Last week, the UK government saw heated debates and closely contested votes on the post-Brexit strategy, including a favourable outcome for the future relationship of the UK and the European Medicines Agency (EMA) — 305 to 301 in favour of keeping the UK in the EMA.
Brexit health
So, what does all this mean for the pharmaceutical industry? We gauge industry response with two key opinion leaders from the sector:
Thomas Beck, senior vice president, quality management, Recipharm:
“Following its latest survey, the EMA has warned that the supply of more than 100 medicines manufactured solely in the UK is at risk of disruption post-Brexit because the necessary work to ensure they can be licensed and released for sale in mainland Europe has not been carried out.
“As a CDMO with a presence in both the UK and mainland Europe, we are well positioned to support our customers through the Brexit transition and have a taskforce dedicated to meeting the challenge head-on. We also expect to see a greater demand for outsourced manufacturing services from UK MAHs wishing to supply to Europe, which is further supported by the EMA’s latest announcement.
“Of course, ensuring the reliable supply of medicines post-Brexit is paramount and should be one of the main focuses of the industry over the coming months. We would like to see more action and guidance from the EMA to help pharmaceutical manufacturers understand the implications and make the required preparations. The initiatives shown by the UK government regarding a pragmatic approach to Brexit have not received any pragmatic response from the EMA which remains firm in its hard-Brexit approach.
“The best outcome is that a mutual recognition agreement is maintained between the EU and UK, meaning there will be limited to no immediate regulatory changes. The worst-case scenario, where no agreement is reached, may result in medicine shortages, which is extremely concerning.
“Treating the UK as a ‘third country’ post-Brexit also has the potential to create additional layers of complexity that manufacturers will have to adapt to if they are not already familiar with third-party importation practices.
“On 17 July 2018, MPs backed an amendment to the government’s suggested Trade Bill on the regulation of medicines after Brexit. MPs voted for the UK to take ‘all necessary steps’ to participate in the regulatory network operated by the EMA after it leaves the EU, which is certainly a positive step in favour of ensuring the smooth flow of medicines to British patients.
“The Brexit challenge needs to be faced in a pragmatic way and details need to be confirmed and communicated as a matter of priority or, as the EMA survey has found, patients across the UK and EU could suffer.”
Paul Brooks, executive director, Regulatory Affairs Professionals Society (RAPS):
“On 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?
“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.
“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.”