The Social Security Financing Bill is a cornerstone in the evolution of the life sciences regulatory framework in France. The 2025 edition was even more noteworthy, given that it had been initiated prior to the dissolution of the Parliament. As a result of a delayed timeframe, the financial constraints were even higher, while the margin of maneuver for the government was very low. Nevertheless, the 2025 social security financing bill introduces important changes, all of which are geared towards increasing savings, while none focus on fostering innovation.
The evergreening clause de sauvegarde (clawback)
One of the key provisions is always the level at which the government imposes a claw-back, requiring companies to pay an additional tax on the turnover above the level of financing accepted by the bill.
For the first time, the government has accepted to cap the claw-back at €1.6 billion, provided that the industry complies with the €600 million savings that the undertakings proactively offered through their syndicate (LEEM).
The bill also renews the reduced rate benefiting to generics products, which was formerly set at two percent instead of 10 percent, now 1.75 percent instead of 12 percent. However, it is broadened to originators reimbursed at the same level of their generics, as well as certain therapeutic classes that will be set by a decree. Importantly, the amount resulting from such reduced rate must be compensated by the rest of the concerned companies, which may give rise to judicial review regarding compatibility with principle of equal treatment.
The ultimatum on contractual savings in imaging and biology
The government has adopted the same line on entrusting the stakeholders with the possibility to agree on contractual savings in the imaging and biology fields. Stakeholders will have four months to agree on a savings plan of at least €300 million for the 2025-2027 period. Failing such agreement, the tariffs will be automatically decreased to generate the same level of savings.
Penalties for shortages
Another major amendment is the increase in measures to prevent and reduce shortages of medications.
The level of sanctions in case of a shortage is increased to up to 50 percent of the concerned turnover, with a cap of €5 million (rather than the previous €3 million), and the sanction will be published on the ANSM website for one year.
The board of pharmacists is responsible for setting up an exchange of information across the supply chain, to anticipate shortages of essential drugs. Financial sanctions will be imposed if they fail to provide notice of products available for the pharmacists, distributors, or marketing authorization holders.
Monitoring of reimbursement through connected devices
Connected devices have been identified as a means to generate savings in case of improper use: for a list of pathologies, healthcare professionals will have to track the use and efficacy of the device and adjust the prescription accordingly. Patients will have to consent to the use of their health data for that purpose, but the device will not be reimbursed if a patient does not provide consent.
Looking ahead
These changes are expected to result in significant savings. It will be interesting to monitor how these provisions will be applied and interpreted if the level of expected savings is not met. Interestingly, the Supreme Court has ruled on almost none of these provisions, leaving the option of future referrals before the Administrative Court.
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