European & National Medicines Regulatory Systems:
challenges for an equitable, timely and suitable access to innovation
10th May 2017, 10:00 – 14:00
European Economic and Social Committee - Room VMA1
rue Van Maerlant 2, 1040 Brussels

09:30 Arrival and registration
Please allow time (up to ½ hour) for security check and registration before the meeting starts

Chair: Neil Betteridge - Neil Betteridge Associates; Global Alliance for Patient Access (GAfPA)

10:00 - 10:35 Opening remarks
Agnes Cser - European Economic and Social Committee SOC section
Vytenis Andriukaitis - European Commissioner for Health and Food Safety (video message)
Mariano Votta - Director of Active Citizenship Network
MEP Andrey Kovatchev – EPP Group
MEP Eleonora Evi - EFDD Group

10:35 - 11:15 1st Session
Sustainability of health care systems vs access iniquities. What role can the EU play to make access to innovative medicines more sustainable?
Martin Seychell - Deputy Director General, DG SANTE
MEPBrando Benifei – S&D Group

Andrew Powrie-Smith - Communications Director, European Federation of Pharmaceutical Industries, EFPIA
Francois Houÿez - Treatment Information and Access Director, European Organisation for Rare Diseases, EURORDIS

Questions & Answers

11:15 - 12:15 2nd Session
Management of innovation: exchange of EU Member Statesexperiences (from Marketing Authorization to concrete access for patients: successes and failures of access in different EU countries).

Focus on:

  • Hepatitis C

Alessia Squillace - Tribunal for Patient Rights, Cittadinanzattiva, Italy
Josep Torrent Farnell - Hospital de la Santa Creu I Sant Pau – Clinical Head of Clinical Pharmacology; EMA COMP member and past Chair, Spain

  • Cancer

Marie-Christiane Vekemans - Vice president of the Belgian Hematology Society, Catholic University of Louvain, Belgium
Regine Deniel Ihlen - Lung Cancer Europe LuCE, Norway

The payers’ perspective on access to innovation

Arnaud Emériau - President of the European Social Insurance Platform (ESIP), Belgium
Gottfried Endel - Department for Evidence Based Economic Health Care, Main Association of Austrian Social Insurance Institutions, Austria

Questions & Answers

12:15 - 13:30 3rd Session
The involvement of patient organisations in the Regulatory Agencies across Europe.
Round table: sharing examples of involvement of patient organizations in the different national medicines agencies processes: the challenges for a better management.

Representatives of National Medicines Agencies
Annemiek van Rensen - Dutch College ter Beoordeling van Geneesmiddelen / Medicines Evaluation Board
Senior advisor patient participation, CBG/MEB, Netherlands
César Hernández García - Head of Department of Medicines for Human Use, Agencia Española de Medicamentos y Productos Sanitarios (AEMPS), Spain
Marco Marchetti – Director of the National Center for the Health Technology Assessment, Italian National Institute of Health, Italy
Veska Gergova – Senior legal advisor, Bulgarian Drug Agency BDA, Bulgaria

Patient associations from countries with an official patients’ committee in the National Medicines Agency:
Thomas Sannié - Association française des hémophiles, member of the patients’ consultative group of the French National Agency for Medicines and Health Products Safety (ANSM), France
Joop van Griensven - Fibromialgie En Samenleving FES, member of the patient consultation and networking group of Dutch Medicines Evaluation Board CBG/MEB, Netherlands

Patient associations from countries without an official patients’ committee in the National Medicines Agency:
Penka Georgieva Babacheva - patient organization “Together with you”, Bulgaria
Gertrude Buttigieg - Malta Health Network, Malta

Questions & Answers

13:30 - 13:45 Closing remarks
Rob Camp - European Patients’ Academy on Therapeutic Innovation (EUPATI), Spain
Antonio Gaudioso - Secretary General of Cittadinanzattiva Onlus, Italy

13:45 Light lunch

european patients rights day 2017


Subscribe to the newsletter

Valore non valido

Valore non valido

Valore non valido

Valore non valido

Valore non valido