In its decision no. 2023-860 DC of December 21, 2023, the Constitutional Council ruled on the conformity with the Constitution of the provisions of Social Security Financing Act no. 2023-1250 of December 26, 2023 (LFSS) for 2024. Published in the Journal Officiel on December 27, 2023, the act came into force on December 28, 2023, unless otherwise provided.
In terms of healthcare products, most of the provisions are not immediately applicable. Indeed, many implementing measures are expected, making the entry into force of the LFSS a real headache.
In order to facilitate the operational implementation of the LFSS 2024 for companies, we publish a timeline of the main measures that concern pharmaceutical products (see also our timeline of measures concerning medical devices and acts).
You will find:
- In table 1, measures relating to market access, namely:
- suppression of the derogatory marketing authorisation regime for blood-derived pharmaceutical products (MDS)
- postponement of the reform of financing for contrast agents
- new restrictions on the reimbursement of pharmaceutical products with a high public health or financial impact
- new provisions for early access authorisations (AAP): specificities for vaccines, reinforced market supply obligations
- broader criteria for granting compassionate access authorisations (AAC)
- the creation of a temporary and derogatory post early access reimbursement regime
- the creation of an authorisation mechanism for the temporary use and reimbursement of cannabis-based medicines
- In table 2, measures relating to regulatory, namely:
- over-the-counter dispensing of certain pharmaceutical products following a diagnostic orientation test (TROD)
- single dispensing
- substitution of biosimilars
- measures relating to supply shortages: conditional dispensation, extension of French National Agency for Medicines and Health Products Safety (ANSM) powers, obligations of manufacturers in the event of suspension/cessation of marketing of pharmaceutical products of major therapeutic interest (MITM)
- In table 3, measures relating to pharmaceutical taxes, namely:
- the safeguard clause relating to pharmaceutical products (CS M): setting the M amounts 2023 and 2024, reform of the basis, capping
- exclusion of MDS from the basis of sales contribution
Table 1: Measures relating to market access
| Art. | Purpose of the measure | Immediate implementation | Implementing measures to be taken |
| Art. 29 | Suppression of the derogatory marketing authorization regime for MDS | YES[1] | / |
| Art. 59 | Postponement of the integration of contrast agents in medical imaging technical packages to March 1, 2024 | YES | / |
| Art. 73 | Possibility of subordinating the reimbursement of high-stakes pharmaceutical products (public health or financial) subject to a formulary to ensure the appropriateness of prescriptions | YES | / |
| Art. 75 | MTI data collection provisions | Provision declared contrary to the Constitution by the Constitutional Council in its decision no. 2023-860 DC of December 21, 2023 | N/A |
| Art. 76 | Adaptation of AAP granting criteria for vaccines | YES | / |
| Art. 76 | AAP subject to commitment toadequate and continuous supply of the French market | YES | / |
| Art. 76 | Possibility of applying for an AAC in the event of an AAP refusal based exclusively on the absence of a presumed innovative character. | YES | / |
| Art. 76 | Increase of annual AAP paybacks for failure to meet supply obligation | NO | Conseil d’Etat decree setting the number of additional points |
| Art. 76 | Introduction of temporary and derogatory post early access regime (see our article on this subject) when available data do not allow registration on the “en sus” list. | NO | – Conseil d’Etat decree determining conditions of application– Decree setting the required SMR and ASMR levels– Decree setting the maximum duration (≤ 3 years) – Decree setting the discount applied to the PAA indemnity |
| Art. 78 | Definition of cannabis-based pharmaceutical products | NO | Decree determining pharmaceutical products specifications and therapeutic indications or clinical situations for which efficacy and safety profile are presumed favorable |
| Art. 78 | Creation of a temporary use authorization mechanism (5 years renewable) for cannabis-based pharmaceutical products | NO | – Conseil d’Etat decree determining the procedure for granting authorization – Conseil d’Etat decree determining (i) the conditions under which ANSM may withdraw these pharmaceutical products from the market, and (ii) the conditions for continuity of treatment |
| Art. 78 | Creation of a reimbursement mechanism for cannabis-based pharmaceutical products | NO[2] | – Conseil d’Etat decree determining reimbursement rules |
Table 2: Measures relating to pharmaceutical products regulatory
| Art. | Purpose of the measure | Immediate implementation | Implementing measures to be taken |
| Art. 52 | Dispensing by pharmacists of certain pharmaceutical productswithout a prescription after a TROD test has been performed | NO | – Conseil d’Etat decree setting the conditions under which pharmacists are authorised to prescribe – Ministerial order establishing the list of pharmaceutical products concerned, their indications, the TRODs to be performed and the results to be obtained – Ministerial order setting the fees for services provided by pharmacists[3] |
| Art. 53 | Single dispensing when the pharmaceutical form allows it | NO | – Conseil d’Etat decree determining the specific terms and conditions – Ministerial order listing the products concerned |
| Art. 54 | Substitution of biosimilars automatically permitted 2 years after the first biosimilar in the group is registered on the “liste ville“ | NO[4] | Ministerial order authorising pharmacists to substitute, unless otherwise advised by ANSM |
| Art. 72 | Definition of supply shortage in the French Public Health Code | NO | Conseil d’Etat decree determining the time limit beyond which the breach is deemed to have occurred and the steps to be taken by the pharmacist |
| Art. 72 | Possibility of imposing conditional dispensing prescriptions or unit dispensing in the event of a supply shortage | YES[5] | / |
| Art. 72 | Prohibition on prescribing out-of-stock pharmaceutical products via telemonitoring | Provision declared contrary to the Constitution by the Constitutional Council in its decision no. 2023-860 DC of December 21, 2023 | N/A |
| Art. 72 | Possibility for ANSM to take public health measures[6] in the event of a shortage or risk of shortage of MITM or a vaccine | YES | / |
| Art. 77 | Possibility for ANSM to complete the MITM list | YES[7] | / |
| Art. 77 | In the event of suspension or cessation of marketing of a MITM, if the need is insufficiently covered: – the marketing authorization holder is obliged to search for a reseller – in the absence of a reseller, the ANSM may impose a free concession to operate and manufacture the product[8] | NO | Conseil d’Etat decree determining implementation procedures |
Table 3: Measures relating to pharmaceutical taxes
| Art. | Purpose of the measure | Immediate implementation | Implementing measures to be taken |
| Art. 4 | Retroactive increase of M amount 2023 to €24.9 billion | YES | / |
| Art. 28 | Reform of the CS M basis on amounts reimbursed by health insurance | NO[9] | Decree defining the procedures for transmission to ACCOSS of CS M calculation data by CNAM, ATIH and Santé Publique France |
| Art. 28 | Inclusion in the CS M basis of pharmaceutical products benefiting from post early access reimbursement | YES[10] | / |
| Art. 28 | Rate of return of CS M at 90% | NO[9] | / |
| Art. 28 | CS M individual capping at 12% of amounts reimbursed by health insurance | NO[9] | / |
| Art. 28 | Setting the M amount 2024 at €26.4 billion | YES | / |
| Art. 28 | Exclusion of pharmaceutical products indicated for the treatment of COVID-19 acquired by Santé Publique Francefrom the CS M basis | NO | Ministerial order establishing the list of pharmaceutical products concerned |
| Art. 28 | Net revenues (excluding VAT and paybacks) are taken into account for the CS M 2024 individual capping[11] | YES | / |
| Art. 28 | CS M 2024 individual capping at 2% of net revenues (excluding VAT) of generic products or products subject to a flat-rate responsibility tariff (TFR)[12] | YES | / |
| Art. 29 | Suppression of the exclusion of MDS from the sales contribution | YES | / |
[1] Applications for authorisation or renewal of marketing authorisation in progress on December 28, 2023 (when the law comes into force) will be examined under the ordinary marketing authorisation procedure.
[2] As of March 26, 2024, and until a pharmaceutical products obtains a temporary authorisation and becomes available, and no later than December 31, 2024, the terms and conditions for the reimbursement by health insurance of cannabis-based pharmaceutical product are set by ministerial decree.
[3] Pending effectiveness of the new contractual stipulations between health insurance and representatives of pharmacists.
[4] For biosimilars registered on the “liste ville” before December 27, 2023, the ANSM’s opinion must be issued before December 31, 2024.
[5] The pharmaceutical products concerned and the measures imposed will be specified by ministerial order. The measures will also be terminated by ministerial order.
[6] Failure to comply with these measures will result in financial penalties.
[7] The MITM list, as completed by ANSM, will be published no later than December 31, 2024.
[8] The concession is granted to a pharmaceutical establishment owned by a public corporation. It applies only to the French market, and lasts for a renewable 2-year period (unless terminated beforehand by ANSM).
[9] Effective from January 1, 2026 for CS M due in respect of 2025.
[10] However, implementing regulations are needed to allow for the implementation of derogatory early access care system. – see art. 76.
[11] This concerns the CS M due for 2024.
[12] The LFSS stipulates that this measure cannot have the effect of reducing the total amount of the contribution. As a result, the amount due for non-generic and under TFR specialities may be increased to ensure a constant yield.
GD Avocats advises and supports companies in their market access and regulatory strategies. Contact us by e-mail: contact@gd-associes.com
