No One's in Charge of Pharmaceuticals in Europe!

November 14, 2014
Peter O'Donnell
Peter O'Donnell

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

Applied Clinical Trials

My recent blog has been overtaken by history, with the departure of Guido Rasi from his post of Executive Director of the European Medicines Agency

My recent blog, entitled 'Who's in charge of Medicines in Brussels?', has been overtaken by history, with the departure of Guido Rasi from his post of Executive Director of the European Medicines Agency. At a time of flux in the European context for pharmaceuticals, Rasi's moderate manner and capacity for strategic thinking were one reassurance amid so much uncertainty. His removal is to be lamented, therefore, not only for the personal setback it represents to Rasi himself, but also for the additional unpredictability it brings to discussions of pharmaceuticals in Europe.

The European Union Civil Service Tribunal may well be right in deciding Rasi's appointment must be annulled on grounds of procedural errors in his appointment. (The merits of the appeal by the disappointed Bulgarian candidate for the post, who triggered the case, may be more open to question.) But the impact is to bring further chaos to what was already a confused situation. Only four years ago, the previous EMA head departed in controversial circumstances. Only a year ago, the European Commissioner for health was forced to resign in connection with a lobbying scandal. Only a month ago the Commission's Director-General for Health resigned abruptly after an injudicious tip-off about an upcoming tender. And only a week ago, the new boss of the European Commission, Jean-Claude Juncker, sowed further confusion with a messy compromise over whether the health commissioner or the industry commissioners should be in charge of pharmaceuticals.

As Kent Woods, chair of the EMA management board, said, on Rasi's departure, "Tthe ruling is about a procedural formality. It is not a reflection on Guido Rasi’s competence or ability to run the Agency, something which he has done successfully since November 2011.” Indeed he has. Not only that, but he has been at the forefront of European thinking on how to resolve one of the big strategic problems facing mediines innovation in Europe—and beyond: how to speed good new drugs to market and reward manufacturesr for doing so. From his first days in office, he indicated interest in the obvious logic which makes efficient market access the corollary of an effective marketing authorisation system. Not, of course, strictly speaking the terrain of the EMA. But terrain it would be foolish nonetheless to ignore. Similarly, and even more strikingly, he has over the last year or so been one of the driving forces in the development of alternative licensing approaches—and again, has pioneered collaboration—even if it has to remain informal—between regulators and payers and their health technology assessment bodies.

No one man is indispensable, and the work that Rasi has very much led on will, doubtless, continue in his absence—whether that is short, long or total. The European Commission and the EMA are taking legal advice on what to do about the tribunal's judgement. Pending further decisions, Andreas Pott, the deputy executive director, will step up – once again, for he also ran the agency in the interregnum before Rasi's appointment.  But whetherthe work will continue with the same energy and focus is another question—and one that is all the harder to answer while there are so many other unknowns swirling across the European pharmaceutical landscape. The implementation of the new clinical trials legislation, the inauguration of the EMA's own new clinical data transparency regime, the reflections on future regulation of the devices and diagnostics that will become increasingly pressing as personalised medicine becomes more of a reality…

It is also unfortunate that Rasi, brought in as a new broom in the EMA (after being brought in as a new broom in the Italian health ministry not long before), has been forced to resign by this fiasco not of his own making. And doubly unfortunate that he shares his nationality with a predecessor at the head of Europe's attempt to make sense of pharmaceutical regulation—Diulio Poggiolini, who fell from grace in a big way in the 1980s. Rasi was a "clean hands" who was well on the way to utterly obliterating that memory and establishing an international reputation that did credit to his country as well as himself. Will the Bulgarian who has catalysed this mess be applying to fill the spot Rasi is now leaving?

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