Protecting the links between the UK and the EMA

On the 17 July, the UK Parliament voted 305-301 in favour of continuing the UK’s involvement with the European Medicines Agency (EMA) after the island leaves the EU. But what does this mean for the pharmaceutical industry and patient healthcare after 2020? Paul Brooks, executive director, Regulatory Affairs Professionals Society (RAPS) shares his views.

"The pharmaceutical industry is in a state of significant uncertainty. We are now less than a year away from the official exit yet there is still ambiguity and important negotiations to take place. However, MPs have now voted for the UK taking "all necessary steps" to participate in the regulatory network operated by the European Medicines Agency (EMA) after it leaves the European Union, which is likely to instil some confidence within the industry. Of course, EMA has yet to determine the terms on which the UK could remain part of the agency post-Brexit.

"In a joint statement on behalf of the pharmaceutical industry in the UK, Mike Thompson, chief executive of the Association of the British Pharmaceutical Industry, and Steve Bates, chief executive of the BioIndustry Association, said: "Parliament has sent a clear message that patients and public health should be a top priority for the Government in these negotiations. Every month, 37 million packs of medicine arrive in the UK from the EU and 45 million move the other way. Therefore, it is essential that the UK continues to participate in the EMA after Brexit, as set out in the Brexit White Paper and in the Prime Minister’s Mansion House speech."

"There have been many warnings from experts within the industry that Brexit could affect access for all Europeans to the most effective, affordable, safe and innovative healthcare products. As negotiations continue, new legislation must protect the links between the UK and the EMA to ensure the smooth flow of medicines and new drugs for British patients after Brexit.

"Following the EMA’s decision to re-locate to Amsterdam post-March 2019, the outcomes and consequences of Brexit are still far from predictable, but it is RAPS’ role as an association for regulatory professionals, to press for practical, effective solutions that serve all stakeholders. The most important goal is that we maintain access to new drugs for patient health."

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