According to a parliamentary report dated 14 October 2021, shortages of health products are on the rise. The number of medicines of major therapeutic interest (MMTI) declared out of supply has increased from 404 in 2013 to 1,499 in 2019. As for medical devices, the French Health Agency (ANSM) estimates that, as of 8 October 2021, one essential medical device is currently subject to supply difficulties and has been for more than a month, which jeopardizes the continuity of patients’ care.
This situation is not new and the French legislator decided a few years ago to strengthen the legislative framework for supply tensions, aiming at preventing shortages of medicines, in particular MMTI. As a reminder, pursuant to article L. 5121-29 of the French Public Health Code (FPHC), marketing authorization holders and pharma companies operating the products (French so-called “exploitant”) must ensure an adequate and continuous supply of the French market so as to cover the needs of patients.
Since 1 September 2021 and the entry into force of the Decree No. 2021-349 of 30 March 2021, the FPHC goes further since these same companies must have a minimum safety stock of medicines intended for the French market and located on French territory or that of another EU country:
- a minimum safety stock of one week’s supply is sufficient for medicines that do not qualify as MMTI, this threshold being increased to one month for medicines that contribute to a public health policy defined by the French Minister of Health;
- at least two month’s supply is required for medicines qualifying as MMTI. ANSM may lower or increase this threshold in certain situations specifically listed in the FPHC.
In addition, the above-mentioned decree requires that marketing authorization holders and pharma company exploitant commercializing MMTI define and implement shortage management plans to prevent, combat and manage shortages as best as possible. On top of that, they must also report to ANSM, without delay, any situation of shortage or risk of shortage that they would face. A platform dedicated to these reports has been set up on ANSM website.
In the same spirit but a little later, the Social Security Financing Bill (SSFB) for 2022, which is currently being examined by Parliament, includes provisions dedicated to the fight against medical device (MD) shortages. This has not been adopted yet and is only a draft, but Medtech companies have already been prepared given that some of these SSFB provisions follow on the procedure put in place by ANSM since 1 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 (IVDD), the lack of which could jeopardize the continuity of care provided to patients.