France has developed specific strategies to prevent and manage shortages of critical health products (medicines and medical devices) (i) to ensure immediate availability of products and (ii) to strengthen long-term industrial independence of the country on these products.
French roadmap 2024-2027 for protecting the supply of medicines (Feuille de route : Garantir la disponibilité des médicaments et assurer à plus long terme une souveraineté industrielle)
In response to ever-increasing medicine shortages, the French government has launched a multi-year strategy focused on both short-term availability and long-term industrial sovereignty.
The strategy includes the following:
- Early Detection of Supply Tensions
A dedicated national observatory continuously monitors and evaluates supply chain pressures, enabling the implementation of tailored, graduated response plans to address emerging shortages effectively.
- Public Health Initiatives
The goal is to encourage the dispensing of medicines in unit doses, encouraging rational prescribing practices, and increasing the use of generics and biosimilars. Educational programs targeting both patients and healthcare professionals also aim to optimize medication adherence and appropriate use.
- Economic and Industrial Measures
The goals are to provide financial incentives and support to facilitate the relocation of manufacturing facilities within France and Europe, and to encourage innovation while modernizing key strategic production sites to enhance resilience and capacity.
- Transparency and Information Sharing
The goal is to enhance a real-time tracking of stock availability across the supply chain, supported by seamless communication among manufacturers, distributors, healthcare providers, and patients. This will ensure accessible, up-to-date information regarding shortages and viable alternatives.
The measures already implemented include mandatory safety stocks for priority medicines and enforcing prescription adaptations during shortages. Large-scale investment plans also support efforts to restore the pharmaceutical sovereignty.
Roadmap 2025-2027 for protecting the supply of medical device (Feuille de route : Anticiper et prévenir les pénuries et améliorer la disponibilité des dispositifs médicaux)
France has established a strategy to anticipate and prevent shortages of medical devices, responding to increasing supply tensions accentuated since the COVID-19 health crisis.
Unlike for medicines, there is no exclusive list of major therapeutic medical devices due to the sector's diversity and the volume of references.
The roadmap is structured around four strategic areas:
- Identifying and Monitoring Risks
Healthcare facilities must conduct detailed mapping of their supply chain vulnerabilities according to specific activity types. They must assess how these risks affect the quality of patient care, enabling targeted risk management.
Efforts must focus on promoting the proper and sustainable use of medical devices through targeted information campaigns and training programs. Supply security is reinforced by encouraging industrial relocation within France, diversifying supplier bases, and optimizing procurement and logistics processes. Pricing policies must be adapted to ensure the viability and diversity of supply, particularly for niche or critical products.
- Anticipating Specific Risks
Enhanced surveillance must target the devices which experience a high demand during epidemic seasons to prevent supply disruptions. The manufacturers are mandated to report potential supply interruptions, with mechanisms in place to foster European and international collaboration for anticipatory risk management.
- Optimizing Shortage Management
A shared information system will facilitate real-time communication and coordination among all stakeholders. This will enable the swift identification and deployment of therapeutic alternatives when disruptions occur, minimizing the impacts on patient care.
As for the medicines, the roadmap involves all stakeholders, backed by national programs like France Relance and France 2030, focusing on industrial resilience and sovereignty to ensure continuous patient care.
---------------------------------------------
List of critical medicines in France
The French list of French critical medicines / medicines of major therapeutic interest (Médicaments d’Intérêt Thérapeutique Majeur - MITM), is a national inventory established by the French drug agency (ANSM). It identifies medicines for which an interruption of treatment could seriously endanger patients’ health in the short or medium term or could represent a significant loss of treatment opportunity due to the severity or progression of the disease.
https://ansm.sante.fr/documents/reference/medicaments-dinteret-therapeutique-majeur-mitm
This list is very comprehensive, encompassing thousands of medicinal specialties (over 8,000 as of 2024), covering a wide range of active substances. It serves multiple purposes, notably to impose enhanced obligations on manufacturers, such as maintaining minimum safety stocks and developing shortage management plans to avoid treatment disruption. The list is regularly updated as new evidence and risks emerge.
In comparison to European lists, the French MITM list is broader and more detailed, tailored specifically to the French healthcare context and population needs. It focuses largely on therapeutic significance and clinical impact within France.
Manufacturer obligations if a supply shortage is predicted in France
In France, applicable rules require pharmaceutical companies to maintain safety stocks for the medicines intended for the domestic market. These measures permit to prevent stock shortages. Manufacturers must immediately notify the French drug agency (ANSM) if a shortage or supply disruption is anticipated.
- For medicines on the critical medicines list
Manufacturers of critical medicines have enhanced obligations. They are required to develop shortage management plans (PGP – Plans de gestion des pénuries) for the medicines of major therapeutic interest (MITM – Médicaments d’intérêt thérapeutique majeure). These plans make it possible to prevent stock shortages by maintaining safety stocks. In the event of supply difficulties, these plans specify the solutions to be implemented as quickly as possible to ensure the continuity of treatment for the patients concerned.
Pursuant to EU and French rules, the manufacturers of medical devices are required to notify the French drug agency (ANSM) of potential supply interruptions, ensure transparency on availability, cooperate in managing risks, and participate in shared information systems designed to coordinate stakeholders and mitigate shortage impacts.
Manufacturer obligations if withdrawing a product in France
Manufacturers must notify the French drug agency (ANSM) well in advance of any withdrawal to allow time for mitigation measures such as securing alternative treatments or suppliers. They must also inform healthcare professionals and patients as appropriate.
- For medicines on the critical medicines list
Due to their importance, the critical medicines are subject to stricter regulatory obligations than other medicines, including:
- Longer Notice Periods Before Withdrawal
The manufacturer must notify the French drug agency (ANSM) at least one year before the planned withdrawal from the market of an MITM.
This extended notice period aims to provide authorities with sufficient time to organize mitigation measures such as finding alternative therapies or suppliers, thereby minimizing risks associated with treatment discontinuity.
2. Facilitation of Replacement or Alternatives
In addition, the manufacturer must facilitate the identification and importation of equivalent or alternative therapeutic options, including medicines from other countries or generics, to guarantee continuity of care.
The manufacturers must notify the French drug agency ahead of withdrawal and cooperate to minimize impacts, including assisting in identifying alternatives and ensuring patient care continuity.
