Diane Bandon-Tourret, partner and head of the life sciences practice at LexCase, and Tamara Milano, associate in the life sciences practice, consider new regulations in France aimed towards avoiding shortages of medical products
These last years, shortages became a major public health concern, highlighted by the Covid-19 crisis and the current shortages of major medicines. As a result, adoption of new regulations to prevent shortages have become a priority for many countries. In the EU, new regulations have strengthened shortages prevention, such as Regulation (EU) 2023/607 which extended the validity period of CE certificates issued under the previous regulation to avoid the unavailability of medical devices (MDs). In France, regulations on shortages recently evolved in the field of medicines, MDs and in vitro diagnostic devices (IVDs).
The French Public Health Code sets specific provisions relating to medicine shortages. Pharmaceutical companies must ensure a continuous and appropriate supply of the French market and maintain a national safety stock of medicines. Additionally, drug operators must notify the French competent authority (the ANSM) in the case of a cessation of a medicine’s marketing.
Since Law 2016-41 of 26 January 2016, a specific body of rules was created for medicines with a major therapeutic interest, which has been modified by the Social Security Financing Bill for 2020. Marketing authorisation holders (MAHs) and drug operators should notably draft a dedicated shortage management plan with specific item actions to avoid shortages. Industrials must also promptly warn the ANSM in case of shortage or risk of shortage and implement their management plan if need be. In the case of a breach of listed obligations, the ANSM can also order fines subject to new guidelines applicable since October 2022.
On 24 November 2022, the ANSM published three sanction decisions reflecting an increase in fines’ occurrence and amount, showing the will of the ANSM to control this new set of rules.
For very urgent situations, dedicated solutions have been implemented. For example, amoxicillin is subject to a specific recommendation dated 29 December 2022, by which the general director of the ANSM allowed pharmacists, on an exceptional and temporary basis, to dispense a magistral preparation suitable for children under 12 directly if the prescribed medicine is not available. Another way to limit shortages’ impact is to regulate access conditions, as for paracetamol since July 2022.
For many years, French law did not include similar provisions for MDs and IVDs. This is why the ANSM had enacted a dedicated process for early management of shortages and risks of shortages applicable to essential MDs and IVDs and implemented on a voluntary basis since 1 September 2021. Law 2023-171 of 9 March 2023 implemented new obligations towards industrials when there is a risk for the patient’s care due to the unavailability of MDs or IVDs. They must notably notify the ANSM of the end of a device’s marketing. They also must implement useful measures to ensure the continuity of the patient’s care and notify the ANSM of any shortages or risks of shortages. The ANSM can also adopt any necessary measure in case of a breach of some of these obligations. We assume that these provisions could be used by the general director of ANSM within its enforcement powers, notably in the case of sanitary police decision. The omission to notify the ANSM of a shortage or risk of shortage can also be sanctioned by a new fine. The ANSM is likely to amend its guidelines on that aspect. For now, application decree is awaited to give full effectiveness to these new obligations.
At the same time, the French government is currently implementing a new ministerial roadmap for the struggle against shortages. A dedicated investigative parliamentary committee has also been recently appointed which conclusions are expected by mid-July. New modifications of the current regulation are thus expected at the end of 2023 at the earliest.