Europe’s counterpart to the US Food and Drug Administration is temporarily scaling back activities as it anticipates greater-than-expected loss of staff when it relocates due to Brexit.
The European Medicines Agency said Wednesday that it would scale back or suspend certain activities through next year so that it can focus on evaluating and supervising medicines ahead of a planned move from its current home in London to Amsterdam, set to take place by the date Brexit occurs, on March 30, 2019. The cutbacks will take place on Oct. 1 “at the latest.”
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The EMA will cut back international collaboration in areas like harmonizing global regulations, in which the agency said it will take only a reactive role. On issues like antimicrobial resistance and vaccines, it will maintain activities “as long as possible,” but review them on a case-by-case basis. Clinical data publication, development and revision of guidelines, working parties not related to products and other activities will be scaled back as well.
In anticipation of the move, EMA staff who will not relocate to Amsterdam have already started leaving, and the agency said it expects the trend to accelerate. Meanwhile, Dutch employment rules mean that 135 short-term contract staff will no longer be able to work for the EMA, and overall the regulator expects to lose about 30 percent of staff, with a “high degree of uncertainty” around mid-term staff retention.
The EMA said in November 2017 that it would relocate to Amsterdam, with the Dutch capital selected from among three finalists that also included Copenhagen and Milan, Italy, out of 19 total applicants. The other applicants were Athens; Barcelona, Spain; Bonn, Germany; Bratislava, Slovakia; Brussels; Bucharest, Romania; Dublin; Helsinki; Lille, France; Milan, Italy; Porto, Portugal; Sofia, Bulgaria; Stockholm; Malta; Vienna; Warsaw; and Zagreb, Croatia.
The EMA has stated as of March 30, 2019, the UK will become a “third country” – meaning one outside the EU and EEA – and thus unable to take part in EMA evaluations of medicines. According to Reuters, despite efforts by the UK to remain under the EMA’s regulatory umbrella after Brexit, drug industry leaders fear regulatory disruption because under the EMA, the UK’s Medicines and Healthcare products Regulatory Agency, or MHRA, reviews around one-fifth of medicines in the EU.
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The agency’s regulatory authority covers the entire European Economic Area, including the entire European Union as well as Norway, Iceland and Liechtenstein, which are members of the EEA but not the EU. Switzerland has an independent agency, Swissmedic.
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