UK Seeks to Collaborate With EMA as Patients Fear Rising Costs, Shrinking Access

The UK government sought to reassure citizens this week that “Brexit,” or the United Kingdom’s withdrawal from the European Union (EU)—and therefore its withdrawal from the European Medicines Agency (EMA)—would not negatively impact patient access to pharmaceuticals.

UK health secretary Jeremy Hunt told the Financial Times in a letter that the UK would seek to “collaborate” with the EU on the approval of medicines “in the interests of public health and safety.” The letter, which stated that the UK sought to continue to work with the EMA even as it developed its own regulatory framework for the approval of medicines, represented a softening of position for Hunt, who had earlier stated that he expected the UK to sever ties with the EMA after leaving the EU. Hunt’s previous position caused many to fear that drug manufacturers would overlook the comparatively small UK marketplace in seeking lucrative drug approvals, forcing UK patients to wait longer for cost-saving treatments such as biosimilars.

As welcome as news of a potential collaboration between the UK and the EMA may be to stakeholders, the UK has yet to gain the agency’s agreement to any such arrangement. The EMA, for its part, says in its official materials that it expects the United Kingdom to become a “third country,” or a non-EU member, by March of 2019.

Brexit will not only affect the United Kingdom’s standing within the EMA; in the lead-up to 2019, the agency, too, will face significant challenges. The EMA must overhaul its frameworks for the ways in which responsibilities for evaluation and monitoring of medicines are shared among member states. It will also be forced to cope with the potential loss of UK staff and institutional knowledge. As it looks to the future, the agency says that it “needs to prepare in a timely manner to ensure that it can continue to deliver on its mission and protect public and animal health beyond March 2019.”

Virginia Acha, DPhil, executive director of research, medicine, and innovation for The Association of the British Pharmaceutical Industry (ABPI), recently echoed the EMA’s call for timeliness with respect to such restructuring, saying that “the timeframes we need to meet to ensure no disruption or delay to medicines supply will require securing swift agreement on both sides with regards to future medicines regulation.”

Despite this growing sense of urgency, answers to some of the most fundamental questions about the EMA’s post-Brexit future will not arrive for some time; the EMA, currently based in England, must be relocated to a remaining EU member state, but the EU has not yet determined a new location for the agency. EU ministers will not vote on proposals from interested EU member states or determine a final location for the agency until November of 2017.

It remains to be seen whether the major overhauls to the agency, and the pressures placed on its staff in the midst of Brexit negotiations, will negatively impact the EMA’s evaluation of medications for which applications have already been submitted. In its July update, the EMA notes that it is currently considering a number of biosimilars products, including 3 adalimumab candidates, 2 bevacizumab candidates, 1 infliximab candidate, and 1 insulin glargine candidate.