France's New Supplementary Contribution and an Extension of the Direct Access Pilot Program
- Kiley Trupiano
- Mar 23
- 1 min read
The New Supplementary Contribution & A Return of the "M" Contribution to its Original Intent
One of the most consequential structural changes in PLFSS 2026 concerns how the French system manages spending overruns. For years, the Safeguard Clause (clause de sauvegarde, or "clause M") served as the primary cost-control backstop but it was criticized for unpredictability and its repeated activation had stripped it of any "exceptional" character.
The system has been reshaped with a new tax based on each company's turnover called the "supplementary contribution". The introduction of this new, in-year contribution is indented to restore the safeguard clause as a genuine "exceptional" backstop. In practical terms, this means manufacturers must now build predictable in-year levies into their financial models rather than planning around year-end claw back uncertainty.
For 2026, the contribution rates are below.
Article 62 Direct Access Program Extended Through 2027
Article 62 of the French Social Security Financing law for 2022 created a pilot program to allow even faster access to innovative medicines in hospitals. Announced in 2026, the pilot program has been extended for an additional two years until September 1, 2027.
Medicines eligible for the program are those with marketing authorization, a high clinical value, are not eligible for other early access programs, and are not yet reimbursed (for any indication). Coverage is eligible for a maximum of one year.
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