The Legal and Regulatory Landscape for Advertising of Medicinal Products and Medical Devices in France

Advertising and promotion of health products in France are subject to a complex framework of laws and regulations. This framework includes both broad and finely tailored rules that pertain to healthcare products.

The provisions of the French Consumer Code and the French Criminal Code prohibit and generally punish misleading commercial practices.

Furthermore, the promotion of health products is subject to specific EU Regulations, Directives, and French legislation, including the French Public Health Code (FPHC) and French Social Security Code (FSSC). Notably, the FPHC governs the promotion of various health products, including:

• medicinal products for human use;
• medical devices (MDs);
• veterinary products;
• food supplements; and
• devices, objects and methods presented as beneficial to health.

In addition to the comprehensive body of legislation, there are numerous – most not legally binding – recommendations, guidelines, charters and ethical codes that oversee advertising within the health products sector. Operators in this field have the flexibility to voluntarily adhere to these standards at the national, European or international levels. The most notable among these are detailed below.

Authorities’ charters, guidelines and recommendations

• Guidelines issued by the French National Agency for Medicines and Health Products Safety (ANSM):
1. recommendations on advertisement of medicinal products, medical devices and in vitro medical devices, and objects and methods presented as beneficial to health; and
2. the charter for the communication and promotion of health products (medicinal products and medical devices) on the internet and e-media.

• The charter for information by canvassing or prospection aiming to promote medicinal products, signed between the Economic Committee for Health Products (CEPS) and the French industry organisation representing pharmaceutical companies (Leem), applicable to operators marketing medicinal products reimbursed by the French health insurance scheme.
• The new charter of quality for professional practices of individuals responsible for the presentation, information, or promotion of individual-use medical devices, healthcare products other than medicines, and possibly associated services which entered into force on 8 March 2022.
• Guidelines and reference documents from the High Authority for Health (HAS) for the certification of activities related to the presentation, information, or promotion of healthcare products and associated services.
• General recommendations of the General Directorate for Competition, Consumer Affairs and Fraud Control (DGCCRF).
• Rules and recommendations from the code of ethics for general advertising of the French Authority for Professional Advertising Regulation (ARPP).

Self-regulation guidelines and codes

• Guidelines and codes issued by industry organisations, such as EFPIA, MedTech, IFPMA, Leem and SNITEM (the French medical device industry association), along with reference documents, ethical professional provisions, and opinions.

Since 2011, there have been no major changes to the rules applicable to health product advertising.

However, some regulations have been completely overhauled in the past few years and have had an impact on the advertising of health products – eg, the early access scheme, the provisions of the new anti-gift act, and the EU regulation on medical devices.

The new charter for the promotion of MDs will encourage the sector to anticipate, certify and monitor its promotional activities even more thoroughly. The implementation of the new charter will require additional regulatory and organisational adjustments once the final certification reference framework (the “HAS referential”) for these activities is published and effective.

The Social Security Financing Law (LFSS) for 2023 significantly strengthened the regulation of MDs, which tends to show increasing similarities with the regulations applicable to medicinal products. The latest LFSS for 2024 introduces specific adaptations affecting the advertising of certain healthcare products. Also, the previous Finance Act for 2023 transfers regulatory authority from the ANSM to other national authorities (ANSES and DGCCRF) regarding cosmetics and tattoo products, effective 1 January 2024.

Furthermore, a new law that became effective on 10 June 2023 defines and regulates the activities of electronic media influencers. This law has had an impact on advertising practices in the healthcare sector, as it formally prohibits the promotion of certain health products by e-influencers.

Promotion of Medicinal Products for Human Use

High-level overview of the French legal framework

Article 86 of EU Directive 2001/83 as implemented in the French Public Health Code (Article L.5122-1 and R.5122-1 et seq) defines the promotion of medicinal products for human use as being any form of information, including that derived from canvassing, prospecting or inducement, designed to promote the prescription, dispensation, sale or consumption of medicinal products, except for information provided by hospital pharmacists.

According to French law, the following are not considered as promotional materials or activities:

• information provided by hospital pharmacists (as stated above);
• correspondence, possibly accompanied by material of a non-promotional nature, needed to answer a specific question about a particular medicinal product;
• factual, informative announcements and reference material relating, for example, to packaging changes, adverse-reaction warnings as part of general drug precautions, trade catalogues and price lists, provided they include no product claims;
• information on human health or human diseases with no reference to a medicinal product; or
• institutional information (ie, information documents of a scientific, technical or financial nature, issued by the establishment or company, which are not intended to promote a medicinal product).

Operators should be aware that if certain content is portrayed as non-promotional or falls within the categories mentioned above, any positive, complimentary or comparative information may transform it into promotional material. This transformation carries the risk of sanctions if the content does not comply with applicable rules.

For example, in the fifth case listed above (institutional information), when an advertisement for a pharmaceutical company mentions a medicinal product, it is automatically subject to promotional legal rules. Consequently, materials must be carefully analysed by internal advertising departments which are, by law, under the supervision and accountability of the pharmacist responsible.

France distinguishes between two different mechanisms depending on whether the targeted audience is the general public (GP) or healthcare professionals (HCPs).

In both situations, advertising is strictly limited to that authorised for marketing or to registered medicinal products for which no benefit/risk ratio reassessment is ongoing.

Promotion and advertising to the general public (GP)

Promotion and advertising of medicinal products to the GP is possible provided that the medicinal product is:

• not subject to medical prescription;
• not reimbursed by the French health insurance scheme; and
• not held back by a prohibition or restriction on advertising to the GP due to a possible risk to public health mentioned in the marketing authorisation or registration.

Notwithstanding the above conditions, regardless of their prescription or reimbursement status, advertising for vaccines and for smoking cessation products is authorised for public health purposes under certain conditions.

Advertising of medicinal products to the GP, including for the above-mentioned vaccines, is subject to prior authorisation (namely a “Visa GP”) granted by the ANSM.

In addition, since April 2023, if advertising content is to be shared on social media, the Visa GP request must provide detailed additional and specific information for a comprehensive submission.

Promotion and advertising to HCPs

The promotion of medicinal products to HCPs (so-called PM) is not limited regarding the product prescription or reimbursement status but requires the pre-approval of the ANSM (in the form of a “Visa PM”).

Unlike GP advertising rules, the provision of free samples of medicinal products to HCPs is permitted provided that certain legal requirements are met.

Advertising application process and periods

Applications to the ANSM for a Visa GP or a Visa PM for authorised products are carried out online and according to the respective filing periods (four periods for a Visa PM, and eight periods for a Visa GP). In some cases, Visa applications may be submitted prior to the granting of the marketing authorisation or its amendment. In both situations, they can only be made during these periods.

The ANSM’s decision dated 23 October 2023 sets out the timetable and submission periods for 2024 along with the form and content of applications for approval of advertisements for medicinal products for human use.

Since 3 October 2022, application forms provided on the ANSM website have been updated along with the notice for applicants.

In the absence of a decision on a Visa application by the ANSM within two months of the day following the end of the filing period, the Visa application is deemed to be accepted.

Both the Visa GP and the Visa PM are valid for two years.

Updating of guidelines and recommendations

The ANSM guidelines for advertising have not undergone any major modification within the last year.

In fact, the only recommendation updated in 2022 by the ANSM was the recommendation on “minor changes that can be made to a material with a valid PM Visa”.

However, the last working group sessions between the ANSM and the industry revealed some important information, as follows.

• The ANSM expressed in early 2022 its intention to review its recommendations regarding the mention of price and reimbursement. However, no specific timeframe has been disclosed.
• Concerning non-promotional communications related to compassionate access and early access, the ANSM is currently developing a guidance document for applicants. In addition, for post-market authorisation of early access programmes, a guidance document is also being prepared by the ANSM regarding promotional communications. The publication dates of these documents are not known at this stage. However, some valuable information is provided in the working group session reports such as compliant communication examples.
• The ANSM recalls the rules applicable to advertising to the general public in social media (eg, the promotional nature must be immediately evident to the public, the use of hashtags (#) in the publication is to be avoided, and mandatory mentions).
• The ANSM has disclosed its recommendations update work programme and priorities for 2024.

In addition, the HAS, in February 2023, published its proposed measures to reduce the impact of influence of healthcare product canvassing on HCPs. This report is the culmination of an analysis of 199 studies and 12 systematic reviews on the subject, published between January 2004 and December 2018 across more than 30 countries. It offers an insightful overview of advertising practices in France.

Promotion of Medical Devices and In Vitro Diagnostic Medical Devices

High-level overview of the French legal framework

The FPHC (Article L.5213-1) defines the promotion of MDs and in vitro diagnostic (IVD) MDs as being any form of information, including canvassing, prospecting or inducement, designed to promote the prescription, dispensation, sale or use of devices, except information provided by hospital pharmacists.

Following the same path as for medicinal products, the following are not considered to be promotional materials or activities:

• labelling and instruction leaflets (IFUs) for MDs and IVD MDs;
• correspondence, possibly accompanied by material of a non-promotional nature, needed to answer a specific question about a particular MD or IVD MD;
• information relating to warnings, precautions for use and adverse effects identified in the context of vigilance, as well as trade catalogues and price lists, provided they include no product claim; and
• information relating to human health or human diseases, if there is no indirect reference to an MD or an IVD MD.

Since 2011, the general legal provisions for advertising, as outlined in the FPHC, for Medical Devices (MDs) and In Vitro Diagnostic Medical Devices (IVD MDs), have not undergone any major or significant modifications. Ordinance No 2022-582 of 20 April 2022 did adapt French law provisions to Regulation (EU) 2017/745 of the European Parliament and of the Council, dated 5 April 2017, concerning medical devices. However, the main principles remained largely unchanged. Respectively, Articles L.5213-1 et seq and L.5223-1 et seq of the FPHC regulate the advertising and promotion of such devices.

Accordingly, promotion and advertising of medical devices is possible for the GP for both reimbursed Class I or IIa MDs and for MDs not reimbursed by the French health insurance scheme. Except for the derogation described below, prior authorisation is not required for such advertising. However, in any case, advertising Class IIb and III MDs is strictly forbidden for the GP.

The promotion of MDs to HCPs (which falls under PM) does not require any pre-approval by the ANSM, except in the cases described below.

The ANSM would eventually control the GP and PM promotion material. In this case, if the advertisement does not comply with the applicable requirements, the ANSM would be able to order the promotional material to be withdrawn after the fact, by following a specific administrative procedure.

By way of derogation in both GP and PM situations, prior authorisation is required for the promotion of MDs that present an important risk to human health. These MDs, listed in a decree dated 24 September 2012, include the following:

• for the GP – dermal depression fillers; and
• for the PM – implantable cardiac defibrillators and ankle, knee, hip and shoulder prostheses, etc.

The promotion of IVD MDs does not require prior authorisation, except in situations where their failure is likely to cause a serious health risk (eg, self-diagnosis IVD MDs for the GP and some specific reagents and reagent products for PM advertising, as stated in the decree dated 24 September 2012).

Where prior authorisation is required by law, the GP and PM Visas for IVD MDs and other MDs are granted for five years, provided that the CE marking is valid.

Unlike medicinal products, applications to the ANSM for promotional materials are not subject to a particular calendar.

What is new regarding MDs?

French Ordinance No 2022-582 adopted on 20 April 2022 to implement the MDR (Medical Devices Regulation)

The legal framework of MDs and IVDs has been reshaped by new Regulations (EU) 2017/745 and 2017/746 of the European Parliament and of the Council of 5 April 2017 on medical devices and on in vitro diagnostic medical devices (the MDR and the IVD MDR, respectively), which became applicable as of 26 May 2021 and 26 May 2022.

An ordinance was adopted on 20 April 2022 by the French Parliament adapting French law to the MDR.

This ordinance has an impact on the FPHC advertising provisions, in particular as follows.

• The ANSM will carry out post-marketing surveillance and market surveillance for MDs and their accessories and for the products not intended for medical purposes listed in Annex XVI of the MDR.
• Accessories to MDs that present an important risk to human health are expressly subject to a prior authorisation for their promotion. The violation of this provision, extended to accessories, constitutes both a criminal offence and an infringement under the terms of the draft ordinance subject to, respectively, a financial penalty and imprisonment, and an administrative fine.
• Advertisement to the GP of MDs and their accessories that are reimbursed, covered or financed (even partially) by the French health insurance scheme, except for reimbursed Class I or IIa MDs, constitutes an infringement under the terms of the draft ordinance.
• The ANSM will be competent to control after the fact, by all appropriate means, the advertising and promotion of products not intended for medical purposes, listed in Annex XVI of the MDR. According to the ordinance, the general power of control of the ANSM will be extended to those products listed in Annex XVI of the MDR, including the advertising activities related to them.
• Misleading conduct regarding promotional materials for MDs and their accessories and for those products listed in Annex XVI of the MDR will constitute an infringement subject to a financial penalty under the terms of the draft ordinance.

Accordingly, the ANSM and the DGCCRF will have a shared sanction power with respect to products regulated by the MDR (MDs and products listed in Annex XVI of the MDR).

To ensure constitutional sustainability of the ordinance, a draft ratification law was introduced before the French Parliament on 13 July 2022.

One notable point of 2023 is related to the DGCCRF investigation prerogatives, which have recently been highlighted by a procedure involving a MD operator that has led to a EUR6.6 million penalty for massive breach of the anti-gift law by an MD group.

New charter dedicated to information and promotion of MDs entered into force on 8 March 2022

The LFSS for 2018 created article L.162-17-9 of the FSSC which requires the establishment of a new charter of quality for professional practices of individuals responsible for the presentation, information, or promotion of individual-use medical devices, healthcare products other than medicines, and possibly associated services.

Negotiations between the stakeholders – ie, relevant professional organisations and the CEPS – involved in the adoption of the charter were lengthy and not easy. In fact, these negotiations were ultimately unsuccessful, and the French Ministry of Health and Social Insurance was left to set out the terms of the MD charter. As a result, the long-awaited charter was eventually adopted by an order dated 4 March 2022, applicable as of 8 March 2022.

The charter aims to provide a better framework for commercial, promotion, presentation or information practices relating to all products and services mentioned in the reimbursement List of Products and Services (LPP) referred to in Article L.165-1 of the CSS, whether or not they are subject to the regulations relating to CE marking, and which could otherwise be detrimental to quality of care, or lead to unjustified expenditure for the French health insurance scheme.

According to Article L.162-17-9 of the FSSC, a financial penalty can be imposed by the CEPS if a company does not comply with the provisions of the Charter.

Under conditions to be determined by the HAS, a certification reference framework (the HAS referential) had to be established within one year from the publication of the charter (8 March 2023) to ensure that certified operators subject to the charter comply with its provisions. To date, HAS referential has not been published and the charter cannot be completely implemented.

Additionally, the certification bodies will be the recipients of any infringements observed and sanctioned by the CEPS, as well as of any financial penalties (up to 10% of turnover excluding tax) resulting therefrom.

According to the LFSS for 2023, the commitment of MD operators to complying with the charter is an essential condition for entering into an agreement with the CEPS.

Updated guidelines

The ANSM recommendations have not been updated since the application date of the new MDR and IVD MDR.

Recent Developments and Points of Attention

ANSM financial and administrative penalties

The ANSM has the power to levy financial penalties on operators who fail to comply with legal provisions.

The ANSM’s decisions on this regard are published on the agency’s website and are reviewed by sector operators as they provide insights into the ANSM’s policies.

In 2021 and 2022, the ANSM did not impose any financial penalties or injunctions related to promotion and advertising infringements on French operators. Pending the publication of the ANSM annual report for 2023, it cannot be determined whether the ANSM inspections focused more on the promotional activities of healthcare operators.

According to the FPHC, breaches of advertising regulations can also result in financial penalties imposed by the CEPS. However, the CEPS annual reports for 2021 and 2022, mention no imposed penalties for either medicinal products or medical devices.

Transfer of surveillance powers for tattoo and cosmetic products

Since 1 January 2024, tattoo and cosmetic products have been excluded from the list of healthcare products of Article L.5311-1 of the FPHC and are no longer under the purview of the ANSM.

The Finance Act for 2023, dated 30 December 2022, stipulates the transfer of market surveillance and control responsibilities for these products from the ANSM to the French National Agency for Food, Environmental and Occupational Health and Safety (ANSES) and the DGCCRF.

Therefore:

• Declarations from establishments manufacturing or packaging cosmetics and tattoo products will now be submitted to the DGCCRF (L.513128 FPHC).
• The ANSES and the DGCCRF will be responsible for market control, health, and surveillance of these products.
• The ANSM will continue to oversee the development of principles of good laboratory practices applicable to non-clinical safety studies aimed at assessing the safety of cosmetic products (L.5131-4 FPHC)

New rules for influencers

A law defining the status of influencers, regulating their practices and ensuring more transparency in their promotional activities, has been adopted by the French Parliament and has been applicable since 10 October 2023.

This law aims to prohibit influencers from promoting pharmaceutical products, medical devices and surgical procedures on social networks unless the influencer is just relaying government public health campaigns.

Ad hoc temporary authorisation for use of cannabis-based medicinal products

As part of the conclusion of the medical cannabis experiment, scheduled for 26 March 2024, cannabis-based medicinal products will now be subject to a temporary “ad hoc” authorisation for use granted by the ANSM for a renewable period of five years pursuant to the LFSS for 2024 which also legally defines cannabis-based medicinal products.

According to new applicable rules, promotion or advertising to the GP is prohibited. Plus, any information relating to this ad hoc authorisation intended for PM must submit to legal advertising rules.

The MedTech code of ethics and its importance for MD operators

In 2015, the European trade association representing the medical technology industry (ie, in vitro diagnostics and medical device manufacturers operating in Europe) published the MedTech Europe Code of Ethical Business Practice (the “MedTech Code”).

This code, which became binding for MedTech Europe corporate members on 1 January 2017, “regulates all aspects of the industry’s relationship with healthcare professionals (HCPs) and healthcare organisations (HCOs), to ensure that all interactions are ethical and professional at all times and to maintain the trust of regulators, and – most importantly – patients”.

In France, since 1 January 2022, all provisions of the MedTech Code are applicable to SNITEM member companies (ie, over 557 members with a significant position in France), which includes non-corporate members of MedTech Europe.

The MedTech Code lays down stricter rules than those governing interactions between HCPs/HCOs and IVD MD/MD operators in France.

Accordingly, relevant operators subject to the MedTech Code will no longer be able to provide direct financial support for individual HCPs to attend third-party organised educational events.

With the new French anti-gift scheme eventually coming into force pursuant to the publication of the long-awaited decree dated 1 October 2020, the IVD-MD and MD industries have had to anticipate every interaction, along with the expected delay, for the competent authority to authorise or respond to a declaration of interaction between HCPs and IVD-MD/MD operators.

It should be noted that the anti-gift law prevents companies manufacturing or marketing healthcare products or providing healthcare services from granting benefits, particularly to HCPs and HCOs. This framework has existed under French law since 1993 and was frequently updated, until being completely reshaped by Ordinance No 2017-49 of January 2017 (ratified by Law No 2019-774 of 24 July 2019). This new framework redefines the strict conditions under which certain benefits can be granted to HCPs and HCOs by healthcare companies. The regulation requires either a prior declaration or a prior authorisation to be submitted to the relevant professional board or relevant competent authority (regional health agency) depending on the amount of benefit to be provided to the recipients.

In any case, feedback from the authority is considered prior to the implementation of the regulated interaction.

The MedTech Code requirements represent a real challenge for operators subject to its provisions. The process for granting an indirect sponsor would need to start sooner, and the SNITEM estimates that the delay between the signature of the grant agreement with the third-party beneficiary and the event date is between four and eight months.

Detailed processes are required to be implemented internally within relevant operators in order to comply with all the ethical and legal requirements.

Conclusion

The legal and regulatory landscape for advertising of medicinal products and medical devices in France is characterised by a complex framework of laws and regulations. This framework encompasses various provisions within the French Consumer Code, French Public Health Code, French Social Security Code, among others. It is further influenced by European Regulations and Directives.

One key takeaway is the consistency and stability in the rules governing health product advertising many years. However, recent changes, such as the early access schemes, the anti-gift law, and the EU regulation on medical devices, have brought about significant impacts on advertising practices in this sector.

Operators in the healthcare industry need to navigate this intricate regulatory landscape with precision. They must be vigilant in adhering to the evolving rules and guidelines. The requirement for prior authorisations, the scrutiny of content on social media, and the influence of industry-specific codes of ethics, further emphasise the need for compliance.

Moreover, the transfer of surveillance powers for tattoo and cosmetic products underscores the dynamic nature of healthcare advertising regulations in France.

In summary, while the core principles of health product advertising remain consistent, recent developments and changes in the legal framework necessitate careful attention and adaptability from industry operators to ensure they comply with the evolving rules and maintain ethical practices in the promotion of medicinal products and medical devices in France.