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Significant staff losses compel European drugs regulator to rein in activities

Agency anticipates shedding 30 per cent of workforce in move to Amsterdam

Caroline White

Friday, 03 August 2018

The European Medicines Agency (EMA) drugs regulator is set to scale back or suspend a range of activities to cope with heavy staff losses and protect its core functions as it prepares to relocate to Amsterdam when Britain leaves the EU next March.

The plans, which are short-term and will be rolled out no later than October, in line with the third phase of its Brexit business contingency plan, have been given added heft by higher than initially anticipated staff losses.

Staff who are not relocating to Amsterdam have already started to leave and this trend is expected to accelerate, says the EMA. What’s more, employment rules in the Netherlands mean that 135 staff on short-term contracts will no longer be able to work for the EMA.

Overall, the Agency expects its workforce to shrink by about 30 per cent, with “a high degree of uncertainty” regarding its ability to retain staff in the medium-term.

The Agency has put in place various measures to ensure the relocation of staff to Amsterdam goes as smoothly as possible, and the Dutch government is providing additional support. A comprehensive staff recruitment programme is already underway.

“However, in the short- to mid-term, EMA will have to reprioritise 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,” the Agency said in a statement earlier this week.

The scaling back or suspension of activities will not only safeguard EMA's essential public health activities but also allow for the training of EMA staff who will be re-assigned to new duties ahead of the peak relocation time which will start in early 2019, it says.

Activities initially affected by phase 3 include collaboration at international level, which will be temporarily scaled back to focus primarily on product-related requests, supply-chain integrity, and procedures under Article 58 (data protection).

In other areas, such as the harmonisation of global medicine regulation, EMA will only take a reactive role. Although its involvement in other global public health issues, such as antimicrobial resistance or vaccines, will be maintained as long as possible, but this will be reviewed on a case-by-case basis.

The development and revision of guidelines will also be limited to those guidelines that address an urgent public/animal health need or are necessary to support preparations for Brexit. Holding of non-product-related working parties will consequently be reduced.

Organisation of, and attendance at, stakeholder meetings will be limited to Brexit-related issues.

And the publication of clinical data will be suspended as of 1 August 2018, but all data for medicines submitted until the end of July will be processed and finalised.

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