EMA Reports Progress on Brexit Preparedness

Nicky Broyd

June 18, 2019

The European Medicines Agency (EMA) reports good progress in Brexit preparations ready for the UK leaving the EU. 

The UK's departure is currently set for October 31st this year – with the details to be worked out by whoever replaces Theresa May as Prime Minister. The result of the Conservative Party's leadership election to name its new leader, who will also become PM, is due in July.

The Royal College of General Practitioners continues to voice its concerns about the impact of a no-deal Brexit.

RCGP Chair, Professor Helen Stokes-Lampard, has written an open letter to the Conservative candidates seeking assurances. She said: "We need to know that regardless of who wins this contest, our health service will remain safe and free at the point of need for our patients – one of the foundations that this great source of national pride was built on."

EMA Staffing Issues

Although the UK has yet to leave the EU – or finalise plans for doing so – the EMA has already moved operations to the Netherlands from London.

It has been working from temporary premises in Amsterdam Sloterdijk for 3 months ahead of a final move to the city's Zuidas district. Staff are expected to begin working there in early January 2020.

However, the move has hit the Agency's headcount. Its latest board meeting heard that a final staff loss of 20-25% is anticipated.

The EMA ended 2018 with a headcount of 901. This month the available workforce was 776. Only 464 staff have moved to the Netherlands so far. A further 312 are teleworking mostly from London.

Recruitment is underway to replace staff who won’t be relocating.

The relocation has impacted the EMA with mainly only high priority, essential work continuing while many activities have been suspended, such as guideline development and most working party meetings.

Some suspended work will now begin to be reinstated and a major IT upgrade is planned.

The Agency reports further resourcing issues with new workloads including those linked to new legislation on medical devices, in vitro diagnostic medical devices, and EU DPR data rules. However, no additional resources have been made available for this work.

Brexit Preparedness

Medicine manufacture and supply is so intertwined across the EU that a lot of work has been done to make sure correct marketing authorisations and other requirements are in place for UK-made drugs.  

Progress reported so far includes:

  • Transfers of 400 UK marketing authorisations - changes made for 397

  • Qualified persons for pharmacovigilance - changes made for 243 out of 335 medicines

  • Pharmacovigilance system master files - changes made for 313 out of 376 medicines

  • Batch release sites - changes made for 95 out of 119 medicines

The EMA has received assurances from responsible companies that they have plans in place but are reminded to make any changes as soon as possible.

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