The European Medicines Agency’s necessary relocation to Amsterdam following the U.K.’s Brexit vote has moved into its next phase with a business continuity plan “aimed at securing essential public and animal health activities” set to launch on Oct. 1, 2018.The physical move will take place in March 2019, and the Phase 3 plan has to safeguard the core activities around medicine regulation as well as deal with potential loss of staff.Activities including international collaboration, development and revision of guidelines, clinical data publication and other programs will have to be scaled back.
Following the U.K.’s momentous decision in 2016 to leave the EU (the clock is ticking), the location and status of the European Medicines Agency and the impact on Europe-wide clinical trials has become a concern for the biopharma industry. Reports indicate that some major pharmaceutical companies are stockpiling medicines in order to avoid supply chain issues in the event of a hard exit.
The EMA found its new home in Amsterdam in November 2017, following a vote so tight it came down drawing names out of a hat after Slovakia abstained over the lack of a candidate from “new” EU countries.
As the move draws near, the European Medicines Agency is faced with prospective staff losses greater than it anticipated. Departures could be as high as 30% of staff, with what the agency describes as “a high degree of uncertainty regarding mid-term staff retention.” Previously, the agency had estimated only a 19% loss of staff.
“Staff who will not relocate to Amsterdam have already started to leave the Agency and this trend is expected to accelerate. 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 said in a statement.
Supportive measures include relocation assistance, help from the Dutch government, a recruitment plan, and EMA staff training. However, in the short- and medium-term, the agency will need to prioritize its shrinking staff resources, which will mean scaling back certain activities. Specific areas will be maintained as much as possible, such as engagement with global issues like antimicrobial drug resistance and vaccination, urgent development or revision of guidelines, and Brexit-related policies. This may also have an impact on drug approvals.
“Clinical data publication, for which the launch of new procedures will be temporarily suspended as of Aug.1 2018; data packages submitted for medicines until the end of July 2018 will be processed and finalized,” the EMA said.
Earlier this year, the EMA raised the concern that U.K. companies, both market authorization holders and manufacturers, are not fully prepared for exit and this may lead to drug shortages. The supply chain could be further disrupted by the worrying possible prospect of a “hard Brexit.”