#2026-448France harmonizes early and compassionate access rules for medicines
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The decree adjusts France’s rules for early access and compassionate access to medicines, mainly by clarifying decision procedures and responsibilities between health authorities and ministers. It affects pharmaceutical companies seeking or holding early access authorizations, as well as public bodies that review, price, or manage these access schemes. The most practical change is stronger financial pressure on companies that fail to meet supply commitments: rebate rates can be increased by 20 to 30 percentage points. The decree also removes some review steps when the medicines agency has already issued an unfavorable view or when an early access authorization is being withdrawn, which should make procedures more direct.
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Key Changes
- Allows some early access files to move forward without an additional commission opinion when the medicines agency has already given an unfavorable view.
- Adds higher rebate penalties, increased by 20 to 30 percentage points, when a pharmaceutical company fails to meet supply commitments.
- Shifts certain notification and decision roles from the Economic Committee for Health Products to the ministers responsible for health and social security.
Obligations
What this law requires
Pharmaceutical companies holding or seeking early access for a medicine must comply with their statutory supply commitment; if non-compliance is established by any means, applicable rebate rates are increased by 20 to 30 percentage points.
For early access matters concerning a medicine covered by Article L. 5121-12 II 1° of the Public Health Code, the competent review commission’s opinion is not required when the National Agency for the Safety of Medicines and Health Products has issued an unfavorable opinion.
For a request to withdraw an early access authorization under Article R. 5121-72-1 II of the Public Health Code, the competent review commission’s opinion is not required before the withdrawal process proceeds.
When the ministers responsible for health and social security plan to apply the procedure formerly initiated by the Economic Committee for Health Products under Article R. 163-39, they must inform the affected company and receive any observations from the company within the applicable procedure.