EMA to Survey Pharma on Brexit Preparedness

The European Medicines Agency (EMA) has launched a survey of pharmaceutical companies to assess their preparedness for the United Kingdom’s upcoming withdrawal from the European Union, as it hopes to identify any concerns about the continued supply of drugs during the Brexit transition.

The EMA is sending its survey directly to companies based in the United Kingdom that hold central EU marketing authorizations for medicines—as well as companies that have their quality control, batch release, import manufacturing sites, or pharmacovigilance operations in the United Kingdom—about their Brexit-related plans. Specifically, the EMA hopes to gain insight into companies’ plans to submit transfers, notifications, or variations to their marketing authorizations.

The EMA says that it hopes that the survey will identify companies in which “…there is a need for concerted action” to ensure the uninterrupted supply of medicines after Brexit and that it can help the EMA and the European Commission plan how to best use their resources in the days ahead. The survey, says the EMA, may also “…serve to stimulate those companies who have not yet taken any action” in planning for Brexit to begin developing and implementing plans.

Concerns about the availability of medicines in the United Kingdom and European Union following Brexit have intensified in recent months; despite recent assurances from the United Kingdom’s Medicines and Healthcare Products Regulatory Agency that there will be no sudden overhauls to UK regulatory frameworks after Brexit, the continued lack of progress on a UK—EU trade deal raises the specter of potential drug shortages.

In November, the European Federation of Pharmaceutical Industries and Associations (EFPIA), an industry group, released the results of its own survey of 43 pharmaceutical companies and 33 national associations, which found that 45% of respondents expect trade delays in the event of a “no deal” Brexit. Currently, 45 million patient-ready packages of medicines are supplied to the European Union from the United Kingdom each month (and the United Kingdom receives 37 million packages each month from the European Union). Any trade delays, according to the EFPIA, could create significant issues for medicine availability.

Pharmaceutical companies will have until February 9 to complete the newly launched EMA survey, and the agency will share its findings and recommendations with the European Commission.