EMA Scales Back Activities to Prepare for Brexit

Aug 09, 2018
By BioPharm International Editors

The European Medicines Agency (EMA) announced on August 1, 2018 that it will temporarily scale back activities for the next phase in its continuity plan. The scale-back is in response to an expected 30% loss in staff as the agency prepares to move its headquarters to Amsterdam, the Netherlands.

According to the agency, it will launch the next phase of its business continuity plan on October 1, 2018 at the latest to prepare for the move. This will allow the agency to safeguard core activities related to the evaluation and supervision of medicines, while it intensifies its preparations for the physical move to Amsterdam in March 2019 and copes with the  “significant staff loss”.

“The temporary cuts in activities are required because it has also become clear that the agency will lose more staff than initially anticipated,” said EMA in a press statement. “Staff who will not relocate to Amsterdam have already started to leave the Agency and this trend is expected to accelerate. 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, EMA expects a staff loss of about 30%, with a high degree of uncertainty regarding mid-term staff retention.”

EMA states that it has put in place supporting measures to facilitate the relocation of staff to Amsterdam and additional support is provided by the Dutch government. Other mitigating actions, such as a comprehensive staff recruitment program, are already taking place. However, in the short- to mid-term, EMA reports that it will have to reprioritize its resources to fully maintain its core activities related to the evaluation and supervision of medicines to the level of quality and within the timelines expected.

Following the implementation of phase one and two of the business continuity plan, EMA, in phase three, will start to temporarily scale back or suspend additional activities through to 2019. This contributes to the protection of EMA’s essential public health activities and allows for the EMA staff, who will be re-assigned to new duties ahead of the peak relocation time, to be trained. Staff training will start in early 2019.

Activities initially impacted by phase three include: international collaboration, which will be temporarily scaled back to focus on issues such as product-related requests and supply-chain integrity; development and revision of guidelines, which will be temporarily limited to those that address an urgent public/animal health need; and clinical data publication, for which the launch of new procedures will be temporarily suspended.

According to the agency, detailed plans for the implementation of these measures are currently being developed and will be communicated to the public as well as stakeholders concerned as soon as they are available.

Source: EMA

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