European Medicines Agency (EMA): concern regarding situation of institutional uncertainty
Declaration of the Italian Health Minister Beatrice Lorenzin
The Italian Minister of Health Beatrice Lorenzin expresses the Italian presidency’s concern regarding the situation of institutional uncertainty that the European Medicines Agency (EMA), the European regulatory body, is experiencing, after an administrative loophole left it without strategic leadership.
The court decision does not question the quality of the Agency’s activity nor the competencies and skills of Guido Rasi as regards his management task. The communication of the European Commission - which is responsible for the procedure - on the initiatives undertaken to ensure that the EMA will continue its activity in line with the previous parameters is awaited.
The European Agency, indeed, cannot afford a lack of guide when it comes to strategic issues such as Adaptive Licensing, publication of clinical data, emergency management (Ebola, shortages), which would inevitably affect the whole health sector of the European Union.