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Special Commission Update No. 3 - Towards the reform of the governance of the Italian Medicines Agency and the Single Commission: where are we?

special 3 on DM AIFA

Update 20 November 2023

The extraordinary State-Regions Conference held on 16 November 2023 sanctioned the long-awaited agreement on the regulation outline of the Minister of Health, in agreement with the Minister for Public Administration and the Minister for the Economy and Finance, amending Interministerial Decree No 245 of 20 September 2004, laying down rules on theorganisation and functioning of AIFA. 

The main points covered are:
  • that the President be appointed by decree of the Minister of Health in agreement with (previously heard) the Permanent Conference for Relations between the State, the Regions and the Autonomous Provinces of Trento and Bolzano;
  • that the post of Administrative Director be conferred by decree of the Minister of Health after consulting the State-Regions Conference;The previous version did not include the CSR among the bodies involved in the nomination process
  • that the post of Technical Scientific Director be conferred by decree of the Minister of Health after consulting the State-Regions Conference; The previous version did not include the CSR among the bodies involved in the nomination process
  • that the Scientific and Economic Medicine Commission be appointed by decree of the Minister of Health and be composed of 10 members, of whom three members appointed by the State-Regions Conference. The previous version had only one member appointed by the CSR. It is likely that the extra 2 are to the detriment of the number of MinSal appointees.

Scientific and Economic Commission_ Nov 23

NEXT STEP:

The reform scheme is forwarded to the Council of State for the expression of a mandatory but non-binding opinion. It will then be published in the Official Gazette.
The expiration of the Commissions remains on 1 December 2023, we believe there could be an administrative extension of 45 days, so that there is time to finalise the decree and start - finally - with the reorganisation of AIFA and the ESC.
Some speculate that the commissions will go on until spring, but at the moment there is no provision in the law indicating such an intention.
Original text

Pharma Value developed with Nomos a background document analysing the draft interministerial decree reforming AIFA.

L'target is to offer one useful tool for orientation in the absence of planning and ideas regarding new governance.

Nomos and Pharma Value undertake to update the document with legal/institutional news, information and reflections on the basis of forthcoming developments.

Soon the document will also be translated into English

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