Today the 27 member states of the European Union have decided on Amsterdam as the new home of the European Medicines Agency. The decision came after three rounds of voting, with Amsterdam eventually emerging the winner after tying with Milan on 13 votes each in the final round. It appears that Slovakia may have abstained.
The Agency now has less than 17 months to manage the move from London, ready to begin operations in Amsterdam by the end of March 2019. The Agency has committed to publishing a monitoring chart by early December that tracks the progress of the move. It intends to collaborate very closely with the Dutch authorities to allow approvals from local authorities, EMA’s Management Board and the EU budgetary authority to be carried out in parallel. The EMA will need to move the 900 households of EMA staff and 600 children of staff will need to be found schools. The move to Amsterdam will be popular with the staff at the Agency. Amsterdam emerged as the location likely to lead to the retention of most staff according to a staff survey conducted in September.
There is much to be done to keep the Agency’s vital work of ensuring the safety of medicines marketed in the EU remains on track during the transition from London to Amsterdam. The Agency will have to re-assign at least 230 medicines for which the UK has acted as rapporteur or co-rapporteur, around 23% of all medicines approved by the Agency so far. This will require the recruitment of substantial new expert resources from the remaining member states unless a way can be found of enabling the MHRA to continue providing these resources post-Brexit.
The EMA has made it clear that, post-Brexit, the UK will be regarded as a third country as far as the EU regulatory regime is concerned. This means that thousands of variation applications will need to be processed by the EMA and some by the competent authorities of the EU27 as companies will need to notify the change of location of their marketing authorisation holder and batch release site out of the UK. Doubts have been expressed by the industry whether this work can be completed on time before March 29 2019 when the UK departs the EU. The industry will be hoping that a transitional period can be agreed when the sector talks begin in earnest in the New Year.
Allen & Overy’s Amsterdam office has considerable life sciences expertise and is able to draw on the skills of our life sciences lawyers across the globe. Frits Gerritzen and Christiaan de Brauw lead our Amsterdam life sciences practice. Please contact Jim Ford, Laëtitia Bénard or Frits and Christiaan if you would like to explore the help we can offer as Brexit approaches.
