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.