European Medicines Agency prepares for Brexit

The European Medicines Agency (EMA) has developed and initiated a business continuity plan to deal with the uncertainty and workload implications linked to the UK’s withdrawal from the European Union (EU) and the Agency’s relocation.

"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. 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," said Noel Wathion, EMA’s Deputy Executive Director and head of EMA’s Brexit task force.

The business continuity plan is a tool that will help EMA take the difficult decision to reallocate the available resources as needed to maintain its priority activities over the next years. It categorises and prioritises tasks and activities according to their impact on public health and the Agency’s ability to function. The plan sets out three layers of priority. In May, EMA started to scale back activities in the outer layer, so-called category 3 activities, to free up 43 staff by the end of 2017 who are focusing on the preparations for the UK’s withdrawal from the EU and EMA’s relocation.

EMA has reduced the number of audits as well as some corporate governance and support activities. Participation of EMA staff in external meetings or conferences has been reduced, as has the organisation of EMA meetings and workshops.

These types of activities can be put on hold for some time to free up or channel resources into core activities that need to be maintained under any circumstances. However, mid-to-long-term EMA will need to analyse how long these activities can be put on hold before they start to seriously undermine the quality of the Agency’s work and its planning, and the expectations of stakeholders.