France – A Charter for the Promotion of Medical Devices (including IVD) | King and Spalding
A prescription (” stopped “) was published in the Official Journal of March 8, 2022 establishing a quality charter governing the professional practices of persons responsible for the presentation of educational information, the marketing or promotion of medical devices for individual use and health products. other than drugs (“Products”) and associated services reimbursed by social security (“Charter”).
The Charter is the result of negotiations between the Economic Committee for Health Products (Economic Committee for Health Products or “CEPS”) and professional associations representing companies producing and distributing related Products and services, most of which have accepted the Charter.
It aims to regulate the commercial, promotional, presentation or information practices relating to the Products and associated services listed in Article L. 165-1 of the Social Security Code in order to prevent these practices from harming the quality care or leading to unjustified social security expenditure. It also intends to ensure the quality and proper use of the Products, the accuracy of the information concerning them and their appropriate prescription by the professionals authorized to prescribe, buy or use these Products or associated services.
The Charter sets the rules governing the content of information and promotional documents, visits to healthcare professionals, ethics, traceability, etc. A free English translation of the Charter is attached for your convenience.
It will be supplemented by a certification system (compulsory) which will be developed and implemented by the High Authority for Health (High Authority of Health or “HAS”) within 12 months. During the transitional period, companies will apply the Charter on a voluntary basis. A similar system – charter with certification – already exists for medicines (Charter of information by canvassing or prospecting aimed at the promotion of medicines) which will undoubtedly serve as a model for medical devices.
The Charter will apply to companies manufacturing and distributing Products, or providing services, which are reimbursed by the French national health insurance system. They must set up a quality system for their presentation, information and promotion activities and be certified in accordance with the Charter.
The Charter will bring significant changes in the promotion of medical devices, including IVDs, in France. K&S regulatory lawyers in our Brussels/Paris office can help you better understand and implement changes and anticipate upcoming certification requirements.
The scope of the Charter is wide, covering almost all forms of communication made by companies or actors concerning the Products and associated services.
Products and services. — The Charter applies to all the products and services mentioned on the list of Products and services provided for in Article L. 165-1 of the Social Security Code used in health or medico-social establishments, as well as at home or in public places. The requirements apply to these Products and services, whether or not they are subject to the rules relating to medical devices (i.e. CE marking).
Article L. 165-1 of the Social Security Code covers medical devices for individual use, human tissues and cells (regardless of the level of processing) and their derivatives, health products other than the medicines in reference in Article L. 162-17 of the Social Security Code, as well as the services associated with these Products.
Actors. – The Charter applies:
- All persons in charge of the activities of promotion, presentation or information of operators and retail distributors of Products and services within the framework of their practices (or during transfers) (“actors”). The requirements apply to the actors’ own activities and responsibilities (as well as those under their control), but the Charter does not address the relationships between the actors.
- All “companies” employing actors, whether they are operators or distributors of Products or service providers.
The “Beneficiaries” are all professionals, health professionals or not, authorized to prescribe, use (free of charge or for a fee) or purchase Products and services, regardless of the type of organization in which they practice (e.g. institutions , health establishments, pharmacies, etc.).
Activities. ─ The Charter covers all forms of promotion, presentation and information concerning the Products and associated services, on the initiative of an actor and with the beneficiaries, regardless of the mode of delivery or the relationship to any visits . The term “visit” covers both physical appointments at the beneficiary’s place of practice and remote contacts (such as videoconference or teleconference but excluding occasional contacts).
Activities fall into three broad categories: (1) presentation of products and services; (2) technical, regulatory or therapeutic information about products and services; and (3) promotional activities for products and services.
2. Visits to professionals
The Charter establishes rules on visits to professionals. The key rule is that all visits initiated by stakeholders must be recorded and documented, on an annual basis, on an online platform made available by CEPS. Companies will have to provide detailed information: nature of each visit; name of beneficiary and institution; date of visit; visit status; therapeutic area; and list of documents and samples given to the beneficiary. Certain visits exempted from the reporting obligation (but not from the traceability system) are listed in the Appendix to the Charter. The aggregated data from the platform will be presented annually to the Monitoring Committee.
Additional rules apply to visits to health or medico-social establishments. For example, actors cannot conduct visits during a bidding period (except for trial, testing, or clinical evaluation periods requiring user training) and cannot conduct a survey to collect facility-specific data.
It is important to note that there is a limit of four visits per year for companies until there is a better understanding of current practices. This reference threshold:
- is fixed by professional or, for establishments, by department;
- does not include visits related to training, vigilance or public procurement.
3. Quality control
Each company is expected to put in place a system to ensure compliance with the Charter. This includes implementing quality checks to ensure that the content of presentations, briefings and promotional activities complies with the Charter, and maintaining a list of materials to be distributed by stakeholders.
The company is responsible for the content of the messages and the delivery conditions of all its actors, including in the event of subcontracting to a third party. He is also responsible for the training of his actors.
Documents used for presentation, information and promotional activities must be kept for five years.
A certification system will be developed and implemented by HAS to ensure that the presentation, information and promotion activities of companies comply with the Charter. The first step will be the development of a certification reference system by the HAS. HAS will also determine the certification procedure.
In accordance with the Medicines Charter, it is expected that certification involves the review of the quality management system put in place by the companies. The certification will be issued following an audit which will probably be carried out by the French Accreditation Committee (French Accreditation Committee or COFRAC). Audits will be carried out both prior to certification and periodically thereafter.
Certification will most likely be mandatory for all manufacturers and distributors of Products and associated service providers who have entered into an agreement with CEPS (for pricing and reimbursement purposes) and who have promotional activities relating to at least one reimbursed Product or service. . The certification system is expected to be implemented within the next 12 months. In the meantime, compliance with the Charter will be on a voluntary basis.
5. Monitoring committee
A Monitoring Committee will be set up to oversee the implementation of the Charter and the achievement of its objectives. The committee will meet at least once a year to analyze reports received from professional associations and regional health agencies and receive aggregated data from the reporting platform.
The Monitoring Committee may adjust, in particular during the first year of application of the Charter, the frequency of visits.