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Realising the Potential of Future Biomedical Innovation: The Role of Intensified EU Cooperation on HTA

Track:
DIAmond Sessions

Day & Time:
April 17, 2:00PM - 3:30PM (Central Europe Standard Time)

Session Number:
DMD3

Room Number:
Singapore

Type:
Session

Title:
Realising the Potential of Future Biomedical Innovation: The Role of Intensified EU Cooperation on HTA

Chair(s):
Timothy Wilsdon, MS
Principal
Charles River Associates International, United Kingdom

Description:

In light of the evolving medicine development paradigm and the limited resources of national HTA agencies it becomes increasingly apparent that the currently national and sub-national approach to the assessment of relative clinical efficacy of medicines will unlikely allow EU patients to optimally realize the potential benefits of the evolving drug development paradigm and future biomedical innovation.

More recently the EMA and EUnetHTA have proposed a new framework for parallel early scientific advice which will be tested and further refined as part of the temporarily funded EUnetHTA JA3 programme. This development represents considerable progress, but the question remains how to increase efficiency and depth in the assessment of the relative clinical efficacy of innovative medicines at and after launch.

Participants of this panel will present their perspectives on how to further advance the EU cooperation between national HTA agencies, EMA and other stakeholders on the assessment of the relative efficacy of medicines.

  • Why - Value proposition of EU REA collaboration
  • How? Pilot experiences in EUnetHTA JA3 and the specific challenges of lifecycle approach
  • How? Importance of constructive pre- and post-launch engagement between industry, EMA and HTA agencies including first experience with new joint EUnetHTA/EMA evidence plan platform and the role of the new “ad hoc” HTA/regulatory agencies SYNERGY group
  • Outlook? The European Commission proposal for a sustainable cooperation post-2020


Presentation(s) & Speaker(s):
Panel Discussion
Michael Berntgen, PhD
Head of Product Development Scientific Support Department
European Medicines Agency, European Union, United Kingdom

Panel Discussion
Ansgar Hebborn
Head – Global Market Access Policy
F. Hoffman-La Roche, Switzerland

Panel Discussion
Niklas Hedberg, MPharm
Chief Pharmacist
Dental and Pharmaceutical Benefits Agency, TLV, Sweden

Panel Discussion
François Meyer, MD
Advisor to the President, International Affairs
French National Authority for Health (HAS), France

Panel Discussion
Ioana-Raluca Siska, MD, PhD
Policy Officer, Health Technology Assessment
European Commission, Belgium