EMA withdrawal threatens UK patient access to cutting edge therapies


Brexit has caused uncertainty in British healthcare and pharmaceutical industries, with unknown implications for funding, staffing, and drug regulation. It has been peculated since the June 2016 referendum that the UK will be forced to withdraw from the EMA, which is predicated to belong to the European Court of Justice.

The EMA presents significant advantages to its member states through the centralised authorisation procedure, where companies submit a single application to gain approval for their product for all EU, European economic area (EEA), and European Free Trade Association (EFTA) member states. This makes Europe a top priority for companies seeking market approval for their drugs, representing 25% of the global market. In comparison, the UK accounts for only 3%. The loss of this mechanism would likely make the UK of less importance to companies planning product approvals, damaging patient access to cutting edge medicines.

This drug lag effect is compounded when considering the other advantages of mutual recognition. Central authorisation allows the EMA to process a greater volume of applications in less time, with the burden of the drug approval process shared across the resources and workforce of member states’ individual regulatory bodies. If the UK national regulator (Medicines and Healthcare Products Regulatory Agency) was to operate without assistance from the EMA, the review time for new drug applications would likely be slow.

Healthcare funding in the UK has seen a steady decline in the years following the 2008 financial crisis and Brexit is expected to restrict NHS budgets further. The IFS has projected that even if funding was to stay at its current level, spend per patient will be down 9.1% in 2018-2019 compared with 2010-2011. The combination of reduced interest in the UK market, increased time for drug approval, and a declining health budget threatens to severely obstruct patient access to superior drug therapies.