Brexit Creating a Period of Uncertainty for EU, UK Drug and Device Regulators

Regulatory NewsRegulatory News | 28 June 2016 |  By 

The fallout from the UK referendum is continuing to create strife among the ranks of the European Medicines Agency (EMA), though a top EMA official told the DIA annual conference on Tuesday in Philadelphia that business at the agency will carry on as usual as negotiations continue.

Emer Cooke, head of international affairs at the EMA, said that the Brexit decision, which may cause the agency to leave London, “is a decision that affects a lot of the staff of the agency, personally and professionally.” She also expressed general shock over the vote, noting, “You sort of don’t believe it,” though she also stressed that it is “too early to say what’s going to happen,” and “we will continue with business as usual – no immediate changes apart from the emotional shock.”

“Our mission is to protect and promote public health,” she said, noting that the EMA will continue to ensure access to medicines across the EU. “We’re a strong agency, with strong leadership and motivated staff, and we will deliver on our core business.”

Cooke replaced the agency’s Executive Director Guido Rasi at the DIA conference and told attendees that Rasi is continuing to support EMA staff in London.

FDA Commissioner Robert Califf also spoke Tuesday alongside Cooke and said that despite the recent events in the UK, regulators need smooth and efficient systems to continue because of the global nature of the pharmaceutical and medical device industries.

The comments come as other experts have stressed the unexpectedness of the vote and the way that the EMA relies on the expertise of UK scientists and public health officials, and vice versa.

Sir Kent Woods, former EMA chairman of the board and former chief executive of the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), who rallied against Brexit in May, told Focus via email, “The result was unexpected to most people and the necessary UK/EU negotiations at political level have not yet started - nor are they likely to until David Cameron's successor as Prime Minister has been chosen.”

Woods also said, not on behalf of EMA or MHRA, that he believes there should be a focus on minimizing duplication and there could be opportunity for the UK to move its regulatory agenda forward more quickly.

“At the operational level, there has hitherto been close working between MHRA and EMA (and between MHRA and the other national regulatory agencies). The MHRA is the largest such agency in the EU and well placed to provide a national function though one would want to minimise duplication of effort wherever possible,” he told us. “Clinical trial authorisation is already a national rather than an EMA responsibility. Most marketing authorisations for generics are granted at national level via the Mutual Recognition procedure; the future of that remains to be determined.

“At the policy level, there is a large body of EU legislation underpinning all UK medicines and devices regulation which has either been transposed into UK law or (in the case of Regulations) has direct effect. Across the whole of government, it will be a large task to review that legislation in depth, but potentially it gives an opportunity to take the Better Regulation agenda forward faster than is possible through the EU institutions.”

And as Cooke told DIA conference attendees, Woods said the future negotiating positions of the EU and UK are not yet clear, which makes it difficult to understand how quickly the Brexit vote will have a direct impact on the two agencies.

“At this point the UK government has not yet initiated the treaty process (Article 50) for withdrawing from the EU,” Woods said. “We therefore have no knowledge of the future EU and UK negotiating positions, which will determine what might be retained of the present medicines and medical devices regulatory systems. It is probably not helpful to speculate on the details until the broad outlines have been drawn.”

Woods' caution echoes sentiments made by an EMA spokeswoman, who told us late last week: “Article 50 of the Treaty on the Functioning of the EU foresees the procedure to be followed in case a Member State notifies the European Council of its decision to withdraw from the Union. No country has ever decided to leave the EU, so there is no precedent for this situation.”


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