EMA Unveils Brexit Plan

On August 1, 2017, the European Medicines Agency (EMA) announced that the agency has developed a business continuity plan in response to the United Kingdom’s exit from the European Union. EMA is currently located in London and must relocate to another EU country.

The plan, which was developed by a taskforce established after the UK referendum, will help the agency prioritize tasks and activities that need to occur. The agency will base the priority of such tasks on their impact on public health and EMA’s ability to function.

There are three levels of priority outlined in the plan. Some category three level activities were scaled back in May 2017 in order to reassign agency employees to relocation preparations. As part of the scale-back, EMA postponed the development of an online portal with information on all drugs marketed in the EU, a transparency roadmap detailing future measures, the agency’s contribution to an e-submission project, and its participation in benchmarking of medicines regulatory authorities. EMA also reduced the number of audits and reduced staff participation in meetings. The agency plans on evaluating how long these tasks can be put on hold.

Category two activities, which include proactive publication of clinical data and EMA’s work on fighting antimicrobial resistance, will continue as long as possible depending on staff. The highest priority activities, category one of the plan, will continue as usual. EMA stressed that these activities, which include safety monitoring of drugs, are crucial in protecting patients. “Any disruption [of these activities] would almost immediately have a detrimental effect on the health and well-being of citizens in Europe and would also jeopardize production and distribution of medicines in the EU,” the agency stated in a press release.

“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 EMA’s Deputy Executive Director and head of EMA’s Brexit task force, Noel Wathion, in the press release. "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.”

Source: EMA