In its decision no. 2025-875 DC issued on Friday, the Constitutional Council ruled on the conformity with the Constitution of the provisions of Social Security Financing Act no. 2025-199 of February 28, 2025 (LFSS) for 2025. Published in the Journal officiel on the same day, the LFSS 2025 came into force on March 1st, 2025, unless otherwise provided.
In terms of healthcare products, most of the provisions are not immediately applicable. Indeed, many implementation measures are expected, making the entry into force of the LFSS a real headache.
In order to facilitate the operational implementation of the LFSS 2025 for companies, we publish a timeline of the main measures that concern pharmaceutical products (see also our timeline of measures concerning medical devices (DM) and acts).
You will find:
- In table 1, measures relating to market access, namely:
- an increase of the maximum commercial discounts that manufacturers may grant for substitutable biosimilars and hybrids
- changes to the system whereby reimbursement of certain pharmaceutical products is dependent on the submission of a form drawn up by the prescriber
- changes to legal price fixing criteria
- the consequences of public (national or European) purchasing of a pharmaceutical product on its reimbursement under common law (and the one of its comparable pharmaceutical products)
- the submission of the CEPS annual report to the French Parliament by September 30, year n+1
- In table 2, measures relating to regulatory, namely:
- measures relating to supply shortages: details on stocks and shortage management plans, wider use of conditional prescriptions, pharmacists’ right to substitute, stricter penalties from the ANSM (amount and publicity)
- the introduction of financial penalties for failure to inform the information system on the availability of pharmaceutical products of major therapeutic interest (MITM)
- the reduction of the time limit for automatic substitution of biosimilars
- In table 3, measures relating to pharmaceutical taxes, namely:
- measures relating to the reform of the safeguard clause (CS M): clarifications and changes to the CS M base and calendar, postponement to January 1st, 2027
- measures specific to the CS M 2025: setting of the M 2025 amount, capping of the individual contribution for certain products, capping of the collective yield
Table 1: Measures relating to market access
| Art. | Purpose of the measure | Immediate implementation | Implementing measures to be taken |
| Art. 33 | Increase of the maximum commercial discounts for substitutable biosimilars and hybrids[1] and reference pharmaceutical products with identical prices (aligned with the maximum commercial discounts for generics) | YES | / |
| Art. 48[2] | Clarification of the possibility of making the reimbursement of a pharmaceutical product when it is particularly costly for health insurance or when there is a risk of misuse, subject to the patientpresenting a document drawn up by the prescriber[3] | NON[4] | Regulatory text allowing the use of a teleservice and specifying the information that the prescriber must provide in order to verify (i) that he has previously consulted the shared medical file (DMP) or (ii) that the prescription complies with the reimbursable indicationsMinisterial orders setting out the pharmaceutical products, acts and services subject to the measure, and specifying the nature of the information to be provided |
| Art. 75 | Addition of a legal price fixing criterion: price or tariff[5] of the pharmaceutical product fixed within the public purchase(national purchase by Santé Publique France or as part of a joint European purchase) | YES | / |
| Art. 75 | Obligation to take account of the geographical location of production sites in price and tariff fixing | YES | / |
| Art. 75 | Possibility for ministers to suspend the reimbursement and price fixing procedures for a pharmaceutical product that is the subject of a public purchase and for all comparable products or products with the same therapeutic aim[6] | YES | / |
| Art. 78 | Submission of the CEPS annual report to the French Parliament by September 30, year n+1 | YES | / |
Table 2: Measures relating to pharmaceutical products regulatory
| Art. | Purpose of the measure | Immediate implementation | Implementing measures to be taken |
| Art. 75 | Possibility for the ANSM to authorize marketing authorisation (MA) holders to temporarily build up a safety stock at a lower level than required in principle[7] | NO | Conseil d’Etat decree determining the conditions for this authorization[8] |
| Art. 75 | Definition of the content, conditions for drawing up and updating shortage management plans and determination of the conditions under which the ANSM may impose stricter requirements on pharmaceutical products that are regularly at risk of running out of stock, or running out of stock | NO | Conseil d’Etat decree (i) determining the content and conditions for drawing up and updating shortage management plans and (ii) setting the conditions for submitting plans to stricter requirements |
| Art. 75 | Extension of the obligation to use conditional prescriptions to cover risks of supply disruption or to preserve the availability of pharmaceutical products whose demand is subject to seasonal variations[9] | YES | / |
| Art. 75 | Extension of the dispensing pharmacist’s option to substitute a MITM with another pharmaceutical product in accordance with a recommendation issued by the ANSM, in the event of a risk of stock shortage | YES | / |
| Art. 75 | Increase in penalties for failure to comply with stock obligations[10] | YES | / |
| Art. 75 | Publication of ANSM penalties for 1 year (unless reduced by the ANSM)[11] | YES, except for the reduction in the duration | Conseil d’Etat decree determining the conditions under which the ANSM may reduce the publication period |
| Art. 76 | Pharmaceutical companies subject to financial penalties for failure to inform the MITM availabilityinformation system[12] | NO | Conseil d’Etat decree specifying the methods of financing the information system, the categories of data to be entered, the conditions of access to the data, their retention period, the recipients and the system’s security and traceability requirements |
| Art. 77 | Reduction of the time limit for automatic substitution of biosimilars to 1 year following registration of the first biosimilar on the “liste ville” (unless otherwise advised by the ANSM)[13] | NO | Ministerial order authorizing pharmacists to substitute, unless otherwise advised by the ANSM |
| Art. 77 | Substitution by a biosimilar limited to the absence of additional expenses for health insurance | YES | / |
Table 3: Measures relating to pharmaceutical taxes
| Art. | Purpose of the measure | Immediate implementation | Implementing measures to be taken |
| Art. 29 | Exclusion of the “écart rétrocession indemnisable”(ERI) and the “écart médical indemnisable” (EMI)[14] from reimbursed amounts included in the CS base M | NON[15] | / |
| Art. 29 | Extension of the base for the CS M to include pharmaceutical products reimbursed under an “AMM miroir” and those reimbursed outside the MA (and outside the compassionate access) | NON15 | / |
| Art. 29 | No contribution when the amount reimbursed for a pharmaceutical company is lower than the amount of paybacks | NON15 | / |
| Art. 29 | Changes to the calendar[16] | NON15 | / |
| Art. 29 | Suppression of the contribution in respect of pharmaceutical products intended for the treatment of hepatitis C | YES | / |
| Art. 29 | Setting the M 2025 amount at €27.25 billion | YES | / |
| Art. 29 | Individual capping of the CS M 2025 at 1.75% of turnover (excluding VAT) for generic pharmaceutical products (1°), those subject to a responsibility flat rate (TFR)(2°) and those belonging to certain therapeutic classes where the selling price is below a certain threshold (3°)[17] | YES, except for the 3° | Decree defining the therapeutic classes and the selling price threshold for each of them enabling pharmaceutical products to benefit from the cap |
| Art. 29 | Clarification of the calculation of the proportion due to turnover growth for CS M 2025 for pharmaceutical products acquired by Santé publique France | YES | / |
| Art. 29 | Exceptional individual capping at 10% of turnover excluding VAT for CS M 2025 | YES | / |
| Art. 29 | CS M 2025 yield capped at €1.6 billion[18] | YES | / |
| Art. 29 | Postponement of the CS M reform to January 1st, 2027[19] | YES | / |
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[1] In principle, commercial discounts are capped, per calendar year and per product line, for each pharmacy, at 2.5% of the face price excluding VAT (PFHT). This measure extends the possibility for dispensing pharmacists to benefit from discounts on substitutable biosimilars and hybrids up to a percentage set by ministerial order and capped at 50% of the PFHT.
[2] The Constitutional Council set out 2 interpretative reservations regarding this article: (i) it will be up to the prescriber to inform the patient in advance of the absence of reimbursement for this treatment if he does not present such a document to the professional called upon to carry out the prescription and (ii) in the absence of such a document or if the document indicates that these conditions have not been met, these provisions must be interpreted as requiring the prescriber, where he has prescribed treatment for the patient which should have given entitlement to reimbursement, to draw up or amend this document within a period of time appropriate to the patient’s state of health and without this resulting in additional costs for the patient.
[3] The LFSS stipulates that as a consequence of this new measure, article L. 162-19-1 of the French Social Security Code (amended by article 73 of the LFSS for 2024), which sets out the current procedure for ensuring the appropriateness of prescriptions, is repealed.
[4] The LFSS provides for an entry into force date of 1st January 2026.
[5] Any paybacks or taxes are deducted.
[6] This is a decision taken by the French ministers for a period that they determine, which may not exceed the period during which stocks of this pharmaceutical product are exhausted, up to a maximum of 2 years.
[7] As a reminder, MA holders are required to maintain stocks of at least 2 months for MITMs and 1 week for other pharmaceutical products (and for MITMs, the ANSM may increase these thresholds by up to 4 months).
[8] This is the same Conseil d’Etat decree as that provided for in the second paragraph of I of Article L. 5121-29 of the French Public Health Code.
[9] These measures are imposed by decree.
[10] For legal entities, the penalties incurred may be up to 50% (compared with 30% previously) of the turnover generated in the last financial year for the product or group of products concerned, subject to a maximum of €5 million (compared with €1 million currently). In addition, a daily penalty payment may be imposed for each day of shortage, up to a maximum of 50% (compared with 30% previously) of the company’s average daily turnover in France in the last financial year for the product in question.
[11] Until now, sanctions were published for 1 month.
[12] A convention between the State, the French Caisse nationale d’assurance maladie (CNAM) and the ANSM must be concluded to entrust the French National Order of Pharmacists (CNOP) with the implementation of the information system. If the convention is not concluded, the French Minister for Health will issue a decree defining the terms and conditions under which the information system will be implemented by another manager.
[13] The deadline set by article 54 of the LFSS for 2024 was 2 years.
[14] The EMI and ERI are mechanisms for compensating healthcare institutions if, for a given pharmaceutical product, the purchase price is lower than the tariffs negotiated nationally by the CEPS. Healthcare institutions are compensated for half the difference between the actual purchase price and the nationally negotiated price.
[15] Application from January 1st, 2027 for the CS M due in respect of 2026.
[16] – Addition to article L. 138-13 of the French Social Security Code: notification by the CEPS of the amount of the exemption payback due, before October 1st, year n+1
– Amendments to article L. 138-15 of the French Social Security Code: communication to French Social Security Central Agency (ACOSS) of the total amount reimbursed in respect of pharmaceutical products before June 15 (but possible postponement to July 15); if no request for rectification of the list of pharmaceutical products taken into account is communicated by the ACOSS within 20 days, the request is deemed to have been accepted; communication by CEPS of the amount of the rebates before July 31.
[17] The LFSS stipulates that this measure may not have the effect of reducing the total amount of the contribution. As a result, the amount due for non-generic pharmaceutical products, products subject to the TFR and products belonging to the targeted therapeutic classes when their price is below a certain threshold, may be increased to ensure a constant yield.
[18] The LFSS provides that the M amount will be revised by the LFSS for 2026, upwards or downwards, in order to guarantee compliance with the economic balance in line with these forecasts.
[19] For the safeguard clause due in respect of 2026.
