French pharmaceutical market access amid budgetary strain and cost containment

In 2026, France is set to enter a new phase of strengthened policies to regulate expenditure on medicinal products, amid persistent budgetary pressure on health insurance. Price reductions decided by the Economic Committee for Health Products ("Comité économique depfizers produits de santé" (CEPS)) will concern both innovative and generic medicines, with price decreases of up to 20%, notably through flat-rate liability tariffs ("tarif forfaitaire de responsabilité" (TFR)), structuring the generic and biosimilar market.

The recent management of TFRs illustrates the sensitivity of these trade-offs. An initial decision to reduce prices for 33 generic groups – which took effect in October 2025 – was subsequently revoked before being reintroduced in December 2025, with further price reductions on 32 groups, reflecting the desired balance between expected savings and market attractiveness. Price reductions on medicinal products resulted in financial savings amounting to €856 million in 2024 and approximately €1.6 billion in 2025, with a target of €1.4 billion in 2026.

French regulation also incorporates growing industrial considerations, with CEPS now required to consider the location of production sites, making pricing policy a lever for health sovereignty. Concurrently, the revised doctrine of the French National Authority for Health ("Haute Autorité de Santé") imposes more stringent criteria for early access.

This dynamic is also reflected in stricter conditions for access to hospital financing. As of 1 January 2026, nine molecules have been removed from the supplementary list. The French Council of State ("Conseil d'Etat") rejected the request to suspend the withdrawal of the Rezzayo® specialty, ruling that the decision did not affect accessibility of the treatment or the economic situation of the laboratory.

These developments are part of a particularly tense international context. In France, the Trump Administration's Most Favored Nation (MFN) policy has the potential to compromise business secrecy and generates tension in price negotiations. The year 2026 is also marked by a major split within Leem, the French professional association representing pharmaceutical companies operating in France, with the departure of some thirty French laboratories to create a new union focused on access to innovation and recognition of the French industrial footprint. These developments highlight a French model of market access that has become systemic, at crossroads of budgetary, industrial, legal, and European issues.

Authors

Charlotte Damiano

Partner Global Regulatory Paris

David Amar

Associate Global Regulatory Paris

Estelle Sigaut Démoulin

Associate Global Regulatory Paris

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