On 24 September, the French National Agency for the Safety of Medicines and Health Products (ANSM) announced fines totalling €8 million against 11 pharmaceutical companies.

These decisions were taken for failure to comply with the obligation to maintain a minimum safety stock of medicines of major therapeutic interest (MMTIs).

What is the safety stock obligation?

Pharmaceutical companies are required to maintain a safety stock of medicines for the French market (decree no. 2021-349 of 30 March 2021). This stock must not exceed four months' supply of medicines, with variations depending on the category of medicine. For MMTIs, the minimum duration is set at two months, which can be extended to four months in the case of regular shortages or risks of shortages. To date, 748 MMTIs are covered by the four-month safety stock requirement.

A draft law, adopted by the national assembly on 1 March 2024, aims to strengthen these requirements by increasing the minimum and maximum thresholds for the safety stocks to be built up[1].

Severe sanctions illustrate the ANSM’s coercive power

The number of sanctions imposed by the ANSM (33 decisions), as well as the total amount of fines imposed on pharmaceutical companies, are unprecedented.

It is legitimate to wonder whether the ANSM did not want to respond to the observations of the Senate’s inquiry committee which, in its report on the shortage of medicines published on 4 July 2023, regretted that "the ANSM's powers to impose sanctions are underused: between 2018 and 2022, the agency took only eight decisions to impose financial sanctions for a total of 922,000 euros. None of these was for a breach of the obligation [...] to maintain a safety stock". All the more so as these sanctions were imposed in an overall less critical context, characterised by a significant reduction in shortages (-42% in the first eight months of 2024 compared to the same period in 2023) and in the risks of shortages (-21%)[2].

Among the laboratories fined, the highest fine was €4 million[3].

With the draft law currently pending before the Senate, financial penalties could be even higher in the future. Indeed, the bill proposes to increase the maximum fine to 50% of the turnover generated by the medicine concerned, with a maximum of €5 million.

Fines: an appropriate and sufficient response?

According to the ANSM, these sanctions are only one tool among others in the fight against shortages and are not sufficient to curb the phenomenon.

The LEEM, the trade association of French pharmaceutical companies, believes that these sanctions, like the obligation they impose, are inappropriate and could jeopardise the continued availability of certain products. It also points out that medicine shortages do not only affect one player in the pharmaceutical distribution chain. It would therefore be necessary to take into account a variety of factors and actors, as well as the international dimension of medicine production.

The LEEM also emphasises that the problem needs to be addressed at European level and not only at national level.

Conclusion

The fines recently imposed by the ANSM represent a turning point in the fight against medicine shortages in France, and are unprecedented in terms of their scale. The adoption of the draft law currently under consideration could strengthen the obligations relating to safety stocks and increase the coercive power of the ANSM.

However, several players in the pharmaceutical sector consider that this response is neither appropriate nor sufficient to address the problem of medicines shortages.

This tough stance towards pharmaceutical companies should therefore be questioned as this generates concerns that it could exacerbate the difficulties faced by the sector instead of resolving them and potentially lead to more shortages than currently being observed.

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[1] See our article dated 25 January 2024 for a detailed analysis

[2] Leem's reaction to the ANSM statement on fines

[3] Financial penalties following the 2023 audit of 4-month safety stocks