EU Rare Diseases Policy

December 18th, 2009

The EMEA is now called European Medicines Agency and the portfolio of pharmaceuticals is being transfered from DG Enterprise to DG Health & Consumers.

This decision is part of a significant reshuffle of responsibilities assigned to each Designated Commissionner in the Barosso II European College of Commissionners. For this decision to be implemented the new Commissionners need first to be approved by the European Parliament in January / February. This transfer is an important change. All medicines agencies in EU Member states as well as USA are under the authority of the Ministries of Health. The situation of the EMEA was anachronic, though understandable as part of the strategy for the creation of the EU unique market and of EU industry competitiveness.

The new authority of DG SanCo should further strengthen the public health strategy and objectives of EMA so to better serve patients and citizens. Our expectation is that under the authority of DG Sanco, the European Medicines Agency will create as soon as possible a new Working Party for the Assessment of the Clinical Added Value of Orphan Drugs so to produce Common Assessment Reports and Road Maps for the post-marketing research activity, in particular on effectiveness and relative effectiveness.

About the author

Yann Le Cam
Chief Executive Officer, EURORDIS (Rare Diseases Europe)

Yann Le Cam is a patients’ association advocate who has dedicated 25 years of professional and personal commitment to health and medical research non governmental organisations in France, Europe and the United States in the fields of cancer, HIV/AIDS and rare diseases. He has three daughters, the eldest of whom has cystic fibrosis. Yann is one of the founders of EURORDIS in 1996-1997 and its Chief Executive Officer since 2002. He is the Vice Chairman of the EU Committee of Experts on Rare Diseases since 2011. He was one of the first patient representatives appointed to the Committee for Orphan Medicinal Products (COMP) at the European Drug Agency (EMA) where he served 9 years and was its Vice Chairman for 6 years. He served on the Management Board and Executive Committee of the French HTA agency ANAES now called HAS for 5 years, on the DIA Advisory Committee Europe for 3 years, on the EPPOSI Board for 6 years. Yann is one of the founding members of the International Alliance of Patients Organisations (IAPO).

Read his/her other articles

In the same category...

Leave a comment

RareDiseaseBlogs.Net is a joint EURORDIS/NORD project