In more detail

• Changes to the safeguard clause
  • Adjustment of the medicines safeguard clause triggering threshold (M amount) for 2023: this threshold is increased by 300 million euros, rising from 24.6 billion euros to 24.9 billion euros. This adjustment reduces the tax burden on pharmaceutical companies.
  • Revision of the tax base of the safeguard clause: from 1 January 2026, the tax base of the safeguard clause will be based on expenses actually reimbursed by the French health insurance system and no longer on the turnover declared by the companies. In order to maintain the effectiveness of the safeguard clause, the mechanism for its application has also been modified. The amount of the safeguard clause contribution will no longer be calculated according to a progressive scale, but according to a lump sum equal to 90% of the difference between the amount reimbursed by the French health insurance system and the M amount.
    • The maximum contribution payable under the safeguard clause for generic medicines and brand-name medicines whose amount is based on the cost of the generic (so-called TRF) is reduced to 2% of the turnover.
    • The maximum contribution payable under the safeguard clause for other medicines remains at 10% of the turnover (excluding VAT), reduced by conventional clawbacks. From 1 January 2026, this limit will be equal to 2% of the amount reimbursed by the French health insurance for these medicines.
  • Setting of the M-amount for 2024: this amount is set at 26.4 billion euros, an increase of 6% on the M amount compared to the M-amount for 2023. This increase has been welcomed by the industry.
  • Setting of the medical devices safeguard clause triggering threshold (Z amount) for 2024: this amount is set at 2.31 billion euros, an increase of 4.5% compared to the Z amount for 2023. According to the French government, this increase reflects its support for the medical devices sector. However, the industry fears that this increase will be too low, given the sector's economic growth, and will unusually trigger the safeguard clause (until now, this clause has only been triggered in 2020).
• Creation of reinforced coordinated pathways (parcours coordonnés renforcés): the LFSS establishes a legal framework for the implementation of reinforced coordinated pathways, adaptable to patients' needs, supported by supporting structures (the list of which will be set by decree) and based on a collective flat-rate fee. For each type of pathway, a decree will define the organization of the pathway, the associated fixed fee and the covered services. This measure allows the generalization of the so-called "Article 51 experiments", which have received a favorable opinion from the CSIS (Conseil Stratégique de l'Innovation en Santé).
• Extension of the competencies of pharmacists: pharmacists will be able to dispense specific antibiotics without a prescription following a positive rapid diagnostic test (French so-called TROD). This dispensation is currently limited to the presentation of a prescription, which may be conditional, or to the affiliation of the pharmacist to a coordinated practice structure (i.e., French communautés pluriprofessionnelles territoriales de santé or maison de santé pluriprofessionnelle). The associated fees and compensation will be determined by the national agreement for pharmacies owners. Until the conclusion of the new agreement (by 31 March 2027), this pricing system will be set by a decree of the French Minister of Health and Social Security, on the recommendation of the French National Union of Health Insurance Funds (UNCAM).
• Maintaining mature medicines of major therapeutic interest (MMTI) on the market to fight shortages: the marketing authorization holder of a MMTI whose patent has expired and who decides to stop marketing it, will be obliged to find a successor to take over the MMTI commercialization if there are insufficient available therapeutic alternatives to meet patients' need on a permanent basis. In the absence of a successor or alternative, the marketing authorization holder must grant free-of-charge to a "pharmaceutical establishment owned by a legal entity under public law, the operation and manufacture of the medicine for the French market, for a renewable two-year period". To date, only the French AP-HP's pharmaceutical establishment has a production line. Failure to comply with this obligation will result in a financial penalty of up to 1 million euros and 30% of the annual turnover (excluding VAT) in France during the last year before the product is withdrawn from the market. While this undoubtedly tightens the current regime, it may also create opportunities for other pharmaceutical companies interested in taking over mature MMTIs, probably at a lower price than it would have been agreed on in a different context.
• Adjustment of derogatory access to medicines
  • The LFSS introduces a derogatory and temporary reimbursement scheme for hospital-use medicines whose reimbursement under the early access has ended, but whose inclusion in the "liste en sus" is subject to the provision of additional data. The purpose of this derogation is to ensure continuity of treatment for patients treated with medicines benefitting from the early access scheme. It will cover the period between the end of the applicability of the early access regime and the reassessment by the French National Authority for Health (HAS) in light of the additional data submitted by the company, up to a maximum of three years of coverage.
  • When submitting its application for early access, pharmaceutical companies must now undertake to ensure an appropriate and continuous supply of the French market to cover the needs of patients in France. If it fails to do so, companies will be subject to clawbacks surcharges.
  • If a medicine is refused early access on the sole grounds that it is not considered innovative, the National Agency for the Safety of Medicines and Health Products (ANSM) will now be able to grant it compassionate access.
  • Pharmaceutical companies applying for early access for a vaccine will need to obtain a recommendation from the HAS on the vaccination scheme.
• Authorization for the use of reprocessed single-use medical devices in healthcare establishments: this use, which is already authorized in some Member states of the European Union, will be possible in France from 1 November 2024 (at the latest) under a two-year experiment. The concerned patients may nevertheless refuse such use. With this measure, the French government aims to achieve savings for healthcare establishments and a significant reduction in the sector's ecological impact.
• New clawback for manufacturers of medical devices whose packaging has a negative impact on the environment: a clawback will be due to the French health insurance by manufacturers of medical devices whose packaging is unsuitable or generates waste, and therefore has a particularly negative environmental impact. The government expects these clawbacks to generate around 10 million euros annually in the first few years. Medtech companies regret that such incentive to adopt a more ecological approach is based on financial penalties, and are concerned about the implementing measures, which have yet to be defined by decree.
• Acceleration of the evaluation procedure for acts associated with medical devices
  • Extension of the potential applicants for the evaluation of acts associated with a medical device: Medtech companies will now be able to apply directly for the evaluation of any act associated with a medical device for collective use, or an in-vitro diagnostic medical device, for reimbursement purposes. To date, only national professional councils, approved patient associations, the Ministry of Health and UNCAM can do so. This measure, which aims to improve patient access to collective-use medical devices and in-vitro diagnostic medical devices, some of which are unavailable due to the lack of evaluation of the associated act, is unanimously welcomed.
  • Removal of the possibility to renew evaluation deadlines for acts associated with a medical device: in the case of complex procedures, the six-month evaluation deadlines set by the HAS for issuing its opinion on the registration of the act, and by the Haut Conseil des Nomenclatures for issuing its report on the description and prioritization of the act can currently be renewed. This possibility of renewal will be abolished as soon as the LFSS enters into force. Difficulties in application are to be expected as these deadlines are currently being renewed very frequently.
• Extension of the scope of certification under the Quality Charter for Professional Practices for Products and Services registered on the List of Reimbursable Products and Services (LPP Charter): under currently applicable texts, the LPP Charter applies to all operators and retail distributors of products and services registered on the List of Reimbursable Products and Services, whether brand-name or generic. However, the so-called "LPP Charter Certification" applies only to companies that have signed an agreement with the French Comité Economique des Produits de Santé, which excludes operators of products listed on the generic line and retail distributors. However, generic products and services account for the majority of reimbursed expenditure (i.e., 75%). The LFSS therefore makes certification compulsory for all companies subject to the LPP Charter.
• Acceleration of the biosimilar substitution: to date, pharmacists can only substitute a biosimilar for a biological medicine if the group to which the biosimilar belongs is on the list of similar substitutable biological groups. This list currently contains only two similar biological groups. If the biosimilar is not included on this list, the LFSS introduces the possibility for the pharmacist to carry out this substitution within two years of the inclusion of the first biosimilar on the list of reimbursable medicines, unless ANSM advises otherwise.
• Revision of the financing of medical, surgical and obstetric (MCO) activities in healthcare establishments, to better value local healthcare offer according to its specific characteristics: until now, MCO activities in healthcare establishments have mostly been financed through activity-based pricing (T2A). The LFSS provides for a new pricing model to be introduced gradually from 2025, with three different sources of funding:
  • Standard activities will continue to be financed through activity-based pricing.
  • Activities that meet public health objectives will be funded by specific allocations.
  • Specific critical care activities will be funded by a combination of activity-based pricing and specific allocations.
• Use of special hospital and officinal formulations
  • The possibility for public hospital pharmacies to prepare "special hospital formulations" when a MMTI is out of stock is extended to situations where the marketing of a MMTI is discontinued. As an exception, retail pharmacies will be able to dispense these formulations.
  • The LFSS creates the category of "special officinal formulations", which may be authorised by the Minister of Health on an exceptional and temporary basis in order to deal with stock shortages or the cessation of the marketing of a MMTI, or to deal with a serious health threat or crisis.
• Reinforcement of medicines savings mechanisms in the event of supply shortages: in the event of shortages of certain medicines, the Minister of Health will be able to impose mandatory unit dispensing and the use of conditional medical prescriptions.
• Creation of a temporary status for medical cannabis: in order to continue the medical cannabis experiment launched in France in 2021, which will end next March, a temporary status for cannabis for medical use has been created. This temporary status is granted by ANSM for a renewable period of five years, pending a decision on marketing authorization by the European authorities. Access to cannabis for medical use will be restricted to specific therapeutic indications, to be defined by ministerial decree.