France’s medicine price-regulation model has come under renewed official scrutiny after two reports questioned the growing reliance on retrospective mechanisms to control reimbursed medicines expenditure.
The General Inspectorate of Finance (Inspection générale des finances, IGF) published Bilan et évolution du dispositif de régulation du prix des médicaments (Assessment and evolution of the medicine price-regulation system) on 7 May 2026. The report reviews the tools used around price negotiation by the Economic Committee for Health Products (Comité économique des produits de santé, CEPS), including product-specific rebates and the safeguard clause.
IGF says product rebates rose from €3.2 billion in 2019 to €8.3 billion in 2023. It also says the safeguard clause – the statutory contribution due from companies when reimbursed medicines expenditure exceeds the threshold set in social security financing legislation – generated more than €1.5 billion in both 2023 and 2024.
In IGF’s assessment, this growth has produced adverse effects. Rebates have made health-insurance expenditure harder to forecast, while the safeguard clause has moved from an exceptional backstop to a recurrent revenue mechanism. The report links this shift to a lower use of direct price reductions.
The Court of Accounts (Cour des comptes, CDC) reaches a similar diagnosis in its 2026 social security report, published on 27 May 2026. It says gross medicine expenditure continued to rise in 2025, although at a slower rate than in 2019-2024. It also notes that rebates and the safeguard clause strongly reduced net expenditure, while making in-year spending control more complex because final amounts are determined late and may be affected by litigation.
IGF says the 2026 social security financing law follows its proposed approach by simplifying the safeguard clause and replacing part of its yield with a more predictable turnover-based contribution. The report also proposes stronger price reductions, regular reassessment of improvement in medical benefit (amélioration du service médical rendu, ASMR), and a reassessment of the use of medicine prices to support industrial-policy objectives.
The reports point to a more predictable model of expenditure control, with direct price reductions and regular reassessment taking a larger role alongside confidential agreements. That would place more pressure on negotiated net and list prices, while reducing dependence on late-year corrective payments to balance the medicines budget.
Source: General Inspectorate of Finance and Court of Accounts
Link: Bilan et évolution du dispositif de régulation du prix des médicaments (Assessment and evolution of the medicine price-regulation system); Un ONDAM tenu en 2025 mais une trajectoire qui reste à infléchir (A national health insurance expenditure objective met in 2025 but a trajectory that still needs to be redirected); L’ONDAM, un outil de régulation des dépenses de santé nécessaire et à renforcer (The national health insurance expenditure objective, a necessary health-spending regulation tool that needs strengthening)
Date: 7 May 2026 and 27 May 2026
