United Kingdom Seeks to Remain Part of the EMA After Brexit

This past week, the United Kingdom’s Members of Parliament voted 305 to 301 to approve an amendment to the Trade Bill that will require the nation’s negotiators to try to secure UK involvement in the European Medicines Agency (EMA) after Brexit.

News of the negotiation objective is welcome in the pharmaceutical industry, which has long warned of the need for regulatory continuity in the wake of the UK withdrawal from the European Union.

In a joint statement, Mike Thompson, chief executive of the Association of the British Pharmaceutical Industry, and Steve Bates, chief executive of the BioIndustry Association, said, “Today, 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 [United Kingdom] from the [European Union] and 45 million move the other way. Therefore, it is essential that the [United Kingdom] continues to participate in the EMA after Brexit.”

Whether the European Union will be amenable to such an arrangement remains unclear, however; earlier this year, after UK Prime Minister Theresa May suggested a continued UK role in the regulatory body, the European Council signaled that, given the United Kingdom’s insistence that it will no longer remain a part of the EU single market, the European Union would not allow “cherry picking” of sectors for UK involvement.

While the UK regulatory authority, the Medicines and Healthcare Products Regulatory Agency, has sought to reassure stakeholders that it is proactively planning for all possible outcomes of Brexit negotiations concerning the EMA, concerns remain about disruption to the supply of crucial drugs after Brexit.

Earlier this month, the EMA revealed the results of a survey of UK pharmaceutical companies concerning their Brexit preparations, and while the majority of companies (94%) have plans to submit transfer applications for their products in a timely manner, the EMA issued a warning that for 108 drug products that are manufactured exclusively in the United Kingdom, there exist “serious concerns” that necessary steps to prepare for Brexit are not on track. Failure to complete crucial regulatory steps pre-Brexit could lead to supply shortages for these drugs.