Growing budgetary pressure is a central theme in France as the country prepares for the publication of the government’s 2026 Social Security Finance Bill (PLFSS). French Prime Minister François Bayrou has requested the Economic Committee for Health Products (CEPS) to create a report, which will be published by the end of July 2025 and released in Q3 2025, outlining its drug pricing policy recommendations.
These policy recommendations are likely to be defined by what Bayrou describes as “changing geopolitical context” and “investment dynamics” for the EU pharma sector. The environment has therefore triggered an opportunity to re-evaluate current price setting and regulation policies, with the potential for greater flexibility and higher prices due to changing business conditions. This principle is already starting to be put in place. From March 2025, the CEPS has been required to consider the manufacturing location of production sites when setting prices, known as the “industrial criterion”. While this policy existed previously, it is now mandated, giving preferential pricing for domestically manufactured medicines. A price premium for local manufacturing will likely improve the generic sector, making it more financially viable.
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Historically, financial viability has been a definitive struggle for generic and biosimilar manufacturers in France. Based on a sample of off-patent, generic, and biosimilar prices, these medicines are typically priced between 38% to 68% lower in France, on average, when compared to the other top European markets. Using the available current prices from GlobalData’s Price Intelligence (POLI) & HTA service, the figure below compares the average price per milligram per unit of pack (one tablet, for example) difference between off-patent, generic, and biosimilar medicines that are available in France and the other four major European markets. The sample from each drug type was generated by including products that have their strength measured in milligrams and are available in all five markets.
Figure 1: Average price per strength unit (euros/unit/mg) comparison of prices in France to the other EU5 market
Furthermore, the Generic Same Drug Association (GEMME) in France has pushed for biosimilars to be excluded from the “safeguard clause” pricing policy. This measure limits public health spending on medicines by requiring pharmaceutical companies to contribute to health spending once the reimbursed expense exceeds a set threshold. There may be further positive news for generics and biosimilars as the government also considers lowering the discount ceiling for generics from 40% down to 20%–25% while setting a low ceiling for biosimilars.
While the upcoming report from CEPS will likely have benefits for the generic/biosimilar sector, it is unclear what potential benefits will be brought to the innovative pharmaceutical sector. There are appeals to change the “safeguard clause” and lower the cap, and there are possible modifications, but it is unlikely to be entirely overhauled. It is more likely that other cost-saving measures will be considered. For example, medicines with low clinical value ratings (Service Médical Rendu, SMR) could be delisted. Products that are reimbursed at the lowest tier (15%) would therefore no longer be reimbursed.
Such measures would likely target non-essential and lifestyle medicines that receive this low SMR rating in their cost-effectiveness assessments. GlobalData’s Price Intelligence (POLI) & HTA service shows that 77 molecules are currently 15% reimbursed and could therefore face a delisting challenge. These products see an average first price cut similar to that of products with a higher clinical rating. The average first price cut across different reimbursement tiers ranges between 6% and 7% for the different clinical ratings. Therefore, products with a low clinical rating see a similar impact on price after launch compared to those with a higher rating, despite being more likely to have competition with alternative treatments on the market.
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By GlobalDataFigure 2: Average first price cut (%) of products based on reimbursement level granted
Additionally, France’s National Health Insurance Agency (Caisse Nationale d’Assurance Maladie, CNAM) has set out proposals to save on pharmaceutical spending. In its annual report, CNAM suggested that medicines with an improvement in actual benefit (Amélioration du Service Médical Rendu, ASMR) that are rated “absent/no improvement” (ASMR V) or “minor” (ASMR IV) should be subject to a discount compared to the net price of the cheapest available comparator. The figure below shows the proportion of brands in France by ASMR ratings granted.
More than 70% of brands, accounting for the majority of the medicines reimbursed in France, have been granted these ratings of ASMR IV or V and would therefore be impacted.
Figure 3: Distribution of medicines in France by ASMR rating
Throughout 2025, CEPS has been coordinating many policy initiatives that will determine and influence the government’s approach to pharmaceutical spending in 2026. As such, the French Government has requested that the CEPS publish a report later in July 2025 to outline its policy recommendations. While this appears to be a quick turnaround for CEPS, the ongoing initial proposals have given a sneak peek into what this report may feature. The generic and biosimilar sectors are likely to benefit from upcoming reforms. Potential amendments could include changes to the limit discount ceiling and possible exclusion from the “safeguard policy”. It is unclear what this report may consider for the innovative sector; however, certain medicines could be delisted based on reimbursement levels, and further discounts could be granted on net prices for products with ASMR IV and V ratings. This report will encompass the progress made for recent and upcoming policy actions, while also giving insight into significant spending constraints for innovative medicines expected for 2026.
This article is produced as part of GlobalData’s Price Intelligence (POLI) service, the world’s leading resource for global pharmaceutical pricing, HTA and market access intelligence integrated with the broader epidemiology, disease, clinical trials and manufacturing expertise of GlobalData’s Pharmaceutical Intelligence Center. Our unparalleled team of in-house experts monitors P&R policy developments, outcomes and data analytics around the world every day to give our clients the edge by providing critical early warning signals and insights. For a demo or further information, please contact us here.
