The European Medicines Agency (EMA) is making preparations even before the name of the city where it will be located after Brexit, when the United Kingdom will leave the EU, is known (see EUROPE 11841). Nineteen applications to host the agency have been submitted. In a press release published on 1 August, the EMA says that it had put some of its activities on hold in order to “free up or channel resources into core activities that need to be maintained under any circumstances”.
Its new business continuity plan categorises and prioritises tasks and activities according to their impact on public health and the agency’s ability to function. It provides for the scaling back or temporary suspension of activities in the third of three categories, the “outer layer”. Among these activities are the development of the European Medicines Web Portal, the development of a transparency roadmap for the EMA and participation in the benchmarking of medicines regulatory authorities in the EU from 2018. The agency also says that it 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. The intention is to free up 43 staff by the end of 2017 to allow them to focus on the preparations for Brexit and EMA relocation.
“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.
At this stage, the EMA intends to continue with the activities in categories 1 and 2. Category 1 includes the highest priority activities that are either directly related to the assessment and safety monitoring of medicines or vital to maintaining the infrastructure of the European regulatory system for medicines, including, for example, the coordination of actions to protect the safety of patients in all EU member states, inspections across the EU and maintenance of the functionality and security of critical IT applications used by member states. Category 2 consists of activities, such as the proactive publication of clinical data, and various initiatives aimed at promoting availability of medicines as well as some political priorities of the EU, for example, EMA’s contribution to the fight against antimicrobial resistance or the Agency’s interactions with Health Technology Assessment (HTA) bodies. “These activities will be maintained for as long as possible”, the agency says.
The city where the EMA will be headquartered is expected to be known by November. At this stage, 19 cities are in the running: Amsterdam (Netherlands), Athens (Greece), Barcelona (Spain), Bonn (Germany), Bratislava (Slovakia), Brussels (Belgium), Bucharest (Romania), Copenhagen (Denmark), Dublin (Ireland), Helsinki (Finland), Lille (France), Milan (Italy), Porto (Portugal), Sofia (Bulgaria), Stockholm (Sweden), SmartCity (Malta), Vienna (Austria), Warsaw (Poland) and Zagreb (Croatia). (Original version in French by Sophie Petitjean)