It was February 22nd when the virologist Giorgio Palù, confirmed as president of the new Aifa just a couple of weeks ago, slammed the door of the Italian Medicines Agency, resigning amid controversy. It's been almost a month and the replacement is still missing. Lots of rumors, but in fact no names. Why? Which figure are you looking for? And where? Guido Rasiprofessor of microbiology at the University of Rome Tor Vergata, former director general of the national regulatory body and twice executive director of the European Medicines Agency EMA, interviewed by Adnkronos Salute, outlines a identikit of the ideal president for Aifa and invites us to hurry: “There is no need for a Nobel scientist”, a super academic, he explains. “It's rather useful a person with a very solid pharmaceutical-regulatory background and an absolute familiarity with English”. And “it's useful right away“, warns Rasi, because in Europe there are many 'hot' dossiers and “Italy must be able to weigh in at international tables”.
“Undoubtedly – the expert began – everyone was surprised by Palù's behaviour, which was unpredictable and perhaps not very responsible, considering that I think he knew how things were from the beginning”. Having said that, looking to the future, who will 'save' Aifa? “My personal opinion – replies Rasi – is that the role of Aifa president, especially as the reform of the agency has designed it, requires a very specific profile for an equally specific job. Certainly clinical expertise would be very useful, but we need to focus more on the work that the Aifa president is called upon to do on a daily basis.”
Which? “The determination of the benefit-risk ratio of new drugs is done by the EMA”, recalls the former director, so this work is 'spared' by AIFA. The president comes into play “after the CSE”, the new single scientific and economic commission, “has assessed the opportunity for a drug to be marketed on the national territory, whether to reimburse it, what type of reimbursement to give it and what indications to provide for its use in clinical practice. The last check”, the final word, “is up to the Board of Directors and its president”. And in a Board of Directors where “everyone is new, good but inexperienced in the matter, at least the president must be. He must be a guide“, claims the former CEO. More: “He is also called to act by developing a strategic vision” on very technical issues. Rasi gives some examples: “He will have to evaluate whether the current definition of innovation is still current; prepare a strategy for advanced therapies, which we do not have; understand whether Law 648, which regulates among other things the compassionate use of medicines, is still valid”.
A key requirement that the Tor Vergata teacher insists on is linguistic competence. The president of AIFA “must be a person who hasabsolute familiarity with English and that he speaks it fluently, because the legal representative of Aifa sits on the Ema Board of Directors and this is strategic”, specifies Rasi who takes some 'pebbles' off his feet on the subject: “The last three general directors” in Europe “are not there they almost never went or never went, and this caused very great damage because many fundamental regulations were written or established without AIFA having had much of a say in the matter. Key dossier, on which it would have been good for Italy to weigh in instead of finding itself 'chasing' provisions that were perhaps more convenient for other countries, while ours was absent from the negotiating table”.
This is why the figure that the expert has in mind “must know the technical-regulatory topic very well and have great familiarity with the European networkbecause this year we will have the new pharmaceutical law, the EMA reform, the regulation on joint clinical evaluation Jca”, lists Rasi. “The president of Aifa must be present – he warns – and bring very clear, very clear-cut and very well-elaborated Italian positions”. Ultimately “you don't need a Nobel scientist, perhaps a very good theorist, but without experience of the regulatory world and international pharmaceutical laws. A technician with scientific-regulatory experience is needed unassailable – he reiterates – let it be person respected or who makes himself respected in Europe. Ideally someone who has already been to Aifa or who is currently thereor who worked closely with the Aifa committees”. In short, “a person from the environment”.
Man or woman as the latest rumors had hoped? “I know many really good women, who correspond well to the description I have given – replies the former number one of the EMA. If we find the right figure in a woman, it would obviously be a good sign. But AIFA, which in any case has many top-level managers within it – Rasi comments – it needs adequate guidance regardless of gender. The right profile, very quickly.”
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