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

Advertising and promotion of health products in France operate within a highly structured and intricate legal and regulatory framework. This framework includes both general provisions and highly specialised rules tailored to healthcare products.

The French Consumer Code and Criminal Code broadly prohibit and penalise misleading commercial practices. In parallel, the promotion of health products is subject to specific EU Regulations and Directives, and to French national laws, notably the French Public Health Code (FPHC) and the French Social Security Code (FSSC). These laws govern the promotion of a wide range of products, including (in particular):

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

Beyond this robust legislative framework, numerous additional instruments such as recommendations, guidelines, charters and ethical codes – some of which are non-binding – guide advertising practices in the health sector. These resources, issued by national, EU or international authorities and organisations, allow operators to align with best practices.

Key examples include the following authorities’ charters, guidelines and recommendations.

• Guidelines issued by the French National Agency for Medicines and Health Products Safety (ANSM):
1. recommendations on advertising of medicinal products, MDs and in vitro MDs, and objects and methods presented as beneficial to health; and
2. the charter for the communication and promotion of health products (medicinal products and MDs) on the internet and e-media.
• The charter on 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 MDs, 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 French Authority for Professional Advertising Regulation’s (ARPP) code of ethics for general advertising.
• Self-regulation guidelines and codes issued by industry organisations, such as EFPIA, MedTech, IFPMA, Leem and SNITEM (the French MD industry association), along with reference documents, ethical professional provisions and opinions.

While no major changes to the core rules governing health product advertising have been introduced since 2011, recent regulatory developments have had significant impacts on promotional practices.

For example, the Social Security Financing Act (LFSS) for 2023 significantly strengthened the regulation of MDs, and shows increasing similarities with the regulations applicable to medicinal products. The latest LFSS for 2024 introduced specific adaptations affecting the advertising of certain healthcare products.

Additionally, the new charter for the promotion of MDs encourages the sector to anticipate, certify and monitor its promotional activities more rigorously. However, its implementation will require additional regulatory and organisational adjustments once the final certification reference framework (the “HAS Referential”) for these activities is published, rendering it fully effective. This publication is expected to occur in March 2025.

Furthermore, a new law aimed at regulating commercial influence and combating the excesses of influencers on social networks (the “Influencer Act”) became effective on 10 June 2023. 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.

These changes underline the evolving need for the sector to anticipate, adapt to and rigorously monitor compliance with both regulatory and ethical standards.

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 FPHC (Article L5122-1 and R5122-1 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 responsible pharmacist.

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 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 (for 2025, 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.

In a decision dated 24 October 2024, the ANSM sets out the timetable and submission periods for 2025, with the form and content of applications for approval of advertisements for medicinal products for human use.

Application forms, along with the notice for applicants, are provided on the ANSM website and were fully updated on 3 October 2022. Since then, the only modification was related to the Visa PM form and was implemented in September 2024.

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 recent major modifications.

In fact, the only recommendation updated by the ANSM in 2022 was that 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 its intention to review some of its recommendations. Indeed, updating is currently underway of both the PM recommendations “generic medicines and substitution” and “mention of the indication and place in the therapeutic strategy (TS)”. However, no specific timeframe has been disclosed.
• Concerning non-promotional communications related to compassionate access and early access (including post-market early access authorisation), in 2023 the ANSM provided some compliant communication examples and guidance (featured in the group sessions report of April 2023).
• Given the significant increase of Visa requests targeting the GP (approvals for materials intended for dissemination on social media), during the group sessions dated April 2023 the ANSM recalled the rules applicable to advertising to the GP 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, use of mandatory mentions, and disabling the “like”, “share” and “comment” functions).
• The ANSM has clarified its position regarding the granting of PM approvals for materials primarily aimed at promoting the company’s “eco-responsibility”, which are more likely to fall under institutional communication.
• In June 2024, the ANSM specified that public advertising (GP) for COVID-19 vaccines will be permitted following the publication of the ministerial order amending the list of vaccines referenced in Article L5122-6 CSP, and, where applicable, the mandatory minimum mentions (MMO) determined by the HAS. To ensure equitable treatment, GP approval requests will be allowed starting from the GP submission period, following the publication of the aforementioned order.
• The ANSM has disclosed its recommendations-updating work programme and priorities for 2025.

Promotion of MDs and In Vitro Diagnostic MDs

High-level overview of the French legal framework

The FPHC (Article L5213-1) 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, as outlined in the FPHC, for advertising MDs and IVD MDs have not undergone any major or significant modifications. Ordinance No 2022-582 of 20 April 2022 did adapt French legal provisions to Regulation (EU) 2017/745 of the European Parliament and of the Council, dated 5 April 2017, concerning MDs.

However, the main principles remained largely unchanged. Respectively, Articles L5213-1 et seq and L5223-1 et seq of the FPHC regulate the advertising and promotion of such devices.

Accordingly, promotion and advertising of MDs is possible for the GP for 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. Advertising reimbursable 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 situations involving both GP and PM, 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/timeframe.

What is new regarding MDs?

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

The legal framework for 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.
• Advertising 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 ANSM’s general power of control 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 sanctioning 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 from 2023 relates to the DGCCRF’s investigation prerogatives – this was recently highlighted by a procedure involving an MD operator that led to a EUR6.6 million penalty for massive breach of the anti-gift law by an MD group.

New charter governing the information and promotion of MDs, effective from 8 March 2022

The LFSS for 2018 introduced Article L162-17-9 of the FSSC, which mandates the establishment of a quality charter governing the professional practices of individuals involved in the presentation, information or promotion of single-use MDs, healthcare products other than medicines, and associated services, where applicable.

Negotiations between stakeholders – namely, relevant professional organisations and the CEPS – on the adoption of the charter were protracted and challenging. Ultimately, these negotiations failed to reach a consensus, leaving the French Ministry of Health and Social Insurance to define the terms of the MD charter. Consequently, the much-anticipated charter was adopted through an order dated 4 March 2022, and came into effect on 8 March 2022.

The charter aims to establish a comprehensive framework for the commercial, promotional and informational practices concerning all products and services listed in the reimbursement List of Products and Services (LPP) referred to in Article L165-1 of the FSSC. These products – whether subject to CE marking regulations or not – must not compromise the quality of care or lead to unjustified expenses for the French health insurance system.

According to Article L162-17-9 of the FSSC, the CEPS has the authority to impose financial penalties on companies that fail to comply with the charter’s provisions. To ensure adherence to the charter, Article L162-17-9 also required the development of a certification reference framework (the HAS Referential) by the HAS within one year of the charter’s publication – ie, by 8 March 2023. However, the HAS Referential has not yet been published, rendering the charter’s full implementation incomplete. The only related document issued to date is a guidance note published in July 2023 by the HAS. This note outlines the procedure for developing and implementing a certification scheme for activities related to the presentation, information and promotion of products and services included in the LPP. The HAS Referential is now scheduled for publication in March 2025.

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

As stipulated in the LFSS for 2023, a commitment by MD operators to comply with the charter is now a fundamental requirement 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

Pharmaceutical advertising figures

According to the last ANSM annual report for 2023, pharmaceutical companies submitted 11,193 advertising approval applications (combined GP and PM).

Over a five-year period (excluding 2020 and 2021, due to exceptional measures related to the COVID-19 pandemic), a steady increase in the number of advertising approval applications was observed (+14% compared to 2017), despite updates to recommendations in 2019 and 2022 aimed at reducing them.

ANSM financial and administrative penalties

The ANSM has the authority to impose financial penalties on operators who fail to comply with legal provisions. Decisions in this regard are published on the agency’s website and are closely reviewed by sector operators, as they provide valuable insights into the ANSM’s enforcement policies.

Since 2021, the ANSM has not imposed any financial penalties or issued injunctions related to promotional and advertising infringements by French operators. It remains unclear whether inspections have shifted focus towards the promotional activities of healthcare operators.

According to the FPHC, breaches of advertising regulations can also result in financial penalties being imposed by the CEPS. However, successive CEPS annual reports for 2021, 2022 and 2023 did not mention any penalties being levied for medicinal products or MDs.

Transfer of surveillance powers for tattoo and cosmetic products

As of 1 January 2024, tattoo and cosmetic products have been removed from the list of healthcare products under Article L5311-1 of the FPHC; as a consequence, they are no longer under the jurisdiction 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 (Article L5131-2 FPHC);
• the ANSES and the DGCCRF will be responsible for market control, health and surveillance of these products; and
• 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 (Article L5131-4 FPHC).

New rules for influencers

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

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

An Order dated 6 November 2024 amends the Influencers Act 2023 in order to ensure the compatibility of French law with the EU legal framework, and to thus respond to the observations made by the European Commission in its letter to the French authorities following the notification made on 12 May 2023 (pursuant to Directive (EU) 2015/1535).

The Order was submitted to the French Parliament on 15 January 2025. Its adoption will enable the full implementation of the Order’s measures.

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

As part of the conclusion of the medical cannabis experiment, scheduled for 31 December 2024 and extended until 1 July 2025, 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. Additionally, 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, IVD and MD 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 589 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.

As such, 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 governed by its provisions. The process for granting an indirect sponsor would need to start sooner, and the SNITEM estimates that the delay between the signing 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 MDs in France is characterised by a complex framework of laws and regulations. This framework encompasses various provisions within the French Consumer Code, FPHC and FSSC (among others). It is further influenced by EU Regulations and Directives.

One key takeaway is the consistency and stability in the rules governing health product advertising over many years. However, recent changes – such as the early access schemes, the anti-gift law and the EU Regulation on MDs – 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 that they comply with the evolving rules and maintain ethical practices in the promotion of medicinal products and MDs in France.