Robert Giovanni Nistico he is the new president of the Italian Medicines Agency. The Permanent Conference for relations between the State, the Regions and the autonomous Provinces has just approved the name proposed by the Minister of Health Orazio Schillacifollowing the farewell of Giorgio Palù, last February 22, in controversy with the same ministry. The new president replaces the acting president, Francesco Feramember of the Board of Directors, previously appointed by the ministry of Lungotevere a Ripa.
We need complete governance
The presidency is the last box, necessary to complete the governance of the Agency, after the reform launched with law number 196 of 2022 and strongly supported by the Meloni government. Based on the innovations introduced, the new president will be the legal representative and guide of the board of directors. But it’s not just the organizational chart that sets the machine in motion, according to experts. “We have to wait – he commented in a recent interview with Aboutpharma Nello Martini, former first general director of the Agency – that the decree on the organization and functioning of the staff be issued. Then we will begin to understand how AIFA is structured and we must also wait for the Regulations of the work of the new single Commission”.
An expert pharmacologist
Nisticò is associate professor of Pharmacology at the University of Tor Vergata, but his CV also includes a specialization in psychiatry and clinical psychology obtained at the Cattolica del Sacro Cuore. Among the roles held recently, stands out that of member of the Committee for Orphan Medicines (Comp) of the European Medicines Agency (EMA) for the scientific and regulatory evaluation of dossiers for orphan drugs and of President of the Master’s degree course in Pharmacy of the Tor Vergata University. He was also principal investigator of the neuropharmacology laboratory of the Rita Levi Montalcini European Brain Research Institute Foundation. He is the son of the politician and pharmacologist Giuseppe Nisticopresident of the Calabria Region from 1995 to 1998 and former senator and European parliamentarian of Forza Italia.
The support of Sif
For the Italian Society of Pharmacology (Sif), the choice of Nisticò by the Ministry of Health is a winner. “It is extremely important – Sif comments in a note – that the national public body that regulates medicines for human use in Italy, which governs pharmaceutical spending and follows the life cycle of the medicine to guarantee its effectiveness, safety and appropriateness is directed by a scientist with high expertise in the field of pharmacology”.
Close to the minister
It is not the first time that the Minister of Health, Orazio Schillaci, chooses among the acquaintances of the Roman university of which he was rector. In fact, Nisticò arrives after the appointment to the dicastery of Francesco Saverio Menniniprofessor of political economy and health economics, now head of the planning department, of Marco Matteiformer medical director of the Tor Vergata Polyclinic and now head of cabinet, and professor Guido Rasiprofessor of Microbiology and consultant to the minister with the role of expert in the pharmaceutical sector since last year.
Guido Rasi’s endorsement
By virtue of his position and personal authority, Rasi himself seems to have played a role in Nisticò’s choice. In a long interview granted to Adnkronos in recent days, he had somehow anticipated the identikit of the future Aifa president. “There is no need for a Nobel scientist and a super academic. Rather, he needs a person with a very solid pharmaceutical-regulatory background and absolute fluency with English. And he is needed immediately because in Europe there are many ‘hot’ dossiers and Italy must be able to weigh in at the international tables. The role of Aifa president, especially given how the agency reform has designed it, requires a very specific profile for an equally specific job.” What will it consist of? Given that the benefit-risk assessment of new drugs is the responsibility of the EMA, noted Guido Rasi, the tasks of the Agency and its new president range from the assessment “of the opportunity for a drug to enter the market on national territory, if reimburse it, what type of reimbursement to give it and what indications to provide for its use in clinical practice”. Above all, Rasi reminds us, the president must “develop a strategic vision” on central issues: from the definition of innovation in force so far, to preparing the field for the entry of (very expensive) advanced therapies. In a recent video interview with Aboutpharma, Rasi had highlighted the need to increase the human resources of the Agency in consideration of the many dossiers to be examined.
