{"id":6527,"date":"2026-09-23T12:38:15","date_gmt":"2026-09-23T10:38:15","guid":{"rendered":"https:\/\/cr451.fr\/mature-medicine-the-blind-spot-of-health-sovereignty\/"},"modified":"2026-09-23T12:38:15","modified_gmt":"2026-09-23T10:38:15","slug":"mature-medicine-the-blind-spot-of-health-sovereignty","status":"publish","type":"post","link":"https:\/\/cr451.fr\/en\/mature-medicine-the-blind-spot-of-health-sovereignty\/","title":{"rendered":"Mature Medicine: The Blind Spot of Health Sovereignty"},"content":{"rendered":"

To download the report: mature-medicines-report-23-09-2026<\/a><\/p>\n

The report begins with an observation of scale. Specialties marketed for more than ten years represent 68% of the turnover of reimbursable medicines sold in pharmacies (DREES, 2024). Mature medicine is therefore in no way a relic of the past. It designates a treatment whose therapeutic benefit is established, still prescribed, sometimes for decades, and on which the daily therapeutic security of the population rests. <\/p>\n

A Central Object That No Text Names<\/h2>\n

First finding of the study: no text, French or European, defines mature medicine. The study has consequently constructed a measurable scope. It includes any reimbursed specialty whose active substance, authorized for more than ten years, is no longer covered by an industrial property title. This scope brings together reference specialties, generics, and hybrid medicines. It follows that the assimilation of mature medicine to generics alone, frequent in public debate, allows a substantial part to escape; however, it has not been possible to integrate medicines whose patent would fall in the short term due to lack of accessible data. <\/p>\n

This definitional vacancy is not without effect on public governance. Essential medicines, medicines of major therapeutic interest, and European critical medicines cover distinct scopes: the comparison made by the study reveals only 204 substances common to the lists analyzed. At the same time, innovative medicines represent only 10 to 20% of the Union’s critical medicines list (Critical Medicines Alliance, February 2025). The public health issue is therefore concentrated, for the most part, on the established segment. This is why the report holds framing to be the prerequisite for any decision. <\/p>\n

A Renewed Budgetary Constraint, Costs That Decouple from Prices<\/h2>\n

Second finding: the pressure exerted on established medicines is the result of a constant public policy choice. Since 2010, the regulator has measured the savings derived from old products still under protection. Since 2017, the law has placed age at the top of the criteria for price reductions. The price effect proves negative in each of the twenty-three fiscal years between 2002 and 2024, at an average of \u20133.0% per year according to regulator data. Such consistency excludes any cyclical reading. <\/p>\n

At the same time, costs have diverged from prices. From 2019 to 2026, the gap between the evolution of industry costs and that of pharmaceutical prices reaches 23 to 32 points (INSEE, Eurostat), across the entire pharmaceutical division. The mature segment, whose administered prices cannot pass on this increase, is even more exposed. Companies respond with individually rational trade-offs: deferring modernization, concentrating production, exiting the market. Cumulatively, however, these trade-offs increase the vulnerability of the whole. <\/p>\n

The report finally sheds light on the tension often described between innovative medicine and mature medicine. Their industrial interests and economic models diverge. Their antagonism is, however, produced by three public provisions: age as the primary legal criterion for reduction, the M amount that caps the envelope and makes the trade-off zero-sum, the regulator’s annual arbitration in favor of innovative products. Since this antagonism is instituted, it is revisable. The study takes note, moreover, of the shift initiated by France since 2023: list of essential medicines, support for relocation, industrial criterion introduced, by exception, in price setting. <\/p>\n

A Dependency That Can Be Mapped Upstream but a Downstream Without Visibility<\/h2>\n

Third finding: industrial dependency peaks upstream in the production chain. Among the critical active substances studied, 63% of European certificate holders are located in India or China. Of all types combined, six out of seven critical substances have no French production site for their active substance. <\/p>\n

The report above all brings to light a paradox. This upstream dependency can be partially mapped, whereas no French public source establishes where the finished medicine is manufactured. The regulator publicly declares that it has no means of knowing the production cost. Yet four of the five locks on this opacity are of public origin and, consequently, revisable. Manufacturers have been declared to the health authority since 2001 without these declarations being published. It follows that part of the data necessary for an industrial strategy already exists. It simply remains beyond the reach of public decision-making as well as independent analysis. <\/p>\n

Protecting the Molecule Without Protecting the Factory<\/h2>\n

Fourth finding, which constitutes the most counterintuitive result of the study: critical and non-critical products come from the same portfolios. As of the count finalized on September 8, 2026, 98.5% of mature references marketed share a portfolio with at least one critical reference. Protecting only the critical molecule therefore leaves the economic mechanism that endangers it intact. Indeed, criticality instruments designate molecules, whereas production capacity is embodied in establishments. <\/p>\n

The study thus identifies 166 French establishments carrying at least one critical mature reference. These establishments, however, represent only the French quarter of a base whose other three quarters are located elsewhere in the Union. This is why a strictly national capacity instrument would address only a fraction of the problem. Coordination at the European level would make it possible to remedy this situation temporarily, starting from the hypothesis that logistical tensions would be lower than with Asian suppliers. The burden on these establishments is measured in number of references, for lack of public data on volumes. <\/p>\n

The Cost of Inaction and the Decision Calendar<\/h2>\n

Safety margins are already shrinking. According to DREES (March 2025), the average number of alternatives available per molecule without shortage or risk of shortage fell from five in summer 2021 to two at the end of 2024. The inertial scenario, considered the most likely in the short term, extends this degradation. For lack of measurement instruments, however, no scenario is evaluable today. <\/p>\n

The report opens several levers for public decision-making. Two prerequisites fall under interministerial arbitration. The first is framing: naming the object, then positioning it at the relevant level\u2014the molecule for criticality, the establishment for capacity. The second is data: the publication, by the health authority that holds them, of declared manufacturers and the allocation of references to production lines. The designation of establishments to which capacity commitments are addressed falls, for its part, under industrial policy. The study finally recommends two regulatory measures. The first is a reasoned and published opinion before the annual price reduction amount is finalized, in order to compare budgetary effects and consequences for sectors. The second is multi-year visibility, which the revision of the framework agreement makes it possible to inscribe. <\/p>\n

Three approaching deadlines confer topicality on these proposals.<\/p>\n

    \n
  • September 30, 2026.<\/strong> The framework agreement on pricing reaches its term, which opens the question of a multi-year trajectory and the risk of a conventional void.<\/li>\n
  • October 1, 2026 and January 1, 2027.<\/strong> Two American reimbursement models indexed to foreign prices, including French prices, are to apply according to the proposed calendar. Insofar as the French envelope is capped, their effects could shift onto the established segment. <\/li>\n
  • November 23, 2026, indicatively.<\/strong> The European Parliament is to vote on the regulation relating to critical medicines, which will set the European scale of capacity.<\/li>\n<\/ul>\n

    The Acknowledged Limits of the Demonstration<\/h2>\n

    Faithful to the CR451 method, the report sets out what it does not establish. No direct causality is demonstrated between the cost-price gap and shortages. Price administration is qualified as an aggravating factor, over which the State retains direct control. The cost price of a mature medicine is not quantified by the State. The share of treatments falling within this segment remains unknown, since public statistics break down age by value. Neither volumes nor capacities are measured. These gaps do not weaken the argument; they constitute one of its results: public decision-making today operates without the instruments that would make it possible to calibrate it, then to evaluate its effects. <\/p>\n","protected":false},"excerpt":{"rendered":"

    To download the report: mature-medicines-report-23-09-2026 The report begins with an observation of scale. Specialties marketed for more than ten years represent 68% of the turnover of reimbursable medicines sold in pharmacies (DREES, 2024). Mature medicine is therefore in no way a relic of the past. It designates a treatment whose therapeutic benefit is established, still […]<\/p>\n","protected":false},"author":13,"featured_media":6530,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_et_pb_use_builder":"","_et_pb_old_content":"","_et_gb_content_width":"","footnotes":""},"categories":[126,125,130],"tags":[],"class_list":["post-6527","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-economic-intelligence","category-economic-warfare","category-featured","et-has-post-format-content","et_post_format-et-post-format-standard"],"acf":[],"yoast_head":"\nMature Medicine: The Blind Spot of Health Sovereignty - CR451<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/cr451.fr\/en\/mature-medicine-the-blind-spot-of-health-sovereignty\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Mature Medicine: The Blind Spot of Health Sovereignty - CR451\" \/>\n<meta property=\"og:description\" content=\"To download the report: mature-medicines-report-23-09-2026 The report begins with an observation of scale. 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