Brexit and biopharma: The UK/EU divorce begins
Last summer, the U.K. population voted in a referendum over whether to stay in the European Union. The vote to leave outpaced the vote to remain by a narrow 52% to 48%. And after ten months of debate (and rather a lot of name calling) the first formal step took place on March 30, when the U.K.'s Prime Minister Theresa May invoked Article 50 of the Lisbon Treaty, triggering the two-year exit process.
The next step will be a meeting on April 30 that will set out the proposals for creating a post-Brexit statute book, including how EU laws will be converted into U.K. laws, with corrections for laws that won't work outside the EU. This could include the so-called 'Henry VIII clauses', which give government the power to repeal legislation without parliamentary approval. After this, the EU and U.K. will vote on the deal in 2019. This will be a long process and it remains to be seen what will actually be the outcome. As Donald Tusk, President of the European Council, said, "Nothing is agreed until everything is agreed."
So what does this mean to biotech and pharma?
While the impact is not yet clear— and will only be determined by time, pharma already began expressing fears about U.K. jobs and research before the vote took place.
The impact on the U.K. regulatory process
The regulatory challenge is going to be the most pressing. The U.K. will no longer be covered by the European Medicines Agency, and so will have to manage its own drug approvals and the monitoring of adverse effects post-marketing. It may also lose access to data held by the EMA on safety, efficacy and pharmacovigilance.
While the government has not yet raised this as an issue, there was a nod to it in the Article 50 letter, which said: "We should therefore prioritise how we manage the evolution of our regulatory frameworks to maintain a fair and open trading environment."
A press statement from the European Federation of Pharmaceutical Industries and Associations (EFPIA) emphasized the importance of alignment between U.K. and EU regulatory regimes, "in order to maintain capacity, processes and time-frames for the introduction of new medicines for patients and avoid divergence and duplication of regulatory standards and practices."
Ripples across Europe
The exit of the U.K. from the EMA could also have a knock-on effect on drug approvals in Europe, as the EMA is currently located in Canary Wharf, previously an East London dock and now one of the U.K.'s two main financial districts. The authority will have to relocate to one of the remaining member states, which could potentially have an impact on staff retention and recruitment, as well as raising the risk of approvals or adverse event alerts being delayed during the process.
The U.K.'s Medicines and Healthcare products Regulatory Agency (MHRA) also plays a role in the centralized and decentralized regulatory processes, and in the voluntary PRIME (PRIority Medicines) scheme that supports drug developers working on therapeutics that target unmet medical needs —further driving concerns that the U.K.'s withdrawal could have an impact on the EMA's workload and patient access to drugs.
Where the new EMA headquarters ends up is dependent on the remaining 27 states in the EU. Official and unofficial pitches so far include the Netherlands, Ireland, Italy, Sweden, Austria, Hungary, Malta, Portugal, Spain, Denmark, Germany and Finland.
The pharma and biotech industry could also face challenges in manufacturing, as companies have supply chains that stretch across Europe, requiring drugs and devices to cross borders during the manufacturing, formulation and packaging process.
Looking for the positives
Scientific and medical research is strong in the U.K., with a long history of innovation in both academia and the industry, as well as good levels of collaboration between the two. The government has assured the pharma industry that it is among the "top three industries that Britain wants to swing behind," and in response, GlaxoSmithKline has shown a commitment through continued investment in its facilities in England and Scotland. There also hasn't been a significant impact on foreign investment over the last few months, signaling a vote of confidence in the U.K.'s presence in the global pharma and biotech industry.
The BioIndustry Association (BIA) is currently working with the U.K. government, the Association of British Pharmaceutical Industries (ABPI) and a number of U.K. pharma companies as part of the U.K. EU Life Sciences Steering Group on the U.K. EU Life Sciences Transition Programme. The aim is to recommend "how the U.K. can seize the opportunity to define a new relationship with the EU." This will include how to make the U.K. life sciences industry attractive to investors and collaborators, and how to best negotiate with the EU and European life sciences bodies to get the best outcome for industry, health systems and patients.
- Steve Bates, chief executive, BioIndustry Association BIA Brexit Briefing Webinar
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