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Brexit

EMA suspends some work as it launches business plan for Brexit

Activities that are being suspended include work on an online information source of medicines marketed in the European Union and an electronic submission method for medicine authorisation.

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The EMA is stopping work on several projects to allow 43 staff to concentrate on preparations for Brexit and the relocation of the EMA to mainland Europe

The European Medicines Agency (EMA) has temporarily suspended some work as it prepares to relocate to mainland Europe once Britain leaves the European Union (EU).

Its move comes as the Brexit Health Alliance (BHA) — a group of health-related organisations — warned that patients would suffer if key areas, such as access to new medicines, were not adequately addressed during negotiations between the UK and the rest of the EU.

The EMA has published a Brexit business continuity plan which grades its activities into three levels of priority during the Brexit transition.

Activities which it says should continue during the transition period include: assessment and safety monitoring of medicines; continuing of inspections across the EU; publishing of clinical data; and action against antimicrobial resistance.

“Preparing for the move, managing the necessary changes, and addressing challenges such as possible losses in skilled and experienced staff, in a proactive and efficient way requires considerable internal resources,” said Noel Wathion, the EMA’s deputy executive director and head of the EMA’s Brexit task force.

“With the business continuity plan we aim to ensure that the assessment of medicines is not disrupted and that patients in Europe continue to have access to high-quality, safe and effective medicines.”

The lowest-priority activities, which are being suspended, include: development of an online information source of medicines marketed in the EU; work on an electronic submission method for medicine authorisation; and involvement in the benchmarking of regulatory authorities.

Fewer audits and governance activities

The EMA has also reduced the numbers of audits and some governance and support activities, and EMA staff are taking part in fewer external meetings.

Stopping work on these projects will allow 43 staff to concentrate on preparations for Brexit and the relocation of the EMA. The agency warns that if it loses many staff due to relocation it could have to restrict more work. It said: “Unexpected higher, faster or more permanent loss of staff as a consequence of the agency’s relocation may lead to a situation in which the EMA’s operations can no longer be maintained.”

The EMA is currently based in Canary Wharf in London but 19 European cities have submitted official bids to host the agency after Brexit, with a decision on its future location due in November.

The BHA has published its priority areas for negotiators to reach agreement to achieve the best outcome for patients and healthcare in the UK post-Brexit. They include: maximising research and innovation collaboration across Europe; aligning the regulation of medicines and medical devices; and ensuring that information is shared — including pharmacovigilance.

“Patients stand to lose out if we cannot go on collaborating in major medical research studies; if we cannot access new treatments and medical devices as we do now; and if UK nationals in the EU are no longer able to benefit from access to healthcare abroad, and vice versa,” said Niall Dickson, co-chair of the BHA and former chief executive of the King’s Fund and the General Medical Council.

Founding members of the BHA include groups representing NHS organisation and patients, and the Association of the British Pharmaceutical Industry, but it has been criticised for having no pharmacy representation.

Workforce issues are being addressed through a sister group, the Cavendish Coalition, which includes the Company Chemists’ Association among its members.

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2017.20203347

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