Dive Brief:
- The European Medicines Agency has signed a pact with the Netherlands to provide security for agency staff members and their families who need to relocate early because of the agency's change in headquarters.
- With the U.K. in the midst of exiting the European Union, more than 370 centrally-authorized products have been reallocated from the U.K.'s portfolio to the 27 remaining member states, plus Iceland and Norway.
- The board endorsed the next step of the EMA's Brexit business continuity plan, including preparations for higher-than-expected staff losses by allowing employees to be mobilized to cover critical functions where needed starting October 2018.
Dive Insight:
While it's still not yet clear what form Brexit will take by the leaving date of March 2019, the EMA is moving forward apace. The U.K.'s narrow vote to leave the EU in 2016 left the agency with notice to quit London, its home since 1995.
In November last year, the EMA member governments voted to move the agency to Amsterdam, and the preparations began to transfer the offices, staff, records and know-how. The transfer of products has begun, and in September 2018 the new countries taking the lead will be given a knowledge transfer package for each product. This contains background information on the regulatory and evaluation history of each product, including the most recent benefit-risk assessment. This will help the national competent authority to make plans, particularly to provide support for complex products.
Brexit could have a major impact on the supply of drugs for those companies remaining in the EU. The European Federation of Pharmaceutical Industries and Associations estimates that more than 2,600 products are manufactured at some stage during production in the U.K., and border restrictions could disrupt the supply chains.
There is still no agreement over what will happen to drug approvals in the U.K. post-Brexit. Some U.K. members of Parliament are calling for some kind of cooperation with the EU to protect both drug access and the pharmaceutical industry. If the U.K. does not retain some level of membership to the EMA, Reuters predicts that separate regulatory requirements could add around £45,000 (around $60,000) per drug.