AIFA reform: what is it and who are the new members of the governance

AIFA, the Italian medicines agency, has recently embarked on a significant reform: a process of restructuring governance to promote investments in pharmaceutical research and development and accelerate drug approval processes. Here are the details.

The AIFA reform is a process of restructuring the agency’s governance aimed at promoting investments in pharmaceutical research and development, in line with Mission 6 of the National Recovery and Resilience Plan (PNRR), and accelerating drug approval processes by streamlining the regulatory framework. The process was initiated in November 2022 with Decree Law No. 169 developed by the Ministry of Health, in conjunction with the Minister of Public Function and the Minister of Economy and Finance in agreement with the State-Regions Conference.

With the AIFA reform decree, the following operations have been implemented:

• Abolition of the General Director. To simplify the organizational structure, the figure of the General Director has been abolished. The President assumes the legal representation of AIFA and chairs the Board of Directors. They will be appointed by a decree of the Minister of Health, in agreement with the State-Regions Conference, and with the consent of the Minister of Economy and Finance. The role of President will be an exclusive appointment, prohibiting any other professional activity, both public and private. Since there are no new indications in the Regulation, specific skills are not required for the President, and the duration of their term remains five years with the possibility of renewal only once.
• Introduction of new managerial roles. Two new figures have been introduced that will take on some of the roles of the General Director.
  • Administrative Director. Responsible for administrative management, they will be appointed by decree of the Minister of Health, after consulting with the Minister of Economy and Finance and the State-Regions Conference. The Administrative Director must have a master’s or specialist degree in legal or economic matters, or equivalent qualifications, along with proven professionalism and managerial experience. The duration of their term is five years with the possibility of renewal.
  • Technical-Scientific Director. Appointed by ministerial decree, following consultation with the Minister of Economy and Finance and the State-Regions Conference. The Technical-Scientific Director must hold a degree in health disciplines or equivalent qualifications, with technical-scientific experience in the pharmaceutical sector. The duration of their term is five years with the possibility of renewal.
• Abolition of the CTS and CPR in favor of the CSE. A key element of the reform is the creation of the Scientific and Economic Commission (CSE) to replace the Technical-Scientific Commission (CTS) and the Prices and Reimbursements Committee (CPR). The Drug Scientific and Economic Commission, appointed by the Minister of Health, is composed of ten members: the Technical-Scientific Director of AIFA and the President of the Higher Institute of Health, or their delegate, are ex officio members. Four members are appointed by the Minister of Health, one of whom will serve as president of the Commission, one member is appointed by the Minister of Economy and Finance, and three members are appointed by the State-Regions Conference. CSE members have a term of three years, renewable once.
• Modification of the Board of Directors. The composition of the Board of Directors undergoes significant changes. Following the reform, it consists of the President and four members, one appointed by the Minister of Health, one appointed by the Minister of Economy and Finance, and two by the State-Regions Conference.

Following the reform, the AIFA President is Robert Giovanni Nisticò. He takes the place of the previously appointed and immediately resigned Giorgio Palù. His mandate lasts five years, with the possibility of renewal once.

The AIFA Board of Directors (CDA) is composed of:

• President Robert Giovanni Nisticò, appointed by the Minister of Health;
• Advisor Vito Montanaro, Director of the Health Promotion Department of the Region, appointed by the Permanent Conference for Relations between the State, Regions, and Autonomous Provinces of Trento and Bolzano;
• Advisor Angelo Gratarola, Regional Health Councilor of the Liguria Region, appointed by the Permanent Conference for Relations between the State, Regions, and Autonomous Provinces of Trento and Bolzano;
• Advisor Emanuele Monti, President of the Welfare Commission of the Lombardy Regional Council, appointed by the Minister of Economy and Finance.

The new AIFA Board of Directors took office on 20/03/2024 as communicated by the agency.

The Administrative Director is Giovanni Pavesi. He is an expert in healthcare management and general director of the Welfare Department of the Lombardy Region. He was appointed by Minister Schillaci (Ministry of Health). His term lasts five years, with the possibility of renewal.

The Technical-Scientific Director is Pierluigi Russo. Previously the head of the AIFA Monitoring Registers Office, he now leads the technical-scientific direction. His term lasts five years, with the possibility of renewal.

The members of the CSE include ex officio the Technical-Scientific Director of AIFA, Pierluigi Russo, and the President of the Higher Institute of Health or their delegate. In addition to these, for a total of ten members:

• Lara Nicoletta Angela Gitto, professor of economics at the University of Messina, appointed by the Minister of Health, serving as president;
• Giancarlo Agnelli, cardiologist and professor of Internal Medicine at the University of Perugia, appointed by the Minister of Health;
• Walter Marrocco, general practitioner, appointed by the Minister of Health;
• Vincenzo Danilo Lozupone, pharmacist, appointed by the Minister of Health;
• Ida Fortino, head of the Pharmaceutical Service of the Lombardy Region, appointed by the Minister of Economy and Finance;
• Elisa Sangiorgi, manager of the Drug and Medical Devices area of Emilia-Romagna, appointed by the Permanent Conference for Relations between the State, the regions, and the autonomous provinces of Trento and Bolzano;
• Giuseppe Toffoli, director of Experimental and Clinical Pharmacology at the Aviano Oncological Center in Friuli Venezia Giulia, appointed by the Permanent Conference for Relations between the State, the regions, and the autonomous provinces of Trento and Bolzano;
• Giovanna Scroccaro, head of the Pharmaceutical Service of the Veneto Region, appointed by the Permanent Conference for Relations between the State, the regions, and the autonomous provinces of Trento and Bolzano.

Non-ex officio members serve a term of three years and are renewable only once.

The long-awaited AIFA reform began in November 2022 and is expected to conclude in May 2024. Here are the stages:

November 2022: the Meloni Government initiates the reform of AIFA governance with Decree Law No. 1691.

November 15, 2023: the State-Regions Conference approves the AIFA reform.

December 1, 2023: the advisory technical-scientific committee and the prices and reimbursement committee, operating at AIFA, are abolished. Simultaneously, the Drug Scientific and Economic Commission is established, with its functions attributed.

December 14, 2023: the AIFA reform is definitively approved by Parliament.

January 15, 2024: ministerial decree of January 8, 2024, No. 3, containing the Regulation amending the organization and functioning of AIFA, is published in the Official Gazette.

January 30, 2024: entry into force of ministerial decree January 8, 2024, No. 3.

February 2, 2024: appointment of the ten members of the Scientific and Economic Commission.

February 6, 2024: Minister of Health Orazio Schillaci signs the decree containing the names of the members who will compose the new Scientific and Economic Commission.

February 8, 2024: appointment of the President, the Administrative Director, and the Technical-Scientific Director.

March 2024: appointment of the members of the Board of Directors.

April 2024: adoption of the Board of Directors’ resolution on the functioning and organization of personnel and reshaping of AIFA’s organic allocation.

May 2024: submission and approval of the resolution by the Ministry of Health.

The AIFA reform, occurring almost twenty years after the establishment of the agency, represents a significant step towards a more functional and secure system. Through the reorganization of governance and the introduction of new managerial figures and advisory bodies, the Agency prepares to face future challenges more efficiently and effectively. The goal of promoting investments in research and pharmaceutical development, along with the acceleration of drug approval processes, promises to bring tangible benefits for both patients and healthcare professionals. It now remains to closely monitor the implementation of the reform and evaluate its impact on the landscape of Italian healthcare.