Brexit trade bill: Not yet

The UK has decided it will continue to be involved with the European Medicines Agency (EMA) after Brexit. Paul Brooks, Executive Director at the Regulatory Affairs Professionals Society (RAPS) asks what does this mean for the pharmaceutical industry and patients after 2020?

The UK is now less than a year away from the official exit yet there is still ambiguity and important negotiations to take place

On the 17 July, UK Parliament voted in favour of continuing the UK’s involvement with the European Medicines Agency (EMA) after leaving the EU. The pharmaceutical industry is in a state of significant uncertainty. The UK is 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 "necessary steps" to participate in the regulatory network operated by the European Medicines Agency (EMA) after it leaves the EU, 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.

RAPS is committed to informing regulatory professionals with the latest news and insights as they develop and is closely monitoring this period of transition. This new development from the House of Commons is a step forward towards a more aligned UK and EU regulatory landscape and should instil confidence in drug manufacturers for a smoother transition post-Brexit, most importantly safeguarding the continuous supply of vital medicines.