The loss of Ema personnel due to the relocation of the office to Amsterdam after Brexit may cover 30% of the staff. The Agency has announced that phase 3 of the business continuity plan will start on October 1rst 2018. The plan involves the reduction or suspension of many non-essential activities.

The temporary cuts in activities are required because it has also become clear that the Agency will lose more staff than initially anticipated. Staff who will not be relocated 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.

Phase 3 business continuity plan

Following the implementation of phase 1 and 2 of the business continuity plan, in phase 3 EMA will start to temporarily scale back or suspend additional activities through to 2019. This contributes to protecting EMA’s essential public health activities and allows for training of EMA staff who will be reassigned to new duties ahead of the peak relocation time which will start in early 2019.

Activities included

According to the Agency’s announcement, the launch of new procedures for the publication of clinical data will be suspended as of 1 August, while the data filed by the end of July will be processed and finalized.

Among the other activities that will be touched by phase 3 there are those of collaboration at international level, which will be focused only on requests related to products, supply-chain integrity and procedures pursuant to Art. 58. The commitment of Ema’s staff on issues such as the regulatory harmonization of medicines will only be globally reactive while we will try to maintain that on issues that impact public health, such as antimicrobial resistance or vaccines, on the basis of considerations that will be made case-by-case.

The development and revision of the guidelines will also be slowed down, and will be limited to documents for which there is an urgent need for public health or animal health, or have a direct impact on preparing and facilitating Brexit. The slowdown in these activities will also entail waiting for work groups not directly related to products.

The suspension and slowdown of many projects will result in a parallel slowdown or suspension of the related governance activities. The organization and participation of Ema’s staff in meetings with stakeholders, in particular, will only be limited to the interactions aimed at Brexit.

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