EMA warns Brexit may permanently damage its capabilities

Print 28 September 2017
Nick Paul Taylor / FierceBiotech

The European Medicines Agency (EMA) has warned its Brexit-driven relocation could permanently damage the region’s regulatory system. EMA sounded the alarm after a staff survey found as few as 6% of its staff would move to some of the 19 cities vying to host the agency when it leaves London.

More than 90% of EMA staff completed the survey and indicated how likely they are to relocate to each of the cities in the hat for the vote on its future home in November. The survey found a sharp difference between the retention rates likely to be achieved by the cities, suggesting the vote will have a major effect on EMA’s ability to hold on to enough staff to keep the European regulatory system functioning.  

The retention rate for eight of the cities came in below 30%, with just 6% of people saying they are likely to move to one location. EMA opted against naming any of the cities but, given its staff and their families currently live in London, it is likely locations in wealthy parts of Western Europe fared better than sites in more distant, less familiar locations to the south and east of the continent. The upheaval caused by moving to Dublin is less significant than relocating to Sofia. 

If European ministers vote to relocate EMA to one of the eight cities its staffers are least likely to move to, the agency thinks there will be “permanent damage to the system.” 

This warning is based on EMA’s assessment of how many employees it needs to perform its highest-priority tasks, such as activities directly related to monitoring drug safety. EMA forecasts it needs 462 full-time staff to do these tasks and a further 140 employees for mid-priority tasks, such as work on antimicrobial resistance. 

The survey data forecasts EMA’s headcount will fall to below 100 if some of the cities win the vote. Even if 30% of EMA staff stay on after the relocation, its headcount will still be less than half that it thinks it needs to adequately perform its top-priority tasks. EMA said this will render it unable to operate, cause a public health crisis, lead to the unravelling of the single market for medicines, make it reliant on foreign regulators for approvals and potentially result in patient deaths.

EMA thinks these events will happen even if the European Union and member states take emergency legislative measures. The agency predicts it would never fully recover from such a big blow to its headcount.

The forecasts of the impact of the selection of the other 11 cities as the EMA’s new home are split up into three categories. The best-case scenario is one of the five cities more than 65% of EMA staff are likely to relocate to wins the vote. This would leave EMA with enough staff to carry out its top-priority tasks. The agency thinks some public health initiatives, such as antimicrobial resistance activities, would move slower for a few years but its core functions would keep running smoothly.

Beyond these five cities are another five with retention rates ranging from 51% to 60%. Those rates result in headcounts well below the 462 EMA needs for its top-priority tasks, resulting in patients having to wait longer for new medicines and delays to the implementation of new regulations. EMA thinks the system would fully recover within five years. 

One city achieved a retention rate of 48%, putting it in a category of its own that falls somewhere between the ‘doomsday’ and ‘bad, but not too bad’ scenarios.

The results and their implications will give ministers something to think about in the run up to the November vote. Cities such as Amsterdam, Copenhagen and Dublin appear well placed to host the city based on the EU’s desire for the new site to be accessible, provide assurance that the agency will be up and running on Brexit day and have adequate educational facilities for children and an appropriate labor market for spouses. 

However, since the race began last year there has been talk the EU will face pressure to move one of the two agencies that needs a new home—the other being the European Banking Authority—to a city in one of the 10 countries in central and eastern Europe that have joined the union since 2004. That would hand an advantage to cities such as Bratislava, Bucharest, Malta, Sofia, Warsaw and Zagreb.

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