Brexit move creates EMA risk: report

The Brexit-inspired need to move the London HQ of the European Medicines Agency will throw up two major risks when it comes to patients and the approval of new medicines, according to a new report.

Maintaining expert support and retaining staff will be the biggest threats as the EMA seeks a new home somewhere else in the European Union, says the study on the impact of the move.

Commissioned by EFPIA and undertaken by Charles Rivers Associates, ‘Assessing the impact of the disruption from the relocation of the European Medicines Agency’ looks in depth at "the potential risk to business continuity as a result of the relocation, in regard to the different activities of EMA as well as the corresponding impact on public health (including patients and healthcare systems)".

It suggests that the EMA’s ability to call on, and manage, the "significant network of expertise it relies on" to support its activities, and its ability to retain its existing staff and capacity, may prove difficult.

No new HQ for the EMA, based in London’s Canary Wharf since 1995, has yet been decided. But the report says two of its major functions – sifting through applications and monitoring medicines safety - have the greatest potential impact on public health if they are disrupted.

The report says: "Delays in evaluating applications for marketing authorisation means delays in access to new medicines for patients across Europe. Disruption to critical safety functions can lead to delays in identifying, management and communication of safety issues, putting patients at risk."

It recommends that transitional arrangements are put in place to ensure the EMA has the time to manage the relocation and safeguard public health.

Moreover, it warns of an increase in the workload of some departments as a result of Brexit, such as marketing authorisation variations or a requirement for new site inspections.

Also, the report points to "significant concern" that activities that are important in the medium term may be neglected. "The result of this would be that Europe ‘falls behind’ the rest of the world in terms of regulatory science; there is especially concern about falling behind Japan and the US. This could have a particular impact on investments into the European market and in particular the growth prospects of small and medium-sized enterprises."

"This report underlines the importance of both the location decision and transitional arrangements to the agency’s future," says EFPIA Director General Nathalie Moll. "Supporting the continuity of its critical functions, its ability to retain staff and access expert networks is central to its future and to public health."