It has now been a year since the United Kingdom voted to leave the European Union. Since then, discussions about the process of achieving Brexit have been fierce — including those affecting the pharmaceutical and biotechnology industries where business is often transnational and drug reviews and approvals have been conducted in a unified manner under the auspices of the European Medicines Authority. While actual negotiations have yet to begin, a number of parties have warned of serious consequences to both industry and patients if negotiators don’t move carefully to minimize disruption to the industry.
Recently, leaders of eight trade associations from across the United Kingdom and Europe joined forces and sent a letter to the chief negotiators, Michel Barnier and David Davis, underlying the importance of securing ongoing cooperation between the EU and UK. The letter warned that the supply of life-saving drugs to patients could be delayed in the event of a disorderly withdrawal of the UK from the EU.
The communication pointed out that the pharmaceutical industry was highly integrated across Europe and regulated under EU law. Disruption of that process could lead to drugs being held at the border or in warehouses, or could necessitate the extensive re-testing of medicines for use in the UK, if no effective deal was reached. While medicines marketed in 2010 or earlier would be covered by reciprocal agreements under the World Trade Organization, and so not affected by tariffs, the same would not apply to drugs produced after that date nor to drug ingredients or placebos required for clinical trials.
The leaders called for the maintenance of previously granted European marketing authorizations both in the UK and EU, as well as continued cooperation between national regulatory authorities as facilitated by the EMA, post Brexit-IT. They’ve also called for the negotiators to respond quickly to their requests, in order to reassure the industry and minimize the risks of disruption.
Several senior politicians in the British government have also called for the country to work closely with EMA after Brexit — or better, to remain under EMA jurisdiction — standing up to their colleagues who have been pushing for a clean break from European regulation.
The UK faces several important risks if the process of Brexit is not handled with considerable deliberation and cooperation with the EU and EMA. Pharmaceutical leaders and economic analysts have in particular warned that patients would likely wait longer and pay more for new drugs if the UK created a drug approval system distinct from the EMA. Differences in drug approval times would be one factor. But more critically, a separate drug licensing authority for the UK would mean separate regulatory filings — and with them, higher workloads and costs for companies seeking approval. The result would likely mean that UK patients would wait longer and pay more for new drugs, as drug developers reclassified the relatively small UK market as much lower priority when compared with the much larger ones of the United States, Europe and even Japan.