Rasi Takes the Reins

Only three years later, Rasi finds himself in a similar role at European level. The reputation of the once-glistening European Medicines Agency had become heavily tarnished during 2011 by accusations of conflicts of interest and mismanagement. Thomas Lonngren, its executive director, provoked sharp criticism when he quit his job to walk straight into consultancy work in the pharmaceutical industry (see Pharm Exec, December 2010). At the same time, charges were flying wildly of agency incompetence and even complicity in leaving unchallenged, for years, Servier's Mediator, by then linked to hundreds of deaths in France. And the European Parliament refused to sign off on the agency's accounts because of concerns over insufficient financial and personnel controls. It was onto this unpromising stage that Rasi stepped last November, after the agency had drifted for nearly a year without an executive director. Small wonder that malicious chuckles ran round Brussels along the lines of "and after all that, they could only get an Italian!"

Rasi's declaration of interests is unequivocal. He says he has no financial interest in any pharmaceutical company, owns no product patents, and that he has no personal gain from any grant or other funding from a pharmaceutical company to any organisation he is employed by. So mani as puliti could be. But Poggiolini is only one of the shadows over the EMA. Now there are other battles of a more technical nature for the London-based agency and its new boss.

Issues to Tackle

One dilemma arises from implementation of new EU pharmacovigilance rules due to come into effect in July, for which large amounts of drug information from companies is supposed to be entered in advance into the agency's EudraVigilance safety database. Rasi has spoken of this as his "biggest headache," because of the administrative implications in handling complex information on more than half a million products. Pragmatically, the EMA reached a compromise agreement last month with companies to smooth the process, after industry warnings that the requirements were unworkable. Rasi himself will lead from the front in tackling the problem, heading a task force set up specifically to oversee the implementation of the legislation.

On the thorny issue of biosimilars, Rasi has shown similar agility. Europe's generic medicines industry is now hopeful of his backing for changes that could cut the cost of developing biosimilars by harmonizing European and U.S. regulation and avoiding the need for duplicative approval procedures. He is planning to create a joint U.S.-EU biosimilar conference to simplify the work while maintaining standards. He has also promised guidelines on the harmonization of regulatory procedures for biomolecules, to increase the use of biosimilars.

He has also indicated ambitions for the EMA to accept a broader responsibility to patients and industry, breaking a taboo that limits its role to merely showing a red or green light to marketing authorization applications. "I see the next phase of the agency's development to be focused on rethinking how medicines contribute more broadly to public health, how access to medicines can be assured in a world of increasing scarcity, and a growing focus on safety," he said on his first day in office. His vision is of an agency that can contribute to ensuring access to medicines by taking some account of what happens to products—on pricing and reimbursement—after authorization. He has spoken of making the agency's work so credible and scientifically authoritative that its thinking is not challenged.

He has also indicated concerns over combating falsified medicines, the challenges of new approaches to medicines development, the lack of harmonization of clinical trials rules across member states, and the need to adapt to the new demands of assessing personalized medicines on the basis of pharmacogenetic criteria. He is alert to what he sees as the "disparity" between the risk/benefit analysis the EMA does and the emerging disciplines of health technology assessment, and he is conscious of the still-to-be-faced challenges of regulating medicines derived from nanotechnology or using new routes and methods of administration. His battles will be many—but at least he comes to it with a spotless record and evident energy.

So maybe Rasi should not be compared so much with Poggiolini as with some of his compatriots currently making the running in Europe—such as Mario Draghi, who is competently piloting the European Central Bank through the turbulent waters of the euro crisis, or Mario Monti, the former European Commissioner who is now trying to salvage Italy from the near-disaster of Berlusconi's misrule. And if Rasi ever gets around to writing his book, it will suffer a less ignominious fate than Poggiolini's 1989 "Practical Guide for Applications for Marketing Authorizations on Medicinal Specialities in the EEC," which has been long since—and unsurprisingly—pulped.

Reflector is Pharm Exec's anonymous columnist, a commentator so close to the action in Europe that his identity must remain secret.