This Charter sets out a new framework for providing information and carrying out promotional practices in relation to reimbursed medical devices.
The publication of the Charter has been awaited for long since it was announced under the Social Security Financing Law for 2018.
The Charter applies to a variety of activities and stakeholders, and adds a further layer to an existing regulatory framework combining the MDR, the French public health code, the French consumer code and guidelines issued by the National Agency for the Safety of Medicines and Health Products (ANSM).
Which products and services are targeted by the Charter?
The Charter applies to all products and services that are mentioned on the list of products and services reimbursed by the French social security (LPPR), and used notably in pharmacies and health institutions. This includes medical devices for individual use as well as health products (other than medicinal products) and associated services, irrespective of whether they are CE marked.
Which stakeholders are targeted by the Charter?
The Charter applies to the interactions between:
-
French and foreign exploitants and distributors of the listed products and associated services, as soon as they conduct the covered activities in France; and
-
all professionals (healthcare professionals or not), authorized to prescribe, use or purchase the listed products and services, regardless of the structure in which they practice (institutions, health care facilities, pharmacies, etc.).
Which are the activities targeted by the Charter?
The Charter aims at regulating all promotional, presentation or information activity, in any form, conducted at the initiative of the companies and service providers mentioned above with the targeted professionals during visits. Visits include both face-to-face meetings at the professional's place of practice and remote contacts (e.g., videoconferencing or teleconferencing, but excluding unplanned contacts).
The three categories of activities are defined by the Charter:
-
presentation of the listed products and services, the aim of which is to ensure an appropriate knowledge of the products or services, and to enable them to be used in accordance with proper use and the conditions of care;
-
information on technical, regulatory or therapeutic information on a listed product or service;
-
advertising of a listed product or service, which aims at encouraging the purchase, prescription, distribution or use of a listed product or service, as well as advertising of medical devices, as defined in the French Public Health Code.
Which are the key takeaways provided by the Charter?
The key takeaways to bear in mind are the following:
- it is now expressly stated that certain type of information must appear in promotional and non-promotional materials (e.g. information on the use of products and services, including adverse effects, precautions for use and contraindications. Restrictions are also imposed on certain claims/information that can be included. The rules provided in the Charter that are applicable to claims implement European regulations applicable to medical devices and in vitro medical devices. Several requirements merely implement ANSM recommendations on advertising of medical devices and extend these to (i) a wider list of products and services (i.e. not only medical devices) and to (ii) a wider list of activities (i.e. not only promotional activities but also informational activities);
- a list of mandatory information on the regulatory and scientific aspects related to the products or services is provided and must appear in the content of the communications. Such information must be given to the 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 prove its delivery to the recipient (or permanent digital access to it) and how it was provided;
- companies must implement a quality control system to ensure that the content of the presentation, information or promotion complies with the Charter. The Charter provides for a more in-depth view of the authorities' expectations regarding the content of the information and promotion of the products and services listed on the LPPR;
- companies must also ensure that both the employees which carry out the targeted activities and which prepare the relevant materials and campaigns, have the necessary knowledge to perform these activities. Companies must ensure that they implement regular training and continued education on these topics;
- specific rules are now in force for the organization and the frequency of the visits. In particular, companies must declare on an online platform all the visits at their initiative aiming at the promotion, the presentation or information on products and services. This platform will be provided by the French authority in charge of pricing of healthcare products (CEPS). Visits must be organized in advance and limits apply to the number of visits (except where visits apply to activities that are out of scope of the Charter, such as technical training on products or visits relating to medical device vigilance or tender procedures);
- companies must ensure that the documents used for presentation, information or promotion activities are accessible upon request by the competent authorities and companies involved in the certification process for 5 years.
What are the penalties in case of non-compliance with the Charter?
Non-compliance with the Charter by a company can lead to a financial penalty imposed by the CEPS. The amount of this penalty may not exceed 10% of the company's turnover (excluding taxes) in France for the last financial year for the product(s) or service(s) concerned.
The French Social Security Code provides that non-compliance identified by healthcare professionals and healthcare establishments must be reported to the Health Regional Agencies (ARS) which must then report them to the CEPS.
This specific financial penalty does not exclude the potential application of other sanctions provided by applicable French regulations, notably sanctions applicable to non-compliance medical device advertising regulations.
Next steps
The adoption of this Charter is a first step in a process which aims at adapting companies’ practices in relation to information and promotion.
This step will be followed by the publication by the Haute Autorité de Santé of certification guidelines, which will ensure that companies comply with the provisions of the Charter, similarly to the pharma sector. These certification guidelines are expected to be adopted within twelve months.
In the meantime, companies operating in the healthcare & life sciences sector must anticipate the implementation of the requirements provided in the Charter, notably under their quality management system. A reassessment of internal practices and procedures may be required, as well as the implementation of new organization and training. Companies must also ensure they raise awareness internally with relevant stakeholders who will be in charge of implementing the requirements of the Charter in practice.
Authored by Mikael Salmela, Joséphine Pour, and Letizia Nieddu.
