EMA unveils its Brexit business plan

The European Medicines Agency (EMA) is preparing to launch the next phase of its business continuity plan with Brexit clearly in its sights.

By 1 October, EMA plans to have in place safeguards for its core activities related to medicine evaluation and supervision, while simultaneously gearing up for what the organization describes as a "significant staff loss," and its move to Amsterdam in March 2019.

The staff who will not relocate to Amsterdam have already have begun to leave the organization. The departures are expected to accelerate as the date of the relocation approaches.

"In addition, due to the employment rules in the Netherlands, 135 short-term contract staff will no longer be able to work for EMA," the agency stated. "Overall, EMA expects a staff loss of about 30% with a high degree of uncertainty regarding midterm staff retention."

To handle its labor shortage, the EMA has taken several steps to complement support from the Dutch government. Eventually, however, EMA plans to temporarily scale back or suspend additional activities through to 2019, which will allow training for EMA staff who will be reassigned to new duties ahead of the peak relocation time, which will start in early 2019.

Under its self-imposed 1 October deadline, EMA's business plan includes the following:

  • Development and revision of guidelines, which will be temporarily limited to those guidelines that address an urgent public/animal health need or are necessary to support and facilitate preparations for Brexit.
  • Programs and projects where activities in relation to project governance will be reduced in line with the reduction/suspension of projects.
  • Organization and attendance will be limited to Brexit-related interactions.
  • Clinical data publication, for which the launch of new procedures will be temporarily suspended as of 1 August 2018. The agency will process and finalize data packages submitted for medicines before or on 31 July.
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