How proportionate

regulation helps ensure

availability of medicines
Amsterdam
15-16 February 2016

Conference with the EU Heads of

Medicines Agencies during the
Dutch EU Council Presidency

Koninklijke Industrieele Groote Club

Dam 27, 1012 JS Amsterdam
The Netherlands

PROGRAMME
Objectives of the conference
2015 marked the 50th anniversary of the European
Union Pharmaceutical Legislation. Without any
doubt, this legislation has considerably improved
the safety, quality and efficacy of all kinds of medicines in the European Union and beyond. However, questions have been raised as to whether the
whole legislative and regulatory system for pharmaceuticals has not become too complex, hence
hindering access to important medicines - either
as a prescription or as a non-prescription medicine. More proportionality has therefore become
an important issue in the debate on the future
regulation of medicines. This concerns the marketing authorisation system in general including the
procedures for variations but in more specific
terms also the implications of the legislative provisions on pharmacovigilance and falsified medicines.
Immediate changes in the pharmaceutical legislation are unlikely to happen. The conference will
therefore focus on adjustements in the implementation of existing rules and consequently on improvements which can be made in a shorter time
frame. Specific attention will be paid to key issues
for the manufacturers of non-prescription medicines such as approval times, consistency in regulatory decisions, switching from prescription to
non-prescription status and umbrella branding.
The programme has been developed in close
cooperation with the Dutch Medicines Evaluation
Board, which will host the first meeting of the
Heads of EU Medicines Agencies during the Dutch
EU Presidency back to back to the conference.

Monday, 15 February 2016

19.30
Opening Reception and Dinner
Welcome by:
Marcel van Raaij, Ministry of Health, Welfare and
Sport, The Netherlands
Roger Scarlett-Smith, AESGP President

Tuesday, 16 February 2016

08.30

Welcome coffee

09.00

Session 1

The importance of proportionate regulation

for the availability of medicines and avoidance
of shortages
Chair: Hugo Hurts, Director, Medicines
Evaluation Board (MEB), The Netherlands
Andr Broekmans, Director Escher Think Tank at
Lygature
Nicola Bedlington, Executive Director,
European Patients Forum (EPF)
Kristin Raudsepp, Director General, State
Agency of Medicines, Estonia
Andrzej Ry, Director, Health Systems, Medical
Products and Innovation, DG SANTE, European
Commission
Hubertus Cranz, Director General, AESGP

10.30

Break

PROGRAMME
11.00

Session 2

New challenges in the pharmaceutical

market place: Ageing population, patient
empowerment, innovative self-care products,
falsification
Chair: Christa Wirthumer-Hoche, Acting Chair
of the EMA Management Board, and Head,
Austrian Medicines and Medical Devices Agency
(AGES MEA), Austria
Beln Crespo, Executive Director, Agency for
Medicines and Health Products (AEMPS), Spain
John Borg, Member of the CHMP, Malta
Christelle Anquez-Traxler, Manager for
Regulatory and Scientific Affairs, AESGP
Bernard Mauritz, Director, Neprofarm, The
Netherlands

Andrzej Ry, Director, Health Systems, Medical

Products and Innovation, DG SANTE, European
Commission

12.30

Lunch

13.30

Session 3

Implementation of the pharmacovigilance

legislation: Do we see the intended impact in
practice?
Chair: Xavier de Cuyper, Chief Executive
Officer, Federal Agency for Medicines and Health
Products (FAMHP), Belgium
Peter Arlett, Head of Pharmacovigilance
Department, European Medicines Agency
June Raine, Chair, European Medicines
Agencys Pharmacovigilance Risk Assessment

Committee (PRAC)
Peter Bachmann, Chair, Co-ordination group for
Mutual recognition and Decentralised procedureshuman (CMDh)
Paul Carter, Global Head Consumer Health Care,
Development, Medicine and Regulatory Affairs,
Boehringer Ingelheim
Elmar Kroth, Director, German Medicines
Manufacturers Association (BAH)

15.30

Break

16.00

Session 4

Making progress in reality

Chair: Hubertus Cranz, Director General, AESGP
Guido Rasi, Executive Director, European
Medicines Agency (EMA)
Ian Hudson, Chief Executive, Medicines and
Healthcare products Regulatory Agency (MHRA),
United Kingdom
Karl Broich, Director General, Federal
Institute for Drugs and Medical Devices (BfArM),
Germany
Luca Pani, Director General, Agenzia Italiana del
Farmaco (AIFA), Italy

17.45

Conclusions

Roger Scarlett-Smith, AESGP President

Stan van Belkum, Deputy Director, Medicines
Evaluation Board (MEB), The Netherlands

18.00

End of the meeting