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EMA cuts back as Brexit staff losses top expectations

Regulator says it faces loss of 30% of staff


The European Medicines Agency (EMA) is scaling back its operations temporarily as it deals with a higher-than-expected staff attrition ahead of its move from London to Amsterdam.

The suspension of some non-urgent activities will allow it to keep essential services running as it faces the loss of around 30% of its headcount, including 135 short-term contract workers who will no longer be able to work for the agency due to Dutch employment law.

“It has…become clear that the agency will lose more staff than initially anticipated,” said the EMA in a statement, adding that “this trend is expected to accelerate” as the date for the relocation approaches. It’s also concerned about the situation after the move, saying there is a “high degree of uncertainty on mid-term staff retention.”

The EMA moves to its new home next year as a consequence of the UK’s exit from the EU, which takes place on 29 March 2019. The final home for the agency won’t be ready for some months, however, and staff will have to move into temporary premises in the city in the meantime.

From 1 October, the EMA will be reining in international collaborations, focusing only on critical areas such as product evaluation and supervision, supply-chain integrity and Article 58 procedures, which deal with access to medical products and public health in low and middle-income countries.

That means less urgent matters such as harmonisation will be will be dealt with only on a reactive basis, and other topics such as antimicrobial resistance will be considered on a case-by-case basis.

Similarly, guidelines development will also be limited to particularly pressing areas, such as Brexit itself or public health emergencies, non-essential working party activities will be curtailed, and it won’t attend stakeholder meetings that are not related to Brexit or the agency’s relocation.

The EMA will also halt the launch of new procedures related to clinical data publication as of August, but will process all data packages submitted through July 2018.

The reduced activities will help maintain essential public health activities and “allows for training of EMA staff who will be re-assigned to new duties ahead of the peak relocation time which will start in early 2019”, according to the regulator.

As the arrangements for a transition period after 29 March is yet to be finalised, the EMA said earlier this month that pharma companies should take this as their deadline date for regulatory changes – adding that it was concerned some companies could be caught out as a result.

In particular, it said companies have to plan for the UK becoming a ‘third country’ to the EU, which means updating any centrally authorised products (CAP) marketing authorisations which have a crucial step registered in the UK.

Article by
Phil Taylor

1st August 2018

From: Regulatory



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