On December 14th, 2022, a draft of the interministerial decree for the new AIFA regulation was shared by “Quotidiano Sanità,” and on September 29th, what appears to be the final version was released.

THE CHANGES IN THE DECREE

• A more hierarchical and politicized structure: all powers will be in the hands of the President, who will be directly appointed by the Minister of Health, in consultation with the Minister of Economy and Finance and with the Permanent Conference for Relations between the State, Regions, and Autonomous Provinces, which will have the legal representation.
• The role of the General Director is abolished.
• New roles of Technical-Scientific Director and Administrative Director are established, appointed by the Minister of Health, in consultation with the Minister of Economy and Finance.
• The two commissions, CTS and CPR, merge to create the new Scientific and Economic Commission on Medicines (CSE), consisting of 10 members, which will assume all the functions currently attributed to the two commissions.

THE MAIN DIFFERENCES FROM THE PREVIOUS DRAFT

1. In the appointment of the President, Administrative Director, and Technical-Scientific Director, as well as in the decision to potentially dissolve the administrative bodies of the Agency for reasons related to the economic and financial balance in the pharmaceutical sector, the Minister of Economy and Finance is also involved.
2. The Minister of Health may decide in the decree appointing the President to remove the exclusivity clause for his office.
3. The Minister of Public Administration will also be involved in defining the functioning and organization of AIFA personnel and in reshaping the distribution of staff positions.
4. The Council of Ministers, upon the request of the Minister of Health, can dissolve the administrative bodies. We believe that all administrative bodies that have objectives related to the appointment defined in the contract are subjected to a “spoil system.”
5. There is an increase in managerial offices at the non-general managerial level to 43 (instead of 38 as specified in the previous draft).
6. There is no deadline by which the Minister of Health must approve the resolution made by the Board of Directors of operation and the Agency’s staff’s organization.
7. Changes in the transitional provisions: the new administrative bodies come into effect the day after the publication of this decree, but the previous administrative bodies cease at the time of the new appointments. CTS and CPR also cease with the appointment of CSE.

NEXT STEPS AND POSSIBLE TIMELINES FOR THE AIFA REFORM (see our attached infographic)

The text will be examined in one of the upcoming State-Regions’ Conference sessions.

While waiting for the publication of the New AIFA Regulation, six extensions of the AIFA Commissions (CTS and CPR) have already been issued. The latest was approved on September 27th, 2023, in the legislative decree extending regulatory deadlines and tax payments, which extended the deadline to December 1st, 2023.