How proportionate

regulation helps ensure

availability of medicines

Conference with the EU Heads of

Medicines Agencies during the

Dutch EU Council Presidency

Amsterdam

15-16 February 2016

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 me-

dicines in the European Union and beyond. Howe-

ver, questions have been raised as to whether the

whole legislative and regulatory system for phar-

maceuticals has not become too complex, hence

hindering access to important medicines - either

as a prescription or as a non-prescription medi-

cine. More proportionality has therefore become

an important issue in the debate on the future

regulation of medicines. This concerns the marke-

ting authorisation system in general including the

procedures for variations but in more specific

terms also the implications of the legislative provi-

sions on pharmacovigilance and falsified medi-

cines.

Immediate changes in the pharmaceutical legisla-

tion are unlikely to happen. The conference will

therefore focus on adjustements in the implemen-

tation of existing rules and consequently on im-

provements which can be made in a shorter time

frame. Specific attention will be paid to key issues

for the manufacturers of non-prescription medi-

cines such as approval times, consistency in regu-

latory 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 procedures-

human (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