The Economic Committee for Health Products (CEPS) has released a new version of its "Internal Regulations of the Economic Committee for Health Products" (Règlement intérieur du Comité économique des produits de santé), dated 16 October 2025. This document, issued under the leadership of President Virginie Beaumeunier, replaces the previous 2018 version and aligns the committee's operations with the Ministerial Guidance Letter (Lettre d’orientations ministérielles) of 5 May 2025.
The revised regulations are structured into three primary chapters covering core values, organisational structure, and administrative procedures. A central focus is placed on deontology and transparency, specifically addressing the public declaration of interests and the role of the ethics officer. These measures ensure that the committee’s dual missions—pricing and regulation—are conducted with high integrity. The document details the composition of the two distinct sections: one dedicated to medicinal products and the other to medical devices and services.
This update formalises the role of the General Secretariat in preparing decisions and monitoring their implementation. It incorporates requirements from the 2025 Social Security Financing Law, which introduces new criteria for price-setting, such as the geographical location of manufacturing sites. The regulations also clarify the voting procedures within the sections, where decisions are reached by majority vote, with the President holding a casting vote in the event of a tie.
Administrative refinements suggest a more structured and predictable environment for price negotiations. The clearer ethical guidelines and formalised secretarial support are likely to enhance the efficiency of the 180-day regulatory window for dossier reviews. Furthermore, the explicit inclusion of industrial criteria in the decision-making process provides a transparent framework for arguing for price stability or increases based on domestic production footprints.
Source: Comité économique des produits de santé (CEPS)
Link: Règlement intérieur du Comité économique des produits de santé (Rules of procedure of the Economic Committee for Healthcare Products)
Date: 16 October 2025
