EMA Rings Alarm Bells Loudly on Brexit Move

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Applied Clinical Trials

The EMA isn't mincing its words about the challenge it faces with the relocation that will be forced on it by Brexit. It has been stated that "the future of public health in Europe is at stake" and this decision will make or break it.

The European Medicines Agency isn't mincing its words about the challenge it faces with the relocation that will be forced on it by Brexit. "The future of public health in Europe is at stake," it cautioned on September 26 in an unprecedently outspoken statement. Coming just days before the European Commission provides its initial assessment of the 19 bids to host the agency, and just weeks before the ministerial meetings that will decide the agency's destination, the intervention carries powerful political undertones. Essentially, the agency's bosses are warning the EU's leaders not to put it somewhere where staff simply will not follow: it has to be seen as a strong "play safe" message to go for one of the few reliable choices-such as Milan, Amsterdam, Lille, Stockholm, or Copenhagen-and avoid the more controversial options like Bratislava, Malta, Bucharest, or Zagreb.   The agency has released details of its most recent staff retention survey, conducted earlier in September, and it says the findings raise "serious concerns," because "for certain locations, staff retention rates could be significantly less than 30%." The agency's management has been pointing out for months that keeping staff in post is one of the most crucial challenges it faces with its impending move, and has been monitoring the temperature among its 800 employees as part of the business continuity planning it initiated as soon as its departure from the UK became an inevitability more than a year ago.   Crucially, this survey was launched after all candidate host cities were known and EMA staff had had the opportunity to study in detail all the member states’ bids. It shows that massive defections would result from some of the choices, and that even in the best-case scenario, the agency stands to retain only around 80% of its current staff. Without identifying candidate cities by name, EMA says that four clusters have emerged from its polling of staff intentions. The first cluster, of five cities, includes those where 65% or more of EMA staff indicated that they are likely to move and remain on EMA's staff. In the second cluster, also of five cities, staff retention would be between 50 and 64%. For the third cluster, in which there is only one city, only 30 to 49% of staff are likely to relocate. In the last-and biggest-cluster of eight cities, "less than 30% of EMA staff said they would follow," says the agency.   "This would mean that the agency is no longer able to function," it says unambiguously-and goes on to insist that "as there is no backup, this would have important consequences for public health in the EU." The consequences would include an unravelling of the EU single market for medicines, with no centralized authorizations, and medicines becoming unavailable. The EU would have to rely on outside countries for approval and importation, and patients would be "exposed to side effects-deaths-litigation."   Some staff losses can be absorbed with EMA’s business continuity plan, it says. "But beyond a critical threshold the agency will no longer be able to fulfil its mandate to protect the health of European citizens."     Read the full EFPIA report about the EMA Relocation here.   Peter O'Donnell is a freelance journalist who specializes in European health affairs and is based in Brussels, Belgium.