EMA relocation will cause drug approval delays even in best case scenario, agency says

pharmafile | September 27, 2017 | News story | Research and Development EMA, brexit, pharma, pharmaceuticals 

As a direct result of the UK’s referendum vote to leave the EU last year, the headquarters of the EMA, currently located in Canary Wharf, London, will be forced to relocate to another EU member state.

19 countries are bidding to become the new host, with the final verdict to be reached next month. Concerns have been rife over the disruption which this upheaval will cause to the agency’s workflow, and now the EMA itself has warned that, at best, we can expect approval delays and, at worst, limited drug availability as its resources are put under duress.

The EMA employs around 700 staff, who would be expected to relocate to the new headquarters if they wish to remain with the organisation. The EMA surveyed its employees to determine the effect of the move on staff retention rates, asking them how likely they were to keep working with the agency dependent upon where it finally settles.

In the leading five candidate cities, the EMA found that staff retention rates were likely to be around 73%, whereas in eight of the cities this rate dropped to just 18% – statistics which will surely factor heavily into the agency’s final decision.

Were it to relocate to one of the leading candidates in terms of staff retention, the EMA estimated that its processes and operations, including drug approvals and safety monitoring, could be delayed by up to three years.

In addition, public health programmes such as antimicrobial resistance initiatives and cooperation with health technology assessment bodies, are likely to suffer, moving more slowly than otherwise.

These delays reach five years if staff retention rates were at around 54%. Were the agency to keep less than 30% of its employees, which is expected in eight of the nineteen candidates, it warned of an “unravelling of the EU single market for medicines”, which would lead to limitations on drug availability and require greater reliance on imports, risking patient health.

Matt Fellows

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