EMA Scales Back Activities, Prioritizes Tasks to Cope With Brexit

The European Medicines Agency (EMA) announced this month that it has initiated a business continuity plan to cope with the political uncertainty and the workload implications of the United Kingdom’s (UK) impending withdrawal from the European Union (EU) and the EMA’s relocation from its current home in London, UK, to an as yet undetermined city.

As of August 1, 19 cities in EU member states—including Dublin, Amsterdam, Brussels, and Stockholm—have submitted proposals to host the agency upon its departure from London. The European Commission will begin assessing those offers by the end of September 2017, and will vote on a final location for the agency in November.

“Preparing for the move, managing the necessary changes, and addressing challenges such as possible losses in skilled and experienced staff, in a proactive and efficient way requires considerable internal resources,” said Noel Wathion, EMA’s deputy executive director. "With the business continuity plan we aim to ensure that the assessment of medicines is not disrupted and that patients in Europe continue to have access to high quality, safe and effective medicines.”

The plan, which categorizes agency activities into 3 levels of priority, is intended to help the EMA reallocate its resources in order to ensure that its critical activities and functions will be maintained over the coming years.

The agency will suspend the following lowest-priority activities:

• Development of the European Medicines Web Portal, the agency’s publicly available online resource concerning medicines marketed in the EU
• Contribution to an electronic submission project that will allow online filing of documents related to the authorization of medicines
• Development of a transparency roadmap for the agency
• Participation in the benchmarking of medicines regulatory authorities in the EU

The agency also scaled back the number of audits it plans, as well as corporate governance and support activities. Staff will attend fewer external meetings and conferences, and the agency will organize fewer meetings and workshops.

In middle tier of priority, activities including publishing clinical data and undertaking initiatives to promote the availability of medicine will be, the agency said, “maintained as long as possible, workload and staffing situation permitting.”

The highest-priority activities, which the agency deems crucial to the health and wellbeing of Europe’s citizens, include inspections, the assessment and safety monitoring of medicines, and the maintenance of critical information technology systems.

The agency says that it will adjust the business continuity plan as it assesses how many of its 900-person strong staff it may lose in its relocation, as well as how such a loss of personnel may affect its ability to carry out its high-priority tasks. If the EMA loses too many workers too quickly as a result of the move, it warns, “the Agency’s relocation may lead to a situation in which EMA’s operations can no longer be maintained.”