The headquarters of the European Medicines Agency (EMA) will relocate to Amsterdam from its location in London following the United Kingdom’s decision to exit (Brexit) from the European Union, which will occur in March 2019. Among other reasons, EU ministers selected Amsterdam from 19 cities to avoid a mass staff exodus, which officials were worried would jeopardize access to new medicines.
EMA Executive Director Guido Rasi, PhD, expects the organization will lose 200 of its 900-person staff. “If we lose people horizontally across the agency it will probably not cause delays in approvals. … However, if there is a collapse in some specific services that would disrupt things more seriously,” he told reporters.
To comply with post-Brexit rules, EMA faces extra work processing market authorizations to companies transferring U.K. product licenses to EU-based entities. “All the companies are working to do all the transfers at the same time, so the regulatory system is going to have a difficult time coping in the 16 months left before Brexit,” Nathalie Moll, director general of European Federation of Pharmaceutical Industries and Associations, told Reuters.
More than 45 million packs of drugs are supplied from the U.K. to other European countries each month, while another 37 million move in the opposite direction. Regulations require the retesting of drugs shipped across borders, forcing manufacturers to set up additional testing centers.
The U.K. government has said it would like to work closely with EMA to avoid the cost of taking over the job of regulating all medicines after Brexit. Asked if he expected such future cooperation, Dr. Rasi said, “it is completely unknown.”
Source: Reuters, November 21, 2017.