The Legal and Regulatory Landscape for Advertising of Medicinal Products and Medical Devices in France
Laws and regulations from various sources govern the advertising and promotion of health products in France; indeed, there are both general and more specific rules applicable to health products.
The provisions of the French Consumer Code and the French Criminal Code prohibit and generally punish misleading commercial practices.
In addition, specific European regulations or directives, as well as French law (ie, the French Public Health Code (FPHC) and French Social Security Code (FSSC)), specifically regulate the promotion of health products. The FPHC, in particular, regulates health products such as:
In addition to the complex and extensive body of legislation, there are numerous – most not legally binding – recommendations, guidelines, charters or ethics codes governing advertising, to which health products operators may subscribe at the national, European or international level. The most important of these are listed below.
Authorities’ charters, guidelines and recommendations
Self-regulation guidelines and codes
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 last 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 drive the sector to anticipate, certify and track their promotional activities even more in-depth. The implementation of the new charter will require additional regulatory and organisational adaptations once the final certification reference framework (the “HAS referential”) for these activities is published and effective. The last Social Security Financing Law (LFSS) for 2023 significantly increased MD regulation, which tends to show increasing similarities with the regulations applicable to medicinal products.
Moreover, a new bill is planned to be introduced in Parliament for examination by the end of March 2023 aiming to regulate e-media influencers’ activities, and more specifically to ban advertising of certain health products by e-media influencers. Considering the actual restrictions, this bill, if adopted, may slightly impact advertising practices in the health products sector.
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:
Companies should be aware that although some material may be presented as non-promotional or as part of the above list, any positive, complimentary or comparative information may convert it into promotional material and lead to a risk of sanction if the material 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 GP
Promotion and advertising of medicinal products to the GP is possible provided that the medicinal product is:
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.
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, 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 14 October 2022 sets out the timetable and submission periods for 2023 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 session between the ANSM and the industry revealed some important information, as follows.
In addition, the HAS recently published its avenues of evolution to decrease the influence of health product canvassing on HCPs. This report is the result of an analysis of 199 studies and 12 systematic reviews published between January 2004 and December 2018 in more than 30 countries on the subject, and brings with it a very interesting description about the 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:
Since 2011, the general advertising legal provisions set out by the FPHC for MDs and IVD MDs have not been subject to any major or significant modifications. 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 doesn’t 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:
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
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.
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.
EU Council vote on the MD Regulation extension
On 6 January 2023, the European Commission adopted a proposal for a regulation as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices.
The proposed amendment has been formally adopted on 17 March 2023 by both the European Parliament and the Council with no modifications.
Accordingly, the delay for certifying medical devices under MDR rules is extended until 2027 or 2028 depending on the class of the MD and under specific conditions. This amendment aims to mitigate the risk of shortages.
The new charter dedicated to information and promotion of MDs, effective 8 March 2022
The LFSS for 2018 created Article L 162-17-9 of the FSSC which required the establishment of a new charter to ensure the quality of professional practices of persons responsible for presenting, providing information on, or promoting MDs for individual use, and for health products other than medicinal products and 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) is 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. Pending the HAS referential, the charter cannot be completely implemented.
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.
Modification of Annex XVI of the MDR
An amendment of Annex XVI of the MDR reclassified certain active products without an intended medical purpose by way of derogation from Annex VIII to Regulation (EU) 2017/745, the impact of which shall be reassessed by operators to ensure compliance with promotion-applicable rules.
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 impose financial penalties on operators who do not comply with legal provisions.
The ANSM’s decisions on this matter are published on the agency’s website and are analysed by operators in the sector, as they provide information on the ANSM’s doctrines.
In 2021, no financial penalties or injunctions related to promotion and advertising infringements were imposed on French operators.
According to the FPHC, infringements of advertising regulations can also be subject to financial penalties imposed by the CEPS. However, the provisional CEPS annual report for 2021, just published in December 2022, mentions no imposed penalties.
Pending the publication of the ANSM annual report for 2022, it cannot be determined whether the ANSM inspections focused more on the promotional activities of health operators.
New rules for influencers in the pipeline
A bill aiming to define the status of influencers, to regulate their practices and to ensure more transparency in their promotional activities was introduced for examination in the French Parliament in late December 2022.
Among other things, the bill proposes 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.
However this bill was withdrawn on 9 February 2023, and is to be integrated into a broader bill that should be introduced in the French Parliament for examination by the end of March.
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.
The regulatory environment of advertising of medicinal products and medical devices has been modified by direct and indirect changes affecting the applicable rules.
In 2022, MD operators are most affected by these changes, due to the implementation of the MDR, the charter dedicated to providing information on and promoting MDs, and the implementation of a restrictive framework for the provision of direct financial support of individual HCPs to attend third-party organised educational events. This has significantly modified the mindset and internal organisation of MD operators.
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