On 28 September 2026, the CEPS (French Pricing Authority) entered into a new framework agreement, with the LEEM (the leading trade association for pharmaceutical companies) and three new pharmaceutical industry associations (Initiative Pharma, MedFrance and the Alliance des Médicaments Abordables). The agreement, which sets the rules governing medicinal product pricing, will apply until 30 September 2030. It succeeds the agreement of 5 March 2021, which was amended in 2022 and 2024 and subsequently extended three times until 3 March 2026. The Ministry of the Economy describes it as ‘completely revised’, balancing access to medicinal products, health sovereignty and financial sustainability.

1. Security of supply

The text introduces an entire section devoted to security of supply, which did not exist in the 2021 agreement. It establishes a pricing incentive for medicinal products manufactured in France or within the European Union, adjusted according to the level of industrial security provided, in line with the 2025 Social Security Financing Law (LFSS), the political context of health sovereignty and the fight against supply tensions and stock shortages. This pricing incentive is conditional upon the company’s commitment to supply the French market satisfactorily. The Minister of Industry presents this measure as a means of strengthening security of supply.

2. Setting and review of medicinal product prices

The new agreement introduces significant changes to the setting and review of prices for medicinal products eligible for reimbursement (reference medicinal products, generics, biosimilars and hybrids).

• Price setting

As in the previous agreement, price cuts apply (i) to the equivalent product relative to the price of the reference medicinal product, and (ii) to the reference medicinal product “as soon as the equivalent product is found to be on the market”. However, the applicable price reduction rates have changed significantly compared with the previous agreement:
 

Article 12 of the agreement also provides that negotiations with the CEPS on the price of the reference medicinal product may begin “upon the expiry of intellectual property rights, even in the absence of any actual marketing of equivalent products (generic, biosimilar, hybrid)”.

With regard to hybrid medicinal products in particular, the new agreement provides that their price cut will be equivalent to that of generics (50 % versus 60 % in city pharmacies) if the reference medicinal product is listed in the generics register and at least one generic is on the market.

• Price review

For reference medicinal products, subsequent price reviews were previously triggered by specific events (market penetration rate, medical re-evaluation); they now follow a pre-determined timetable, with an initial review after 3 to 4 years, then every 2 years until the loss of market exclusivity. At this point (10 to 11 years after MA grant for the reference medicinal product), Article 11 stipulates that clawbacks are converted into price reductions and that a minimum price cut of 10 % applies. This initial price cut is then supplemented following the actual launch of a generic, biosimilar or hybrid product to reach the levels set out in Article 12.

For generics, hybrids² and biosimilars, the price review will now also follow a fixed timetable, with a review every 2 years and a maximum review period set at 10 years after the first equivalent product is placed on the market (with some exceptions).

In both cases, the date of the next review will therefore now be known in advance, rather than being triggered by a market event. The LEEM welcomes this development, as the agreement “brings greater predictability and stability to the contractual framework”.

3. Declarations of intellectual property rights

In the area of intellectual property, the annual declaration of the rights of holders of reference medicinal products listed for reimbursement – which was submitted “for information purposes only” in 2021 – is now mandatory, with additional information to be provided: the estimated launch date of the first generic, biosimilar or hybrid product. Furthermore, it should be noted that the 2021 clause providing that the CEPS would make these declarations available to any pharmaceutical company upon request no longer features in the new text; this remains to be checked with the Committee.
The new agreement also formalises a practice established under the previous agreement, namely that the publication of the price of a generic, biosimilar or hybrid product is conditional upon an explicit commitment by the operating company to (i) respect intellectual property rights and (ii) place its product on the market within six months of the publication of the price notice in the Official Journal. One might, however, question whether this new provision entails an enforceable obligation to place the equivalent medicinal product on the market, and what sanctions would apply if the deadline were not met.

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As the LEEM itself points out, this agreement “will only be valid if it is effectively implemented”: the practical significance of this new framework agreement will depend on how it is applied in practice in the coming months.

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[1] - 30 % upon biosimilar entry on the market.

[2] - Except for hybrid products belonging to a group of substitutable hybrids (which follow the pricing structure for reference medicinal products) and hybrid products whose reference medicinal product belongs to a generic group and for which a generic product is already on the market (which follows the pricing structure for generics).