In brief

On 15 January 2024, the Decree of the Minister of Health No. 3 of 8 January 2024 on “Changes to the regulation on the organization and functioning of the Italian Medicines Agency” was published in the Official Gazette. The Decree will enter into force on 30 January 2024.

Key takeaways

The Decree provides, amongst other things, for the abolition of the role of General Director (while the position of the President as the body and legal representative of the Agency is maintained) and the creation of the management positions of the Administrative Director and the Technical-Scientific Director.

A further change introduced by the Decree concerns the composition of the Board of Directors, which will be composed of the President, appointed by decree of the Minister of Health in agreement with the State-Regions Conference after consultation with the Minister of the Economy and Finance, and four members, one appointed by the Minister of Health, one by the Minister of the Economy and Finance and two by the State-Regions Conference.

The Decree also provides for the establishment of the Scientific and Economic Commission of Medicines, to which are assigned the functions of the Technical-Scientific Advisory Commission and the Pricing and Reimbursement Committee, both of which are abolished.

Lastly, the Decree modifies the procedures and requirements for the election of the Administrative Director, the Technical-Scientific Director and the Scientific and Economic Medicine Commission.