EMA Relocation Worries Intensify in the Final Stages of the Decision

Applied Clinical Trials

Tensions mount across the European pharmaceutical scene over the fate of the EMA with just weeks before the final decision is going to be made on where it will be moved to.

I had promised my editor (and my readers) to cut back on the Brexit coverage-but I have to break my word again as the tensions mount across the European pharmaceutical scene over the fate of the EMA, with just weeks to go before the decision is made on where it will move to. The most alarming development is the publication by the European Medicines Agency of a "Business Continuity Plan for Brexit"-a sort of minimum-service program of what it reckons it will be able to do "in a profoundly changing environment" as it is forced to relocate from London.
Top of its priority list is staff retention-unsurprising in the light of recent revelations about reluctance among many of its employees to move to some of the candidate sites, such as Zagreb, Bratislava, or Bucharest. So it is aiming to come up with generous offers of entitlements for staff and their families and other services to make a move-wherever the destination turns out to be-as painless as possible. But it recognizes explicitly that it could suffer more losses than it would be able to compensate for through recruitment of replacements-a situation that "will most likely only arise after the decision on the new seat for EMA is taken," and would be "likely to continue after the physical move has taken place, in a worst case situation even over a prolonged period."

A cascaded list of priorities gives greatest importance to "core scientific activities"-which is its role in "urgent and significant public health threats relating to the safety and quality of medicines." Assessing marketing authorization applications comes lower down the list, and is followed by other fee generating activities such as for pharmacovigilance and inspections, because for EMA, as a largely self-sustaining agency, it is vital "to ensure a stable income." Servicing of EMA's working parties, scientific advice or health technology assessment makes it only into a second-ranked category-and cutting back on most of these will, the EMA admits, "impact the deliverables" of the EMA work program. In the lowest category are "governance, transparency, information, and communication."

But "deep concern" has also been expressed by European patients' organizations about the destination of EMA. The European Patients’ Forum wrote to Europe's leaders just ahead of their October summit urging them to ignore questions of "fairness" in the evaluation of bids to host the agency, and go for a choice that is above all practical. "Whether the new host country already has an EU agency or not should, therefore, not be a consideration, said EPF-dismissing at a stroke the "sub-optimal" candidacies of most east European countries, which are the newer EU member states, and widely seen as too distant and too unprepared. To minimize the evident risks from relocation, the decision "must be taken based objectively on the best interest of European patients and of public health-not the political or economic interests of any particular member state."

Meanwhile, in the run-up to the final decision, which will emerge from a secret voting session at a November 20 meeting of the Council of Ministers, Brussels has been under siege by candidate cities pleading their case to all who will listen. And that has highlighted another risk: one of the most likely winner has been-until recently-Barcelona. But since the Catalan region of which Barcelona is the capital is now in the throes of a campaign to obtain independence from Spain-in effect a national equivalent of Brexit-the prospects for disruption from such a choice have multiplied. That didn't stop senior figures from both the regional and national governments energetically setting out Barcelona's stall in mid-October, with a bizarre refusal to discuss the obvious downside of moving EMA from one seceding part of Europe to another. 

The smart money is moving increasingly towards Amsterdam as the choice-but in a Europe so wracked by dissension, it is, unfortunately, no longer possible to count on any rational decisions.

Peter O'Donnell is a freelance journalist who specializes in European health affairs and is based in Brussels, Belgium.