France - Briefings

The French National Agency for Medicines and Health Products Safety, Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM), offers a scientific advice service to assist pharmaceutical companies in the development of health products. This service provides guidance on scientific, technical, regulatory, and legal aspects, aiming to facilitate the development and market access of innovative health products.

The National Agency for the Safety of Medicines and Health Products (Agence nationale de sécurité du médicament et des produits de santé, ANSM) plays a role in improving patient access to new therapies in France. By implementing regulatory procedures and offering scientific support, the agency aims to ensure timely access to treatments while maintaining safety and efficacy standards.

France has implemented early access programmes to provide patients with innovative medicines before full marketing authorisation or reimbursement. These programmes include the Early Access Authorisation (AAP), Compassionate Access Authorisation (AAC), and Compassionate Prescription Framework (CPC). They are designed to address serious, rare, or disabling diseases lacking appropriate treatment options, ensuring timely access to potentially life-saving therapies.

The HAS’s structured approach to economic evaluation follows a robust process to ensure transparency, efficiency, and equity in healthcare decision-making. By integrating rigorous analyses with stakeholder engagement, the process balances cost-effectiveness with patient access to innovative treatments. This comprehensive methodology supports the long-term sustainability of the healthcare system while maintaining its commitment to high-quality patient care.

The French government’s France 2030 plan is a national initiative to modernise health research, accelerate scientific discoveries, and improve patient care. It is led by the French Ministry of the Economy, Finance and Recovery (Ministère de l’Économie, des Finances et de la Relance, MEFR).

France's healthcare system is centrally coordinated and regionally administered through Agences Régionales de Santé (ARS), ensuring universal coverage and equitable access to services. The Haute Autorité de Santé (HAS) evaluates medical benefits and improvements, informing reimbursement decisions, while the Comité Économique des Produits de Santé (CEPS) negotiates medicine prices. France operates two main early access programmes, the Autorisation d’Accès Précoce (AAP) and Autorisation Compassionnelle (AC) pathways to expedite patient access to innovative treatments.

France's healthcare system is a hybrid model that combines public and private sectors to deliver comprehensive medical services to its residents. This overview addresses the main components of France's healthcare framework, focusing on the organisation of the healthcare system, funding mechanisms, service provision, medicines approvals, and pharmaceutical access.

The French National Authority for Health (Haute Autorité de Santé, HAS) has in place a structured action plan issued in 2020 to adopt evaluation processes for innovative medicines. The plan focuses on three core initiatives: issuing conditional opinions for early access, implementing real-world monitoring to confirm efficacy and safety, and streamlining assessments for high-value medicines.

The Haute Autorité de Santé (HAS, National Authority for Health) offers an Early Dialogue scientific advice service to guide pharmaceutical companies in designing pivotal clinical trials for innovative medicinal products. This voluntary and confidential service provides non-binding recommendations to optimise evidence generation for Health Technology Assessments, focusing on unmet medical needs and aligning with national requirements.

The French Health Technology Assessment (HTA) process, overseen by the French National Authority for Health (Haute Autorité de Santé, HAS), is a comprehensive evaluation system designed to assess the medical, economic, and public health value of pharmaceuticals. This process informs decisions regarding the reimbursement and pricing of medications within the French healthcare system.

The National Agency for the Safety of Medicines and Health Products (Agence Nationale de Sécurité du Médicament et des Produits de Santé, ANSM) is the French national authority responsible for ensuring the safety, efficacy, and quality of health products, including medicines, medical devices, and other health-related products. Working closely with the European Medicines Agency (EMA) and operating under the Ministry of Health, the ANSM oversees the entire lifecycle of these products, from development through to post-market surveillance.

Pharmaceutical companies submitting a dossier for the evaluation of a medicinal product to the French National Authority for Health (Haute Autorité de Santé, HAS) must adhere to clearly defined procedures. The process ensures that applications are reviewed efficiently, allowing timely market access for medicines.

The temporary reimbursement framework complements the early access schemes described in other briefings by providing funding to allow early patient access to promising treatments during the price negotiation process, while ensuring the collection of robust evidence to support final reimbursement decisions.

The price of medicines and other life science products is negotiated by the manufacturer with the Economic Committee for Health Products (Comité Économique des Produits de Santé, CEPS). CEPS is a French interministerial body operating under the joint authority of the Ministers responsible for health, social security, and the economy. Its primary mandate is to set the prices of reimbursable health products, including medications and medical devices, ensuring a balance between patient access and the financial sustainability of the healthcare system.