Britain’s departure from the European Union (EU) will necessitate a vast amount of changes, including a new location for the European Medicines Agency (EMA). Its leader worries that the move could slow down the drug approval pipeline.
Last week, Britain formally announced its intention to withdraw from the EU in a move commonly called “Brexit.” It will now have to sever ties from numerous European agencies within the 2-year transition window, including the EMA. Since the drug regulatory body’s inception 22 years ago, it has been located in London, but it will now have to find a new home by March 2019.
According to Reuters, Guido Rasi, the EMA’s executive director, voiced concerns that moving the agency could throw a wrench in its operations, which ensure the safety of the medicines taken by the 743 million residents of the EU. He is particularly worried that the European Council would drag its feet in determining the future home of the agency and its 900 staff. Italy, Denmark, Sweden, Spain, France, Ireland, and Poland have all expressed interest in becoming the EMA’s final destination. The decision could be made as early as this June, and Rasi expressed his view that a quick transition period is essential to getting the agency’s work back on track.
Complicating the issue is the depleted work force of the EMA, as Reuters reports it is having a hard time recruiting replacements for several key staff who have left the agency. It normally receives around 2000 applications for its training program, but this year has only gotten 700.
The EMA already has a significant amount of work on its plate, including in the field of biosimilar review and approval, as it now prepares for the upheaval of moving. In March, for instance, Amgen announced that it had filed for European approval of its trastuzumab biosimilar used to treat breast cancer, joining 3 other trastuzumab biosimilar applications in the agency’s queue. According to the EMA’s website, it was in the process of evaluating 37 proposed biosimilars or non-orphan generics as of February.
A second question associated with the move will be that of redistributing the drug application reviews among 27 other countries, after Britain pulls out. Britain is expected to face the most impact, as the other countries currently contribute 80% of the work. Rasi suggested that EU and British leaders may forge an agreement that allows for mutual recognition of drug approvals in an effort to alleviate the burden to both sides. This deal could include components like the one announced in March between the US and the EU, which indicated that the regulatory bodies will mutually recognize one another’s pharmaceutical manufacturing inspections.