Science and Engineering Ethics (2005) 11, 81-92

Can drug patents be morally justified?a

Sigrid Sterckxb
Ghent University and University of Antwerp, Belgium

Keywords: global ethics, medical ethics, patents, drugs

ABSTRACT: This paper offers a few elements of an answer to the question to what
extent drug patents can be morally justified. Justifications based on natural rights,
distributive justice and utilitarian arguments are discussed and criticized. The author
recognizes the potential of the patents to benefit society but argues that the system is
currently evolving in the wrong direction, particularly in the field of drugs. More than
a third of the world’s population has no access to essential drugs. The working of the
patent system is an important determinant of access to drugs. This paper argues that
drug patents are not easily justified and that the ‘architecture’ of the patent system
should be rethought in view of its mission of benefiting society.

Introduction
I have chosen a very general title for this contribution ― in this paper I will obviously
only be able to offer a few elements of an answer to this question.
When I criticize ‘patents’, I will mean the kind of patents we know today: the
strong patents which have been globalized by the WTO Agreement on Trade Related
c
aspects of Intellectual Property rights (TRIPs Agreement, 1994). Hence, none of my
comments or critiques imply that the patent system should be abolished.

a. An earlier version of this paper was presented at an international conference, “The Ethics of
Intellectual Property Rights and Patents,” held in Warsaw, Poland on 23-24 April, 2004.
b. The author is a part-time Senior Research Fellow of the Fund for Scientific Research, Department
of Philosophy and Moral Science, Ghent University (Belgium) and a part-time Professor,
Department of General Economics, University of Antwerp (Belgium).

c. GATT Scretariat ed. (1994) Annex 1C: Agreement on Trade-Related Aspects of Intellectual
Property Rights, in: The Results of the Uruguay Round of Multilateral Trade Negotiations. The
Legal Texts. WTO, Geneva: 365-403. Also available at:
docsonline.wto.org/DDFDocuments/t/UR/FA/27-trips.doc
_________________________________________________________________________________

Address for correspondence: Dr. Sigrid Sterckx, Ghent University, Department of Philosophy
and Moral Science, Blandijnberg 2, 9000 Ghent, Belgium; email: sigrid.sterckx@ugent.be.
1353-3452 © 2005 Opragen Publications, POB 54, Guildford GU1 2YF, UK. http://www.opragen.co.uk

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S. Sterckx

From my point of view as an ethicist, the patent system is an extremely fascinating

object of study and I think it could be an almost perfect example of what fair social
institutions should look like. It could be… However, at present it certainly isn’t ― and
it is not developing in the right direction either. But the present state of affairs is not
the only possible one. The system can be reformed. Instead of taking it for granted, we
should investigate how it came about and which alternatives are possible.
The patent system has a wonderful potential to benefit societies ― to create more
social justice rather than, as seems to be the case today, increasing the wealth gap
between the owners of patents and those who wish to use or sometimes desperately
need patented objects. We need to investigate in what ways the ‘architecture’ of the
system should be modified to realize this potential to the fullest extent. This implies,
among other things, that we need to construct a convincing theory about the moral
justification of the patent system.

Faith is not good enough

Some ― in fact many ― people don’t see the point of such an undertaking. They think
patents justify themselves. Pamela Samuelson, a specialist in the field of copyright,
talks about a ‘collective faith’ in the benefits of intellectual property rights  a
collective faith that clouds our ability to evaluate them seriously:
The modern faith in intellectual property does not seem likely to be shaken soon,
primarily because that faith is supported by such evidence as high levels of
innovation, high levels of investment in innovation, and the concomitant
prosperity. The intellectual property laws may not have been responsible, but most
observers believe that those laws have played a part. If intellectual property law is
stifling research or steering research in the wrong direction, our collective faith
d
may keep us from recognizing it.

But faith is not good enough ― intellectual property in general and patents in
particular are not that easily or obviously justified. And one of the reasons why we
should study the problems involved in the justification of intellectual property rights, is
that these rights are less socially neutral than other property rights. They interfere to a
greater extent with the rights of others, because of the non-exclusive character of the
objects of intellectual property rights: “the pattern of interference that intellectual
property rights set up in the lives of others is far greater than in the case of other kinds
e
of rights”. Therefore, the justification of intellectual property rights must be more
convincing than the justification of other property rights.
Let us now return to the case of patents. A patent is a certificate delivered by or on
behalf of the government, attesting that the subject-matter of the patent meets a number

d. Samuelson, P. (1989) Innovation and Competition: Conflicts over Intellectual Property Rights in
New Technologies, in: Weil, V. & Snapper, J. eds., Owning Scientific and Technical Information
– Value and Ethical Issues. Rutgers University Press, New Brunswick: 179.
e. Drahos, P. (1996) A Philosophy of Intellectual Property. Dartmouth, Aldershot: 211.

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 Can drug patents be morally justified?

of legal requirements ― novelty, nonobviousness, utility and sufficient disclosure of

f
the invention. Most patent laws provide a number of exceptions to the general rules of
patentability (e.g. the exclusion from patent protection of certain categories – laws of
nature and mathematical formulae are classic examples).
As to the rights ensuing from a patent, a distinction is made between product
patents and process patents. Both confer far-reaching rights. If the object of the patent
is a product, the patentee has the right to prevent others from the acts of making, using,
offering for sale, selling, or importing the product for one of these purposes. Holders of
a process patent have the right to prevent others from the act of using the process, and
also from the acts of using, offering for sale, selling, or importing for one of these
g
purposes at least the product obtained directly through the application of the process.
These rights are limited in two ways: in time (in most countries patent protection lasts
twenty years, from the date of application) and in space (the patent is only valid in the
jurisdiction of the Patent Office that issued it).
Many developing countries have traditionally excluded pharmaceutical products
from patent protection; only processes for the production of pharmaceuticals could be
patented. When the Uruguay Round of trade negotiations (which resulted in the
establishment of the WTO) started in 1986, more than 50 countries did not grant
patents on drugs. The entry into force of the WTO TRIPs Agreement implies the quasi-
worldwide implementation of high standards for the protection and enforcement of
patents. E.g., it makes it impossible for developing countries to practise a ‘selective’
policy for the grant of patents, i.e. to exclude particular fields of technology from
h
patentability. Drugs cannot be excluded from patentability under TRIPs. This may
make it even more unlikely for patients in developing countries to get access to
i
essential drugs, as will be explained below. Of course there is the Doha Declaration on
j
TRIPs and Public Health, which stipulates that the TRIPs Agreement can and should
be interpreted and implemented in a manner supportive of member states’ rights to

f. See e.g. Grubb, P. (1999) Patents for Chemicals, Pharmaceuticals and Biotechnology. Clarendon,
Oxford.
g. See art. 28 TRIPs.
h. See art. 27(1) TRIPs: “… patents [can] be granted for any inventions, whether products or
processes, in all fields of technology ... [and] patent rights are enjoyable without discrimination as
to the place of invention, the field of technology and whether products are imported or locally
produced”. (emphasis added)
i. I should emphasise that I do not understand the concept of ‘essential drugs’ as ‘drugs that are
mentioned on the World Health Organization’s list of essential drugs’. As some proponents of
strong drug patents like to remark, more than 95% of the drugs on that list are not patented
(anymore). However, the reason for this seems to be that a drug must inter alia be ‘affordable’ in
order to be included in that list and patented drugs are usually expensive. In my view, the fact that
a drug is expensive does not necessarily imply that it cannot be ‘essential’ ― in the sense of badly
needed by patients.
j. The outcome of the WTO Ministerial Meeting in Doha (Qatar) in November 2001.
WT/MIN(01)/DEC/2, 20 November 2001.

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S. Sterckx

protect public health and to promote access to medicines for all. However, the major
k
industrialized countries apparently don’t want to see this Declaration implemented.
At the WTO as well as in various other forums, debates have been going on about
the potential impact of patents on access to healthcare. In August 2000 the UN
Commission on the Promotion and Protection of Human Rights adopted a resolution
stating that there are apparent conflicts between the TRIPs regime and human rights
(including the right to health). Other commentators consider the property right of
patent holders as a human right and argue for a further strengthening of patents. Yet
others, instead of framing the problem in terms of rights, attempt to justify patents with
economic arguments or by invoking fairness. This paper makes a few remarks on the
extent to which these different arguments can justify the patenting of drugs,
particularly in poor countries.

Natural rights

Let us start with the first ground on which patents could be justified: natural rights.
Some people believe that man has a natural right to his ideas and therefore the use of
ideas without the authorisation of the ‘owner’ must be considered as ‘theft’ or ‘piracy’.
A ‘natural’ right is a right that takes precedence over social institutions ― it
predates the apparatus of the state, so its existence does not depend on formal legal
recognition. Natural rights are moral imperatives ― they must be respected whatever
the consequences. This view differs fundamentally from a utilitarian view, in which
rights are regarded as ‘tools’ which serve certain purposes ― and if it turns out they no
longer serve those purposes, or if society decides that other purposes have become
more important, people are free to violate rights.
Discussions of the natural rights argument usually refer to John Locke’s ‘labour
l
theory of property’. Although Locke seems to identify property with land, several
commentators have applied his theory to so-called ‘intangible’ or ‘intellectual’ goods.
According to Locke’s theory, the appropriation of a thing occurs when man applies his
m
labour to it. Through ‘mixing’ the thing with his labour, he adds something of his
own (his labour) to the thing and thereby excludes others from having a right to it. How
is it, according to Locke, that we own our labour? Because we own our body – and that
is because we have been created by God. God has a property right over man and man,

k. See numerous communications on the ‘ip-health’ list server of the NGO Consumer Project on
Technology. www.cptech.org/ip/health/
l. Which he formulated in his Second Treatise on Government (1690). See Laslett, P. ed. (1988).
Locke, Two Treatises of Government. Cambridge University Press, Cambridge: 285-302.
m. The famous libertarian philosopher Robert Nozick, who has formulated a theory of property that
is partly based on Locke’s theory, has raised the following pertinent question: why isn’t mixing
what I own with what I don’t own a way of losing what I own rather than a way of gaining what I
don’t? He gives the example of spilling a can of tomato juice in the sea: “If I own a can of tomato
juice and spill it in the sea so that its molecules (made radioactive, so I can check this) mingle
evenly throughout the sea, do I thereby come to own the sea, or have I foolishly dissipated my
tomato juice?” Nozick, R. (1974) Anarchy, State and Utopia. Blackwell, Oxford: 175.

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 Can drug patents be morally justified?

made by God to his image, has a property right over his creations. This is a religious
version of the natural rights theory of property, but the theory also exists in a very
influential secular version, according to which property rights are crucial because
n
people need them to carry out their ‘life projects’.
The natural rights argument became very popular in the 19th century, although
o
mostly on the continent. Today, this argument is still frequently used in patent
discussions. Some fifty years ago, Edith Penrose made a very important observation
which is still valid today:
[T]he loose use of the word “stealing” remains in most patent discussions to
remind us of the natural property right conception of patents. Stealing … is used in
a [wide] and [vague] sense to include the use by another of a man’s ideas even
though they are not in fact patented or patentable under the law applying to him
who uses them. Upon this concept all charges of “piracy” are based when they are
leveled against nations who permit their nationals to use freely inventions patented
p
elsewhere but which are not patentable under their own laws.

Even in the Universal Human Rights Declaration the echo of the natural rights
justification resounds. Art. 27(2) of the UHRD stipulates that:
Everyone has the right to the protection of the moral and material interests
resulting from any scientific, literary, or artistic production of which he is the
author.

However, at the same time, art. 27(1) of the UHRD provides that:
[Everyone has] the right freely to participate in the cultural life of the community,
to enjoy the arts and to share in scientific advancement and its benefits.

A system based on a ‘natural rights’ conception of patents implies, e.g., that

q
compulsory licensing would be inconceivable. It would also entail the perpetual

n. See e.g. Lomasky, L. (1987) Persons, Rights, and the Moral Community. Oxford University
Press, Oxford. Also see Rothbard, M. (1982) The Ethics of Liberty. Humanities Press, Atlantic
Highlands, NJ.
o. See Dutton, H. (1984) The patent system and inventive activity during the industrial revolution,
1750-1852. Manchester University Press, Manchester: 18. Also see MacLeod, C. (1988)
Inventing the industrial revolution. The English patent system, 1660-1800. Cambridge University
Press, Cambridge: 197, 199.
p. Penrose, E. (1951) The Economics of the International Patent System. Johns Hopkins Press,
Baltimore: 24-25.
q. A patent holder can transfer his rights, as a whole or in part, without losing the property of the
patent: he can grant a licence to one or more third parties. Such licences are called ‘voluntary’ or
‘contractual’ licences. They can be either exclusive (one licensee), or non-exclusive (several
licensees). A voluntary licence can be granted for free, but in most cases the licensee pays
royalties to the patent owner. Opposite to voluntary licences are compulsory licences. The
granting of the latter implies that―after an administrative or judicial procedure to check whether
certain conditions are met―the government forces a patent holder to grant a licence to one or
more third parties for the use of his patented product or process. The rights of use ensuing from
the possession of a compulsory licence are similar to those ensuing from the possession of a

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validity of patent rights, instead of a limitation in time. Some people don’t think that
would be a problem. They argue that the existence of a patent does not deprive other
people of anything, since the object of the patent would not exist if the inventor hadn’t
been there. We can assume, however, that at some point in time another person would
have invented it. This could be a reason for putting a time limit on the validity of patent
rights (by calculating the time it would take an independent inventor to invent the same
thing). It seems likely that if the protection period would be determined on this basis:
(1) in most cases, it would be much shorter than under the current patent system; and
(2) there would be a differentiation of protection periods depending on the field of
technology.
I cannot elaborate on other problematic implications of natural rights theories of
patents, but if we look at the implications of Locke’s theory ― as this is indeed the
theory that is most frequently appealed to ― the main question seems to be: how much
‘labour’ is really involved in the R&D of drugs? The greater part of pharmaceutical
R&D budgets is spent on ‘me-too’ drugs — slightly changed versions of successful
products manufactured by competitors. The American Food and Drug Administration
(FDA), for example, classifies the applications it receives either as ‘priority drugs’
(considered to represent a significant improvement compared to existing drugs) or as
‘standard drugs’ (considered similar to drugs that are already on the market). Of the
1035 drugs approved by the FDA between 1989 and 2000, two thirds were slightly
altered or even identical versions of the (active ingredients of) drugs already available
on the market. Only 1 in 3 consisted of so-called ‘new chemical entities’: drugs based
on new chemical substances forming a new treatment.
Moreover, not every ‘new chemical entity’ represents a significant improvement
over existing medicines. Of the 1035 medicines approved in the abovementioned 12-
year period, only 24% was categorized by the FDA as ‘priority drug’ (i.e. a significant
improvement), while the remaining 76% was designated as ‘standard drug’. This is
borne out by a large-scale survey by the National Institute for Health Care
Management Foundation entitled Changing patterns of Pharmaceutical Innovation, the
r
results of which were published in May 2002. This survey also clearly shows that the
ratio between priority-rated drugs and standard-rated drugs is constantly shifting
towards less of the former and more of the latter. Furthermore, the researchers found
that all new drugs are far more expensive than their approved predecessors. These
trends are in part related to the working of the patent system.
Representatives of the pharmaceutical industry usually answer criticism on the fact
that they spend a considerable part of their budgets on ‘me-too’ drugs with a story

patent, except for the fact that compulsory licences have to be granted predominantly to supply
the domestic market of the country that grants them; in other words, they cannot be used mainly
for export purposes. See art. 31(f) TRIPs.
In the context of the patent system, compulsory licences play a double role: on the one hand,
to force the patent owner to allow society to benefit from his invention, and on the other hand to
boost the industrialization of the country in question. The basic principle underlying the grant of
compulsory licenses is the public interest.
r. See http://www.nihcm.org/innovations.pdf.

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 Can drug patents be morally justified?

about the mechanisms of the free market and their responsibilities towards their
shareholders: no profits means no shareholders, which in turn means no research. This
makes a lot of sense, but a big difference between the pharmaceutical market and other
markets is that―so-called ‘lifestyle’ products left aside―the pharmaceutical market is
a free market only for producers and not for consumers. After all, patients do not
choose to be ill.
The development of all those ‘me-too’ drugs is not ‘labour-intensive’ (if ‘labour’ is
understood as creative intellectual labour). Also in view of the patentability
s
requirement of inventiveness, the granting of patents for such drugs seems hard to
justify.

Distributive justice

Patents could also be justified on distributive justice grounds. In this framework, the
fundamental argument is that fairness requires that inventors be rewarded because they
render a service to society. It would be unfair to allow others a ‘free ride’ at the
expense of inventors.
When applied to the context of drug patents, this argument, too, appears
problematic. A first question that arises is whether fairness does not also require that
patients get an equal access to drugs, which is impeded by the working of the patent
t
system.
Secondly: is it fair to grant private property rights to the results of R&D which is,
to a large extent, publicly funded? In the US, e.g., the National Institutes of Health
(NIH) (subsidized by the federal government) are possibly the greatest benefactors of
the pharmaceutical industry. This year, the NIH will be spending $26.9 billion on
research, and of course other public institutes exist which also invest in health-related
research. Much of this research directly benefits the industry, including the so-called
‘blockbuster drugs’. According to the NIH, 55% of the research projects leading to the
development of the 5 best-selling drugs in 1995 was performed by researchers whose
u
work had been financed with taxpayers’ money. This seems to strengthen the case for
allowing maximum access to the products of that research.
Thirdly: is it fair to grant inventors rewards that are excessive? Many producers of
brand-name drugs persistently try to obtain extensions of the protection term of their
patents, and they often succeed. This hampers producers of generic drugs, which are

s. The differences between the subject-matter claimed in a patent application and the prior art have
to be substantial. The subject-matter should not have been obvious or trivial to a person having
ordinary skill in the art, at the time the application was filed. In other words, it must contain an
inventive step.
t. In a utilitarian context, as I will discuss below, the unequal access is considered to be justified by
the incentive effect it creates. However, in a framework of distributive justice such an argument
cannot be decisive.
u. National Institutes of Health (2000) NIH Contributions to Pharmaceutical Development
(administrative document), cited in: Public Citizen (2002) America’s Other Drug Problem: A
Briefing Book on the Rx Drug Debate. Public Citizen, Washington, DC: 51.

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usually much cheaper than brand-name drugs. Even in the US, according to the Kaiser
Foundation, the (retail) price of a prescription brand-name drug is 3-4 times higher
than the price of a generic drug. In developing countries, the difference is often even
bigger. The public is expected to pay twice: people have to pay artificially high prices
for drugs, as well as the costs of a legal system used by pharmaceutical companies to
defer competition.
Even supposing that strong patents could be justified on fairness grounds, the
justification of the quasi-worldwide introduction of drug patents on such grounds
would remain difficult. As Dan Brock rightly notes:
It can quite plausibly be argued that in not respecting patents developing countries
are free riding on the research and development efforts of drug companies that are
supported by the prices of drugs in countries in which patents are respected. But
that free riding and resulting unfairness may not be enough to make it, all things
considered, morally wrong for developing countries not to respect product patents.
… When developing countries choose not to respect product patents as their only
effective means of making available pharmaceuticals necessary to save lives and
protect the health of their citizens, doing so is arguably a step towards greater
justice between the developed and developing world ...v

The health crisis in many poor countries has indeed reached proportions beyond
the conceivable. More than a third of the world’s population has no access to essential
drugs. The urgency of ensuring access to the necessary drugs cannot be ignored any
longer. Rethinking the patent regime is one of the things that need to be done.

Utilitarian arguments

The utilitarian justification of patents basically entails the following two arguments:
(a) The ‘incentive-to-invent-and-innovate’ argument: in the absence of patents,
inventions can be copied by competitors, which would erode the incentive to
invent and innovate. A ‘special’ incentive is required to encourage people to
invest in R&D. According to this argument, the patent system provides such an
incentive.
(b) The ‘incentive-to-disclose’ argument: As one of the patentability requirements is
that the applicant must disclose the invention in sufficient detail, the patent system
encourages inventors to disclose their inventions instead of keeping them secret.

Several commentators claim that these arguments are nowhere more valid than in
the pharmaceutical sector, as this is the most research-intensive of all industrial sectors.
However, both arguments are problematic. I will only mention some of the problems
with the ‘incentive-to-invent-and-innovate’ argument as the argument regarding the
‘incentive-to-disclose’ is less relevant here.

v. Brock, D. (2001) Some questions about the moral responsibilities of drug companies in
developing countries. Developing World Bioethics 1: 36-37.

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 Can drug patents be morally justified?

The reason why a ‘special’ incentive to invent and innovate is needed follows from
w
the fact that knowledge has the characteristics of a ‘public good’. Therefore the
government must intervene in the production of knowledge, according to the utilitarian
argumentation, because the market does not offer an efficient solution for the
production of ‘public goods’.
A first characteristic knowledge has in common with other ‘public goods’ is that it
cannot be exhausted: it can be used over and over againand by several people
without it becoming exhausted. The production of knowledge demands enormous
means, but as soon as it is produced, it costs comparatively little to reproduce it. It is
thus very difficult, and sometimes even impossible, to prevent others from
appropriating the advantages of the knowledge which has been produced. Hence, it is
impossible to bring about an optimal allocation of means for the production of
x
knowledge (inventions) via the market ― government intervention is required.
The failure of the market in the production of ‘public goods’ can be solved in three
ways: the granting of subsidies (e.g., a system of prizes or research scholarships), direct
production by the government (e.g., laboratories run by the government) and the
introduction of monopolies (e.g., patents). In a lot of countries several mechanisms are
used simultaneously when the production of knowledge is concerned.
The patent solution is not necessarily the best. The stimulating effect of patents lies
in the fact that patent owners can limit the dissemination and use of the patented
invention. This is, for example, not the case if the government subsidizes research ―
this way of stimulating the production of knowledge does not automatically limit the
dissemination of knowledge.
Of course the availability of patents does result in more inventions of drugs; it is
not my intention to question that ― but this does not prove that the patent system
induces innovation. The positive effects of the availability of a greater number of
inventions may well be cancelled out by the limitation of the dissemination of those
inventions. It takes more than purely theoretical reasoning to find an answer to the
question to what extent the patent system induces innovation. Obviously, empirical
research is needed as well.
The patent system allows prices of patented items to be kept artificially high. The
introduction of product patents for drugs in developing countries will almost certainly
y
lead to a price increase of 200-300%. Moreover, as mentioned earlier, pharmaceutical

w. In economic theory, the term ‘public good’ is used differently than in the public debate. Some
commentators designate essential drugs as ‘public goods’ or ‘global public goods’ ― their
reasoning is that essential drugs have or should have the status of ‘global public goods’ because
of the scope of the advantages they offer: they offer advantages for nearly everyone, including
future generations.
x. Arrow, K. (1962) Economic welfare and the allocation of resources for invention, in: Nelson, R.
ed. The rate and direction of inventive activity: Economic and social factors. Princeton University
Press, Princeton: 609-25.
y. Watal, J. (2000) Access to Essential Medicines in Developing Countries: Does the WTO TRIPS
Agreement Hinder It? (Science, Technology and Innovation Discussion Paper No. 8). Center for
International Development, Harvard University, Cambridge, MA.: 5.

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companies frequently try to postpone the market entry of generic drugs. This thwarts
access to drugs even more.
Many commentators automatically assume that the utilitarian arguments invoked to
justify the patent system in industrialized countries also apply to developing countries.
Proponents of strong drug patents claim that the implementation of the TRIPs
Agreement will produce the following advantages: (1) local drug research would be
encouraged, which would allow the development of new drugs meeting the country’s
specific needs; (2) industrialized countries would make important new drugs available
in developing countries; and (3) developing countries could attract foreign investments
in the pharmaceutical sector. However, each of these arguments is susceptible to
criticism.
Hardly any drugs for diseases occurring primarily or exclusively in developing
countries are being developed. Of the 1223 molecules that were sold worldwide
z
between 1975 and 1996, less than 1% was intended for tropical diseases. R&D of
drugs for these diseases is desperately needed. According to some commentators, if
developing countries were to grant strong patents for drugs, local research would be
stimulated. Not granting strong patent protection may well yield short-term advantages,
but in the long run it would be harmful, they maintain, because under such
circumstances drugs that meet the specific needs of the country in question will never
be produced.
The introduction of new technologies is indeed an important instrument for the
improvement of the standard of living in developing countries. However, the fact that
few new technologies are being developed in developing countries has more to do with
fundamental economical problems―such as a lack of skilled workers and the absence
of infrastructures capable of absorbing new technologies―than with the fact that, until
recently, these countries applied relatively low patent protection standards. Even if a
stronger patent system than the one we know today would be implemented, the
right―in the sense of ‘most needed’―R&D would still not be undertaken.
Moreover, the economic purpose of patents is to enable patentees to recoup their
investments and, preferably, also to generate profits. In the pharmaceutical sector, high
profits are the norm: the pharmaceutical industry is eight times more profitable than the
aa
average of all industries represented in the Fortune 500 list. It is highly unlikely that
the recent strengthening of the patent regime will motivate pharmaceutical companies

z. See B. Pécoul et al. (1999) Access to Essential Drugs in Poor Countries – A Lost Battle? Journal
of the American Medical Association 281: 365, Table 2. See also the recent survey by experts of
the Harvard School of Public Health and an international group of experts, the Drugs for
Neglected Diseases Working group, available on www.accessmed-msf.org. See also another
recent survey which the umbrella organisation of the American pharmaceutical industry
(Pharmaceutical Research and Manufacturers of America) held among its members, New
Medicines in Development, available on www.phrma.org.
aa. See Fortune 500. Fortune Magazine 2002; April. In 2001, the profits of America’s 10 largest
pharmaceutical companies went up by 33% — from 28 to 37.3 billion dollars! — despite the bad
economic situation. Profits are also growing much faster than the volume of R&D investments.
According to the 2001 Fortune 500 ranking, the pharmaceutical industry was the most profitable
industry for the tenth time in a row.

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 Can drug patents be morally justified?

to invest in R&D of drugs for diseases occurring primarily or exclusively in developing

countries, as the majority of these patients have little or no purchasing power. The
pharmaceutical industry develops profitable drugs for the wealthy regions of the world.
In 2000, eight drugs for impotence and erectile dysfunction, seven for obesity, and four
bb
for sleeping disorders were in the pipeline of American pharmaceutical companies.
More money is invested in research of products against baldness than in research of all
tropical diseases combined…! Strengthening drug patents in developing countries is
not likely to change that.
The classical argument regarding the encouragement of transfer of technology is
that owners of technology are not too keen on transferring their technological
knowledge to countries with a ‘weak’ patent system, in view of the risks of ‘piracy’. If
a developing country were to strengthen its patent system, so the argument goes, rich
countries will make new medicines available in that country. However, this prediction
does not appear credible. Drugs that can be produced via conventional processes are
already marketed by local producers in several developing countries. Those drugs of
which the production involves sophisticated technologies are usually not copied in
developing countries, as they lack the required manufacturing capacities. Moreover,
only a very limited (paying) market exists for these expensive drugs in poor countries.
It is thus highly unlikely that the strengthening of patent protection in these countries
will bring in previously unavailable technology.
As far as the role of patents in the encouragement of foreign investments is
concerned, various commentators claim that the level of protection of intellectual
property rights is an important factor affecting investment-related decisions of
companies. However, under the TRIPs regime patentees are no longer obliged to
manufacture their inventions in the (developing) country where they obtained the
patent. Lack of local exploitation of a patented invention can no longer be invoked as a
ground for compulsory licensing. Patentees are free to supply the market from their
own country — foreign investments are not necessary. Under these circumstances,
foreign companies will only invest in branches in developing countries if the available
human resources and/or infrastructures offer them exceptional cost-reducing
opportunities. As far as the pharmaceutical industry is concerned, such a situation is
not very likely to occur. Moreover, investment decisions are influenced by a whole
series of different factors, one of which is the strength of patent protection in the
cc
country in question  but this is certainly not the most important one.
So the benefits of the introduction of strong drug patents in developing countries
appear uncertain. What about the costs? Although the fact that more than a third of the
world’s population has no access to essential drugs obviously has to do with a variety
of factors ― some of which are linked to market failure, others to public policy failure

bb. Cf. the results of a survey which the umbrella organization of the American pharmaceutical
industry (PhRMA) held among its members. See New Medicines in Development, available on
www.phrma.org.
cc. See e.g. C.A.P. Braga et al. (1999) Intellectual property rights and economic development
(Background paper for the World Development Report 1999). World Bank, Washington, DC.

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― the working of the patent system is one of the important factors determining the lack
of access to essential drugs, for two of the likely effects of drug patents are higher drug
prices and less choice of sources of drugs.
Spokespersons of the pharmaceutical industry and other defenders of strong drug
patents don’t cease to repeat that even the slightest wakening of drug patents would
mean that no more new drugs will be produced. Again, I do not mean to deny the
incentive effect of patents, but I think two remarks should be made in this regard:
(1) Empirical economic research on the incentive effect of the patent system hardly
exists – most of what we are hearing are slogans, ideological statements, expressions
of a ‘faith’ in the benefits of strong patents and the even greater benefits of even
stronger patents; and
(2) Even if these statements would be less exaggerated than they seem to be, they
are based on alleged long term effects. From an ethical point of view, that is not good
enough. We also need to be deeply concerned about short and medium term effects of
patents on patients’ access to essential drugs. Justifications of the current state of the
world are often based on arguments about the long term. For example,dd when some
public health officials try to justify their choice to focus on HIV/AIDS prevention
rather than treatment, they present the following scenario: “Let’s look at the situation
of a man who is HIV infected, whose wife is HIV infected and who has some HIV
infected children. Now, you ask that man whether he would rather have treatment for
himself, or prevention to make sure that his children and all the other children in the
community are not infected.” And then they say: “I think that man would choose
prevention, because he would think more about the future.” And they say this in a very
complimentary way, complimenting the decision making processes of the HIV infected
man. But one can simply say that no human being should ever have to make that choice
because asking people to make such a choice is inhuman.
It is equally inhuman to expect poor people to accept the reasoning that, although
they ― and their children, friends, neighbours, etc…― may be dying because they
cannot afford to pay for the drugs they need, this is a fair price to pay to ensure that
pharmaceutical R&D remains profitable in the long term. Surely, we would never ever
accept such reasoning if it were our husbands, wives, children and friends who were
dying!
To think that long-term reasoning absolves us from the moral responsibility of
ensuring access to treatment for sick people is completely wrong. The main objective
in determining which kind of patent regime should apply to healthcare products must
be healthcare considerations. Essential drugs are of vital importance to people ― this
should be reflected in the policies pertaining to patenting in this field.

dd. See a recent interview with Dr. Jim Yong Kim, a doctor and medical anthropologist and co-
founder of Partners in Health, a Boston-based (USA) organisation co-operating with poor
communities in Boston, Haiti, Peru and Russia. Cf. Persistent Plagues, Persistent Paradigms &
the Responsibility of Physicians in the HIV Epidemic: An Interview with Dr. Jim Kim by Faiz
Ahmad, 8 November 2002, available on http://www.zmag.org.

92 Science and Engineering Ethics, Volume 11, Issue 1, 2005