Article L. 162-17-9 of the Social Security Code, created by the LFSS for 2018, provides – in the same spirit as what already existed for drugs – for the establishment of a Quality Charter for the professional practices of persons responsible for presenting, informing or promoting medical devices (“MD Charter“).
The MD Charter, set by the order of March 4, 2022 published in the Official Journal this morning, applies as of today.
What activities are covered by the MD Charter?
The Charter covers all forms of promotion, presentation or information of products and services registered on the LPPR.
A contrario, therefore :
- Manufacturers who do not have products registered on the LPPR are not subject to the Charter ;
- Manufacturers who have products registered on the LPPR are not subject to the Charter for activities relating to other products (e.g. MD not registered on the LPPR, drugs, cosmetics, etc.)
What are the obligations imposed by the Charter?
Obligations related to the quality of the information provided
In particular, it is specified which claims can be used by manufacturers, which information must or must not appear in the advertisement, and which information the manufacturer must provide to the visited professional.
In practice, manufacturers subject to the Charter will therefore have to ensure that the documentation they prepare complies not only with general regulations (European regulations, public health code, consumer code), but also with the additional requirements laid down by the Charter.
Obligations related to the organization and frequency of visits
The Charter imposes to declare on a dematerialized platform all the visits at the initiative of the industrialist (or the provider) aiming at the promotion, the presentation or the information.
It also lays down a certain number of obligations concerning the organization of visits. In particular, the visit must be organized in advance (formalized record of the appointment, prior agreement of the managers of restricted structures). Furthermore, it is forbidden to organize a survey to collect data concerning the structure visited, to carry out visits during the tender procedure (except during the trial, test or clinical evaluation phases) and to meet with students without the prior agreement of their manager and without the presence of a supervising professional.
Finally, the Charter sets a “benchmark” of 4 annual visits per company (excluding visits related to training, material vigilance, or tendering procedures) and per professional, department or structure visited (as appropriate).
This “benchmark” is provisional: the Charter provides for the establishment of an observatory of visits in order to objectivize the situation and better understand existing practices.
Quality control obligations
The industrialists must set up a quality control system which guarantees the conformity with the Charter of the diffused information. The manufacturers must also ensure that the visitors have the knowledge necessary to the exercise of their profession and that they receive regular continuous training (whose content is specified by the Charter).
Finally, it should be noted that a certification standard guaranteeing that certified companies comply with the MD Charter will be established under conditions to be determined by the HAS.
What are the penalties for non-compliance with the Charter?
Companies that fail to comply with the Charter may be subject to financial penalties imposed by the CEPS. The amount of these penalties can be up to 10% of the company’s turnover (excluding tax) in France for the last financial year for the product(s) or service(s) concerned by the breach.
That said, the effective capacity of the CEPS to monitor the application of the Charter and to impose possible sanctions is questionable.
It should be noted that Article R. 165-79 of the Social Security Code involves professionals in the sector in the effective application of the Charter. Health professionals, health care institutions and observatories are responsible for “establishing that there has been a breach”, and they transmit the reports to the ARS. The ARS and local health insurance organizations are responsible for reporting to the CEPS any “significant breaches” of the Charter that they observe.
GD Avocats advises manufacturers on issues related to the advertising of health products.