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Executive Summary

The European Medicines Agency is working to ensure it can cope with the many challenges it will face as a result of the UK leaving the EU. Those challenges could include the agency losing 50% of its staff, according to the EMA’s deputy head Noel Wathion.

 


The European Medicines Agency could lose up to half its nearly 900-strong staff if the agency moves from London following the departure of the UK from the EU. Nonetheless, the agency is determined to avoid disruption to its operations and to continue to meet its public health obligations, both in the run-up to Brexit and following it.

“What we cannot afford – no matter what happens – is a disruption of our operations” or a delay in the evaluation and pharmacovigilance of medicines for which the EMA is responsible, Noel Wathion, the EMA’s deputy executive director, said.

The figure of potential staff losses of “up to 50%” comes from the EMA having surveyed its staff and looked at other agencies facing similar situations, Wathion told a conference in London*. Losing UK expertise completely and losing a considerable number of other staff members would be a worst-case scenario for the agency, but it may have to prepare for just that, he said.

UK nationals account for 60 (6.68%) of the agency’s total workforce of 890. In addition, the UK medicines regulator, the MHRA, deals with around 20% of the EMA’s workload. (Also see "Brain Drain And Recruitment Risks for EMA post UK Brexit Vote" - Pink Sheet, 18 Jul, 2016.)

Various scenarios 

The two key issues are the location of the EMA post Brexit and the future relationship between the UK and the EU in the area of medicines regulation. Wathion, who is one of the co-chairs of the Brexit task force the EMA set up following the surprise result of the UK referendum on the EU on June 23, outlined various scenarios for both issues.

Theresa May, the UK prime minister, insists that the formal two-year negotiation process that will lead to the UK leaving the EU will begin by the end of March 2017. One scenario is that the decision on whether to move the EMA and where it will go is made early in the formal Brexit negotiations. In that case, the agency could have “a lengthy period” of around two years in which to prepare. However, it will be a “completely different story” if that decision is taken late on in the process and the agency has little time in which to prepare to move, Wathion said.

The timing of the decision will determine when the EMA invokes its business continuity plan (BCP), the EMA deputy head continued. The agency has only had to use its BCP once before – during the 2009 influenza pandemic – and it is being adjusted for use in this new situation.

 

“We cannot afford – no matter what happens – a disruption of our operations.” Noel Wathion, EMA.

 

Assessing the impact of Brexit on the capacity and capability of the EMA and more broadly the European medicines regulatory network is also hard at this stage. If the UK remains in the European Economic Area, the impact on the workload of the EMA would be minimal, said Wathion. If the UK does not remain within the EEA, “there are so many different scenarios” and the eventual situation, he said, will depend on the ultimate outcome of the negotiations that take place among EU member states.

“We are planning for the best-possible scenario – the UK remaining in the EEA – and for the worst-case scenario,” said Wathion.

The task force will have to adapt depending on the information the EMA receives throughout the negotiation process.

Impact assessment

The task force of which Wathion is a co-chair is in the process of preparing an extensive impact assessment with regard to the potential implications of Brexit on the agency.

The EMA’s Tony Humphreys, another co-chair of the task force, described Brexit as “a big joker in the pack in terms of destabilization and uncertainty.” While we can hope for the best option, we need to prepare for the worst option, he said, as to do otherwise would be indefensible.

*Noel Wathion and Tony Humphreys were speaking at the Annual European Medicines Agency Review of the Year and Outlook for 2017, which is organized jointly by the EMA and The Organisation for Professionals in Regulatory Affairs and which is taking place in London on Dec. 1 and 2.

 

From the editors of Scrip Regulatory Affairs.

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