This Charter defines a new framework for information and implementation of promotional practices relating to reimbursed medical devices.
The publication of the Charter is long awaited since it was announced as part of the social security financing law for 2018.
The Charter applies to a variety of activities and actors, and complements an existing regulatory framework combining the MDR, the public health code, the consumer code and the recommendations issued by the National Security Agency. medicine and health products. (ANSM).
What products and services are covered by the Charter?
The Charter applies to all products and services mentioned on the list of products and services reimbursed by French social security (LPPR), and used in particular in pharmacies and health establishments. This includes medical devices for individual use as well as healthcare products (other than medicines) and related services, whether or not they are CE marked.
Who are the actors targeted by the Charter?
The Charter applies to interactions between:
French and foreign operators and distributors of the referenced products and associated services, provided that they carry out the targeted activities in France; and
all professionals (health professionals or not), authorized to prescribe, use or buy the products and services referenced, regardless of the structure in which they practice (establishments, health establishments, pharmacies, etc.).
What are the activities covered by the Charter?
The Charter aims to provide a framework for any promotional, presentation or information activity, in any form whatsoever, carried out on the initiative of companies and service providers. mentioned above with the professionals targeted during the visits. Visits include both face-to-face meetings at the professional’s place of practice and remote contacts (eg, videoconference or teleconference, but excluding unscheduled contacts).
The three categories of activities are defined by the Charter:
the presentation of the referenced products and services, the purpose of which is to ensure appropriate knowledge of the products or services, and to allow their use in accordance with proper use and maintenance conditions;
information on technical, regulatory or therapeutic information on a referenced product or service;
advertising a referenced product or service, which is intended to induce the purchase, prescription, distribution or use of a referenced product or service, as well as advertising for medical devices, within the meaning of the public health code.
What are the main lessons provided by the Charter?
The main points to remember are:
- it is now expressly stated that certain types of information must appear in promotional and non-promotional materials (for example, information on the use of products and services, including adverse effects, precautions for use and counter- instructions). Restrictions are also imposed on certain claims/information which The rules provided for in the Charter applicable to claims implement European regulations applicable to medical devices and in vitro medical devices Several requirements merely implement ANSM recommendations on the advertising of medical devices and extend them to (i) a broader list of products and services (i.e. not only medical devices) and (ii) a broader list of activities (i.e. i.e. not only promotional activities but also informational activities);
- a list of mandatory information on regulatory and scientific aspects related to the products or services is provided and must be included in the content of communications. This information must be communicated to professionals or otherwise provided in digital form. This information must include the date on which it was produced or updated, and the company must be able to justify its delivery to the recipient (or permanent digital access to it) and the way in which they have been provided;
- companies must set up a quality control system to ensure that the content of the presentation, information or promotion complies with the Charter. The Charter makes it possible to deepen the expectations of the authorities with regard to the content of the information and the promotion of the products and services referenced in the LPPR;
- companies should also ensure that the employees who perform the targeted activities and who prepare the relevant materials and campaigns have the necessary knowledge to carry out these activities. Companies must ensure that they set up regular and continuous training on these topics;
- specific rules are now in force for the organization and frequency of visits. In particular, companies must declare on an online platform all visits to their initiative aimed at the promotion, presentation or information on products and services. This platform will be made available by CEPS. Visits must be arranged in advance and limits apply to the number of visits (except when the visits apply to activities outside the scope of the Charter, such as technical training on products or visits relating to materiovigilance or tendering procedures);
- companies must ensure that the documents used for presentation, information or promotional activities are accessible on request by the competent authorities and the companies involved in the certification process for 5 years.
What are the penalties for non-compliance with the Charter?
Non-compliance with the Charter by a company may lead to a financial penalty imposed by the CEPS. The amount of this penalty may not exceed 10% of the turnover (excluding taxes) achieved in France by the company for the last financial year for the product(s) or service(s) concerned.
The social security code provides that non-compliance noted by health professionals and health establishments must be reported to the Regional Health Agencies (ARS), which must then report them to CEPS.
This specific pecuniary sanction does not exclude the possible application of other sanctions provided for by the applicable French regulations, in particular the sanctions applicable in the event of non-compliance with the regulations on the advertising of medical devices.
The adoption of this Charter is a first step in a process that aims to adapt business practices in terms of information and promotion.
This step will be followed by publication by the High Authority of Health certification standards, which will ensure that companies comply with the provisions of the Charter, following the example of the pharmaceutical sector. These certification guidelines should be adopted within twelve months.
In the meantime, companies operating in the health and life sciences sector must anticipate the implementation of the requirements set out in the Charter, in particular within the framework of their quality management system. A reassessment of internal practices and procedures may be necessary, as well as the establishment of a new organization and training. Companies must also ensure that they raise awareness internally of the relevant stakeholders who will be responsible for putting the requirements of the Charter into practice.