The Regulation governing the organisation and operation of the Scientific and Economic Committee for Medicines (CSE) has been published on AIFA's institutional website. The CSE has the task of performing the functions attributed in the past to the Scientific-Technical Committee (CTS) and the Price and Reimbursement Committee (CPR), following the reform initiated by Law No. 196/2022 and recently completed by the Ministry of Health Decree No. 3/2024.

The Regulations is composed of three Titles.

The first Title is dedicated to the organisational rules, in which, the members of the Committee are identified and the investigative role of the AIFA Offices is specified, supporting the assessment and subsequent issuance of opinions by the Committee, which also has the possibility of availing itself of experts with proven technical and scientific experience, as well as of setting up advisory sub-commissions on specific issues.

The second Title, on the other hand, is dedicated to the operating rules and identifies the functions, tasks and organisation of the Committee's work, which must be carried out in compliance with the general principles set out in Article 6, i.e. (i) guaranteeing universal and homogeneous access to all essential medicines; (ii) ensuring safe and appropriate ways of using medicines; (iii) adopting a pricing policy aimed at rewarding medicines with added therapeutic value and (iv) taking into account the guidelines of the EMA and other European regulatory agencies.

Within the framework of the Committee's activities, the importance of patients' associations and scientific organisations is expressly recognised. In particular, patients' associations and scientific organisations can be convened to hearings in order to broaden the Committee's knowledge in decision-making processes (cf. Art. 11).

Finally, the third Title is dedicated to the final rules and, in particular, to access to the Committee's records (reference is made to the recent regulation adopted by the Agency), to the conflict of interest and confidentiality of the members of the Committee (who may not meet representatives of pharmaceutical companies outside the Agency in connection with procedures concerning medicinal products submitted to the them for assessment), and to fees and transparency in relation to the fees received by each member.