Brexit and Pharmacovigilance


One of the areas that the UK has led on in the EU, and worldwide, is the science of pharmacovigilance and regulatory science. The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) is a world class organisation in drug regulation, and has been a leader on drug safety since the thalidomide disaster in the 1960s. Since 1995, the European Medicines Agency (EMA) has regulated drug approvals centrally and has sought to harmonise drug safety and pharmacovigilance systems across the EU and across the pharmaceutical industry. EMA is a the EU equivalent of the US’s FDA. It plays a crucial role in the provision of safe medicines, and in the delivery of new medicines across the EU’s single market.

By creating a harmonised system of regulation it allows the pharmaceutical industry to market products across Europe more easily, and yet at the same time increases the safety of medicines by pooling drug safety resources, including spontaneous reports of adverse effects. Prior to this companies had to negotiate a complex system of individual member state regulatory systems.

EMA is in large part built on a MHRA model, with a knowledge base of UK experts in drug regulation and pharmacovigilance. Even the EU legislation has the clear imprint of British expertise. The UK’s black triangle is now Europe wide. EMA is based in London, employing 600 staff (mainly British). There is concern about its future if we leave the EU.

In the event of a Brexit, which could also cast uncertainty over the future of the bank authority, Europe’s equivalent of the U.S. Food and Drug Administration may have to find a new home, in a jolt to the current drug approval system.

This could slow the approvals of medicines across Europe during this transition process, including in Britain if it has to re-engineer its system.

Losing Britain could also punch a big hole in the EMA’s scientific capability, since British experts are the biggest single contributors to its drug assessment system.

EMA would most likely re-locate to another EU state, and there would be a loss of UK staff from the agency. Drug regulation in the EU and UK would be disrupted. The pharmaceutical industry damaged for a short period. In the medium to long term, it is likely the a corresponding increase in MHRA staff (presumably obtained from EMA staff unwilling to relocate) could take over work that previously EMA carried out. In the short term, a difficult transition phase would occur. Indeed, as noted in the Reuters article above one could argue that EU drug regulation would be more damaged than the UK’s: UK experts led on 27 new drug approvals, compared to 15 by German experts in 2014 – the next highest group. Even if one accepted that the MHRA would adjust relatively quickly compared to EMA, the damage to harmonisation, and pooled resources for drug safety, would be a net loss for the UK.

UK pharmaceutical companies may also end up having to apply for UK licencing and EU licencing, unless the UK was willing to accept drug licencing from an EU body they are no longer part of (which is as unlikely as them accepting FDA approvals, and hardly the ‘sovereignty’ the Leave group are voting for).

Drug regulation and pharmacovigilance may not be the deciding factor for anyone in the EU vote, but it highlights the complexities of the relationships we have in the EU. A Leave vote should come with a drug safety warning in this area at least.