A new two-month postponement of the renewal of the AIFA Commissions was approved last night in the Council of Ministers of Wednesday, 27 September 2023, within the discussed Urgent Provisions on the Extension of Regulatory Deadlines and Tax Payments (Decree-Law).

For the members of the Technical and Scientific Advisory Commission (STC) and the Pricing and Reimbursement Committee (PRC) of the Italian Medicines Agency, their term of office has been extended from 1 October 2023 to 1 December 2023.

This is the sixth extension after the natural expiry in November 2021 of the members of the two commissions appointed by the Minister of Health's decree of 20 September 2018.

The term of office of the CTS and CPR members was supposed to end in September 2021, although with the 45-day extension of public administration bodies it ended - the first time - in November 2021.

The series of extensions is linked to the reform of the Agency envisaged by the ddl approved on 14 December 2022 containing 'urgent provisions for the extension of the participation of military personnel in the strengthening of NATO initiatives, measures for the health service of the Calabria region, and commissions at AIFA'.

Below are all the extensions since that first deadline:

• 8 November 2021 - Decree-Law no. 152 of 6 November 2021 "PNRR decree" (Official Gazette no. 265 of 6-11-2021)extended its expiry until 28 February 2022 : "Pending the reorganisation of the Italian Medicines Agency (AIFA), also aimed at promoting investment in public research and development on medicines in implementation of mission no. 6 of the PNRR, and in any case until 28 February 2022, the members of the Technical and Scientific Advisory Commission (STC) and the Pricing and Reimbursement Committee (CPR) remain in office."

• 21 February 2022 - With the conversion into law of Decree-Law No. 228 of 30 December 2021, containing urgent provisions on legislative deadlines, the "Milleproroghe Decree", the deadline of 30 June 2022 was set: "A further extension (from 28 February 2022) to 30 June 2022 of the members of Aifa's advisory committees (the Technical-Scientific Committee for the Evaluation of Medicines and the Pricing and Reimbursement Committee), which expired last November, is provided for."

• 22 June 2022 - By Decree-Law No. 73 of 21 June 2022, the Fiscal Simplifications Decree establishes that the commissions will remain in office until 15 October 2022 so as to ensure continuity and full operability of AIFA: 'In Article 38, paragraph 1, of Decree-Law No. 152 of 6 November 2021, converted, with amendments, by Law No. 233 of 29 December 2021, the words "30 June 2022" are replaced by the following: 15 October 2022'

• 4 November 2022 - With the 'DL Ministeri', the Council of Ministers extended the term of office of the members of the Technical and Scientific Advisory Commission and the Price Committee operating at the Italian Medicines Agency (AIFA) until 23 February 2023.

• 10 May 2023 - the further extension of the AIFA Commissions, which became effective with the publication in the OJ of the Decree-Law of 10 May 2023, according to which the members of the CTS and CPR will remain in office until 1 October 2023

• 27 September 2023 - within the Urgent Provisions on the Extension of Regulatory Deadlines and Fiscal Payments (Decree-Law), in PMC No. 52 a further extension of the AIFA Commissions until 1 December 2023 is foreseen.

In May this year, Pharma Value developed with Nomos an in-depth document analysing the draft inter-ministerial decree reforming the AIFA, if you want to read more Commission Special No. 3 - Towards the reform of the governance of the Italian Medicines Agency and the Single Commission: where are we?