In France, pharmaceutical companies are subject to strict regulatory obligations designed to prevent and manage shortages of medicinal products for human use. Despite this framework, 2025 was again marked by reported medicine shortages. These situations included shortages affecting medicines classified as medicines of major therapeutic interest (MITMs).

The reported shortages were associated with several factors as manufacturing incidents, quality defects, temporary production shutdowns, logistical constraints, and short-term demand variations. In some cases, supply relied on a limited number of manufacturing sites, notably located outside French territory.

Under French law, marketing authorization holders are required to ensure appropriate and continuous supply of medicines placed on the French market. They must inform the French National Agency for Healthcare and Medicinal Products' Safety (ANSM) of any actual or foreseeable shortage as soon as they become aware of it. For MITMs, stricter obligations apply, including the implementation of shortage management plans and enhanced notification requirements.

In 2025, the ANSM further detailed this framework through a decree clarifying the mechanisms for preventing and managing shortages of MITMs. It defined the public health measures that may be taken by ANSM in the event of an actual or a risk of shortage. These measures may include restrictions or suspensions of exploitation, distribution, or export, as well as authorizations for alternative therapeutic imports. Such measures must be proportionate and limited in duration. The decree also specified conditions under which the Minister of Health may, on an exceptional basis, authorize the preparation of special pharmacy compounds to address a stock shortage or the marketing cessation of a MITM.

In addition, the ANSM has implemented the obligations applicable in cases of marketing suspension or cessation of a MITM. Pharmaceutical companies are required to notify the ANSM in advance and to document the foreseeable impact on patients. Where no sufficient therapeutic alternative is available, the ANSM may require the marketing authorization holder to seek a third party to take over commercialization of the product.

The law continues to define and enforce reporting, management, and accountability obligations related to medicine shortages. It allows for administrative measures, financial penalties, and exceptional stock management mechanisms. These tools strengthen enforcement of the regulatory framework. However, French regulators have not (yet) dealt with manufacturing conditions, authorized production capacity, or existing economic and logistical constraints. These elements still remain outside of the scope of legal intervention.