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Relocation of the European Medicines Agency: Preventing a Serious Risk to Public Health by Keeping the Agency Fully Operational

 

On 20th November 2017 the General Affairs Council will vote on the relocation of the European Medicine Agency (EMA), which becomes necessary after the United Kingdom decided to withdraw from the European Union.

 

EMA is certainly one of the most prestigious European agencies and absolutely vital for the protection of public health in Europe by
-    providing the basis for new and the maintenance of existing marketing authorisations for a multitude of vital medicines in Europe,
-    by supervising medicines safety and taking immediate action in cases of risks to public health and by
-    promoting scientific research and innovation in the healthcare sector.
It shapes the global regulatory debate on the safety and efficacy of medicines and maintains crucial databases on post-marketing information on adverse effects of essential medicines.

To keep the Agency fully operational it is essential for patients and citizens of Europe by securing access to life saving medicines and their safety in Europe on a day to day basis.

Disruptions or delays of the agency´s work will have serious adverse effects on public health in Europe. Therefore, it is of vital importance that the choice of the new location – whichever it will be – will secure, that all necessary means to ensure the business continuity from day one will be provided.  

The relocation should not lead to a level of highly skilled employees leaving the Agency which might threaten its vital functions. The agency – at all reasonable costs – must maintain its high-level standards and functionality during the transition period in order to avoid disastrous disadvantages for patients and delayed access to necessary treatments.  

Therefore, we call the Member States to base their decision for the new host of EMA on objective criteria and the need to keep the disruption as minimal as possible. EMA is not a suitable object for political bargaining. The choices to be made in the process of relocation must follow the aim to prevent a serious risk to public health.