In 2023, the European Commission warned that “The COVID-19 pandemic and the Russian military aggression against Ukraine [have] exposed Europe’s supply chains dependencies and the risk that economic dependency could be weaponised. This has also heightened awareness of the risk of medicine shortfalls, experienced across all Member States and involving both original and generic medicines.”

On 17 September 2025, the European Court of Auditors released its special report on critical shortages of medicines which observed that:

“Faced with shortages, member states started to impose unilateral national stockpiling requirements for industry, not coordinated with other member states. While stockpiles in a given member state can help minimise shortages and provide authorities with time to act, such stock may have spill-over effects and exacerbate shortages in other member states.”

In that regard, the European Commission’s proposal for a regulation addressing the supply of critical medicinal products, called the Critical Medicines Act (or “CMA”), presented on 11 March 2025 sets out in article 20 that:

“Measures on security of supply applied in one Member State shall not result in any negative impact in other Member States. Member States shall, in particular, avoid such an impact when proposing and defining the scope and timing of any form of requirements for companies to hold contingency stocks.

Member States shall ensure that any requirements they impose on companies in the supply chain to hold contingency stocks are proportionate and respect the principles of transparency and solidarity.”

Overall, however, the Court of Auditors report points out that the Commission’s proposed legislative response aimed at tackling the underlying causes of medicine shortages remain at an early stage (the Commission’s proposal for the authorisation and supervision of medicinal products for human use, released on 26 April 2023, does not directly address the issue of contingency stocks).

Among the European countries that currently impose contingency stock requirements on industry actors, France recently hardened its national regime by increasing applicable fines and introducing new reporting obligations for pharmacists and for so-called pharmaceutical establishments.

The French Code of Public Health has, since 2019, provided for administrative fines in case of failure by companies marketing a medicinal product:

• to keep a safety stock of medicines of major therapeutic interest (“MITMs”) covering at least two months’ demand for the domestic market (the ANSM may decide to increase the duration to four months’ supply where a medicine has regularly been at risk of stock shortages, or has been out of stock, in the previous two calendar years); and
• to alert the French National Agency for Medicines and Health Products (“ANSM”) as soon as they become aware of any risk of MITM stock shortages.

In March 2025, the Code of Public Health was amended in particular to increase the administrative fine applicable to such non-compliance to 50% (increased from 30%) of the previous financial year’s turnover for the product or group of products concerned, up to a limit of five million euros (increased from one million euros), and to increase the daily penalty that the ANSM may apply in case of late compliance up to a cap of 50% (increased from 30%) of the daily turnover for the product. In addition, the code now provides that the ANSM will publish its decisions to apply such fines on its website for at least one year.

Moreover, a new amendment provides for a national database on the availability of MITMs which is aimed at better anticipating and dealing with shortages or risks of shortages in the supply of medicines and promoting exchanges between actors in the supply chain.

Under the Code of Public Health, medicinal products may only be manufactured, imported and sold by authorised pharmaceutical establishments. Following the recent legislative amendments, those pharmaceutical establishments must keep up to date the national MITM database under threat of the administrative fines set out above.

The legal obligation to keep up to date the national MITM database also applies to pharmacists, with fines of up to 150 000 euros for a natural person and up to 10% of turnover for the last financial year, up to a limit of one million euros, for a legal person – in additional to a penalty of up to 2500 euros per day that the ANSM may apply in case of late compliance.

The French industry association representing generic medicines manufacturers, the GEMME, has strongly criticized the amendments warning that “Faced with the scale of the financial penalties or the risk of being penalised, manufacturers will be forced to withdraw from the market, leading to shortages and the discontinuation of treatments that are nevertheless of major therapeutic interest.”

In that regard, in the absence of a central European database, the European Court of Auditors’ report recommends that the European Medicines Agency should operate a single medicines database and reporting platform that includes all medicines authorised in the EU, their marketing status and information on their availability.

While waiting for a European system to take shape, France appears determined to go it alone in its regulatory approach.

It remains to be seen, however, to what extent France’s policies in particular regarding stockpiling requirements and associated fines may conflict with emerging EU laws, in particular that CMA’s prohibition on measures that result in any negative impact in other Member States.

[1] Communication from the Commission addressing medicine shortages in the EU, 24 October 2023.