The long-awaited, new regulation on the organization and functioning of the Italian Medicines Agency (AIFA) was published in the Italian Official Journal on 15 January 2024 and has finally become effective since 30 January 2024.
As discussed in our previous blog (“New AIFA Regulation: where are we?” see link), the new AIFA Regulation includes major changes in the organization and functioning of the Italian Agency, such as:
- new powers for the President of AIFA;
- abolition of the role of the General Director;
- establishment of the new roles of Technical and Scientific Director and of Administrative Director, with specific duties and responsibilities;
- creation of a new single Scientific and Economic Commission for Pharmaceuticals (CSE) in place of the Technical-Scientific Commission (CTS) and the Price and Reimbursement Committee (CPR).
Since the publication of the decree with the new AIFA regulation, the names of the people covering the key roles have been identified and officially appointed.
The new figures of the Administrative Director and of the Technical and Scientific Director have been identified, respectively, in the persons of Giovanni Pavesi, Economists and Director General of the Welfare Unit of the Lombardia Region, and of Pierluigi Russo, physician specialized in pharmacology with a PhD in Pharmacoeconomics, current Director of the Monitoring Registries Office and the Economic Evaluations Office in AIFA.
The much discussed and long-awaited new CSE has also been created, with the official appointment of its 10 members.
The members by right include the Technical-Scientific Director of AIFA (Pierluigi Russo) and the President of the National Institute of Health (Rocco Bellantone) or a delegate.
Elected members are the following:
Lara Nicoletta Angela Gitto (President of the CSE): Associate Professor of Political Economics and Health Economics, University of Messina.
Giancarlo Agnelli: Professor Emeritus of Internal Medicine, University of Perugia.
Walter Marrocco: General Practitioner, former member of the CTS of AIFA (2007-2015).
Vincenzo Danilo Lozupone: Private Pharmacist, Secretary of FEDERFARMA Bari.
Ida Fortino: Manager of the Pharmaceutical and Medical Devices Organizational Unit, former member of the CPR of AIFA (2009-2012) and of the CTS of AIFA (2018-2024) and former Director of the “Strategy and Economy Area” of AIFA.
Giovanna Scroccaro: Director of the Pharmaceutical, Prosthetic and Medical Devices Department of the Veneto Region, former member of the CPR of AIFA (2015-2024) and President of the CPR from 2019.
Giuseppe Toffoli: (Friuli Venezia Giulia Region) Clinical Pharmacologist (Oncology), former member of the CTS of AIFA (2015-2018).
Elisa Sangiorgi: Hospital Pharmacist, Manager of the Drug and Medical Devices Governance Area of the Emilia-Romagna Region
The new AIFA Board of Directors (BoD) is also starting to take shape, with the appointments of Angelo Gratarola, Councillor for Health Care of the Liguria Region and Vito Montanaro, Director of the Department of Health Promotion and Animal Welfare of the Puglia Region.
As to the role of President of AIFA, after the initial confirmation, for another year, of Giorgio Palù, former full professor of Microbiology and Virology and Dean of the Faculty of Medicine at the University of Padova and already President of AIFA since December 2020, on 22 February he decided to resign.
Now next steps include: the appointment of a new President of AIFA and of the 2 remaining members of the new AIFA Board of Directors (within March 2024), the adoption of the AIFA BoD decision concerning the organization and functioning of the staff within the Italian Agency (within April 2024) and the adoption of the AIFA BoD decision concerning the organization and functioning of the CSE (within March 2024).
A few questions remain as to when the new CSE is going to be fully operative, how it is going to work and manage the assessment of the many HTA procedures and if the average assessment timelines are going to be improved or not.
Regulatory Pharma Net is closely monitoring the evolvement of the Italian legislation and landscape and is ready to share updates and discuss any potential impacts and implications of the new AIFA regulation and other important changes on current and future applications and market access activities.