The long-awaited implementation in statutory law of the fight against medical devices and in vitro diagnosis medical devices (MD/IVDMD) shortages mechanism is currently being discussed in the French Parliament, in a bill containing various provisions adapting French law to European Union law on diverse topics and particularly in the field of public health (“Draft Bill“).
In more detail
The National Agency for the Safety of Medicines and Health Products (ANSM) reported that it has observed an increasing number of MD/IVDMD shortages in recent years that it attributes both to difficulties related to the implementation of the European regulations and those related to the current global economic and geopolitical context destabilizing the usual logistical routes. These shortages concern a wide variety of devices.
Whilst ANSM set up a discretionary procedure to anticipate MD/IVDMD (or risks of shortages) in September 2021, the French legislator is currently working on the implementation of such a mechanism in statutory law.
In France, the stock management of medicinal products is strictly regulated: the marketing authorization holders/French so-called exploitants must comply with a stockpiling obligation, and they must inform ANSM, without delay, of any risk of a supply shortage or any supply shortage of medicinal product of a major therapeutic interest that they could face.
The Draft Bill provides for the implementation of similar obligations for the MD/IVDMD manufacturer or its authorized representative, its importer, or distributor of a medical device (retail sales being excluded). This set of obligations would only concern MD/IVDMDs that are deemed essential, i.e. MD/IVDMDs, the unavailability of which is likely to create a situation of serious risk for the patient in terms of access to healthcare.
For those essential MD/IVDMDs, MD/IVDMD operators would have to respect stock monitoring obligations:
- Any decision to suspend or cease the marketing of an essential MD/IVDMD, or any knowledge of a fact that could cause the suspension or the ceasing of marketing must be notified to ANSM, at least one year before the foreseeable date
- In case of a shortage, or risk of shortage of essential MD/IVDMD, the MD/IVDMD operator must implement all useful measures in advance, to avoid this (risk of) shortage and therefore avoid disruption of availability
- If the shortage is unavoidable, the MD/IVDMD operator must make a declaration to ANSM
- If the operator fails to meet the above-listed obligations, ANSM may take any action to avoid the shortage of the essential MD/IVDMD
As far as sanctions are concerned, in its current version, the Draft Bill proposes to extend the sanctions applicable to medicinal products stock management obligations for essential MD/IVDMDs.
That being said, this Draft Bill is not binding yet. It has to be debated in Parliament and voted to enter into force. Then, ministerial orders will be expected to further define the scope of those obligations and sanctions.