France: Fight against shortages of health products
According to a parliamentary report of October 14, 2021, shortages of health products are increasing. The number of medicinal products of major therapeutic interest (MMTI) declared out of supply increased from 404 in 2013 to 1,499 in 2019. With regard to medical devices, the French Health Agency (ANSM) estimates that at October 8, 2021, an essential drug device is currently experiencing supply difficulties for more than a month, which jeopardizes the continuity of patient care.
This situation is not new and the French legislator decided a few years ago to strengthen the legislative framework of supply tensions, aimed at preventing shortages of medicines, in particular of MMTI. As a reminder, pursuant to Article L. 5121-29 of the Public Health Code (FPHC), the holders of a marketing authorization and the pharmaceutical companies exploiting the products (known as “operator”) must ensure an adequate and continuous supply of the French market. market to meet patient needs.
Since September 1, 2021 and the entry into force of Decree No. 2021-349 of March 30, 2021, the FPHC has gone further since these same companies must have a minimum safety stock of medicines intended for the French market and located on French territory or who from another EU country:
- a minimum security stock of one week’s supply is sufficient for drugs not eligible for the MMTI, this threshold being increased to one month for drugs contributing to a public health policy defined by the Ministry of Health;
- a minimum of two months’ supply is required for MMTI-qualified drugs. The ANSM can lower or increase this threshold in certain situations specifically listed in the FPHC.
In addition, the aforementioned decree requires that marketing authorization holders and the pharmaceutical company operator market MMTI define and implement shortage management plans to prevent, combat and best manage shortages. In addition, they must also report to the ANSM, without delay, any situation of shortage or risk of shortage with which they would be confronted. A platform dedicated to these reports has been set up on the ANSM website.
In the same spirit but a little later, the social security financing bill (SSFB) for 2022, currently being examined by Parliament, includes provisions dedicated to the fight against shortages of medical devices (MD). This has not yet been adopted and is only a draft, but the Medtech companies have already been prepared given that some of these SSFB provisions follow the procedure put in place by the ANSM since the 1st September 2021, for the early management of shortages and risks of shortages in the availability of medical devices (MD) and in vitro diagnostic medical devices (IVD), the absence of which could compromise the continuity of care provided to patients.