On 28 September 2026, the Comité économique des produits de santé (CEPS) and four organisations representing the pharmaceutical industry – Leem, Initiative Pharma, MedFrance and ALMA – signed a fully revised framework agreement for medicinec pricing in France.
The four-year agreement applies until 30 September 2030. The French Government describes it as a new conventional framework designed to balance three objectives: patient access to innovative and mature medicines, health sovereignty and security of supply, and the financial sustainability of the French social protection system.
A New Pricing Framework Built Around the Full Product Lifecycle
CEPS has highlighted the introduction of a clearer price trajectory across the medicine lifecycle. The objective is to provide greater predictability for companies while strengthening regulation later in the lifecycle, particularly as competition increases or exclusivity is lost.
This represents a shift in emphasis. Rather than treating the initial negotiated price as the central pricing event, companies will need to model a sequence of pricing events from launch through maturity. The new framework establishes scheduled review points and strengthens the role of observed volumes, competition, real-world evidence and supply considerations in subsequent discussions.
Temporary Launch Pricing Creates New Launch Levers
For eligible innovative medicines, the agreement introduces a temporary launch-price mechanism. The potential pricing advantage is linked to factors including the level of ASMR, prior early-access status and, in defined circumstances, French participation in pivotal clinical trials.
A French recruitment share of at least 5% of the total pivotal-trial population can contribute to the calculation for eligible products.
The strategic implication is important: clinical development choices may now have a more direct connection with French pricing. For global teams, France’s participation in pivotal trials should therefore be considered not only from a regulatory, medical and operational perspective, but also as an input into launch economics.
This strengthens the case for involving Market Access earlier in clinical-development planning.
Supply Security and Industrial Footprint Become More Relevant to Pricing
The agreement also gives greater practical effect to the statutory requirement to consider security of supply linked to production-site location.
For eligible medicines, production in France or Europe can support a pricing advantage where it demonstrably contributes to security of supply for the French market. The benefit is conditional: companies must document the relevant production chain and maintain satisfactory supply performance.
Manufacturing evidence therefore becomes more relevant to pricing strategy. Market Access teams should be able to explain where active substances, finished dosage forms and packaging are produced, how the supply chain reduces vulnerability, and which commitments can be maintained over time.
Advantages linked to industrial or supply criteria are evidence-based and may be revisited if the underlying conditions are no longer met.
Healthcare-System Savings Can Support Pricing – but Must Be Demonstrated
Another important development is the treatment of positive externalities.
For medicines still benefiting from commercial exclusivity, significant direct medical cost savings for the healthcare system may be considered in the pricing discussion if sufficiently documented. Where a pricing advantage is granted on this basis, the expected savings must be verified through a real-world study within three years, validated by an independent third party.
This creates an opportunity for products whose value is not fully captured by clinical endpoints alone, for example where treatment reduces hospital use, procedures or other directly attributable medical resource consumption.
However, it also creates an evidence obligation. Companies seeking recognition of these savings will need a credible baseline, transparent economic logic and a practical plan to demonstrate whether the expected savings materialise after launch.
Orphan Medicines No Longer Have a Dedicated Pricing Framework
One notable change is the removal of the dedicated pricing provisions for orphan medicines that existed under the previous Accord-Cadre. Those provisions included specific rules on the selection of comparators and, where agreement could not be reached under the general pricing rules, the possibility of a negotiated budget-cap mechanism for high-cost orphan medicines.
The new agreement does not reproduce these orphan-specific provisions. Orphan medicines will therefore need to be considered within the broader pricing mechanisms of the revised framework, with the practical impact depending on how CEPS applies the new rules in individual negotiations. For rare-disease developers, this will be an important area to monitor as the new agreement is implemented.
Price Trajectories Become More Predictable – and More Consequential
The agreement introduces predefined review logic rather than relying only on ad hoc price reductions.
For innovative medicines, the first price review is generally expected after several years on the market, followed by recurring review points. The most favourable timing may depend on the product’s innovation profile and, in exceptional cases, the strength and localisation of the production chain.
At the other end of the lifecycle, the framework reinforces the role of competition and loss of exclusivity in price regulation.
MedFrance has highlighted a clearer endpoint for mature medicines: price regulation is intended to stop ten years after the first generic is marketed. The agreement also structures the treatment of generics, biosimilars and certain hybrid medicines.
The aim is to combine stronger savings during the competitive phase with an eventual limit on continued price erosion for older products that remain important to supply.
Negotiations Are More Formally Time-Bounded
The agreement establishes a 13-month ceiling for the conventional negotiation process from receipt of the updated economic-interest dossier. The clock can pause while additional information requested from the company remains outstanding.
This is intended to provide a clearer outer boundary for negotiations, although the practical duration will still depend on dossier completeness, negotiation complexity and the speed with which questions are resolved. For companies, the key operational point is therefore not simply the existence of a deadline. Strong preparation becomes even more important.
How Could This Agreement Affect Pharma and Biotech Teams?
The agreement does more than update individual pricing rules. It creates a more explicit framework for how value can be recognised at launch, how favourable pricing conditions may depend on verifiable commitments, and how prices should evolve as products mature and competition develops.
French price negotiations therefore become more visibly connected to decisions made earlier in development, including clinical-trial footprint, production strategy and evidence planning.
Five areas deserve particular attention:
- Rebuild the French launch-price model: Consider not only ASMR and comparators, but also early-access history, clinical-trial participation, healthcare-system savings and relevant industrial criteria.
- Map evidence commitments before submission: Any advantage linked to healthcare savings, supply security or industrial footprint should have a defined evidence owner, data source and verification plan.
- Model the full lifecycle: Forecast the expected price trajectory through scheduled reviews, indication expansion, competitive entry and loss of exclusivity rather than relying on a single launch-price scenario.
- Connect Market Access with R&D and supply-chain decisions earlier: French pivotal-trial recruitment and manufacturing configuration may influence the economic case in ways that cannot easily be changed at launch.
- Prepare for implementation risk: Leem has stated that it will assess how the framework is applied during its first 12 months, highlighting that the practical value of the new provisions will depend on how CEPS implements them on a case by case basis.
Why Partner With Our Market Access Consulting Experts?
At Justin Stindt Consultants, we actively monitor European policy developments to provide pharmaceutical, biotech and medical device companies with timely Market Access insights and strategic guidance.
Our team combines expertise in pricing, reimbursement, HTA and payer strategy with practical experience navigating evolving national Market Access frameworks.
For companies preparing to enter or expand in the French market, the new CEPS-industry framework reinforces the importance of early planning across launch strategy, evidence generation, pricing negotiations and lifecycle management.
Our Market Access consulting services help clients translate policy developments into clear commercial and access strategies.
- France Market Access Expertise: We support clients in understanding French pricing and reimbursement requirements, CEPS negotiation dynamics and evolving policy frameworks.
- Strategic Pricing and Reimbursement Planning: We help companies develop evidence-based pricing strategies aligned with payer expectations and long-term product value.
- Lifecycle Market Access Support: From pre-launch strategy through reimbursement, price evolution and loss of exclusivity, we support clients across the full product lifecycle.
- Integrated EU and Global Perspective: Our experience across EU Market Access and US Market Access helps clients assess national developments within broader global pricing and access strategies.
Get in Touch With Our Market Access Consultancy
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