EMA starts planning for the UK’s withdrawal from the EU

Members of the European Medicines Agency’s (EMA) management board and heads of national competent authorities (NCAs) met yesterday to discuss the consequences of Brexit. The aim of the meeting was to establish key principles on how the work related to the evaluation and monitoring of medicines will be shared between Member States once the UK withdraws from the EU.

The EMA’s Executive Director Guido Rasi said “I am reassured to see the overall commitment of the Member States to step up their efforts and to explore the options to take on a bigger share of the workload. “The expertise available across the network is impressive and this is an opportunity to streamline the way we work, increase our capacity and work even more efficiently.”

The following general principles for workload distribution were noted:

  • Ensuring business continuity;
  • Maintaining quality assurance and robustness of the scientific assessment;
  • Continuing to comply with legal timelines;
  • Ensuring knowledge retention, either by building on existing knowledge or through knowledge transfer;
  • Assuring an easy implementation and medium- and long-term sustainability.

A working methodology was agreed that will include a mapping of current and future capacity and expertise in the network and a gap analysis. Moving forward, different options for workload distribution will be evaluated. A further meeting will take place on 5 July 2017.

The EMA press release acknowledges that as negotiations the terms of the UK’s departure have not yet officially commenced and one cannot prejudge their outcome.  However, on the basis of the work that has commenced, it seems that a continuing role for the UK in EU medicines procedures post-Brexit is unlikely.

You can read the EMA press release here.