EMA relocation's possible impact on safety monitoring 'alarming,' EU R&D chiefs say

As the saga of the EMA's location after Brexit rumbles on, European pharma leaders have drafted an open letter calling for strenuous efforts to avoid disruption at the regulator.

The R&D heads say they are particularly concerned about the impact of any disruption on the EU's pharmacovigiliance machinery, which is operated from the EMA and serves as an early warning system in cases where medicine safety comes into question.

"It is a stark and alarming reality that such fundamental activities would undoubtedly be impeded were the operations of the agency to be disrupted as a result of the U.K.'s exit from the E.U.," the letter reads. "To put it concisely: in the event of obstruction or failure, Europe possesses no backup option."

The letter—published on the website of EU trade association EFPIA—is signed by 19 big pharma and biotech R&D leaders and comes as the future home of the EMA has become a fiercely contested issue, with 21 of the 27 post-Brexit member states vying for consideration at last count.

It has even been suggested that the U.K. may be able to retain the EMA in London, but that notion was slapped down by the European Commission last week. Now, according to a leaked document secured by Politico, EU officials are planning to insist that the EMA must leave London, and also that the U.K. should be prepared to foot the bill for the relocation.

The political wrangling over the future of the agency raises the risk that the fears expressed by the pharma executives will come to pass, and they ask for a speedy decision on the matter, ideally when the EU Council of Ministers meets in Brussels on 22-23 June.

"The EMA is a world class regulator, whose scientific recommendations are a vital element of the ongoing effort to provide EU citizens with effective, safe and high-quality medicines," they write.

"It is vital for the benefit of patients in Europe that the system—this 'well-oiled machinery'—continues to function with the current level of internationally-acknowledged efficiency, and that this is taken into account when the decision regarding the location of the EMA will be taken."

According to EMA Director General Guido Rasi, the uncertainty is already having an impact on the operations of the agency, with applicants for training programs on the slide and staff already heading for the exit.

The EFPIA letter also lays out a wish list of important criteria for the future hosting city, including "world class connectivity"—particularly international transport links and a high level of accommodation capacity—as well as "sufficient and decent housing, access to international/European schools for staff with children [and] employment opportunities for spouses/partners."

Source