Valued fifth globally in terms of overall revenues and enjoying year-on-year growth rates exceeding five percent, the French pharma market is undeniably one of the great global life science powerhouses, playing host to virtually all top-tier, big-brand biopharma. Yet alongside its well-forged reputation for sophisticated healthcare infrastructure, manufacturing excellence, and as an epicentre of scientific innovation, France is also often considered somewhat challenging when it comes to securing timely market access and commensurate reimbursement for big-ticket, next-generation, originator medicine.
“It’s fair to say there is not one, but rather multiple French markets depending upon which therapeutic areas you are active in, and the precise characteristics of the innovative medicine that you are trying to introduce. Perspectives can vary wildly depending on your starting point,” opines Nienke Feenstra, general manager at Takeda.
“When therapies are eligible for early access and direct access pathways, the difference is striking. Patients with pressing unmet needs can obtain treatment swiftly, and drug developers can generate valuable real-world data that support market authorisation and reimbursement decisions both in France and internationally. When those avenues are closed, however, the process can become extremely elongated and cumbersome with assessments and negotiations bogged down in a seemingly endless ‘millefeuille’ of regulation,” she elaborates.
France’s expedited access pathways for orphan drugs, next-generation oncology, and Advanced Therapy Medicinal Products (ATMPs), from cell and gene therapies to tissue-engineered medicines, have certainly generated acclaim the world over. “These schemes enable speedy use of promising medicines with a favourable benefit-to-risk profile and have offered meaningful options to countless patients living with severe or rare conditions,” enthuses Franck Cousserans, general manager for France and the Benelux at the Irish-headquartered neuroscience and oncology-focused biopharma, Jazz Pharmaceuticals. “Their structured, evidence-driven underpinnings without doubt place France among the more enlightened and advanced access systems in Europe,” he affirms.
Among them, an Early Access Scheme, the so-called ‘Accès Précoce,’ functions as a veritable clinical lifeline in permitting access to patients for presumed innovation that still lack complete data and formal reimbursement evaluation but respond to a clear therapeutic vacuum of serious unmet need.
Concurrently, the country’s Direct Access Scheme acts more as a commercial accelerator. This scheme has been designed to overcome the curiously French paradox whereby some medicines are deemed clinically innovative by the Haute Autorité de Santé (HAS) but remain stuck in pricing negotiations with Comité Économique des Produits de Santé (CEPS) by allowing the drug developer to commence selling the therapy before final price determination.
“Over the past year alone, we have launched several therapies and indications across multiple therapeutic areas, including prostate, bladder, and gastric cancers, as well as women’s health, the vast majority of which were rendered possible thanks to the country’s ingenious early access mechanisms,” acknowledges Olivier Zambelli, general manager of the Japanese specialty biopharma, Astellas. “Statistics suggest that, within a three-year period, more than 100,000 patients have benefited from treatments that had not received full regulatory approval. In our eyes, this progress stands as clear evidence of France’s prowess as a market that truly champions innovation,” he declares.
Parallel Worlds
Accounts from those companies forced to navigate the country’s conventional market access procedure paint a wholly different picture, however. “While the expedited access schemes undeniably work well, they nonetheless cover only a limited number of patients. France’s policymakers made deliberate choices over the years to prioritise fields like oncology, neurology, and rare disease to the detriment of other areas,” warns Anne-Laure Dreno, president of AstraZeneca, noting that “there is no comparable framework for chronic diseases, where patient need remains very elevated.”
“The mainstream process for bringing originator medicines to market in France ranks among the slowest in Europe, often exceeding 520 days versus 50 days in Germany. This is a consequence of multiple structural factors, including lengthy evaluations by the HAS, protracted price negotiations with the CEPS, and frankly outdated comparator-based pricing models that undervalue genuine therapeutic progress,” she argues.
“Access to the French market commences with a submission to the HAS supported by global trial data, after which they assign an ‘Amélioration du Service Médical Rendu (ASMR)’ rating from one to five, indicating their assessed additional clinical value compared to existing treatments. Most products – some 90 percent – receive ratings of four or five, equating to low or no added value. Exceptional and medically transformational products may achieve one or two. This rating then determines our negotiating position with the CEPS, where we submit pricing proposals,” details Nicolas Dufourt, general manager at Danish allergy specialist, ALK. “Typically, we propose prices aligned with German or average European pricing. However, if we receive a rating of five, achieving reasonable pricing becomes almost impossible,” he adds.
Moreover, pricing discussions with the CEPS can be notoriously complex. “France’s uncompromising and drawn-out reimbursement procedures typically require over 500 days to accomplish, as opposed to less than 150 in our home market of Denmark,” observes Etienne Tichit, Novo Nordisk’s general manager and corporate vice president. So much so, that his company has had to come up with creative strategies to circumvent the prolonged delays it entails. “For our innovative obesity solutions, we took the strategic decision to start offering our GLP-1 therapy through out-of-pocket payment while still negotiating because of the sheer volume of French patients who could benefit and were missing out on that treatment,” he recalls.
“Negotiations can indeed drag on unnecessarily, even for very marginal price differences,” concedes Virginie Beaumeunier, President of the Economic Committee for Health Products within CEPS, but she attributes these delays in part to unrealistic expectations on the part of the drug developers. “In many cases, the process is lengthened because laboratories begin with pricing expectations that are simply not aligned with economic realities and the assessed therapeutic value of the product.”
“This often leads to a counterproductive dynamic, where we respond with very low offers in return, and both parties become stuck in a cycle of unproductive rounds,” she continues. “At times, we see price gaps of up to 100-fold between the initial industry proposal and our first offer, which clearly signals a breakdown in positioning, and can only be remedied if all stakeholders are willing to mutually depart from adversarial negotiating towards a more collaborative realism.”
Pricing Squeeze
Such an assessment is revealing because it suggests that France’s primary market access bottleneck is far less to do with regulatory process per se, than about the State’s willingness to pay for medical innovation. “For far too long French policymakers have been treating pharmaceuticals as an inconvenient cost, rather than the investment in prosperity, societal well-being, and productivity that it really is,” argues Laurence Peyraut, director general of Les Entreprises du Médicament (LEEM), the primary professional body representing life sciences entities across the pharmaceutical value chain. “Medicines presently account for roughly EUR 30 billion in spending, representing a mere nine percent of the nation’s health insurance expenditure, yet they are often erroneously portrayed as driving system deficits, and subjected to punitive and repeated cost-cutting,” she bemoans.
Fabrice Ruggeri, country manager at Organon, a women’s health and established brands focused player spun off from MSD, very much agrees. “In truth, drugmakers in France have been subjected to some of the lowest drug prices in Europe, yet our segment contributes over half of all savings required by health insurance, that is in excess of EUR three billion annually, despite representing less than one-fifth of overall healthcare costs. Not only is this categorically unfair, but it can also seriously threaten industrial viability and jeopardize the ability to innovate,” he warns.
Just how serious are such levels of profit erosion for drug developers in what is, after all, a very well-established, sizable, affluent, and highly mature Western European market? “To put everything into context, France currently combines some of the lowest prices in Europe with some of the highest taxation, creating a scissors effect that undoubtedly harms investment,” observes Didier Véron, president of G5 Santé, a strategic think tank composed of the global CEOs of France’s eight leading homegrown healthcare companies. The G5 Santé companies’ combined annual investment into in-country R&D habitually exceeds EUR 3.8 billion.
“Market prices languish systematically below the European average, not only at launch but throughout the entire product lifecycle. And, for patented medicines, only Poland and Greece register lower price levels, while the fiscal burden placed on originator drugmakers never ceases to grow,” he laments.
Such a scenario has profound consequences. “Unlike in markets such as the UK, where prices can remain stable longer, in France, we are seeing them being revised downward every two or three years. For some biologics, prices have fallen to such an extent that we are compelled to organise distribution ourselves to secure access for French patients by controlling and managing stock availability. This situation is clearly unsustainable and requires urgent correction,” ventures Karine Duquesne, general manager at LEO Pharma.
Associated segments, such as in vivo diagnostics, have also been feeling the pinch. “We have witnessed a 30 percent contraction of our sales in value terms in France. This is far from neutral, particularly for a French company where your home market represents your largest market,” reveals Jerome Estampes, CFO and interim CEO of iconic contrast imaging firm Guerbet, whose contrast agents are injected or ingested into patients to help diagnose diseases like cancers.
“Margins that major pharmaceutical companies used to command are simply no longer being accepted in markets like France. Successive French governments have pursued cost containment, and it seems unlikely that anything can fundamentally alter that policy direction now. The impetus thus falls upon industry to adapt our model, refocus on core business, and work on profitability, but it is a bitter pill to swallow. This is especially true for differentiated actors like Guerbet that are not pure pharma in the traditional sense and certainly cannot fall back on revenues from products with blockbuster potential,” he sighs.
Ripple Effect: Cross-Border Implications
Another repercussion that is often overlooked is the weight of the French price beyond France itself. “Our market sits at the centre of several external reference pricing systems, so a non-viable price in France does not remain contained within the national market. For any organisation operating globally, this creates a tangible downstream risk. If a medicine is priced too low in France, its long-term availability can be affected not only domestically but also in other reference countries,” notes Jazz Pharma’s Franck Cousserans. Little wonder, then, that a massive 40 percent of medicines approved by the EMA are currently not available in France.
“French prices are referenced by 50 countries worldwide. These countries monitor French pricing and adjust their own prices downward accordingly. This makes launching products in France at prices below other major markets extremely problematic from a global business perspective. At ALK, we are regularly confronted with this issue, and it explains why our innovative ragweed allergy tablet has never been launched in France despite generating excellent clinical value,” confides Dufourt.
“It’s true that we are increasingly hearing from laboratories that French list prices are being used as reference points—not only by smaller or less well-resourced countries, but potentially even within the framework of US public programmes like Medicare and Medicaid or China,” confirms CEPS’ Virginie Beaumeunier.
“While there remains a significant gap between political announcements and actual implementation in markets like the United States, the realistic possibility that French list prices could influence reimbursement benchmarks abroad adds a further layer of complexity to our own pricing strategy and reinforces the importance of maintaining a coherent, evidence-based approach that anticipates downstream effects in global markets,” she acknowledges.
PLFSS 2026: Pharma Under Pressure
Recent legislation looks set to only provide meagre respite. The latest Social Security Financing Bill (PLFSS 2026), which was formally enshrined in early January 2026, targets reducing France’s social security deficit from EUR 23 billion to 17.5 billion, with a whopping further 1.4 billion in price cuts to be shouldered by patented medicines.
Moreover, the reform imposes strict new cost-containment controls on the Direct Access pathway by stipulating that drugmakers must start supplying the drug at their own expense if a pricing negotiation deadline of 12 months duration is missed, and by toughening up the rules governing repayment in instances where the final price negotiated with the CEPS is lower than the initial entry price.
Predictably, many drugmakers have reacted with deep displeasure: a sentiment exemplified by the dramatic mass resignation from the LEEM – the organisation hitherto designated as the primary interlocutor representing industry in interactions with the government – of France’s largest seven innovative labs, and thus the association’s most influential and distinguished members.
In the words of Thierry Hulot, chairman of Merck and incumbent president of the LEEM, the Bill represents “a decision to sacrifice therapeutic progress and a strategic industrial sector in favour of purely accounting-based logic” and is tantamount to “the slow strangulation of the country’s life science innovators.”
“We perceive real difficulties arising when formal negotiations conclude and companies are suddenly called upon to reimburse the full difference between the early access price and the final net price, multiplied by the number of patients treated. Under certain conditions, this repayment could represent as much as 80 percent of the turnover generated during that period,” points out Jean-Claude Roche, general manager at the Italian midcap specialty outfit, Recordati. He foresees companies like his potentially being compelled to provision massive amounts of cash on their balance sheets.
Meanwhile, AstraZeneca’s Anne-Laure Dreno reckons that “very few entities could reasonably commit to providing a therapy for free after 12 months, which would be the practical outcome of the new framework,” and instead predicts that “less capitalised actors may well consider this too risky and eschew launching altogether.”
Others rail against the entire concept of an annual PLFSS for not providing sufficient regulatory certainty to be able to plan ahead. “The rigidity of the one-year budget cycle compounds the problem. Healthcare is simply not something that can be managed effectively in short bursts; prevention and the treatment of chronic disease require continuity across a patient’s lifetime, which, by definition, demands multi-annual planning,” insists Takeda’s Nienke Feenstra. “Biopharma works on horizons of ten to fifteen years, so stability and predictability absolutely matter,” concurs Francois Rauch, general manager at Belgium headquartered biotech, argenx.
There are indications, though, that the authorities are proactively working to mitigate this uncertainty. “Companies understandably struggle with unanticipated revenue reductions, creating explanatory difficulties for French subsidiaries within international corporate structures,” empathises CEPS’ Virginie Beaumeunier.
“Whilst we cannot abandon pricing adjustments, we are exploring enhanced product lifecycle visibility through predetermined review schedules established at initial inscription, potentially incorporating two-year pricing reviews based on objective criteria with guaranteed stability periods,” she reveals. Already this year’s PLFSS takes some steps in that direction by abolishing the much-criticised and unpredictable year-end clawback, the ‘Clause de Sauvegarde,’ in favour of permanent in-year charges: notably a 0.2 percent tax on pretax sales and 1.6 percent tax on reimbursed amounts.
A New Equilibrium?
For many the status quo cannot endure indefinitely, though, and the country will have to consider alternative funding models if it is to sustain access to innovation over the long run. “Certain peer markets appear to have hit upon more attractive regulatory models based on reward and incentives,” reflects Didier Véron, referencing Germany with its price premiums linked to domestic manufacturing and Scandinavia’s robust public–private governance.
Beaumeunier, for her part, thinks pay-for-performance-based contracting can deliver mutually acceptable outcomes all round. “Especially for introducing costly, next-generation transformational therapies such as single-administration, personalised medicines with enduring effects, this could be an excellent option involving initial forfeit payments at administration followed by patient monitoring protocols requiring verification over extended periods,” she conjectures.
Others see far greater scope for biosimilars to free up public health expenditure which could then be reinvest back into financing future waves of medical innovation. “There is still considerable room for expansion in both generics and biosimilars in France. In generics, the number of molecules listed in the Répertoire Des Groupes Génériques remains relatively limited compared to countries such as Germany. Broadening that list would allow a wider range of treatments to reach patients and significantly increase market penetration. The same holds true for biosimilars, where France still lags its European peers,” remarks Tiago Bartolomeu, General Manager of EG Labo, part of STADA group.
Organon’s Fabrice Ruggeri, meanwhile, notes that France recently became unique in allowing pharmacists to substitute certain biologic originator drugs with biosimilars directly at the pharmacy level. “Until recently, substitution depended on prescriber choice, which limited adoption to around 30 to 40 percent, far below the government’s 80 percent target. To address this, authorities have now authorised pharmacists to substitute biosimilars directly for selected biologic groups, mirroring the generic medicines model with tremendous potential implications for affordability,” he predicts.
For LEEM’s Laurence Peyraut, though, any future viable financing model presupposes a fundamental shift of mindset and new governance structure. “France’s core difficulty is governance in silos – what I call ‘swimming lanes’ – that rarely intersect,” she identifies. “Each stakeholder, be it the CEPS, the HAS, or the Ministry is totally and utterly convinced they are fulfilling their mandate, but by operating in isolation, as if in a vacuum, are jeopardizing the collective good. For none of these actors can ever be ‘right’ alone,” she insists.
“What we lack is a transversal view, which is why we are calling for the formation of an “états généraux du médicament” or life science council bringing together innovators, generics manufacturers, industrial partners, clinicians, payers, and regulators. Our sector depends upon this wider ecosystem, and the only kind of model that can truly work is one where the entire chain benefits,” she concludes.
