Almost one year after the publication of the relevant law, the long-awaited reorganisation of the Italian Medicines Agency (AIFA) seems to be close to its final approval and implementation.
The new AIFA Regulation includes major changes in the organization and functioning of the Italian Agency, such as:
- creation of a new single Scientific and Economic Commission for Pharmaceuticals (CSE) in place of the current Technical and Scientific Commission (CTS) and Price and Reimbursement Committee (CPR);
- new powers for the President of Aifa, who will be the legal representative of the Agency and will be appointed by the Minister of Health with the agreement of the Permanent Conference for Relations between the State, Regions, and Autonomous Provinces;
- establishment of the new roles of Technical and Scientific Director and of Administrative Director, with specific duties and responsibilities;
- abolition of the role of the General Director.
- What are the roles and the composition of the new Scientific and Economic Commission for Pharmaceuticals (CSE)?
The creation of the single Commission is an important step towards the simplification and improvement of the activities of AIFA.
The new Scientific and Economic Commission for Pharmaceuticals (CSE) performs the activities already attributed to the CTS and the CPR, with the responsibility of evaluating the efficacy and safety of drugs, as well as establishing prices and reimbursement.
The Commission is appointed by a decree of the Minister of Health and is composed of ten members, including:
- the Technical-Scientific Director of the Agency;
- the President of the Italian National Institute of Health (Istituto Superiore di Sanità, ISS) (or their delegate);
- four members appointed by the Minister of Health, identified among persons of proven and documented national and international technical-scientific expertise, with at least five years of experience in the evaluation of drugs and in the area of drug pricing methodology and Pharmacoeconomics. One of those members shall serve as chairman;
- one member appointed by the Minister of Economy and Finance;
- three members appointed by the Permanent Conference for Relations between the State, Regions and Autonomous Provinces of Trento and Bolzano.
The appointed members serve for 3 years, after which the membership can be renewed consecutively only once.
- What are the new powers of the AIFA President under the new regulation?
The president of AIFA is appointed by the Minister of Health with the agreement of the State-Regions Conference and has the legal representation of the Agency and full powers, including the responsibility of coordinating the activities of the Agency and representing it at the national and international level.
In particular, the president of AIFA:
- convenes and presides over the Board of Directors;
- supervises, the overall activities of the Agency and its Offices;
- takes care of the relations with public and private research institutes, scientific societies, industrial associations and consumer and patient associations and with international organizations and bodies, including Agencies of other Countries and the EMA;
- submits the budget and final accounts, prepared by the Administrative Director, to the Board of Directors;
- in cases of qualified urgency adopts measures within the competence of the Board of Directors;
- transmits periodic information reports to the Minister of Health, after approval by the Board of Directors.
- What are the responsibilities of the Technical-Scientific Director and the Administrative Director under the new regulation?
The Technical-Scientific Director is responsible for directing the technical-scientific activity of AIFA, ensuring that the agency’s functions follow the relevant regulations and coordinating with the European Medicines Agency.
The Administrative Director is responsible for the administrative activity of the Agency, preparing and submitting the Agency’s budget, contracts and agreements, overseeing the allocation of resources to the various functional areas, handling legal affairs and quality control procedures and exercising spending powers.
Both the Technical-Scientific Director and the Administrative Director are appointed by the Minister of Health with the consultation the State-Regions Conference.
- What are the next steps and possible timeline for the AIFA reform?
The text of the new AIFA regulation, which implements the dispositions set by Law 196 of 16 December 2022, was prepared and circulated at the end of September 2023 by the Ministry of Health together with the Ministry of the Public Administration and the Ministry of Economics and Finance and then received the agreement by the State-Region Conference after some changes on 15 November 2023.
The Council of State has now suspended its decision while waiting for some additional reports.
After the positive opinion of the Council of State, the New AIFA Regulation will be published in the Italian Official Journal and then there will be the official appointments of the Technical-Scientific Director, the Administrative Director and the members of the Scientific and Economic Commission for Pharmaceuticals.
Meanwhile, the two current Committees (Technical and Scientific Commission -CTS- and Price and Reimbursement Committee -CPR-), which had been appointed in 2018 and whose duty has been repeatedly extended since September 2021, are probably going to continue working until at least mid-January 2024, to allow for the remaining steps needed for the AIFA reorganization to come into effect.
In conclusion, the new AIFA regulation represents an important step for the Italian pharmaceutical world and all involved stakeholders (particularly Pharmaceutical Companies, Scientific Societies, Patient Associations) are eager to understand the practical implications in terms of assessment timelines and efficiency of the procedures.
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.