European Medicines Agency Scales Back In Preparation for Brexit

EMA_Editorial_Alessandro Zappalorto

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As Britain’s “Brexit” from the European Union moves closer and closer, the European Medicines Agency (EMA), the equivalent to the U.S. Food and Drug Administration (FDA), temporary halted some of its activities in preparation. Because the agency expects to lose about 30 percent of its staff in the move from London to Amsterdam, it is stripping operations down to core activities.

Labiotech writes, “As a result of the temporary cuts, international collaborations will be scaled back so that the EMA will only have a reactive role in negotiating global medicine regulations. The EMA’s engagement in addressing other international health issues, such as combating antimicrobial resistance or vaccines, will be maintained for as long as possible.”

It expects to continue business-as-usual, at least as much as possible, in 2019 after Brexit occurs.

The cuts are likely to affect other EMA activities, such as developing scientific guidelines for regulatory approval applications, and the publication of clinical data to support regulatory applications.

It was reported yesterday that pharmaceutical companies are stockpiling drugs in preparation for the likelihood of supply chains being disrupted during the withdrawal. Sanofi, AstraZeneca and Novartis AG have indicated they are stockpiling drugs. AstraZeneca, headquartered in Cambridge, UK, announced last month that it planned to increase its drug stockpiles by about 20 percent in preparation for Britain leaving the European Union. Roche, based in Switzerland, has indicated it was taking “appropriate action” to review and manage inventory, as did London-based GlaxoSmithKline. GSK announced last week it was acting to secure its drug and vaccines supplies.

Reuters wrote, “Supplies of thousands of medicines are at risk of disruption if Britain leaves the EU without a deal, forcing manufacturers to prepare duplicate product testing and licensing arrangements to ensure their drugs stay on the market. More than 2,600 drugs have some stage of manufacture in Britain and 45 million patient packs are supplied from the UK to other European countries each month, while another 37 million flow in the opposite direction, industry figures show.”

Lawmakers in Britain have called for a deal that would allow the country to continue participating in the European medicines regulatory framework, but so far that hasn’t been firmed up.

The EMA was founded in 1994 with the goal of simplifying and centralizing the European Union’s drug approval process, which was scattered over 28 different countries. Since then, it has largely replaced the activities of the member countries’ own regulatory bodies.

Labiotech notes, “After Brexit is complete, the UK will not be a part of the EMA and will regulate its own drug approvals. But as the temporary cuts illustrate, the consequences of Brexit have compromised the entire EMA, which will affect all remaining member states. Not only will this make it more complicated for European life science companies to reach regulatory approval for their treatments, it also mitigates the EU’s active role in addressing global public health issues.”

The EMA stated, “It has … become clear that the agency will lose more staff than initially anticipated…. This trend is expected to accelerate” as the agency’s relocation gets closer. It added, there is a “high degree of uncertainty on mid-term staff retention.”

The official date of Brexit is March 29, 2019.

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