by Natalie Morrison

LONDON, July 2 (APM) - The European Medicines Agency (EMA) has conceded that higher-than-expected loss of staff as a result of its Brexit-driven relocation could mean its operations can "no longer be maintained".

Its statement, part of a business continuity plan released on Tuesday afternoon, came around the same time as The Telegraph's report that 75% of the regulator's staff are unwilling to move after Brexit.

As the EMA pledged to cut back its operations to focus on Brexit "uncertainties", UK Conservative MP Geoffrey Clifton-Brown called on Britain to poach staff who wanted to remain in London.

The EMA promised to "free up" 43 staff by the end of 2017, who will focus on Brexit preparations and uncertainties.

It did not mention how it would deal with staff unwillingness to relocate in the statement, nor did it refer to numbers of staff unwilling to leave. In The Telegraph's article, a spokesperson could not confirm how many staff would be willing to move with the regulator.

However, the regulator did nod towards possible losses in the statement, when deputy executive director and head of the EMA Brexit task force Noel Wathion said: "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".

The EMA added: "Unexpected higher, faster or more permanent loss of staff as a consequence of the Agency's relocation may lead to a situation in which EMA's operations can no longer be maintained".

According to The Telegraph's report, as many as 75% of EMA staff have told European MEPs in "behind-closed-doors" Brussels meetings that they do not want to leave the UK.

Clifton-Brown, who is Conservative MP for the Cotswolds, called on the UK to poach the workers, saying "if that could be achieved that would be great. The Europeans will have to move it though, but a lot of those people were involved in shaping the European legislation and I imagine our legislation will have to be very similar to the Europeans'".

He added: "If there is anything economically and legitimately sensible that we could do we should try and keep them," The Telegraph reports.

The news follows the European Commission's announcement on Tuesday morning of the 19 cities now in the running to host the EMA after applications closed on Monday (APMMA 54149). The 19 cities which could host the EMA after Brexit are listed below.

Previously, UK MPs have called for the UK's continued cooperation with the EMA in regulating medicines (APMMA 53771). The UK's regulator, the MHRA, has so far given little away as to whether full EMA partnership after Brexit is on the cards (APMMA 53938).

EMA Brexit scaleback

As part of its continuity plan, the EMA said it has decided to temporarily suspend activities which have the least impact on public health and the agency's ability to function.

It has also cut the number of audits it carries out, as well as some corporate governance and support activities. Its participation in external meetings and conferences has been reduced, as have EMA meetings and workshops.

Suspended activities include

• the development of the European Medicines Web Portal; a new publicly available online information source on marketed EU medicines
• the EMA's contribution to the e-submission project that will allow applicants to electronically submit documents linked to filings
• the development of a transparency road map (APMMA 20479) for the EMA
• its participation in benchmarking of European drug regulators as of 2018.

"These types of activities can be put on hold for some time to free up or channel resources into core activities that need to be maintained under any circumstances. However, mid-to-long-term EMA will need to analyse how long these activities can be put on hold before they start to seriously undermine the quality of the Agency's work and its planning, and the expectations of stakeholders," the EMA said.

Important activities such as the publication of clinical data and promoting medicines availability as well as political priorities - including working on antibiotics resistance - will be "maintained for as long as possible, workload and staffing situation permitting, in order to maintain the development of new medicines", it said.

Regulatory activities of the highest priority, such as those directly related to assessment and safety monitoring of medicines, are "absolutely critical" and must be continued, since "any disruption would almost immediately have a detrimental effect on the health and well-being of citizens in Europe and would also jeopardise production and distribution of medicines in the EU", it added.

High-priority activities also include the coordination of actions to protect the safety of patients in all EU member states, inspections across the EU or maintenance of the functionality and security of critical IT applications used by all EU countries.

"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," Wathion said.

Locations in the running to play host to the EMA are

• Amsterdam (the Netherlands)
• Athens (Greece)
• Barcelona (Spain)
• Bonn (Germany)
• Bratislava (Slovakia)
• Brussels (Belgium)
• Bucharest (Romania)
• Copenhagen (Denmark)
• Dublin (Ireland)
• Helsinki (Finland)
• Lille (France)
• Milan (Italy)
• Porto (Portugal)
• Sofia (Bulgaria)
• Stockholm (Sweden)
• Vienna (Austria)
• Warsaw (Poland)
• Zagreb (Croatia)
• Malta

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