The European Medicines Agency (EMA) has announced a temporary cutback in activities as it prepares for a workforce loss of up to 30% following its move to Amsterdam.
The cutback in activities forms the third phase of the agency’s business continuity plan, designed to “safeguard continuity of EMA’s operations to protect public health” as it prepares for Brexit. The plan prioritises core activities and reallocates resources where needed.
In a statement released on 1 August 2018, the EMA said the scaledown of functions, which will begin on 1 October 2018 “at the latest”, was necessary because it had “become clear that the agency will lose more staff than initially anticipated” as it prepares to relocate from London.
“Staff who will not relocate to Amsterdam have already started to leave the agency and this trend is expected to accelerate,” the statement continued. “In addition, due to the employment rules in the Netherlands, 135 short-term contract staff will no longer be able to work for EMA. Overall, [the] EMA expects a staff loss of about 30%, with a high degree of uncertainty regarding mid-term staff retention.”
Activities to be scaled down include international collaboration, with the agency taking a reactive-only role in the harmonisation of global medicine regulation; the development and revision of guidelines, which will be limited to those that address an urgent public or animal health need, or are necessary to facilitate Brexit; and organisation and attendance at stakeholder meetings, which will also be limited to Brexit-related interactions.
As of 1 August 2018, the agency has also suspended the launch of new procedures under its clinical data publication arm. It will process and finalise data packages for medicines that were submitted before the end of July 2018.
The agency added that it will continue to be engaged in global public health issues, such as antimicrobial resistance or vaccines, for as long as possible, but that the engagement will be “reviewed on a case-by-case basis”.
The EMA has said that detailed plans of the phase 3 implementation procedures will be communicated to the public and other stakeholders as soon as they are available.