expansion of Singapore's healthcare interests
overseas); Singapore Tourism Board (branding and marketing of its healthcare services).

64. India has introduced a special visa category – an M visa – to cater for the growing number of
medical tourists (Chinai and Goswami, 2007) as well as allowing tax breaks to providers. Sengupta (2008)
notes that medical tourism facilities allow increased rate of depreciation on life saving equipments, and
also prime land at subsidised rates.

65. In Malaysia, the National Committee for Promotion of Medical and Health Tourism was formed
by the Ministry of Health in 1998. It developed a strategic plan and networked both domestically and
overseas with relevant interests. Tax incentives were provided for buildings, equipment, training,
advertising and IT, and providers were encouraged to pursue accreditation with an emphasis on quality
(Chee, 2007).

66. Toyota (2011) suggests that the medical tourism markets of both Singapore and Dubai, alongside
those of India, Thailand, and Malaysia should be considered as the ‗first wave‘ of Asian medical tourism.
She points to the post-2008 expansion of both the Japanese and South Korean medical tourism markets as
representing a second wave, one marked by increasing state involvement. Both the Japanese and Korean
governments have declared publically the desire to place medical tourism at the heart of plans for future
economic growth (Sang-Hun, 2008, Hall, 2009, ITTimes, 2009, Independent, 2010, Kester, 2011) and both
have matched this commitment with a relaxation of visa laws (Sang-Hun, 2008, Toyota, 2011), making
inbound medical tourism easier. Here, however, the similarities largely end. In the Japanese case, the low
numbers of trained doctors and high cost of treatment has severely constrained the growth of the medical
tourism market (Hall, 2009, Toyota, 2011, p.10). Indeed, as Connell highlights, Japan has until recently
been primarily thought of as a source country rather than a destination country in terms of medical tourism,
with large numbers of Japanese citizens travelling abroad for healthcare (Connell, 2006, p.1096).

67. The Japanese government has recently outlined plans to reverse the outbound medical tourism
trend, rolling out a new organisation with the sole aim of increasing inbound medical tourism. This will
work alongside the Ministry of Economy, Trade and Industry (METI), which currently coordinates medical
tourism strategies (Hall, 2009, Toyota, 2011, p.9). METI has placed particular emphasis on the high-end,
high-cost and skills-intensive procedures that are perhaps not offered or taken up in lower cost Asian
medical tourism markets such as India and Thailand (Hall, 2009). The rationale being that Japan cannot
compete with the lower costs offered in such markets and thus should concentrate on the types of
procedure where access and quality are the primary motivations for medical tourism rather than simply the
cost (Hall, 2009).

22
68. In contrast to Japan, the Korean government have matched their commitment to the expansion of
the inbound medical tourism market with investment in a market to directly compete with other Asian
countries. In particular, the Korean government have created through an Act of Government the Korean
Medical Institute (KMI), which alongside the Korean Tourism Organisation and the Korean International
Medical Association has actively sought to promote the healthcare industry, both domestically and
internationally (Toyota, 2011, p.5). Similarly, the state-funded Korean Health Industry Development
Institute has placed the development of a Korean market that is globally competitive at its heart (KHIDI,
2011). Where the Japanese market is somewhat stifled by domestic issues such as the number of doctors,
the cost of procedures, and the high internal demand for healthcare services, Korea markets itself as
offering high-quality care at ‗hospitals in the developed world‘, with lower costs (Sang-Hun, 2008,
ITTimes, 2009, Independent, 2010). The development of healthcare cities akin to the DHCC in Seoul
(Sang-Hun, 2008), Daegu (ITTimes, 2009) and Jeju (Sang-Hun, 2008, Toyota, 2011, p.6) are particular
strategies. The high quality and low cost of treatment is also being used as part of a targeted campaign to
encourage Korean expatriates and members of Korean communities in countries such as the United States
and New Zealand (Lee et al., 2010, pp.108-109) to opt for procedures in Korea with plans currently in train
to open a marketing office in Los Angeles to attract Korean-Americans (Sang-Hun, 2008, Toyota, 2011,
p.6). For some, the expansion of the Korean market, which has been put at between 40,000 and 60,000, is
simply a matter of time (ITTimes, 2009, Independent, 2010, Toyota, 2011, p.5).

69. State involvement in the medical tourism industry is not confined to Asia. As with Asian
countries, State involvement varies from country to country with a mixture of private and public facilities
catering for medical tourism. In Poland, a popular destination for dental tourists and cosmetic tourists,
medical tourism is facilitated through private companies, many of the clinics used are state-owned, serving
Polish citizens alongside medical tourism. This reflects the Polish government‘s desire to capture the
potential of medical tourism and marked by the creation of the Polish Medical Tourism Chamber of
Commerce (Reisman, 2010, p.133) and networking with the Polish Association of Medical Tourism
(PAMT). The Polish government is actively attempting to harness the potential of recent EU accession to
compete with more far-flung destinations for the custom of European medical tourists.

70. Hungary has also sought to harness the opportunities presented by EU accession and develop a
medical tourism industry. While many of the clinics offering treatment to medical tourists are undoubtedly
private, the role of the Hungarian government should not be overlooked. Terry refers to Hungary as the
―dental capital of the world‖ (2007, p.419) and only a cursory glance at medical tourism sites reveals that a
wide range of procedures are being actively marketed to tourists.

71. Beyond national strategies there a range of ways that national policy can directly foster the
domestic medical tourism industry. Examples include:

 From 2009 the South Korean Government allowed hospitals to fully market health services to
foreign patients

 Supporting trade fairs: many of which include government support (through tourism, airlines or
health) – UAE, Dubai, Turkey, Cyprus, and Malta.

 In some cases, governments have directly supported the process by encouraging the acquisition
of international accreditation by their hospitals, for example in Singapore and Dubai (UAE).

23
 SECTION THREE
TREATMENT PROCESSES

Quality, safety and risk

72. There are a range of organisational dimensions related to the quality and safety of medical
treatment abroad. Many of these are not necessarily unique to medical tourism in that health care is replete
with information asymmetries and potential threats to the quality and safety of patient care pathways, but
these are intensified given the dimensions of ―distance‖ including legal jurisdiction.

73. Ideally, a common regulatory platform and reporting system would serve as the basis of an
assessment of comparative quality of care using a range of performance indicators as facilitated by
international accreditation and certification. Presently, there is a lack of comparative quality and safety
data, and knowledge of infection rates for overseas institutions and reporting of adverse events is lacking.
Importantly, bodies like the World Health Organisation have yet to publish any firm guidance on this and
there does not appear to be any immediate intention to do so. For some, a lack of transparency on quality is
an impediment to a fully developed market in medical tourism (Ehrbeck et al., 2008, p.6). Availability of
evidence about the quality of a particular surgeon or clinical team, some suggest, would encourage more
people to pursue medical tourism (Unti, 2009).

74. As with all medical treatments, an element of risk exists to the patient‘s health, which is
supposedly outweighed by the potential benefits resulting from the treatment. What can be gleaned from
the literature concerning risk and safety-related incidents for medical tourism is limited. Whilst there is
evidence regarding, for example, the occurrence of adverse events in UK hospitals (Sari et al., 2007), there
is no similar overseas/international data.

75. Medical tourism adds a new dynamic to this element of risk, due to the overseas travel involved.
The journey home can be difficult and painful, especially following surgery. A study of Norwegian
patients found that this was perceived as the most negative aspect of visiting overseas providers (HELTEF,
2003). Travelling when unwell can lead to further health complications, including the possibility of deep
vein thrombosis (Crooks et al., 2010). Despite medical tourism involving air travel, there is no published
evidence on travel risk resulting from medical tourism, for example on thrombosis.

Patient satisfaction

76. Patient satisfaction is an important dimension of healthcare treatment. Relatively little is known
about the experience and satisfaction of medical tourists. According to Ehrbeck et al (2008, p.7), patients
report generally high satisfaction with quality of care received overseas but it is not clear that this can be
extrapolated outside of the US and to a range of treatments. Patient clinical outcomes and satisfaction do
not necessarily go together and satisfaction is not always the primary indicator for some treatments such as
dental work. Similarly, with regard to cosmetic surgery there is evidence that a small percentage of patients
may suffer from psychological body-related issues that make such judgements problematic (Grossbart and
Sarwer, 2003). Conversely, Hanna et al (2009) note that for a sample of outsourced patients (rather than
medical tourists) whilst the majority of patients operated upon abroad obtained comparable functional
results with those expected locally, they were often dissatisfied with the overall experience. There is a gap

24
in understanding of patient expectations and how these may be raised by individuals paying a market-price
and taking responsibility for choosing a provider.

Clinical outcomes

77. Evidence of clinical outcomes for medical tourist treatments is limited and reports are difficult to
obtain and verify. Little is known about the relative clinical effectiveness and outcomes for particular
treatments, institutions, clinicians and organisations. There is scant evidence on long or short-term follow-
up of patients returning to their home countries following treatments at the range of destinations.

78. That a positive treatment outcome should result is important, not least because the patient‘s local
health care provider takes on the responsibility and funding for post-operative care including treatment for
complications and to remedy side-effects (Cheung and Wilson, 2007). In the event of an adverse outcome,
it should be known whether, and to what extent, the patient has recourse for redress.

79. Patient follow-up by providers is rare; a study of 20 patients presenting at a German university
hospital after overseas refractive surgery concluded that there was insufficient management of
complications and a lack of post-operative care (Terzi et al., 2008). For ‗transplant tourism‘, Canales‘
(2006) study of kidney patients transplanted abroad found that there was a high incidence of serious post-
operative infections (6 serious infections for 4 patients), although graft survival and function were
concluded to be good – see also Geddes‘ follow-up of kidney patients who had travelled from Scotland to
Pakistan for treatment (Geddes et al., 2008). Similarly, Gill et al., (2008) followed 33 kidney transplant
patients and concluded that graft and patient survival are not significantly worse but that there was a more
complex post-transplantation course and higher incidence of acute rejection and severe infectious
complications.

80. With regard to cosmetic surgery, 203 out of 325 members of the British Association of Plastic,
Reconstructive and Aesthetic Surgeons responded to an Association survey and, of these, 76 (37%) had
seen patients in the NHS with complications arising from overseas cosmetic surgery (Jeevan and
Armstrong, 2008). In an audit of the pan-Thames region, 35 out of 65 consultants replied to requests about
cosmetic surgery impacts (Birch et al., 2007). Sixty per cent of those replying had seen complications and
the majority of these cases (66%) were emergencies that required inpatient admission. Australian research
on professionals raises a similar issue (MacReady, 2007) and there are detailed case studies of detrimental
outcomes from surgery abroad incurring significant public costs to rectify poor outcomes (Cheung and
Wilson, 2007). Birch et al., (2010) highlight the case of medical tourist patients who sought bariatric
surgery and required urgent surgical management at a tertiary care centre within Canada.

81. For the growing phenomenon of ‗fertility tourism‘, a UK study of 11 years follow-up of high
order multiple pregnancy found that 26% had fertility performed overseas (McKelvey et al., 2009).

82. In terms of dental treatment abroad there are some reported cases of complications having to be
dealt with by the home health system. Barrowman et al (2010) report cases histories of five Australian
travellers requiring attention by oral and maxillofacial surgeons because of dental implants. Case reporting
from the UK documents two returning dental tourists requiring hospital and dentist consultation
(Milosevic, 2009).

83. In sum, relatively little is known about readmission, morbidity and mortality following self-
funded medical treatment abroad (see also Balaban and Marano, 2010). The overseas and private nature of
delivery explains why there is such a dearth of information relating to clinical outcomes, post-operative
complications, lapses in safety and poor professional practice (cf Alleman et al., 2010).

25
Continuity of care

84. It is ethical to ensure that patients are as well cared for as possible and, to this end, patients
should receive appropriate advice and input at all stages of the caring process. When medical treatment is
sought abroad, the normal continuum of care may be interrupted. It is useful to consider the cycle of care
through all its possible stages, pre- or post- the period of hospital care.

 There is a period prior to travelling, and if this involves travel to a country with a tropical or a
sub-tropical climate such as Thailand or India, where the disease ecosystem is different, then this
should be factored into the system.

 There may be issues around pre-counselling and informed consent for procedures being
contemplated. Individuals may have a pre-existing illness (e.g. diabetes mellitus, cardiovascular
deficiency, respiratory disease, renal failure, HIV disease) or be taking significant medications
prior to travelling, which will need to be dealt with at the earliest possible opportunity.

 There may be shortcomings of communication surrounding immediate treatment processes.

Canales‘ (2006) study of kidney transplants, for example, concludes there was inadequate
communication of information – immunosuppressive regimens and preoperative information.
Similar gaps may be evident elsewhere.

 The medical traveller/tourist may become ill while in the foreign country, perhaps in a way quite
unrelated to their primary reason for becoming a medical traveller, or they might develop
complications or side effects related to their treatment.

 Problems can develop during the return flight, such as deep venous thrombosis and pulmonary
thromboembolism, or a myocardial infarct.

 Subsequent to arriving home, complications, side-effects and post-operative care become the
responsibility of the home medical care system, and patients may encounter problems accessing
adequate healthcare. For example, physicians in the US may be uncomfortable dealing with
patients who had travelled overseas to another country and undergone an operation to implant a
kidney they had purchased (Boschert, 2007).

85. Patients should be aware that the quality of post-operative care can vary dramatically depending
on hospital and country, and may be different from US or Western European standards. The medical
traveller is usually in hospital for only a few days or even weeks, and then may go on the vacation portion
of their trip or return home, when complications, side-effects and post-operative care then become the
responsibility of the healthcare system in the patients‘ home country.

Privacy and confidentiality

86. The use of IT information by professionals and how patient information flows across national
boundaries are further important questions for the regulation of the medical tourism industry. Continuity of
care can be facilitated by sharing of patient records. Data protection regulations among countries – even
within the EU, however, make difficult ease of access to medical records. It is not clear to what extent the
European Health Card will foster improvements in this regard.

87. According to the World Tourism Organization‘s ―Global Code of Ethics for Tourism‖ (1999),
there is an expectation that tourists and visitors should have the same rights as citizens of destination
countries with regard to the confidentiality of their personal data and information, especially when these

26
are stored in electronic formats. Laws and regulations will vary in different parts of the world in relation to
medical confidentiality, including the protection of data kept on computer. On the other hand, people may
travel to other countries for treatment for personal reasons related to an expectation of greater
confidentiality in that country compared to the home country (e.g. HIV care, treatment for infertility,
gender reassignment surgery).

88. There may also be issues of confidentiality related to the clients of companies who act as
facilitators of medical tourism. The staff of medical tourism facilitators‘ offices may be party to clinical
information on patients, and this private and sensitive information would need to be dealt with very
carefully and there is potential for them to sell the information to other medical service companies.

89. In the UK, signed informed consent prior to an elective procedure is considered best practice and
a standard requirement ensuring that patients are fully informed as to the benefits and adverse effects of a
procedure or treatment they are being advised to undergo, and they also have the opportunity to ask
questions and seek answers (GMC, 2008). This may not be available every time in the medical tourism
setting, and it is possible that medical tourists may come to regret this if there are failings in professional or
clinical practice (Pennings, 2004, Barclay, 2009, Jeevan et al., 2011).

Infection and cross-border spread of antimicrobial resistance and dangerous pathogens

90. The public health aspects of medical tourism have not been adequately studied. Of significance is
the potential for hazardous micro-organisms transferring between hospitals located in different parts of the
world on the body of a medical tourist (Green, 2008). These could include antimicrobial resistance, such as
the potential for Clostridium difficile, VRSA (CDC, 2005) or XDRTB (CDC, 2009), or a dangerous
pathogen, such as SARS or Congo-Crimean Haemorrhagic Fever, with potentially fatal implications for
hospital staff (Suleiman et al., 1980). The rapid spread of North American ―swine‖ flu out of the United
States and Mexico to the rest of the world in 2009 and after illustrates the ease with which micro-
organisms can be transported across borders.

91. Instances of infection outbreaks arising from treatment of US citizens at overseas ‗medical
tourist‘ facilities have been reported within the literature (Newman et al., 2005). Anecdotally, one author
(Green) is aware of cases where hepatitis B was acquired during cardiac surgery in Pakistan and renal
transplantation in India. A study of medical tourists undergoing kidney transplants concludes there was
inadequate communication of information regarding preoperative information and postoperative
immunosuppressive regimens (Canales et al., 2006).

92. Medical travellers may be travelling from home to countries with very different ecosystems and
disease profiles, and in some destinations may encounter diseases such as malaria, dengue and other
arthropod-borne infections. All people, whether medical travellers or not, who are travelling to different
countries should be made aware of the potential for acquiring diseases and injuries which are not common
in their own country. Immunisations, preventative medications (e.g. anti-malarials) and general precautions
should be considered and arranged for prior to the trip overseas. The lack of any routine data means there
is little idea of how prevalent infections are or how they compare with rates from regular tourists.

External Quality Assessment and accreditation

93. Quality maximisation and risk minimisation are two key ingredients for creating better and safer
health care services, whether they are providing services for domestic consumption or for medical
travellers. This can only be accomplished through the setting-up of appropriate forms of organisational
framework within the hospital or clinic designed to assess quality, identify risk, and deal with all relevant
issues, and at the same time promote a culture of remaining vigilant. At the present time, medical tourism

27
services remain largely unregulated and a huge issue that needs to be faced up to is whether or not the
quality and safety standards on offer through medical tourism are to be trusted.

94. External Quality Assessment (EQA) – the introduction of a trusted third party to assess quality
control – contains within it the potential for increasing both the information flow, especially exchange of
good practice between organisations, and transparency within organisations. A number of EQA models
exist that the medical tourism industry could draw upon:

 Statutory inspection (including licensing)

 Public sector educational programs for training and testing private providers
 Industry-based assessments:
o ISO certification
o Evaluation (usually internal) against the ‗business excellence‘ framework.
 Healthcare-based assessment through peer review:
o Reciprocal visiting
o Increase regulation and monitoring of private providers
o Self-directed quality improvement tools
o Licensure, certification, and accreditation.

Accreditation

95. Concerns for the quality and safety of the medical care provided overseas have also emerged due
to the lack of robust clinical governance arrangements and quality assurance procedures in provider
organisations, intended to safeguard the quality of care provided to tourists (Zahir, 2001). There have also
been questions over the training, qualifications, motivations and competence of health care professionals.
In response to such concerns, a range of independent accreditation schemes have been established with the
aim of assuring the care of medical tourists in a way that avoids potential conflicts of interest. Groups such
as the Joint Commission International from the United States (covering 44 countries:
http://www.jointcommissioninternational.org/Accreditation-and-Certification-Process/) and Quality
Healthcare Advice Trent Accreditation in the UK for example have accredited a number of health
providers centres around the world.

96. Accreditation is a form of EQA where surveying is carried out by a third-party conformity
assessment body known as an ―accreditation scheme‖, using a combination of self-assessment and external
peer review led by a team of external peer reviewers. Common characteristics of all accreditation schemes
are:

 Surveys and reviews conducted by professional peers with appropriate training;

 The means should be put into place by which problems can be identified prospectively and
corrected and continuous improvement ensured;

 A mechanism within the accreditation process for ensuring follow-up action takes place on any
recommendations that arise from the survey and for correcting any problems identified by the
measurement process; and

 The assessment process should be repeated periodically, usually between two to four years.

 Accreditation is generally accepted to apply to organisations rather than individuals, although it

can apply as readily to a dental clinic as to a full hospital. Accreditation has come to be thought
of as a ―stamp of approval‖ verifying the authenticity and quality of the services provided.

28
97. Potential problems with accreditation include:

 The commercial needs and aspirations of the accreditation schemes themselves may be allowed
to dominate the picture. Many (but not all) of the accreditation schemes operating internationally
are private companies or corporations.

 Less well-off countries may have no access to the accreditation process, or engaging in
accreditation may lead to financial hardship.

 Accreditation processes may not tackle ethically contentious areas, such as organ trafficking,
payment issues around organ and tissue donation, selective gender abortion, surrogate pregnancy,
unnecessary operations, use of currently unproven therapies such as human stem-cell therapy for
cosmetic reasons.

98. Standards are at the heart of accreditation, and they must be directed towards those factors that
may make a difference to the quality of care. Accreditation schemes should be fit for purpose, based on the
results of the best available research, and sensitive to change.

99. There are therefore three categories of area where accreditation is of interest to the medical
tourism market:

a) Offering assurance to commercial interests of the quality and safety of the product they are
selling to the public, which in turn may reduce their liability and minimise bad publicity in the
future.

b) Potential access to funding from overseas sources: In the USA, accreditation schemes such as the
JCAHO, the American Osteopathic Association and DNV‘s National Integrated Accreditation for
Healthcare Organizations, are routes to US Medicare participation.

c) Attraction of business: Potential customers for medical tourism may look at whether or not a
hospital has accreditation, and hospitals can in turn advertise their being in possession of
accredited status.

100. Currently, there is no universal ―official agency/group‖, such as the United Nations, the World
Health Organization, the World Tourism Organization or the World Trade Organization, engaged in either
the delivery of accreditation, the co-ordination of delivery of accreditation, or licensing or studying the
existing schemes that deliver accreditation. Mandatory accreditation may appeal to governments and
commercial healthcare purchasers such as third-party payers (e.g. insurance companies and occupational
healthcare providers). Accreditation has most often been used as a marketing tool by wealthier provider
hospitals, medical tourism facilitators and the governments of provider countries seeking to grow their
share of the medical tourism business.

29
 SECTION FOUR
SYSTEM IMPLICATIONS: COUNTRY OF ORIGIN

Origin and destination

101. Some places may be simultaneously acting as countries of origin and destination in the medical
tourism marketplace. High-income countries may service overseas elites whilst at the same time their
citizens choose to travel as medical tourists to Lower and Middle Income Countries for treatments. Thus,
Harley Street in the UK and facilities including the Mayo and Cleveland Clinics in the United States have
longstanding reputations in the international provision of healthcare. Conversely, the emergence of lower-
cost treatments in Thailand, India or parts of Eastern Europe will attract individuals from higher incomes
countries who pursue treatments on the basis of cost. This section focuses on the implications for countries
from the perspective of them being an origin or source of medical tourists. In trade parlance, this concerns
the services that a country imports (if their patients go overseas to receive care, then effectively they are
importing a service). It explores a range of financial, social, political, ethical and legal issues, and
implications for local industry.

Financial impacts

102. There are financial impacts on individuals and their families. Some families may fall into debt to
fund treatments. It is also the case that not all medical tourism is treatment ‗on the cheap‘ – travel to
countries for experimental treatment may consume considerable family resources (Song, 2010). This
assertion of choice and autonomy may, however, lead to externalities at the system level.

103. There are a range of financial impacts for source countries that may arise for the publicly funded
health care system. Costs may result from overseas cosmetic surgery or dental work that requires
emergency or remedial treatment within home countries (Cheung and Wilson, 2007, Jeevan and
Armstrong, 2008, Healy, 2009). Infection outbreaks resulting from travel will also bring their own costs (cf
Newman et al., 2005). Similarly, there may be health and social care costs that arise from multiple births
(cf Ledger et al., 2006) arising from overseas fertility treatments. But there has been little systemic
collection of evidence or attempts to estimate overall system costs.

104. There are also potential impacts on private health activity – given that they potentially lose
business to overseas providers, for example cosmetic surgery. There are associated costs of patients
travelling overseas – the necessity to monitor/regulate advertising and provide detailed information and
advice to support potential or actual medical tourists carries its own costs. Again, there are no detailed
estimates of the implications.

Exacerbation of a two-tier system

105. There is the likelihood that large numbers of medical tourists will impact on the source country‘s
own health system, perhaps increasing trends that are encouraged by the current domestic private
provision. Outflows of high-income patients for example from LMIC will reduce both revenue and dilute
political support for developing local services. Such flows also reduce the pressure for investment in
particular facilities and technology. Indeed, there is an argument that some types of outflows of medical
tourists for treatments that could be provided locally signal a failure of policy and delivery in the sender
country.

106. But it is also within higher income countries where the possibilities of a exacerbating two-tier
system can emerge. If, for example, eligibility for services such as fertility or dental work is tightened, then

30
those with private resources may choose to travel overseas to maintain access (thus exercising choice and
exit). Those lacking the resources to travel may retain only the option of voice. Patients who are able to
circumvent waiting times highlight the familiar issues of access and equity.

107. In those countries where third-party insurers are exploring medical tourism as a provider option,
those that are insured under these plans – perhaps unable to get alternative cover – may find themselves
disadvantaged.

108. Clearly, however, source-country payers may benefit from outflows of patients – including
employers and employees contributing to health plans, and the public insurance system itself. There may
be some opportunities for financial benefit if medical tourism is an option. Mattoo and Rathindran (2006),
for example, highlight that for the United States 15 treatment that would show savings of $1.4b annually if
one in ten US patients chose to undergo treatment abroad. Such savings could be beneficial for public
health systems. For instance, a recent study looking at possible bi-lateral medical tourism trade between the
UK and India demonstrated substantial savings could accrue to the UK NHS from sending its patients to
India, both financially and in alleviating waiting lists (Chanda et al., 2011, Smith et al., 2011c, Smith et al.,
2011b, Smith et al., 2011a). If one takes the waiting lists for a selected number of procedures suitable for
medical tourism, and compares the cost of sending those patients (plus an accompanying adult) to India,
with the costs of getting treatment in the UK, the savings would be of the order of £120 million (Table 2).
This figure becomes £200 million if no accompanying adult is paid for (Table 3). Some subsets of the
population, such the Indian Diaspora, may prefer to go back ―home‖ for treatment, and may be happy to
cross-subsidise some of the costs, or may not need an accompanying adult, further increasing the amount
saved.

Table 2: Cost for patient and one accompanying person travelling

Procedure Cost Cost Cost of Hotel Total Cost Waiting Total saved
c d e
UK procedure flight Stay cost saved per list (£)
a b
(£) India (£) India operation
(£)
CABG 8,631 3,413 1000 230 4,643 3,988 97 386836
Coronary 2,269 2,363 1000 69 3,432 -1,163 25,241 Not worth it
angioplasty
Total hip 8,811 3,413 1000 322 4,735 4,076 28,800 117,388,800
replacement
Total knee 6,377 5,145 1000 161 6,306 71 53,911 3,827,681
replacement
Femoral hernia 1,595 819 1000 69 1,888 -293 1,686 Not worth it
repair
Inguinal hernia 1,595 717 1000 46 1,763 -168 65,064 Not worth it
repair
Total 121,603,317
a
NHS reference costs 2007-2008
b
From Fortis Healthcare Mohali (JCI accredited)
c
From British Airways, two week in advance of flying (i.e. 30th of September)
d
Used exchange rate £1=89.7 Rp £23/night in Mohali (where Fortis is), luxury accommodation (Imperial Hotel Mohali).
e
Obtained from Hospital Episode Statistics, Main procedures and operations 2007-2008

31
 Table 3: Cost for only patient travelling

Procedure Cost UK Cost Cost Total Cost saved Waiting Total saved (£)
a d
(£) procedure of cost per list
b c
India (£) flight India operation
(£)
Coronary artery 8,631 3,413 500 3,913 4,718 97 457,646
bypass graft
(CABG)
Coronary 2,269 2,363 500 2,863 -594 25,241 Not worth it
angioplasty
Total hip 8,811 3,413 500 3,913 4,898 28,800 141,062,400
replacement
Total knee 6,377 5,145 500 5,645 732 53,911 39,462,852
replacement
Femoral hernia 1,595 819 500 1,319 276 1,686 465,336
repair
Inguinal hernia 1,595 717 500 1,217 378 65,064 24,594,192
repair
Total 206,042,426
a
NHS reference costs 2007-2008
b
Conversion used £1=$1.66, rounded to the nearest pound
c
From British Airways, two week in advance of flying (i.e. 30th of September)
d
Obtained from Hospital Episode Statistics, Main procedures and operations 2007-2008

109. Plausibly, the health systems within source countries could develop relations with off-shore
medical tourism facilities to leverage cost savings – providing individuals with a choice of overseas
destinations. This could also reduce waiting lists – and reflects a form of outsourcing or more ‗collective‘
medical travel (Smith et al., 2011c).

Competitive pressure on local providers

110. One of the drivers for medical tourism is price because treatments may often be available locally
within the private sector, but at greater cost. There are arguments that some medical systems are inefficient
and face restrictive barriers to entry. A development such as medical tourism can potentially exert
competitive pressure on systems importing health care and help drive down the costs and prices offered in
domestic systems (Herrick, 2007). Medical tourism may encourage economies to maximize their
comparative advantage in labour costs, technology and/or capacity.

32
 SECTION FIVE
SYSTEM IMPLICATIONS: DESTINATION COUNTRY

111. We have seen in Section 4 that source counties – or those importing health services – may benefit
from medical tourism through alleviating waiting lists and lowering healthcare costs, but may risk quality
of care and legal liability. In this section we turn our attention to destination countries – or those exporting
health services. What potential benefits and risks do they face?

112. Medical tourism has historically been from lower to higher income countries, with better medical
facilities and more highly trained and qualified professionals. However, this trend is now reversing, and
most recently ―hubs‖ of medical excellence have developed which attract people regionally (Horowitz et
al., 2007, Lautier, 2008). Many countries participate in medical tourism as importers, exporters or both.
The main importing countries (those where the medical tourists come from) are in North America and
Western Europe. Although current levels of movement are relatively limited, as outlined in Section Four ,
the potential, if payment was covered by third-party payers, is significant. For instance, a study carried out
by Beecham (2002) suggested that 40% of the patients questioned in a UK nationwide poll would be
willing to travel outside the UK for treatment; 26% would apparently travel anywhere in the world!

113. The main exporting countries (those who provide the services to medical tourists) are located
across all continents, including Latin America, Eastern Europe, Africa and Asia. Countries have
specialised in certain procedures. For instance, Thailand and India specialise in orthopaedic and cardiac
surgery, whereas Eastern European countries are hotspots for dental surgery (Smith et al., 2011c). Thus,
although all countries may possibly be source and destination countries for medical tourists, this section
will take the view that it is predominantly LMIC who are the destination countries, and HIC the source
countries. Nonetheless, many of the issues are quite generic and will affect any destination country,
regardless of the level of economic development, just to a greater or lesser extent. It is also worth noting
that the magnitude of the possible effects being discussed is largely unknown – in many cases the potential
or actual occurrence of these effects has been observed, but the scale of effect, and how this scale may
differ between countries is an unknown quantity (Smith et al., 2009b).

Economic impacts

114. Most countries that engage in delivering care to medical tourists do so to increase the level of
direct foreign exchange earnings coming into their country; to improve their balance-of-payments position
(Timmermans, 2004, Ramírez de Arellano, 2007, Turner, 2007). To some extent this might be income
thought of as accruing directly to the health system. For instance, foreign patients purchase health care
services, and hence provide an income that can be used within hospitals to cross-subsidise care for
domestic patients, or could be used to help fund capital investment, such as MRI scanners, that are then
used by all patients in the hospital. For instance, in Singapore the authorities stress that involvement in
medical tourism enables them to provide a broader range of clinical services to the indigenous population
than would be the case if income was not being generated through medical tourism (India and Malta use
such arguments) (Lee, 2010, Lee and Hung, 2010). Similarly, Ramírez de Arellano (2011) suggests that the
Cuban experience is to reinvest income from foreign patients into the national system. It is therefore
possible that some countries may seek foreign patients in order to develop facilities to better serve local
patients (e.g. improve staff, investment, specialist expertise, cross-subsidise, etc) – although these
arguments are more likely to be ‗window dressing‘ of the core motive which is to earn foreign exchange.

33
115. However, one must remember that foreign patients are merely an addition to domestic private
patients; and this may be a significant or insignificant addition. There may also be different economic
implications depending if these patients are simply using spare capacity or competing with domestic
patients. For instance, the push by Thailand to be a hub for medical tourists in the 1990‘s was a result of
the economic crisis in Asia generating a fall in domestic private patients and hence leading to spare
capacity in their private sector. In this case, increasing foreign patients was more or less a net benefit to the
private health system with substantial income and little real opportunity cost. However, where there is not
spare capacity, and hence this capacity has to be developed, there are substantial potential costs in financial
terms, but also in the wider context of fears of two-tier system developments, internal brain drain, etc., as
outlined below.

116. Although there may be income generated for the health sector, it is typically not health care
income that concerns destination countries of course, but general increases in tourist income, since there is
hoped to be a substantial level of expenditure by medical tourists, and their companions, that is not related
to medical care (food, accommodation, sights, travel). Certainly medical tourism can be an important
source of foreign exchange. A report by the Tourism Research and Marketing Group estimates that there
are 37 million health-related trips each year, generating €33 billion (TRAM, 2006). A report carried out by
McKinsey and CII (2002) predicts that by 2012, India‘s medical tourism industry will be worth US$2
billion.

117. Indeed, it is the promise of these earnings that often drives government involvement in investing
directly or indirectly (tax incentives) in private hospitals and actively promoting medical tourism (Ramírez
de Arellano, 2007, Reed, 2008, Lee, 2010). Indeed, the Indian government stated in its National Health
Policy in 2002 that medical tourism was considered to be a ―deemed export‖ and therefore awarded it
fiscal incentives, including lower import duties, prime land at subsidised rates and tax concessions (Garud,
2005, Ramírez de Arellano, 2007, Sengupta, 2008). Similarly, the Thai policy promoting medical tourism
has been deemed to be such a success that it has recently been renewed. Thus, sectors other than medical
care – especially those associated with hospitality and travel – may benefit to some degree from increased
medical tourism, as will the government more centrally through increased taxation revenue. This revenue
can, of course, help support the domestic public health system, for example.

118. Nonetheless, the net income from medical tourism may not be as significant as it appears. Part of
the rationale for the pursuit of medical tourists is to generate additional tourism income, which presupposes
that these individuals (and their companion(s)) would not otherwise have been in the country. However, in
many cases medical tourists are either Diaspora or patients who have previously visited the country and are
likely to again. Thus, they are ‗regular‘ visitors who on one trip happen to ‗add in‘ an element of medical
care. In this situation it is highly likely that the non-health care revenue would have been raised
irrespective of their visit for medical reasons. In this situation clearly the additional income generated by
the ‗medical‘ element of medical tourism is far more limited, and the overall addition to the economy
consequently less, which may put a different perspective on the balance of benefits and risks.

119. Further, there are also financial costs to be borne from inviting medical tourists into a country. As
mentioned above, often there are requirements for upgraded infra-structure – either specifically within the
health sector (e.g. hospital facilities) and/or outside of that sector, such as roads, telecommunications etc.
However, such infrastructural investments will create favourable spillovers for non-medical tourists and
the local population. There are also likely to be costs concerned with appropriate staffing of facilities,
possible accreditation schemes, and other requirements to attract medial tourists.

120. For instance, 35 countries have sought accreditation from the US-based Joint Commission
International (JCI), the international arm of the Joint Commission, which accredits US hospitals. India has
already sought and obtained JCI accreditation for seventeen hospitals, and Thailand for fourteen (JCI,

34
2011). Other international accreditation bodies include the Australian Council for Healthcare Standards,
the Canadian Council on Health Services and the Society for International Healthcare Accreditation. This
high number of accreditation associations shows there is a strong commitment from exporting countries to
develop or strengthen their medical tourism industry. However, there are costs associated with increasing
and ensuring standards to meet these various criteria, maintenance of these accreditations, and the
processing costs themselves.

Trickle down of best practice/technological transfer

121. Stemming from the economic, or financial, benefits which are sought, there is an associated
argument around ‗trickle down‘ of best practice and technological diffusion. Part of this relates to the
increased ability to purchase the latest technology for example. However, part of this also relates to the
exposure to international patients and staff that may generate more qualitative advances. Thus, there is an
argument that servicing the needs of foreign patients may broaden the case-mix for staff, or may increase
throughput to enable them to become more skilled; it might open up the door to secondments to overseas
facilities which, provided migration is temporary, may lead to enhancement of human capital; it may
provide increased quality through ensuring compliance with (higher) international standards for care (as
alluded to above); and it may promote a culture of personal development in skills and technologies
available to treat patients generally, which local patients will of course benefit from.

122. However, there are also associated risks. For example, there is the possibility of resources being
taken away from the domestic population and invested into private hospitals; another possibility is that
investment is directed towards urban tertiary care rather than rural primary care centres which more
appropriately reflect domestic population needs. There may also be a skew in the resources devoted to the
conditions associated with medical tourists rather than those associated with local populations, such as a
focus on high technology orthopaedic, dental and reproductive care, rather than more basic public health
measures focused on infectious disease. It is also not clear how much the accreditation of private hospitals
dealing with medical tourists will be replicated in private, or public, hospitals which do not serve this client
base.

Internal brain drain and reverse brain drain

123. Some exporting countries have taken advantage of the growth of medical tourism to attract back
to their home country health workers who had emigrated, thus reversing the ‗brain drain‘ (Chinai and
Goswami, 2007, Dunn, 2007, Connell, 2008). It is argued that this is possible since hospitals catering for
medical tourists can offer competitive salaries and working conditions more comparable with overseas
institutions. This has the double benefit of giving a high quality signal, as international patients are more
likely to trust doctors who have trained or practiced in their countries of origin, as well as ensuring that
precious human resources are brought back to the country or are less likely to leave (Connell, 2008).

124. However, there is uncertainty over the precise magnitude of this affect, and also of the extent to
which human resources are made available for the domestic population and thus of benefit to the domestic
health system, or rather are simply an ‗internal export‘ by only treating the same patients that they would
have if they had migrated, it is just that they are doing this ‗at home‘.

125. Closely related to this, is that whilst the prospect of reversing the international brain drain is very
positive, there are concerns that medical tourism will cause an internal brain drain, with health
professionals leaving the public health system to work for the hospitals that attract medical tourists, lured
by the better salaries and work opportunities just alluded to (Arunanondchai and Fink, 2006, Burkett, 2007,
Chinai and Goswami, 2007). This would decrease the quality of the public health system and the doctor-to-
patient ratio. As with other aspects of medical tourism, there is little empirical evidence of whether this is

35
happening, and to what extent; and what there is, is unclear. For instance, Vijaya (2010) found that there
was an internal brain drain from the Thai public to private system. However, another study which assessed
the influence of medical tourism on the internal brain drain in Thailand concluded that it is not the influx of
foreign patients, but the numbers of Thai private patients that have the highest influence on the internal
brain drain (Wibulpolprasert and Pachanee, 2008). As raised earlier, it is important – and seldom if ever
done – to separate the effects of private care from the additional impact of a sub-sample of foreign private
patients and seek to isolate the effect that being a foreign private patient per se has.

Two-tier system

126. All of this, of course, leads us to the primary concern about the possibility of medical tourism
generating – or at the least exacerbating – a two-tiered health system, where foreign patients benefit from
sophisticated private hospitals with a high staff-to-patient ratio and expensive, state-of-the-art medical
equipment, whereas the local population only has access to basic, under-resourced health facilities
(Chanda, 2002, Garud, 2005, Ramírez de Arellano, 2007, Connell, 2008, Leahy, 2008).

127. Certainly there is the potential for medical tourism to have effects in terms of the distribution of
healthcare resources for the less well-off local population, unless the government has some sort of policy
of wealth redistribution in place, or there are robust charitable ventures in place to assist the local
population (Chee, 2008, Heung et al., 2010). There is anecdotal evidence that may support this. For
instance, there have been various accusations that in some countries private-sector medical tourists may be
accumulating medical resources and taking healthcare services and personnel away from the local
population (Sengupta, 2011), and one study (Pennings, 2007) suggests that although private hospitals in
India may have a responsibility under the Public Trust Act to provide free health care to the extent of 20%
of resources, there are no checks undertaken to ensure that this occurs and others have suggested that
Indian hospitals renege on promises to provide free healthcare (Shetty, 2010).

128. Nonetheless, as with much in this area, there is no strong evidence that medical tourism creates a
two-tier system (especially given the point earlier about the extent to which they may simply add some
additional private patients to an already sizable domestic private sector), or even that they may exacerbate
this.

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 SECTION SIX
HARM, LIABILITY & REDRESS

129. Whilst ethical and legal issues arise for all forms of medical care – informed consent, liability
and legislating for clinical malpractice – these are intensified for medical tourism. ‗Cosmetic tourism‘,
‗fertility tourism‘, ‗transplant tourism‘, to say nothing of recent developments in the areas of ‗stem cell‘-
tourism‘ and ‗euthanasia tourism‘, raise ever-more complex medico-legal and ethical questions. We are
entering relatively uncharted and rapidly developing territory with regards to the legal dimensions.
Currently, there is no clear legislative picture or developed body of case law to guide practice in this area.
Clearly, however, as the range of treatments and sites offering them expands there is a need to understand
these issues – for patients, surgeons, overseas facilities and legal systems.

Medico-legal issues (quality of care, redress, liability, litigation)

130. In the event of an adverse outcome arising from failings in clinical and professional practice, how
do patient fare in seeking redress given there is no international regulation of medical tourism? There are
warnings that clinics overseas are not necessarily regulated according to source-country standards and
regulations. Choosing an overseas treatment centre brings a number of challenges – difficulties in assessing
comparative quality and performance of alternative providers, differences in legal liability and knowledge
concerning the processes of how to pursue complaints and receive redress (MacReady, 2007).

131. If patients experience poor-quality treatment which results in adverse outcomes and as a result
wish to bring a civil or criminal case, they face potential confusion with a number issues not fully clarified
(Vick, 2010). A combination of services may contribute towards the medical tourist experience including
product advertising, initial internet consultation, a brokerage service, surgery itself, and various mixes
therein.

132. With regards to advertising and promotional material, there are typically national and European
restrictions on what can be advertised, but given the role of the internet in promoting medical tourism this
may be difficult to regulate and hold miscreants to account.

133. There are complexities regarding who could be subject to legal proceedings, the jurisdiction of
hearing any case, and the country‘s law that should govern any case (Svantesson, 2008, Vick, 2010). There
are questions about who to sue and whether a dissatisfied medical tourist should sue the individual
surgeon, the clinical team, the hospital, or even the broker that may have arranged the treatment. The
jurisdiction question concerns where any legal case would be heard and the laws and legislation that would
govern it. For an Australian citizen for example, domestic legislation would provide three potential routes
for redress: action for breach of contract; action for tort of negligence; action under the misrepresentation
of Trade Practice (contracts) Act (1974) (Svantesson, 2008, see also Vick, 2010 for a UK analysis).

134. A potential difficulty in pursuing a breach of contract or clinical negligence is that medical
tourists may be encouraged to sign legal disclaimers prior to receiving treatment that restrict where any
subsequent case will be held, the law that will cover it, and include further liability limitation or exclusion
clauses. Such clauses may seriously reduce effective redress options, although they are themselves
potentially subject to legislation with regard to the fairness of their contract terms (Vick, 2010).

37
135. Pursuing a legal case overseas brings its own difficulties. Should complications arise during
medical tourism, patients may not be covered by insurance or indemnity policies that are carried by the
hospital, the surgeon or physician treating them, and they may have little recourse to local courts or
medical boards.

136. Travelling to an overseas country to pursue a legal case also involves having to employ a suitable
lawyer, and problems with regard to arranging travel and accommodation as well as the potential legal,
language and cultural difficulties of courtroom understanding. In India, for example a civil case could be
brought using the Fatal Accidents Act and Section 357 of the Code of Criminal Procedure (or via a
consumer route under consumer protection legislation). But 95% of cases are dismissed because there is
not a culture of professional critique (Howze, 2007). If a favourable judgement is handed down in an
overseas jurisdiction – to what extent is this enforceable or likely to ensure a significant financial award?
Patients should be made aware that other countries might have different malpractice laws and legal
traditions and these will impact on the size of malpractice payouts. One reason US health care is so
expensive is the size of malpractice premiums, an indication that US citizens are litigious and value their
right to seek legal redress. Unti (2009) cites the example of professional liability insurance premiums for
surgeons in India that are estimated at only 4% the premium for a similar practicing surgeon in New York.

137. Informed-consent practices for undergoing procedures vary around the world, and may in fact not
be available in some countries. What happens if there is a complication and the patient‘s subsequent
necessary spell in the Intensive Care Unit is beyond their ability to pay? Will the hospital repatriate the
body of a patient who dies on the operating table? What if the patient acquires VRSA, HIV or Clostridium
difficile while an in-patient at the overseas hospital? As suggested earlier, there are strong arguments that
consent is given in writing.

Issues for providers, ancillary interests and third-party funders

138. The current legal uncertainly with regard to medical tourism raises key issues for those providing
medical tourism treatments and services. As Vick (2010) suggests ―By promoting their services across
international borders to attract overseas patients, clinics may not appreciate that they may become subject
to the jurisdiction and laws of those countries, with important implications for litigation and insurance
cover‖.

139. New insurance products exist that do provide legal and financial protection for the patient should
medical malpractice arise while they are overseas undergoing treatment, and such insurance and financial
services are increasingly becoming available. Clearly with such products the devil is often in the detail and
medical tourists need to check carefully any exemptions the policy may carry. It may also be advisable for
medical tourist brokers to consider insurance cover for themselves given they potentially could become
subject to claims for damages whether via commercial or criminal routes.

140. Issues clinics are well advised to pay close attention to include:

 considering a patient‘s history and communicating appropriately

 detailed documentation of decision-making and treatment pathways

 fully informed consent and consideration of risk, particularly when there are vulnerable patients
(including those with psychological issues, the seriously ill, and children)

 validating qualifications of surgeons

38
  clarifying the relationships of the clinic and its surgical and clinical staff

 ensuring adequate insurance

 recovery planning (Vick, 2010)

141. Beyond the liability of brokers, surgeons and clinics, what are potential liability issues for Health
Maintenance Organizations that decide to include overseas providers within their suite of referrals? Under
such circumstances should they be expected to validate the credentials of physicians, and are they likely to
be subject to vicarious liability, or is this avoidable through disclaimers? Within some states in the US,
regulatory power over health insurance will prevent those insurers within the state from offering plans that
require the insured to travel overseas to receive healthcare services (Cohen, 2010).

142. In summary, there are several important issues relating to the legal context and redress
mechanisms available to medical tourists. Should regulation be introduced to tackle the range of issues
outlined above and, if so, how would it operate? Furthermore, what legal information is available to
prospective and actual medical tourists? A starting point is the requirement to comprehensively review
national frameworks and practices in terms of legal redress, and to review and analyse the experience of
bilateral legal proceedings to date. Legal remedies are dealt with in Section Seven.

Ethical dimensions

143. An established framework for healthcare ethics suggests the importance of:

 Autonomy (respecting a person‘s right to be their own person and make their own decisions, and
ensuring those are reasoned informed choices).

 Nonmaleficence (avoid doing harm and endeavour to reduce risk – whilst all treatments will
involve some measure of harm, it should not be disproportionate to the treatment benefits).

 Beneficence (promote patients‘ welfare and consider the risk/benefit balance).

 Justice (consider benefits, risks and costs distribution; patients in similar positions should be
treated in a similar manner) (Beauchamp and Childress, 2001).

144. To what extent do these hold for medical tourism? At its root medical tourism is underpinned by
trade in health services and competition amongst providers. Whilst there have always been some traditions
of fee for service, medical tourism is qualitatively different – what is the balance of commercial and
professional ethics? Price as an allocation mechanism in the competitive marketplace provides the
opportunity to avoid long waiting lists in the home country but also – within an unregulated market – to
offer unproven and potentially illegal treatments. Moreover, does medical tourism reflect deeper ethical
dilemmas such as existing forms of health care funding and delivery that allow the number of uninsured to
grow (cf Pennings, 2007)?

145. Who should fund the treatment of any medical complications and adverse health outcomes for
patients returning from overseas private surgery? Should a patient‘s local health care system take on the
responsibility and foot the bill for post-operative care including treatment for complications and side-
effects? Discussions in the US, UK and Australia have all pointed towards costs being imposed on publicly
funded health systems and the implications for local population health (e.g. exacerbating waiting lists even
further) (Cheung and Wilson, 2007, Jeevan and Armstrong, 2008, Barrowman et al., 2010).

39
146. As outlined in Section Five, medical tourism raises particular issues when treatments are carried
out in LMIC destinations. Questions include whether economic and health benefits trickle down to local
populations (Mudur, 2004, Bose, 2005, Sengupta and Nundy, 2005, Meghani, 2011) and does the use of
local health care professionals, doctors and nurses reduce the level and quality of health provision for local
populations.

147. Different ethical standards may operate in different parts of the world due to religious and
cultural differences, for example in relation to treatments including fertility therapy, organ donation and
plastic surgery. Stem-cell therapy may not involve fully developed notions of informed consent and there
may be little involvement of ethics review boards compared to practices within developed countries
(MacReady, 2009). Some countries may seek to provide treatments that are illegal or highly experimental
in other countries (Cortez, 2008). For example, rewarded kidney donation is controversial and even illegal
in some parts of the world but not in others (Rouchi et al., 2009). There are major concerns about the
vulnerability of organ donors motivated by financial incentives (The Declaration of Istanbul of Organ
Trafficking and Transplant Tourism has condemned transplant tourism and the associated practices).
Particular worries concern the possibility of poor aftercare and absence of separate clinical advocacy for
donors. Officially it has become illegal for the organs of executed Chinese prisoners to be made available
for transplant to foreign transplant tourists (Rhodes and Schiano, 2010). Questions remain, however, over
how transplant programmes in high-income countries should deal with returning patients who have
managed to circumvent overseas restrictions.

Nonmaleficence and beneficence

148. Given that ability to pay rather than need alone is the allocative mechanism in the medical
tourism market, there are concerns that commercial rather than professional priorities are privileged in
decision-making. This may include unnecessary or multiple treatments being offered to patients. There are
also treatments where there are more likely to be associated psychological factors than with the broader
population – such as those seeking cosmetic surgery who may have associated conditions such as body
dysmorphic disorder (Grossbart and Sarwer, 2003).

149. Human stem-cell therapies are a controversial procedure and scientifically are of unproven value,
especially as beauty therapies. Within the medical tourism field there are examples of countries offering
stem-cell therapies targeted at specific conditions including Parkinson‘s, stroke and brain infections. What
should be made of such treatments given there are no clinical trials to assess efficacy and effectiveness?
The pursuit of unproven – and even dangerous – therapies across national boundaries may be particularly
marketed as treatments for desperate patients who cannot obtain these in their own country of origin. There
are particular ethical issues when these are pursued for children (Zarzeczny and Caulfield, 2010), and
complex ethical dilemmas of ‗hopeful‘ treatments being marketed to those who are gravely ill (Murdoch
and Scott, 2010).

150. There are therefore many potential roles for professional associations, regulatory authorities and
domestic physicians in counselling, advising, providing information and in the extreme possibly deterring
would-be medical tourists. Such activity itself needs to be balanced with consideration of the principle of
patient autonomy.

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 SECTION SEVEN
CONCLUSIONS AND CONSIDERATIONS FOR FUTURE RESEARCH

151. Despite high-profile media interest and coverage, there is a lack of hard research evidence on the
role and impact of medical tourism. Whilst there is an increasing amount written on the subject of medical
tourism, such material is hardly ever evidence-based. In light of this, our broad review outlines key health
policy considerations, and draws attention to significant gaps in the research evidence. In order to make
sense of the diversity of material and the gaps in extant knowledge, it is worth framing the conclusions and
recommendations in terms of Frenk‘s (1994) framework for health policy analysis. This hierarchical
framework presents four levels within any health system: systemic (regulation and finance), programmatic
(system priorities), organisational (service management) and instrumental (clinical interface with patients).

System issues

152. Key issues at this level relate to the finance and regulation of medical tourism. Despite concerns
generated by the current financial crisis, there is no sign that economic liberalization is slowing down. As
the trading opportunities in other sectors become exhausted, as experience within services trade generally
expands, and as the financial climate stabilises, countries will increasingly look to the opportunities that
international trade in services has to offer. For importing services, this will centre on cost, quality and
timeliness. For exporting services, this will centre on technology transfer, skill enhancements and foreign
income.

153. At present, medical tourism is driven by commercial interests lying outside of organised and
state-run health policy-making and delivery. Are there possibilities to bring it more within the remit of
domestic policy competency, involving for example third-party payers sending patients overseas? Given
the heavily ‗politicized‘ nature of health care in all countries (even those with substantial private health
care sectors), there will also be concerns about the threats this poses, including aspects related to brain
drain, quality of care and equity. The Crisp Report (2007), commissioned to look at how UK experience
and expertise in health could be used to best effect to help improve health in developing countries, argues
that by engaging in country-level agreements, and drawing up Memorandum of Understandings between
two countries, international recruitment of health professionals can be done ethically and based on a
‗twinning‘ arrangement of reciprocal movement and benefit. If an agreement is achieved to send patients
abroad on a more bi-lateral basis, then this may open channels for other agreements such as these, which
can then combine international recruitment with training and work experience programmes to address brain
drain issues in the importing country. If such a route were taken, this would effectively be a form of
outsourcing, with such agreement typically following the well-worn tracks of medical tourist mobility. At
this point medical tourism would begin to merge into other forms of patient mobility (EU-cross border care
and state-sponsored outsourcing).

154. Countries continue to evaluate their positions on trade liberalization in health, as part of wider bi-
lateral, regional and multilateral trade agreements. The latter especially has been the focus of debate,
centred on the World Trade Organization‘s General Agreement on Trade in Services (Blouin et al., 2006).
However, there is widespread recognition that the trade agenda (in services generally, and health
specifically) is increasingly pursued at the regional or bi-lateral levels (Smith et al., 2009a). Not only have
multi-lateral trade negotiations ‗stalled‘ with the ongoing Doha round of WTO trade negotiations, but
neighbouring countries often have similar culture, language and economic systems, as well as shorter

41
travel times, facilitating engagement in trade relations. As a result, trading blocs, such as the European
Union (EU) or the Association of South East Asian Nations (ASEAN) have developed, where a significant
proportion of international trade takes place. Additionally, many countries bypass the GATS system and
engage in direct bi-lateral trade agreements (Smith et al., 2009a). Could this development be broadened to
include medical tourist exchanges with countries where travel distance are longer, culture and language
less familiar, but where cost savings to the public purse are more apparent?

155. This is an important shift in the dialogue, as greater bi-lateral and regional trade may reduce
many of the concerns expressed over health services trade, and offer greater benefits. For instance, it may
result in greater quality assurance, as well as better litigation procedures. However, much of the research
evidence, anecdote and opinion on trade in health services remain focussed on this multi-lateral
perspective. It is important, therefore, to explore bi-lateral trade in more detail, and to assess how it
compares to multi-lateral trade. Such a focus would move discussion from the level of global medical
tourism to more specific bilateral exchanges – for particular treatments, under specific quality-assured
conditions (Smith et al., 2011c).

156. Beyond the national level, medical tourism raises questions for trans-national and global
structures and processes. How, indeed if at all, should the medical tourism industry be best regulated, and
where is intervention most likely to be effective? There is currently a lack of agreed international standards
for assessing and ensuring quality and safety of medical tourism providers and health professionals, and no
obligation for them to ensure quality and safety other than an ethical one. Currently, there is no universal
―official agency/group‖, such as the United Nations, the World Health Organization, the World Tourism
Organization or the World Trade Organization, engaged in either the delivery of accreditation, the co-
ordination of delivery of accreditation, or licensing or studying the existing schemes that deliver
accreditation. There is a range of possible solutions (both national and transnational) ranging from
interventions that provide more information (although by whom and at what points is not clear); those that
restrict choice of potential consumers (either directly prohibited or through discouragement); or attempts to
restrict supply (whether approving or licensing providers or intermediaries). There are also interventions
that may aim to offer consumer protection around poor-quality treatments which could involve
encouraging independent holistic accreditation by recognised schemes, advising that clinicians responsible
for delivering services take out personal medical indemnity which would compensate their patients in the
event of problems occurring as a consequence of their seeking healthcare, or requiring medical tourists to
take out insurance coverage (Cohen, 2010). Source health systems may attempt to shift risk onto individual
medical tourists, for example with disclaimers to prevent medical tourists from seeking to rectify poor
outcomes at cost to the public purse.

Programme issues

157. What are the programme priorities surrounding medical tourism for both source and destination
countries? As outlined, medical tourist choice may lead to externalities at the system and programme level.
Costs may result from overseas cosmetic surgery or dental work that requires subsequent treatment within
home countries. There are few case reports or studies of these aspects and the scale of any problem is not
clear. Large numbers of medical tourists will also impact on the source country‘s own health system,
because outflows reduce both revenue and support for local services. Patients who circumvent waiting
times make access and equity for the wider population more problematic. Opportunities for financial
benefit from medical tourism include potentially exerting competitive pressure on systems importing
health care and may help drive down the costs and prices offered in domestic systems, or relaxing legal
restictions in order to stimulate domestic provision of treatments.

158. Most countries that engage in delivering care to medical tourists do so to increase their level of
direct foreign exchange earnings. Some countries may promote health services in order to develop facilities

42
to better serve local patients, although the possibility of resources being diverted from the domestic
population and invested into private hospitals and away from rural areas remains a potential dysfunctional
outcome. Similarly, whilst the prospect of reversing the international brain drain is very positive, there are
concerns that medical tourism will cause an internal brain drain, with health professionals leaving the
public health system to work for the hospitals that attract medical tourists.

159. Research is needed on the economic impact for source and destination countries, particularly
those low- and middle-income countries where there is speculation but little evidence about the impact of
medical tourism treatments on local citizens, either in a health sense or indeed an economic sense. Country
case studies of such state-driven support for medical tourism would be a useful starting point to better
understand the positive and negative impacts on country finances and populations of involvement with
medical tourism.

Organisation and clinical issues

160. In terms of management of services and treatments, there are continuing questions about the
range of information and its quality. Given the role of the internet, how (if at all) the quality of medical
tourism information is best addressed is unclear: ranging from codes of conduct, through quality labels,
user guidance tool, third-party quality and accreditation labels, to educating users and assisting those
wishing to search (Lunt et al., 2010). Frontier medicine and the marketing of biotechnologies present a
particular issue (Murdoch and Scott, 2010) given that such treatments may not be based on proven clinical
trials.

161. A number of business models (e.g. brokers, ownership forms) are emerging within medical
tourism. These should be better documented and understood, including their strengths and drawbacks, as
well as the implications for managing quality, safety and risk. The relations of emerging business models
(e.g. partnership, multinational providers) and patterns and trends of accreditation require investigation.

162. The roles and responsibilities of clinicians and healthcare providers within both provider
countries and countries of origin, and organisations responsible for credentialing and continuing
professional development of clinicians in provider countries, require clarification regarding their duties in
relation to patients who seek help and advice in advance of engaging in medical tourism. What is the role
of informing, persuading and advocating for individuals that intend to travel abroad, and the role on return?
What about the public health dimensions, such as pre-travel vaccination, anti-malarial prophylaxis etc.?
How may publicly-funded providers and professional associations be involved? Should clinical ethics
committees with lay membership have a greater role?

163. At the clinical interface the normal continuum of care may be interrupted. Full medical
documentation, both pre and post-treatment, is crucial in order to minimise risk. In the UK, signed
informed consent prior to an elective procedure is considered best practice and a standard requirement
ensuring that patients are fully informed as to the benefits and adverse effects of a procedure or treatment.
Patient-clinician dialogue may be problematic given language and distance, and treatment decisions may
be unduly influenced by patients having already arrived in the destination country for pre-treatment
consultation. Relatively little is known about readmission, morbidity and mortality following self-funded
medical treatment abroad. Within treatment speciality there is a need to link together reports of adverse
infection control or sub-optimal outcomes. Any legal cases that are pursued should also be documented so
that it is possible to build national and international understanding of the implications of trade in health
services.

43
Summary

164. The central conclusion from this review is that there is a grave lack of systematic data concerning
health services trade, both overall and at a disaggregated level in terms of individual modes of delivery,
and of specific countries. This is both in terms of the trade itself, as well as its implications. For instance,
there is little robust evidence that medical tourism adds especially to the economies of destination
countries, as figures tend to be quoted in aggregate, but not at the marginal level of the additional tourist-
related income specifically resulting from medical tourism. This review has also touched upon overarching
legal and ethical considerations surrounding medical tourism. Prior to considering any regulation we need
more information and understanding (cf. Smith et al., 2009a).

165. Research and evaluation has not kept pace with the development of medical tourism and there is
a need for national governments and potentially international bodies (e.g. EU, OECD, WHO) to invest in
research this area. To this end, the UK National Institute for Health Research has recently commissioned
research on the implications for the NHS of inward and outward medical tourism and it is hoped that the
evidence generated from this study will help inform the development of future policy and practice in this
area (Lunt et al., 2011).

166. The lack of data is significant if countries are to keep fully informed about the significance
(potential or actual) of medical tourism for their health systems. Mechanisms are needed that help us track
the balance of trade around medical tourism on a regular basis. The evidence base is scant to enable us to
assess who benefits and who loses out at the level of system, programme, organisation and treatment. On
balance there is a pressing need to explore further as to whether medical tourism is virus, symptom, or
cure.

44
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WTO (1999), WTO Global Code of Ethics for Tourism. Madrid: World Tourism Organisation.

Youngman, I. (2009), Medical tourism statistics: Why McKinsey has got it wrong. International Medical
Travel Journal. Available:
http://www.imtjonline.com/articles/2009/mckinsey-wrong-medical-travel/

Zahir, K. (2001), Clinical governance in the UK NHS. London: Department for International Development
Health Resource Centre.

Zarzeczny, A. & Caulfield, T. (2010), Stem Cell Tourism and Doctors' Duties to Minors:A View From
Canada. The American Journal of Bioethics, 10, 3-15.

54
 RECENT RELATED OECD PUBLICATIONS

HELP WANTED? PROVIDING AND PAYING FOR LONG-TERM CARE (2011)

OECD HEALTH DATA 2011, available online in OECD.Stat at www.oecd.org/health/healthdata.

IMPROVING VALUE IN HEALTH CARE: MEASURING QUALITY (2010)

IMPROVING HEALTH SECTOR EFFICIENCY – THE ROLE OF INFORMATION AND

COMMUNICATION TECHNOLOGIES (2010)

MAKING REFORM HAPPEN – LESSONS FROM OECD COUNTRIES (2010)

HEALTH AT A GLANCE: ASIA/PACIFIC (2010)

HEALTH AT A GLANCE: EUROPE (2010)

VALUE FOR MONEY IN HEALTH SPENDING (2010)

OBESITY AND THE ECONOMICS OF PREVENTION: FIT NOT FAT (2010)

HEALTH AT A GLANCE 2009: OECD INDICATORS (2009)

See http://www.oecd.org/health/healthataglance for more information

ACHIEVING BETTER VALUE FOR MONEY IN HEALTH CARE (2009), OECD HEALTH POLICY
STUDIES

OECD REVIEWS OF HEALTH SYSTEMS - TURKEY (2009)

THE LOOMING CRISIS IN THE HEALTH WORKFORCE: CAN OECD COUNTRIES RESPOND? (2008)

PHARMACEUTICAL PRICING POLICIES IN A GLOBAL MARKET (2008)

OECD REVIEWS OF HEALTH SYSTEMS - SWITZERLAND (2006)

LONG-TERM CARE FOR OLDER PEOPLE (2005), OECD HEALTH PROJECT SERIES

HEALTH TECHNOLOGIES AND DECISION MAKING (2005), OECD HEALTH PROJECT SERIES

OECD REVIEWS OF HEALTH CARE SYSTEMS - FINLAND (2005)

OECD REVIEWS OF HEALTH CARE SYSTEMS - MEXICO (2005)

For a full list, consult the OECD On-Line Bookstore at www.oecd.org,

or write for a free written catalogue to the following address:
OECD Publications Service
2, rue André-Pascal, 75775 PARIS CEDEX 16
or to the OECD Distributor in your country

55
Chapter 8

Quality and Safety

Transparency

This chapter contains the opinions, analysis, and statements of the author. It is the
responsibility of every reader to evaluate the accuracy, completeness, or usefulness of
any information, opinion, advice, or other content contained in this chapter.

Lisa Beichl, Transparent Borders LLC

Consulting Affiliate, Mercury Healthcare Advisory Group, Inc.

Successful business enterprises typically provide smart solutions to fill a market demand.
Sustainable solutions not only meet market demand, but also provide high perceived quality. In
healthcare, quality focused and patient safety practices yielding positive medical outcomes have
become the hallmark of successful hospital strategies. As hospitals consider expanding into the
medical tourism market, transitioning from a traditional domestic strategy to global outreach
requires a fundamental shift from a focus on purely domestic quality agendas to expanding and
including strategies that proactively address cultural bias, social/psychological preferences, travel
constraints, and effective transitions of care to the locally based provider.
Medical tourism is a nascent industry. In this chapter we review quality program development.
In summary we aim to

1. Define the different medical tourism groupings and general patient flow.
2. Identify resulting medical tourism risks (that quality programs seek to manage).
3. Highlight the importance of transparency to manage risks.
4. Outline system-level quality and propose tools to support quality initiatives.
5. Suggest medical tourism quality outcomes measures (medical, functional, patient satisfac-
tion) as well as patient preference groupings.

To put quality initiatives in context, Figure 8.1 summarizes the general strategic development of
a medical tourism strategy.

65
66  ◾  Handbook of Medical Tourism Program Development

Measurement
Market Demand
• Impact of program on
Assessment
overall strategy
• Identify markets (focus
• Impact of program on
groups, interviews)
patient outcomes
• Define services and costs
(medical, functional, and
• Distribution channels
social/psychological)

Risk Assessment
• Based on market demand,
identify risks (market,
patient, medical treatment
and transfer)
• Evaluate quality programs to
mitigate risks (proactive)

Figure 8.1  Main steps in developing a medical tourism strategy.

This chapter does not define market demand assessment, but does outline the two general
demand groupings (general and selective medical tourists) and two general venues (domestic
and international). It also provides important ideas regarding risk assessment for these groupings
and venues, how quality initiatives can mitigate these risks, and the measurement of outcomes
(medical, functional, social/psychological). At the end of the chapter are recommended metrics for
the industry to begin assessing medical and social outcomes of medical tourism.

Two General Types of Medical Tourism Groups

and Venues That Shape Quality Initiatives
Medical Tourism Groups
Medical tourism has existed for a long time. In the United States, there are Centers of Excellence*
attracting patients with unusual or complicated medical histories seeking specific treatments.
Studies show that there is a relation between select medical specialties and quality outcomes:
trained specialists performing a consistent volume of a service yield better quality outcomes than
generalists.† In addition, higher surgeon and hospital volumes are often associated with improved
clinical outcomes, in particular for less common and more complex operations.‡
In the United States, hospitals including the Mayo Clinic and Johns Hopkins have interna-
tional departments designed to manage the medical tourism patient segment. In some markets
such as Nigeria, a lack of availability of some specialized healthcare treatments means that patients
must travel to neighboring countries for those services. In both of these instances, medical ­tourism

* A hospital that provides specialty services typically associated with high volume and positive medical outcomes.
Although the U.S. government has criteria for the term, some hospitals and insurers have created their own
criteria for defining a Center of Excellence.
† “Relation between hospital orthopaedic specialization and outcomes in patients aged 65 and older: Retrospective

analysis of U.S. Medicare data,” BMJ 2010; 340 doi 10.1136/bmj.c165 (Published 11 February 2010).
‡ “Provider volume and clinical outcomes in surgery: Issues and implications,” Lee, Clara N., MD, MPP, Daly,

John M., MD, FACS: June 2002, Bulletin of the American College of Surgeons.
 Quality and Safety Transparency  ◾  67

General medical tourism (Includes any

hospital that can provide an affordable,
quality-focused, accessible medical
treatment)

Selective medical tourism (Centers

of Excellence where technology and
clinical expertise are the highest
priority — typically not cost-driven)

Figure 8.2  Diagram of the relationship between selective and general medical tourism.

occurs as an “exception,” and is termed selective medical tourism. Selective medical tourism is
driven by specialization, typically at important institutions (Centers of Excellence) with proven
medical quality outcomes.
The concept of medical care outsourcing for complex cases or selective treatments is not a new
idea; however, the expansion of the concept to attract patients in the general population (general
medical tourism) requires a shift in focus. General medical tourism defines those cases where an
individual selects an alternative (not home-based) venue to receive medical treatment. The general
medical tourist typically seeks treatment for a straightforward intervention, including elective and
cosmetic treatments, at a reasonable cost. The medical treatment may take place in a hospital that
is not considered a Center of Excellence. Competition for these services is growing; therefore cost
(rather than specialization) is often an important criterion. Selective medical tourism is a subset of
general medical tourism. See Figure 8.2.

Medical Tourism Venues

The two venues where medical tourism can take place are domestic and international. Domestic
medical tourism refers to medical treatment where travel for care occurs within the boundaries
of a state or region. International medical tourism refers to movement for healthcare beyond the
national border. Both domestic and international medical tourism are similar and involve travel
to another locale for medical treatment, however, international medical tourism is complicated by
involving a foreign marketplace with different regulations, quality standards, culture, communi-
cation styles, and so forth.

General Medical Tourism Flow (Domestic and International)

Figure 8.3 depicts a simple medical tourism event.* The internal circle generally depicts a tradi-
tional inpatient admission (gray hatch indicates the actions that would happen in the local con-
text). Taken together, the two concentric circles illustrate the patient flow both in the home and
medical tourism environments. The dotted edge surrounding the home environment points to
the fact that the market in which the medical tourism care is received is expected to be different.
Closer inspection of the external circle reveals the two aspects of a medical tourism event:
* The framework is drawn from the Health Climate Calculator™, from Transparent Borders™ LLC (2010).
68  ◾  Handbook of Medical Tourism Program Development

Patient risk (domestic and Patient risk (domestic and

international): international):
- Medical underwriting Cross-Border - Transparency/Corruption levels
- Environmental underwriting Hotel - Legal regulations
- Personal preferences
- Quality regulations, medical
(and fears)
equipment/pharmaceutical sourcing

Home Cross-Border
Rehabilitation
Rehabilitation

Hatched boxes
represent a
typical patient
Patient flow if there Home
Home
or home was not a Hospital
provider medical
initiate tourism event
medical
tourism
event
Home Cross-Border
Provider Hospital

Cross-Border
Provider Medical treatment risk (domestic
Transition risk (medical and
geographic) (domestic and and international):
international): - Risk of the treatment, procedure,
- Evidence-based fit-to-fly guidelines intervention
- Cross-border hotel amenities - System-level quality
- Followup care upon return - Clinical expertise

Figure 8.3  General relationship between the home and medical tourism.

◾◾ Medical treatment/intervention
◾◾ Travel, transition of care (medical transition, getting to and from the destination and follow-
up care)
Successful management of these aspects increases the likelihood of a positive medical outcome.
These two aspects of a medical tourism event are susceptible to four distinct risks*: market risk,
transition risk, medical treatment risk, and patient risk. Effective identification and management
of these risks increases likelihood of a quality medical outcome.
In a domestic medical tourism event, the market in which the care is received is similar to the
home environment so there are limited compatibility risks. However, when the event is interna-
tional, there is not only market risk, but the market characteristics influence the other risk groups.

Risk Assessments† within the Medical

Tourism Flow Identify Quality Gaps
Before embarking on a medical tourism strategy, hospitals typically coordinate a thorough demand
assessment. Creating quality programs for target markets requires risk assessments of the follow-
ing categories.
* Risk groupings taken from the Health Climate Calculator™, from Transparent Borders™ LLC (2010).
† The Risk Assessment methodology is drawn from the Health Climate Calculator™, from Transparent Borders™
LLC (2010).
 Quality and Safety Transparency  ◾  69

Market risk assessment requires a solid understanding of the market elements that could affect a
safe patient journey. These include regulations regarding medical device and pharmaceutical import-
ing, the level of healthcare innovation, as well as the importance of efficiency and effectiveness. For
example, if a patient elects to undergo knee replacement surgery in an international market, match-
ing the device regulations to the home market is critical both for follow-up care (a home doctor may
refuse to manage a complication on a device that is not accepted in the home market) as well as for a
positive medical outcome (if the inserted device fails in a shorter period of time than other options).
Another example is Singapore, which has a strong medical quality history including superior blood
management and supply protocols. However, the donor population could potentially be infected
with dengue,* adding a patient safety issue that might be important to an individual (who may
prefer to bring his own blood). Finally, matching legal liability differences may also be important to
identify, particularly if a patient is receiving care in a market with substantially different malpractice
regulations. Market risk affects all other risks (transition, medical treatment, and patient).
Transition risk refers to both the administrative management of the travel itself, as well as the
clinical components of ensuring fitness to fly/travel and coordinating medical follow-up when
the patient returns home. For example, a patient seeking bariatric banding may determine that the
procedure does not require any follow-up at home. However, both in terms of clinical outcomes
and creating transparency, all treatments are ideally discussed with the home provider to ensure a
complete patient history.
An important development in reducing transition risk of a medical tourism event is the advance-
ment of telemedicine. Telemedicine is defined as “the use of medical information exchanged from
one site to another via electronic communications for the health and education of the patient or
healthcare provider and for the purpose of improving patient care. Telemedicine includes consul-
tative, diagnostic, and treatment services.Ӡ Advancing telemedicine techniques will support the
globalization of healthcare by enabling the distant medical provider to follow up with the patient
directly rather than solely depending on the home provider.
Medical treatment risk identifies the potential hazards that arise from the treatment and include
a clinical and facility components. Here are four types of risk typically identified.

◾◾ System risk: The chance that a bottleneck in the hospital system will negatively affect patient
safety (e.g., patient discharge was delayed due to the attending physician being on vacation,
ensuring equipment use is understood and practiced regularly, use of checklists, practices to
manage similar sounding drug names)
◾◾ Medical risk: The hazard of the medical treatment itself (e.g., the chance of a poor medical
outcome, impact of comorbid conditions, new and available technology)
◾◾ Human management risk: the risk that the clinical expertise or sufficient patient care is not
available (e.g., the chance that the attending physician is not apprised of best practices for a
new surgery or medical technology)
◾◾ Infrastructure risk: the chance that something will go wrong due to poor infrastructure man-
agement (e.g., the patient had an adverse outcome because of the lack of necessary equip-
ment such as an MRI machine needed to diagnose a head injury and necessary treatment)

* Merriam Webster, www.merriam-webster.com/dictionary/dengue, an acute infectious disease caused by a flavi­

virus (species Dengue virus of the genus Flavivirus), transmitted by aedes mosquitoes, and characterized by
headache, severe joint pain and a rash—called also breakbone fever, dengue fever.
† Medicine.net website: http://www.medterms.com/script/main/art.asp?articlekey=33620 extracted November

2010.
70  ◾  Handbook of Medical Tourism Program Development

Patient risk for medical tourism treatments includes not only basic medical underwriting (e.g.,
assessing the individual risk of the treatment due to high body mass index (BMI), smoking his-
tory, chronic diseases, etc.), but also environmental underwriting (e.g., risks associated with the
home or medical tourism venue that could complicate a positive medical outcome including pol-
lution levels, infectious diseases, and food-borne illnesses), and personal preferences (e.g., if the
patient feels strongly about the country having a positive human rights track record, or if the
person is afraid of being away from family and friends for a long period of time). All of these issues
affect a patient outcome. With these risks effectively identified, the development of quality and
safety transparency begins.

Importance of Transparency in Managing Risks

Merriam Webster defines something transparent as being free from deceit or pretense, eas-
ily detected or seen through, readily understood, characterized by visibility or accessibility of
information especially concerning business practices.* The presence of transparency enables a full
assessment of issues in the open, so that both problems and successes can be identified and studied.
In the medical tourism context, transparency is important at the market level (where the medical
tourism event occurs) as well as at the patient level (what and how medical treatments and pro-
cesses occur).

Importance of Market Transparency

in International Medical Tourism
Market transparency in an international context refers to the extent of corruption or the existence
of gray markets† in a country. Transparency International (www.transparency.org) publishes an
annual Corruptions Perception Index providing insight into perceived corruption based on analysis
of myriad international data sources and opinion surveys from credible country experts and busi-
ness leaders.‡ Empirical work to quantify the economic extent of corruption in a market has been
limited; however, studies show that the more market corruption, the less investment and economic
growth in a country.§ This suggests that innovation and quality standards are less likely to be
present because there is reduced investment initiative. Translated, if healthcare quality is driven
by innovation and competition, a corrupt market could have a more difficult time achieving a
sustainable medical tourism strategy. However, there are examples of very successful (quality-
focused) medical tourism hospitals operating in corrupt markets. Market transparency, therefore
can be managed. Finally, without a reliable regulatory environment that can be trusted to manage
basic services, the quality of infrastructure and services in corrupt markets requires additional
verification.
Attracting patients from markets with high corruption levels, or seeking medical care in mar-
kets with a different corruption level is ripe for conflict. A critical component of a risk analysis

* Merriam Webster dictionary, extracted 15 Nov 2010 www.merriam-webster.com/dictionary/transparent.

† A gray market exists when solutions are created through unofficial means.
‡ Corruptions Perceptions Index 2010, “Short methodological note” http://www.transparency.org/policy_research/

surveys_indices/cpi/2010/in_detail#4 (November 18, 2010).

§ Mauro, Paolo, “Why Worry About Corruption,” International Monetary Fund, Economic Issues (6), 1997.
 Quality and Safety Transparency  ◾  71

Table 8.1  Market Transparency and Effect on International Medical Tourism Risk

Risk Category Some Market Transparency Matching Tasks

Patient Identify the difference between the home and medical tourism
destination corruption levels for possible communication or behavior
concerns

Medical treatment Identify differences in hospital and healthcare regulations between the
home and medical tourism destination and how market transparency
could affect (e.g., counterfeit medicines, using a medical device that is
not supported by evidence-based medicine, etc.)
Map the likelihood of an adverse event based on the identified market
differences

Transition Create a process to identify the impact of corruption on the transition

(medical and of care including evidence of home provider’s willingness to take care
geographic) of the patient upon return home.

includes understanding the difference between the patient market and the target medical tour-
ism market so that gaps are identified and addressed. Table 8.1 identifies some important issues
to consider.

Quality and Safety Transparency

With a solid understanding of the market demand and associated risks, hospitals can develop
quality-focused medical tourism programs. In healthcare, quality is often the umbrella term
for superior outcomes, but the Institute of Medicine (Crossing the Quality Chasm: A New Health
System for the 21st Century) expanded the idea by expressing the quality as the “degree to which
health services for individuals and populations increase the likelihood of desired health outcomes
and are consistent with current professional knowledge.*”
As a starting point in the quality discussion, a standard model of healthcare quality developed
by Avedia Donabedian focuses on structure, process, and outcomes. Specifically, effective struc-
tures and processes support positive medical outcomes.† This approach also states that the ultimate
medical outcome reflects all influences (even external) on the patient journey.
When adapting this concept to the medical tourism market, medical outcome evaluation will
have to address specific quality components in transitions of care. This theoretically includes patient
fitness to fly/travel as well as ensuring that the home physician is willing to provide follow-up care
and ways to measure the effectiveness of the process. A positive medical outcome that is compro-
mised through a poor transition plan will emerge as a poor medical outcome in spite of the effective
on-site medical treatment. Knowing specifically where the problem occurred (and why) increases
the likelihood of resolution. Furthermore, follow-up of a medical tourism quality program typi-
cally includes a longer tail than typically practiced, specifically up to 36 months post discharge.

* Institute of Medicine, Crossing the Quality Chasm: A New Health System for the 21st Century, National Academies
Press; 1 edition (July 18, 2001).
† Donabedian, A., 1988, “The quality of care: How can it be assessed” JAMA 260, (12); 1743–1748.
72  ◾  Handbook of Medical Tourism Program Development

Accreditation
Hospital accreditation seeks to improve healthcare delivery and quality of care. The concept is
broadly accepted by the international community including the World Health Organization
(WHO) which views accreditation as an important component of healthcare quality.*
Internationally, there are many hospital credentialing groups including: Trent Accreditation
Scheme (United Kingdom–Europe), Joint Commission International (JCI; United States),
Australian Council for Healthcare Standards International (ACHSI), and the Canadian Council
on Health Services (CCHSA). If your hospital strategy is focused on targeting one specific
country, consider the accreditation most closely associated with it. Additional domestic and
international safety standards include ISQUA (International Society for Quality HealthCare).
In 1999 it launched the International Accreditation Programme (IAP), designed to “Accredit
the Accreditors.Ӡ

Patient Safety
Patient safety focuses on prevention of errors leading to adverse events. This can include physi-
cal patient safety (avoiding slips and falls) and negative medical outcomes such as postsurgical
infections. Safety includes continuous identification of potentially harmful issues and methods to
measure and manage them.
Along with the vast quality credentialing and safety approaches, there are growing informa-
tion resources on the Internet that offer information on safety issues that potential patients can
access. These information sources may create both real and imagined quality obstacles that hospi-
tals should be able to address. Consider the availability of instant online information in the form
of “Google Alerts” and as well as the impact of country geography (tsunamis, pandemics, etc.).
Proactively identify, address, and communicate safety issues that may be present in your environ-
ment. Both hospital and patient safety initiatives primarily work to reduce medical treatment risk.

Quality Tools to Promote Transparency

There are international quality tools that support hospital quality and patient safety initiatives.
These generally focus on error prevention. Consider two general types of errors:‡

◾◾ Errors of ignorance: Mistakes occurring because there is insufficient knowledge

◾◾ Errors of ineptitude: Mistakes occurring due to inadequate use of available knowledge

Errors of ignorance can be reduced by research, knowledge sharing, and incentives to use best
international evidence-based medicine when treating a patient. Evidence-based medicine develop-
ment includes identifying clinical information needs, searching published objective literature for
findings, and application to a clinical pathway.§

* http://www.emro.who.int/mei/HA.htm
† ISQua website: http://www.isqua.org/accreditations.htm. Extracted 21 November 2010.
‡ Gawande, A., The Checklist Manifesto. Metropolitan Books; 1st edition (December 22, 2009).
§ Sackett, D.L.; Rosenberg, W.M.; Gray, J.A.; Haynes, R.B.; and Richardson, W.S. (1996). Evidence based medi-

cine: What it is and what it isn’t. British Medical Journal 312(7023):71–72.

 Quality and Safety Transparency  ◾  73

Errors of ineptitude can be reduced by adopting best practices through the use of checklists.
Checklists, or lists of items that need to be completed before completing a procedure, treatment, or
surgery, are a growing source of discussion in the medical field.* Sample surgical checklists (aimed
at transparency) collect information confirming patient status, specific steps required in the brief-
ing process, contingency plans with defined action items listed, as well as a debriefing of the episode
postsurgery including counting instruments. The World Health Organization offers a surgical safety
checklist and documentation in concert with the Institute for Healthcare Improvement (www.ihi.
org).† In both instances, transparency in information (defining the particular best practice), and use
of checklists (to identify action items) emerge as consistent with a best medical practice.

Risks and Rewards of Medical Tourism

Although most agree that quality and safety transparency are critical components of a medical
tourism journey, being transparent has benefits as well as drawbacks. Before the medical tourism
community commits to providing data on medical outcomes in both the short- and the long-term,
a first step is to accept relatively basic quality and safety approaches. Returning to the four identi-
fied risk groupings that quality initiatives can control, here are some practical recommendations.

◾◾ Market Risk
−− Depending on your strategy (general or selective medical tourism; domestic or interna-
tional patients) identify potential risks, and proactively manage.
◾◾ Transition Risk
−− Access evidence-based guidelines on fitness to fly or travel for medical care.
−− Ensure appropriate accommodations including culture-specific issues (local language televi-
sion) as well as physical site issues (telephone in the bathroom, wheelchair accommodation).
−− Identify potential transition risks including: pharmaceutical management (pre- and
posttreatment), local regulations regarding durable medical equipment or medical
device sourcing.
−− Create a standard process to communicate and confirm follow-up treatment with the
local provider, including follow-up assessments up to 36 months post discharge
−− Create measurements to identify (internally) management of the transition risks (both
clinical and geographic).
◾◾ Medical Treatment Risk
−− If checklists are part of the surgical process, document which were included and affect
patient safety, evaluate impact of use on patient outcome.
−− Identify best practices for the procedure, treatment, or intervention and the general
clinical pathway.
−− Create a case management protocol for internal use to identify clinical and social issues
potentially impeding a positive medical outcome.
◾◾ Patient Risk
−− Identify medical, environmental, and personal preference risks specific to your hospital
strategy.

* Gawande, A.l, The Checklist Manifesto, Metropolitan Books; First Edition (December 22, 2009). New York, NY.
† W H O   S u r g i c a l   S a f e t y   C h e c k l i s t :   h t t p : // w w w. i h i . o r g / I H I / P r o g r a m s / I m p r o v e m e n t M a p /
WHOSurgicalSafetyChecklist.​htm (extracted 22 November 2010)
74  ◾  Handbook of Medical Tourism Program Development

With these four risk groupings evaluated and proactively managed prior to the medical treatment,
assess medical outcomes posttreatment.

Measuring Outcomes
Medical approaches are affected by culture. From the practice of alternative treatments in China,
to the aggressive medical treatments in the United States,* understanding the medical approach
(and managing patient expectations) is important to a long-term positive outcome. Although it is
difficult to separate the physician from the culture, the impact on outcomes is even less obvious.
For this reason, the mapping of both clinical as well as patient satisfaction rates is critical to the
growth of the industry.
Overall health outcome measures refer to the impact of the treatment on the patient (all things
being equal). For medical tourism treatments for the general population, collect data on three
aspects of medical tourism: (1) medical outcomes, (2) patient improvement and functional health,
and (3) patient satisfaction.
Each hospital may collect outcome data on specific issues; however, for potential comparison
purposes in the medical tourism arena, the following medical outcome data are suggested:

◾◾ Surgical site infection rates: Postoperative infection is a major cause of patient injury, mor-
tality and healthcare cost. Specifically, in the United States:†
−− An estimated 2.6% of 30 million operations are complicated by surgical site infections
(SSIs) annually.
−− Infection rates up to 11% are reported for certain types of operations.
−− Each infection is estimated to increase a hospital stay by an average of 7 days and add
over $3,000 in charges (1992 data).
−− Appropriate preoperative administration of antibiotics is effective in preventing infection.
◾◾ Readmission rates within seven and 30 days (both for initial diagnosis as well as any other
diagnosis): Readmissions are an important quality metric pointing to potential quality issues
in the initial patient stay. Categorizing the type of readmission (related and nonrelated to
the initial admission) is important to capture, as it provides insight into both quality and
population characteristics. As an example, the Mayo Clinic defines a hospital readmission
as a patient admitted to a hospital within seven days after being discharged from an earlier
hospital stay. The standard benchmark used by the Centers for Medicare and Medicaid
(CMS) is the seven-day readmission rate. Rates at the 75th percentile or lower are considered
optimal by CMS.‡
◾◾ Mortality rates and discharge status: to capture patients discharged to home, or to hotel or
a long-term care facility. Basic discharge status options: discharged to home, discharged to
hotel, discharged to rehabilitation, and death.

There are challenges collecting these data,§ particularly if hospitals are not required to provide
them to a regulatory body. If the results are not audited, assessing validity and reliability can be
* Payer, L.. Medicine and Culture, New York: Holt Paperbacks (November 15, 1996).
† Institute for Healthcare Improvement: http://www.ihi.org/IHI/Topics/PatientSafety/SurgicalSiteInfections/
(extracted 22 November 2010).
‡ Mayo Clinic website: http://www.mayoclinic.org/quality/readmission-rates.html (extracted 24 November 2010).
§ Any analysis of medical outcomes requires a robust assessment of demographics and diagnoses to ensure case

mix adjustments accurately reflect population differences.

 Quality and Safety Transparency  ◾  75

problematic, particularly in corrupt markets. This could discourage sharing outcome data pub-
licly. One alternative is to give an international governing group the authority to verify the veracity
of results, so that there is a perceived fair environment. Alternatively, objective and licensed third-
party administrators or licensed insurers could also fulfill this role.
Assess patient satisfaction and functional status. For patient improvement and functional status,
consider using the Short Form 36 (SF 36) questionnaire (developed by RAND) at both pre- and
posttreatments. The SF 36 surveys patient health and is used in economic studies as a variable in
the calculation of a Quality Adjusted Life Year (QALY). QALYs are used in studies to measure the
cost-effectiveness of procedures or treatments.
The original SF 36 was constructed by the RAND Corporation (http://rand.org) and is a
multipurpose survey profiling both functional health and well-being. It is a generic measure rather
than disease- or age-specific. The questionnaire has been translated in more than 50 countries as
part of the International Quality of Life Assessment (IQOLA) Project.*
The SF survey evaluates patient health from the following perspectives: health perception (and
change over time), physical limitations and impact on personal life, personal mental health (feel-
ings of negativity or uselessness), and the individual’s perspective on physical impairments. A
critical advantage of the SF approach is that the survey has been tested in multiple languages. This
enables the beginning of documentation regarding health improvement (or deterioration) upon
completing a medical tourism treatment. This approach, therefore, includes a cultural sensitivity
that may be lacking in other methodologies.
Patient satisfaction surveys should be designed to address the specific medical tourism grouping
(general or selective) as well as venue (domestic or international). Surveys should include satisfac-
tion with the medical treatment, the medical outcome, the provider’s capabilities and communica-
tion, the hotel or rehabilitation accommodations (functional, social, and longevity), and the ease
of transitioning back home to receive follow-up care.
Although follow-ups after 7 days and 30 days after discharge occur, for the medical tourism
patient, perform overall follow-ups for up to 36 months posthospital discharge to ensure solid
understanding of issues in health, transitioning care, follow-up treatment, and any personal behav-
ioral changes as a result of the experience.
An additional aspect to medical outcomes analysis particular to medical tourism is to profile
the demographics of your patient base. This information enables retrospective review of market
characteristics, which can be linked to patient outcomes. Specifically, track the following demo-
graphic data:
◾◾ Reasons for medical tourism event: where the medical tourist emerged and reason he or she
sought medical tourism
◾◾ Insurances: insurances held (or not; including travel insurance)
◾◾ Travel history: passports held, languages spoken, last time on a flight, frequent flyer status,
general use of Internet to book travel, and so forth
◾◾ Preferences and fears: country requirements (e.g., human rights or personal safety), personal
concerns/fears. Fears are important to identify as they may impede an otherwise healthy
medical outcome and include issues such as, “I am worried I will not understand my doctor,
fearful of the long flight, and missing my family and friends.”
With these cumulative data, hospitals can identify quality gaps and opportunities to proactively
address patient concerns and preferences.

* SF-36.org, http://www.sf-36.org/tools/sf36.shtml extracted November 15, 2010.

Chapter 9

Risk Management and

Liability Mitigation in the
Medical Travel Industry

This chapter contains the opinions, analysis, and statements of the author. It is the
responsibility of every reader to evaluate the accuracy, completeness, or usefulness of
any information, opinion, advice, or other content contained in this chapter.

Tracy H. Simons
President, Custom Assurance Placements, Ltd.

How does the liability exposure of the medical travel industry affect you? The question that seems
to be on everyone’s mind is,“What if something goes wrong for a medical traveler?”
Stakeholders have done a good job in setting standards of care for the medical travel industry.
There is an AMA recommendation on the topic of medical tourism. In addition there are many
other studies and scholars who have explored and published findings about the criteria for setting
benchmarks for quality care in the medical travel industry. Stakeholders are using provider cre-
dentialing tools, developing procedures for medical records, hiring medical professionals to advise
patients, implementing privacy protections, and introducing many other services to provide high-
quality care and service to medical travelers. However, the industry is still in the developmental
stages of setting self-regulating guidelines to determine what the quality and safety requirements
should include and where the liability for administrators, facilitators, hospitals, employers, and
individuals begins and ends.
It has taken several years to develop insurance solutions that provide coverage for all the
aspects of liability for all the stakeholders involved. The products are continuously changing as
claim exposure is realized through loss experience and exposures are assessed and understood in
international settings. What are the known exposures?

77
78  ◾  Handbook of Medical Tourism Program Development

◾◾ The Individual Medical Traveler

−− Unforeseen expenses from a medical complication
• Immediate and long-term expenses
−− Additional expenses of unforeseen emergent care or corrective care once the patient
returns home
−− A medical malpractice occurrence
−− An accident that occurs in the course of travel to and from a medical destination
◾◾ Facilitators, Receiving Hospitals and Employers
−− Both direct and indirect or vicarious liability associated with a mishap from implement-
ing a medical travel benefit or managing a person’s healthcare

The individual will look to a “professional advisor” (i.e., facilitator), receiving hospital, or
employer to solve unforeseen problems during the course of travel or while under care. He or she will
have an expectation of knowledge that is assumed from verbal and published descriptions of service,
from descriptions of high-quality medical care, and from any other direct, implied, or assumed level
of expertise that is expected by the client. This exposure is called “managed healthcare liability.”
Managed healthcare liability, broadly defined, includes services and activities performed
whether by the organization itself or performed by others on the organization’s behalf (vicarious
liability) and it includes these activities whether they are provided on paper, in person, electroni-
cally, or in any other form.
Services and activities include all of the following:

◾◾ Provider selection
◾◾ Utilization review
◾◾ Care coordination
◾◾ Advertising, marketing, selling, or enrollment for sponsored benefit plans
◾◾ Claim services
◾◾ Establishing provider networks
◾◾ Reviewing the quality of medical services or providing quality assurance; design or imple-
mentation of financial incentive plans
◾◾ Wellness or health promotion education
◾◾ Development or implementation of clinical guidelines, practice parameters, or protocols
◾◾ Approval of payment for covered medical services or directives on what services would
be allowable
◾◾ Services or activities performed in the selection, administration, servicing, or management
of, including but not limited to, handling records in conjunction with such plans, or affect-
ing enrollment, termination, or cancelation of coverage for participants under such plans.

In the medical travel arena, this can be broadened to include other aspects of the services
provided by a medical travel service stakeholder, and then adding the exposure of an interna-
tional setting.
Risk management provides a solution, and a venue to stand out from the competition. There
are two lines of defense, liability insurance and accident insurance. Insurance has helped indus-
tries be on the developing edge of emerging markets by allowing those at risk to transfer it to an
insurer. This is evidenced from the first ship that was insured from a coffee house in London,
which later became known as Lloyd’s of London.
 Risk Management and Liability Mitigation in the Medical Travel Industry  ◾  79

◾◾ Liability Insurance
−− Managed healthcare liability
• Includes vicarious liability—the liability associated with the act of another party.
• Includes defense costs.
• Includes damages and settlements.
• Is available from a few carriers in the United States.
• You will need a local representative to purchase this type of coverage in your home
country.
◾◾ Accident Insurance
−− First-party coverage
• These types of policies do not require one to recover from an at-fault party. The
claimant is also the insured.
• Claim payments are intended to make the injured party whole and mitigate the need
for a lawsuit against an at-fault party.

Accident insurance has long been used as a risk mitigation tool. Your everyday and common liability
policies include a no-fault accident benefit for the purpose of mitigating a liability claim proceeding.
Note: Be careful when assuming that a regular travel accident policy will meet the needs of a medical
traveler. There are specific exclusions on travel accident policies for persons traveling for the purpose
of receiving medical care. There is also no coverage for complications on these policies. Furthermore,
specially designed medical travel accident policies vary greatly in what they will cover. Make sure
that you explore and compare the policies and know the strengths and weaknesses of each.
Here are some types of coverage typically on a medical travel accident policy.

◾◾ Additional medical or surgical treatment as the result of a complication

◾◾ Accidental death and dismemberment
◾◾ Disability
◾◾ Repatriation of mortal remains
◾◾ Family coordination
◾◾ Household modification
◾◾ Loss of reproductive function
◾◾ 24/7 International assistance service

Coverage can also include an accidental injury not associated with the procedure: that is, the
taxi accident or trip and fall that could be blamed on the result of traveling for a medical procedure.
Who is buying this coverage?

◾◾ Individuals: alone or through medical travel facilitators, appointed agents or directly

online
◾◾ Groups
−− Employers are providing this for all employees when they utilize the medical travel ben-
efit on their group plan
−− Hospitals/facilitators are including the coverage on every patient to mitigate liability
exposure
 SECȚIUNEA 2
ETICĂ ÎN COMUNICAREA CU PACIENȚII
SUBTEMELE: 2.1, 2.2, 2.5, 2.6
 SPERLING, Daniel (2008), Law and Bioethics: A Rights-Based Relationship and Its
Troubling Implications; în Michael Freeman (2008), Law and Bioethics: Current Legal
Issues, vol. 11; Oxford University Press, Oxford, pp. 52-78.

 BREEN, Kerry J. & Stephen M. Cordner & Colin Jh. Thomson & Vernon D.
Plueckhahn (2010), Good Medical Practice. Professionalism, Ethics, and Law, Chapter 3:
„Communication Skills”; Cambridge University Press, Cambridge, pp. 33-48.

SUBTEMELE: 2.3, 2.4

 BREEN, Kerry J. & Stephen M. Cordner & Colin Jh. Thomson & Vernon D.
Plueckhahn (2010), Good Medical Practice. Professionalism, Ethics, and Law, Chapter 4:
„Consent and Informed Decision Making”; Cambridge University Press,
Cambridge, pp. 49-58.

ÎNTREBĂRI
Q1. Un medic de familie obișnuiește să țină ușa de la cabinet larg deschisă pe
parcursul discuțiilor cu pacienții. Este un obicei pe care foarte puțini pacienți l-au observat,
iar aceștia închid ușa de fiecare dată când intră în cabinet. Între cabinet și sala de așteptare
este o distanță foarte mică, de numai 1 metru. Există rațiuni pentru care medicul să fie
blamabil din punct de vedere moral?

Q2. Un pacient a ajuns la medicul stomatolog după o seara de petrece, încă amețit
de aburii alcoolului. Acesta are un comportament agresiv, ceea ce îl deranjează pe medicul
său, care decide într-un final să respingă efectuarea unui consult de urgență pentru un
abces destul de grav. Ca urmare, medicul îi dă fișa medicală pacientului și îl poftește să
părăsească spațiul cabinetului, lucru care se și întâmplă. Este acest comportament unul
corect din punct de vedere moral?
3 COMMUNICATION SKILLS

hapter 1 emphasised how respect for patient autonomy has become more
C central to the doctor–patient relationship while beneficence has been dimin-
ished in importance because of its paternalistic overtones. Effective commu-
nication strengthens patient autonomy by enhancing understanding and is
essential for good medical practice. It is the means of history taking, obtain-
ing consent for examinations and procedures, and explaining diagnoses and
treatment. Effective communicators are able to establish rapport, trust and
confidence with patients more easily than ineffective communicators, thereby
enhancing the flow of crucial information and increasing the likelihood that
advice will be heeded. Effective communication decreases the likelihood of
complaints [1], acrimony or legal action if adverse events occur [2–3]. Good
communication skills alone are not sufficient for professional medical prac-
tice and must be accompanied by clinical competence, empathy and ethical
behaviour [4]. Good communication skills are also a necessary prerequisite if
the doctor is to provide effective leadership of the ‘health-care team’.
Effective communication also improves the quality of health care [5–6] and
can have a very positive effect on the satisfaction gained from a consultation by
both doctor and patient. Breakdowns in communication are the most common
basis of patient dissatisfaction. Surveys show that dissatisfied patients criticise
their doctor for not listening, for not providing adequate explanations or for
appearing disinterested. Satisfied patients perceive their doctor to demonstrate
humaneness, understanding, ability to listen without hurrying the patient, and
the skill of involving the patient in decision making [7–9]. Poor performance
in communication skills as assessed at licensing examinations in Canada pre-
dict complaints to medical boards [1], a finding consistent with the fact that
failure of communication underlies the majority of complaints made against
doctors (see Chapters 7 and 8). The opportunity for a patient to exercise
his or her autonomy is undermined when a doctor is a poor communicator
or appears to be unapproachable or unwilling to respond to the questions
or concerns of patients. A large proportion of problems of a medico-legal

33
34 Good Medical Practice

nature which arise in clinical practice are generally precipitated by the latter
factors [10]. Even the tone of the surgeon’s voice has been shown to correlate
with malpractice claims [11].
A traditional perception has been that the possession of good communica-
tion skills (‘a good bedside manner’) was innate, but it is now well accepted that
effective communication is a clinical skill that can be taught and practised [7–8,
12–13]. Doctors who graduated prior to the provision of teaching in these skills
had to learn their communication skills ‘on the job’ and from good role mod-
els. Role models remain an important influence on students and young doctors,
although negative effects may also result [14]. Workshops in communication skills
for doctors in practice are available from a variety of sources.
This chapter highlights obstacles to communication, describes key skills for
effective communication and provides advice in regard to such matters as the
use of interpreters, how to respond when patients are angry or when things have
gone wrong and how to approach sensitive issues such as discussing sexuality.
The chapter briefly mentions the importance of good written communication but
Chapter 6, on medical record keeping, should also be consulted.

3.1 OBSTACLES TO EFFECTIVE COMMUNICATION

Obstacles to good communication may relate to a lack of skills and/or to a poor
attitude of the doctor, to factors in the clinical practice setting, or to the patient’s
own communication issues. These matters are well outlined in a 2004 publication
of the National Health and Medical Research Council entitled Communicating
with Patients: Advice for Medical Practitioners [15].

3.1.1 Doctor-related obstacles

The reasons why some doctors are poor communicators include:
r lack of training in communication skills
r inadequate role models during training
r lack of insight into communication deficiencies
r lack of time in clinical practice
r misapprehensions or subconscious anxieties (for example, the anxiety not
to create patient dependence, or discomfort at the inability to cope with
information that might arise when a patient has the confidence to be frank) –
these anxieties can translate into curtness, professional detachment or
authoritarianism
r lack of attention to emotional content in the consultation
r unresolved emotional and psychological problems of the doctors themselves
 Communication skills 35

r upbringing and obtaining initial medical education in a culture different from

that of the patient, combined with insensitivity to or lack of awareness to
cultural differences
r inadequate attention to practice administration.
In addition, the doctor’s own emotions can interfere with communication [16]
while the purpose of the examination (for example, clinical care as a treating
doctor versus medico-legal assessment as an independent medical examiner) can
also influence the effectiveness of communication.
A common doctor-related reason for communication failure observed by med-
ical boards and health complaints agencies is lack of insight; that is, doctors are
unaware or deny that their style of communication is negatively perceived by their
patients. Lack of insight has been shown also in a study of medical students where
students’ confidence in their communication skills was negatively correlated with
their actual skills independently assessed via videotaped interviews with simulated
patients [17].
Another reason for communication difficulty is a mismatch between the pa-
tient’s expectations and the doctor’s communication style. Many doctors assume
that patients prefer a doctor who is confidently in control of the consultation
(paternalistic in style), whereas many patients anticipate a more equal patient–
doctor interaction. Such patients will respect doctors for their expert knowledge,
but in return expect the doctor to respect their autonomy and right to make their
own informed decisions about their health care [9]. Determining the patient’s
expectations in this regard, early in a consultation, is an important communication
skill. Judgment in responding to those expectations is an important additional
professional skill.

3.1.2 Obstacles in the clinical setting

The adequacy of the waiting area, the attitude of reception staff to the patient and
the physical surroundings of the consulting room may affect the subsequent com-
munication between patient and doctor. Good communication may be impeded
by failure to ensure a comfortable and secure environment that meets the need for
privacy. The consulting room should be soundproof and staff instructed to knock
before entering.
Some doctors consider that a desk between patient and doctor is a barrier to
communication, but individual practitioners need to decide what is comfortable
and appropriate for the nature of their practice. Computer use can also be a barrier
to effective communication. Use should be limited to what is essential within the
consultation. If the patient cannot see the computer screen, an explanation of
what the doctor is viewing may be appropriate. Some interruption to take essential
telephone calls about clinical matters is unavoidable for most doctors, but every
36 Good Medical Practice

attempt should be made to minimise this. When calls are taken, an explanation or
apology should be made to the patient who is with you and consideration given
to the need to move to another telephone. As described later, time constraints,
real or anticipated by the patient, can also interfere with communication.

3.1.3 Patient-related obstacles

Readily recognisable factors include differences between doctor and patient in
age, gender, social class, level of education, ethnic background, language barriers
and variations in patients’ attitudes and emotional responses to their illness. Other
factors include the effects of illness or medication, embarrassment, intimidation
related to the setting and difference in status between patient and doctor, the
use of medical jargon, reluctance to ask questions and patient concern over time
pressure for the doctor [15]. These barriers can be reduced by the doctor by such
steps as asking questions designed to elicit a patient’s understanding and by taking
care to explain the doctor’s understanding of the health issue at hand.

3.2 THE USE OF COMMUNICATION SKILLS

IN MEDICAL PRACTICE
Most doctor–patient interactions occur within the consultation. Of the several
separate skills used during the consultation, all except one are critically dependent
on effective communication. These skills are the:
r clinical skill of history taking and physical examination
r diagnostic skill of formulating an hypothesis and pursuing it effectively
r skills involved in explaining the diagnosis and proposed management, includ-
ing obtaining consent (see also Chapter 4)
r skill of patient education
r skill of effective prescribing
r skill of counselling in some clinical settings.
All of the above skills are capable of being learned and improved. They are skills
that need to be accompanied by perceptiveness and an attitude that conveys to
the patient respect, sensitivity and empathy.

3.2.1 Starting a consultation: putting the patient at ease

The technique used will vary according to the setting and the clinical problem. An
essential first step is to ensure that the patient is aware that the doctor has seen
and acknowledged him or her as a whole person before the doctor tackles the
clinical problem the patient presents. The introduction should make the patient
feel welcome and as comfortable as possible. Doctors should introduce themselves
by name, but should be aware of unconscious signals of power imbalance even
 Communication skills 37

at this stage; ‘Hello Mary, I’m Dr Smith’ sends a different message from ‘Hello
Mrs Jones, I’m Dr Smith’.
Pre-reading existing records or a letter of referral before the patient is brought
into the consultation room allows the conversation to begin immediately, permits
maintenance of eye contact at a crucial time, shows respect for the patient and
avoids the impression for review patients that the doctor may have totally forgot-
ten them. A helpful open introductory question such as ‘Perhaps you can tell me
in your own words what brings you to see me today’ or ‘How can I help you?’ or
‘How have you been since I last saw you?’ should be used to open the consulta-
tion. A broad opening question is more inviting and ultimately more productive
than a closed question.
Having commenced the consultation, it is important to avoid premature con-
trol of the flow of spontaneous information by the use of direct and closed ques-
tions. Studies have shown that doctors interrupt patients on average within twenty
seconds of the start of the consultation. The same studies have demonstrated that
patients are able to convey their issues adequately if the doctor permits them to
express themselves in an uninterrupted fashion for 90–120 seconds. Such listening
improves patient satisfaction and improves the quality of the communication [18–
19]. Premature interruption of this phase of the consultation is likely to prevent
the expression of the patient’s real concerns and may lead to the doctor focus-
ing on irrelevant matters. In addition, early interruption reduces the chances of
establishing good rapport and trust. There are exceptions to this general advice,
as one’s approach needs to be modified for garrulous or demented patients and in
emergencies.

3.2.2 Active listening

An active listener is able to learn more than just what is contained in the spo-
ken words [15–20]. Active listeners maintain eye contact and ask open-ended
questions. They are attuned to tone of voice, demeanour, vocabulary, gestures,
linguistic pattern and non-verbal messages. It has been estimated that more than
half the information communicated in a consultation is by non-verbal means.
Body language is a major element of non-verbal communication. Doctors need
to be aware also of their own body language (posture, eye contact, fiddling and
other actions). For those who have computerised their medical records, this must
include taking care that the patient and not the computer screen is the focus of
attention.
An active listener also conveys to the patient that the patient is being seen,
heard and understood. This may require verbal acknowledgement when distress
is apparent (for example, ‘I see this distresses you’). Silence with maintained eye
contact or a simple nod of the head will also convey empathy. Limited verbal
encouragement such as ‘Uh-huh’ or ‘Yes’ assures the patient you are listening and
38 Good Medical Practice

wish them to continue. Summarising briefly back to the patient also reassures the
patient that the doctor has listened effectively, as well as providing the patient
with the opportunity to correct any misunderstanding.

3.2.3 Lack of time

Most patients are aware of time constraints on doctors. The duration of a con-
sultation alone is virtually never the cause for complaint; it is the perception of
being rushed. Patients perceive the consultation to be rushed if they are not lis-
tened to, are frequently interrupted, or observe body language that suggests the
doctor is anxious to be elsewhere. Complex problems that clearly require more
listening time are best addressed by a frank explanation and an offer of another
appointment when sufficient time will be available.
In the hospital setting, the doctor who stands at the end of the bed when
communicating may send the following message to a patient: ‘I have no time to
sit and listen and I want to stay near the door so that I may move off quickly’.
Conversely where the doctor takes a chair by the side of the bed or, with the
patient’s permission, sits on the edge of the bed clearly sends a warmer message,
which is, ‘What you have to say is important to me and I will take the time
to listen’. This may take no longer and will enhance communication with the
patient [21].

3.3 APPRECIATING PSYCHO-SOCIAL FACTORS

IN PATIENTS WHO SEEK MEDICAL HELP
The primary emphasis of the science-driven, disease-based Western medical model
is on establishing a diagnosis and treating that disorder or relieving its symptoms.
This is appropriate and effective for many physical illnesses but has severe lim-
itations when a doctor is faced with a person whose symptoms are probably
secondary to personal, psychological or social pressures and difficulties. In addi-
tion, physical illness is often accompanied by psychological distress and social
consequences. In many spheres of practice more than half the patients present-
ing to doctors will not have a physical illness and can be recognised as suffering
from tension, anxiety, depression or functional or somatoform disorders. The
strongest material that will assist doctors in recognising these presentations and
the most effective means of helping relieve their distress is to put greater effort
into communication to find out more about the patient and the personal envi-
ronment that has set the scene for the development of these symptoms. Studies
have shown that many doctors avoid engaging in the social and psychologi-
cal dimensions of patient’s problems but that, where they do so engage, better
outcomes are achieved [22]. Doctors who feel that this approach to communica-
tion and history taking should be the province of psychiatrists and psychologists
would be well advised to read the original work of Balint [23] or enlightening
 Communication skills 39

books by Hislop, an Australian physician [24], and Barbour, an American physi-

cian [25].

3.4 THE PHYSICAL EXAMINATION

Communication skills are also an essential element of this part of the consultation.
Medical students and new graduates soon become inured to the breach of privacy
involved in physical examinations such that patient anxiety and vulnerability may
be overlooked. All new patients and most review patients should be interviewed
before being asked to undress. When a proper examination requires that the
patient undress, the need for this should be explained and the doctor should
leave the room or direct the patient to an adequately screened area. A gown and/
or a cover sheet should be provided, depending upon the examination to be
undertaken. There are certain situations when even greater care must be taken
in explaining the need for and nature of the examination, obtaining consent and
providing for privacy (and sometimes a chaperone). These include any intimate
examinations (for example, breast, vaginal or rectal examinations), especially
where the patient is young or may never have experienced such an examination
or where the patient is new to your practice. It also includes the examination of
some patients from different cultural backgrounds (see also Chapter 4 on consent).
To reduce the anxiety experienced by patients during examination, it may be
useful to engage the patient in conversation, for example by completing elements
of history taking in regard to family, past medical or social history. Alertness to
non-verbal communication is also a skill to be valued during the examination (for
example, the first evidence that an area of the abdomen is tender when palpated
may come from the patient’s facial expression, not from any comment or response
to a question).

3.5 TRANSCULTURAL ISSUES AND THE USE

OF INTERPRETERS
Living in multicultural Australia means that most doctors will encounter patients
with different backgrounds from their own. While these patients will not expect
the doctor to have a great knowledge of or understanding of their language and
culture, the doctor–patient relationship will be enhanced if the doctor clearly
shows respect for these differences. This can be demonstrated in small ways such
as by asking questions of their country and its heritage, by indicating knowledge
of their country of origin, or by taking additional trouble to ensure that the patient
is fully understood.
As a medical consultation involves the exchange of complex and subtle infor-
mation, the barrier of language needs to be reduced by the use of interpreters,
especially when obtaining consent for treatment (see also Chapter 4). Ideally the
interpreter should be properly trained and, if requested by the patient, of the
40 Good Medical Practice

same sex as the patient. Family members or other hospital staff should not be
used to interpret medical information. Where in an emergency this is unavoid-
able, a qualified interpreter should be called as soon as practicable after the event
to ensure that accurate information has been obtained. Contact details for access
to telephone interpreters are provided in Chapter 15.
Using an interpreter appropriately is a skill that needs to be learnt. Medical
interpreters undertake formal training of which doctors should be aware (see
Chapter 15). Problems may arise if the language of the patient has not been cor-
rectly identified and if the interpreter has not been arranged in a timely manner. It
may be appropriate to provide the interpreter with some background information
about the patient and the purpose of the consultation. The interpreter should be
introduced by name to the patient and his or her role explained. When using
an interpreter, the questions and eye contact should be directed at the patient,
not at the interpreter. Questions should be brief or, where this is not possible,
care should be taken to break up the passages to be interpreted. In addition, the
doctor should be alert to signals from the interpreter that he or she is being over-
loaded and to any hint that the patient is not comfortable with the interpreter
[26–28].
For doctors working in areas where a large proportion of their patients are
Aboriginal or Torres Strait Islander, or are drawn from cultural groups new to
Australia, information about their culture and beliefs, especially as this might
pertain to issues around health and health-care practices, should be regarded as
essential. Several helpful articles and books on these topics relating to Aboriginal
or Torres Strait Islander and immigrant Australians are listed at the end of this
chapter.

3.6 CONCLUDING THE CONSULTATION

This aspect of the consultation is especially important if there is not to be ongoing
regular contact with the patient or when new and serious diagnostic information
is being provided. This information needs to be conveyed slowly in simple terms
and, if possible, the doctor should ensure that the patient has understood. Note
taking and/or the presence of a relative or close friend should be encouraged.
Where medical jargon is unavoidable, it needs to be explained, or written down
such that the patient can look up the meaning again later. A wise doctor presumes
no prior knowledge at this point even when the patient is another doctor or health
professional. Encourage and be responsive to any questions asked by the patient
or any accompanying person at this point in the consultation. Not every question
in medicine can be answered and it is reasonable to say ‘I don’t know’; patients
are usually able to tolerate a degree of uncertainty. Doctors also need to be
aware that the manner in which the uncertainty is conveyed may be unsettling to
patients [29].
 Communication skills 41

It is human nature to be optimistic, but optimism without discernment in the

consulting room is misplaced. Thus care must be taken not to imply or promise
outcomes that cannot be delivered. It is also human nature to transfer one’s own
feelings to others and assume that the person would feel as you would in their
situation; doctors must avoid judging or criticising the actions or behaviour of
patients according to their own personal standards or beliefs. It is wise to antici-
pate that patients will not recall or will only selectively recall what you tell them,
particularly if the information is unexpected or distressing. If the information is
critical, then taking the trouble to write it down and arranging to see the patient
again, or ensuring that a relative or friend is present, is strongly advised. This
will assist the patient to assimilate information that was not immediately taken
in because of emotional distress. If appropriate, conclude the consultation with
an anticipation of the outcome of the illness and clear instructions in regard to
follow-up.

3.7 COMMUNICATING WHEN THINGS GO WRONG

Special attention to communication is needed when an unexpected or adverse
outcome or event transpires in medical practice. It is essential in such situations
to be open and frank in communicating with patients and their families. This
should involve telling the patient as early as possible that something untoward
has occurred. In so doing it is important to acknowledge any patient distress and
to express concern and regret, without admitting any wrongdoing or liability. The
latter advice is based on the requirements of indemnity insurers as well as the fact
that the doctor is not in a position to make such a judgment, especially ‘in the
heat of the moment’ [30–33].
Changes to medical negligence laws reinforce this concept of ‘open disclosure’
(see Chapter 7).

3.8 COPING WITH ANGRY PATIENTS

One of the most challenging situations even for experienced doctors is dealing
with angry patients, especially those angered because their complaints have been
ignored or badly handled. As Niselle has wisely written, in such situations ‘the
patient is allowed to be irrational, illogical, emotional and accusatory, but the
doctor is meant at all times to be fair, reasonable, dispassionate, measured, and
above all, professional’ [34]. Key elements in responding include making time
available as early as possible to meet with the patient, acknowledging the person’s
distress, making genuine attempts to respond positively to the complaint (which
may include referring the person to the relevant complaints agency if you are
unable to conciliate the issues) and giving the patient some power in the resolution
of the complaint [30–31, 35].
42 Good Medical Practice

3.9 MEDICO-LEGAL EXAMINATIONS

Proportionately more complaints to medical boards and health complaints agen-
cies arise from this field of practice than any other. The reasons include the
absence of the usual patient–doctor relationship, the need for the doctor to pro-
vide a detailed report to a third party and the underlying concern of the patient
that the report may be not favourable. This topic is discussed in more detail in
Chapter 25.

3.10 TOUCHING PATIENTS

Physical touching is another form of human communication. Touching a patient
without consent is an assault (or more precisely in legal terms ‘battery’), yet touch-
ing is a very human means of conveying concern and warmth and is very much
part of the healing role of doctors, nurses and other health professionals. During
any physical examination, touching is permitted because the patient has given
consent, usually implied, for the examination to occur (hence the advice above
to explain such examinations before conducting them). However, there are other
times during a consultation when touching may be appropriate and helpful, for
example if a patient is distressed by receiving bad news. There is no way in which
specific advice can be given as to when touching, for example holding a hand or
placing an arm around a shoulder, is safe or appropriate. It is more likely to be
safe and appropriately interpreted if a third party is present, if the patient is clearly
distressed, if the patient is well known to you and if it is timely yet brief. Doctors
also need to be alert to the patient’s reactions to being touched, especially if neg-
ative, or inappropriately positive. A very helpful discussion concerning touching
as an aspect of communication is given by Myerscough [36].

3.11 TALKING ABOUT SEX AND SEXUALITY

As sexual difficulties can themselves bring patients to doctors or can complicate
other illnesses, the need for doctors to be competent in seeking information in
this sensitive area is self-evident. While it is not necessary nor justified to include
questions about sexual function in every medical interview, doctors should be
alert to clinical situations where sexual difficulties are more likely, including
patients presenting with gynaecological problems, with symptoms suggesting a
sexually transmitted disease, with marital problems, with certain disorders asso-
ciated with sexual dysfunction and after certain types of surgery (such as mastec-
tomy, colostomy or ileostomy). Introducing questions of this nature should not
be done until rapport has been established and should always be preceded by a
simple explanation as to why the questions are regarded as necessary. This simple
 Communication skills 43

explanation will prepare the patient and at the same time make it clear that the
doctor is comfortable in having such a discussion.

3.12 TALKING WITH THE DYING

Most doctors will at some time in their careers have the task of conveying infor-
mation about serious illness to patients. A smaller proportion will be involved in
the ongoing care of the terminally ill. The development of oncology and palliative
care services and the hospice movement may have suggested that only specialists
need training in communication in these areas. However, all doctors in clinical
practice should be able to convey information about serious illnesses to patients
with sensitivity and with awareness of the needs of patients with fatal illnesses
[37–38].
The task of conveying bad news has already been touched on above where
it was emphasised that adequate time must be made for this, privacy must be
assured, the patient should be encouraged to have a relative or friend present and
an early follow-up appointment offered [15]. On receipt of bad news, patients
typically respond over time with a sequence of denial, anger, bargaining, depres-
sion and then acceptance [39], a sequence of reactions that may vary in its pace of
evolution, and with overlap of the reaction phases. Very rarely, denial dominates
the entire final illness [39]. Denial is to be appreciated as an important mechanism
whereby patients cope with the news of their mortality. Doctors who deny their
own eventual mortality may have the greatest difficulty in coping effectively in
communication in this area [39].
In this clinical setting, doctors must be sensitive to the stage each patient is
at and not try to provide information until the patient wishes it. As stated by
Charlton, ‘the most important issue is not what most patients or doctors think,
but what the particular patient in the particular circumstance wants at the time’
[38]. Kubler-Ross has also emphasised the critical importance of always leaving
some room for hope, making clear the doctor’s willingness to listen, avoiding
mention of a prognosis in terms of a specific time period, and assuring the patient
that he or she will not be abandoned. Her work also demonstrated that most
patients are aware of their diagnosis, but readily collude when the health-care
team tries to protect them from such bad news. Although the prognosis of many
of the illnesses has changed considerably since the original work in this field by
Dr Kubler-Ross, her 1969 short book, On Death and Dying [39], remains an
outstanding and very relevant source of guidance on this topic.
After the death of a patient, doctors also can play a valuable role in assisting
the relatives of the deceased to cope with their grief by making themselves available
to answer questions about the death. At times, grief will be manifested as anger,
which may be directed at others, including the doctor [40].
44 Good Medical Practice

3.13 DOCTORS AND OTHER HEALTH-CARE

PROFESSIONALS AS PATIENTS
The particular difficulties for doctors in regard to seeking care for their own
health are addressed in Chapter 11. It is well recognised that doctors caring
for other doctors or other health professionals can make dangerous assumptions
about their patients’ understanding of their illness, proposed investigations, pro-
cedures or treatment, and with compliance. It is appropriate not to make any
such assumption of knowledge but to impart information at the appropriate level
for that patient, having established their level of understanding and the need for
information, as with any patient. Good communication skills will ensure that
even where the patient happens to be well informed, no offence will be taken
and the patient will have greater confidence in the doctor’s ability to provide
good care.

3.14 THE IMPORTANCE OF WRITTEN COMMUNICATION

The written record needs to be clear, to contain all relevant information (this will
often mean information regarding the patient’s knowledge of their illness and
their emotional state) and to be signed by the person who wrote it. It is usually
not relevant to include critical, judgmental or emotive descriptors and these can
cause substantial embarrassment if the record is read by the patient or read out
in court. Abbreviations should be limited to those used widely throughout the
health-care system. Medical record keeping is discussed in depth in Chapter 6.
In undergraduate medical education, much importance is attached to the stu-
dent being able to elicit and then record systematically a detailed history and
physical examination. In the early postgraduate phase, attention is also paid to
the adequacy of progress notes and discharge summaries. Later the emphasis
shifts to record keeping for defensive reasons (would your medical records stand
up to the scrutiny of the court?). While this is a powerful incentive to keep clear
contemporaneous records, there are many other reasons why written communi-
cation, whether in hospital progress notes, in clinic cards or in letters to doctors
and others, should be carefully and conscientiously attended to [15]. Not the least
of these reasons are the increasing size of the medical team caring for patients and
the shorter hours worked by doctors.

3.15 INTRA- AND INTER-PROFESSIONAL COMMUNICATION

AND RELATIONSHIPS
The good communication practices outlined above apply also to communication
between doctors and to communication between doctors and other professionals
involved in the care of the patient, in order that patients receive optimal care.
 Communication skills 45

Patient care may be compromised when there is poor communication between

health-care professionals. As medical practice and health care frequently involve
cooperative teamwork, and as care has become more specialised and at times
compartmentalised, with multiple professionals involved concurrently and at dif-
ferent times during the course of patients’ illnesses, the risk of communication
failure has increased.
Doctors need to be alert to this risk and to openly share relevant information
with other professionals, with the patient being informed and involved, when this
is possible. This applies especially to the information provided in referrals for
consultation and in the responses to these, to the documentation of progress and
of changes in treatment, and when health care is transferred to other individuals
or teams. For example, when many doctors are involved, each with expertise
essentially confined to some but not all of the body systems, and each with
the capacity to change medications, it is essential that all relevant professional
colleagues are involved in, or informed of, decisions about changes before they
are implemented.
Providing relevant information for other health-care providers implies that
doctors must understand and respect the potential contribution of others. Chapter
15 is devoted to the roles played by other health professionals. Appropriate respect
on the part of doctors for these non-medical professional roles is demonstrated
by open and effective oral and/or written communication.
A closely related issue is the importance of protecting patients from unjustifi-
able direct or implied criticism of another doctor or health-care professional. One
problem is that any criticism might be ill-informed, especially if based on incom-
plete information. Apart from being disrespectful to other health professionals
and having the potential to destabilise patient confidence, this behaviour can also
be a factor leading to unwarranted civil litigation by a patient (see also Chapter 7).
In many clinical instances, robust evidence for specific interventions is lacking,
meaning that there are likely to exist well-meant and appropriate variations in
professional opinions. In such situations, discussion and resolution of differences
of opinion by the professionals involved, before options are presented to patients,
represents good medical practice.

References
1. Tamblyn R, Abrahamowicz M, Dauphinee D et al. Physician scores on a national
clinical skills examination as predictors of complaints to medical regulatory
authorities. JAMA 2007; 298: 993–1001.
2. Simpson M, Buckman R, Stewart M, Maguire P, Lipkin M, Novack D et al.
Doctor–patient communication: the Toronto consensus statement. BMJ 1991; 303:
1385–7.
46 Good Medical Practice

3. Levinson W, Rotor DL, Mullooly JP et al. Physician–patient communication. The

relationship with malpractice claims among primary care physicians and surgeons
JAMA 1997; 277: 553–9.
4. Laidlaw TS, Kaufman DM, Sargeant J et al. What makes a physician an exemplary
communicator with patients. Patient Educ Couns 2007; 68: 153–60.
5. Meryn S. Improving doctor–patient communication. BMJ 1998; 316: 1922.
6. Stewart MA. Effective physician–patient communication and health care outcomes: a
review. Can Med Assoc J 1995; 152: 1423–33.
7. Kaplan SH, Greenfield S, Gandek B et al. Characteristics of physicians with
participatory decision-making styles. Ann Intern Med 1996; 124: 497–504.
8. Ong LM, de Haes JC, Hoos AM, Lammes FB. Doctor–patient communication: a
review of the literature. Soc Sci Med 1995; 40: 903–18.
9. Coulter A. Patients’ views of the good doctor. BMJ 2002; 325: 668–9.
10. Hickson RB, Clayton EW, Entman SS et al. Obstetricians’ prior malpractice
experience and patients’ satisfaction with care. JAMA 1994; 272: 1583–7.
11. Ambady N, La Plante D, Nguyen T et al. Surgeons’ tone of voice: a clue to malpractice
history. Surgery 2002; 132: 5–9.
12. Maguire P, Pitceathly C. Key communication skills and how to acquire them. BMJ
2002; 325: 697–700.
13. Smith S, Hanson JL, Tewksbury LR et al. Teaching patient communication skills to
medical students: a review of randomized controlled trials. Eval Health Prof 2007; 30:
3–21.
14. Paice E, Heard S, Moss F. How important are role models in making good doctors?
BMJ 2002; 325: 707–10.
15. National Health and Medical Research Council. Communicating with Patients.
Advice for Medical Practitioners, NHMRC, Canberra, 2004. http://www.nhmrc.gov.
au/publications/synopses/e58syn.htm
16. Buckman R. Communications and emotions. BMJ 2002; 325: 672.
17. Marteau TM, Humphrey C, Matoon G et al. Factors influencing the communication
skills of first year clinical medical students. Med Educ 1991; 25: 127–34.
18. Langewitz W, Denz M, Keller A et al. Spontaneous talking time at the start of
consultation in outpatient clinic: cohort study. BMJ 2002; 325: 682–3.
19. Beckman AB, Frankel RM. The effect of physician behaviour on the collection of data.
Ann Intern Med 1984; 152: 692–6.
20. Robertson K. Active listening: more than just paying attention. Aust Family Physician
2005; 34: 1053–5.
21. Bruera E, Palmer JL, Pace E et al. A randomized trial of physician postures when
breaking bad news to cancer patients. Palliat Med 2007; 21: 501–5.
22. Neuwirth ZE. Physician empathy – should we care? Lancet 1994; 350: 606.
23. Balint M. The Doctor, His Patient and the Illness. 2nd edn. Pitman Medical, London,
1964.
24. Hislop I. Stress, Distress and Illness. McGraw Hill, Sydney, 1991.
 Communication skills 47

25. Barbour AB. Caring for Patients: A Critique of the Medical Model. Stanford
University Press, Stanford, 1995.
26. Department of Human Services Victoria. Making the Connection. http://www.dhs.vic.
gov.au/multicultural/connection/index.htm
27. ACT Office of Multicultural Affairs. Working with Interpreters. http://www.dhcs.act.
gov.au/matsia/multicultural/publications
28. Multicultural Disability Advocacy Association. Using Interpreters Successfully.
http://www.mdaa.org.au/faqs/interpreters.html
29. Dobson R. Sharing of uncertainty can unnerve patients. BMJ 2002; 325: 1319.
30. Niselle P. Angered patients and the medical profession. Med J Aust 1999; 170:
576–7.
31. Vincent C, Young M, Phillips A. Why do people sue doctors? A study of patients and
relatives taking legal action. Lancet 1994; 343: 1609–13.
32. Hickson GB, Clayton EW, Githens PB et al. Factors that prompted families to file
medical malpractice claims following perinatal injuries. JAMA 1992; 267: 1359–63.
33. Kraman SS, Hamm G. Risk management: extreme honesty may be best policy. Annals
Int Med 1999; 131: 963–7.
34. Niselle P. Caring for angry patients. Australian Doctor 16 July 1999, p. 56.
35. Daniel AE, Burn RJ, Horarik S. Patients’ complaints about medical practice. Med J
Aust 1999; 170: 598–602.
36. Myerscough PR. Talking With Patients: A Basic Clinical Skill. Oxford University
Press, Oxford, 1989.
37. Hinton J. Whom do dying patients tell? Br Med J 1980; 281: 1328–30.
38. Charlton RC. Breaking bad news. Med J Aust 1992; 157: 615–21.
39. Kubler-Ross E. On Death and Dying. Macmillan, New York, 1969.
40. Hinton J. Dying 2nd edn. Penguin, Harmondsworth, Mddx, 1972.

Additional reading
Ainsworth-Vaughan N. Claiming Power in Doctor–Patient Talk. Oxford University Press,
New York, 1998.
Anderson I. Koori Health in Koori Hands: An Orientation Manual in Aboriginal Health
for Health-care Providers. Koori Health Unit, Health Dept., Melbourne, Victoria,
1988.
Del Mar CB. Communicating well in general practice. Med J Aust 1994; 160: 367–70.
Ferguson B, Browne E (eds). Health Care and Immigrants: A Guide for the Helping
Professions. MacLennan & Petty, Sydney, 1991.
Gask L, Usherwood T. ABC of psychological medicine: the consultation. BMJ 2002; 324:
681–2.
Hinton J. Dying. 2nd edn. Penguin, Harmondsworth, Mddx, 1972.
Kerr DN. Teaching communication skills in post-graduate medical education. J R Soc Med
1986; 79: 575–80.
48 Good Medical Practice

Kleinman A, Eisenberg L, Good B. Culture, illness and care: lessons from anthropologic
and cross-cultural research. Ann Intern Med 1978, 88; 251–8.
Kubler-Ross E. On Death and Dying. Macmillan, New York, 1969.
Myerscough PR. Talking with Patients: A Basic Clinical Skill. Oxford University Press,
Oxford, 1989.
National Health and Medical Research Council. Cultural Competency in Health: A Guide
for Policy, Partnerships and Participation. NHMRC, Canberra, 2006.
Pauwels A. Cross Cultural Communication in the Health Sciences: Communicating with
Migrant Patients. Macmillan Education Australia, South Melbourne, 1995.
Pendeleton D, Schofield T, Tate P et al. The New Consultation: Developing
Doctor–Patient Communication. Oxford University Press, Oxford, 2003.
Reid J, Trompf P (eds). The Health of Aboriginal Australia. Harcourt Brace Jovanovich,
Sydney, 1991.
Silverman J, Kurtz S, Draper J. Skills for Communicating with Patients. Radcliffe Medical
Press, Oxford, 1998.
Stewart MA, Roter D (eds). Communicating with Medical Patients. Sage Publications,
Newbury Park, CA, 1989.
Whitehouse CR. The teaching of communication skills in United Kingdom medical
schools. Med Educ 1991; 25: 311–18.
4 CONSENT AND INFORMED DECISION
MAKING

here are ethical and legal reasons why doctors must adequately inform
T patients about proposed treatments or procedures, especially in regard to
risks and dangers, and be satisfied that patients understand and consent to
such measures. Ethically, this arises principally out of respect for the auton-
omy of the patient. The two-way information exchange required in order to
bring patients to a position from which they can provide meaningful consent
(an exchange referred to as ‘shared decision making’) is an essential compo-
nent of good medical practice. Doctors who fail to adequately inform their
patients about their condition, treatment options or material risks of treat-
ment may be sued on the grounds of negligence (see Chapter 7). Exceptions to
the requirement for consent are uncommon but include genuine emergencies
and situations where treatment has been authorised by a court. In addition, if
a doctor undertakes any procedure that involves touching the patient without
consent, the doctor is guilty of an assault or, more precisely in legal terms, a
battery, and an action in trespass may be brought against the doctor in a civil
or a criminal court.
Just as there are both ethical and legal reasons for seeking informed con-
sent, so too there are ethical and legal paths to understanding the principles
involved in seeking informed consent. The legal pathway involves a detailed
appreciation of what the courts in Australia and elsewhere have said about
consent [1]. The ethical or professional pathway involves seeking good com-
munication with the patient, as has been outlined in the previous chapter. The
present chapter refers briefly to the relevant legal cases where appropriate, but
in general adopts the ethical pathway as this is more likely to be readily under-
stood, assimilated and applied by medical trainees and medical practitioners
and is as likely to conform to legal obligations. The Australian High Court
has suggested that the term ‘duty to disclose’ might be preferable to ‘informed
consent’ [2]. Others have suggested the use of terms such as ‘shared and/or
informed decision making’. We have retained the term ‘informed consent’ as
it remains in widespread use and appears to be well understood. Although the

49
50 Good Medical Practice

term ‘informed consent’ has become enshrined in law in the USA, this is not the
case in Australia.
While the ethical and legal requirements of obtaining informed consent are
accepted and broadly understood by doctors, difficulties in obtaining a patient’s
consent still arise, particularly in regard to what and how much information needs
to be disclosed, what constitutes a material risk, what to do when dealing with
minors, or adults who may not be competent to give consent, what constitutes
implied consent and whether ‘therapeutic privilege’ can be claimed. This chapter
provides advice in regard to these difficulties and identifies recent professional
and legal developments that have helped clarify how doctors should meet these
difficulties.

4.1 ELEMENTS OF VALID CONSENT

For consent to be valid, it needs to:
r be freely given; this includes avoiding pressuring patients through failure to
provide sufficient time for the patient to consider matters or failing to recognise
other pressures (for example, from family)
r involve disclosure by the doctor of sufficient information including material
risks (see page 53)
r be specific for the proposed procedures – the catch-all phrase ‘any other pro-
cedures that may be deemed necessary’ should only be relied on to undertake
unforeseen and urgent procedures and, if the phrase is used, a note should be
made of the matters discussed under it
r be given by a person who is competent to consent – this will ordinarily be the
patient unless the patient is believed to be not competent
r involve some assessment or indication that the patient has an understanding
of the proposed procedure or treatment.
No guidance exists in relation to how long consent, once given, remains valid.
If significant time has elapsed between obtaining consent and the commencement
of treatment, the existence of valid consent should be confirmed.

4.2 IMPLIED, ORAL OR WRITTEN CONSENT

Consent may be given orally, given in writing or be implied. The more major
the proposed treatment, such as a surgical procedure, an invasive investigation
or medical treatment with potentially serious side effects, the greater the need is
that the patient be fully informed and the greater the desirability that the patient’s
consent be attested to in writing. However, the recommendation that consent
be in writing is not a legal requirement. The existence of a signed consent form
does not constitute conclusive evidence of adequately informing patients; consent
forms are more usefully regarded as an important reminder that sufficient infor-
mation be given for the consent to be valid and as prima facie evidence that the
 Consent and informed decision making 51

discussion took place. Traditionally, written consent has not been obtained when
medications are prescribed, but nevertheless the duty to warn patients of signifi-
cant side effects must not be overlooked. Depending upon each clinical situation,
doctors may be wise to make a note of any discussion held of the possible serious
side effects of drug treatments and diagnostic procedures. The documentation of
consent for more major procedures, especially surgical, is outlined below.
In everyday medical practice, for example when patients attend for consul-
tations, accept prescriptions or proffer an arm for blood pressure measurement,
venesection or injection, consent is either implied or verbal. Depending upon any
pre-existing doctor–patient relationship that provides a basis for mutual under-
standing, the nature of the clinical problem, and the patient’s attitude and capacity
to understand, more or less time may need to be devoted to communication specifi-
cally directed towards consent. It is not possible to provide advice that predictably
or fully covers every eventuality. The following list of situations where special con-
sideration in regard to oral or implied consent should be given is neither exclusive
nor ranked in any order of importance. This list does not contain reference to
major surgery or more serious therapeutic procedures, as consent for these should
be documented and must fulfil the requirements of valid consent noted above.
Consent to surgical or other major invasive procedures is discussed in more detail
below.
r History taking, in regard to sexual or personal questions, where the link with
the patient’s reason for attending may not be immediately apparent to the
patient
r Physical examination, for any intimate or invasive examination, especially
where the patient is young or inexperienced as a patient or where there are
any reasons to anticipate communication difficulties, such as undue anxiety,
cultural differences or language barriers
r Laboratory investigations, in situations where the outcomes may be of special
significance as in testing for HIV and in genetic testing. In both of these
examples consent needs to be accompanied by counselling. Pre-test counselling
may be a legal requirement in certain situations. For example in both Victoria
and Tasmania, it is a legal requirement to counsel patients before seeking
consent for HIV testing (see also Chapter 26). Other investigations that may
be precursors to major interventions, such as screening tests for cancer, should
be looked at in a similar light.
r Minor procedures, such as certain injections and inoculations, which carry
real and serious although rare complications
r Prescribing medications, especially when prescribing a medication for the first
time and where the medication carries known serious or predictable side effects
r Diagnostic procedures, especially where there has been no prior discussion of
risks inherent in procedures such as invasive radiology, endoscopy and organ
biopsy. For these procedures, most hospitals insist on written documentation
of consent.
52 Good Medical Practice

r Release of information to other parties, especially if this does not fall within
the usual expectation of the patient (see also Chapter 7 on confidentiality and
privacy)
r Participation in medical research: there are additional ethical considerations
involved in seeking such consent and these are covered in Chapter 17.
If at any point in undertaking an examination, treatment or procedure, a
patient should resist the attention or withdraw consent, the doctor should not
continue even if discontinuation is likely to see the patient’s condition deteriorate.
Even where a doctor believes that a patient will certainly die without treatment,
a request by that patient to be left alone must be heeded. Every attempt should
be made to advise the patient of consequences of his or her decision. Such situa-
tions arise infrequently. Where they do, the doctor will be wise to seek a second
opinion and/or take advice from a medical indemnity assurer or a clinical ethics
committee. Refusal of treatment is discussed in more detail on page 66 and in
Chapter 22.

4.3 CONSENT FOR SURGICAL OR OTHER MAJOR

INVASIVE PROCEDURES
Most case law and most ethical advice regarding obtaining informed consent
is directed towards major procedures that carry significant risks. Based on a
combination of case law, inquiries by government agencies, guidelines developed
by statutory bodies and professional organisations such as the colleges and medical
indemnity organisations, as well as in legislation in a small number of states
(Queensland and Tasmania), there now exists reasonably clear advice as to how
doctors should approach the matter of consent. Although the advice is clear,
there are many aspects that will regularly require careful judgment. Mechanical
application of such guidelines, without considering the personality, temperament,
cultural background, level of education and other characteristics of the patient
at hand, will not represent good clinical practice and may do more harm than
good. While the guidelines at first reading may appear daunting, the doctor who
communicates effectively with his or her patients and listens and responds to his
or her patient’s questions is likely to conform to the guidelines and most unlikely
to encounter legal difficulties.
In 1993 the National Health and Medical Research Council (NHMRC) pub-
lished General Guidelines for Medical Practitioners on Providing Information to
Patients [3]. This publication, which was reviewed and reissued unchanged in
2004, can be regarded as an authoritative guide to the extent and nature of infor-
mation a doctor should communicate to a patient to assist the patient in making
an informed decision. When reissued in 2004, these guidelines were accompa-
nied by complementary guidelines entitled Communicating with Patients: Advice
for Medical Practitioners [3]. This publication expands upon the material to be
 Consent and informed decision making 53

discussed with patients and provides practical advice about achieving effective
communication. The following advice is drawn directly from the latter guidelines:

Patients seek many types of information and advice from doctors. To enable
them to participate meaningfully in decisions affecting their health care,
patients need relevant information presented in a way they can understand.
It is not possible, however, to provide information about every detail of all
intervention∗ options, potential benefits or harms, and all possible outcomes.
It is also not possible to assess risks with complete certainty, and this uncer-
tainty should be communicated to patients.
Where possible, information about the benefits and risks of interven-
tions should be framed in ways which assist the patient to best under-
stand his or her situation (for example using absolute, rather than relative,
risk data) and to understand the nature of the risk. The patient should
be advised of material risks, as described by the High Court in Rogers v
Whitaker in 1992 [2]. Material risks are those to which a reasonable per-
son in the patient’s position is likely to attach significance, or those to which
the doctor knows or ought to know the particular patient is likely to attach
significance.
Known risks that reasonable people would regard as significant should be
disclosed, whether an adverse outcome is common and the detriment slight, or
whether an adverse event is severe though its occurrence is rare.
The communication process described in this Advice should enable a doctor
to become aware of risks that a particular patient would treat as significant.

6.5 Providing information about diagnosis

When discussing the diagnosis, the following should be considered:
r the possible or likely nature of the illness or condition
r the degree of uncertainty of any diagnosis
r the possible need for referral for diagnostic confirmation or refutation
r the extent and soundness of medical knowledge about the specific condition
r the status of the patient’s illness, whether temporary, chronic or terminal
r the involvement of the patient in the formulation of the ongoing care
r patient’s request for information
r sensitivity to the patient’s wishes for information, and
r alternative sources of reliable information.

∗ The NHMRC advice explains the term ‘intervention’ thus: ‘The general term “Intervention” is
intended to cover diagnostic procedures and tests, and all forms of treatment (pharmaceutical, surgical
etc). The principles involved in providing information for decision making may extend to other
interventions including counselling and screening for diseases (eg genetic screening tests) wherever
the intervention brings with it risks be they physical, emotional, financial or other.’
54 Good Medical Practice

Section 6.7 [not reproduced] addresses additional considerations that

should be taken into account if the doctor needs to communicate bad news to
the patient.

6.6 Providing information about interventions

When discussing what proposed intervention involves with the patient, the
following information should be conveyed in plain language:
r a description of the intervention
r what will happen to the patient
r whether the proposed intervention is critical, essential, elective or discre-
tionary
r whether the proposed intervention represents current accepted medical
practice
r whether the proposed intervention is conventional, experimental or inno-
vative
r whether the proposed intervention is part of a clinical trial or other research
project
r the degree of uncertainty about the benefit(s) of the proposed intervention
r how quickly a decision about the proposed intervention needs to be made
r who will undertake the proposed intervention, including their status and
the extent of their experience, and that of the supervising doctor, where
this information is known
r how long the proposed intervention will take
r how long until the results of the intervention will be available
r how long will be needed for recuperation and/or rehabilitation
r what the estimated costs are (where known), including out-of-pocket costs,
and
r what, if any, conflicts of interest the doctor might have, including financial
ones.
The potential consequences of any proposed intervention should be conveyed
including:
r the expected benefits
r common side effects, common complications, contraindications and pos-
sible harms, including their likelihood and degree
r uncommon side effects to which the particular patient may be exposed, or
that are of concern to that patient
r any outcomes that may require further intervention, and
r any significant long-term adverse outcomes (physical, emotional, mental,
social, sexual, financial or other).
The patient should be advised of alternative options including:
r what those options are
r their availability and potential consequences, and
 Consent and informed decision making 55

r likely short- and long-term consequences that may arise if they choose not
to proceed with the proposed intervention or with any intervention at all.
The patient should be advised of proposed follow-up arrangements including:
r clearly stated arrangements for providing the results of the intervention
(usually an investigation), and where relevant
r feasibility and costs of the follow-up arrangements.
Complex interventions usually require the provision of detailed information,
as do treatments where the patient has no physical illness, for example cosmetic
surgery.

Among many issues to be covered in explaining proposed procedures to a

patient is the possible personal financial cost for the patient (what is needed is
‘informed financial consent’). The Australian Medical Association issued a posi-
tion statement on this topic in 2006 [4]. Other than in Queensland and Tasma-
nia, there are no legal requirements for obtaining informed consent, although the
standard of care in giving advice is a matter of statute in other states. Section
21 of the Queensland Civil Liability Act 2003 provides that doctors must give
(a) ‘information that a reasonable person in the patient’s position would, in the cir-
cumstances, require to enable the person to make a reasonably informed decision
about whether to undergo the treatment or follow the advice’ and (b) ‘informa-
tion that the doctor knows or ought reasonably to know the patient wants to be
given before making the decision to undergo the treatment or follow the advice’.
Section 21 of the Tasmanian Civil Liability Act 2002 has almost identical provi-
sions. The legislation in these two states thus embodies the principles laid down
by the High Court in Rogers v Whitaker [2].
Informed consent is essentially an issue of good communication. Doctors
should indicate to patients that they are willing to answer any further questions
they may have and should provide time for these to be answered. As good clinical
practice, and to provide evidence should complaints or claims of negligence arise,
doctors are strongly advised to document in the patient’s record what has been
discussed, especially the risks canvassed. Where a patient refuses to consent to
more extensive surgery this needs to be recorded. In the ideal situation, the doctor
who is to undertake the procedure should obtain consent and document it, but this
requirement may be modified in situations as may apply in large teaching hospitals,
so long as the delegated doctor is equipped to provide all the relevant information.
Doctors should familiarise themselves with the policies of the hospitals in which
they work.
In relation to the subject of communication with patients, particularly in the
problematic area of perceptions of risks and benefits of health-care interventions,
the NHMRC has issued a detailed handbook entitled, Making Decisions about
Tests and Treatments: Principles for Better Communication between Healthcare
Consumers and Healthcare Providers [5].
56 Good Medical Practice

4.4 THERAPEUTIC PRIVILEGE AND

WITHHOLDING INFORMATION
Therapeutic privilege refers to the concept that a doctor may choose to withhold
information regarding the risks of a proposed treatment or procedure, or infor-
mation regarding diagnosis and prognosis, if, in the doctor’s opinion, disclosure
may harm the patient. This approach was once more widely followed and was
based upon the ethical principles of beneficence and non-maleficence. It is now
increasingly seen as paternalistic and not in accord with the principle of respect
for patient autonomy. Patients wish, and need to be invited wherever possible, to
participate in a more open, shared decision-making process and expect to be given
all relevant information. The possibility that a doctor may withhold information
may be a source of anxiety for, or increase the anxiety of, patients. Nevertheless
the courts have indicated that therapeutic privilege is still acceptable as a reason
for failing to disclose information. In Rogers v Whitaker, the High Court con-
firmed this, when referring to a doctor’s duty to warn patients of material risks
inherent in proposed treatments, by saying, ‘This duty is subject to therapeutic
privilege’ [2]. Great caution should be used in claiming therapeutic privilege, as in
the same High Court case, in a dissenting opinion, Gaudron J made the following
remarks:

Leaving aside cases involving a medical emergency or a situation where the

circumstances of the individual require special consideration, I see no basis
for treating the doctor’s duty to warn of risks (whether involved in the treat-
ment or procedures proposed or otherwise attending the patient’s condition
or circumstances) as different in nature or degree from any other duty to
warn of real or foreseeable risks. And as at present advised, I see no basis
for any exception or ‘therapeutic privilege’ which is not based in a medical
emergency. [2]

To withhold information on this basis is likely to be strictly interpreted by the

courts. Doctors need to be able to show that they believed on reasonable grounds
that giving the patient the information would impose a significant risk of serious
harm to the patient’s physical or mental health. It is not enough that the patient
might be alarmed or distressed or might not give consent to a procedure recom-
mended by the doctor. Occasionally a doctor is faced with the opposite situation,
where the patient expressly indicates that information is not desired. While doc-
tors must respect patient autonomy in this situation, such an attitude may reflect
intense denial by the patient, and alert the doctor to the need for a more sensitive
and discerning approach to communication [3].
Another variant of this difficulty is where a doctor is asked by family mem-
bers to withhold potentially distressing information from a patient. This needs to
 Consent and informed decision making 57

be handled sensitively and with respect for the cultural background that is pro-
ducing the difficulty. With time, most families can appreciate that withholding
information completely is virtually impossible and that the patient’s confidence
in the doctor will be seriously undermined if the doctor is not free to respond
to questions and impart crucial information. The distress that family members
are expressing in this situation is often their own and not that of the patient.
Placed theoretically in the patient’s position, they can usually accept the need for
open communication; acceptance is made easier if they perceive the doctor to be
compassionate and tactful.

4.5 PATIENTS WHO MAY NOT BE LEGALLY

ABLE TO CONSENT
Adults (18 years of age or over) are presumed to be legally competent to give
consent, a presumption that can be rebutted by evidence that shows a lack of
competence. Such patients must also have cognitive capacity to understand the
medical condition, the options for treatment, what the doctor is recommending,
any material risk and what may happen if no treatment is given. We examine first
the issues surrounding consent from people who are not yet adults and thus pre-
sumed not to be competent to give consent. Whether the question of competence
to consent arises in adults or children, the treating doctor is responsible for assess-
ing in each case whether the patient is competent to understand [6]. The test for
competence involves determining whether a person is capable of understanding
the general nature and effect of the proposed treatment or procedure. A higher
level of understanding is required for more complex or risky procedures.
The issues that need to be addressed when assessing competence or decision-
making capacity include the patient’s ability to communicate a choice, to under-
stand relevant information, to appreciate his or her situation and its possible
consequences, and to reason about treatment options. While there will be times
where the assistance of experts such as psychogeriatricians or the application of
formal cognitive testing is appropriate, all doctors are capable of making such
assessments using a series of relatively simple questions (see Table 4.1), rein-
forced as needed by information from those who know the patient well, such as
the general practitioner and close family members [7–8].

4.6 CONSENT OF CHILDREN AND TEENAGERS

People under the age of 18 in Australia are regarded in law as minors (they reach
the age of majority at 18 years, when they can exercise all normal civil rights).
Teenagers are not recognised in law, but in New South Wales and Tasmania there
is legislation recognising a ‘young person’ at ages 16 and 17 (Children and Young
Persons (Care and Protection) Act 1998 (NSW); Children, Young Persons and
58 Good Medical Practice

Table 4.1 Approach to assessing decision-making capacity∗

Capacity: Questions for clinical assessment

Communicating a choice: Have you decided whether to follow my advice about

treatment? Can you tell me what your decision is?

Understanding relevant information: Please tell me in your own words what I have
told you about your health problem, recommended treatment, and benefits, risks or
discomfort of the proposed treatment, any other options and the risks and benefits of no
treatment.

Appreciating the situation and its consequences: Please tell me what you believe is
wrong with your health now, whether you believe you need treatment, what the
treatment will do for you and what you think will happen if you have no treatment.

Reasoning about treatment options: How did you decide to accept or reject the
recommended treatment? What makes this choice better than another option?
∗
Table modified from [7–8].

Their Families Act 1997 (Tas)), while in the Australian Capital Territory a young
person is defined as aged 12 to 17 years. There is no uniform age of consent
for medical treatment but South Australia and New South Wales have legislation
covering the rights of children to consent to treatment (see below).
Parents can generally consent to medical procedures for their children provided
that the proposed procedure is in the child’s ‘best interests’. However, doctors
should not proceed without the additional consent of the child if the child is aged
14 or older.
In common law, the starting point is that a minor does not have the compe-
tence to consent to medical treatment, unless it is demonstrated that the minor
is competent via ‘achieving a sufficient understanding and intelligence to enable
him or her to understand fully what is proposed’ [9]. Where a proposed proce-
dure is relatively minor, older children can provide consent themselves. For more
serious procedures or operations, a doctor will need to very carefully assess the
competence of the young patient and generally should also seek the consent of
a parent or guardian, other than in true emergencies. In New South Wales, the
Minors (Property and Contracts) Act 1970 allows minors over 14 years of age
to give consent for medical and dental treatment. Despite this provision, doctors
should proceed cautiously if any treatment is opposed by the parents. The same
Act provides protection from liability for assault when a doctor treats a minor
under 16 years of age with the consent of a parent or guardian. Where the parents
are requesting that a procedure be done but a competent child aged over 14 years
old is opposed to the treatment, the refusal of the minor should be respected and
independent advice sought. Such conflicts between parent and child might best
be resolved by a court order. In South Australia, under the Consent to Medical
 Consent and informed decision making 59

Treatment and Palliative Care Act 1995, doctors can accept the consent of a child,
provided the child is capable of understanding what is proposed, the treatment is
in the child’s best interests, and a second doctor has assessed the child and has
concurred in writing.
A frequently faced problem is the request from a sexually active teenage girl for
advice on contraception, where the teenager makes it clear that her parents are not
to be informed of her attendance. Each case should be judged on its merits, but for
practical purposes it is generally permissible for doctors to treat teenagers who are
16 years or over, provided they are mature and appear to understand the proposed
treatment. If they meet these criteria, they are also entitled to have their medical
information kept confidential from their parents. When the teenager is under 16
or where doubt exists as to the maturity of a teenager over 16 years, greater care
must be taken and the doctor should endeavour to explain to the teenager the
need to obtain the consent of the parent or guardian as well, unless the minor
clearly objects. The doctor is not necessarily obliged to provide treatment to such
a minor, other than in an emergency.
Another practical difficulty that may emerge is where parents are separated or
divorced and the custody of the child is at issue. In the absence of a court order,
both parents remain responsible for the care of children under 18 years and either
parent is entitled to provide consent. Nevertheless, other than in an emergency,
doctors should take care to accurately establish the social and legal situation with
regard to which parent is able to consent on behalf of the child, especially when
procedures carrying risks are proposed. The situation can be made more complex
if the separated parents are not communicating well, or if one parent has custody
but the other is responsible for medical expenses.
Where a child is temporarily in the care of a teacher, babysitter, relative,
sports coach or the like, again care should be taken to obtain consent from a
parent for medical treatment other than for first aid or in an emergency. Legal
protection for certain emergency procedures on children exists in some states.
Thus in Victoria, Queensland, Western Australia, Tasmania and the Australian
Capital Territory, blood transfusions may be given in a life-threatening emergency
without the consent of the parents. In Northern Territory, the Emergency Medical
Operations Act 1973 permits emergency surgery without the consent of parents,
while in South Australia, the Consent to Medical Treatment and Palliative Care
Act 1995 places an obligation on the doctor to seek the consent of the parent or
guardian. In both the Northern Territory and South Australia, there are require-
ments for a second medical opinion. In New South Wales, the Children and Young
Persons (Care and Protection) 1998 provides for emergency treatment without
consent ‘in order to save his or her life or to prevent serious damage to his or her
health’.
Special rules apply for non-therapeutic procedures such as sterilisation, or
treatment or surgery that may incidentally lead to permanent infertility. In New
60 Good Medical Practice

South Wales, the Children and Young Persons (Care and Protection) Act 1998
provides that such special medical treatment on a child is permitted in matters of
urgency or where authorised by the Guardianship Tribunal.
Most states have similar specific legislation covering such issues. In addition,
the Family Law Act 1975 also provides the Family Court with the power to autho-
rise such procedures. Order 23B of the Family Law Rules ‘applies to applications
for a declaration that a person is authorised to consent to a medical or surgical
procedure for a child’. Such applications may be made by:
r a parent, guardian or custodian of the child
r any other person who has an interest in the welfare of the child
r if a parent, guardian or custodian is not the applicant, he or she must be joined
as a respondent to the applicant.
Applications are made on a special form and the applicant must lodge with the
application affidavits, which include relevant medical and psychological reports.
These must set out the exact nature and purpose of the proposed medical or
surgical procedure and the likely long-term effects of the procedure on the child.
In addition the following information must also be provided:
r that alternative and less invasive procedures or treatments would be, or have
proved to be, inadequate
r that the procedure proposed is necessary for the welfare of the child
r that the child is incapable of making his or her own decision about undergoing
the procedure
r that the child is unlikely to develop sufficiently to be able to make an informed
judgment about undergoing the procedure within the time in which the pro-
cedure should be carried out, or within the foreseeable future
r that there are any other reasons for granting the application.

4.7 CHILDREN WHO ARE INTELLECTUALLY DISABLED

For intellectually disabled people under 18 years, the power to give consent gen-
erally resides with the parents, other than for non-therapeutic procedures, partic-
ularly treatments designed to affect reproductive capacity. The law in regard to
sterilisation procedures is clear. In New South Wales and South Australia, this is
covered by the legislation previously referred to, via the Children and Young Per-
sons (Care and Protection) Act 1998 in New South Wales and the Guardianship
and Administration Act 1993 in South Australia. The Family Court (a federal
court) also has powers under the Family Law Act 1975 to authorise such proce-
dures. These powers were reinforced in a decision of the High Court when a ruling
by the Family Court in 1992 was appealed by the Northern Territory Department
of Health and Community Services [10]. Thus no parents or guardians can make
these decisions in relation to sterilisation procedures.
 Consent and informed decision making 61

4.8 SUBSTITUTE DECISION MAKERS

In clinical practice, particularly in hospitals and other institutions that care for
the elderly, doctors are frequently faced with patients who are temporarily or
permanently lacking the capacity to give their consent for treatment and proce-
dures. Medical decisions in these situations are sometimes made after consulting
relatives and/or carers. There is no authority in common law to authorise this
practice but most jurisdictions have put in place, or are in the process of putting
in place, guardianship legislation to guide doctors and to authorise substitute
decision makers, without the need to appoint official guardians [11].
When managing a patient assessed as incompetent to give consent, the doctor
should first seek to establish whether the patient has signed an advance care
directive (see Chapter 22) or if there is already a guardian appointed who is
authorised to make medical decisions on behalf of the patient. If neither is the case
then, other than for minor treatments (see below), the guardianship legislation
must be followed. The relevant titles of this legislation, the websites and the
contact telephone numbers for the Guardianship Board, Public Guardian or Public
Advocate are given in Table 4.2 (p. 62).
The legislative framework and its details vary considerably between the juris-
dictions. In New South Wales, Tasmania and Victoria, the legislation identifies a
hierarchy of ‘persons responsible’. The most detailed hierarchy, in priority order,
is provided in the Victoria legislation as follows [12]:
1. an agent – appointed by the patient under enduring power of attorney (medical
treatment)
2. a person – appointed by VCAT to make decisions about the proposed treat-
ment
3. a guardian – appointed by VCAT with health-care powers
4. an enduring guardian – appointed by the patient with health care powers
5. a person – appointed by the patient in writing to make decisions about medical
and dental treatment including the proposed treatment
6. the patient’s spouse or domestic partner
7. the patient’s primary carer, including carers in receipt of a Centrelink Carer’s
payment but excluding paid carers or service providers
8. the patient’s nearest relative over the age of 18 years, which means (in order
of preference):
(a) son or daughter
(b) father or mother
(c) brother or sister (including adopted people and ‘step’ relationships)
(d) grandfather or grandmother
(e) grandson or granddaughter
(f) uncle or aunt
(g) nephew or niece.
62 Good Medical Practice

Table 4.2 Guardianship legislation and guardianship boards/tribunals

State Act Telephone

New South Wales Guardianship Act 1987 Guardianship Tribunal

Tel: (02) 9555 8500
Toll free: 1 800 463928
http://www.gt.nsw.gov.au

Victoria Guardianship and Office of the Public Advocate

Administration Tel: (03) 9603 9500
Act 1986 Toll free: 1 300 309 337
http://www.publicadvocate.vic.gov.au

Queensland Guardianship and Guardianship and Administration Tribunal

Administration Tel: (07) 3234 0666
Act 2000 Toll free: 1300 780 666
http://www.justice.qld.gov.au/473.htm

South Australia Guardianship and Guardianship Board and Public Advocate

Administration Tel: (08) 8269 7515
Act 1993 Toll free: 1 800 800501
http://www.opa.sa.gov.au

Western Australia Guardianship and Guardianship and Administration Board

Administration Tel: (09) 9219 3111
Act 1990 Toll free:1 300 306 017
http://www.publicadvocate.wa.gov.au/

Tasmania Guardianship and Guardianship and Administration Board

Administration Tel: (03) 6233 3085
Act 1995 http://www.guardianship.tas.gov.au

Northern Territory Adult Guardianship Office of Adult Guardianship

Act 1988 Tel: (08) 8922 7343
http://www.health.nt.gov.au/Aged and
Disability/Adult Guardianship/index.aspx

Australian Capital Guardianship and Guardianship and Management

Territory Management of of Property Tribunal
Property Act 1991 Tel: (06) 257 4281
and Public Advocate
Tel: (06) 207 0707
http://www.publicadvocate.act.gov.au/

Where there are two relatives in the same position (for example, a brother and
sister) the elder will be the person responsible.
When a relative or carer accepts the role of person responsible, there are obli-
gations and restrictions. Decisions must be made in the best interests of the patient
and efforts must be made to determine the wishes of the patient and the patient’s
 Consent and informed decision making 63

family. There are restrictions in the Victorian legislation as to the decisions a

person responsible may take. For example, if the patient is likely to be able to
consent within a reasonable period of time, the person responsible can consent to
treatment only where the failure to treat would result in a significant deteriora-
tion in the patient’s condition. In addition, a person responsible cannot consent
to ‘special procedures’ – procedures likely to lead to infertility, termination of
pregnancy and removal of tissue for transplant. In these situations in Victoria,
the person responsible must apply to the Victorian Civil and Administrative Tri-
bunal, which has the power to authorise such treatments. Similar provisions apply
in other jurisdictions (see the section on special procedures below).
In South Australia, in the absence of an appointed guardian, the nearest relative
is deemed under section 59 of the Guardianship and Administration Act 1993 to
have ‘appropriate authority’ to make decisions on behalf of an incompetent adult.
In South Australia, a ‘relative’ is defined to include a spouse or domestic partner,
a parent, a person who acts in loco parentis (a carer), a brother or sister 18 years
or older, and a son or daughter 18 years or older. In Queensland, via sections 62
and 63 of the Powers of Attorney Act 1998, a similar list of relatives and carers
(in order, commencing with spouse) are authorised to act as ‘statutory health
attorneys’. In Western Australia, the Guardianship and Administration Act 1990
has been amended by the Acts Amendment (Consent to Medical Treatment) Act
2008, bringing provisions similar to those of Victoria, but the amendment had
not been promulgated at time of writing, while in the Australian Capital Territory
a discussion paper on the topic has been issued, and in Northern Territory there
is no legislation. In these three jurisdictions, ‘consent could be given informally
by relatives and carers or by a guardianship body or court’ [11].

4.9 CONSENT FOR SPECIAL PROCEDURES

In most jurisdictions, there are provisions in the legislation for people not com-
petent to give consent where consent is required for sterilisation, termination of
pregnancy, and other procedures termed ‘special’ or ‘prescribed’. Such procedures
cannot be authorised by substitute decision makers other than a court or tribunal.
The focus is generally on procedures that lead to infertility, but may include other
medical or surgical treatments and clinical research. The most extensive list of
special procedures is contained in the New South Wales legislation and includes
treatments intended or likely to render a person permanently infertile, new treat-
ments not yet supported by a ‘substantial number’ of doctors, treatments declared
under the regulations to be special, the long-term use of drugs of addiction for
non-cancerous conditions, treatments involving aversive stimuli, the administra-
tion of drugs affecting the central nervous system in doses or combination outside
accepted modes of treatment, and the use of androgens for behavioural control.
Such procedures can be authorised only by the New South Wales Guardianship
64 Good Medical Practice

Tribunal. As each jurisdiction has slightly different definitions and requirements,

and as in some jurisdictions the regulations may change, the reader is advised to
check local legislative requirements for specific information (see Table 4.2).

4.10 TREATMENT WITHOUT CONSENT

4.10.1 Emergencies when the patient is unable to consent
Genuine emergencies are the principal exception to the general rule that a doctor
who goes outside the scope of authority expressly or implicitly conferred by
a patient risks liability in trespass. The exception presumes that the patient is
temporarily incapable of giving consent, that immediate treatment is required to
save the patient’s life or prevent serious damage to their health and that there is no
substitute decision maker immediately available. This exception does not absolve
the doctor from adhering to appropriate standards of care in the circumstances
of the emergency. As soon as the patient’s condition is sufficiently improved or
stabilised, consent for ongoing treatment must be obtained.
In all states and territories with the exception of the Australian Capital Ter-
ritory, there is legislation that covers the subject of emergency treatment without
consent. For New South Wales, Victoria, Queensland, Western Australia and
Tasmania, this is the relevant guardianship legislation. In South Australia, emer-
gency treatment is covered by the Consent to Medical Treatment and Palliative
Care Act 1995; the legislation calls for a second doctor to personally examine
the patient and provide written support for the treatment plan, unless such a
second opinion is not practicable. In Northern Territory, section 3 of the Emer-
gency Medical Operations Act 1992 permits emergency treatment for children and
adults.

4.10.2 Non-urgent but necessary treatment

in incompetent patients
In this area, there are considerable differences between jurisdictions. In New
South Wales, the legislation distinguishes between major and minor treatment.
Minor treatment is any treatment that is neither major nor special. In New South
Wales, section 33(1)(d)–(f) of the guardianship legislation identifies as examples of
minor treatment non-intrusive physical examinations, first aid, the administration
of usual medication, and treatment that is not major or special or part of a clinical
trial. The New South Wales Guardianship Tribunal advises that minor treatment
also includes general anaesthesia for the management of fractures or for endoscopy
and the single use of certain prescription drugs [13]. In New South Wales, where
such minor treatment is deemed necessary and neither a guardian nor a person
responsible can be located, the doctor may proceed but is obliged to note in the
 Consent and informed decision making 65

record that treatment will promote the patient’s health and wellbeing and that
the patient is not objecting. Where major treatment is proposed and a person
responsible cannot be identified, the New South Wales Guardianship Tribunal
must be approached.
In Victoria, the legislation does not differentiate between major and minor
treatment but permits a doctor to carry out non-urgent treatment (other than
special procedures – see above) without consent if there has been failure to locate
a person responsible, and where the proposed treatment is in the best interests
of the person, the doctor gives notice in writing to the Public Advocate ahead of
the treatment, and the Office of the Public Advocate confirms by phone that the
legislation is being complied with. In Queensland, similar provisions apply but
only to treatment that is ‘minor and uncontroversial’, while in Tasmania section 41
of the Act states that, where a person responsible is not available, the doctor may
proceed if the treatment is deemed necessary, is to be provided in the form that
‘will most successfully’ promote the person’s health and wellbeing, the person
does not object and the doctor documents all the above in the person’s medical
record.

4.10.3 Minor procedures in incompetent patients

In some jurisdictions, public guardians have advised that minor procedures may be
undertaken without consent (and presumably without going through the process
of seeking and not finding a person responsible). However, ‘minor procedures’ are
indeed minor. Thus, in Victoria, the Public Advocate has provided as examples
of minor treatment ‘a visual examination of the patient’s mouth, providing first
aid, or the administration of a prescribed drug within recommended dosages’
[14]. The Guardianship and Administration Board in Tasmania gives the same
examples [15].
Other than in an emergency, when considering undertaking treatment without
consent, it is clear that doctors must make judgments about exactly what is covered
by the legislation in their jurisdiction in this regard. If in any doubt, and especially
where relatives or carers are expressing any concern or where an apparently simple
procedure could have serious implications or complications, doctors should seek
the advice of the state guardianship office or equivalent (see Table 4.2).

4.11 CONSENT AND THE MENTALLY ILL

The foregoing sections on consent to treatment for the incompetent person do not
apply to the mentally ill in most jurisdictions. The laws relating to the care of the
mentally ill and to consent for specific treatments are discussed in Chapter 23.
When obtaining consent, the diagnosis of a mental illness does not necessarily
preclude the capacity to consent and the doctor’s first action should be to assess
66 Good Medical Practice

the patient’s capacity to give consent. Only if this capacity is lacking is it necessary
to refer to the relevant state legislation.
Under the relevant Mental Health Act (or similar title), provisions are made
to ensure that consent for most treatments, other than electroconvulsive therapy
or psychosurgery, can be obtained from an authorised person. In New South
Wales, Victoria, South Australia and the Australian Capital Territory, specific
and stricter provisions apply when electroconvulsive therapy or psychosurgery
is being contemplated. The Mental Health Act 1996 in Western Australia leaves
decisions in the hands of the treating psychiatrist, while the Mental Health Act
2000 in Queensland has different requirements according to whether the patient
has been admitted voluntarily or involuntarily or whether the treatment is required
urgently.

4.12 REFUSAL OF TREATMENT

This topic is covered more fully in Chapter 22 where preservation or prolongation
of life is discussed. A competent patient at all times may refuse treatment or
withdraw previously given consent to treatment, even where that treatment is
regarded by the doctor as life-saving. Difficulties arise where an illness renders a
previously competent person incompetent and decisions need to be made as to
whether treatment should be continued. Some doctors have expressed concern as
to their legal position if they withdraw treatment in this situation. In Victoria, this
problem has been addressed by the Medical Treatment Act 1988, which allows
patients to complete a refusal of treatment certificate in advance of their becoming
incompetent. It also allows patients to appoint someone to make decisions on
their behalf should they become incompetent. Similar powers for patients to give
advance directives regarding life-prolonging measures exist under legislation in
South Australia in the Consent to Medical Treatment and Palliative Care Act
1995, in Northern Territory in the Natural Death Act 1988, in Queensland in
the Powers of Attorney Act 1998 and in the Australian Capital Territory in the
Medical Treatment (Health Directions) Act 2006. In 2004, the New South Wales
Health Department issued guidelines on advanced care directives [16] and in 2005
issued updated guidelines on end-of-life care and decision making [17].

4.13 REFUSAL OF BLOOD TRANSFUSION

Because of the beliefs of some religious groups, doctors not infrequently encounter
patients and their families who refuse blood transfusion. As a starting point, the
first consideration should be whether there are safe alternatives to blood transfu-
sion. However, the refusal of transfusion by a competent adult must be respected.
Where parents refuse life-saving blood transfusion for a child, all jurisdictions have
legislation that enables doctors to provide blood transfusion in an emergency [18].
 Consent and informed decision making 67

This legislation does not cover non-emergency treatment and, for those situations
involving children, advice should be sought from the Guardianship Board.

4.14 INFORMED CONSENT AND THE PERFORMANCE

RECORD OF THE DOCTOR
Traditionally consent follows when patient and doctor have adequately commu-
nicated about the options, risks, benefits and costs of a proposed treatment or
procedure. However, barriers beyond those of poor communication do exist and
can prevent valid informed consent. From the patient’s perspective, it is argued by
some that information regarding a doctor’s past record in relation to such things
as complication rates, malpractice claims or health status should be available and
that a doctor’s HIV status should be known [19]. These arguments have generally
not been supported in Australia, where information regarding doctors is limited
to that available in the medical register of any state or territory, known personally
by the referring general practitioner or acquired by the patient in direct contact
with the doctor concerned. However, the above does not absolve the treating
doctor of the ethical responsibility to consider his or her capacity to safely carry
out any proposed treatment. The obligations on doctors who carry HIV infection
are discussed in Chapter 11.

References
1. Mulheron R. Twelve tests to identify whether a medical risk is ‘material’. National
Law Review 2000; 11: 1–19 (also accessible at http://www.pandora.nla.gov.au).
2. Rogers v Whitaker [1992] 109 ALR 625.
3. General Guidelines for Medical Practitioners on Providing Information to Patients
and Communicating with Patients: Advice for Medical Practitioners. NHMRC,
Canberra 2004. http://www.nhmrc.gov.au/publications/synopses/e57syn.htm and
http://www.nhmrc.gov.au/publications/synopses/e58syn.htm
4. Australian Medical Association. Position Statement on Informed Financial Consent.
2006. http://www.ama.com.au/web.nsf/doc/WOOD-6S987R
5. Making Decisions About Tests and Treatments: Principles for Better Communication
Between Healthcare Consumers and Healthcare Providers. NHMRC, Canberra, 2005.
http://www.nhmrc.gov.au/publications/synopses/hpr25syn.htm
6. Savelescu J, Kerridge IH. Competence and consent. Med J Aust 2001; 175: 313–15.
7. Appelbaum PS. Clinical practice. Assessment of patients’ competence to consent to
treatment. NEJM 2007; 357: 1834–40.
8. Grisso T, Applebaum PS. Assessing Competence to Consent to Treatment: A Guide for
Physicians and Other Health Professionals. Oxford University Press, New York, 1998.
9. Gillick v West Norfolk AHA [1986] AC 112.
68 Good Medical Practice

10. Secretary, Department of Health and Community Services v JWB and SMB (1992)
FLC 92–293.
11. Skene L. Law and Medical Practice. Rights, Duties, Claims and Defences 3rd edn.
LexisNexis Butterworths, Sydney, 2008, p. 168.
12. Guardianship and Administration Board Act 1986 (Vic). http://www.dms.dpc.vic.gov.
au/
13. New South Wales Guardianship Tribunal. Substitute Consent. http://www.gt.nsw.gov.
au/information/doc 14 substitute consent.htm
14. Medical/Dental Treatment for Patients Who Cannot Consent: The Person
Responsible. Office of the Public Advocate Victoria. http://www.publicadvocate.vic.
gov.au/Medical-Consent.html
15. Tasmania Guardianship and Administration Board. Consent to Medical and Dental
Treatment. http://www.guardianship.tas.gov.au/consent for treatment
16. New South Wales Health Department 2004. Using Advance Care Directives.
http://www.health.nsw.gov.au/pubs/2004/adcaredirectives.html
17. New South Wales Health Department 2005. End-of-Life Care and Decision-Making
Guidelines. http://www.health.nsw.gov.au/policies/gl/2005/GL2005 057.html
18. Stewart C, Kerridge I, Parker M. The Australian Medico-Legal Handbook. Churchill
Livingstone Elsevier, 2008, pp. 121–3.
19. Clark S, Oakley J (eds). Informed Consent and Clinical Accountability. The Ethics of
Report Cards on Surgeon Performance. Cambridge University Press, Melbourne, 2007.
 4
Law and Bioethics:
A Rights-Based Relationship and
Its Troubling Implications
Daniel Sperling*

Some argue that law is the discipline which has mixed most prominently with
bioethics,¹ and that ‘bioethicists can be seduced by the law and by legal pro-
cedures’.² While there is a great consensus that law has influenced bioethics in
significant and important ways, certainly much more than it influenced other
‘law and . . .’ disciplines,³ scholars dispute as to the exact role which the law
plays in bioethics, the goals it purports to achieve, and the implications of its
relationship with the discipline of bioethics. Th is chapter aims to explore the
relationship between law and bioethics and calls for a careful evaluation of
the law’s contributions to bioethics. Specifically, it will be argued that while
the law contributed extensively to the development of bioethics it introduced a
language and a way of thinking that are not necessarily appropriate to handle
and resolve bioethical issues, and which, in a significant portion of cases, was
irrelevant and had little impact on decision-making and behavioural patterns
of patients. Moreover, law’s interference with and shaping of bioethical issues
resulted in serious threats to some of the major characteristics of such issues and
brought about other societal concerns which the law did not consider seriously.

* SJD, LLM (University of Toronto); LLB, BA (Philosophy) (The Hebrew University of

Jerusalem). Senior Lecturer, The Federmann School of Public Policy and Government and Braun
School of Public Health & Community Medicine, The Hebrew University of Jerusalem, Israel
<dsperling@pluto.mscc.huji.ac.il>.
¹ AR Jonsen, The Birth of Bioethics (New York: Oxford University Press, 1998) 342. See
GJ Annas, Standard of Care: The Law of American Bioethics (New York: Oxford University Press,
1993) 3: (‘American law, not philosophy or medicine, is primarily responsible for the agenda, devel-
opment and current state of American bioethics’) (hereinafter ‘Annas, Standard of Care’). See also
W Van Der Burg, ‘Bioethics and Law: A Developmental Perspective’ (1997) 11(2) Bioethics 91, 93.
² G Annas, ‘From Selection to Rationing: Policy’ Birth of Bioethics Conference, Seattle,
Washington, 24–25 September 1992, 75–80, mentioned in Jonsen (n 1 above) at 343.
³ AM Capron and V Michel, ‘Law and Bioethics’ (1993–4) 27 Loyola of Los Angeles Law Review
25, 32–3.

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 A Rights-Based Relationship and Its Troubling Implications 53
The chapter will conclude that it is now time to re-evaluate the direction which
bioethics should take in the next years, specifically whether it should continue
to integrate with law or other disciplines, or alternatively become a more auton-
omous and independent discipline.

I. Law’s Contributions to Bioethics

There are two main areas in which the law has significantly contributed to the
field of bioethics. The law facilitated the transformation and evolution of the field
of medical ethics into the discipline of bioethics. More importantly, that law has
introduced the rights discourse to the therapeutic relationship and bioethical
issues more generally.

A. From Medical Ethics to Bioethics

As soon as the practice of medicine began to evolve, ethical questions concern-
ing the limits of the therapeutic authorization were raised mainly by healthcare
providers. The traditional area of medical ethics was developed to meet the chal-
lenges made by an omni-competent doctor and dependent patient derived from
an inherent inequality of members of the two groups.⁴ However, under such
ethics the practice of medicine was paternalistic so that the right thing for the
patient was to do what her physician thought best.⁵ The traditional practice of
medicine involved little communication between physician and patient.⁶ In the
old era, physicians used to withhold therapeutic information from their patients
believing that the latter would not understand it or would be better off not know-
ing it. As explained by a bioethics historian David Rothman:
Well into the post-World War II period, decisions at the bedside were the almost exclu-
sive concern of the individual physician, even when they raised fundamental ethical and
social issues . . .
. . . Moreover, it was usually the individual physician who decided these matters at the
bedside or in the privacy of the hospital room, without formal discussion with patients,

⁴ DW Brock, ‘Legal Rights and Moral Responsibilities in the Health Care Process’ in
SF Spicker, JM Healey, and HT Engelhardt (eds), The Law-Medicine Relation: A Philosophical
Exploration (Boston: Reidel, 1981) 279.
⁵ Of course, some paternalism is and must be embedded in the physician-patient relationship,
the latter of which is premised on the specific technical training and competency of the physician.
As Mark Siegler and Dudley Goldblatt note, such specialized knowledge and proficiency serves
to assist the patient in her illness and suffering and is an inherent part of the therapeutic context.
M Siegler and D Goldblatt, ‘Clinical Intuition: A Procedure for Balancing the rights of Patients
and the Responsibilities of Physicians’ in SF Spicker, JM Healey, and HT Engelhardt (eds), The
Law-Medicine Relation: A Philosophical Exploration (Boston: Reidel, 1981) 5, 6.
⁶ cf D Oken, ‘What to Tell Cancer Patients: A Study of Medical Attitudes’ (1961) 175(13)
JAMA 1120 (a study showing that only 12% of physicians told patients they had cancer while most
patients wanted to know).

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 54 Daniel Sperling
their families or even with colleagues, and certainly without drawing the attention of
journalists, judges or professional philosophers. And they made their decisions on a case-
by-case basis, responding to the particular circumstances as they saw fit, reluctant by
both training and practice to formulate or adhere to guidelines or rules.⁷
It is suggested that the law was responsible for the redefinition of what was then
regarded as the principle of beneficence to paternalism.⁸ Such a shift in language
and in goal was part of a larger effort to redress the balance of power between
doctor and patient. Various reasons have contributed to the dramatic change and
development of the area of medical ethics into bioethics.
As significant advances were made in medical knowledge and technology,
contributors to these advances have raised concerns that medical ethics is too
weak to meet the ethical challenges posed by these developments. The traditional
Western medical ethics attached absolute respect for the sanctity of life. However,
modern developments, such as the population explosion and the appearance of
new medical technologies, forced society and physicians particularly to balance
that value and confront it with other competing values, such as quality of life
and respect for persons.⁹ In addition, traditional medical ethics mainly focused
on the qualities of a good physician and on what Jonsen calls ‘bedside manners’
such as the requirements that the doctor be gentle, pleasant, comforting, discreet,
firm, etc. Gradually, these requirements were perceived as being trivial and mere
gestures. A more grave morality was sought, that which was best articulated in a
language of duties imposed on the medical profession and which was rooted in
deep moral beliefs about the nature of the act of healing itself and its effects on
persons subjected to it, namely the patients.¹⁰ A new ethic for medicine and bio-
logical sciences was necessary. Bioethics thus became ‘the systematic study of the
moral dimensions—including moral vision, decisions, conduct and policies—of
the life sciences and health care, employing a variety of ethical methodologies in
an interdisciplinary setting’.¹¹ The law helped in transforming medical ethics to
bioethics by imposing duties on physicians and empowering patients and human
subjects with privacy, freedom of choice, autonomy, and the like.

⁷ DJ Rothman, Strangers at the Bedside: A History of How Law and Bioethics Transformed Medical
Decision Making (New York: Basic Books, 1991) 1,2 (hereinafter ‘Rothman, Strangers’).
⁸ DJ Rothman, ‘The Origins and Consequences of Patient Autonomy: A 25-Year Retrospective’
(2001) 9 Health Care Analysis 255, 257 (hereinafter ‘Rothman, Origins and Consequences’).
⁹ Jonsen, (n 1 above) 5.
¹⁰ ibid 6.
¹¹ WT Reich, ‘Introduction’ in Reich (ed), The Encyclopedia of Bioethics (revised edn). (New York:
Simon Schuster Macmillan, 1995), mentioned in Jonsen (n 1 above) vii. The term ‘bioethics’ was
first suggested by Van Rensselaer Potter, a biochemist and professor of oncology at the University
of Wisconsin (Madison) in ‘Bioethics: Bridge to the Future’ (C P Swanson, (ed), 1971) mentioned
in MA Rothstein, ‘The Growth of Health Law and Bioethics’ (2004) 14 Health Matrix 213. Some
attribute the first use of the word ‘bioethics’ to the Kennedy Institute of Ethics, which was estab-
lished in 1971. Others claim that Sargent Shriver was the first to introduce the term ‘bioethics’ to
Andre Hellegers who was organizing the Kennedy Institute of Ethics at Georgetown University.
Capron and Michel, (n 3 above) 26, n 6.

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 A Rights-Based Relationship and Its Troubling Implications 55

Along with these substantial changes there were few scandals, the most
serious of which took place during the Nazi regime, which discredited the faith
in health providers, exposed an inherent potential for exploiting the patient or
the human subject of clinical trials, and challenged the idea that the physician’s
main purpose is to benefit the patient. A series of disgraceful actions revealed
how a medical team may be self-interested and mainly concerned with pursuing
the reputation of its members, and gaining professional credit and wealth even
at the cost of the patient’s well-being.¹² Examples of these scandals include the
Nazi medical experiments on inmates in concentration and extermination camps
aiming to ascertain how long individuals survive in freezing water and how well
they function at different pressure levels existing at high altitudes. Other dread-
ful experiments included the practicality of various sterilization techniques, the
development of new vaccines, and novel surgical techniques. In addition, Nazi
physicians were involved in implementing the ‘euthanasia programme’ which
involved ‘the systematic and secret execution of the aged, insane, incurably ill, or
deformed children and other persons, by gas, lethal injections and diverse other
means in nursing homes, hospitals and asylums’.¹³ After the Second World War,
twelve US military trials were held in Nuremberg from 1946 to 1949. One of
the trials (US v Karl Brandt et al ) was concerned with the prosecution of twen-
ty-three physicians responsible for carrying out of these medical experiments.
The trial ended with fifteen defendants found guilty and sentenced to death and
with the enactment of the Nuremberg Code, leading to the establishment of the
Declaration of Helsinki regarding the rights of human research subjects in 1964.
A few years later, an article published in the New England Journal of Medicine
revealed a series of studies undertaken by medical researchers in the United States.
The studies were concerned with experiments subjecting normal newborns to
catheterization and multiple x-rays to study their bladders, examining the period
of hepatitis infectivity after children with mental defects were given the virus,
and exploring the rheumatic fever of men in service who were denied treatment
for streptococcal respiratory infection.¹⁴
During the same years, between 1932 and 1972, a large clinical study was con-
ducted in Tuskegee, Alabama, in which almost 400 poor and illiterate African
American were denied treatment for syphilis. The study was performed without the
subjects’ informed consent and was terminated after it was leaked to the press.¹⁵

¹² See generally G Annas and M Gordin (eds), The Nazi Doctors and the Nuremberg Code
(Oxford: Oxford University Press, 1992).
¹³ T Taylor, ‘The Nuremberg War Crimes Trials’ (April 1949) 450 International Conciliation
282, mentioned in SD Stein, ‘Nuremberg Trials Held by the United States of America Under
Control Council Law No. 10’, available at <http://www.ess.uwe.ac.uk/genocide/cntrl10_trials.
htm#Overview> (accessed 18 July 2008).
¹⁴ HK Beecher, ‘Ethics and Clinical Research’ (1966) 274 New England Journal of
Medicine 1354.
¹⁵ Centers for Disease Control and Prevention, ‘U.S. Public Health Service Syphilis Study at
Tuskegee’, available at <http://www.cdc.gov/tuskegee/timeline.htm> (accessed 18 July 2008).

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 56 Daniel Sperling
The shift from medical ethics to bioethics can also be explained by more gen-
eral developments, most prominently the emancipation process in which citizens
claimed their rights and freedoms mainly by an appeal to the law.¹⁶ With the
advent of the civil rights movement in the second half of the twentieth century,
public opinion has changed substantially with regard to the rights of individuals
as against the state and other individuals and social or political institutions.
The civil rights movement called for the increase of rights for and within health
care.¹⁷ This movement, along with the information revolution which took place
at that time, brought about a profound distrust and suspicion of authority and
led to a general resistance to paternalism.¹⁸ Other events contributing to these
general developments include the feminist critique of medical care institutions
by womens’ groups in the1960s and 1970s,¹⁹ and the new claims of people with
mental and physical disabilities and the subjects of medical research to be treated
equally and with respect.
The law facilitated and encouraged the dramatic development and transform-
ation of the area of medical ethics into the new interdisciplinary field of bioeth-
ics as advocacy for rights within health care has been advanced mainly through
courts.²⁰ Beginning with case decisions in torts, the law developed the idea of
integrity of the body, implying that no individual should be touched, let alone
treated without her prior consent. Any unapproved appropriating of the body was
regarded as battery and breach of duty of care.²¹ Gradually, the law established
and developed the requirement of consent, which not only protected patients
from unwanted touching but also empowered them with new and advanced
rights, in particular the right to autonomy and self-determination.²² Next, the
law expanded the requirement of consent to include the obligation to provide the

See generally JH Jones, Bad Blood: The Tuskegee Syphilis Experiment (New York: Macmillan
Publishing, 1993); SM Reverby (ed), Tuskegee’s Truths: Rethinking the Tuskegee Syphilis Study
(Chapel Hill, North Carolina: University of North Carolina Press, 2000).
¹⁶ Van Der Burg (n 1 above) 96.
¹⁷ P Starr, The Social Transformation of American Medicine: The Rise of a Sovereign Profession and
the Making of a Vast Industry (New York: Basic Books, 1982).
¹⁸ Rothman, Origins and Consequences, (n 8 above) 256.
¹⁹ S B Ruzek and J Becker, ‘The Women’s Health Movement in the United States: From
Grass-Roots Activism to Professional Agendas’ (1999) 54 Journal of American Medical Women’s
Association 4, 5.
²⁰ Even when advocacy was not pursued by lawyers, it focused on securing legal or statu-
tory change. MA Rodwin, ‘Patient Accountability and Quality of Care: Lessons from Medical
Consumerism and the Patients’ Rights, Women’s Health and Disability Rights Movements’ (1994)
20 American Journal of Law and Medicine 147.
²¹ See eg Schloendorf v Society of NY Hospital 105 NE 92, 93 (NY 1914) (‘Every human being of
adult years and sound mind has a right to determine what shall be done with his own body; and a
surgeon who performs an operation without his patient’s consent commits an assault, for which he
is liable in damages.’). For the duty of care in connection with the duty to provide information to
patients, see eg Bolam v Friern Hospital Management Committee [1957] 1 WLR 582; Canterbury v
Spence, 464 F 2d 772 (DC Cir 1972).
²² Most notably this right was acknowledged in the area of abortion law as part of a woman’s
constitutional right to privacy: Roe v Wade 410 US 113 (1973).

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 A Rights-Based Relationship and Its Troubling Implications 57

patient with sufficient knowledge about treatment, risks, and alternatives so that
her giving of consent should not only be free but also informed.²³ Finally, case
law and advance directive legislation established the right to refuse treatment,
including life-sustaining treatment, and more generally to participate actively in
medical decision-making.²⁴
There were few reasons for the incorporation and active involvement of law in
bioethical matters.²⁵ On the personal level, many scholars who are concerned with
issues in medical ethics and bioethics have strong legal academic backgrounds.²⁶
A partial list of these scholars includes Gerorge Annas, Alexander Carpron,
Bernard Dickens, Michael Freeman, Lawrence Gostin, Angela Holder, Jay Katz,
John Robertson, Patricia King, William Winslade, and Joseph Healey.²⁷ These
and many other legal scholars have framed and reshaped the bioethical questions
in legal language, and offered original ways to address the moral problems raised
in the clinical setting as if they were legal problems deserving a ‘right’ justifi-
able answer. Along with this line, Carl Schneider argues that the language of law
‘enriched bioethical discourse by generating vivid and pressing instantiations of
bioethical issues, by scrutinizing them—in part—in moral terms, and by prof-
fering means of resolving them’.²⁸ Along with the development of health law and
the increased jurisprudence in this latter area of law, legal scholars contributed
their personal knowledge and familiarity with case law and legislation and used it
as a means to structure decision-making processes in bioethics.²⁹
Second, the methodology used in law to develop and sustain legal rules and
principles and to resolve disputes was found to be close enough to that used in
medical ethics. As a practical discipline providing guidance for clinical decisions,
bioethics was receptive to the methodologies of both principlism and casuistry.³⁰
While the first methodology calls for the application of four major moral abstract

²³ Salgo v Leland Stanford Jr University Board of Trustees 317 P 2d 170 (Cal Ct App 1957).
See also J Katz, Th e Silent World of Doctor and Patient (New York: Free Press, 1984) 59–84.
But cf Annas, who argues that the doctrine of informed consent was not born at case law but
at Article 1 of the Nuremberg Code (‘The voluntary consent of the human subject is absolutely
essential’). GJ Annas, ‘American Bioethics after Nuremberg: Pragmatism, Politics and Human
Rights’ (Boston University Lecture, 2005), 8 (hereinafter ‘Annas, University Lecture’).
²⁴ For the discussion of a patient’s right to make health-related decisions under the autonomy
model see CE Schneider, The Practice of Autonomy: Patients, Doctors, and Medical Decisions (New
York and Oxford: Oxford University Press, 1998) 11–32 (hereinafter ‘Schneider, Autonomy’).
²⁵ See also RB Dworkin, Limits: The Role of Law in Bioethical Decision Making (Bloomington
and Indianapolis: Indiana University Press, 1996) 2.
²⁶ CE Schneider, ‘Bioethics in the Language of the Law’ (1994) 24(4) Hastings Center Report 16
(hereinafter ‘Schneider, Language’).
²⁷ Jonsen, (n 1 above) 342.
²⁸ Schneider, Language (n 26 above). However, Schneider also argues that since the law has
social goals and limits arising from its social purpose, the effect on and usefulness of law’s language
to bioethics are incomplete.
²⁹ For the development of health law see Rothstein (n 11 above).
³⁰ Other less dominant methodologies in bioethics include virtue ethics, the narrative method,
and the phenomenological method. See, ED Pellegrino, ‘Bioethics at Century’s Turn: Can
Normative Ethics Be Retrieved?’ (2000) 25(6) Journal of Medicine and Philosophy 655, 663–5.

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 58 Daniel Sperling
principles to almost every issue in bioethics,³¹ the second focuses on ad hoc
analysis of concrete cases.³² Both methodologies have their counterparts in law.
Third, since the law has binding effect on people’s preferences, it usually enjoys
the public faith and respect confirming its social and moral authority. This is
why the law was mostly suitable to redress the loss of estimation and suspicion
in health providers and researchers by bringing in new objective and credible
legal language to regain trust in health providers.³³ From this perspective, law’s
involvement and interference with the physician-patient relationship was not
seen as special given that ‘whenever there is a social sense of wrong, or injustice, or
an abuse of power by some people or some institutions (including government),
those who feel abused often turn to the law for protection.’³⁴
Fourth, law’s integration with bioethical issues and moral dilemmas in the
medical context was facilitated by a false assumption that law reflects ethics.
Charity Scott, for example, makes such an assumption when he argues that
the law reflects a consensus statement by our society on what we believe to be
ethically appropriate behaviour. In his view, the law reflects society’s idealism.³⁵
However, in the light of Legal Positivism this is a partial understanding of the
law. Whereas law obliges people to comply with society’s normative require-
ments, ethics is a tool for making such requirements specific, thereby obliging
persons to make their conduct conform, in a non-obligatory fashion, to such
norms.³⁶ An example for the separation of law from morals is seen in the writ-
ings of HLA Hart. Hart argued that ‘the most prominent general feature of law
at all times and places is that its existence means that certain kinds of human
conduct are no longer optional, but in some sense obligatory.’³⁷ The assumption
that law is not distinguished from ethics is easy to make when there is a vacuum
in other areas which may have integrated with bioethics, as explained by Daniel
Callahan:
I suspect that there has come to be some enormous moral vacuum in this country, which
for lack of better institutional candidates has been left to the law to fill. The churches are
either too sectarian or too morally bland, the universities too caught up in professional-
ism or culture wars, the journals of opinion tiresomely focused on the religious right (the

³¹ The major advocates of principlism are Tom Beauchamp and James Childress. See
TL Beauchamp and JF Childress, Principles of Biomedical Ethics (New York: Oxford University
Press, 4th edn, 1994).
³² The prominent advocates of that methodology are Albert Jonsen and Stephen Toulmin.
See AR Jonsen and S Toulmin, The Abuse of Casuistry: A History of Moral Reasoning (Berkeley:
California University Press, 1998). Interestingly, the authors note that some regard such method-
ology as ‘common-law ethics model’ (ibid 330).
³³ MA Hall, ‘Law, Medicine, and Trust’ (2002–3) 55 Stanford Law Review 463, 469.
³⁴ C Scott, ‘Why Law Pervades Medicine? An Essay on Ethics in Health Care’ (2000) 14 Notre
Dame Journal of Law, Ethics and Public Policy 245, 272.
³⁵ ibid.
³⁶ MC Sullivan and DF Reynolds, ‘Where Law and Bioethics Meet . . . and Where They Don’t’
(1997–8) 75 University of Detroit Mercy Law Review 607.
³⁷ HLA Hart, The Concept of Law (Oxford: Oxford University Press, 2nd edn, 1994) 6.

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 A Rights-Based Relationship and Its Troubling Implications 59
left) or assaulting politically correct liberals (the right), and political life reduced during
this campaign year to nasty negative attach on anything and everyone. That leaves the
law. It is relatively free of scandal, still generally respected, national and relatively uni-
form in its scope, and ready to take on ethics if that is what gets served up to it for the
making of decisions. It may be the best institution we have, but it is a poor substitute for
moral consensus and public debate on ethics.³⁸

B. The Rights Movement in Bioethics

The most significant contribution the law has made to bioethics lies in the
incorporation of the idea and language of rights to bioethical issues.³⁹ The rights
movement in bioethics began with case law and sporadic legislation, but also
gained weight by commentaries especially written by legal scholars and lawyers.
One of the prominent leaders of the rights movement in bioethics is George
Annas. In a leading article published in 1974, which marks the beginning of
this movement, George Annas and Jospeh Healey introduce for the first time
the idea of protecting the patient’s interests in the exercise of her rights. Such an
idea would provide, towards the end of this article, a bill of rights in the medical
context:
We begin with two fundamental propositions: (1) The American medical consumer pos-
sesses certain interests, many of which may properly be described as ‘rights’, that he does
not automatically forfeit by entering into a relationship with a doctor or a health care
facility; and (2) most doctors and health care facilities fail to provide for their protection
or assertion, and frequently limit their exercise without recourse for the patient.⁴⁰
A few years later, Annas publishes another essay where he writes:
. . . Both the health care provider and the patient will be better off if the status of the law
regarding both the patient’s and provider’s rights is understood, and the means of change
or challenge well delineated. I would go even further. An understanding of the law can
be as important to the proper care of patients as an understanding of emergency medical
procedures or proper drugs dosages.⁴¹
Although originally the rights movement in bioethics was addressed both to
patients’ and physicians’ rights, its most powerful effect was on patients, who

³⁸ D Callahan, ‘Escaping from Legalism: Is It Possible?’ (1996) 26(6) Hastings Center Report 34.
³⁹ A call to ensure patients’ rights in health care was also made by some medical sociologists,
most notably Eliot Freidson. See LR Staffen, ‘Heroic Medicine, Physician Autonomy, and Patient
Rights’ (1994) Law and Social Inquiry 753.
⁴⁰ GJ Annas and JM Healey, ‘The Patient Rights Advocate: Redefining the Doctor-Patient
Relationship in the Hospital Context’ (1974) 27 Vanderbilt Law Review 243, 245. See also
GJ Annas, The Rights of Hospital Patients: The Basic ACLU Guide to a Hospital Patient’s Rights (New
York: Discus, 1975).
⁴¹ G Annas, ‘Legal Rights in the Health Care Setting’ in SF Spicker, JM Healey, and
HT Engelhardt (eds), The Law-Medicine Relation: A Philosophical Exploration (Boston: Reidel,
1981) 265, 266 (hereinafter ‘Annas, Legal Rights’).

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 60 Daniel Sperling
were regarded defenseless and in need of legal protection. The introduction of
the new rights discourse to bioethics, which partly involved the acknowledge-
ment of constitutional rights,⁴² was purported to reflect a societal consensus over
how the ethical balance ought to be weighed between doctors and patients.⁴³
Such a discourse was thought to be necessary in an area where people are most
vulnerable and hopeless. Acknowledging, respecting, and enforcing rights in the
medical context was seen as a useful way to give some power to incapable patients
and guarantee that they would be treated with respect and dignity.⁴⁴
The language of rights added to the moral discourse in bioethics statements
providing vital protections of life, liberty, expression, and property and was
extremely important.⁴⁵ It was successful in its conjunction with medical ethics
in part because traditional medical ethics was understood to deal with the pro-
tection of individuals’ interests as against their physicians, and rights were pri-
mary instruments to achieve this end. As a reaction to medical authority and
paternalism, the language of rights seemed the best way to empower patients
as against their doctors and to confer on them a sense of control and responsi-
bility wherefrom they could gain some benefits that were not dependent on the
physician’s good will, on chance, or on money. As explained by Beauchamp and
Childress, strong advocates of the rights movement in bioethics:
Being a rights-bearer in a society that enforces rights is both a source of personal protec-
tion and a source of dignity and self-respect. By contrast, to maintain that someone has
an obligation to protect another’s interest may leave the recipient in a passive position,
dependent upon the other’s good will in fulfilling the obligation. When persons possess
enforceable rights correlative to obligations, they are enabled to be independent agents,
pursuing their projects and making claims. What we often cherish is not that someone is
obligated to us, but that we have a right that secures for us the opportunity to pursue and
claim as ours the benefit or liberty that we value.⁴⁶
The rights discourse in general, and the right to autonomy and self-determination
specifically, focused on three levels of relationship. First and foremost is the rela-
tionship between the patient and her physician. Within this context the rights
discourse empowered the patient by providing her rights which her physician
has had duties to fulfil. Through that discourse the patient regained her position
and standing vis-à-vis her health provider, making both parties more or less equal
within that relationship. This level of relationship was influenced by the liberal
thought respecting a person’s rights to privacy, autonomy, and bodily integrity.
A second level of relationship concerns the relationship between the patient and
the state, the latter of which represents the public interest. The rights discourse

⁴² For the importance of constitutional rights in adjudication see Dworkin (n 25 above) 15–18.
⁴³ Scott (n 34 above) 263.
⁴⁴ Annas, Legal Rights (n 41 above) 268.
⁴⁵ TL Beauchamp and JF Childress, Principles of Biomedical Ethics (New York: Oxford
University Press, 5th edn, 2001) 355.
⁴⁶ ibid 362.

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 A Rights-Based Relationship and Its Troubling Implications 61

at this level provided individuals, who needed access to medical technology or

treatment, or required some assistance in order to achieve their health-related
goals, a sense of security from state interventions and limitations. Rights in
this category were mainly established in abortion or end-of-life legal cases and
include the right to cease or refuse treatment and, more generally, the rights to
privacy and bodily integrity. Such rights were usually constitutional, protecting
and promoting a zone of privacy from the state’s interventions. This level of rela-
tionship was influenced by the libertarian philosophy, and was most dominant in
American case law.
A third level of relationship within which the rights discourse was developed
concerns the rights of an individual patient as against her state in the light of
a more general understanding of human rights and the right to access health
care, mainly established in international treaties and conventions. Such a level of
relationship was influenced by arguments concerning the equal access to health
services and the enhancement of one’s freedom, especially one’s freedom of repro-
duction. Examples of rights developed in this context include Diane Blood’s
right to export her deceased husband’s sperm for insemination in Belgium,⁴⁷ and
more recently Ms and Mr Evans’ rights to respect for both decisions to (corres-
pondingly) become and not to become a parent under Article 8 of the European
Convention.⁴⁸
Although the rights discourse is now dominant in bioethics, there are many
problems and difficulties which such discourse gives rise to. The following section
will discuss the most important of these.

II. Critique of the Rights Movement in Bioethics

Much of the criticism against the rights movement in bioethics expressed in this
section can be explained by the more general critique of the Critical Legal Studies
movement of liberalism.⁴⁹ However, it is possible to identify five major areas of
criticism which are highly appealing to rights in the medical context.

A. Missing Right-Holder
First, since ethical dilemmas in the medical context were formed and articulated
in a language of rights, such a language was found inapplicable to certain parties
affected by bioethical issues who were incapable of holding rights. These include

⁴⁷ R v Human Fertilisation and Embryology Authority, ex p Blood [1997] 2 WLR 806.

⁴⁸ Evans v Amicus Healthcare Ltd and Ors [2004] 2 WLR 781; Evans v UK (Application
No 6339/05) European Court of Human Rights (7 March 2006) available at <http://www.
familylawweek.co.uk/library.asp?i=1776> (accessed 18 July 2008).
⁴⁹ See eg D Kennedy, ‘Form and Substance in Private Law Adjudication’ (1976) 89 Harvard
Law Review 1685.

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 62 Daniel Sperling
aborted embryos, frozen eggs, brain-dead patients, etc. Hence, for example, if a
frozen embryo is not a human being and does not hold rights how can one justify
the special respect we owe to it while making a decision on whether to discard or
donate it to others,⁵⁰ to produce from it stem cells for research, or to select its sex
before it is implanted?⁵¹ If a person does not have a proprietary right in her body
or bodily parts, how can we compensate her for an unauthorized but profitable
use of her cells and bodily parts?⁵² Or, if a brain-dead pregnant woman cannot
be said to hold rights, what prevents us from artificially sustaining her life for
the sake of her foetus and society’s general interest in safeguarding life?⁵³ These
questions and many more reflect the fact that the rights discourse could not pro-
vide a satisfactory and complete mechanism through which ethical dilemmas in
bioethics can be resolved.

B. Balance of Rights and Emphasis on Procedure

The concept of rights involves the viewing of the world in terms of contradictory
dualities and values. The law facilitates the hiding of the conflicts inherent in
such dualities and values through, for example, moving from one possible result
to another without any consistent normative theory.⁵⁴ The rights discourse has
proved impractical and insufficient since it requires the balance of competing
rights involved. The result of such a balance is nevertheless unnecessary and in
any event gives no answer or solution to the kind of problem at stake. Moreover,
since more issues in bioethics have been resolved on a case-by-case basis and on
an individual balance of competing rights, the law of one state on a particular
issue may be opposite to that of another, while a third state may not have consid-
ered the issue at all.⁵⁵
Furthermore, the rights discourse in bioethics refers more to the question
of who is the right-holder and explores less about the content of the right at

⁵⁰ Davis v Davis, 842 SW 2d 588 (Tenn 1992).

⁵¹ Van Der Burg (n 1 above) 105–6.
⁵² Moore v Regents of the University of California, 793 P. 2d 479 (Cal 1990).
⁵³ D Sperling, ‘Maternal Brain-Death’ (2004) 30(4) American Journal of Law and Medicine 453.
For a detailed account of posthumous rights and interests, see D Sperling, Posthumous Interests:
Legal and Ethical Perspectives (Cambridge: Cambridge University Press, 2008). Other issues related
to the use of dead bodies include the suggestion of having their organs automatically available for
transplantation or practising resuscitation procedures on those bodies without informing families
or seeking consent. See correspondingly J Harris, ‘Law and Regulation of Retained Organs: The
Ethical Issues’ (2002) 4 Legal Studies 527; KV Iserson, ‘Teaching without Harming the Living:
Performing Minimally Invasive Procedures on the Newly-Dead’ (2005) 8 Journal of Health Care,
Law and Policy 216; D Sperling, ‘Breaking Through the Silence: The Illegality of Performing
Resuscitation Procedures on the Newly-Dead’, (2004) 13(2) Annals of Health Law 393.
⁵⁴ Ed Sparer, ‘Fundamental Human Rights, Legal Entitlements, and the Social Struggle:
A Friendly Critique of the Critical Legal Studies Movement’ (1984) 36 Stanford Law Review
509, 517.
⁵⁵ JL Dolgin and LL Shepherd, Bioethics and the Law (New York: Aspen Publishers, 2005) 7.

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 A Rights-Based Relationship and Its Troubling Implications 63

stake.⁵⁶ The discourse provides a mere procedure to resolve disputes in bioethics

or better articulate them but fails to address substantive issues raised by those
disputes.⁵⁷ The mechanism of rights puts emphasis on how conflicts are settled
rather than why. As a result, bioethics has come to be characterized by a lack
of substantive reflection represented by its difficulty in establishing a norma-
tive ethics for the biomedical sciences.⁵⁸ One of the prominent scholars who is
disturbed by this lack of normative moral background to bioethical questions
is Eduard Pellegrino. Pellegrino critically claims that bioethics has become a
procedure for resolving ‘value’ conflicts whether those values are moral or not,
and that bioethics is now concerned with ‘what “works” or what is “useful”, ie
what is justifiable to the parties making the decision irrespective of whether or
not the conflict resolution is true or good’.⁵⁹

C. A Social Justice Critique

An emphasis on rights in bioethical issues encouraged an atomistic approach
to ethical issues raised in the medical context. Although rights may have
enhanced personal enrichment through personal and individual freedom, the
idea of rights often leaves behind other individuals and groups, thereby ignor-
ing important segments of the population who are depleted by their inability to
fulfi l their powers.⁶⁰ Moreover, the rights movement in bioethics made it easy
for health providers to ignore the social implications, effects, and causes of the
various decisions and dilemmas they are confronted with, and to take no notice
of the way in which the medical institutions and legal doctrines shape and
influence the social life and behaviour of individuals and patients in society.
The language of rights has thus depressed any attempt to subsume individual
interests under broader social interests, thereby communicating a clear mes-
sage that bioethics—like law more generally—is all about rights, duties, and
sanctions.
The rights discourse in bioethics discouraged a rich and broad understanding
of the social factors affecting the dilemmas at issue and the possible solutions

⁵⁶ AM Capron, ‘What Contributions Have Social Science and the Law Made to the
Development of Policy on Bioethics?’ (1999) 128(4) Daedalus 295, 297.
⁵⁷ cf Wendy Mariner, who argues: ‘Of course, law is not a tool to enforce understanding. Just as
law cannot make people kind or generous, it cannot make them understand something. The best it
can do is require the presence of objectively observable factors that make understanding possible.’
WK Mariner, ‘Informed Consent in the Post-Modern Era’ (1988) 13 Law and Social Inquiry 385,
402. For the general role of procedure in law, see Dworkin (n 25 above) 6.
⁵⁸ JP Bishop and F Jotterand, ‘Bioethics as Biopolitics’ (2006) 31 Journal of Medicine and
Philosophy 205, 206.
⁵⁹ Pellegrino (n 30 above) 657.
⁶⁰ cf Halpern, who writes that membership of patient-rights advocacy groups is overwhelmingly
white, well-educated, and middle class, as patients in these demographic groups are most interested
in participating in medical decision-making. SA Halpern, ‘Medical Authority and the Culture of
Rights’ (2004) 29(4–5) Journal of Health Politics, Policy and Law 835, 845.

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 64 Daniel Sperling
available.⁶¹ More generally, the rights movement led to an approach ignoring the
social detriments to health and health inequalities. The emphasis on legal stand-
ing and the need merely to characterize one’s legal entitlements (rights) against
the other or the state and establish an alleged mechanism to balance between
them made a shift in the interest of bioethics from the right to health to the
right to health care. Such a shift left bioethicists considerably silent on the moral
issues faced when limited health care resources are prioritized.⁶² While bioeth-
ics seemed to have developed through cases establishing the freedom of choice
of individuals, whether patients or the subjects of clinical trials, it remained far
behind with regard to issues relating to access to medical treatment, for example
access to assisted reproductive technologies, and to cases concerning the distribu-
tion of health care such as the allocation of organs for transplantation.
Moreover, emphasis on autonomy and individual rights supported the
Rawlsian belief that justice is concerned with individual actions, social institu-
tions, and outcomes which are within human control.⁶³ Such a belief made it
difficult to justify a right to health given that the latter may be influenced by
factors which are not controlled by the individual, such as her genetic inherit-
ance, poverty, racial and national background, exposure to infectious diseases,
etc. Instead, the rights movement in bioethics was able only to justify a right to
health care leading to health factors controlled by the autonomy of the person
in need. A precondition for that right would now be the individual’s ability to
participate in social life and to be able to enhance her primary goods (civil and
political liberties) through such participation. Under such an understanding,
any individual who, for her medical condition, could not take active measures in
social life or for whom treatment is not aimed to restore the ability to be socially
active, for example a terminally ill patient receiving palliative care, could not
be justified in having a right to health or to that specific health treatment/
procedure.

D. General Conceptual Difficulties

Although law in general and the rights movement in particular were developed
to resolve ethical issues in bioethics and were erroneously perceived as a substi-
tute to ethics,⁶⁴ they did not succeed in establishing infrastructure to resolve

⁶¹ WM Sage, ‘The Lawyerization of Medicine’ (2001) 26(5) Journal of Health Politics, Policy
and Law 1179, 1186.
⁶² DW Brock, ‘Broadening the Bioethics Agenda’ (2000) 10(1) Kennedy Institute of Ethics
Journal 21, 22.
⁶³ J Rawls, A Theory of Justice (Cambridge, Mass.: Harvard University Press, 1971).
⁶⁴ cf Charity Scott who writes: ‘Law pervades medicine because ethics pervades medicine, and
in America, we use the law to resolve ethical dilemmas in health care’, and ‘In health care, our soci-
ety has used the law to ask (and answer) questions about what are ethically appropriate behaviors
among those who provide, or receive, or pay for health care services.’ Scott (n 34 above) 245, 248.
See also Annas, Standard of Care (n 1 above) 3: ‘It seems natural for Americans, for example, that

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 A Rights-Based Relationship and Its Troubling Implications 65

ethical dilemmas in bioethics because of substantive conceptual difficulties lying

in the differences between law and ethics. First, ethical dilemmas in bioethics
are always between two competing alternative conducts both of which are right
things to do. When law interferes with a conflict between two actions that are
right, writes Roger Dworkin, the law’s job is very difficult in mediating between
the ‘rights’ and in attempting to sacrifice as little as possible of what is ‘right’ on
both sides.⁶⁵
Second, the law in itself demands for and is satisfied with minimum require-
ments and does not aspire to create or produce a praiseworthy moral conduct.⁶⁶
So, in the area of informed consent, for example, the law sets the conditions for
the patient to be informed about diagnosis, treatment, and alternatives but it is
not concerned with the question of whether the patient has in fact understood
the information she was given. On this issue Robert Levine comments: ‘A focus
on rights and rules . . . has a tendency to yield a “minimalist ethics”. In a minim-
alist ethics, much of the behavior we value in the caring physician is regarded
as supererogatory or optimal—nice but not morally required.’⁶⁷ In addition to
these different standpoints of law and morals, rights also run the risk of creating a
poor understanding of the moral significance of motives, supererogatory actions,
virtues, and the like characterizing the field of ethics.⁶⁸
Third, as a result of institutional differences between law and ethics, legal con-
ceptions and legal terms do not always fit the bioethical discourse. Developed
under tort law, the law of informed consent for example, can have only limited
power by retrospectively compensating victims for their injuries rather than pro-
spectively reforming the relationship between physicians and patients so that it
would include the duty to share and communicate to the latter substantive infor-
mation and treatment.⁶⁹ Additionally, the legal language of rights associated
with and developed through case law (especially torts) usually employs the idea
of wrongs. Such language focuses on the fulfilment of those rights and the satis-
faction of the subject of rights, thereby allowing physicians to separate themselves
from their patients. Indeed, rights may be vested in the therapeutic relationship

the morality of abortion has been recast as the “right to abortion” and that the morality of medical
treatment near the end of life is now called simply “the right to die”.’
⁶⁵ Dworkin (n 25 above) 7, 165.
⁶⁶ ‘By addressing what we have generally agreed is wrong behavior or bad actions, the law sets
the legal minimums for behavior; it does not address the ethical maximums. The law provides
sanctions for wrongdoing; it does not tend to provide rewards for doing good or even sanctions for
failing to do good.’ Scott (n 34 above) 260. The tendency to regard the physician-patient relation-
ship as a contract may also indicate the minimalism of the law. Van Der Burg (n 1 above) 102, n 30.
The contract model is also explained by the patient’s exercise of rights vis-à-vis her health provider.
See Brock (n 4 above) 280.
⁶⁷ R Levine, ‘Medical Ethics and Personal Doctors: Conflicts between What We Teach and
What We Want’ (1987) 13 American Journal of Law and Medicine 351, 362.
⁶⁸ Beauchamp and Childress (n 45 above) 361.
⁶⁹ Schneider, Language (n 26 above).

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 66 Daniel Sperling
but their conferral is at the expense of a genuine and caring dialogue between
physicians and patients.⁷⁰

E. Rhetorical Contribution
Rather than having practical effects on ethical issues, the main contribution of
the rights movement to bioethics was its strong rhetorical and expressive func-
tion. The language of rights helped articulate and construct a balance between
competing interests, making the empowerment of patients more visible, but it
had limited consequences. In this important respect, the legal interference with
bioethics can exemplify how the ‘law in books’ stands in contradiction to ‘the law
in action’.
The limited effect of the rights movement in bioethics is best observed in the
right to refuse treatment which was regarded as correlative to the right to give
consent and consequently led to the establishment of three related patient rights:
the right to die with dignity and to refuse treatment; the right to receive assisted
suicide; and the right to leave a valid advance directive.
Although case law developed and made it a legal obligation to obtain patients’
approval for medical treatment, having explored the full consequences of such
treatment, empirical studies suggest that only a few physicians view consent as
integral to medical practice or give it much attention.⁷¹ Studies show that phy-
sicians prefer some treatments over others and are sceptical regarding whether
informed consent can bring any gain to their patients. Moreover, it is reported
that most patients prefer to leave treatment choices to their physicians, and that
less than a third want veto power over those decisions.⁷² Recent studies reveal
that almost half of respondent patients prefer to rely on physicians for medical
knowledge rather than seeking out information themselves.⁷³ Leading to these
data is the fact that many patients are incapable of comprehending and manipu-
lating complex information about risks associated with proposed treatment and
alternatives to it.⁷⁴ Hence, physicians frequently do not genuinely embrace the
goals of informed consent and these are not implemented within the physician-
patient relationship.⁷⁵ The lack of patients’ participation in medical decisions is
also observed in studies of intensive care units, where physicians insist that deci-
sions require understanding of technical information and that patients’ families

⁷⁰ ibid. ⁷¹ Halpern (n 60 above) 840–1.

⁷² CW Lidz, A Meisel, M Osterweis, JL Holden, JH Marx, and MR Nunetz, ‘Barriers to
Informed Consent’ (1983) 99 Annals of Internal Medicine 539.
⁷³ W Levinson, A Kao, A Kuby, and RA Th isted, ‘Not All Patients Want to Participate in
Decision Making’ (2005) 20(6) Journal of General Internal Medicine 531.
⁷⁴ DI Shalowitz and MS Wolf, ‘Shared Decision-Making and the Lower Literate Patient’ (2004)
32 Journal of Law, Medicine and Ethics 759.
⁷⁵ A Meisel and M Kuczewski, ‘Legal and Ethical Myths about Informed Consent’ (1996) 156
Archives of Internal Medicine 2521.

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 A Rights-Based Relationship and Its Troubling Implications 67

are too emotional to give or make medical choices.⁷⁶ Finally, in the context of
biomedical research, studies also show that researchers rarely supply broad infor-
mation about the process and goals of the type of research being conducted, and
as a result human subjects make false assumptions about the studies in which
they participate.⁷⁷
Beginning with Karen Ann Quinlan’s case, which addressed the right of an
unconscious patient to withdraw life-sustaining treatment as expressed by her
father,⁷⁸ courts have acknowledged a patient’s or surrogate’s right to accept or
refuse medical treatment, including a constitutional right to die with dignity.⁷⁹
Courts have also recognized the right of mentally competent patients to refuse
treatment even at the cost of death. Examples of the latter cases include the right
of a Jehovah’s Witness to refuse a blood transfusion,⁸⁰ and the right of a patient
with a disability to refuse nutrition and hydration.⁸¹
Indeed, the Quinlan case symbolizes the beginning of a new era where the
courts expand the patient’s rights to decline life-sustaining treatment, com-
pel physicians to respect patients’ Do-Not-Resuscitate demands, and even-
tually require physicians’ assisted help to terminate individuals’ lives. But, as
illuminated by Tina Stevens, this is a false genealogy since this era marks the
beginning of a fatal turn from the ambit of patients, health providers, and com-
munities to the sphere of the courtroom and the language and limitations of
rights.⁸² The court’s refusal to acknowledge Nancy Cruzan’s right not to be fed
by her doctors and its requirement for clear and convincing evidence to demon-
strate the wishes of an incompetent adult patient,⁸³ as well as the reluctance of
the US Supreme Court to recognize a general constitutionally protected right
to commit suicide with the help of her physician⁸⁴ suggests that the movement
is misdescribed.
The right to refuse treatment was not as fully acknowledged as its rhetorical
presentation might have suggested. Such a right was not respected by courts
when the interests of a minor were at stake or for the protection of a foetus.
For example, the court ordered that a mother of an infant who was a Jehovah’s
Witness should receive a blood transfusion,⁸⁵ and that doctors are free to force

⁷⁶ Halpern (n 60 above) 841.

⁷⁷ JA Fisher, ‘Procedural Misconceptions and Informed Consent: Insights from Empirical
Research on the Clinical Trials Industry’ (2006) 16(3) Kennedy Institute of Ethics Journal 251.
⁷⁸ Re Karen Ann Quinlan 355 A 2d 647 (NJ 1976).
⁷⁹ Cruzan and Ors v Director, Miscuri Department of Health 497 US 261, 110 S Ct 2841 (1990).
⁸⁰ Norwood Hospital v Munoz 564 NE 2d 1017 (Mass. 1991).
⁸¹ Bouvia v Superior Court 225 Cal Rptr 297 (Ct App 2d Dist 1986).
⁸² MLT Stevens, Bioethics in America: Origins and Cultural Politics (Baltimore and London: The
Johns Hopkins University Press, 2003) 151.
⁸³ Cruzan and Ors v Director, Missouri Department of Health 497 US 261, 110 S Ct 2841 (1990).
⁸⁴ Washington v Glucksberg 521 US 702 (1997); Vacco v Quill 521 US 793 (1997).
⁸⁵ Application of the President and Directors of Georgetown College Inc 331 F 2d 1000 (DC Cir
1964).

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 68 Daniel Sperling
pregnant woman to have a cesarean section to save the life of her foetus.⁸⁶
Moreover, empirical studies suggest that 34 per cent of 879 surveyed physi-
cians practicing in adult intensive care units in the United States continue to
provide life-sustaining treatment against the wishes of patients or their surro-
gates.⁸⁷ In the area of Jehovah’s Witnesses’ right to refuse blood transfusions,
careful analysis shows that some cases acknowledging such a right were held
after the patient was successfully transfused, after she successfully recovered
without needing the transfusion, or when the decision was rendered moot by
the patient’s ‘willingness to be coerced’.⁸⁸ The rhetorical function of the rights
discourse is explained by Lisa Staffen:
Despite the presence of the law in defining the nature of some of the patient’s rights, the
evidence from the books under review here clearly suggests that the rights of patients
depend on the actions of physicians. Physicians may fulfill their obligation to seek con-
sent for some medical interventions, but this obligation does not extend to full disclosure
of the range of treatment options or full access to the decisions about which course of
treatment is appropriate. In addition, physicians have a great deal of discretion in decid-
ing when treatment is futile and whether a decision is the kind that requires patient and
family participation.⁸⁹
Moreover, since the rights discourse in bioethics hardly involved the estab-
lishment of positive rights, no right to receive medical treatment, let alone to
be given assistance that will hasten one own’s death was acknowledged. This
is especially puzzling since the law did recognize other rights protecting the
very same interest justifying those positive rights, namely the privacy inter-
est of patients. Although empirical studies suggest that around 16 per cent of
surveyed oncologists participated in euthanasia or physician-assisted suicide,⁹⁰
courts (including the US Supreme Court) ruled that there is no constitutional
right to receive a physician’s assistance in committing suicide.⁹¹ Courts declined

⁸⁶ Jeff erson v Griffin Spalding County Hospital Authority 274 SE 2d 457 (Ga 1981). For a detailed
analysis of legal interventions involving the bodies of pregnant women, see D Sperling, Management
of Post-Mortem Pregnancy: Legal and Philosophical Aspects (Aldershot: Ashgate, 2006) 15–34.
⁸⁷ DA Asch, J Hansen-Flaschen and PN Lanken, ‘Decisions to Limit Life-Sustaining Treatment
by Critical Care Physicians in the US’ (1995) 151(2) American Journal of Respiratory and Critical
Care Medicine 288.
⁸⁸ Siegler and Goldblatt (n 5 above) 24.
⁸⁹ Staffen (n 39 above) 756. cf Robert Zussman, who writes that law’s impact is largely cere-
monial in that it influences how physicians document their decisions on DNR orders but not the
process through which such decisions are made. R Zussman, Intensive Care: Medical Ethics and
the Medical Profession (Chicago: Chicago University Press, 1992), mentioned in Halpern (n 60
above) 841.
⁹⁰ EJ Emmanuel, ER Daniels, DL Fairclough, and BR Clarridge, ‘The Practice of Euthanasia
and Physician-Assisted Suicide in the Uninted States’ (1998) 280(6) JAMA 507.
⁹¹ Vacco v Quill 521 US 793 (1997); Washington v Glucksberg 521 US 702 (1997); R (on the
Application of Pretty) v Director of Public Prosecutions [2002] 1 AC 800. Oregon is the only state in
the US which has passed a law (in 1994) permitting physician-assisted suicide under certain cir-
cumstances: Or Rev Stat §§ 127.800–127.897 (2005). The Act allows physicians to prescribe lethal
medication for competent terminally ill patients who make a written request, but removes the

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 A Rights-Based Relationship and Its Troubling Implications 69

to promulgate a new liberty interest in having assistance to end one’s own life
and saw no violation of the equal protection of the law by preventing compe-
tent terminally ill patients from receiving assistance as opposed to incompetent
patients. Moreover, courts concluded that every state might rationally forbid
anyone from assisting another to commit suicide.⁹² To secure the inexistence of
such a right, US Federal law prohibits the use of funds to subsidize physician-
assisted suicide,⁹³ and states also include a ban of physician-assisted suicide in
their national legislation.⁹⁴
The mere rhetorical function of the rights movement in bioethics is also
evidenced in the area of the right to leave a valid advance directive for the
determination of health treatment to be provided or withdrawn in the state of
incompetency. Such a right was acknowledged by national and federal legis-
lation in the United States,⁹⁵ Canada,⁹⁶ United Kingdom,⁹⁷ and many other
Western countries.⁹⁸ However, studies show that the law has had little effect
on the issuing and use of advance directives; that it is implemented by medical
institutions and personnel in a passive manner; and that the involvement of phy-
sicians in its implementation is lacking.⁹⁹ Beside the fundamental flaws in and
unexpected problems of advance directives, usually associated with the handing
of authority regarding incompetent patients to persons other than the person
who issues the directive,¹⁰⁰ completion rates among most patient groups run
at only 4 to 25 per cent and intensive education and promotion barely improve
those rates.¹⁰¹ Other studies suggest that the concept of advance directives may

physician from civil or criminal liability in compliance with such a request. A recent majority deci-
sion of the US Supreme Court held that an interpretive rule regarding the Controlled Substances
Act, making the use of a controlled substance to assist suicide not a legitimate medical practice
and an unlawful act, could not prohibit physicians from prescribing drugs for use in suicide under
Oregon law permitting the procedure, Gonzales and Ors v Oregon and Ors 546 US 243 (2006).
⁹² See Capron (n 56 above) 314–15.
⁹³ Federal Assisted Suicide Funding Restriction Act, 42 USC (1997).
⁹⁴ Scott (n 34 above) 279, n 90.
⁹⁵ Patient Self Determination Act, 42 USC (1992). The Act requires that hospitals and other
health providers inform their patients of their right to make end-of-life decisions and issue an
advance directive.
⁹⁶ For an exhaustive description of legislation in Canada, see <http://www.utoronto.ca/jcb/
outreach/ documents/ JCB_Living_Will.pdf> (accessed 18 July 2008).
⁹⁷ Mental Capacity Act 2005, ss 24–26.
⁹⁸ Recently, Israel has enacted the Dying Patient Act 2005 which legalizes the withdrawal of
medical treatment from a patient suffering from an incurable medical condition and whose life
expectancy is no more than 6 months. Sections 31–36 regulate the issuing and validation of an
advance directive relating to such a physical state.
⁹⁹ JL Yates and H Glick, ‘The Failed Patient Self Determination Act and Policy Alternatives for
the Right to Die’ (1997) 9(4) Journal of Aging and Social Policy 29.
¹⁰⁰ R Dresser, ‘Relitigating Life and Death’ (1990) 51 Ohio Law Journal 426–37; Allen E
Buchanan and Dan W Brock, Deciding for Others: The Ethics of Surrogate Decision Making
(Cambridge: Cambridge University Press, 1989) 185.
¹⁰¹ Henry S Perkins, ‘Controlling Death: The False Promise of Advance Directives’ (2007)
147(1) Annals of Internal Medicine 51.

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 70 Daniel Sperling
appeal only to certain subsets of the population (mostly the white middle-class
population), limiting the effectiveness of such legal mechanism.¹⁰²
The legal policy about end-of-life decisions and ethical dilemmas, mostly
manifested through the areas of refusal of treatment, the right to be given end-
of-life assistance, and the issuing of advance directives demonstrates how the
rights discourse in bioethics was adopted without much empirical reason to
believe it could be effective and of real use.¹⁰³ The main rhetorical function of
the rights discourse in bioethics can be explained more generally by the limits
of the law’s ability to shape and influence individuals’ behaviour deriving from
society’s complexity and the diversity in patients’ expectations regarding dis-
closure of their diagnosis or prognosis, the general importance they give to
truth-telling, and the way in which they deal with the nature of their illness and
treatment options.¹⁰⁴ As Carl Schneider commented:
People are enticed by many pressures beyond those the law creates. They have their own
agendas and, more important, their own normative systems. The law writes rules, but the
governed—when they know the rules—often have the incentives, and energy to avoid
them . . .
. . . While the language of law may have penetrated into the bosom of society, it must
still, in quotidian life, compete with the many other languages that people speak more
comfortably, more fluently, and with much more conviction. These are the languages of
religion and morality, of love and friendship, of pragmatism and social accommodation,
of custom and compromise. The danger of bioethicists, then is believing too deeply that
law can pierce the Babel, can speak with precision, can be heard.¹⁰⁵

III. Implications of the Rights Movement in Bioethics

In addition to the difficulties associated with the incorporation and applica-

tion of legal rights to bioethics, there are several other implications which the
consideration of rights in the medical context has brought about. Some of these
implications took different directions than those originally intended by the rights
movement. Four major implications will be now identified.

A. Change of the Therapeutic Relationship

The rights movement in bioethics brought dramatic changes to the therapeutic
relationship. First, strange parties were suddenly involved in and became part of
the therapeutic relationship and stood in between the patient and their physician.

¹⁰² Capron (n 56 above) 312. ¹⁰³ ibid 306–25.

¹⁰⁴ ibid 312–13, 318. The court’s assumption in the Quinlan case that hospital ethics commit-
tees were common institutions for resolving ethical problems is an example of a legal proposition
made in bioethics which is not grounded on empirical data (ibid 321).
¹⁰⁵ Schneider, Language (n 26 above).

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 A Rights-Based Relationship and Its Troubling Implications 71

As a result, physicians turned into strangers and became a group apart from their
patients. Emphasis on patient rights invited lawyers, clinical bioethicists, and
hospital ethics committees to protect and strengthen the patient’s role in med-
ical decision-making.¹⁰⁶ While the rights discourse was aimed at recovering the
physician-patient relationship, which suffered from excessive paternalism and
possible exploitation and abuse of patients, such discourse created an atmosphere
under which medicine becomes adversarial practice and physicians lack trust-
worthiness. As observed by Richard Sherlock: ‘The language of rights and the
language of trust move in opposite directions from one another. The scrupulous
insistence on observance of one’s rights is an admission that one does not trust
those at hand to care properly for one’s welfare.’¹⁰⁷ The physician’s response to
the increase in legal intrusions and control of medical practice also resulted in
viewing such an interference as an attack upon physicians’ competence, leading
to defensiveness and suspicion among physicians.
Second, emphasis on rights in bioethical issues, and especially an admiration
of autonomy, allowed physicians to detach themselves from the consequences of
their actions and involve themselves less in the exercise of discretion. As a result,
physicians became more remote from their patients and preferred to focus on for-
mal communication with them. William Sage summarizes this point nicely when
he comments: ‘Why grapple with moral dilemmas when one can concentrate on
achieving a technical result and let the patient decide if it is good or bad?’¹⁰⁸

B. A Shift to Patient-controlled Medicine

It would not be an exaggeration to argue that the rights movement in bioeth-
ics resulted in a patient-controlled medicine whereby patients are not only
empowered to choose between various courses of treatment but they may com-
pel health providers to provide them with treatment or medical procedures
which are not necessarily for their benefit. In this new position, the patient has
become a ‘consumer’ of health, while ‘health’ is regarded as a ‘product’ which
the physician must supply to her. Under such a view the patient is motivated by
her self-interests and these allow her to choose who should provide medical serv-
ices and what kind of services or products to purchase.¹⁰⁹ The physician, on the

¹⁰⁶ Rothman, Strangers (n 7 above) 108–9.

¹⁰⁷ R Sherlock, ‘Reasonable Men and Sick Human Beings’ (1986) 80 American Journal of
Medicine 2, 3. See also Rothman, Strangers (n 7 above) 109: ‘Physicians who were strangers could
not be trusted to exercise discretion over weighty matters of life and death; hence, a growing con-
tingent insisted that physicians would be compelled to tell patients the truth, no matter how grim
the diagnosis.’
¹⁰⁸ Sage (n 61 above) 1185. Next, he writes: ‘bioethics pushed medicine toward a lawyer-like
approach to fact-finding through formal deliberative bodies and frank judicial oversight, overcom-
ing the medical profession’s traditional preference for empiricism and deference to experience’.
¹⁰⁹ Rodwin (n 20 above) 153. For a critique of patients’ consumerism and the market meta-
phor, see G Annas, Some Choice: Law, Medicine and the Market (Oxford: Oxford University Press,
1998). See also Schneider, Autonomy (n 24 above) 207–10.

04_Freeman-1_Ch04.indd 71 8/29/2008 8:25:58 AM

 72 Daniel Sperling
other hand, is regarded as the patient’s passive agent and her responsibilities and
expertise are relevant insofar they coincide with the patient’s desires.
A good example of the shift to patient-controlled medicine facilitated by
the rights movement would be the recent development of direct to consumer
advertising (DTCA). This is an area where a cynical use of rights language is
made by drug companies to enhance their profits at the cost of health providers’
professional autonomy, making the vast majority of physicians accommodate
patients’ requests for an advertised drug.¹¹⁰ Alan Holmer cites a survey showing
that more than 53 million Americans asked their physicians about advertised
drugs, arguing that patients have the right to receive such advertised informa-
tion and ask their doctors about new treatment.¹¹¹ According to a telephone
poll conducted among 199 primary care doctors in the United States, whose
patients asked them about drugs advertised in the media, in 36 per cent of
the cases doctors gave in to the patient’s pressure, even when the drug was not
their first choice.¹¹² As Sydney Halpern notes, ‘directed marketing provides a
reminder that multiple constituencies can adopt the rhetoric of rights for a var-
iety of purposes—not all of them consistent with consumers’ interests’.¹¹³ The
patient sometimes demands a certain medication which is not necessarily in her
best interest. The result of such a phenomenon is a decrease in public confidence
and trust in their health providers,¹¹⁴ which may also lead to violent attacks on
physicians.¹¹⁵
Another area where medicine’s cognitive authority is being challenged and
controlled by patients, and more generally by the public, concerns the creation
of medical knowledge through clinical trials. Two recent examples include the
effect of AIDS activists on research into new treatments for HIV/AIDS, by, for
example, hastening the speed with which new drugs are available for testing
and broadening the eligibility for those drugs, and the involvement of groups of
patients with genetic disorders and their families in the promotion and design
of genetic research.¹¹⁶ These examples reflect the fact that patient rights, which
were first understood as a way to stand up to physicians’ intervention with
patient freedoms (negative rights) transformed to and are perceived as patients’

¹¹⁰ Thompson and Ors v Western States Medical Center and Ors 535 US 358, 383 (2002) (referring
to a poll where 84% of patients reported that doctors accommodated such requests).
¹¹¹ A Holmer, ‘Direct-To-Consumer Marketing of Prescription Drug Advertising Builds
Bridges between Patients and Physicians’ (1999) 281(4) JAMA 380. See also MF Hollon,
‘Direct-to-Consumer Marketing of Prescription Drugs’ (1999) 281(4) JAMA 382.
¹¹² D Spurgeon, ‘Doctors Feel Pressurised by Direct to Consumer Advertising’ (1999) 319
BMJ 1321.
¹¹³ Halpern (n 60 above) 846. See also J Donohue, ‘A History of Drug Advertising: The Evolving
Roles of Consumers and Consumer Protection’ (2006) 84(4) The Milbank Quarterly 659.
¹¹⁴ M Schlesinger, ‘A Loss of Faith: The Sources of Reduced Political Legitimacy for the
American Medical Profession’ (2002) 80(2) The Milbank Quarterly 185.
¹¹⁵ See generally JL Morrison, JD Lantos, and W Levinson, ‘Aggression and Violence Directed
Toward Physicians’ (1998) 13(8) Journal of General Internal Medicine 556.
¹¹⁶ Halpern (n 60 above) 838–9.

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 A Rights-Based Relationship and Its Troubling Implications 73

entitlements as against their providers (positive rights), imposing duties on the

latter, the fulfilment of which is not always in the best interests of the patient.

C. Expansion of the Idea of Rights Outside the Therapeutic

Relationship
The rights movement in bioethics has brought about that the idea of rights not
only applies to the therapeutic relationship but also to the concept of managed
care,¹¹⁷ thereby positing the physician and the patient in one place as against
managed care organizations and other entities paying for health care services.
Rights to and within that concept make managed care ‘the battlefield on which
physicians applied the accumulated legal experience of prior decades’.¹¹⁸ Hence,
for instance, the rights discourse and legalization of medicine more generally has
made it possible for physicians to employ lawyers to form corporations, negotiate
contracts, secure their intellectual property rights, and focus more on providing
technical services to clients and less on playing a social role. It also transformed
physicians to serve as patient advocates, thereby protecting their ‘clients’ from the
possible conflicts of interest of their colleagues and from unnecessary costs.¹¹⁹
Under such an approach health care is now seen as an industry rather than a pro-
fession and so issues arising within the therapeutic relationship are now subjected
to antitrust law and policy considerations.¹²⁰
Some expansion of the idea of rights outside the traditional therapeutic rela-
tionship is noticed in issues concerning public health, and more specifically with
the rise of preventive medicine. This area, which is primarily concerned with
prevention of diseases and the promotion and preservation of health in the indi-
vidual, may also serve as an indicator of the emphasis on the rights discourse.¹²¹
Recognition by the courts of a liberty right, the right to privacy in medical deci-
sion-making or the more general freedom to act in accordance with one’s religious
beliefs, is used as a claim against the state interest in regulation of mandatory

¹¹⁷ Managed care programmes are: ‘Health insurance plans intended to reduce unnecessary
health care costs through a variety of mechanisms, including: economic incentives for physicians
and patients to select less costly forms of care; programs for reviewing the medical necessity of
specific services; increased beneficiary cost sharing; controls on inpatient admissions and lengths
of stay; the establishment of cost-sharing incentives for outpatient surgery; selective contracting
with health care providers; and the intensive management of high-cost health care cases. The
programs may be provided in a variety of settings, such as health maintenance organizations and
preferred provider organizations.’ Medical Subject Headings, US National Library of Medicine’s
controlled vocabulary, available at <http://www.ncbi.nlm.nih.gov/sites/entrez> (accessed
25 November 2007).
¹¹⁸ Sage (n 61 above) 1189. Interestingly, the US federal legislation reform in managed care was
referred to as a ‘patient’s bill of rights’. Scott (n 34 above) 235, n 23.
¹¹⁹ Sage (n 61 above) 1190–1.
¹²⁰ AJ Rosoff, ‘Antitrust Law and the Health Care Industry: New Warriors into an Old Battle’
(1979) 23 St Louis University Law Journal 446.
¹²¹ Van Der Burg (n 1 above) 106.

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 74 Daniel Sperling
vaccination.¹²² Recently, more cases of personal objections to vaccination have
also been witnessed, especially those of parents who exercise their autonomy by
choosing to leave their children unvaccinated on the basis of personal concerns
about the risks of vaccination. Privacy concerns are also frequently raised against
reporting infected individuals for the treatment and prevention of transmitted
diseases and an argument for a breach of autonomy is raised against forced checks
of arrested prostitutes or other groups in danger of epidemiological diseases.¹²³
These and many other cases raise the serious costs and the cumulative effect of
respecting patients’ rights in the area of public health.

D. Rights Understood Internationally as Means

to Achieve Global Health
The inclusion of the concept of rights in bioethics paved the way for breaking
free from the focus on the physician-patient relationship and medical technol-
ogy and aspiring to global force for health and human rights.¹²⁴ The concept of
rights made it easy for Western medicine and ethical norms to engage and influ-
ence developing countries and Eastern cultures in the name of the protection of
international human rights. The enormous effect of law on bioethics, especially
through the rights movement, demonstrating how law shapes ethical discourse
and medical practice, initiated the development of an international agenda for
human rights in health. Such an ambition has been mostly directed by George
Annas in recent years.¹²⁵ Annas argues that American bioethics should be reborn
as a global force by accepting its Nuremberg Code and actively engage in a human
rights agenda. This would be made possible by the harmonization of three dis-
ciplines: bioethics, health law, and human rights.¹²⁶ The development of such
a view seeks to recognize and employ two interrelated forces which shape the
world, thereby providing new frameworks for ethical analysis and action: these
are globalization and public health. By globalization, Annas refers merely to a
new focus on international human rights law and its aspirations as manifested in
the Universal Declaration of Human Rights and subsequent treaties.¹²⁷ What
is meant by public health, on the other hand, is the emphasis on populations

¹²² KM Malone and AR Hinman, ‘Vaccination Mandates: The Public Health Imperative and
Individual Rights’ in RE Hoff man, W Lopez, GW Matthews, MA Rothstein, and KL Foster (eds),
Law in Public Health (Oxford and New York: Oxford University Press, 2nd edn, 2007) 338–60.
¹²³ See eg Reynolds v McNichols 488 F 2d 1378 (10th Cir 1973).
¹²⁴ Annas, University Lecture (n 23 above) 4.
¹²⁵ See GJ Annas, American Bioethics: Crossing Human Rights and Health Law Boundaries
(Oxford: Oxford University Press, 2004).
¹²⁶ For a critique, see A Jonsen (Book Review) (2005) 5(3) American Journal of Bioethics 71–2.
¹²⁷ UNESCO’s Declaration on Bioethics and Human Rights is regarded as an attempt to
develop an international bioethics framework based on the Universal Declaration of Human
Rights. See <http://portal.unesco.org/shs/en/ev.php-URL_ID=1883&URL_DO=DO_TOPIC&
URL_SECTION =201.html> (accessed 18 July 2008).

04_Freeman-1_Ch04.indd 74 8/29/2008 8:25:59 AM

 A Rights-Based Relationship and Its Troubling Implications 75

and prevention, global health inequalities, and widespread diseases.¹²⁸ From this
perspective the rights revolution in bioethics is only just beginning.

IV. The Future of Law and Bioethics

The previous sections discussed one of the greatest contributions of law to bioeth-
ics, namely the integration of rights in ethical dilemmas and issues arising within
the medical context. Such a contribution nevertheless creates many difficulties
and has various implications, some of which go in different directions from those
originally expected. It is possible to anticipate three paths which bioethics may
take as a result.
The first is the search for support and justification of some substantive theory
and the conceptualization of basic principles to realize ethical dilemmas in the
medical context. Such theory may be developed from the area of ethics and the
disciplines of philosophy and religion more generally. By providing a universal,
applicable, and acceptable normative content, bioethics will regain faith as a
branch of ethics involving moral norms to evaluate human conduct. The norma-
tive theory will complement the procedural mechanism suggested by the rights
discourse and will become more dominant than law’s influence and interference
with bioethics.¹²⁹ Under such an alternative, law and ethics would become more
independent and distinct. The more there is a plurality of ethical approaches and
normative understanding of ethics, the more we can supplement the rights model
in bioethics and minimize the law’s strong effect on problems in medical ethics.
If we follow this approach we will not have to regress to the pre-rights model of
bioethics. Instead we will progress to a post-rights model under which morality
becomes a more important component of resolving problems and moral dilem-
mas in bioethics.¹³⁰
A second approach would be the search for a better understanding of ethical
issues in bioethics by an appeal to the social sciences and other related disciplines.
A social science critique of bioethics argues that traditional bioethics ideal-
izes rational thought and ignores social and cultural factors which shape one’s
thought and choices. As this chapter shows, this is made possible with the guise
of the rhetorical language of rights. The social science critique asks bioethicists to
support their claims in more empirical research, to be reflexive, and to challenge
theories which are based on evidence.¹³¹ A better understanding of social implica-
tions for and construction of health and disease and a closer look at the role social
science plays in framing and resolving decisions in bioethics may address serious

¹²⁸ Annas, University Lecture (n 23 above) 3.

¹²⁹ Pellignero (n 30 above).
¹³⁰ Van Der Burg (n 1 above) 111–14.
¹³¹ AM Hedgecoe, ‘Critical Bioethics: Beyond the Social Science Critique of Applied Ethics’
(2004) 18(2) Bioethics 120.

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 76 Daniel Sperling
problems in justice and equality that are left unresolved by a pretext of rights and
by the law’s interference with bioethics more generally.¹³² Along with this argu-
ment, Albert Jonsen invites bioethicists in the new millennium to consider insti-
tutional structures, organizational patterns, financial and economic calculations,
etc in addressing their questions.¹³³ However, such an approach may lead to the
result that bioethics will become an amorphous expansion of discipline consist-
ing of a mix of preferences, opinions, value choices, and more. Under such terms,
it will be hard to isolate a concrete and acceptable normative content which will
make bioethics a unique and autonomous field, and from this perspective this
second proposed approach seems less appealing than the first.
A third possible direction may be to withdraw the use of legal rights discourse
and more generally the legal regulation of issues in bioethics, and to resolve
disputes in bioethics by an appeal to constitutional rights only in exceptional
cases. Generally, constitutional rights are regarded as a mechanism to contest
the abuse of power by government or the majority.¹³⁴ An alternative and perhaps
more appropriate discourse in bioethics may be that which emphasizes health
providers’ responsibility and the considerations of a multitude of factors such as
risk and benefits; the physician-patient and other relationships occurring within
the medical context; concerns, needs, and abilities of patients and third parties
who may be affected by the proposed medical decision, etc.¹³⁵ The best way to
create such discourse would be to have ethics committees resolving and deter-
mining specific cases in bioethics.
Leaving the decision-making processes to ethics committees rather than
lawyers or judges could not only lead to a more neutral and inclusive discus-
sions of these matters but also reduce chances to err and minimize the risk to
parties involved. Following this suggestion, Roger Dworkin argues that ethics
committees are a very attractive decision-making group, combining expertise
and popularity. It is argued that these institutions are able to work quickly, infor-
mally, and inexpensively and their advantage lies in the fact that they lack the
power to submit people to stigmatizing or inappropriately severe sanctions.¹³⁶
Although the institutionalization of ethics committees was encouraged by case
law and legislation and was mandatory for every institution conducting experi-
mentation with human subjects,¹³⁷ its major purpose was to free doctors from

¹³² Capron (n 56 above) 305.

¹³³ AR Jonsen, ‘Why Has Bioethics Become So Boring?’ (2000) 25(6) Journal of Medicine and
Philosophy 689, 693.
¹³⁴ ‘The institution of rights is therefore crucial, because it represents the majority’s promise
to the minorities that their dignity and equality will be respected. When the divisions among the
groups are most violent then this gesture, if law is to work, must be most sincere . . . If the govern-
ment does not take rights seriously, then it does not take law seriously either.’ R Dworkin, Taking
Rights Seriously (Cambridge, Mass.: Harvard University Press, 1978) 205.
¹³⁵ See eg J Ladd, ‘Legalism and Medical Ethics’ (1979) 4(1) Journal of Medical Philosophy 70.
¹³⁶ Dworkin (n 25 above) 168.
¹³⁷ Despite the fact that some Catholic hospitals already maintained ethics committees, the
first call for the establishment of such committees was made by a pediatrician in a law review

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 A Rights-Based Relationship and Its Troubling Implications 77

taking responsibility in difficult cases.¹³⁸ For example, in Re Quinlan, the court

referred with agreement to the argument that ‘it would be more appropriate to
provide a regular forum for more input and dialogue in individual situations and
to allow the responsibility of these judgments to be shared’.¹³⁹ Such a recommen-
dation was followed only scarcely, and in some instances it also created tensions
and a sense of uneasiness.¹⁴⁰ While in 1983 only 1 per cent of American hospitals
had ethics committees, and existing committees reviewed an average of one case
per year,¹⁴¹ in 1998 over 90 per cent of a random sample of 1,000 hospitals in the
United States had ethics committees.¹⁴² Gradually, hospital ethics committees
developed guidelines and principles and their tasks were progressively defined.¹⁴³
As Albert Jonsen remarks: ‘In hundreds of hospital ethics committees, discourse
about ethics went on; thousands of persons became familiar with the issues and
arguments. When asked to consider a question, many committees had already
developed the competence to respond in an informed and orderly manner.’¹⁴⁴
However, the functioning of ethics committees was criticized by scholars and
little was known about them. Bernad Lo, for example, argued that hospital ethics
committees are biased and have no procedure to deal with questions and prob-
lems raised.¹⁴⁵ John Fletcher and Dianne Hoffman commented that ethics com-
mittees and committee members often lack the requisite education and skills for
effective participation in committee meetings and called for the establishment of
quality standards to govern the operation of committees.¹⁴⁶ As a result, in 2000,

article. K Teele, ‘The Physician’s Dilemma: A Doctor’s View: What the Law Should Be’ (1975) 27
Baylor Law Review.
¹³⁸ ‘Physicians, by virtue of their responsibility for medical judgments are, partly by choice
and partly by default, charged with the responsibility of making ethical judgments which we are
sometimes ill-equipped to make . . . [The concept of ethics committees] diff uses the responsibility
of making these judgments. Many physicians, in many circumstances, would welcome this sharing
of responsibility’ Teele (n 137 above) 8–9.
¹³⁹ Re Quinlan 355 A 2d 647, 668 (NJ 1976). See also Re Colyer 660 P 2d 738 (1983).
¹⁴⁰ eg Tina Stevens mentions that legal counsel for the AMA, BJ Anderson, commented that
such ethics committees are unnecessary because ‘a treating physician is certainly able to determine
whether a patient is in a terminal condition. If he is unsure of anything, the doctor can ask for con-
sultation with another doctor.’ Stevens (n 82 above) 142. See also Superintendent of Belchertown
State School v Saikewicz 373 Mass. 728, 370 NE 2d 417 (1977).
¹⁴¹ Jonsen (n 1 above) 363.
¹⁴² G McGee, JP Spanogle, AL Caplan, D Penny, and DA Asch, ‘Successes and Failures of
Hospital Ethics Committees: A National Survey of Ethics Committees Chairs’ (2002) 11
Cambridge Quarterly of Healthcare Ethics 87. The increase in the number of ethics committees was a
response to a 1991 mandate by the Joint Commission on Accreditation of Healthcare Organizations
and state legislation raising the status of such committees.
¹⁴³ cf Annas, who argues that the law contributed immensely to the development of ethics com-
mittees mainly through the threat of legal liability and community disapproval, which could have
led to new laws. Annas, Standard of Care (n 1 above) 6.
¹⁴⁴ Jonsen (n 1 above) 364.
¹⁴⁵ B Lo, ‘Behind Closed doors: Promises and Pitfalls of Ethics Committees’ (1987) 317(1) New
England Journal of Medicine 46.
¹⁴⁶ JC Fletcher and DE Hoff man, ‘Ethics Committees: Time to Experiment with Standards’
(1994) 120(4) Annals of Internal Medicine 335–8.

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 78 Daniel Sperling
the Society for Health and Human Values—Society for Bioethics Consultation
Task Force on Standards for Bioethics Consultation issued a position paper
detailing the core competences for members involved in ethics consultation.¹⁴⁷
Despite these guidelines other problems relating to the legitimacy and account-
ability of those committees remain unresolved.¹⁴⁸

V. Conclusion

One of the major characteristics of the relationship between law and bioethics,
and probably the most important contribution of law to bioethics, concerns the
introduction of the idea and language of rights. As David Rothman argues, the
patient rights movement in bioethics was ‘highly democratizing, removing, as it
were, the hallow around the expert and giving encouragement to the laymen’.¹⁴⁹
The rights movement in bioethics seemed promising indeed. However, as this
chapter shows, the idea of rights is objectionable and creates many difficulties all
of which reflect the limits of the law in terms of shaping and influencing decision-
making in bioethical issues. Such a movement was proved too narrow to encom-
pass and realize many of the issues raised by new technologies and changing
therapeutic relationships in the modern era. The specific role the rights movement
has played in bioethics is therefore disputable and hinges upon, inter alia, our
understanding of the origins and future of bioethics. Did bioethics grow out of
the need to control scientific change and medical progress, purporting to deliver
exotic technologies into social acceptance?¹⁵⁰ Or did it evolve out of the necessity
to control and protect the basic freedoms of patients and human subjects? Should
bioethics continue to integrate with law or other disciplines, or should it become
a more autonomous and independent discipline? While scholars may continue
debate on these substantial questions it is clear that the time to re-evaluate the
direction which bioethics should take in the next years has come.

¹⁴⁷ MP Aulisio, RM Arnold, and SJ Youngner, ‘Health Care Ethics Consultation: Nature,
Goals and Competences’ (2000) 133(1) Annals of Internal Medicine 59.
¹⁴⁸ Dworkin (n 25 above) 170.
¹⁴⁹ Rothman, Origins and Consequences (n 8 above) 263.
¹⁵⁰ Stevens (n 82 above) 149.

04_Freeman-1_Ch04.indd 78 8/29/2008 8:25:59 AM

 SECȚIUNEA 3
ETICĂ ÎN RELAȚIA CU
FURNIZORII ȘI PRODUCĂTORII DE MEDICAMENTE
SUBTEMELE: 3.1, 3.2
 *** (), A Roadmap for New Physicians. Avoiding Medicare and Medicaid Fraud and Abuse;
U.S. Department of Health & Human Services, Office of Inspector General, p. 21-24.

 Codul ARPIM de etică în promovarea medicamentelor eliberate pe bază de prescripţie

medicală şi în interacţiunile cu profesioniştii din domeniul sanitar; Asociația Română a
Producătorilor și Importatorilor de Medicamente, 2014, art. 7-14, 16-20.

 ANGELL, Marcia (2009),Drug Companies & Doctors: A Story of Corruption; în

„New York Review of Books”, 15 ianuarie. Url:
http://www.nybooks.com/articles/archives/2009/jan/15/drug-companies-doctorsa-
story-of-corruption/.

 SCHACHTER, Steven C. & William Mandell & L. Scott Harshbarger & Randall
Grometstein (2008), Managing Relationships with Industry. A Physician’s Compliance
Manual; Elsevier, Amsterdam, pp. 153-178.

Website-ul ProPublica din Statele Unite ale Americii este un foarte bun instrument pentru
a urmări cazuri specifice privind interacțiunea de ordin financiar între doctori și industria
Pharma: http://www.propublica.org/series/dollars-for-docs

ÎNTREBĂRI
Q1. Un medic cardiolog care lucrează atât într-un spital de stat, cât și în propriul
cabinet, a fost invitat să coordoneze un studiu clinic în calitate de expert în tahicardii
ventriculare. Respectivul studiu clinic urmărește să măsoare eficiența unui nou
medicament menit să regleze ritmul ventricular. Întrucât la cabinetul propriu are un număr
foarte ridicat de pacienți cu tahicardie ventriculara, medicul decide să selecteze dintre
aceștia posibili candidați pentru studiul clinic. Este acest lucru incorect din punct de vedere
moral?

Q2. Un medic ginecolog de la o policlinică socială a fost invitat la un eveniment de

prezentare a unui nou medicament pentru prevenirea sarcinilor nedorite. Evenimentul are
loc la Hotelul Vega din Mamaia, timp de 3 zile, de joi seara până duminică. Compania care
distribuie respectivul medicament îi asigură medicului transportul nu doar pentru el, ci
pentru întreaga familie. Medicamentul respectiv este unul extrem de inovativ, care elimină
multe din efectele adverse ale tuturor celorlalte pilule similare. Ce ar trebui să facă
medicul?
Drug Companies & Doctors: A Story of Corruption by Marcia Angell |... http://www.nybooks.com/articles/archives/2009/jan/15/drug-companie...

Font Size: A A A

Marcia Angell JANUARY 15, 2009 ISSUE

A Note to Readers

Side Effects: A Prosecutor, a Whistleblower, and a Bestselling Antidepressant on Trial

by Alison Bass
Algonquin Books of Chapel Hill, 260 pp., $24.95

Our Daily Meds: How the Pharmaceutical Companies Transformed Themselves into Slick Marketing Machines and
Hooked the Nation on Prescription Drugs
by Melody Petersen
Sarah Crichton/Farrar, Straus and Giroux, 432 pp., $26.00

Shyness: How Normal Behavior Became a Sickness

by Christopher Lane
Yale University Press, 263 pp., $27.50; $18.00 (paper)

Recently Senator Charles Grassley, ranking Republican

on the Senate Finance Committee, has been looking into
financial ties between the pharmaceutical industry and
the academic physicians who largely determine the
market value of prescription drugs. He hasn’t had to
look very hard.

Take the case of Dr. Joseph L. Biederman, professor of

psychiatry at Harvard Medical School and chief of
pediatric psychopharmacology at Harvard’s
Massachusetts General Hospital. Thanks largely to him,
children as young as two years old are now being
diagnosed with bipolar disorder and treated with a
cocktail of powerful drugs, many of which were not
approved by the Food and Drug Administration (FDA)
for that purpose and none of which were approved for
An advertisement for Paxil in The American
children below ten years of age. Journal of Psychiatry, October 1999; from
Christopher Lane’s Shyness: How Normal
Legally, physicians may use drugs that have already Behavior Became a Sickness. Paxil is one of
been approved for a particular purpose for any other the drugs about which unfavorable research
has been suppressed by pharmaceutical
purpose they choose, but such use should be based on companies.
good published scientific evidence. That seems not to

1 of 11 16/09/2015 10:04
Drug Companies & Doctors: A Story of Corruption by Marcia Angell |... http://www.nybooks.com/articles/archives/2009/jan/15/drug-companie...

be the case here. Biederman’s own studies of the drugs he advocates to treat childhood
bipolar disorder were, as The New York Times summarized the opinions of its expert
sources, “so small and loosely designed that they were largely inconclusive.”1

In June, Senator Grassley revealed that drug companies, including those that make drugs
he advocates for childhood bipolar disorder, had paid Biederman $1.6 million in consulting
and speaking fees between 2000 and 2007. Two of his colleagues received similar amounts.
After the revelation, the president of the Massachusetts General Hospital and the chairman
of its physician organization sent a letter to the hospital’s physicians expressing not shock
over the enormity of the conflicts of interest, but sympathy for the beneficiaries: “We know
this is an incredibly painful time for these doctors and their families, and our hearts go out
to them.”

Or consider Dr. Alan F. Schatzberg, chair of Stanford’s psychiatry department and

president-elect of the American Psychiatric Association. Senator Grassley found that
Schatzberg controlled more than $6 million worth of stock in Corcept Therapeutics, a
company he cofounded that is testing mifepristone—the abortion drug otherwise known as
RU-486—as a treatment for psychotic depression. At the same time, Schatzberg was the
principal investigator on a National Institute of Mental Health grant that included research
on mifepristone for this use and he was coauthor of three papers on the subject. In a
statement released in late June, Stanford professed to see nothing amiss in this
arrangement, although a month later, the university’s counsel announced that it was
temporarily replacing Schatzberg as principal investigator “to eliminate any
misunderstanding.”

Perhaps the most egregious case exposed so far by Senator Grassley is that of Dr. Charles
B. Nemeroff, chair of Emory University’s department of psychiatry and, along with
Schatzberg, coeditor of the influential Textbook of Psychopharmacology.2 Nemeroff was
the principal investigator on a five-year $3.95 million National Institute of Mental Health
grant—of which $1.35 million went to Emory for overhead—to study several drugs made
by GlaxoSmithKline. To comply with university and government regulations, he was
required to disclose to Emory income from GlaxoSmithKline, and Emory was required to
report amounts over $10,000 per year to the National Institutes of Health, along with
assurances that the conflict of interest would be managed or eliminated.

But according to Senator Grassley, who compared Emory’s records with those from the
company, Nemeroff failed to disclose approximately $500,000 he received from
GlaxoSmithKline for giving dozens of talks promoting the company’s drugs. In June 2004,
a year into the grant, Emory conducted its own investigation of Nemeroff’s activities, and
found multiple violations of its policies. Nemeroff responded by assuring Emory in a
memorandum, “In view of the NIMH/Emory/GSK grant, I shall limit my consulting to
GSK to under $10,000/year and I have informed GSK of this policy.” Yet that same year,
he received $171,031 from the company, while he reported to Emory just $9,999—a dollar
shy of the $10,000 threshold for reporting to the National Institutes of Health.

Emory benefited from Nemeroff’s grants and other activities, and that raises the question
of whether its lax oversight was influenced by its own conflicts of interest. As reported by

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Gardiner Harris in TheNew York Times,3 Nemeroff himself had pointed out his value to
Emory in a 2000 letter to the dean of the medical school, in which he justified his
membership on a dozen corporate advisory boards by saying:

Surely you remember that Smith-Kline Beecham Pharmaceuticals donated an

endowed chair to the department and there is some reasonable likelihood that Janssen
Pharmaceuticals will do so as well. In addition, Wyeth-Ayerst Pharmaceuticals has
funded a Research Career Development Award program in the department, and I have
asked both AstraZeneca Pharmaceuticals and Bristol-Meyers [sic] Squibb to do the
same. Part of the rationale for their funding our faculty in such a manner would be my
service on these boards.

ecause these psychiatrists were singled out by Senator Grassley, they received a great
deal of attention in the press, but similar conflicts of interest pervade medicine. (The
senator is now turning his attention to cardiologists.) Indeed, most doctors take money or
gifts from drug companies in one way or another. Many are paid consultants, speakers at
company-sponsored meetings, ghost-authors of papers written by drug companies or their
agents,4 and ostensible “researchers” whose contribution often consists merely of putting
their patients on a drug and transmitting some token information to the company. Still more
doctors are recipients of free meals and other out-and-out gifts. In addition, drug
companies subsidize most meetings of professional organizations and most of the
continuing medical education needed by doctors to maintain their state licenses.

No one knows the total amount provided by drug companies to physicians, but I estimate
from the annual reports of the top nine US drug companies that it comes to tens of billions
of dollars a year. By such means, the pharmaceutical industry has gained enormous control
over how doctors evaluate and use its own products. Its extensive ties to physicians,
particularly senior faculty at prestigious medical schools, affect the results of research, the
way medicine is practiced, and even the definition of what constitutes a disease.

Consider the clinical trials by which drugs are tested in human subjects.5 Before a new
drug can enter the market, its manufacturer must sponsor clinical trials to show the Food
and Drug Administration that the drug is safe and effective, usually as compared with a
placebo or dummy pill. The results of all the trials (there may be many) are submitted to
the FDA, and if one or two trials are positive—that is, they show effectiveness without
serious risk—the drug is usually approved, even if all the other trials are negative. Drugs
are approved only for a specified use—for example, to treat lung cancer—and it is illegal
for companies to promote them for any other use.

But physicians may prescribe approved drugs “off label”—i.e., without regard to the
specified use—and perhaps as many as half of all prescriptions are written for off-label
purposes. After drugs are on the market, companies continue to sponsor clinical trials,
sometimes to get FDA approval for additional uses, sometimes to demonstrate an
advantage over competitors, and often just as an excuse to get physicians to prescribe such
drugs for patients. (Such trials are aptly called “seeding” studies.)

Since drug companies don’t have direct access to human subjects, they need to outsource

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their clinical trials to medical schools, where researchers use patients from teaching
hospitals and clinics, or to private research companies (CROs), which organize
office-based physicians to enroll their patients. Although CROs are usually faster, sponsors
often prefer using medical schools, in part because the research is taken more seriously, but
mainly because it gives them access to highly influential faculty physicians—referred to by
the industry as “thought-leaders” or “key opinion leaders” (KOLs). These are the people
who write textbooks and medical journal papers, issue practice guidelines (treatment
recommendations), sit on FDA and other governmental advisory panels, head professional
societies, and speak at the innumerable meetings and dinners that take place every year to
teach clinicians about prescription drugs. Having KOLs like Dr. Biederman on the payroll
is worth every penny spent.

A few decades ago, medical schools did not have extensive financial dealings with
industry, and faculty investigators who carried out industry-sponsored research generally
did not have other ties to their sponsors. But schools now have their own manifold deals
with industry and are hardly in a moral position to object to their faculty behaving in the
same way. A recent survey found that about two thirds of academic medical centers hold
equity interest in companies that sponsor research within the same institution.6 A study of
medical school department chairs found that two thirds received departmental income from
drug companies and three fifths received personal income.7 In the 1980s medical schools
began to issue guidelines governing faculty conflicts of interest but they are highly
variable, generally quite permissive, and loosely enforced.

ecause drug companies insist as a condition of providing funding that they be intimately
involved in all aspects of the research they sponsor, they can easily introduce bias in order
to make their drugs look better and safer than they are. Before the 1980s, they generally
gave faculty investigators total responsibility for the conduct of the work, but now
company employees or their agents often design the studies, perform the analysis, write the
papers, and decide whether and in what form to publish the results. Sometimes the medical
faculty who serve as investigators are little more than hired hands, supplying patients and
collecting data according to instructions from the company.

In view of this control and the conflicts of interest that permeate the enterprise, it is not
surprising that industry-sponsored trials published in medical journals consistently favor
sponsors’ drugs—largely because negative results are not published, positive results are
repeatedly published in slightly different forms, and a positive spin is put on even negative
results. A review of seventy-four clinical trials of antidepressants, for example, found that
thirty-seven of thirty-eight positive studies were published.8 But of the thirty-six negative
studies, thirty-three were either not published or published in a form that conveyed a
positive outcome. It is not unusual for a published paper to shift the focus from the drug’s
intended effect to a secondary effect that seems more favorable.

The suppression of unfavorable research is the subject of Alison Bass’s engrossing book,
Side Effects: A Prosecutor, a Whistleblower, and a Bestselling Antidepressant on Trial.
This is the story of how the British drug giant GlaxoSmithKline buried evidence that its
top-selling antidepressant, Paxil, was ineffective and possibly harmful to children and

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adolescents. Bass, formerly a reporter for the Boston Globe, describes the involvement of
three people—a skeptical academic psychiatrist, a morally outraged assistant administrator
in Brown University’s department of psychiatry (whose chairman received in 1998 over
$500,000 in consulting fees from drug companies, including GlaxoSmithKline), and an
indefatigable New York assistant attorney general. They took on GlaxoSmithKline and part
of the psychiatry establishment and eventually prevailed against the odds.

Ephemera, Inc.

‘Drug signs’; from Lane’s Shyness

The book follows the individual struggles of these three people over many years,
culminating with GlaxoSmithKline finally agreeing in 2004 to settle charges of consumer
fraud for $2.5 million (a tiny fraction of the more than $2.7 billion in yearly Paxil sales
about that time). It also promised to release summaries of all clinical trials completed after
December 27, 2000. Of much greater significance was the attention called to the deliberate,
systematic practice of suppressing unfavorable research results, which would never have
been revealed without the legal discovery process. Previously undisclosed, one of
GlaxoSmithKline’s internal documents said, “It would be commercially unacceptable to
include a statement that efficacy had not been demonstrated, as this would undermine the
profile of paroxetine [Paxil].”9

any drugs that are assumed to be effective are probably little better than placebos, but
there is no way to know because negative results are hidden. One clue was provided six
years ago by four researchers who, using the Freedom of Information Act, obtained FDA
reviews of every placebo-controlled clinical trial submitted for initial approval of the six

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most widely used antidepressant drugs approved between 1987 and 1999—Prozac, Paxil,
Zoloft, Celexa, Serzone, and Effexor.10 They found that on average, placebos were 80
percent as effective as the drugs. The difference between drug and placebo was so small
that it was unlikely to be of any clinical significance. The results were much the same for
all six drugs: all were equally ineffective. But because favorable results were published and
unfavorable results buried (in this case, within the FDA), the public and the medical
profession believed these drugs were potent antidepressants.

Clinical trials are also biased through designs for research that are chosen to yield
favorable results for sponsors. For example, the sponsor’s drug may be compared with
another drug administered at a dose so low that the sponsor’s drug looks more powerful. Or
a drug that is likely to be used by older people will be tested in young people, so that side
effects are less likely to emerge. A common form of bias stems from the standard practice
of comparing a new drug with a placebo, when the relevant question is how it compares
with an existing drug. In short, it is often possible to make clinical trials come out pretty
much any way you want, which is why it’s so important that investigators be truly
disinterested in the outcome of their work.

Conflicts of interest affect more than research. They also directly shape the way medicine
is practiced, through their influence on practice guidelines issued by professional and
governmental bodies, and through their effects on FDA decisions. A few examples: in a
survey of two hundred expert panels that issued practice guidelines, one third of the panel
members acknowledged that they had some financial interest in the drugs they
considered.11 In 2004, after the National Cholesterol Education Program called for sharply
lowering the desired levels of “bad” cholesterol, it was revealed that eight of nine members
of the panel writing the recommendations had financial ties to the makers of cholesterol-
lowering drugs.12 Of the 170 contributors to the most recent edition of the American
Psychiatric Association’s Diagnostic and Statistical Manual of Mental Disorders (DSM),
ninety-five had financial ties to drug companies, including all of the contributors to the
sections on mood disorders and schizophrenia.13 Perhaps most important, many members
of the standing committees of experts that advise the FDA on drug approvals also have
financial ties to the pharmaceutical industry.14

n recent years, drug companies have perfected a new and highly effective method to
expand their markets. Instead of promoting drugs to treat diseases, they have begun to
promote diseases to fit their drugs. The strategy is to convince as many people as possible
(along with their doctors, of course) that they have medical conditions that require
long-term drug treatment. Sometimes called “disease-mongering,” this is a focus of two
new books: Melody Petersen’s Our Daily Meds: How the Pharmaceutical Companies
Transformed Themselves into Slick Marketing Machines and Hooked the Nation on
Prescription Drugs and Christopher Lane’s Shyness: How Normal Behavior Became a
Sickness.

To promote new or exaggerated conditions, companies give them serious-sounding names

along with abbreviations. Thus, heartburn is now “gastro-esophageal reflux disease” or
GERD; impotence is “erectile dysfunction” or ED; premenstrual tension is “premenstrual

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dysphoric disorder” or PMMD; and shyness is “social anxiety disorder” (no abbreviation
yet). Note that these are ill-defined chronic conditions that affect essentially normal people,
so the market is huge and easily expanded. For example, a senior marketing executive
advised sales representatives on how to expand the use of Neurontin: “Neurontin for pain,
Neurontin for monotherapy, Neurontin for bipolar, Neurontin for everything.”15 It seems
that the strategy of the drug marketers—and it has been remarkably successful—is to
convince Americans that there are only two kinds of people: those with medical conditions
that require drug treatment and those who don’t know it yet. While the strategy originated
in the industry, it could not be implemented without the complicity of the medical
profession.

Melody Petersen, who was a reporter for The New York Times, has written a broad,
convincing indictment of the pharmaceutical industry.16 She lays out in detail the many
ways, both legal and illegal, that drug companies can create “blockbusters” (drugs with
yearly sales of over a billion dollars) and the essential role that KOLs play. Her main
example is Neurontin, which was initially approved only for a very narrow use—to treat
epilepsy when other drugs failed to control seizures. By paying academic experts to put
their names on articles extolling Neurontin for other uses—bipolar disease, post-traumatic
stress disorder, insomnia, restless legs syndrome, hot flashes, migraines, tension headaches,
and more—and by funding conferences at which these uses were promoted, the
manufacturer was able to parlay the drug into a blockbuster, with sales of $2.7 billion in
2003. The following year, in a case covered extensively by Petersen for the Times, Pfizer
pleaded guilty to illegal marketing and agreed to pay $430 million to resolve the criminal
and civil charges against it. A lot of money, but for Pfizer, it was just the cost of doing
business, and well worth it because Neurontin continued to be used like an all-purpose
tonic, generating billions of dollars in annual sales.

hristopher Lane’s book has a narrower focus—the rapid increase in the number of
psychiatric diagnoses in the American population and in the use of psychoactive drugs
(drugs that affect mental states) to treat them. Since there are no objective tests for mental
illness and the boundaries between normal and abnormal are often uncertain, psychiatry is
a particularly fertile field for creating new diagnoses or broadening old ones.17 Diagnostic
criteria are pretty much the exclusive province of the current edition of the Diagnostic and
Statistical Manual of Mental Disorders, which is the product of a panel of psychiatrists,
most of whom, as I mentioned earlier, had financial ties to the pharmaceutical industry.
Lane, a research professor of literature at Northwestern University, traces the evolution of
the DSM from its modest beginnings in 1952 as a small, spiral-bound handbook (DSM-I)
to its current 943-page incarnation (the revised version of DSM-IV) as the undisputed
“bible” of psychiatry—the standard reference for courts, prisons, schools, insurance
companies, emergency rooms, doctors’ offices, and medical facilities of all kinds.

Given its importance, you might think that the DSM represents the authoritative distillation
of a large body of scientific evidence. But Lane, using unpublished records from the
archives of the American Psychiatric Association and interviews with the princi-pals,
shows that it is instead the product of a complex of academic politics, personal ambition,
ideology, and, perhaps most important, the influence of the pharmaceutical industry. What

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the DSM lacks is evidence. Lane quotes one contributor to the DSM-III task force:

There was very little systematic research, and much of the research that existed was
really a hodgepodge—scattered, inconsistent, and ambiguous. I think the majority of
us recognized that the amount of good, solid science upon which we were making our
decisions was pretty modest.

Lane uses shyness as his case study of disease-mongering in psychiatry. Shyness as a

psychiatric illness made its debut as “social phobia” in DSM-III in 1980, but was said to be
rare. By 1994, when DSM-IV was published, it had become “social anxiety disorder,” now
said to be extremely common. According to Lane, GlaxoSmithKline, hoping to boost sales
for its antidepressant, Paxil, decided to promote social anxiety disorder as “a severe
medical condition.” In 1999, the company received FDA approval to market the drug for
social anxiety disorder. It launched an extensive media campaign to do it, including posters
in bus shelters across the country showing forlorn individuals and the words “Imagine
being allergic to people…,” and sales soared. Barry Brand, Paxil’s product director, was
quoted as saying, “Every marketer’s dream is to find an unidentified or unknown market
and develop it. That’s what we were able to do with social anxiety disorder.”

Some of the biggest blockbusters are psychoactive drugs. The theory that psychiatric
conditions stem from a biochemical imbalance is used as a justification for their
widespread use, even though the theory has yet to be proved. Children are particularly
vulnerable targets. What parents dare say “No” when a physician says their difficult child
is sick and recommends drug treatment? We are now in the midst of an apparent epidemic
of bipolar disease in children (which seems to be replacing attention-deficit hyperactivity
disorder as the most publicized condition in childhood), with a forty-fold increase in the
diagnosis between 1994 and 2003.18 These children are often treated with multiple drugs
off-label, many of which, whatever their other properties, are sedating, and nearly all of
which have potentially serious side effects.

he problems I’ve discussed are not limited to psychiatry, although they reach their most
florid form there. Similar conflicts of interest and biases exist in virtually every field of
medicine, particularly those that rely heavily on drugs or devices. It is simply no longer
possible to believe much of the clinical research that is published, or to rely on the
judgment of trusted physicians or authoritative medical guidelines. I take no pleasure in
this conclusion, which I reached slowly and reluctantly over my two decades as an editor
of TheNew England Journal of Medicine.

One result of the pervasive bias is that physicians learn to practice a very drug-intensive
style of medicine. Even when changes in lifestyle would be more effective, doctors and
their patients often believe that for every ailment and discontent there is a drug. Physicians
are also led to believe that the newest, most expensive brand-name drugs are superior to
older drugs or generics, even though there is seldom any evidence to that effect because
sponsors do not usually compare their drugs with older drugs at equivalent doses. In
addition, physicians, swayed by prestigious medical school faculty, learn to prescribe drugs
for off-label uses without good evidence of effectiveness.

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An advertisement for Paxil, 1999

It is easy to fault drug companies for this situation, and they certainly deserve a great deal
of blame. Most of the big drug companies have settled charges of fraud, off-label
marketing, and other offenses. TAP Pharmaceuticals, for example, in 2001 pleaded guilty
and agreed to pay $875 million to settle criminal and civil charges brought under the
federal False Claims Act over its fraudulent marketing of Lupron, a drug used for treatment
of prostate cancer. In addition to GlaxoSmithKline, Pfizer, and TAP, other companies that
have settled charges of fraud include Merck, Eli Lilly, and Abbott. The costs, while
enormous in some cases, are still dwarfed by the profits generated by these illegal
activities, and are therefore not much of a deterrent. Still, apologists might argue that the
pharmaceutical industry is merely trying to do its primary job—further the interests of its
investors—and sometimes it goes a little too far.

Physicians, medical schools, and professional organizations have no such excuse, since
their only fiduciary responsibility is to patients. The mission of medical schools and
teaching hospitals—and what justifies their tax-exempt status—is to educate the next
generation of physicians, carry out scientifically important research, and care for the
sickest members of society. It is not to enter into lucrative commercial alliances with the
pharmaceutical industry. As reprehensible as many industry practices are, I believe the
behavior of much of the medical profession is even more culpable.19 Drug companies are
not charities; they expect something in return for the money they spend, and they evidently
get it or they wouldn’t keep paying.

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o many reforms would be necessary to restore integrity to clinical research and medical
practice that they cannot be summarized briefly. Many would involve congressional
legislation and changes in the FDA, including its drug approval process. But there is
clearly also a need for the medical profession to wean itself from industry money almost
entirely. Although industry–academic collaboration can make important scientific
contributions, it is usually in carrying out basic research, not clinical trials, and even here,
it is arguable whether it necessitates the personal enrichment of investigators. Members of
medical school faculties who conduct clinical trials should not accept any payments from
drug companies except research support, and that support should have no strings attached,
including control by drug companies over the design, interpretation, and publication of
research results.

Medical schools and teaching hospitals should rigorously enforce that rule, and should not
enter into deals with companies whose products members of their faculty are studying.
Finally, there is seldom a legitimate reason for physicians to accept gifts from drug
companies, even small ones, and they should pay for their own meetings and continuing
education.

After much unfavorable publicity, medical schools and professional organizations are
beginning to talk about controlling conflicts of interest, but so far the response has been
tepid. They consistently refer to “potential” conflicts of interest, as though that were
different from the real thing, and about disclosing and “managing” them, not about
prohibiting them. In short, there seems to be a desire to eliminate the smell of corruption,
while keeping the money. Breaking the dependence of the medical profession on the
pharmaceutical industry will take more than appointing committees and other gestures. It
will take a sharp break from an extremely lucrative pattern of behavior. But if the medical
profession does not put an end to this corruption voluntarily, it will lose the confidence of
the public, and the government (not just Senator Grassley) will step in and impose
regulation. No one in medicine wants that.
Letters
A Puzlax For Readers March 12, 2009

‘Drug Companies & Doctors’: An Exchange February 26, 2009

A Note to Readers February 12, 2009

1 Gardiner Harris and Benedict Carey, “Researchers Fail to Reveal Full Drug Pay,” The New York Times, June 8, 2008.↩

2 Most of the information in these paragraphs, including Nemeroff’s quote in the summer of 2004, is drawn from a long letter written by Senator
Grassley to James W. Wagner, President of Emory University, on October 2, 2008.↩

3 See Gardiner Harris, “Leading Psychiatrist Didn’t Report Drug Makers’ Pay,” The New York Times, October 4, 2008.↩

4 Senator Grassley is current investigating Wyeth for paying a medical writing firm to ghost-write articles favorable to its hormone-replacement
drug Prempro.↩

5 Some of this material is drawn from my article “Industry-Sponsored Clinical Research: A Broken System,” TheJournal of the American
Medical Association, September 3, 2008.↩

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6 Justin E. Bekelman et al., “Scope and Impact of Financial Conflicts of Interest in Biomedical Research: A Systematic Review,” The Journal of
the American Medical Association, January 22, 2003.↩

7 Eric G. Campbell et al., “Institutional Academic–Industry Relationships,” The Journal of the American Medical Association, October 17,
2007.↩

8 Erick H. Turner et al., “Selective Publication of Antidepressant Trials and Its Influence on Apparent Efficacy,” The New England Journal of
Medicine, January 17, 2008.↩

9 See Wayne Kondro and Barb Sibbald, “Drug Company Experts Advised Staff to Withhold Data About SSRI Use in Children,” Canadian
Medical Association Journal, March 2, 2004.↩

10 Irving Kirsch et al., “The Emperor’s New Drugs: An Analysis of Antidepressant Medication Data Submitted to the US Food and Drug
Administration,” Prevention & Treatment, July 15, 2002.↩

11 Rosie Taylor and Jim Giles, “Cash Interests Taint Drug Advice,” Nature, October 20, 2005.↩

12 David Tuller, “Seeking a Fuller Picture of Statins,” The New York Times, July 20, 2004.↩

13 Lisa Cosgrove et al., “Financial Ties Between DSM-IV Panel Members and the Pharmaceutical Industry,” Psychotherapy and Psychosomatics,
Vol. 75, No. 3 (2006).↩

14 On August 4, 2008, the FDA announced that $50,000 is now the “maximum personal financial interest an advisor may have in all companies
that may be affected by a particular meeting.” Waivers may be granted for amounts less than that.↩

15 See Petersen, Our Daily Meds, p. 224.↩

16 Petersen’s book is a part of a second wave of books exposing the deceptive practices of the pharmaceutical industry. The first included
Katharine Greider’s The Big Fix: How the Pharmaceutical Industry Rips Off American Consumers (PublicAffairs, 2003), Merrill Goozner’s
The $800 Million Pill: The Truth Behind the Cost of New Drugs (University of California Press, 2004), Jerome Avorn’s Powerful Medicines:
The Benefits, Risks, and Costs of Prescription Drugs (Knopf, 2004), John Abramson’s Overdo$ed America: The Broken Promise of American
Medicine (HarperCollins, 2004), and my own The Truth About the Drug Companies: How They Deceive Us and What to Do About It (Random
House, 2004).↩

17 See the review by Frederick Crews of Lane’s book and two others, The New York Review, December 6, 2007.↩

18 See Gardiner Harris and Benedict Carey, “Researchers Fail to Reveal Full Drug Pay,” The New York Times, June 8, 2008.↩

19 This point is made powerfully in Jerome P. Kassirer’s disturbing book, On the Take: How Medicine’s Complicity With Big Business Can
Endanger Your Health (Oxford University Press, 2005).↩

© 1963-2015 NYREV, Inc. All rights reserved.

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 COD HCP ARPIM
CODUL ARPIM DE ETICĂ ÎN PROMOVAREA
MEDICAMENTELOR ELIBERATE PE BAZĂ DE
PRESCRIPŢIE MEDICALĂ ŞI ÎN INTERACŢIUNILE CU
PROFESIONIŞTII DIN DOMENIUL SANITAR

Adoptat de Adunarea Generală Statutară a ARPIM

la data de 27 noiembrie 2014 (Ediţia 2014)*

*
Aplicabil de la data de 1 Ianuarie 2015.

1
Articolul 7. Transparenţa promovării
Secţiunea 7.01. Promovarea nu trebuie să fie deghizată.
Secţiunea 7.02. Studiile non-interventionale, evaluările post-autorizare sau orice alte colectări de
date nu trebuie să constituie promovare deghizată. Evaluările, programele şi studiile de acest fel
trebuie efectuate în primul rând în scop ştiinţific sau educaţional.
Secţiunea 7.03. Atunci când se publică în presă materiale promoţionale ca urmare a unor servicii
angajate de către un membru ARPIM, de un afiliat al său sau de o companie asociată (de exemplu,
compania de relaţii publice - RP - a membrului ARPIM), materialul promoţional trebuie să
precizeze cu claritate compania membră ARPIM care a comandat articolul sau beneficiarul final al
articolului. Articolele de acest fel nu trebuie să se asemene cu materialele editoriale independente.
Secţiunea 7.04. Fiecare membru ARPIM este răspunzător pentru materialele informative referitoare
la produsele sale medicamentoase, fie că sunt de natură promoţională sau nu. În cazul în care aceste
materiale sunt difuzate de agenţiile de relaţii publice cu care compania membră ARPIM se află sub
contract, aceasta trebuie să se asigure că este clar indicat faptul că difuzarea a fost sponsorizată de
către respectivul membru ARPIM.

Articolul 8. Limitarea recomandărilor medicale personale

Secţiunea 8.01. În cazul solicitărilor de sfaturi cu privire la chestiuni medicale (de sănătate şi/sau
boală) personale venite din partea unor membri individuali ai publicului larg, solicitanţii trebuie
sfătuiţi să consulte un profesionist din domeniul sanitar.

Articolul 9. Materiale informative şi/sau educaţionale şi Obiecte de utilitate medicală

Secţiunea 9.01. Transmiterea materialelor informative şi/sau educaţionale şi a obiectelor de utilitate
medicală este permisă cu condiţia ca acestea să fie:
(i) “necostisitoare”;
(ii) direct relevante pentru practicarea medicinei sau farmaciei; şi
(iii) în scopul direct al îngrijirii pacienţilor.
Obiectele de utilitate medicală destinate în mod direct educării profesioniştilor din domeniul sanitar
şi îngrijirii pacienţilor pot fi oferite dacă sunt necostisitoare şi nu interferă cu activitatea
profesională curentă a destinatarului.
Scopul transmiterii materialelor informative şi/sau educaţionale şi a obiectelor de utilitate medicală,
aşa cum a fost acesta definit, nu trebuie să fie transformat în metodă de eludare a prevederii de
interzicere a cadourilor definită în Articolul 17 al acestui cod.
Transmiterea acestor materiale sau obiecte nu va reprezenta un îndemn de a recomanda, a prescrie,
a achiziţiona, a distribui, a vinde sau a administra un produs medicamentos.

Articolul 10. Evenimente şi ospitalitate

Secţiunea 10.01. Toate întâlnirile promoţionale, ştiinţifice sau profesionale, congresele,
conferinţele, simpozioanele şi alte evenimente asemănătoare (fiecare denumit „eveniment“)
inclusiv dar fără a fi limitate la întâlniri de tip “advisory board”, vizite la locuri de producţie sau la
laboratoare de cercetare, întâlniri destinate activităţilor de planificare, educaţie (cursuri) sau
întâlniri ale investigatorilor pentru studiile clinice şi pentru studiile non-intervenţionale, organizate
sau sponsorizate de către un membru ARPIM trebuie să aibă loc într-o locaţie adecvată,
corespunzătoare scopului principal al evenimentului, ospitalitatea putând fi oferită doar atunci când
aceasta corespunde cu prevederile codului ARPIM.
Secţiunea 10.02. Niciun membru ARPIM nu poate organiza sau sponsoriza un eveniment care
are loc în afara României, cu următoarele excepţii:

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 a) majoritatea invitaţilor sunt din afara României şi, date fiind ţările de origine ale celor mai
multţi invitaţi, are mai mult sens din punct de vedere logistic ca evenimentul să aibă loc
într-o altă ţară, sau
b) dată fiind localizarea resurselor sau a expertizei relevante care constituie obiectul sau
subiectul evenimentului, are mai mult sens din punct de vedere logistic ca evenimentul să
aibă loc într-o altă ţară (un “eveniment internaţional”).

Secţiunea 10.03. Informaţiile promoţionale care apar pe standurile de prezentare sau sunt distribuite
participanţilor la evenimente internaţionale pot, în afară de cazul în care acest lucru este interzis sau
altfel reglementat prin legi şi reglementări locale, să se refere la produse medicamentoase (sau
indicaţii) care nu sunt înregistrate în ţara în care are loc evenimentul sau sunt înregistrate în condiţii
diferite, atâta timp cât:
(i) orice astfel de material promoţional (exclusiv ajutoarele promoţionale) are
ataşată o declaraţie corespunzătoare care să indice ţările în care este înregistrat
produsul şi să clarifice că produsul sau indicaţia nu este înregistrată la nivel local
şi
(ii) orice astfel de material promoţional care se referă la informaţiile de prescriere
(indicaţii, atenţionări, etc.) autorizate într-o ţară sau în ţări în care medicamentele
sunt autorizate trebuie să aibă ataşată o declaraţie explicativă menţionând că, la nivel
internaţional, condiţiile de înregistrare diferă.

Secţiunea 10.04. Ospitalitatea oferită în legătura cu evenimentele promoţionale, profesionale sau

ştiinţifice trebuie să se limiteze la cheltuielile de deplasare, masă, cazare şi taxele reale de
participare.
Nu este permisă sponsorizarea participării profesioniştilor din domeniul sanitar la evenimente
independente sau conexe manifestării ştiinţifice cum ar fi evenimente mondene, sportive sau
culturale.
Secţiunea 10.05. Companiile Membre nu vor asigura sau oferi nici o masă (mâncare şi băuturi)
profesioniştilor din domeniul sanitar, decât dacă, în fiecare caz, valoarea acestei mese (mâncare şi
băuturi) nu depăşeşte pragul monetar stabilit în secţiunea “Punerea în aplicare şi Normele de
Procedură” din Codul ARPIM. Limita valorică pentru masă stabilită în ţara unde are loc
evenimentul (de exemplu „tara gazdă") va prevala.
Secţiunea 10.06. Orice tip de ospitalitate poate fi oferită numai persoanelor care se califică în baza
propriului lor drept ca participanţi.
Secţiunea 10.07. Toate formele de ospitalitate oferite profesioniştilor din domeniul sanitar vor fi
rezonabile ca nivel şi limitate strict la durata şi la scopul principal al evenimentului. Ca regulă
generală, ospitalitatea oferită nu trebuie să depăşească ceea ce profesioniştii din domeniul sanitar ar
fi, în mod normal, dispuşi să plătească ei înşişi.
Secţiunea 10.08. Pentru a nu influenţa profesioniştii din domeniul sanitar, membrii ARPIM vor
evita utilizarea locaţiilor renumite pentru facilităţile lor de divertisment, sportive sau pentru
“extravaganţa” lor.
Membrii ARPIM trebuie să respecte recomandările, aşa cum au fost furnizate în Cod sau în legătură
cu Codul ARPIM, cu privire la înţelesul termenilor „rezonabil“, “extravagant”, aşa cum sunt
utilizate în acest Articol, conform prevederilor din secţiunea “Punerea în aplicare şi Normele de
procedură” a codului ARPIM.
Secţiunea 10.09. Orice document emis invitaţilor, care pune un accent necuvenit asupra luxului sau
ambianţei locaţiei sau cazării, restaurantelor sau altor activităţi sociale este interzis.
Secţiunea 10.10. Companiile membre ARPIM trebuie să respecte îndrumările privitoare la
semnificaţia termenilor: “rezonabil”, “corespunzător”, “renumit” şi “extravagant”, aşa cum sunt
detaliate în mod specific în secţiunea “Punerea în aplicare şi Normele de Procedură” din Codul
ARPIM.

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Articolul 11 Sponsorizări/Donaţii/Subsidii care sprijină asistenţa medicală sau cercetarea
Secţiunea 11.01. Sponsorizările/Donaţiile şi/sau Subsidiile (în numerar sau în natură sau în alt mod)
către instituţii publice, organizaţii sau asociaţii care sunt formate din profesionişti din domeniul
sanitar şi/sau care oferă servicii de îngrijire medicală sau de cercetare (care nu sunt reglementate în
alt mod de prezentul Cod ARPIM sau de Codul ARPIM de practică etică în interacţiunea cu
organizaţiile de pacienţi ) sunt permise dacă:
(i) sunt realizate cu scopul de a sprijini îngrijirea sănătăţii sau cercetarea;
(ii) sunt documentate şi arhivate de către sponsor/persoana care a acordat subsidiul; şi
(iii) nu constituie un îndemn de a recomanda, prescrie, achiziţiona, distribui, vinde sau
administra anumite produse medicamentoase.
(iv) se bazează pe solicitarea specifică a instituţiei / organizaţiei respective
Donaţiile şi subsidiile acordate individual profesioniştilor din domeniul sanitar nu sunt permise
conform acestei secţiuni. Sponsorizarea de către companie a profesioniştilor din domeniul sanitar
pentru participarea la evenimente internaţionale este acoperită de Articolul 13. Companiile sunt
încurajate să facă publice informaţiile legate de donaţii şi subsidii (în numerar sau în natură sau
altfel) acoperite în această Secţiune 11.01.

Membrii ARPIM sunt responsabili să includă în contractele de sponsorizare interdicţia de a utiliza

echipamentele în interes personal sau pentru a obţine avantaje materiale de către angajaţii
beneficiarului, iar beneficiarul se obligă să utilizeze obiectul obţinut prin aceste donaţii,
sponsorizări exclusiv în beneficiul gratuit al pacienţilor;membrii ARPIM vor face publice toate
aceste activităţi, conform reglementărilor din Codul de Publicare ARPIM.

Articolul 12 Onorarii pentru servicii

Secţiunea 12.01. Contractele dintre companii şi instituţiile, organizaţiile sau asociaţiile
profesioniştilor din domeniul sanitar, conform cărora aceste instituţii, organizaţii sau asociaţii
prestează orice tip de servicii în favoarea companiilor (sau orice alt tip de finanţare neacoperită
conform Articolului 11 sau neacoperită în alt mod prin prezentul Cod ARPIM) sunt permise numai
dacă aceste servicii (sau alte finanţări):
i. sunt prestate cu scopul de a sprijini îngrijirea sănătăţii sau cercetarea;
şi
ii. nu constituie un îndemn de a recomanda, a prescrie, a achiziţiona, a distribui, a vinde sau a
administra produse medicamentoase specifice.

Articolul 13 Sponsorizarea profesioniştilor din domeniul sanitar

Secţiunea 13.01. Companiile trebuie să respecte criteriile de selectare şi sponsorizare a
profesioniştilor din domeniul sanitar pentru a participa la cursuri sau evenimente, după cum este
prevăzut în Codul (Codurile) Aplicabil(e) sau în legătură cu acestea. Finanţarea nu trebuie oferită
pentru a compensa timpul petrecut de profesioniştii în domeniul sanitar cu participarea la
evenimente. În cazul evenimentelor internaţionale pentru care o companie sponsorizează
participarea unui profesionist din domeniul sanitar, dacă este asigurată o finanţare a acestui
profesionist conform prevederilor prezentei Secţiuni 13.01, această finanţare este supusă regulilor
jurisdicţiei ţării în care respectivul profesionist din domeniul sanitar îşi desfasoara profesia, şi nu
celor în care are loc evenimentul internaţional. Pentru evitarea oricărui dubiu, această Secţiune
13.01 nu este menită să interzică extinderea ospitalităţii către profesioniştii din domeniul sanitar,
conform Articolului 10 din prezenta.

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Articolul 14. Utilizarea consultanţilor
Secţiunea 14.01. Este permis ca membrii ARPIM să angajeze profesionişti din domeniul sănătăţii
pentru servicii, cum ar fi, dar fără a se limita la următoarele: prelegeri, consultare şi/sau consiliere
(participare la şedinţele de tip „advisory board”, dar fără a se limita la aceasta), şi implicarea în
activităţi şi studii medicale/ştiinţifice, servicii de training şi participarea la cercetări de piaţă, atât în
grupuri cât şi în mod individual.
Toate formalităţile care acoperă aceste servicii de consultanţă sau alte servicii trebuie, în măsura în
care este relevant pentru angajamentul respectiv, să îndeplinească criteriile următoare:
a) un contract sau un acord scris este agreat înainte de începerea prestării serviciilor: Acesta
specifică natura acestor servicii şi, conform clauzei (g) de mai jos, este baza pentru plata
acestor servicii;
b) o nevoie legitimă pentru serviciile respective a fost clar identificată înainte de solicitarea
serviciilor şi de încheierea acordurilor cu viitorii consultanţi;
c) criteriile de selectare a consultanţilor sunt legate în mod direct de nevoia identificată, iar
persoanele responsabile pentru selectarea consultanţilor au expertiza necesară pentru a
evalua dacă profesioniştii respectivi din domeniul sanitar îndeplinesc aceste criterii;
d) numărul profesioniştilor din domeniul sanitar implicaţi/angajaţi nu este mai mare decât
numărul necesar în mod rezonabil pentru a îndeplini nevoia identificată;
e) compania contractantă ţine evidenţe privitoare la serviciile prestate de consultanţi şi le
utilizează în mod corespunzător;
f) angajarea profesionistului din domeniul sanitar pentru a presta serviciul relevant nu este un
îndemn pentru a recomanda, a prescrie, a achiziţiona, a distribui, a vinde sau a administra un
produs medicamentos; şi
g) compensarea pentru servicii este rezonabilă şi reflectă valoarea corectă de piaţă a serviciilor
prestate; în acest sens, acordurile de consultanţă nu trebuie utilizate pentru a justifica
compensarea profesioniştilor din domeniul sanitar.
Secţiunea 14.02. Pentru serviciile prestate, consultanţilor externi li se vor oferi compensaţii
rezonabile, inclusiv rambursarea cheltuielilor rezonabile de călătorie, masă şi cazare (dacă este
cazul). Limitele considerate rezonabile (tarife orare nete) sunt descrise în secţiunea “Punerea în
aplicare şi Normele de Procedură” din Codul ARPIM şi trebuie respectate de companiile membre
ARPIM.
Secţiunea 14.03. În contractele scrise încheiate cu consultanţii, companiile sunt puternic încurajate
să includă prevederi privitoare la obligaţia consultantului de a declara că este consultant pentru
companie ori de câte ori scrie sau vorbeşte în public în legătură cu un aspect care este subiect al
acordului sau cu orice alt subiect referitor la companie. În mod similar, companiile care angajează,
part-time, profesionişti din domeniul sanitar care continuă să îşi practice şi profesia sunt încurajate
cu tărie să se asigure că aceste persoane au obligaţia de a-şi declara acordul de angajare cu
compania ori de câte ori scriu sau vorbesc în public despre o chestiune care este subiect al angajării
sau orice alt aspect legat de companie. Prevederile acestei Secţiuni 14.03 se aplică chiar dacă Codul
ARPIM nu acoperă în alt mod informaţiile nepromoţionale, generale în legătură cu companiile
(discutate la secţiunea “Sfera de Aplicare” a Codului ARPIM).
Secţiunea 14.04. Cercetarea de piaţă restrânsă, cum ar fi interviurile telefonice de tip „one-off” sau
chestionarele prin poştă/e-mail/internet sunt excluse din sfera de aplicare a acestui Articol 14, cu
condiţia ca profesionistul din domeniul sanitar să nu fie consultat într-un mod repetat (atât în ceea
ce priveşte frecvenţa apelurilor în general, cât şi a apelurilor legate de aceeaşi cercetare) şi ca
remuneraţia să fie minimă.
Secţiunea 14.05. Dacă un profesionist din domeniul sanitar participă la un eveniment (un eveniment
internaţional sau de alt fel) în calitate de consultant sau consilier, se vor aplica prevederile relevante
din Articolul 10.

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Secţiunea 14.06. Companiile membre ARPIM îşi vor defini intern sumele nete maxime rezonabile
pentru astfel de servicii care pot fi plătite individual unui profesionist din domeniul sanitar în
decursul unui an fiscal.

Articolul 16. Mostre

Secţiunea 16.01. În conformitate cu legile şi reglementările în vigoare în România şi conform
Directivei UE 2001/83/CE, în principiu, nu pot fi acordate mostre medicale, cu excepţia unor cazuri
extraordinare.
Mostrele medicale nu pot fi date ca stimulent pentru a recomanda, prescrie, achiziţiona, distribui,
vinde sau administra anumite produse medicamentoase şi nu trebuie date doar cu scopul de a trata
pacienţi.
Mostrele medicale sunt furnizate profesioniştilor din domeniul sanitar pentru ca aceştia se se poată
familiariza şi să dobândească experienţă cu medicamentele.
Conform legilor şi reglementărilor naţionale şi/sau ale UE, un număr limitat de mostre medicale –
ale unor produse medicamentoase noi – pot fi furnizate în cazuri excepţionale şi pentru o perioadă
limitată de timp, în conformitate cu articolele de mai jos.
În acest context, un medicament nou este un produs pentru care a fost emisă o nouă autorizaţie de
punere pe piaţă (APP), fie după solicitarea iniţială în vederea obţinerii APP, fie după solicitarea
unei extensii de linie pentru noi concentraţii/forme de dozare care să includă o nouă indicaţie.
Extensiile APP la noi concentraţii/forme de dozare pentru indicaţiile existente sau mărimi de
ambalaj (numărul de unităţi din ambalaj) nu pot fi considerate ca medicamente noi.
Secţiunea 16.02. Numărul de mostre acordate pentru fiecare medicament eliberat pe bază de
prescripţie medicală este limitat la maxim 4 unităţi din cea mai mică formulare disponibilă pe piaţa
locală, pe medic, pe an, timp de 2 ani de la primirea primei solicitări pentru produsele lansate după
31 decembrie 2011.
Pentru produsele tranzacţionate în baza unei Autorizaţii de Punere pe Piaţă emisă înainte de această
dată, nu pot fi acordate mostre.
Secţiunea 16.03. Membrii ARPIM trebuie să aibă sisteme corespunzătoare de control şi gestionare
pentru mostrele pe care le distribuie şi pentru toate medicamentele date ca mostre de către
reprezentanţii lor.
Secţiunea 16.04. Fiecare mostră nu va fi mai mare decât cea mai mică formă de prezentare
comercializată.
Secţiunea 16.05. Fiecare mostră trebuie inscripţionată ca fiind „mostră medicală gratuită - nu este
destinată vânzării” sau o altă formulare cu acest înţeles şi trebuie să fie însoţită de un exemplar al
rezumatului caracteristicilor produsului.
Secţiunea 16.06. Nu este permisă furnizarea de mostre pentru următoarele produse
medicamentoase:
a) cele care conţin substanţe definite drept stupefiante sau psihotrope în înţelesul convenţiilor
internaţionale, precum convenţiile Naţiunilor Unite din 1961 şi 1971 şi legislaţiei naţionale.
b) cele pentru care livrarea de mostre este inadecvată, potrivit reglementărilor autorităţilor
competente, actualizate periodic.

Articolul 17. Interzicerea cadourilor.

Secţiunea 17.01. Niciun cadou, avantaj financiar sau beneficiu în natură nu trebuie acordate, oferite
sau promise unui profesionist din domeniul sanitar.
Plăţile în numerar sau echivalente de numerar (cum ar fi certificatele sau cupoanele cadou) sunt
interzise.

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Plata taxelor de membru în asociaţii medicale naţionale sau internaţionale sau susţinerea
profesioniştilor din domeniul sanitar în vederea editării de literatură medicală nu sunt permise.

Articolul 18. Personalul membrilor ARPIM

Secţiunea 18.01. Fiecare membru ARPIM se va asigura că reprezentanţii săi, inclusiv personalul
utilizat prin contract cu terţe părţi şi orice alţi reprezentanţi ai membrilor ARPIM care vizitează
profesionişti din domeniul sanitar, farmacii, spitale sau alte unităţi din domeniul sanitar pentru
promovarea produselor medicamentoase (fiecare denumit “reprezentant”) sunt familiarizaţi cu
cerinţele relevante ale Codului ARPIM precum şi cu toate legile şi reglementările româneşti
relevante, sunt adecvat pregătiţi şi au suficiente cunoştinţe ştiinţifice pentru a putea furniza
informaţii precise şi complete despre produsele medicamentoase pe care le promovează.
a) Reprezentanţii trebuie să respecte toate cerinţele Codului ARPIM şi toate legile şi
reglementările româneşti relevante, iar fiecare membru ARPIM este răspunzător de
asigurarea respectării acestora.
b) Reprezentanţii trebuie să îşi îndeplinească îndatoririle profesionale în mod responsabil şi
etic.
c) În cursul fiecărei vizite, reprezentanţii trebuie să înmâneze profesioniştilor din domeniul
sanitar cu care intră în contact, sau să aibă la dispoziţie pentru aceştia, rezumatul
caracteristicilor produsului pentru fiecare produs medicamentos pe care îl prezintă, precum
şi detalii asupra preţului şi a modului de compensare a produsului medicamentos respectiv.
d) Reprezentanţii trebuie să transmită imediat departamentului relevant al companiei lor
(Medical, Farmocovigilenţă, Asigurarea Calităţii) orice informaţii pe care le primesc în
legătură cu utilizarea medicamentelor în afara indicaţiilor aprobate în România, sau în
legătură cu utilizarea acestora în cursul sarcinii şi, de asemenea, rapoartele cu privire la
reacţii adverse sau raportări de deficienţe de calitate ale produselor medicamentoase ale
companiei lor.
e) Reprezentanţii trebuie să se asigure că frecvenţa, momentul şi durata vizitelor la
profesioniştii din sistemul sanitar, farmacii, spital şi alte unităţi de asistenţă a sănătăţii,
precum şi modul în care acestea sunt făcute, nu vor provoca inconvenienţe.
f) Reprezentanţii nu trebuie să utilizeze niciun subterfugiu pentru a obţine o întâlnire. Nu se
poate plăti sau oferi niciun onorariu pentru acordarea unei întâlniri. În cursul întâlnirii sau
atunci când solicită o programare pentru o întâlnire, reprezentanţii trebuie , încă de la
început, să ia toate măsurile rezonabile pentru a se asigura că nu induc în eroare cu privire la
identitatea lor sau a membrului ARPIM pe care îl reprezintă.
Secţiunea 18.02.
a) Atât angajaţii unui membru ARPIM, cât şi angajaţii contractaţi prin terţe părţi care se ocupă
cu pregătirea sau aprobarea materialelor sau activităţilor promoţionale, trebuie să fie pe
deplin familiarizaţi cu cerinţele Codului ARPIM şi cu legile şi reglementările româneşti în
vigoare aplicabile.
b) Fiecare membru ARPIM trebuie să înfiinţeze un departament medical şi/sau ştiinţific
responsabil de asigurarea informaţiei ştiinţifice şi promoţionale despre produsele sale
medicamentoase şi de aprobarea şi supervizarea studiilor non-intervenționale şi
epidemiologice.
Acest departament medical trebuie să includă cel puţin un medic sau, dacă este cazul, un
farmacist care va răspunde de aprobarea oricărui material promoţional înaintea difuzării,
care va fi responsabil şi de aprobarea studiilor non-intervenționale, inclusiv supravegherea
responsabilităţilor legate de aceste studii. Această persoană trebuie să certifice că protocolul
a fost revizuit şi este aprobat în conformitate cu toate cerinţele din reglementările şi codurile
relevante.
Această persoană trebuie să certifice că a examinat forma finală a materialului promoţional
şi a protocoalelor activităţilor specifice de cercetare şi că, în opinia sa, acestea sunt în

7
 conformitate cu cerinţele codului ARPIM şi cu legile şi reglementările din România,
respectă rezumatul caracteristicilor produsului şi reprezintă o prezentare corectă, echilibrată
şi de încredere a dovezilor privitoare la produsul medicamentos, având valoare ştiinţifică.
c) Fiecare membru ARPIM trebuie să implementeze un program de training pentru toţi
angajaţii - atât la angajare, cât şi de fiecare dată când au loc schimbări semnificative în
Codul ARPIM sau în legile şi reglementările româneşti în vigoare.

Articolul 19. Conştientizare şi educaţie

a) Fiecare membru ARPIM trebuie să implementeze un program de training pentru toţi
angajaţii – atât la angajare cât şi ori de câte ori există modificări semnificative ale Codurilor
ARPIM sau ale legilor şi reglementărilor româneşti în vigoare. În plus, fiecare membru
ARPIM va organiza un training la cel puţin fiecare doi ani pentru ca personalul său să
rămână informat în legătură cu cerinţele Codului ARPIM şi cu legile şi reglementările
româneşti în vigoare, aplicabile. Membrii ARPIM vor organiza anual evaluarea
cunoştinţelor personalului, utilizând platforma ARPIM şi având ca referinţă materialul de
training publicat pe site-ul ARPIM.
Fiecărui angajat i se vor aloca, aleatoriu, un număr de 20 de întrebări pentru testarea
cunoştinţelor şi scorul satisfăcător va fi obţinut prin 17 răspunsuri corecte.
Revizuirea şi actualizarea periodică a acestui material este realizată de Grupul de lucru
pentru probleme etice la cel puţin 2 (doi) ani şi/sau ori de câte ori legea sau reglementările
de referinţă sunt modificate.
Fiecare companie membră ARPIM trebuie să desemneze un angajat responsabil cu
supervizarea tehnică şi coordonarea evaluării cunoştinţelor.
b) Materialele de training trebuie să fie revizuite şi aprobate de către Departamentul Medical
sau alte Departamente relevante înainte de a fi prezentate personalului.
c) Fiecare membru ARPIM trebuie sa numească/desemneze un angajat cu funcţie de
conducere/senior care să răspundă de asigurarea respectării normelor de etică şi complianţă
şi să notifice către secretariatul ARPIM numele acestei persoane responsabilă de etica în
promovare la nivelul respectivei organizaţii în maxim 30 de zile de la numirea/înlocuirea
acesteia. Acest angajat va răspunde de asigurarea implementării prevederilor prezentului
cod şi a legislaţiei în vigoare precum şi supervizarea respectării cerinţelor şi standardelor
acestora. Fiecare membru ARPIM va trebui să asigure un sistem eficient de control al
respectării de către toţi angajaţii sau contractorii a standardelor de etică stabilite în prezentul
cod.

Articolul 20. Reclamaţii şi sancţiuni

Primirea reclamaţiilor
Reclamaţiile pot fi depuse la ARPIM sau la EFPIA.
Reclamaţiile primite de EFPIA vor fi procesate după cum urmează:
a. EFPIA va înainta orice reclamaţii primite (fără a lua în considerare admisibilitatea
acestora sau fără a le comenta) către Asociaţia Membră relevantă.
b. EFPIA va transmite o confirmare de primire către reclamant, indicând Asociaţia
Membră relevantă la care a fost transmisă reclamaţia pentru procesare şi soluţionare
c. În plus, la primirea de către EFPIA a unor multiple reclamaţii din mediul extern
(adică mai multe reclamaţii asupra aceleiaşi probleme sau unei probleme similare
depuse din afara industriei împotriva mai multor sucursale ale unei companii),
EFPIA va comunica aceste reclamaţii Asociaţiei Membre a companiei mamă sau a
sucursalei europene desemnate de către compania mamă.

8
Table of Contents

Introduction������������������������������������������������������������������������������������������������������������� 2

Fraud and Abuse Laws�������������������������������������������������������������������������������������������� 3

False Claims Act [31 U.S.C. §§ 3729–3733]������������������������������������������������������� 3
Anti-Kickback Statute [42 U.S.C. § 1320a-7b(b)]����������������������������������������������� 4
Physician Self-Referral Law [42 U.S.C. § 1395nn]��������������������������������������������� 6
Exclusion Statute [42 U.S.C. § 1320a-7]������������������������������������������������������������� 7
Civil Monetary Penalties Law [42 U.S.C. § 1320a-7a]��������������������������������������� 8

I. Physician Relationships With Payers���������������������������������������������������������������������� 9

Accurate Coding and Billing�������������������������������������������������������������������������������� 9
Physician Documentation���������������������������������������������������������������������������������� 12
Enrolling as a Medicare and Medicaid Provider With CMS����������������������������� 12
Prescription Authority���������������������������������������������������������������������������������������� 13
Assignment Issues in Medicare Reimbursement����������������������������������������������� 14

II. Physician Relationships With Fellow Providers: Physicians,

Hospitals, Nursing Homes, Etc.���������������������������������������������������������������������������� 16
Physician Investments in Health Care Business Ventures��������������������������������� 16
Physician Recruitment��������������������������������������������������������������������������������������� 19
Tips for Medical Directors��������������������������������������������������������������������������������� 20

III. Physician Relationships With Vendors��������������������������������������������������������������� 21

Free Samples������������������������������������������������������������������������������������������������������ 21
Relationships With the Pharmaceutical and Medical Device Industries������������ 22
Transparency in Physician-Industry Relationships�������������������������������������������� 24
Conflict-of-Interest Disclosures������������������������������������������������������������������������� 24
Continuing Medical Education�������������������������������������������������������������������������� 25

Compliance Programs for Physicians������������������������������������������������������������������� 26

Where To Go for Help������������������������������������������������������������������������������������������ 26

What To Do If You Think You Have a Problem������������������������������������������������������� 28

What To Do If You Have Information About Fraud and

Abuse Against Federal Health Care Programs������������������������������������������������������ 29
 Introduction

Most physicians strive to work ethically, render high-quality medical care to their
patients, and submit proper claims for payment. Society places enormous trust in
physicians, and rightly so. Trust is at the core of the physician-patient relationship.
When our health is at its most vulnerable, we rely on physicians to use their expert
medical training to put us on the road to a healthy recovery.

The Federal Government also places enormous trust in physicians. Medicare, Medicaid,
and other Federal health care programs rely on physicians’ medical judgment to treat
beneficiaries with appropriate services. When reimbursing physicians
and hospitals for services provided to program beneficiaries, the
Federal Government relies on physicians to submit accurate
and truthful claims information.

CAUTION The presence of some dishonest health care providers

who exploit the health care system for illegal personal
gain has created the need for laws that combat fraud and
abuse and ensure appropriate quality medical care. This
brochure assists physicians in understanding how to comply
with these Federal laws by identifying “red flags” that could lead
to potential liability in law enforcement and administrative actions. The information
is organized around three types of relationships that physicians frequently encounter
in their careers:

I. Relationships with payers,

II. Relationships with fellow physicians and other providers, and
III. Relationships with vendors.
The key issues addressed in this brochure are relevant to all physicians, regardless
of specialty or practice setting.

2
 Fraud and Abuse Laws

The five most important Federal fraud and abuse laws that apply to physicians are the
False Claims Act (FCA), the Anti-Kickback Statute (AKS), the Physician Self-Referral
Law (Stark law), the Exclusion Authorities, and the Civil Monetary Penalties Law
(CMPL). Government agencies, including the Department of Justice, the Department
of Health & Human Services Office of Inspector General (OIG), and the Centers for
Medicare & Medicaid Services (CMS), are charged with enforcing these laws. As you
begin your career, it is crucial to understand these laws not only because following
them is the right thing to do, but also because violating them could result in criminal
penalties, civil fines, exclusion from the Federal health care programs, or loss of your
medical license from your State medical board.

False Claims Act [31 U.S.C. §§ 3729–3733]

The civil FCA protects the Government from being overcharged or sold shoddy
goods or services. It is illegal to submit claims for payment to Medicare or
Medicaid that you know or should know are false or fraudulent. Filing false
claims may result in fines of up to three times the programs’ loss plus $11,000 per claim
filed. Under the civil FCA, each instance of an item or a service billed to Medicare or
Medicaid counts as a claim, so fines can add up quickly. The fact that a claim results
from a kickback or is made in violation of the Stark law also may render it false or
fraudulent, creating liability under the civil FCA as well as the AKS or Stark law.

Under the civil FCA, no specific intent to defraud is required. The civil FCA defines
“knowing” to include not only actual knowledge but also instances in which the
person acted in deliberate ignorance or reckless disregard of the truth or falsity of
the information. Further, the civil FCA contains a whistleblower provision that allows
a private individual to file a lawsuit on behalf of the United States and entitles that
whistleblower to a percentage of any recoveries. Whistleblowers could be current or
ex-business partners, hospital or office staff, patients, or competitors.

There also is a criminal FCA (18 U.S.C. § 287). Criminal penalties for submitting false
claims include imprisonment and criminal fines. Physicians have gone to prison for
submitting false health care claims. OIG also may impose administrative civil monetary
penalties for false or fraudulent claims, as discussed below.

3
 Anti-Kickback Statute [42 U.S.C. § 1320a-7b(b)]

The AKS is a criminal law that prohibits the knowing and willful payment of
“remuneration” to induce or reward patient referrals or the generation of business
involving any item or service payable by the Federal health care programs (e.g., drugs,
supplies, or health care services for Medicare or Medicaid patients). Remuneration
includes anything of value and can take many forms besides cash, such as free
rent, expensive hotel stays and meals, and excessive compensation for medical
directorships or consultancies. In some industries, it is acceptable to
reward those who refer business to you. However, in the
Federal health care programs, paying for
referrals is a crime. The statute covers the payers
of kickbacks—those who offer or pay remuneration—
as well as the recipients of kickbacks—those who
solicit or receive remuneration. Each party’s intent is a
key element of their liability under the AKS.

Criminal penalties and administrative sanctions for

violating the AKS include fines, jail terms, and exclusion
from participation in the Federal health care programs. Under the CMPL,
physicians who pay or accept kickbacks also face penalties of up to $50,000
per kickback plus three times the amount of the remuneration.

Safe harbors protect certain payment and business practices that could otherwise
implicate the AKS from criminal and civil prosecution. To be protected by a safe harbor,
an arrangement must fit squarely in the safe harbor and satisfy all of its requirements.
Some safe harbors address personal services and rental agreements, investments in
ambulatory surgical centers, and payments to bona fide employees.

For additional information on safe harbors, see “OIG’s Safe Harbor Regulations”
available at http://oig.hhs.gov/fraud/safeharborregulations.asp.

As a physician, you are an attractive target for kickback schemes because

you can be a source of referrals for fellow physicians or other health care providers
and suppliers. You decide what drugs your patients use, which specialists they see, and
what health care services and supplies they receive.

4
Many people and companies want your patients’ business and would pay you to send
that business their way. Just as it is illegal for you to take money from providers and
suppliers in return for the referral of your Medicare and Medicaid patients, it is illegal
for you to pay others to refer their Medicare and Medicaid patients to you.

Kickbacks in health care can lead to:

BB Overutilization
BB Increased program costs
BB Corruption of medical decisionmaking
BB Patient steering
BB Unfair competition

The kickback prohibition applies to all sources

of referrals, even patients. For example, where the
Medicare and Medicaid programs require patients to
pay copays for services, you are generally required to collect that money from your
patients. Routinely waiving these copays could implicate the AKS and you may not
advertise that you will forgive copayments. However, you are free to waive a copayment
if you make an individual determination that the patient cannot afford to pay or if your
reasonable collection efforts fail. It is also legal to provide free or discounted
services to uninsured people.
Besides the AKS, the beneficiary inducement statute (42 U.S.C. § 1320a-7a(a)(5)) also
imposes civil monetary penalties on physicians who offer remuneration to Medicare
and Medicaid beneficiaries to influence them to use their services.

The Government does not need to prove patient harm or financial loss to the programs
to show that a physician violated the AKS. A physician can be guilty of violating
the AKS even if the physician actually rendered the service and the service was
medically necessary. Taking money or gifts from a drug or device company
or a durable medical equipment (DME) supplier is not justified by the
argument that you would have prescribed that drug or ordered that
wheelchair even without a kickback.

5
 Physician Self-Referral Law [42 U.S.C. § 1395nn]

The Physician Self-Referral Law, commonly referred to as the Stark law, prohibits
physicians from referring patients to receive “designated health services” payable by
Medicare or Medicaid from entities with which the physician or an immediate family
member has a financial relationship, unless an exception applies. Financial relationships
include both ownership/investment interests and compensation arrangements. For
example, if you invest in an imaging center, the Stark law requires the resulting
financial relationship to fit within an exception or you may not refer patients to the
facility and the entity may not bill for the referred imaging services.

“Designated health services” are:

• clinical laboratory services;

• physical therapy, occupational therapy, and outpatient speech-language
pathology services;
• radiology and certain other imaging services;
• radiation therapy services and supplies;
• DME and supplies;
• parenteral and enteral nutrients,
equipment, and supplies;
• prosthetics, orthotics, and prosthetic
devices and supplies;
• home health services;
• outpatient prescription drugs; and
• inpatient and outpatient hospital services.
The Stark law is a strict liability statute, which means proof of specific intent to
violate the law is not required. The Stark law prohibits the submission, or causing
the submission, of claims in violation of the law’s restrictions on referrals. Penalties
for physicians who violate the Stark law include fines as well as exclusion from
participation in the Federal health care programs.

For more information, see CMS’s Stark law Web site available at
http://www.cms.gov/physicianselfreferral/.

6
 Exclusion Statute [42 U.S.C. § 1320a-7]

OIG is legally required to exclude from participation in all Federal health care
programs individuals and entities convicted of the following types of criminal offenses:
(1) Medicare or Medicaid fraud, as well as any other offenses related to the delivery of
items or services under Medicare or Medicaid; (2) patient abuse or neglect; (3) felony
convictions for other health-care-related fraud, theft, or other financial misconduct;
and (4) felony convictions for unlawful manufacture, distribution, prescription, or
dispensing of controlled substances. OIG has discretion to exclude individuals and
entities on several other grounds, including misdemeanor convictions related to
health care fraud other than Medicare or Medicaid fraud or misdemeanor
convictions in connection with the unlawful manufacture, distribution,
prescription, or dispensing of controlled substances; suspension,
revocation, or surrender of a license to provide health care for reasons
bearing on professional competence, professional performance,
or financial integrity; provision of unnecessary or substandard
services; submission of false or fraudulent claims to a Federal health
care program; engaging in unlawful kickback arrangements; and
defaulting on health education loan or scholarship obligations.

If you are excluded by OIG from participation in the Federal health

care programs, then Medicare, Medicaid, and other Federal health care
programs, such as TRICARE and the Veterans Health Administration,
will not pay for items or services that you furnish, order, or prescribe.
Excluded physicians may not bill directly for treating
Medicare and Medicaid patients, nor may their services be
billed indirectly through an employer or a group practice. In
addition, if you furnish services to a patient on a private-pay basis, no
order or prescription that you give to that patient will be reimbursable by
any Federal health care program.

For more information, see OIG’s Special Advisory Bulletin entitled “The Effect of
Exclusion From Participation in Federal Health Care Programs” available at
http://oig.hhs.gov/fraud/docs/alertsandbulletins/effected.htm.

7
You are responsible for ensuring that you do not employ or contract with excluded
individuals or entities, whether in a physician practice, a clinic, or in any capacity
or setting in which Federal health care programs may reimburse for the items or
services furnished by those employees or contractors. This responsibility requires
screening all current and prospective employees and contractors against OIG’s List of
Excluded Individuals and Entities. This online database can be accessed from OIG’s
Exclusion Web site. If you employ or contract with an excluded individual or entity
and Federal health care program payment is made for items or services that person or
entity furnishes, whether directly or indirectly, you may be subject to a civil monetary
penalty and/or an obligation to repay any amounts attributable to the services of the
excluded individual or entity.

For more information, see OIG’s exclusion Web site available at

http://oig.hhs.gov/fraud/exclusions.asp.

Civil Monetary Penalties Law [42 U.S.C. § 1320a-7a]

OIG may seek civil monetary penalties and sometimes exclusion for a wide variety of
conduct and is authorized to seek different amounts of penalties and assessments based
on the type of violation at issue. Penalties range from $10,000 to $50,000 per violation.
Some examples of CMPL violations include:
BB presenting a claim that the person knows or should know is for an item or service
that was not provided as claimed or is false or fraudulent;
BB presenting a claim that the person knows or should know is for an item or service
for which payment may not be made;
BB violating the AKS;
BB violating Medicare assignment provisions;
BB violating the Medicare physician agreement;
BB providing false or misleading information expected to influence a decision to
discharge;
BB failing to provide an adequate medical screening examination for patients
who present to a hospital emergency department with an emergency medical
condition or in labor; and
BB making false statements or misrepresentations on applications or contracts to
participate in the Federal health care programs.

8
 I. Physician Relationships With Payers

During residency, you probably are not focused on who pays for your patients’ care.
Once you start practicing, it is important to understand who the payers are. The U.S.
health care system relies heavily on third-party payers, and, therefore, your patients
often are not the ones who pay most of their medical bills. Third-party payers include
commercial insurers and the Federal and State governments. When the Federal
Government covers items or services rendered to Medicare and Medicaid
beneficiaries, the Federal fraud and abuse laws apply. Many States also
have adopted similar laws that apply to your provision of care under State-financed
programs and to private-pay patients. Consequently, you should recognize that the
issues discussed here may apply to your care of all insured patients.

Accurate Coding and Billing

Payers trust you, as a physician, to provide necessary, cost-effective, and quality care.
You exert significant influence over what services your patients receive, you control the
documentation describing what services they actually received, and your documentation
serves as the basis for bills sent to insurers for
services you provided. The Government’s
payment of claims is generally based solely
on your representations in the claims
documents.

Because the Government invests so

much trust in physicians on the front end,
Congress provided powerful criminal, civil,
and administrative enforcement tools for
instances when unscrupulous providers abuse that trust. The Government has broad
capabilities to audit claims and investigate providers when it has a reason to suspect
fraud. Suspicion of fraud and abuse may be raised by irregular billing patterns or
reports from others, including your staff, competitors, and patients.

9
When you submit a claim for services performed for a Medicare or
Medicaid beneficiary, you are filing a bill with the Federal Government
and certifying that you have earned the payment requested and complied
with the billing requirements. If you knew or should have known that the submitted
claim was false, then the attempt to collect unearned money constitutes a violation. A
common type of false claim is “upcoding,” which refers to using billing codes that
reflect a more severe illness than actually existed or a more expensive treatment than
was provided. Additional examples of improper claims include:

BB billing for services that you did not actually render;

BB billing for services that were not medically necessary;
BB billing for services that were performed by an improperly supervised or
unqualified employee;
BB billing for services that were performed by an employee who has been excluded
from participation in the Federal health care programs;
BB billing for services of such low quality that they are virtually worthless; and
BB billing separately for services already included in a global fee, like billing for an
evaluation and management service the day after surgery.

CAUTION CAUTION CAUTION CAUTION CAUTION CAUTION CAUTION

Upcoding
Medicare pays for many physician services using Evaluation and Management
(commonly referred to as “E&M”) codes. New patient visits generally require more
time than follow-up visits for established patients, and therefore E&M codes for
new patients command higher reimbursement rates than E&M codes for established
patients. An example of upcoding is an instance when you provide a follow-up office
visit or follow-up inpatient consultation but bill using a higher level E&M code as
if you had provided a comprehensive new patient office visit or an initial inpatient
consultation.

Another example of upcoding related to E&M codes is misuse of Modifier 25.

Modifier 25 allows additional payment for a separate E&M service rendered on the
same day as a procedure. Upcoding occurs if a provider uses Modifier 25 to claim
payment for an E&M service when the patient care rendered was not significant,
was not separately identifiable, and was not above and beyond the care usually
associated with the procedure.

CAUTION CAUTION CAUTION CAUTION CAUTION CAUTION CAUTION

10
Case Examples of Fraudulent Billing
• A psychiatrist was fined $400,000 and
permanently excluded from participating in the
Federal health care programs for misrepresenting
that he provided therapy sessions requiring
30 or 60 minutes of face-to-face time with the
patient, when he had provided only medication checks for
15 minutes or less. The psychiatrist also misrepresented that he provided
therapy sessions when in fact a non-licensed individual conducted the sessions.

• A dermatologist was sentenced to 2 years of probation and 6 months of home

confinement and ordered to pay $2.9 million after he pled guilty to one count of
obstruction of a criminal health care fraud investigation. The dermatologist admitted
to falsifying lab tests and backdating letters to referring physicians to substantiate
false diagnoses to make the documentation appear that his patients had Medicare-
covered conditions when they did not.

• A cardiologist paid the Government $435,000 and entered into a 5-year Integrity
Agreement with OIG to settle allegations that he knowingly submitted claims for
consultation services that were not supported by patient medical records and did
not meet the criteria for a consultation. The physician also allegedly knowingly
submitted false claims for E&M services when he had already received payment for
such services in connection with previous claims for nuclear stress testing.

• An endocrinologist billed routine blood draws as critical care blood draws. He

paid $447,000 to settle allegations of upcoding and other billing violations.

11
 Physician Documentation

Physicians should maintain accurate and complete medical records and documentation
of the services they provide. Physicians also should ensure that the claims they submit
for payment are supported by the documentation. The Medicare
and Medicaid programs may review beneficiaries’ medical
records. Good documentation practice helps ensure that
your patients receive appropriate care from you and
other providers who may rely on your records for
patients’ past medical histories. It also helps you address
challenges raised against the integrity of your bills. You may have
heard the saying regarding malpractice litigation: “If you didn’t
document it, it’s the same as if you didn’t do it.” The same can be
said for Medicare and Medicaid billing.

For more information on physician documentation, see CMS’s Documentation

Guidelines for Evaluation and Management Services available at
http://www.cms.gov/MLNEdWebGuide/25_EMDOC.asp.

Enrolling as a Medicare and Medicaid Provider

With CMS
CMS is the Federal agency that administers the Medicare program and monitors the
Medicaid programs run by each State. To obtain reimbursement from the Government
for services provided to Federal health care program beneficiaries, you must:

1. Obtain a National Provider Identifier (NPI). An NPI is a unique health

identifier for health care providers. You may apply for your NPI at
https://nppes.cms.hhs.gov/NPPES/Welcome.do.
2. Complete the appropriate Medicare Enrollment Application. During the
enrollment process, CMS collects information to ensure that you are qualified
and eligible to enroll in the Medicare Program. Information about Medicare
provider enrollment is available at
http://www.cms.gov/MedicareProviderSupEnroll/.
3. Complete your State-specific Medicaid Enrollment Application.
Information about Medicaid provider enrollment is available from your State
Medicaid agency.
Once you become a Medicare and/or Medicaid provider, you are responsible for
ensuring that claims submitted under your number are true and correct.

12
 For tips you can share with your patients on how they can protect themselves from
medical identity theft, see OIG’s brochure entitled “Tips to Avoid Medical ID
Theft” available at
http://oig.hhs.gov/fraud/IDTheft/OIG_Medical_Identity_Theft_Brochure.pdf.

Prescription Authority

The Drug Enforcement Administration (DEA) is a Department

of Justice agency responsible for enforcing the Controlled
Substances Act. When you prepare to enter practice, you
probably will apply for a DEA number that authorizes you
to write prescriptions for controlled substances. You also
will apply for your State medical license and any additional credentials your State
requires for you to write prescriptions. You must ensure that you write prescriptions
only for lawful purposes.

Case Examples of Misuse of Physician Provider and

Prescription Numbers
• A physician was ordered to pay $50,000 in restitution to the Government for
falsely indicating on his provider number application that he was running his own
practice when, in fact, a neurophysiologist was
operating the practice and paying the physician a
salary for the use of his number.

• An osteopathic physician was sentenced to 10

years in prison and ordered to pay $7.9 million in
restitution after she accepted cash payments for signing preprinted
prescriptions and Certificates of Medical Necessity for motorized wheelchairs for
beneficiaries she never examined. More than 60 DME companies received Medicare
and Medicaid payments based on her fraudulent prescriptions.

• An internal medicine physician pled guilty to Medicare fraud and to conspiring

to dispense oxycodone, morphine, hydrocodone, and alprazolam. The physician
allowed unauthorized and non-medical employees at his pain center to prescribe
drugs using his pre-signed blank prescription forms. Prescriptions were issued in
his name without adequate physical exams, proper diagnoses, or consideration of
alternative treatment options. He paid $317,000 in restitution to the Government.

13
 Assignment Issues in Medicare Reimbursement

Most physicians bill Medicare as participating providers, which is referred to as

“accepting assignment.” Each year, Medicare promulgates a fee schedule setting the
reimbursement for each physician service. Once beneficiaries satisfy their annual
deductible, Medicare pays 80 percent of the fee schedule amount and the beneficiary
pays 20 percent. Participating providers receive the Medicare program’s
80 percent directly from the Medicare program and bill the beneficiary
for the remaining 20 percent. Accepting assignment means that the
physician accepts the Medicare payment plus any copayment or
deductible Medicare requires the patient to pay as the full payment
for the physician’s services and that the physician will not seek any
extra payment (beyond the copayment or deductible) from the
patient. Medicare participating physicians may not bill Medicare
patients extra for services that are already covered by Medicare.
Doing so is a violation of a physician’s assignment agreement and
can lead to penalties.

The second, less common, way to obtain Medicare reimbursement is to bill as a non-
participating provider. Non-participating providers do not receive direct payment
from the Medicare program. Rather, they bill their patients and the patients seek
reimbursement from Medicare. Although non-participating providers are not subject to
the assignment rules, they still must limit the dollar amount of their charges to Medicare
patients. Generally, non-participating providers may not charge Medicare beneficiaries
more than 15 percent in excess of the Medicare fee schedule amount. It is illegal to
charge patients more than the limiting charge established for physicians’ services.

DO NOT Excluded providers may not receive

Medicare payment either as participating
ENTER or non-participating providers.

You may see advertisements offering to help you convert your practice into a “boutique,”
“concierge,” or “retainer” practice. Many such solicitations promise to help you work
less, yet earn more money. If you are a participating or non-participating
physician, you may not ask Medicare patients to pay a second time for
services for which Medicare has already paid. It is legal to charge patients
for services that are not covered by Medicare. However, charging an “access fee” or
“administrative fee” that simply allows them to obtain Medicare-covered services
from your practice constitutes double billing.

14
Case Example of a Physician Violating an Assignment
Agreement by Charging Beneficiaries Extra Fees
• A physician paid $107,000 to resolve potential
liability for charging patients, including Medicare
beneficiaries, an annual fee. In exchange for
the fee, the physician offered: (1) an annual
physical; (2) same- or next-day appointments;
(3) dedicated support personnel; (4) around-the-clock
physician availability; (5) prescription facilitation; (6) expedited and
coordinated referrals; and (7) other amenities at the physician’s discretion. The
physician’s activities allegedly violated the assignment agreement because some of
the services outlined in the annual fee were already covered by Medicare.

15
 II. Physician Relationships With Fellow
Providers: Physicians, Hospitals,
Nursing Homes, Etc.

Any time a health care business offers something to you for free or at below fair market
value, you always should ask yourself, “Why?” For example, if a DME supplier offers to
give you cash or to pay for your summer vacation, you should suspect that the supplier
is trying to induce you to refer your patients to that vendor. If a laboratory offers to
decorate your patient waiting room, you should suspect that it is trying to induce you
to send your lab business its way.

For more information on physician relationships with:

fellow providers, see OIG’s “Compliance Program Guidance for Individual and
Small Group Physician Practices” available at
http://oig.hhs.gov/authorities/docs/physician.pdf;

hospitals, see OIG’s “Supplemental Compliance Program Guidance for Hospitals”

available at http://oig.hhs.gov/fraud/docs/complianceguidance/012705HospSupplem
entalGuidance.pdf; and

nursing homes, see OIG’s “Supplemental Compliance Program Guidance for

Nursing Facilities” available at
http://oig.hhs.gov/fraud/docs/complianceguidance/nhg_fr.pdf.

Physician Investments in Health Care

Business Ventures
Some have observed that physicians who invest in health care business ventures with
outside parties (e.g., imaging centers, labs, equipment vendors, or physical therapy
clinics) refer more patients for the services provided by those parties than physicians
who do not invest. Maybe this disproportionate utilization partly reflects the physicians’
belief in the value of the services or technology, prompting the investments in the
first place. However, there also is a risk that the physicians’ belief in the value of
the services or technology is less a cause than an effect of the investment interest.
The physician investors’ disproportionate utilization may be motivated partly by the
physicians’ ability to profit from the use of the ancillary services. These business
relationships can sometimes unduly influence or distort physician decisionmaking
and result in the improper steering of a patient to a particular therapy or source of
services in which a physician has a financial interest. Excessive and medically
unnecessary referrals waste Government and beneficiary money and

16
can expose beneficiaries to harm from unnecessary services. Many of these
investment relationships have serious legal risks under the AKS and Stark law.

If you are invited to invest in a health care business whose products you might order or
to which you might refer your patients, you should ask the following questions. If the
answer is “yes” to any of them, you should consider carefully whether you are investing
for legitimate reasons.

VV Are you being offered an investment interest for a nominal capital contribution?
VV Will your ownership share be larger than your share of the aggregate capital
contributions made to the venture?
VV Is the venture promising you high rates of return for little or no financial risk?
VV Is the venture or any potential business partner offering to loan you the money to
make your capital contribution?
VV Are you being asked to promise or guarantee that you will refer patients or order
items or services from the venture?
VV Do you believe you will be more likely to refer more patients for the items and
services provided by the venture if you make the investment?
VV Do you believe you will be more likely to refer to the venture just because you
made the investment?
VV Will the venture have sufficient capital from other sources to fund its ongoing
operations? 

17
 For more information on physician investments, see:

OIG’s Special Fraud Alert entitled “Joint Venture Arrangements” available at

http://oig.hhs.gov/fraud/docs/alertsandbulletins/121994.html;

OIG’s Special Advisory Bulletin on contractual joint ventures available at

http://oig.hhs.gov/fraud/docs/alertsandbulletins/042303SABJointVentures.pdf; and

OIG’s “Supplemental Compliance Program Guidance for Hospitals”

available at http://oig.hhs.gov/fraud/docs/complianceguidance/012705HospSupplem
entalGuidance.pdf.

Case Examples Involving Kickbacks for Referrals

and Self-Referrals
• Nine cardiologists paid the Government over
$3.2 million for allegedly engaging in a kickback
scheme. The cardiologists received salaries
under clinical faculty services agreements
with a hospital under which, the Government
alleged, they did not provide some or any of the services.
In exchange, the cardiologists referred their patients to the hospital for
cardiology services. Two of the physicians also pled guilty to criminal embezzlement
charges involving the same conduct.

• A physician paid the Government $203,000 to settle allegations that he violated the
physician self-referral prohibition in the Stark law for routinely referring Medicare
patients to an oxygen supply company he owned.

18
 Physician Recruitment

A hospital will sometimes provide a physician with a recruitment incentive to induce

the physician to relocate to the hospital’s geographic area, become a member of its
medical staff, and establish a practice that helps serve that community’s medical needs.
Often, such recruitment efforts are legitimately designed to fill a “clinical gap” in a
medically underserved area to which it may be difficult to attract physicians in the
absence of financial incentives. However, as you begin planning your professional
future and perhaps receiving recruitment offers, you need to be aware that in some
communities, especially ones with multiple hospitals, the competition for patients can
be fierce. Some hospitals may offer illegal inducements to you, or to the established
physician practice you join in the hospital’s community, to gain referrals. This means
that the competition for your loyalty can cross the line into illegal arrangements for
which both you and the hospital can be liable.

Recruitment arrangements are of special interest to graduating residents and fellows.

Within very specific parameters specified in the Stark law and subject to compliance
with the AKS, hospitals may provide relocation assistance and practice support under
a properly structured recruitment arrangement to assist you in
establishing a practice in the hospital’s community. Alternatively, a
hospital may pay you a fair market value salary as an employee or pay
you fair market value for specific services you render to the hospital
as an independent contractor. However, the hospital may not
offer you money, provide you free or below-market rent for
your medical office, or engage in similar activities designed
to influence your referral decisions. You should admit
your patients to the hospital best suited to care for
their particular medical conditions or to the
hospital your patient selects based on his or her
preference or insurance coverage. As noted, if a hospital
or physician practice seperately or jointly is recruiting you as a
new physician to the community, you may be offered a
recruitment package. But, you may not negotiate for benefits in
exchange for a promise—implicit or explicit—that you will
admit your patients to a specific hospital or practice setting
unless you are a hospital employee. You should seek
knowledgeable legal counsel if someone with whom you are
entering into a relationship requires you to admit patients to a
specific hospital or practice group.

19
 Tips for Medical Directors

If you choose to accept a medical directorship at a nursing home or other facility,

you must be prepared to assume substantial professional responsibility for the care
delivered at the facility.  As medical director, patients (both your own patients and the
patients of other attending physicians) and their families count on you, and State and
Federal authorities may hold you accountable as well.  To do this job well, you should:

• actively oversee clinical care in the facility;

• lead the medical staff to meet the standard of care;
• ensure proper training, education, and oversight for physicians, nurses, and other
staff members; and
• identify and address quality problems.

Case Examples of Medical Directorship Issues

• A physician group practice paid the Government
$1 million and entered into a 5-year Corporate
Integrity Agreement to settle alleged violations of
the AKS, FCA, and Stark law related to medical
directorships with a medical center.  Allegedly,
the agreements were not in writing, the physicians were
paid more than fair market value for the services they rendered, and the
payment amounts were based on the value of referrals the physicians sent to the
medical center.

• Two orthopedic surgeons paid $450,000 and $250,000 to settle allegations related
to improper medical directorships with a company that operated a diagnostic imaging
center, a rehabilitation facility, and an ambulatory surgery center.  The company
allegedly provided the physicians with valuable compensation, including free use
of the corporate jet, under the medical directorship agreements, which required the
physicians to render limited services in return. The agreements with the physicians
allegedly called for redundant services and served to encourage the physicians to
refer their patients to the facilities operated by the company.

20
 III. Physician Relationships With Vendors

Free Samples

Some physicians welcome visits from pharmaceutical salespeople, while other

physicians prefer not to directly engage with industry representatives. If you decide to
make your practice accessible to salespeople, you probably
will be offered product samples. Many drug and biologic
companies provide physicians with free samples that
the physicians may give to patients free of charge. It
is legal to give these samples to your patients
for free, but it is illegal to sell the samples.
The Government has prosecuted physicians
for billing Medicare for free samples. Opinions
differ on whether sampling practices ultimately
increase or decrease patients’ long-term drug costs. If
you choose to accept samples, you will need reliable systems in place to safely store the
samples and ensure that samples are not commingled with your commercial stock.

Case Example Involving Drug Samples

• Several urologists pled guilty to charges of conspiracy, paid restitution in the tens
of thousands of dollars, and received sanctions against their medical licenses for
billing Medicare for injectable prostate cancer
drugs they received for free from two
pharmaceutical companies. The pharmaceutical
companies paid $1.4 billion for their part of the
alleged scheme to give urologists free samples
and encourage them to bill Medicare at an inflated
price. The pharmaceutical companies also provided urologists with
additional inducements to use their drugs over the competitor’s products, including
drug rebates, education grants, volume discounts, free goods, and debt forgiveness.

21
 Relationships With the Pharmaceutical and Medical
Device Industries
Physician-industry collaboration can produce important medical advances. However,
some pharmaceutical and device companies have used sham consulting agreements
and other arrangements to buy physician loyalty to their products. Such illegal
arrangements induce physicians to prescribe or use products on the basis of that loyalty
to the company or to get more money from the company, rather than because it is the
best treatment for the patient.

As a practicing physician, you may have opportunities to work as a consultant or

promotional speaker for the drug or device industry. For every financial relationship
offered to you, evaluate the link between the services you can provide and the
compensation you will receive. Test the propriety of any proposed relationship by
asking yourself the following questions:

VV Does the company really need my particular expertise or input?

VV Does the amount of money the company is offering seem fair, appropriate, and
commercially reasonable for what it is asking me to do?
VV Is it possible the company is paying me for my loyalty so that I will prescribe its
drugs or use its devices?

A good discussion that assists in distinguishing between legitimate and

questionable industry relationships is located in the OIG’s “Compliance Program
Guidance for Pharmaceutical Manufacturers” available at
http://oig.hhs.gov/authorities/docs/03/050503FRCPGPharmac.pdf.

22
If your contribution is your time and effort or your ability to generate useful ideas and
the payment you receive is fair market value compensation for your services without
regard to referrals, then, depending on the circumstances, you may legitimately serve
as a bona fide consultant. If your contribution is your ability to prescribe a
drug or use a medical device or refer your patients for particular services
or supplies, the proposed consulting arrangement likely is one you should
avoid as it could violate fraud and abuse laws.
For example, if a drug company offers to pay you and a hundred other
“thought leaders” to attend a conference in the Bahamas without
requiring preparatory work on your part or information about
your expertise in the field (other than the fact that you are a
licensed physician), you should be suspicious that the company
is attempting to influence you to prescribe its drug.

Case Example of Kickbacks in the Device Industry

• Four orthopedic device manufacturers paid $311 million to settle kickback and
false claims allegations that the companies bribed surgeons to recommend their hip
and knee surgical implant products. The companies
allegedly would award physicians with vacations,
gifts, and annual “consulting fees” as high as
$200,000 in return for the physicians’
endorsements of their implants or use of them in
operations. Many of the individual orthopedic
surgeons at the receiving end of the kickbacks are the subject of
ongoing investigations by the Government. One orthopedic surgeon recently paid
$650,000 to resolve allegations that the surgeon accepted payments from device
manufacturers to use their hip and knee implants.

23
 Transparency in Physician-Industry Relationships

Although some physicians believe that free lunches, subsidized trips, and gifts do
not affect their medical judgment, research shows that these types of perquisites can
influence prescribing practices. Recent pharmaceutical company settlements with
the Department of Justice and OIG require “transparency” in physician-industry
relationships, whether by requiring the pharmaceutical company to provide the
Government with a list of physicians whom the company paid and/or by requiring
ongoing public disclosure by the company of physician payments. The public will
soon know what gifts and payments a physician receives from industry.
The Patient Protection and Affordable Care Act of 2010 requires drug, device, and
biologic companies to publicly report nearly all gifts or payments they make to
physicians beginning in 2013.

Academic institutions also may impose various restrictions on the interactions

their faculty members or affiliated physicians have with industry. These and other
considerations may factor into your decision about whether you want to conduct
industry-sponsored research; serve as a consultant or director for a drug, biologic,
or device company; apply for industry-sponsored educational or research grants; or
engage in other relationships with industry.

Both the pharmaceutical industry (through PhRMA) and the medical device
industry (through AdvaMed) have adopted codes of ethics for their respective
industries regarding relationships with health care professionals. Both codes are
available online.

Conflict-of-Interest Disclosures

Many of the relationships discussed in this brochure are subject to conflict-of-interest

disclosure policies. Even if the relationships are legal, you may have an obligation
to disclose their existence. Rules about disclosing and managing conflicts of interest
come from a variety of sources, including grant funders, such as States, universities,
and the National Institutes of Health, and from the Food and Drug Administration
(FDA) when data are submitted to support marketing approval for new drugs, devices,
or biologics. To “manage” your conflicts of interest, consider the conflicts policies that
affect your professional activities, candidly disclose any industry money subject to
these policies, and adhere to restrictions on your activities. If you are uncertain whether
a conflict exists, ask someone. You always can apply the “newspaper test” and ask
yourself whether you would want the arrangement to appear on the front page of your
local newspaper.

24
 Continuing Medical Education

After finishing your formal graduate medical training,

you will assume greater responsibility for your continuing
medical education (CME) to maintain State licensure,
hospital privileges, and board certification. Drug and device manufacturers sponsor
many educational opportunities for physicians. It is important to distinguish
between CME sessions that are educational in nature and sessions that
constitute marketing by a drug or device manufacturer. Industry satellite
programs that occur concurrently with a society meeting are generally promotional,
even if the primary speaker is a physician who is well known in the field. You should
be circumspect about a discussion that focuses on a particular brand drug or device, as
opposed to all the treatment alternatives for a specific condition.

For example, if speakers recommend use of a drug to treat conditions for which
there is no FDA approval or use of a drug by children when FDA has approved
only adult use, you should independently seek out the empirical data that support
these recommendations. Note that although physicians may prescribe
drugs for off-label uses, it is illegal under the Federal Food, Drug,
and Cosmetic Act for drug manufacturers to promote off-label uses
of drugs.
Advertisements and other promotional materials for drugs, biologics, and medical
devices must be truthful, not misleading, and limited to approved uses. FDA is
requesting physicians’ assistance in identifying misleading advertisements through
its Bad Ad Program. If you spot advertising violations, you should report them to
FDA by calling 877-RX-DDMAC (877-793-3622) or by emailing badad@fda.gov.

If you are invited to serve as faculty for industry-sponsored CME, ask yourself the
following questions:

VV Does the sponsor really need my particular expertise or input?

VV Does the amount of money the sponsor is offering seem fair and appropriate for
the educational value I will add to the presentation?
VV Is it possible the sponsor is paying me for my loyalty so that I will prescribe its
drugs or use its devices?
VV Does the sponsor prepare a slide deck and speaker notes, or am I free to set the
content of the lecture?

25
 Compliance Programs for Physicians

Establishing and following a compliance program will help physicians avoid fraudulent
activities and ensure that they are submitting true and accurate claims. The following
seven components provide a solid basis upon which a physician practice can create a
voluntary compliance program:

1. Conduct internal monitoring and auditing.

2. Implement compliance and practice standards.
3. Designate a compliance officer or contact.
4. Conduct appropriate training and education.
5. Respond appropriately to detected offenses and develop corrective action.
6. Develop open lines of communication with employees.
7. Enforce disciplinary standards through well-publicized guidelines.
With the passage of the Patient Protection and Affordable Care Act of 2010, physicians
who treat Medicare and Medicaid beneficiaries will be required to establish a
compliance program.

For more information on compliance programs for physicians, see OIG’s

“Compliance Program Guidance for Individual and Small Group Physician
Practices” available at http://oig.hhs.gov/authorities/docs/physician.pdf.

Where To Go for Help

When you are considering whether or not to engage in a particular billing practice;
enter into a particular business venture; or pursue an employment, consulting, or other
personal services relationship, it is prudent to evaluate the arrangement for potential
compliance problems. The following is a list of possible resources that can help you.

ЈЈ Experienced health care lawyers can analyze your issues and provide a
legal evaluation and risk analysis of the proposed venture, relationship, or
arrangement.

26
ЈЈ The Bar Association in your State may have a directory of attorneys in your area
who practice in the health care field.
ЈЈ Your State or local medical society may be a good resource for issues affecting
physicians and may have listings of health care lawyers in your area.
ЈЈ Your specialty society may have information on additional risk areas specific to
your type of practice.
ЈЈ CMS’s local contractor medical directors are a valuable source of information
on Medicare coverage policies and appropriate billing practices. The contact
information for local contractors is available at
http://www.cms.gov/MLNGenInfo/30_contactus.asp.
ЈЈ CMS’s “Medicare Physician Guide: A Resource for Residents, Practicing
Physicians, and Other Health Care Professionals” available at
http://www.cms.gov/MLNProducts/downloads/physicianguide.pdf, provides an
overview of the Medicare program and information on Medicare reimbursement
and payment policies.
ЈЈ The OIG’s Web site, available at http://oig.hhs.gov, provides substantial
fraud and abuse guidance.
ЈЈ As discussed above, OIG issues Compliance Program Guidance documents that
include compliance recommendations and discussions of fraud and abuse risk
areas. These guidance documents are available at
http://oig.hhs.gov/fraud/complianceguidance.asp.
ЈЈ OIG issues advisory opinions to parties who seek advice on the application of the
AKS, CMPL, and Exclusion Authorities. Information on how to request an OIG
advisory opinion and links to previously published OIG advisory opinions are
available at http://oig.hhs.gov/fraud/advisoryopinions.asp.
ЈЈ CMS issues advisory opinions to parties who seek advice on the Stark law.
Information on how to request a CMS advisory opinion and links to previously
published CMS advisory opinions are available at
http://www.cms.gov/PhysicianSelfReferral/95_advisory_opinions.asp.

27
 What To Do If You Think You Have a Problem

If you are engaged in a relationship you think is problematic or have been following
billing practices you now realize were wrong:

ЈЈ Immediately cease filing the problematic bills.

ЈЈ Seek knowledgeable legal counsel.
ЈЈ Determine what money you collected in error from your patients and from the
Federal health care programs and report and return overpayments.
ЈЈ Unwind the problematic investment.
ЈЈ Disentangle yourself from the suspicious relationship.
ЈЈ Consider using OIG’s or CMS’s self-disclosure protocols.

OIG Provider Self-Disclosure Protocol

The OIG Provider Self-Disclosure Protocol is a vehicle for physicians to voluntarily
disclose self-discovered evidence of potential fraud. The protocol allows providers
to work with the Government to avoid the costs and disruptions entailed in a
Government-directed investigation. For more information on the OIG Provider
Self-Disclosure Protocol, see http://oig.hhs.gov/fraud/selfdisclosure.asp.

Case Examples of Physician Liabilities Resolved Under

the OIG Provider Self-Disclosure Protocol
• A Minneapolis physician paid $53,400 and
resolved liability for violating his Medicare
assignment agreement by charging patients a
yearly fee for services, some of which were
covered by Medicare.

• A Florida physician paid $100,000 and resolved liability related to

referring patients to a lab owned by his brother.

• A neurosurgery practice paid $10,000 and resolved liability for employing an

individual who was excluded from participation in the Federal health care programs.

28
 What To Do If You Have Information About
Fraud and Abuse Against Federal Health
Care Programs

If you have information about fraud and abuse against Federal health care programs,
use the OIG Fraud Hotline to report that information to the appropriate authorities. The
Hotline allows the option of reporting anonymously.

Phone: 1-800-HHS-TIPS (1-800-447-8477)

Fax: 1-800-223-8164
Email: HHSTIPS@oig.hhs.gov
TTY: 1-800-377-4950
Mail: Office of Inspector General
Department of Health & Human Services
Attn: HOTLINE
P.O. Box 23489
Washington, DC 20026

For additional information about the Hotline, visit the OIG Web site at
http://oig.hhs.gov/fraud/hotline/.

29
This publication is available on the OIG Web site. You may reproduce, reprint,
and distribute this publication for educational purposes. You may not charge a
fee for this publication. http://oig.hhs.gov/fraud/PhysicianEducation/
 Chap t er

5
••••••••••

LEGAL AND ETHICAL ASPECTS

OF SPECIFIC PHYSICIAN–INDUSTRY
FINANCIAL RELATIONSHIPS
••••••••••••••••••

There are over 920,000 active physicians and 600,000 non-physician licensed
healthcare practitioners who are legally authorized to write prescriptions in
the United States for approximately 8000 different pharmaceutical products
in various forms, strengths and doses.1 The American Medical Association
(AMA) and other professional associations have estimated that there is one
drug company sales representative for every 4.7 physicians in the United
States2 and approximately one drug sales representative for every two U.S.
physicians who actively write prescriptions.3 When direct and independent
distributor sales representatives for device companies are added to the mix,
the ratio between sales people and physicians may be in the 1–3 range.
It is estimated that pharmaceutical companies alone spend $19 billion
annually on doctors in the form of lecture honoraria, conference registration

1
Physician Characteristics and Distribution in the United States, 2008, American Medical
Association; IMS Health, Inc. v. Ayotte, No. 06-cv-280-PB (D.N.H. April 30, 2007).
2
J.L. Rose, Physicians’ Expectations of Industry and Sales Personnel (American Medical
Association, 2002) p. 4.
3
Daren Fonda and Barbara Kiviat, Curbing the Drug Marketers, Time, July 5, 2004, p. 41.

© 2008 Steven Schachter, William Mandell, Scott Harshbarger, and Randall Grometstein
Published by Elsevier Inc. All rights reserved. 153
154 Managing Relationships with Industry

fees, research grants, trips, meals, drug samples and other gifts.4 A signifi-
cant percentage of these clinicians have considerable influence over which
prescriptions are written by their colleagues, and which medical devices
and other items are purchased for use in surgeries, procedures and other
treatments. The amount spent ($3.8 billion) on direct-to-consumer adver-
tising for roughly the same period pales by comparison.5 Drug companies
increased their total spending on promotion in the United States by 93%
from 1997 to 2002.6
Clearly, the interaction between physicians and industry sales forces has
been and will continue to be pervasive. As reviewed throughout this book, a
major paradigm shift has taken place within the realm of physician–industry
relationships. Focus and concern by the public and the U.S. federal and
state governments, as well as healthcare purchasers and public advocates,
over the legality of certain types of relationships has resulted in major gov-
ernment prosecutions and whistleblower law suits, culminating in billions of
dollars of liability for drug and device companies and significant legal and
financial risks for physicians. Virtually, all of the major pharmaceutical and
device companies have adopted compliance programs along the lines sug-
gested by the Office of the Inspector General (OIG) in its 2003 Compliance
Guidance for Pharmaceutical Companies. Companies that have settled civil
and criminal cases have significantly curtailed their prior marketing prac-
tices to physicians, such as promotion of off-label uses. Under Corporate
Integrity Agreements (CIAs) entered into with the OIG, companies have also
been required to use outside monitors to oversee their marketing activities
as part of their settlements with the federal government.
In addition to government regulatory guidance and prosecutorial push
back against industry marketing practices, the voluntary professional and
trade association codes of conduct outlined in Chapter 4 have moved the
line of legal and ethical acceptability away from gifts of substantial value to
physicians and from arrangements that have little or no educational and/or
scientific purpose.
Also, the media, particularly the New York Times, Wall Street Journal
and Boston Globe, have focused their health reporting extensively on the
influence of industry on medical treatment and product approvals. The
medical field itself is undergoing a process of self-scrutiny and criticism
about its relationship with industry, as evidenced by the recent spate of
physician-authored books, medical journal articles and blogs challenging the
ethics, legality and societal costs of the medical profession’s interactions

4
Press Release, U.S. Special Committee on Aging, June 27, 2007, Kohl Examines Drug
Industry Practice of Providing Payments to Doctors, Influencing Prescribing Behaviors.
5
Michael Blanding, Bad Medicine, Boston Magazine, February 2005, p. 57, 62.
6
Daren Fonda and Barbara Kiviat, Curbing the Drug Marketers, Time, July 5, 2004, p. 41.
 Chapter 5 / Specific Physician–Industry Financial Relationships 155

with drug and device companies. This public exposure and re-evaluation,
along with the prosecutions and lawsuits described in Chapter 3, are the
main driving forces toward the reformation of the acceptable norms of
industry-physician interactions.
Drug and device companies, academic medical centers (AMCs) and
some major physician groups and professional associations have adopted
updated compliance plans and codes of conduct to self-regulate financial
relationships between industry and physicians. These efforts have resulted
in better staff training on the acceptable parameters of these relationships.
Drug and device companies have taken major strides to establish internal
organizational procedures to provide further guidance and legal counsel on
questions and proposed relationships, and to establish internal reporting
systems to detect and address violations of codes of conduct and conflict-
of-interest policies.
In the meantime, though, federal and state governments are reacting
to public concern over drug and device company marketing to physicians
and other healthcare providers by proposing and passing laws that require
public disclosure of payments and gifts by companies to physicians and
other healthcare organizations. Further, while the norms of drug and device
marketing to the medical profession have undergone profound change in the
last decade, these marketing efforts have also become more sophisticated
and subtle. As blatantly questionable activities, such as payments to doctors
for switching patients to different prescription drug products, are on the
decline, other questionable gift-giving practices and financial relationships
continue to exist, and there is a high level of uncertainty and confusion
among physicians and medical organizations about what is acceptable and
advisable from legal and ethical perspectives.
In his update of Blues legend Sonny Boy Williamson’s song “Cross My
Heart,” Bruce Springsteen sings the following new verse that he added:

Well, you may think the world’s black and white

And you’re dirty or you’re clean
You better watch out you don’t slip
Through them spaces in between.7

This verse aptly states the dilemma faced by many physicians today who
have financial relationships with drug and device companies. The acceptable
legal and ethical lines for their interactions with industry may not be clear.
This lack of clarity is undoubtedly widespread. As confirmed by the results
of a national survey mailed to 3000 U.S. physicians and published in 2007

7
Cross My Heart, Copyright © Bruce Springsteen (ASCAP) 1992.
156 Managing Relationships with Industry

by the New England Journal of Medicine (NEJM), most doctors report

having some sort of financial relationship with a drug or device company.8
A total of 1500 U.S. physicians responded to the survey, which was con-
ducted under the direction of Eric G. Campbell, PhD, associate professor at
the Institute for Health Policy at Massachusetts General Hospital and Har-
vard Medical School.9 Ninety-four percent of the responding doctors had
some type of financial relationship with the pharmaceutical industry, and
most of these relationships involved receiving food in the workplace (83%)
or receiving drug samples (78%). Nearly one in three received reimburse-
ment for costs associated with professional meetings or CME, and more than
one-quarter received payments for consulting, giving lectures or enrolling
patients in trials. Specialists were more than twice as likely as family practi-
tioners to receive payments. Family practitioners met more frequently with
industry representatives than did other specialists, and physicians in solo,
two-person, or group practices met more frequently with industry sales
representatives than did physicians practicing in hospitals and clinics.10
In reaction to the NEJM survey, the editor-in-chief of Journal Watch
General Medicine, Dr. Allen S. Brett, noted the following:

Physicians may disagree about the extent to which relationships with indus-
try influence medical care, the benefit or harm resulting from that influ-
ence, and the overall ethical propriety of each type of relationship. But one
thing, confirmed by this study, is clear: Physician–industry relationships
are pervasive in the U.S.11

Dr. Campbell oversaw another major survey on industry financial rela-

tionships focused on U.S. AMC department chairs. This study, also published
in the Journal of the American Medical Association (JAMA) in 2007,
revealed that almost two-thirds of the responding department chairs had
some type of relationship with industry, including 27% who served as con-
sultants, 27% who served on company scientific advisory boards, 14% who

8
Eric Campbell, PhD, et al., A National Survey of Physician–Industry Relationships. NEJM,
Vol. 356, April 26, 2007, p. 1742. The authors conducted a national survey of 3167 physicians in
six specialties (anesthesiology, cardiology, family practice, general surgery, internal medicine
and pediatrics) in late 2003 and early 2004 with a weighted response rate of 58%.
9
Id.
10
Id.
11
Allan S. Brett, MD, Relationships Between Physicians and Industry—A Survey. Journal
Watch General Medicine, April 25, 2007 available at http://general-medicine.jwatch.org/
cgi/content/full/2007/425/1.
 Chapter 5 / Specific Physician–Industry Financial Relationships 157

were paid speakers, 7% who were company officers, 9% who were founders
of companies and 11% who served on a company board of directors.12
This survey also found that two-thirds of AMC departments had rela-
tionships with industry. Clinical departments were substantially more likely
than non-clinical departments to receive research equipment, unrestricted
funds, residency or fellowship training financial assistance and CME sup-
port, while non-clinical departments were more likely to receive funding
from intellectual property licensing.
Similar to the findings from Dr. Campbell’s previous general study of
physician–industry relationships, more than two-thirds of the respondents
believed that having a relationship with industry had no effect on their
professional activities. However, 72% said there is a negative impact on
a department’s ability to conduct independent unbiased research when a
department chair has more than one industry-related activity.13
Advocates for reform within medicine have proposed more stringent
ethical standards beyond the mere limits of legality in order to preserve the
independence and integrity of the profession itself against encroachment
by commercial interests. These voices challenge the profession to further
push the lines back beyond those espoused in the voluntary trade codes
and the 2003 OIG Guidance to a more absolute and restrictive position,
including bans on all gifts and complete barriers between corporate sponsors
for educational and research activities and recipient physicians.
Physicians who understand the importance of medicine’s relationships
with industry but want to be sure to respect and uphold the integrity and
independence of their own clinical, educational and scientific judgment
and activities, and those of their specialty societies, therefore need greater
clarity on how to approach actual situations in which they may interact with
drug and device companies. Indeed, the current state of affairs on physician
relationships with industry is anything but clear for physicians and their
professional organizations, medical practices and facilities.
In this chapter, we give very focused, concrete and practical guidance to
physicians and medical organizations broken down by each type of industry–
medicine interaction. Where necessary, we repeat elements of relevant laws
and trade association codes of conduct that pertain to the discussion.
The guidance set forth in this chapter is not intended to supplant spe-
cific legal advice that may be appropriate in any given situation. No physician
or medical organization should venture into uncertain types of relationships

12
Eric G. Campbell, PhD, et al., Institutional Academic–Industry Relationships. JAMA, Vol.
298, 2007, pp. 1779–86. (The survey, conducted in 2006, was sent to 688 department chairs
of 125 accredited allopathic medical schools and 15 of the largest U.S. independent teaching
hospitals, and a total of 459 completed the survey yielding an overall response rate of 67%.)
13
Id.
158 Managing Relationships with Industry

without getting their own legal advice from a competent and knowledgeable
healthcare attorney. As discussed in Chapter 6, effective management of
industry relationships should include a vibrant compliance program, with
established organizational policies on industry relationships, as well as legal
review of specific proposed relationships that are in an uncertain legal or
ethical zone.
 No physician or medical organization should venture into uncertain types
 of relationships without getting their own legal advice from a competent
 and knowledgeable healthcare attorney.

Beyond the general legal standards, this chapter also identifies a stan-
dard conflict-of-interest approach in each case for physicians and their
organizations that is realistic and workable. While directed to physicians and
their professional groups and societies, these suggestions also have applica-
tion to and can be instructive for non-physician practitioners who have pre-
scribing authority, as well as executives and compliance staff at community
hospitals, AMCs and other facilities that have interactions between their
staff physicians and industry.
As a threshold summation of prior legal sources, for all relationships
between industry and physicians or medical facilities, the arrangement
should not have the “potential to interfere with, or skew, clinical decision-
making”14 nor can any remuneration included in the relationship have as
even one of its purposes the inducement of physicians to order or prescribe
in any fashion.

GIFTS, MEALS AND VISITS BY COMPANY

SALES REPRESENTATIVES
Walk around the hallways, common areas and waiting rooms of most medical
office or hospital departments during the work week in the United States and
you are still likely to see sales representatives of drug or device companies’
attempting to secure some direct face time with physicians to discuss their
companies products, including their latest brand-name drugs or devices. As
trained sales professionals, their goal is to increase sales of their companies
products, and one of the best ways to accomplish this goal is through
building long-term relationships with prescribers and others in positions to
influence sales.

14
OIG Compliance Program Guidance for Pharmaceutical Manufacturers, 68 Fed. Reg. at
23,743 (May 5, 2003).
 Chapter 5 / Specific Physician–Industry Financial Relationships 159

Some studies have questioned the value of in-person meetings with drug
or device sales representatives. A study published in 1995 in JAMA concluded
that 11% of the in-person statements made to physicians by pharmaceuti-
cal sales representatives contradicted information that was readily available
to them.15 Sales representatives and independent distributors are generally
working on a commission basis and many have come from sales positions in
other fields, and there is a tendency for their message to be an extension of
company promotion. On the other hand, representatives of drug and device
companies are often an important source of valid information about their com-
panies’ products for physicians in independent practices, particularly those
isolated from AMCs.16 A spokesperson for the Pharmaceutical Research and
Manufacturers of America (PhRMA) points out that many sales represen-
tatives are nurses or pharmacists by background and thus are well-trained
technically to talk to doctors “about when to use medicines properly.”17
Medical offices and departments handle their interactions with com-
pany sales representatives in a variety of ways. Some allow easy access.
Others are becoming increasingly reluctant to allow meeting time during
their day with sales representatives, especially without an appointment, if
at all. Meanwhile, reacting to the decreasing amount of direct face time
with physicians, pharmaceutical and device companies and their consul-
tants are devising alternative marketing techniques to reach and influence
physicians, such as direct mail, online strategies (including eDetailing) and
using “experiential marketing”—a novel marketing approach that diverges
from traditional marketing focused on selling based on a product’s features
and benefits to one that strives to link the customer emotionally to a brand,
thereby creating brand loyalty.
Many companies have national and regional medical science liaison
staffs that operate outside of their sales departments. Often a medical sci-
ence liaison (MSL) is called upon to be the source of information on the
clinical aspects of a drug or device product, to interact with a physician
who will be a presenter at an educational program funded by that liaison’s
company, or to answer questions and disseminate requested safety and effi-
cacy information about the off-label uses of his or her company’s products.
MSLs are frequently licensed professionals with advanced scientific train-
ing and degrees in life sciences. Jane Chin, PhD, founder and president of
the Medical Science Liaison Institute, which advocates for ethical practices

15
Michael G. Ziegler, Pauline Lew and Brian C. Singer, The Accuracy of Drug Information
from Pharmaceutical Sales Representatives. JAMA, Vol. 273, 1995, pp. 1296–8.
16
See blog www.kevinmd.com in which blogger and internist, Kevin Pho, MD, of Nashua,
NH, has made the case that rural practices would not have access to data and free drug samples
without visits by drug representatives.
17
Michael Blanding, Bad Medicine, Boston Magazine, February 2005, p. 57, 64.
160 Managing Relationships with Industry

and scientific independence for MSLs within their companies, describes

MSLs as “catalysts of collaboration between pharmaceutical companies and
thought leaders” and says they are “essential conduits to the quality and suc-
cess of transmission of timely information, research resources, and business
intelligence.”18
At the same time, some drug and device companies have made no secret
of the fact that their goal is to develop a single unified corporate strategy
where the medical affairs functions will serve the overall marketing and sales
goals. MSLs, in particular, are charged with the recruitment and management
of academic physicians referred to as “key opinion leaders” or “KOLs”. The
companies expect their MSLs to cultivate and develop long-term relation-
ships with these academic physician leaders and position them to influence
other physicians in their medical specialty. KOLs are regularly contracted
as speakers and to serve on company scientific advisory boards. MSLs also
seek to commission, sponsor or support academic physicians in publishing
journal articles, and in conducting Phase IV clinical trials (sponsored post-
market research of drug or devices to test for safety, adverse interactions,
change in dosages and expanded uses to further determine the product’s
risks, benefits and optimal uses) and investigator-initiated studies (research
studies where the physician acts as both sponsor and investigator).
The byword of marketing excellence in the pharmaceutical industry is
“physician influence mapping”—the process of using information technol-
ogy and social networking to identify the best KOLs to maximize company
marketing efforts. Academic physicians who are possibly approached by
representatives of drug or device companies because they are a KOL must
therefore be fully aware that their involvement in what may appear to be
purely clinical, educational or research functions may really be part of the
company’s underlying marketing and sales endeavors.
Overall, there is nothing inherently illegal about a company marketing
and selling products through its medical and scientific outreach functions.
Companies have more recently focused greater resources and attention on
having their medical affairs staff liaison with KOLs, and other physicians,
in compliance with legal and ethical standards. But there continues to be
uncertainty in many respects as to where marketing initiatives and commer-
cial considerations cross legal and ethical lines of acceptability, particularly
in the areas of off-label information, education, research and grant making
to academic departments and professional societies. In fact, the OIG has
identified the strategy of MSLs presenting themselves as scientific experts

18
Jane Chin, PhD, Medical Science Liaisons: An Overview, 2000, available at http://
www.mslinstitute.com/article_MSL_an_overview.php.
 Chapter 5 / Specific Physician–Industry Financial Relationships 161

in a particular disease to promote off-label uses as an abusive practice it

will potentially prosecute as a violation of the anti-kickback statute.19
Brennan et al. recommended a ban on all gifts and free samples starting
at AMCs, other than vouchers for low-income patients, as well as a ban on
AMC physicians serving on company speakers bureaus.20 There are valid
reasons to view AMCs differently than other practice settings and medical
organizations in relation to managing relationships with industry. Drug and
device company representatives have focused a significant amount of their
marketing efforts on medical students, as well as residents and fellows, who
are found at AMCs. One research study determined that the majority of
third-year medical students had experienced more than three personal con-
versations with a pharmaceutical company sales representative about a drug
product since starting medical school.21 A company sales representative
can bond easily with medical students and residents, who are over-worked,
underpaid and often under-appreciated, by simply showing them the kind-
ness of delivering a pizza to their department conference room while telling
them about his or her company’s latest products. Drug and device company
representatives have also been known to offer free stethoscopes, textbooks
and tickets to sports and concert events to medical students, residents
and fellows, and have funded Grand Rounds and provided scholarships for
trainees to attend national conferences.
In a recent survey of physicians, only 46% of the respondents felt that
it would be improper for a medical student to accept gifts from a company
sales representative while more than 60% of the same responding physicians
felt it would be inappropriate for a politician to accept a gift.22 Other studies
of the attitudes among medical students toward drug company marketing
efforts tend to show that students form an opinion early on that drug
and device company free gifts and sponsored educational activities are to
be expected and are ethically acceptable.23 Consequently, Brennan et al.

19
Testimony of Lewis Morris, Chief Counsel to the Inspector General, Allegations of Waste,
Fraud and Abuse in Pharmaceutical Pricing: Financial Impacts on Federal Health Pro-
grams and the Federal Taxpayer, House Committee on Oversight and Government Reform
Hearing, February 9, 2007, p. 6.
20
Troyen Brennan, MD, MPH, et al., Health Industry Practices That Create Conflicts of
Interest. JAMA, Vol. 295, No. 4, 2006.
21
James L. Wofford and Christopher A. Ohl, Teaching Appropriate Interactions with Phar-
maceutical Company Representatives: The Impact of an Innovative Workshop on Student
Attitudes. BMC Medical Education, Vol. 5, No. 5, 2005 available at http://www.biomedcentral.
com/1472-6920/5/5.
22
P. Palmisano and J. Edelstein, Teaching Drug Promotion Abuses to Health Profession
Students. Journal of Medical Education, Vol. 55, 1980, pp. 453–55.
23
F. Sierles, et al., Medical Students’ Exposure to and Attitudes About Drug Company
Interactions. JAMA, Vol. 294, No. 9, 2005, pp. 1034–42.
162 Managing Relationships with Industry

purposely focused on the AMC setting as the place to commence reform

to the financial relationships between industry and medicine. The authors
stated that “(r)esearch reveals that the habits learned or acquired during
training persist into practice. Objectivity and scientific integrity should be
central tenets of physician training.”24
Since Brennan et al.’s article was published, many AMCs have adopted
bans or limitations on drug company sales representatives’ gift giving or
on-campus meals and require sales representatives to make appointments
in advance if they want to talk to physicians. Some large medical practices
have also followed suit.25
The actions of the University of Massachusetts, University of
Pennsylvania,26 Yale University and Stanford University were discussed
previously. The Stanford Industry Interactions Policy,27 which became
effective on October 1, 2006, governs interactions between its academic
and clinical physicians and the pharmaceutical, biotech, medical device,
and hospital and research equipment and supplies industries. In 2007, the
University of California at Davis Health System banned all gifts of any
value from drug and device companies and their sales representatives. The
Henry Ford Health Center in Detroit banned free lunches and gifts effective
January 1, 2007 and now requires sale representatives to schedule appoint-
ments in advance. As previously discussed in Chapter 4, other AMCs are
following suit.28
The main intent of these new AMC conflict-of-interest policies is to
limit the influence of drug and device company sales efforts on clinical
decision-making. But there are broader goals as well.
Immediately following the adoption of the Stanford Industry Interactions
Policy, Clarence Braddock, MD, MPH, an associate professor at Stanford
and a member of the Stanford Center for Biomedical Ethics, told American
Medical News that “[t]here’s a growing awareness that pharmaceutical pro-
motions subtly, and not so subtly, impact physicians’ decisions…[e]ven if
[you believe] there’s not a real impact, the public perception of us cozying
up with industry was not something we felt comfortable with.”29 A further

24
Troyen Brennan, MD, MPH, et al., Health Industry Practices That Create Conflicts of
Interest. JAMA, Vol. 295, No. 4, January 25, 2006, p. 430.
25
See Stephanie Saul, Drug Makers Pay for Lunch as They Pitch, The New York Times, July
28, 2006.
26
See Myrle Croasdale, Some Medical Schools Say No to Drug Reps’ Free Lunch, AMNews,
October 9, 2006.
27
See http://med.stanford.edu/coi/siip/.
28
E.G. Campbell, Doctors and Drug Companies—Scrutinizing Influential Relationships.
NEJM, Vol. 357, 2007, pp. 1796–7.
29
Myrle Croasdale, Some Medical Schools Say No to Drug Reps’ Free Lunch, AMNews
staff. October 9, 2006.
 Chapter 5 / Specific Physician–Industry Financial Relationships 163

reason for an AMC to adopt a ban like Stanford’s comes from studies demon-
strating that physicians form their attitudes and develop their ethical stan-
dards about industry marketing during medical school and residency, while
they spend excessive amounts of time in AMC settings.30
These are exactly the goals that Brennan et al. had in mind: to improve
the public perception and thus confidence in the independence of its physi-
cians and to positively influence those now training to be physicians and to
set an example for physicians practicing outside the academic setting.31 Yet
it is interesting to note that there is variance among current AMC policies.
Despite the growing number of AMCs adopting some or all of Brennan
et al.’s recommendations (JAMA 2006;295:429–33), the majority of med-
ical practices, particularly office/outpatient based groups, continue to
engage with sales representatives. And while industry sales representatives
acknowledge that their member companies’ practices of lavish gift giving
have been significantly curtailed, others reveal that doctors continue to
receive gifts, watches, leather jackets and golfing trips despite extensive
compliance efforts of the drug and device industry.32 Even in the face of
OIG’s regulatory guidance and heightened concerns of prosecution or civil
liability, physicians continue to be offered, and continue to request and
receive, free items of value from sales representatives.33
An increasingly common practice used by sales representatives to stay
within the limits on gift giving suggested by the AMA, PhRMA Code and
OIG Guidance is to give doctors and their staffs free meals. Morning cof-
fee, gourmet sandwiches for lunch, pizza dinners and other sundries are
frequently delivered to medical offices and hospital staff conference rooms,
ostensibly to curry favor with physicians and their staffs. By doing so, sales
representatives hope that the recipients will be more receptive to listening
to a presentation about their company’s products. These practices, when
offered on more than an occasional basis in conjunction with a bona fide
educational or scientifically valuable program, are questionable, and as we
conclude below, could form the basis for a legal action against both the
offering company and the receiving medical organization.

30
F. Sierles, et al., Medical Students’ Exposure to and Attitudes About Drug Company
Interactions. JAMA, Vol. 294, No. 9, 2005, pp. 1034–42; B.B. McCormick, G. Tomlinson, P. Brill-
Edwards and A.S. Detsky, Effect of Restricting Contact Between Pharmaceutical Company
Representatives and Internal Medicine Residents on Post-Training Attitudes and Behavior.
JAMA, Vol. 286, 2001, pp. 1994–9.
31
Troyen Brennan, MD, MPH, et al., Health Industry Practices That Create Conflicts of
Interest. JAMA, Vol. 295, No. 429, 2006, p. 430.
32
Julie Appleby, States Want Info About Drugmakers’ Gifts to Doctors, USA Today,
February 16, 2006.
33
See Gardiner Harris, Senators to Push for Registry of Drug Makers’ Gifts to Doctors,
The New York Times, June 28, 2007.
164 Managing Relationships with Industry

Similarly, the giving of pens, pads, coffee mugs and other usable items
labeled with the name of a company’s latest product also continues to be
common during office visits by sales representatives and in the exhibition
hall at virtually all national conferences of professional medical societies.
Going one step further, many innovative companies are attuned to the
lifestyles of today’s doctors and offer other complimentary items, such as
yoga mats and running gear, bearing the logo of the latest product name for
physicians who hold a visit in their office with the sales rep, or come by the
company’s booth at the national meeting.

The law on gifts to physicians

The offering or giving, or soliciting or receiving, of a gift with the intent to
induce or reward referrals or ordering of items by a physician potentially vio-
lates the federal and most state anti-kickback laws. In the 2003 Compliance
Guidance for Pharmaceutical Manufacturers, the OIG recommended that
manufacturers consider whether gifts given to physicians by their represen-
tatives constitute “a valuable tangible benefit.”34
When reviewed together, the OIG Guidance, the history of federal anti-
kickback enforcement and agency interpretation, as well as the AMA’s
Council on Ethical and Judicial Affairs ethical opinion on Gifts to Physi-
cians from Industry and the PhRMA and AdvaMed Codes, can be read to
suggest that physicians cannot legally accept gifts of cash or cash equiv-
alents, such as frequent flyer miles, and cannot solicit any type of gift.
Additionally, these sources indicate that it would be illegal for a physician
to accept any type of gift of any value if it was offered as an inducement
to prescribe or order a certain product. Finally, any gift that constitutes a
valuable tangible benefit to the receiving physician, including travel, meals,
recreation, entertainment and other items of pleasure, does not pass muster
legally.35
Comparatively, unsolicited gifts of nominal value that are related to
the physician’s professional activities have not been deemed to be illegal.
The acceptance of nominal items of value that have some relationship to
a physician’s work, such as pens, pads or medical textbooks, is unlikely to
create any legal risk for the physician.
Some physicians may not find personal relevance with these legal con-
clusions because, for example, they have been asking for and securing event

34
OIG Compliance Program Guidance for Pharmaceutical Manufacturers, 68 Fed. Reg. at
23 745 (May 5, 2003).
35
Reasonable accommodations for travel and meals provided for physicians rendering legit-
imate and contracted services are permitted and are covered later in this chapter.
 Chapter 5 / Specific Physician–Industry Financial Relationships 165

tickets or complimentary dinners at nice restaurants for years from their

sales representatives without repercussion. A lack of detection, however,
should not be confused with a lack of potential interest by prosecutors,
investigators and private whistleblowers, and a pattern of repeated instances
of potentially violating the anti-kickback law makes detection more likely.
As outlined in Chapter 3, the interest of government enforcers and private
litigants has grown exponentially beginning with the first wave of major
cases against pharmaceutical company marketing practices.
In addressing courtesies and gratuities offered by drug and device
companies, the OIG stated in its Compliance Guidance for Pharmaceutical
Companies that “compliance with the PhRMA Code with respect to these
arrangements should substantially reduce a manufacturer’s risk.”36 Thus,
reference to the PhRMA Code is instructive but not binding on the govern-
ment’s view of the legally permissible lines for drug company gifts.
The PhRMA Code basically follows the AMA ethical rules on gifts and
allows the giving of limited types of gifts to physicians and other healthcare
professionals. It does explicitly permit the giving of items that primarily
benefit patients valued at $100 or less per company per year offered on an
occasional basis. Examples of such acceptable gifts cited by the PhRMA Code
include anatomical models for use in an examination room and stethoscopes.
By comparison, a media disc player would not be acceptable because its
personal benefit to the physician would outweigh its benefit to patients.
The PhRMA Code also permits gifts of minimal value primarily related
to professional practice (e.g., pens, pads, “reminder” items) and they may
have company or product logos. However, gifts that do not primarily benefit
patients and are not primarily related to professional activity, such as golf
balls, sports bags, floral arrangements, artwork, music CDs, gift certificates,
frequent flyer miles or tickets to an event, are not permitted.
Such gifts that provide patient benefit or are sufficiently related to
clinical practice, even if appropriate, may only be accepted on an occasional
basis. An accumulation of such largesse could thus pose risk to the physician
or medical practice.
In 2007, the International Federation of Pharmaceutical Manufacturers
and Associations (IFPMA) issued its revised Code of Pharmaceutical Mar-
keting Practice, announcing that the Code contained changes in its policy
so that its members would no longer provide expensive gifts to physicians.
The revised IFPMA Code is substantially similar to the PhRMA Code on
company gift giving and gratuities. IFPMA does permit its members to give
inexpensive gifts or gifts with medical utility or that are related to pre-
scription drugs, such as pens, stethoscopes or medical textbooks, provided

36
Id. pp. 23 738.
166 Managing Relationships with Industry

that they are of modest value and are beneficial to the provision of medical
services and for patient care. The IFPMA Code also prohibits holding med-
ical and scientific meetings at “renowned or extravagant venues” and limits
having them outside the attendees’ home country unless it is appropriate
and justified to do so logistically, such as international scientific congresses
and symposia that include participants from many countries, or for security
reasons. Also, entertainment and hospitality provided at sponsored events
cannot be in excess of the level for which physicians would personally
pay. The IFPMA membership includes the largest pharmaceutical compa-
nies such as Pfizer, Eli Lilly, Novartis, Merck and AstraZeneca, as well as
national trade associations, including PhRMA.
Under both the PhRMA and IFPMA Codes, the provision of free drug
samples for patient use in accordance with the Prescription Drug Market-
ing Act (PDMA) is also deemed to come within this acceptable gift-giving
category and is covered more extensively later in this chapter.
On the device side, the AdvaMed Code similarly admonishes its mem-
bers to adhere to the anti-kickback statute and all other applicable laws in
the realm of gifts and all other physician–industry relationships. Therefore,
its focus is on both the value of gifts and services and the parties’ intent.
Specifically, the scope of permissible gift giving is virtually the same as
the PhRMA and IFPMA Codes. Also, the AdvaMed Code permits modest
occasional meals and other hospitalities conducive to the exchange of infor-
mation that is necessary to discuss product features, contract negotiations
or sales terms. Such meals and hospitalities, however, are permitted for only
those physicians who need to attend the meeting with device company sales
representatives on these topics.
Physicians must keep in mind that the federal and most state anti-
kickback laws prohibit not only the offering and paying of such inducements
but also the solicitation or receipt of the gift by the physician as well. Thus,
physicians who simply call their local drug company sales representative
and ask for a couple of concert tickets, or for a free lunch for their entire
office staffs, or a complimentary meal at a restaurant, have essentially com-
mitted an act that potentially could be the subject of a criminal prosecution,
agency enforcement action and government program exclusion, as well as
a whistleblower private lawsuit, even if the request was not granted.
 Physicians must keep in mind that the federal and most state anti-kickback
 laws prohibit not only the offering and paying of such inducements but also
 the solicitation or receipt of the gift by the physician as well. Ultimately,
 the asking for or receipt of any gift, however small, potentially implicates
 federal and state anti-kickback statutes, if any one purpose of the gift is to
 generate business for the offering company.
 Chapter 5 / Specific Physician–Industry Financial Relationships 167

Ultimately, the asking for or receipt of any gift, however small, poten-
tially implicates federal and state anti-kickback statutes, if any one purpose
of the gift is to generate business for the offering company, a purpose that
may not necessarily be obvious to the gift recipient. Where such a purpose
exists, compliance with the PhRMA, IFPMA or AdvaMed Code guidelines
will not serve as a safe harbor from possible enforcement action, civil suit or
prosecution. The OIG clearly states that “under the [federal] anti-kickback
statute, neither a legitimate purpose for an arrangement (e.g., physician
education), nor a fair market value payment, will necessarily protect remu-
neration if there is also an illegal purpose (i.e., the purposeful inducement
of business).”37 Thus, while the risks of legal action as a result of the request
or acceptance of nominal items or items that provide patient benefit are
remote, the only sure-fire way to eliminate the legal risk is to adopt a policy
banning the receipt of any and all gifts.

Manufacturer’s support

Another issue under gifts and free items is whether physicians and providers
can accept assistance or support for free that is provided as part of the
sale of an item by the manufacturer. For example, can a drug manufacturer
offer assistance to a medical practice with third party payer reimbursement,
including patient pre-qualifications and credit for payment denials? Such a
reimbursement assistance program was reviewed by the OIG in Advisory
Opinion No. 00-10.38 The OIG stated that where such added services have
no “independent value” to providers apart from the products, that is, they
are properly considered part of the products purchased and their cost is
already included in the products’ prices, the added services would not
implicate the federal anti-kickback statute. An example of this would be a
drug manufacturer’s offer of free assistance to a medical practice by serving
as a clearinghouse for information regarding insurance coverage criteria and
reimbursement levels for its products.
By comparison, if the manufacturer offers services or programs that
do confer an independent financial benefit to referring providers, then the
arrangement would violate the anti-kickback law. The OIG cites as an exam-
ple of such independent benefit the coupling of a reimbursement support ser-
vice with a program either (1) requiring payment for ordered products only if
the referring provider is paid or (2) guaranteeing a minimum “spread” between

37
Id.
38
OIG Advisory Opinion No. 00-10 (December 15, 2000) available at http://oig.hhs.gov/fraud/
advisoryopinions/opinions0097.html.
168 Managing Relationships with Industry

the purchase price and third party reimbursement levels. These types of pro-
grams may implicate the anti-kickback statute if they eliminate the normal
financial risks facing providers, potentially raising the risk of over-utilization
and increased federal healthcare program costs. For example, in the case
presented in Advisory Opinion 00-10, the OIG concluded that while the com-
pany’s offering of extended payment terms and credits did confer indepen-
dent value to the referring physicians, implicating the anti-kickback statute,
OIG would not impose sanctions because the program was limited in scope,
the drug company agreed to provide assistance to low-income patients and
in the opinion of the OIG it would not result in over-utilization.39
Device companies commonly provide their customers with technical
assistance on the use of purchased devices. The AdvaMed Code states that
technical instruction and reimbursement support to aid in the proper use
and billing of purchase devices are permissible unless they are offered by
the device company for the purpose of unlawfully inducing the purchase of
its products.40
Therefore, physicians being offered free technical instruction and reim-
bursement support from drug and device companies must steer clear of
any offers simply intended to induce the ordering of the product. However,
where the instruction or support has no real independent value separate
and apart from the acquired products, there should be little or no risk of
liability. Hopefully, the OIG will provide more guidance in the future on
the definition of “independent value,” but for now, providers may consider
programs that have such value if they are limited, include free products
or services for under- and uninsured patients, and have safeguards against
over- or unnecessary utilization.

Applicable state laws

Acceptance of meals and gifts by physicians is just one of the many finan-
cial relationships between doctors and industry for which Congress and
many state legislatures have a growing interest and concern. As discussed
in Chapter 4, some states have passed laws requiring public disclosure by
drug companies of gifts and financial relationships with physicians.41 These

39
Id.
40
AdvaMed Code of Ethics on Interactions with Healthcare Professionals, p. 5, available at
http://www.advamed.org/MemberPortal/About/code/default.htm.
41
Gardiner Harris, Senators Seek Public Listing of Payments to Doctors, The New York
Times, September 7, 2007. As of the date of publication, Maine, Minnesota, Nevada, Vermont,
West Virginia and Washington, DC have passed laws on drug companies’ disclosure of gifts
and relationships and other states are considering similar measures. The Minnesota disclosure
 Chapter 5 / Specific Physician–Industry Financial Relationships 169

state laws generally require reporting and public disclosure of physician gifts
and other forms of consideration from drug companies, such as consulting
fees, but the language varies from state to state. Some states are proposing
statutes that would only require reporting of gifts and fees actually received
by physicians, hospitals, pharmacists, nursing homes and other providers,
while others would more broadly require reporting of any gift, fee, payment,
subsidy, or other economic benefit provided in connection with detailing or
promotional activities, which arguably would require reporting and public
disclosure of company grants to professional societies and academic depart-
ments, as well as gifts made to a charity at the request of or on behalf of a
physician.42
On the other hand, Vermont has passed, and other states are consid-
ering, a reporting law that does not require disclosure of the names of
individual recipients. Further, many of these marketing reporting laws would
categorically exempt several areas, such as free drug samples, fair market
value payments for clinical research and scholarships for medical students.
There are, however, a growing number of states that are considering the
passage of laws establishing mandatory public disclosure of commercial
sponsors of clinical trials.
California has enacted a law that requires drug companies to adopt
a compliance program governing their marketing practices, including the
giving of gifts, and other interactions with healthcare professionals. The
Drug Marketing Practices Law43 mandates that the drug company compli-
ance program conforms to the OIG Compliance Guidance for Pharmaceu-
tical Companies and the PhRMA Code, including a specific annual dollar
limit on gifts or other donated promotional items, other than free sam-
ples, CME grants and scholarships, and consulting agreement fees that
meet the requirements of the anti-kickback law. The law requires that
pharmaceutical companies post these mandated compliance plans on their
websites.
As this book went to press, there was pending federal legislation entitled
The Physician Payments Sunshine Act, which would create a national
registry of gifts and payments to doctors by medical device as well as drug

system has revealed that between 1997 and 2005, drug companies paid more than 5,500 doctors,
nurses and other healthcare workers in Minnesota at least $57 million. Another $40 million
went to clinics, research centers and other organizations. More than 20% of the state’s licensed
physicians received payment from drug companies, with the median payment per professional
at $1,000 and more than 100 professionals received more than $100,000. See Gardiner Harris
and Janet Roberts, Doctors’ Ties to Drug Makers Are Put on Close View, The New York Times,
March 21, 2007.
42
See generally The National Conference of State Legislatures 2007 Prescription Drug State
Legislation Website, available at http://www.ncsl.org/programs/health/drugbill07.htm.
43
California Health and Safety Code §§119,400 et seq.
170 Managing Relationships with Industry

companies.44 The bill, spearheaded by Senators Charles Grassley and Herb

Kohl,45 is broader than existing state disclosure laws and would cover a much
broader range of gifts, contracts and educational grants, including those
provided through universities and medical education and communication
companies (MECCs). It would not require disclosure of the giving of free
samples or research grants for clinical trials. The reported relationships
would be posted on a website. Senator Grassley identified the purpose of
the legislation as follows:

Right now the public has no way to know whether a doctor’s been given
money that might affect prescribing habits. This bill is about letting the sun
shine in so that the public can know. Whether it’s dinner at a restaurant or
tens of thousands of dollars or more in fees and travel, patients shouldn’t
be in the dark about whether their doctors are getting money from drug
and device makers.46

Likewise, on June 27, 2007, the U.S. Senate Special Committee on

Aging held a hearing to examine the pharmaceutical industry’s practice of
providing payments and gifts to doctors and to consider how these practices
are influencing physicians. Senator Kohl, serving as the chairperson of the
committee, said the following in his opening statement:

While there are voluntary guidelines already in place, it is clear they are
not being followed. I intend to vigorously pursue stronger adherence to
these guidelines, as well as propose a national registry to require disclosure
of payments and gifts. We need transparency, at the minimum and at the
outset. Many of these gifts are not illegal, but we need them disclosed.

44
Id.; Gardiner Harris, Senators to Push for Registry of Drug Makers’ Gifts to Doctors,
The New York Times, June 28, 2007.
45
The Physician Payments Sunshine Act is also co-sponsored by Senators Claire McCaskill,
Chuck Schumer, Amy Klobuchar and Ted Kennedy. It would apply to manufacturers with $100
million or more in annual gross revenues. The Act would require drug and device manufacturers
to disclose to the Secretary of Health and Human Services, on a quarterly basis, anything of
value given to doctors, such as payments, gifts, honoraria or travel. The reporting companies
would have to report the name of the physician, the value of the nature and remuneration and
the date of the payment or gift, its purpose, and what, if anything, was received in exchange.
Penalties for not reporting would range from $10,000 to $100,000 per violation. The legislation
requires the Secretary of Health and Human Services to create a website and post-payment
information in a clear and understandable manner.
46
U.S. Senate Press Release, September 6, 2007, Grassley, Kohl Say Public Should
Know When Pharmaceutical Makers Give Money to Doctors, available at http://www.finance.
senate.gov/press/Gpress/2007/prg090607a.pdf.
 Chapter 5 / Specific Physician–Industry Financial Relationships 171

These interactions involving things of value between the pharmaceutical

industry and doctors must be made public.47

At least one drug manufacturer is disclosing on its website certain grants

it has made, and others may follow suit.48
Therefore, before accepting any item from, or engaging in any relation-
ship with, a drug or device company, or their agents, all physicians, medical
organizations and facilities should consider the possibility that all of their
gifts from, and financial relationships with, drug and device companies will
ultimately become a matter of public record. Thus, whether doctors adhere
to absolute legality and the highest ethical standards in their relationships
with industry will be evidenced, in part, by public disclosures.
 Before accepting any item from, or engaging in any relationship with, a
 drug or device company, or their agents, all physicians, medical organi-
 zations and facilities should consider the possibility that all of their gifts
 from, and financial relationships with, drug and device companies will
 ultimately become a matter of public record. Thus, whether doctors adhere
 to absolute legality and the highest ethical standards in their relationships
 with industry will be evidenced, in part, by public disclosures.

The ethics of gifts to physicians

As discussed above and in Chapter 4, there is a divergence in the views
on the ethics of gifts between the professional and trade associations for
medicine and industry, and the national voices of reform, such as Brennan
et al. (JAMA 2006;295:429–33), who advocate that AMCs set an example for
the entire medical profession on conflicts of interest with industry financial
relationships and interactions. They propose a prohibition of all gifts of even
nominal value, including free meals and token gifts, cautioning that social
science and psychological research dispels the assumption that small gifts
do not influence physician behavior49 and concluding that the OIG Guid-
ance and self-regulatory codes and guidelines by professional and industry
groups are “not sufficiently stringent and do not adequately uphold a profes-
sional commitment to patient welfare and research integrity.”50 The authors

47
U.S. Special Committee on Aging, Press Release, June 27 2007, Kohl Examines Drug
Industry Practice of Providing Payments to Doctors, Influencing Prescribing Behaviors.
48
See Section on Grants, later in this Chapter.
49
See pp. 132–139.
50
Troyen Brennan, MD, MPH, et al., Health Industry Practices That Create Conflicts of
Interest. JAMA, Vol. 295, No. 429, 2006, p. 429.
172 Managing Relationships with Industry

postulate that even small gifts such as pens and writing pads, as well as
meals, have a substantial influence on a physician’s prescribing and order-
ing,51 a view bolstered by others studying the interactions between industry
and medicine.52
Meanwhile, the AMA and most medical specialty societies, as well as
PhRMA and AdvaMed, continue to permit certain gift-giving practices. The
AMA, however, in clarifying this ethical opinion through a question and
answer addendum in 2000, has clearly stated that the acceptance of gifts
that are related to a physician’s work are unethical if they have substantial
value, such as handheld devices or other electronic equipment.53
Ethically the question each physician must answer for himself or herself
is whether the acceptance of even a nominal gift that could benefit patients
or is related to their practice of medicine could subconsciously influence
their clinical judgment. It is, of course, difficult to become consciously
aware of a subconscious influence. Physicians may realize the extent of
the subconscious influence only if they completely forego gifts or other
financial considerations from drug and device companies for an extended
period and reevaluate their prescribing habits and their opinions regarding
the treatments sold by companies they had previously received gifts from, as
expressed in their educational presentations or publications. Additionally,
each physician must ask himself or herself whether the acceptance of such
a gift, if known to the patient, would potentially appear to the patient as a
conflict of interest or improper. What about the perception of the patient
who sits next to the drug company representative in the waiting room and
observes the representative outwardly touting his company’s products to
the office staff?
These may seem like mundane and non-consequential considerations,
but they draw on the essence of ethics and conflicts of interest. Profession-
als should not only avoid actual conflicts but must strive to avoid even
the appearance of a conflict.
While many physicians considering these real-life scenarios may rea-
sonably conclude that the acceptance of nominal items with product logos
displayed and seen by patients will not have any adverse affect on their rela-
tionships with patients and their ability to act in the patients’ best interests.

51
Id.
52
John G. Scott, MD, assistant professor of Family Medicine at the University of Medicine and
Dentistry of New Jersey-Robert Wood Johnson Medical School, after conducting an examination
of the interaction between medical practices and drug company sales representatives found
that some offices got breakfast and lunch every day and concluded that food was the “currency”
that bought access to doctors’ offices for drug representatives. See Stephanie Saul, Drug
Makers Pay for Lunch as They Pitch, The New York Times, July 28, 2006.
53
AMA E-11.02 Clarification of Opinion 8.061 available at www.ama-assn.org.
 Chapter 5 / Specific Physician–Industry Financial Relationships 173

These doctors may rightfully believe that since their patient relationships are
built on a sufficient level of trust and familiarity, an item emblazoned with
a drug company product, or a drug company sales representative observed
marketing in the office, will not cause the patient to question the doctor’s
judgment or result in a loss of confidence in the doctor’s ethical standards.
By contrast, the ethical arguments in favor of an absolute ban on gifts,
free meals and interactions with company representatives are as follows:

• The protection of the integrity of the medical profession against any

conflict of interest between the clinical independence of physicians
and sales efforts of industry;
• The protection of patients against prescribing and ordering decisions
that may not be in their best interests in terms of quality and cost;
• The avoidance of even the appearance of a conflict or compromised
independence; and
• The utility of a consistent and understandable rule to avoid indus-
try interaction that may unintentionally be unethical or even
illegal.

Another consideration that may eventually drive more physicians and medi-
cal practices to shun all but nominal gifts is the growing number of state and
possibly federal marketing reporting mandates on companies. As previously
discussed, the resulting public disclosure of company gifts, grants and fees
will likely lead to the public identification of physician and other provider
recipients, even if their identities are not required to be disclosed by the
reporting companies.
A contrary view to an absolute ban on gifts is held by the pharma-
ceutical and device industries, the AMA and most professional associations
and medical societies. To generalize, their view is that an absolute legal
ban on gifts, meals and meetings with company sales representatives is
not necessary to ensure unbiased prescription and ordering decisions and
ethical behavior, and may even have adverse consequences. For exam-
ple, an absolute ban might limit the autonomy and professional discre-
tion that one would expect of a physician because a ban may make it
more difficult for physicians to receive valuable and needed information
with clinical and medical value about new products. Furthermore, certain
gifts, particularly free drug samples, may also have significant benefit for
patients.
However, a growing number of AMCs and health systems have con-
cluded that a total ban on gifts and meals makes sense especially within
the circles of academic medicine among medical students, residents and
fellows. Likewise, medical schools should also be encouraged to include
174 Managing Relationships with Industry

within their required courses information on the law and ethics of industry
and financial relationships.
The argument for such a prohibition, however, among independent,
non-AMC medical practices may be different. Physicians who follow the
ethical and legal standards on accepting gifts only of the type and in the lim-
ited circumstances described above and do not solicit any gifts can engage
in legal and ethical behavior without refusing to accept all offered items.
Strictly following the existing ethical guidance on gifts would result in a
significant diminution of the compromising situations that have the great-
est tendency to influence a physician’s prescribing and ordering decisions.
The most effective way to ensure that this happens is through the adop-
tion of a compliance program and an understandable and clear policy on
industry interactions along with annual training on the policy and an organi-
zational official charged with overseeing the program, as further described
in Chapter 6.
Yet while most physicians realize that the era of the “dine and dash”
is over and a growing number are heeding the call of the reformers and
are refusing all gifts and requests for meetings with sales representatives,
there continues to be a cohort of physicians who continue to take whatever
is offered from company representatives.54 Interestingly, some surveys of
the medical profession show that a majority of respondents believe that
physicians can be influenced by gifts from industry and interactions with
sales representatives but that they do not believe their own interactions
and acceptance of gifts has any effect on their own prescription or device
ordering practices.55
Meanwhile, those advocating for an absolute ban on any gifts have
pointed to the increased use of free meals by sales representatives as evi-
dence that the voluntary ethical standards established by industry have not
been sufficient to control market-driven conflicts of interest.56 They have
also suggested that an absolute ban eliminates potential gray areas that can
greatly ease the burden of compliance.57

54
See Gifts to Emergency Physicians from the Biomedical Industry, American College
of Emergency Physicians (ACEP) Policy Resource and Education Paper—explication of the
ACEP Policy Statement Gifts to Emergency Physicians from the Biomedical Industry, revised
and approved, April 2005 at http://www.acep.org/practres.aspx?id=29482.
55
M.A. Steinman, M.C. Shilpak and S.J. McPhee, Of Principles & Pens: Attitudes of Medicine
House Staff Toward Pharmaceutical Industry Promotions. American Journal of Medicine,Vol.
110, 2001, pp. 551–7; see also, W. McKinney, et al. Attitudes of Internal Medicine Faculty and
Residents Toward Professional Interaction with Pharmaceutical Sales Representatives. JAMA,
Vol. 264, 1990, pp. 1693–7.
56
Troyen Brennan, MD, MPH, et al., Health Industry Practices That Create Conflicts of
Interest. JAMA, Vol. 295, No. 429, 2006, p. 433.
57
Id., p. 431.
 Chapter 5 / Specific Physician–Industry Financial Relationships 175

However, in actuality, the existing voluntary ethical standards on free

meals, if followed by sales representatives and medical practices and
departments, would satisfactorily limit, but perhaps not eliminate, undue
conflicts. Both the law and the ethics on food in the office have been mis-
construed: the provision of free meals should only accompany an actual
educational program or informational presentation that has scientific or
educational value. Breakfast spreads, midday supplies of coffee and pizza
lunches delivered to medical offices outside of the context of an educa-
tional program or informational presentations are improper, if not arguably
illegal. Nonetheless, busy physician offices and departments may accept
the offering of free food as a seemingly harmless ritual in their regular
schedule, and consequently, the use of free food has been clearly abused.58
The delivery of free food has a strong tendency to create an unconscious
reaction of reciprocity and to keep the delivering sales representatives’
products in the “front of the mind” of the prescribing or ordering healthcare
professionals.59
A growing awareness and sensitivity to the subtle influences of industry
marketing through the provision of free food, and mouse pads and cof-
fee mugs whose logos are brand-name drugs, has led to several initiatives
within medicine to “just say no” to the offers of free items, however legal
and arguably ethical. An example is “No Free Lunch”, a primarily online
campaign run by a not-for-profit organization, the Corporation for Non-
Promotion-Based Medicine, directed by Bob Goodman, MD, a New York
City general internist. Its funding comes from membership fees, donations
and sales of its own products, such as a “Just Say No to Drug Reps” coffee
mug.60 Its message is to encourage medical practices and departments to
stop taking free meals and nominal items that advertise products, and its
goal is to enhance evidence-based medical decision-making by diminishing
the influence of pharmaceutical company marketing. As P.J. Brennan, MD,

58
One former pharmaceutical representative who founded a national lunch-ordering com-
pany estimated that pharma companies were spending about $4 million a day—or as much as
$1 billion a year—on meals for doctors’ offices. Stephanie Saul, Drug Makers Pay for Lunch
as They Pitch, The New York Times, July 28, 2006.
59
L. Lewis Wall, MD, DPhil, and Douglas Brown, PhD, The High Cost of Free Lunch,
Obstetrics & Gynecology, Vol. 110, 2007, pp. 169–73.
60
See www.nofreelunch.org. The American Medical Student Association has also been quite
passionate in its policy statements and advocacy on the relationship with industry. It launched
a national Pharm Free Campaign and holds an annual Pharm Free day to educate and train
medical students to interact “professionally and ethically with the pharmaceutical industry.”
It also offers its members the opportunity to sign a PharmFree pledge, which states they will
“accept no money, gifts or hospitality from the pharmaceutical industry” and “seek unbiased
sources of information.” AMSA is the only national medical organization to ban all pharmaceu-
tical advertising in its publications and at its events. See www.amsa.org.
176 Managing Relationships with Industry

chief medical officer at the University of Pennsylvania Health System, told

Business Week, “[W]e don’t think about whose pen we’re holding or who
bought us that last pizza, but it creates influence.”61
The issue of free meals is really the tip of a larger iceberg. Are the regular
visits and interactions between physicians and company sales people—with
or without food involved—problematic in and of themselves? Studies per-
formed over the last several decades have indicated that there is a corre-
lation between interactions with drug company sales representatives and a
physician’s (1) preference for new brand-name medications, even though
they may not be superior to existing, less costly ones, and (2) a decrease
in their prescriptions for generics.62 Brennan et al. assert that “the rate of
drug prescriptions by physicians increases substantially after they see sales
representatives….”63
But once informed of these issues and related guidance and Codes,
physicians need to take the lead within their practices and departments
to adopt appropriate compliance plans. At the local medical practice and
department level, every physician needs to better control any effort by
company sales representatives to provide more meals than are acceptable.
Physicians also need to rein in any colleagues who solicit from sales repre-
sentatives. In one account by a former drug company sales representative
published on an online bulletin board, doctors in the representative’s terri-
tory would not speak to him unless the representative bought them lunch,
and one doctor told the representative he would write a certain volume of
prescriptions depending upon the model of personal digital assistant the
representative bought for him.64 Such interaction is illegal as discussed
earlier and could endanger the reputation and resources of the offending
physician’s practice or organization. Many state licensing boards are also
taking an interest in physicians who engage in solicitation of items and

61
Arlene Weintraub and Amy Barrett, Medicine in Conflict, BusinessWeek, October 23,
2006. See also Arlene Weintraub, Cracking Down on Pharma Swag, BusinessWeek, On Line
Extra, October 23, 2006 (quoting Dr. David Korn, senior vice-president of the Associa-
tion of American Medical Colleges, as stating “[m]ost doctors tell me they aren’t influ-
enced by gifts, and I think they believe that…[b]ut there are real neuropsychological
changes that occur when you get a gift, even a ballpoint pen, for God’s sake.”) available at
http://www.businessweek.com/magazine/content/06_43/b4006085.htm?chan=search.
62
Ray Moynihan, Who Pays for the Pizza? Redefining the Relationships Between Doctors
and Drug Companies. BMJ, Vol. 326, May 31, 2003, pp. 1189–92; D. Katz, A. Caplan and J.
Merz. All Gifts Large and Small: Toward and Understanding of the Ethics of Pharmaceutical
Industry Gift Giving. American Journal of Bioethics, Vol. 3, 2003, pp. 39–46.
63
Troyen Brennan, MD, MPH, et al., Health Industry Practices That Create Conflicts of
Interest, JAMA, Vol. 295, No. 429, 2006, p. 431 citing at footnote 21, N. Lurie, E.C. Rich,
D.E. Simpson, et al., Pharmaceutical Representatives in Academic Medical Centers. Journal of
General Internal Medicine,Vol. 5, 1990, pp. 240–243.
64
Michael Blanding, Bad Medicine, Boston Magazine, February 2005, p. 57, 65.
 Chapter 5 / Specific Physician–Industry Financial Relationships 177

contracts of value or acceptance of excessive gifts. Licensing boards have

authority to enforce general ethical standards, including the ethical guide-
lines established by the AMA, and other medical associations, as conditions
of licensure.
Is an across-the-profession mandatory absolute ban on free food and
interaction with company sales representatives necessary and advisable? As
set forth in Chapter 3, the American College of Physicians (ACP) main-
tains that doctors can and ideally should be left with the discretion and
judgment on how and when to permit company sales representatives to
provide a nominal gift or meal as part of a presentation on the scientific or
medical properties of a product. Even so, the ACP cautioned its members
on accepting gifts that will not pass muster if ever publicly disclosed:

Gifts, hospitality, or subsidies offered to physicians by the pharmaceutical

industry ought not to be accepted if acceptance might influence or appear
to others to influence the objectivity of clinical judgment. A useful [test
to apply is]: Would you be willing to have these arrangements generally
known?65

In the following section on detailing, we offer suggested steps to confirm

that a presentation accompanying a meal will have a sufficient level of
educational content. Any offered meeting that will involve a free meal has
to be more than a friendly get-together with a sales representative to talk
about their products. Physicians should look at the scheduled topic and
speaker and decide if there will be any useful information presented on
a particular drug or device that could add to the physician’s knowledge
base. Any physician who can show that he or she made such a reasonable
evaluation and decided to attend has arguably fulfilled his or her legal and
ethical duties. Physicians should identify and avoid programs sponsored by
company sales representatives who have a history of organizing events that
have more of a marketing pitch than scientific or educational substance.
Finally, as more thoroughly discussed in the next chapter, physicians should
actively encourage their medical practices and departments to hold regular
meetings for the presentation of scientifically valid information on products
that are alternatives to those that are detailed by sales representatives and
accompanied by meals that they provide.
To summarize, physicians should never accept gifts of cash, gifts tied
to prescription or ordering practices, or gifts or gratuities with an aggregate
value in excess of $100 per year from any one company. They should never

65
American College of Physicians. Physicians and the Pharmaceutical Industry (Position
Paper). Annals of Internal Medicine, Vol. 112, 1990, pp. 624–6.
178 Managing Relationships with Industry

solicit items of value from drug and device company representatives for
their own personal use or pleasure. These actions are not only unethical but
also illegal.
To conclude this section, consider the findings of a study by Dr. Allen
Brett and two coauthors from the Department of Medicine at the University
of South Carolina School of Medicine, in their 2003 Archives of Internal
Medicine article, Are Gifts from Pharmaceutical Companies Ethically
Problematic?66 The authors surveyed faculty members and residents with
questions on the ethics of 18 pharmaceutical company scenarios. Among
other findings, the authors point out that both faculty and residents had
more ethical concerns as the value of the gift or consideration bestowed
upon the physician went higher. Dr. Brett and his coauthors suggest that
doctors who engage with drug and device companies or are offered gifts
should pay more attention to the underlying rationale for the offer to the
doctor and less on the fine distinctions among the types and value of gifts.67
As a spokesperson for PhRMA has said, “It’s up to doctors to set limits on
their exposure to sales representatives and to assess the information they
receive.”68
Another area of risk related to gifts is the making of contributions to
charity by drug and device companies on behalf of physicians. The making of
the contribution itself is not illegal or unethical. But if the contribution was
also tied to another relationship, it could violate the anti-kickback statute—
for example, if the physician had pledged funds to the charity and asked the
company to make the donation on his or her behalf or if the company knew
the physician served on the board of the charity and would be benefited by
the making of the contribution in some fashion. Asking for contributions is
not the problem; the risk would arise if there was evidence the contribution
was made to benefit the physician and was intended to induce or influence
the prescribing or ordering of the company’s products by the physician or
other physicians he or she has influence over.
 Physicians should never accept gifts of cash, gifts tied to prescription or
 ordering practices, or gifts or gratuities with an aggregate value in excess
 of $100 per year from any one company. They should never solicit items

 of value from drug and device company representatives for their own
personal use or pleasure.

66
Allan S. Brett, MD, Wayne Burr, MD and Jamaluddin Moloo, MD, MPH, Are Gifts from
Pharmaceutical Companies Ethically Problematic? Archives of Internal Medicine, Vol. 163,
2003, pp. 2213–8.
67
Id.
68
Michael Blanding, Bad Medicine, Boston Magazine, February 2005, p. 57, 64.
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