Managing drug stocks: current issues in France and challenges at European level

Agathe Simon
Mercure Avocats, Paris
a.simon@mercure-avocats.com

Managing drug shortages is a major concern in France and Europe. Legal and regulatory obligations require pharmaceutical companies to give earlier notification of any supply tension. This heightened vigilance on the part of players has not systematically resulted in actual disruptions: indeed, official data show that, in France, disruptions/risks of disruptions themselves decreased by 20 per cent in 2024.

Nevertheless, the French legislator – notably through the French Social Security Financing Law (Loi de Financement de la Sécurité Sociale or LFSS) for 2025 – is continuing to tighten these regulations.

These measures are part of a wider movement at supra-national level, with the adoption of the European ‘pharmaceutical package’ still in progress – an overhaul of European regulations aimed in particular at securing the supply chain and better managing crisis situations on a regional scale.

The legislative process for the ‘pharmaceutical package’ is currently continuing between the European institutions involved. Adopted at first reading by the European Parliament on 10 April 2024, the text was then approved by the Council of the European Union on 4 June 2025 with a few adjustments. These include, in particular, the possibility for Member States to impose an obligation on marketing authorisation holders (MAHs) to commercialise their products to ensure that the needs of patients in their territory are satisfied. This adoption by the Council now paves the way for a new phase of ‘inter-institutional’ negotiations, known as the ‘trilogue phase’. The first trilogue was held on 17 June 2025. The final adoption of the text could take place in 2026, with entry into force estimated at the earliest mid-2027 and at the latest early 2029.

The European legal arsenal is largely inspired by the French model, which for several years has been imposing strict obligations on the various players in the supply chain (MAHs, wholesaler-distributors and pharmacists), in order to prevent and manage drug shortages. These legal and regulatory obligations, which were strengthened with the LFSS for 2025 and are set out in the French Public Health Code (Code de la Santé Publique or CSP), include the following:

• The obligation to build up safety stocks, the duration of which varies according to the category of drug:
  • one week for drugs other than ‘drugs of major therapeutic interest’ (MITM);
  • two months (or even four months, further to a decision of the General Director of the Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM)) for MITMs; and
  • one month if the drug contributes to public health policy, in accordance with Article L 5121-29 of the CSP.
• The obligation to notify MITM stock shortages and risks of shortage: Article L 5121-32 of the CSP requires MAHs and pharmaceutical companies to notify, to the health authorities, without delay, any shortage or identified risk of shortage.
• Widespread use of the DP-Rupture platform: this system requires dispensing pharmacists and pharmaceutical establishments to report directly any information on the availability of MITMs at their level (Article L 5121-29-1 I of the CSP).

The LFSS for 2025 has also considerably raised the ceiling on financial penalties (Article L 5471-1 of the CSP) applicable to players in the supply chain in the event of non-compliance with their obligations, following fines imposed by the ANSM on 11 pharmaceutical companies in 2024. The maximum financial penalty is now 50 per cent of sales, up to a limit of €5m.

Additionally, a recent Decree (French Decree no 2025-760, dated 4 August 2025) has specified certain conditions of the former LFSS for 2024, particularly with regard to:

• Special pharmaceutical preparations (SPPs), which are drugs manufactured directly in pharmacies as exceptional, temporary and derogatory measures: they can be authorised by ministerial order in situations of market shortage.
• Public health policing measures that may be taken by the General Director of the ANSM (such as restriction or suspension of manufacturing, export or wholesale distribution) in order to ensure an adequate and continuous supply in the event of a shortage or risk of shortage of an essential medicinal product (MITM) or a vaccine.

The said Decree outlines the procedure that MAHs must follow to report a suspension or discontinuation of commercialisation, following a defined template and describing any alternative measures taken. It also clarifies the specific time limits applicable to the obligation to find a successor in the event of discontinuation of marketing of a MITM that no longer benefits from patent protection: the ANSM shall have a period of two months to decide whether to trigger this obligation.

France is not isolated in this regulatory approach: most countries have similar systems, such as Germany and Brazil, where increased notification obligations to health authorities have also been introduced to guarantee the safety of drug supplies. In Germany, for example, measures targeting generic drugs for which only few suppliers are present on the market have been adopted for 2023.

Despite these efforts, drug shortages remain a growing concern. In a report published in September 2025, the European Court of Auditors identified 136 shortages across the EU between January 2023 and October 2024. These shortages are becoming increasingly frequent and result from multiple factors, including supply chain disruptions, the EU’s dependence on Asian suppliers for active ingredients and precursors, and price disparities between Member States.

However, the question arises of the proportionality of these measures – taking into account the real capacities of manufacturers/pharmaceutical companies, and the economic and logistical imperatives that condition the pharmaceutical production and distribution chain – with the requirements of public health protection. While patient protection and treatment availability are indisputable priorities, the obligations imposed on manufacturers must remain proportionate and compatible with economic, logistical and technical realities.

In particular, the obligation to hold minimum stocks of products, while being a legitimate foresight requirement, raises practical difficulties. Some treatments are very costly, making it economically difficult or even dissuasive to build up large volumes dedicated solely to storage. Added to this are specific constraints linked to the storage conditions of certain products, all of which complicate logistics and risk hampering the ability to bring certain drugs to market. This is why most players are calling for action at EU level, stressing that stockpiling measures taken in isolation by one Member State can have perverse effects, and that a regional approach based on cooperation would be more effective.

In addition, the obligation to notify and share information between players in the chain and the authorities is an essential lever for anticipating situations of tension. However, the information shared must remain strictly necessary to achieve their purpose, and shall not be strategic information – otherwise, anti-competitive practices could be characterised.

In this context, artificial intelligence, and in particular blockchain, offer promising prospects, enabling real-time monitoring of stock levels and more accurate anticipation of tensions.

Faced with these challenges, the response cannot be limited to a constant tightening of obligations (and penalties) weighing on pharmaceutical companies, at the risk of further increasing their burden and hampering their competitiveness. A more global and concerted approach is needed, particularly at European level, to reconcile the imperatives of health safety and the economic realities of the pharmaceutical sector.