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.
Rasi has shown some lithe thinking about squaring some of the circles he is confronted with, and doing so with what are widely
recognized as insufficient resources for a growing workload and ever-more-sensitive decision-making. He has publicly admitted
there are problems, and has publicly promised "not to hide from them."
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.