AESGP

Conference Report

AESGP Conference with the Heads of

EU Medicines Agencies (HMA)

26 - 27 February 2018| Lisbon

Public and Consumer Health: Future Priorities for EU Medicines Agencies

Since 2005, AESGP has been organizing meetings with
the Heads of EU Medicines Agencies. Lisbon was the
location of this year’s event entitled “Public and Con-
sumer Health: Future Priorities for EU Medicines Agen-
cies”.
gal was rising and it was vital that the country’s
“regulators, health professionals and industry” played
their part in providing the public with “good infor-
mation” and ensured that products allowing consumers
to self-medicate were widely available.

Welcoming delegates, Maria do Céu Machado, Presi-
dent of Infarmed – the Portuguese national authority of
medicines and health products, emphasized that Portu-
gal has prioritised empowering its citizens to be able to
practice self-care, e.g. through the stakeholder project
Tratar de Mim. She added that health literacy in Portu-
This was echoed by Bogdan Kirilov, Deputy Director of
the Bulgarian Medicines Agency representing the cur-
rent EU Presidency, who explained that it was important
not to miss the opportunities to drive self-care. Com-
munication would be key, he added, noting that it was
vital that all national regulatory agencies not only fo-

Discussing HMA structure and the value of self-care (from left to right): Hubertus Cranz, AESGP Director General;
Christa Wirthumer-Hoche, Head of the Austrian Medicines and Medical Devices Agency (AGES MEA); Klaus Cichutek,
Chair of the HMA Management Group; Andreja Čufar, Executive Director of the Public Agency of the Republic of Slo-
venia for Medicinal Products and Medical Devices (JAZMP); Bogdan Kirilov, Deputy Director of the Bulgarian Medi-
cines Agency; Maria do Céu Machado, Infarmed President; and Rui Santos Ivo, Infarmed Vice-President.

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 How to improve the regulatory environment for non-prescription medicines (from left to right): Zaide Frias, Head of Human Medicines
Evaluation Division of the European Medicines Agency (EMA); Karl Broich, Director General of the Federal Institute for Drugs and Medi-
cal Devices (BfArM); Hugo Hurts, Director of the Medicines Evaluation Board (MEB); Ian Hudson, Chief Executive of the Medicines and
Healthcare products Regulatory Agency (MHRA); Dirk Ossenberg-Engels, AESGP Vice-President and Head of Bayer Consumer Care´s
Europe South, Central Eastern Europe and Middle East business unit; and Lars Ritter, European Parliament.

cused on evaluating medicines that could be switched
to non-prescription status, but also led the way in edu-
cating the public and healthcare professionals on the
benefits of self-care.
Outlining the industry position, Hubertus Cranz, AESGP
Director General, referred to the AESGP Self-Care Agen-
da 2020, the draft of which was discussed with the
Heads of EU Medicines Agencies at the conference in
Amsterdam in 2016. A key element of the agenda is the
need for regulatory optimization. AESGP is convinced
that better service to the people in Europe can be pro-
vided with reduced administrative burden and without
any compromise to public health. In all regulatory deci-
sions, the benefit of self-care options should really be
kept in mind, not only the sometimes more theoretical
risks. The so-called Brass model remains the point of
reference with regard to an appropriate benefit-risk
analysis. This position was in principle agreeable to Hu-
go Hurts, Director of the Medicines Evaluation
Board (MEB), The Netherlands; Ian Hudson, Chief Execu-
tive of the Medicines and Healthcare products Regula-
tory Agency (MHRA), United Kingdom; Karl Broich, Di-
rector General of the Federal Institute for Drugs and
Medical Devices (BfArM), Germany; and Zaide Frias,
Head of Human Medicines Evaluation Division of the
European Medicines Agency (EMA); who explained in
the second session of the conference their considera-
tions in the given context.
Talking about innovation and incentives for research,
industry was “absolutely interested in switches”, insisted
Dirk Ossenberg-Engels, AESGP Vice-President and
Head of Bayer Consumer Care´s Europe South, Central
Eastern Europe and Middle East business unit, after the
sector’s commitment to prescription-to-OTC switches
was challenged by Christa Wirthumer-Hoche, Chair of
the Management Board of the European Medicines
Agency (EMA) and Head of the Austrian Medicines and
Medical Devices Agency (AGES MEA). However, switches
were a “huge undertaking” for firms. What was needed
to encourage more switches, he argued, was a
“probability assessment early on”, e.g. in the form of a
Multi Stakeholder Scientific Advice Procedure, which
would gauge how likely a switch was to be successful
before companies spent “all their energy” on applica-
tions. Firms also needed “better protection” on their
investment, Ossenberg-Engels added, noting that cur-
rently companies may only get data exclusivity for one
year for related scientific work, which is simply not suffi-
cient.
Looking at the wider challenges for the consumer health
industry and the priorities towards public health, An-
dreja Čufar, Executive Director of the Public Agency
of the Republic of Slovenia for Medicinal Products and
Medical Devices (JAZMP), explained the difficulties with
illegal self-care products, including in particular food
supplements, which may destroy the reputation of the
whole sector. Efficient enforcement of the legal provi-
sions is key to ensure a sustainable market environment
for both citizens and manufacturers.
The implementation of the new legal provisions for
medical devices and in vitro diagnostics was discussed
in the third session of the conference chaired by Xavier
de Cuyper, Chief Executive Officer of the Belgian
Federal Agency for Medicines and Health Products

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 Conference report

(FAMHP). The challenges related to workload for all ac-
tors in the regulatory system, including in particular
medicines authorities with responsibility for medical
devices and notified bodies, were highlighted by Lor-
raine Nolan, Chief Executive of the Irish Health
Products Regulatory Authority (HPRA); John Wilkinson,
Director of Medical Devices at the Medicines and
Healthcare products Regulatory Agency (MHRA); Sinisa
Tomic, Director of the Croatian Agency for Medici-
nal Products and Medical Devices; and Oliver Bisazza,
Director Regulations & Industrial Policy at MedTech Eu-
rope. Maud Perrudin, AESGP Deputy Director General,
drew particular attention to borderline products and the
classification of substance-based medical devices. In this
context, clearer definitions for the terms
“pharmacological”, “immunological”, and “metabolic”
were regarded as necessary. The classification of a spe-
cific product will remain a case-by-case decision based
on an assessment of the formulated products. It is criti-
cal for AESGP members that, at any time in the product
lifetime, any process aiming at determining the regula-
tory classification of a product allows (1) the gathering
of all the information necessary from the manufacturers
for ensuring the consistent evaluation of a specific case
and (2) the consultation of the appropriate scientific
expertise to differentiate between the different modes
of action in light of the whole formula of the product.
This holds also true for the classification of devices com-
posed of substances or combination of substances. The
implementation of Rule 21 should always be propor-
tionate and risk-based. AESGP also reminded authorities
that the requirement for notified bodies to consult the
medicine authorities in the context of the conformity
assessment under the MDR only applies to devices fall-
ing under the first indent of Rule 21. It is critical that a
common understanding of this rule applies so that noti-
fied bodies do not consult medicine authorities in a dis-
proportionate manner.
For all products on the market, it will be important to
have a uniform interpretation of the rules and respect
for the transition periods to ensure that medical devices
remain on the European market in the interim period.
These transition periods are particularly critical for sub-
stance-based medical devices currently falling under
Class I, for which there are no existing certificates with
defined periods for these products, which will be the
first to have to fully meet the MDR requirements from
26 May 2020. In this allotted transition period, the in-
dustry is concerned that based on the current invest-
ment of resources, notified bodies may not be available
and be able to certify the vast number of products early
enough to avoid any disruption in the supply of medical
devices to the market.

Looking at the implementation of the new medical device legislation (from left to right): Xavier de Cuyper, Chief Executive Officer
of the Belgian Federal Agency for Medicines and HealthProducts (FAMHP); Lorraine Nolan, Chief Executive of the Irish Health
Products Regulatory Authority (HPRA); Sinisa Tomic, Director of the Croatian Agency for Medicinal Products and Medical Devices;
Oliver Bisazza, Director Regulations & Industrial Policy at MedTech Europe; Maud Perrudin, AESGP Deputy Director General; and
John Wilkinson, Director of Medical Devices at the Medicines and Healthcare products Regulatory Agency (MHRA).

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The final session looked first at the numerous activities
related to Brexit. Pharmaceutical policy is always part of
a wider agenda, but here, even details depend a lot on
overall politics with limited possibilities for specific ar-
rangements in sectors. Evidently, AESGP follows the de-
velopments carefully and put out several position pa-
pers, some of them together with other associations in
the healthcare sector (Life Science Industry Coalition
Position Paper). Participants favored the strongest pos-
sible integration of the United Kingdom to limit nega-
tive repercussions for all sides involved and above all for
the European citizens.
Due to the high number of national authorizations and
registrations, the self-care sector is somewhat less af-
fected than other parts of the pharmaceutical industry,
but AESGP remains concerned in light of the resources
it takes and the risk of a lowering attention to non-
prescription medicines in regulatory procedures. The
additional uncertainties around the move of the EMA
were explained by the EMA Executive Director, Guido
Rasi.
Thomas Senderovitz, Director General of the Danish
Medicines Agency, and Andrzej Rys, Director of Health
Systems, Medical Products and Innovation, Directorate
General Health and Food Safety of the European Com-
mission, discussed the implications of the debate
around big data on regulatory decision making and how
to differentiate big from relevant data. Information leaf-
lets should in the future also be provided electronically,
but should not replace the printed version for the time
being. AESGP is following related debates closely and
was happy to see a strong reference to the importance
of citizens’ empowerment in the Council conclusions on
Health in the Digital Society, which were adopted on 8
December 2017 by the Employment, Social Policy,
Health and Consumer Affairs Council. This is now a
good basis for the upcoming European Commission
communication on Digital Transformation of health and
care in the context of the Digital Single Market, which is
expected to be adopted soon.
Belén Crespo Sánchez-Eznarriaga, Director General
of the Spanish National Agency for Medicines and
Health Products, and Rui Santos Ivo, Vice-President of
Infarmed, put the reflections at the conference in the
context of their national self-care policies, which aim for
better information and citizen empowerment. There was
agreement that brands – along with responsible public
advertising – could play a role in ensuring consumers to
better understand the medicines they were taking.

Discussing future challenges for the self-care sector (from left to right): Andrzej Rys, Director of Health Systems, Medical Products
and Innovation, Directorate General Health and Food Safety of the European Commission; Thomas Senderovitz, Director General
of the Danish Medicines Agency; Guido Rasi, Executive Director of the European Medicines Agency (EMA); Belén Crespo Sánchez-
Eznarriaga, Director General of the Spanish National Agency for Medicines and Health Products; and Hubertus Cranz, AESGP
Director General.

Self care: The first choice in healthcare

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