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The AESGP Regulatory Conference in Amsterdam follows a long-standing tradition of facilitating exchange between
the self-care industry and regulators. The conference welcomed more than 100 medicinal products and medical de-
vices regulators, consumer health industry professionals and other stakeholders, who discussed the opportunities
and challenges of the evolving regulatory environment marked by digitalization, the MDR implementation and cen-
tralised switch experience.
The second session provided an update on the imple- Helena Dzojic, Head of Department of Medical Devices,
mentation of the Medical Devices Regulation (MDR) the Swedish Medical Products Agency, and newly elect-
which will be applied from 26th May 2020. ed Chair of Competent Authorities for Medical Devices
(CAMD) Executive Group, shared her views on the role
The session was chaired by Maud Perrudin, AESGP and priorities of CAMD in this critical phase of the MDR
Deputy Director General, who gave insight into AESGP including the identified opportunities for collaboration
work with regard to the implementation of the MDR with the HMA Management Group.
with a particular focus on self-care medical devices that
are composed of substances or combination of sub- Zaide Frias, Head of Human Medicines Evaluation Divi-
stances (such as saline solution nasal sprays, creams to sion, EMA, provided the EMA perspective on the imple-
treat or prevent minor skin irritations or anti-flatulence mentation process regulation considering the new roles
products). These are classified as devices in light of their and responsibilities mandated to the EMA as well as
mode of action which is not pharmacological, immuno- national medicines authorities by the MDR. Referring to
logical or metabolic but relies on chemico-physical pro- the discussion from the first session, it was noted that
cesses such as local pH changes, sequestering actions of digitalization brings about new kinds of medical devices
molecules, and physical barrier formation. The scope and different digital tools which offer huge potential,
and complexity of the MDR are proving challenging for yet can add additional burden to the existing regulatory
all stakeholders involved with the implementation of the activities. An update was provided on the ongoing EMA
new regulation, especially as regards their capacity and activities regarding the borderline and classification
expertise. work, the MDR consultation procedure of medicines
authorities applicable to substances based medical de-
vices falling under Rule 21, and the guidance docu- application in practice. A reasonable transition period is
ments developed in relation to Article 117 MDR needed in order to make sure that products are compli-
(medicinal product with an integral medical device.). ant and can be reviewed by notified bodies on time to
remain on the market. Most urgently, he recalled that
Françoise Schlemmer, Director of the European Associ- sufficient Notified Body availability capacity must exist
ation of Medical Devices Notified Bodies (TEAM-NB), many months before the dates of application. Conclud-
presented the impact on the notified bodies. She shared ing the session, Maud Perrudin insisted that appropriate
the results of the TEAM-NB recent survey on the noti- expertise to assess substance based devices was critical-
fied bodies’ designation process under the MDR and ly needed. Regulators and notified bodies yet too often
IVDR, which indicate the increase in the number and start by considering look-like-medicines products as
scope of the applications for designation and the ongo- medicines without carrying a case-by-case assessment.
ing capacity building. Furthermore, once it is considered a medical device,
substance-based products need to be looked at individ-
Oliver Bisazza, Director, Regulations & Industrial Policy, ually to determine the applicable risk class. AESGP posi-
MedTech Europe, reminded the audience of the various tion papers on Rule 14 and Rule 21 have been devel-
showstoppers for the MDR system readiness and called oped to assist in such exercise.
for lead-time between the readiness of the system and
From left to right: Maud Perrudin, AESGP Deputy-Director General; Helena Dzojic, Head of Department of Medical Devices, the
Swedish Medical Products Agency, and newly elected Chair of Competent Authorities for Medical Devices (CAMD) Executive Group;
Zaide Frias, Head of Human Medicines Evaluation Division, EMA; Françoise Schlemmer, Director of the European Association of Medi-
cal Devices Notified Bodies (TEAM-NB); and, Oliver Bisazza, Director, Regulations & Industrial Policy, MedTech Europe.
The third session, chaired by Christelle Anquez- lion Euros collectively to employed patients and to na-
Traxler, Regulatory and Scientific Affairs Manager at tional health expenditure.
AESGP, took stock of the lessons learnt in the ten years
since the first centralized switch and discussed the way Ilaria Passarani, Secretary General of the Pharmaceuti-
forward. There have been four successful changes of cal Group of the European Union (PGEU), further
legal status from prescription to non-prescription (so- stressed the value of switching, not just in addressing
called ‘switch’) through the centralized marketing au- the burden faced by the national health systems, but
thorization procedure since the procedure became ac- also for patient empowerment and ease of access. In
cessible for a switch: orlistat, pantoprazole, esomepra- addition, self-care contributes to the role of pharmacists
zole and ulipristal. evolving and going beyond dispensing the product to
providing services.
Professor Claudio Jommi, Professor of Practice of Gov-
ernment, Health and Not for Profit at SDA Bocconi Gabriella Grippaudo, Senior Director Regulatory &
School of Management, set the scene of the session by Medical Affairs EMEA, Pfizer Consumer Healthcare, pre-
presenting the results of a recent Italian economic study sented the success factors in the switching of
on the potential economic and social benefits of reclas- esomeprazole but also cautioned on the need for flexi-
sification. It showed a potential savings of 1.1 to 2.4 bil- bility and agility in the regulatory routes to access to
From left to right: Christelle Anquez-Traxler, Regulatory and Scientific Affairs Manager (AESGP); Professor Claudio Jommi, Professor
of Practice of Government, Health and Not for Profit at SDA Bocconi School of Management; Ilaria Passarani, Secretary General of
the Pharmaceutical Group of the European Union (PGEU); Gabriella Grippaudo, Senior Director Regulatory & Medical Affairs EMEA,
Pfizer Consumer Healthcare; Helene Guillard, Global Rx-to-OTC Switch Director, HRA Pharma; and, Zaide Frias, Head of Human Me-
dicines Evaluation Division, EMA
market, citing the case of "Viagra Control", which was According to Zaide Frias, Head of Human Medicines
switched nationally in the UK. Evaluation Division, EMA, the Agency never expected a
high amount of switch applications but rather innova-
For Helene Guillard, Global Rx-to-OTC Switch Director, tive, first in line switches. The introduction of Joint EMA/
HRA Pharma, the centralised procedure was a game CMDh Multi-Stakeholder Scientific Advice procedure,
changer for ellaOne which gave access to an additional for which AESGP has been continuously advocating, and
40 million more women. The key to the success of the the establishment of which is currently on hold due to
switch was the “switch by design” approach, which en- Brexit, would be a welcome platform for early discussion
tailed an early start of the project, the use of the Brass with the presence of different stakeholders. Digital
benefit-risk methodology and addressing the concerns transformation, especially the changing data landscape,
proactively through collecting clinical data to address could also contribute to overcoming a number of hur-
gaps. However the pure national launch following the dles to switching and unleash the potential of the cen-
positive EC decision is in itself another challenge. tralized procedure in particular for new indications and
innovation.
Conclusions
Hugo Hurts, Executive Director, Dutch Medicines Evaluation Board (MEB), on behalf of regulatory authorities, and
Birgit Schuhbauer, AESGP President and Global Vice-President strategic marketing OTC, Johnson & Johnson, on
behalf of the industry, summed up the discussions of the conference. Hugo Hurts commended AESGP on the format
of the conference, while Birgit Schuhbauer reflected on the results of the conference and how they fit into the overall
AESGP strategy.
Digitalization of regulatory science and healthcare provides a unique opportunity to drive operational im-
provements as well as more strategic innovation in regulation and, most importantly, to implement person-
centered care. European regulatory network for medicines and medical devices is intended for the benefit of
all citizens; the consumer health Industry is prepared to play its role in the ongoing developments and espe-
cially when implementing the medical devices regulation and improving access to non-prescription medicines
across Europe.