French National Authority for Health (HAS) and Transparency Committee

The French National Authority for Health is an independent public scientific authority, created in 2004, whose tasks include assessing health products with a view to their reimbursement by the national health insurance system. It issues its opinions on medicinal products through the Transparency Committee, which assesses the actual clinical benefit and the improvement in actual clinical benefit of each medicinal product, indication by indication. These opinions prepare the ministerial decisions on inclusion on the reimbursement list and the price negotiation before the Economic Committee for Health Products.

Remit of the French National Authority for Health regarding medicinal products

Besides assessment for reimbursement, the French National Authority for Health decides on early access, draws up good practice guidelines and, through its Committee for Economic and Public Health Assessment, issues cost-effectiveness opinions based on health economic assessment. It also represents France in the joint clinical assessment work organised under Regulation (EU) 2021/2282. Medical devices fall within the remit of a separate committee.

Procedure before the Transparency Committee

The Committee acts on an application from the company, which files a dossier containing the available clinical data and, where appropriate, a comparison with reference treatments. It also examines medicinal products when their listing is renewed, or on its own initiative for a reassessment. The company receives the draft opinion and may submit written observations or ask to be heard before the final opinion is adopted. This adversarial phase is decisive, because the rating adopted determines the reimbursement rate and the room for manoeuvre in the price negotiation.

Challenging the opinions

The Committee’s opinion is a preparatory act. As a rule, it is challenged in the course of the action brought before the administrative courts against the decision that follows it, such as the ministerial order of inclusion or removal. The court reviews the regularity of the procedure and the consistency of the scientific assessment, without substituting its own assessment for that of the Committee.

Key points

Through its ratings, the Transparency Committee sets the medical value recognised for the medicinal product, and that value governs both reimbursement and price. The dossier should be prepared with the comparator the Committee will adopt in mind, and full use should be made of the adversarial phase on the draft opinion. In patent infringement litigation, the Committee’s published opinions are also a useful source for assessing the actual place of a medicinal product in the therapeutic strategy.

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This glossary entry is general in scope and does not constitute legal advice.

Dhenne Avocats acts in pharmaceutical patent disputes and on the medicines regulatory questions that accompany them, from the marketing authorisation to the supplementary protection certificate.

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