Pharmaceutical advertising regulation and medical device advertising in France

Rules applicable to the advertising of veterinary medicines are not addressed in this questionnaire.

1.1 Medicines

The main rules applicable regarding advertising of medical devices were amended by (i) law n° 2011-2012 dated December 29, 2011 on strengthening the health safety of medicines and health products and (ii) decree n° 2012-741 dated May 9, 2012 on medicine advertising.

These provisions are codified in articles L.5122-1 to L.5122-16 and R.5122-1 to R.5122-26 of the French public health Code. 

1.2 Medical devices

The main rules applicable regarding advertising of medical devices were created by (i) law n° 2011-2012 dated December 29, 2011 on strengthening the health safety of medicines and health products and (ii) decree n° 2012-743 dated May 9, 2012 on medical devices advertising. 

These provisions are codified in articles L.5213-1 to L.5213-7, L.5122-1 and R.5213-1 to R.5213-11 of the French public health Code. 

To the provisions which are specific to medicines or medical devices, provisions of the French consumer Code are also applicable:

• Article L.121-1 to L.121-5 of the French consumer Code on unfair and misleading practices; 
• Article L.122-1 to L.122-7 of the French consumer Code on comparative advertising.

2.1 Medicines

There are no self-regulatory codes of conduct per se but the National Agency for the Safety of Medicines and Health Products (“ANSM”) enacts some regulatory codes of conduct governing the advertising of medicines.

Their guidelines focus either on advertisement to the general public or to HCP. 

Some guidelines are specific to (i) a therapeutic class: antibiotics, vaccines, hypnotics and anxiolytics for instance or (ii) to the media support of the promotion of the medicine (whether it airs on tv, radio or on the internet).

2.2 Medical devices

The ANSM enacts some regulatory codes of conduct governing the advertising of medical devices: 

• Guidelines on advertisement on MD;
• Policy on communication and promotion of healthcare products on the internet and e-medias.

3.1 The general public

For medicines

Advertising is allowed only for medicines that are not reimbursed i.e. financed by compulsory health insurance scheme and/or subject to a medical prescription (see section 4 hereafter). 

Advertising to the general public for medicines or vaccine advertising campaigns (see section 4 hereafter) are subject to prior authorisation by the ANSM, known as an “advertising visa” or “visa GP”.

For medical devices

There is no prior approval or license requirement for medical devices advertisement. 

However, there is an ex-post control: if the advertisement does not comply with minimal information defined by law, the director of the ANSM can, after formal notice, prohibit the said advertisement.

Besides, advertising of medical devices with high-risks for human health is subject to prior authorisation by the ANSM. 

3.2 Healthcare professionals

For medicines

Since 2012, advertising of medicines to HCP is also subject to prior authorisation by the ANSM. Companies must receive a “visa PM”.

For medical devices

There is no approval or license requirement for medical devices advertisement. 

However, there is an ex-post control: if the advertisement does not comply with minimal information defined by law: the director of the ANSM can, after formal notice, prohibit the said advertisement. 

Besides, advertising of medical devices with high-risks for human health is subject to prior authorisation by the ANSM.

3.3. Fees

The application for authorisation for the advertising (“advertising visa”) of medicines and medical devices (when necessary, as mentioned hereabove) involves the payment of a €510 fee.

Yes. 

Advertising to the general public is prohibited for prescription-only medicines. Advertising of such products is only authorised to HCPs.

5.1 Medicines

Advertising is only allowed for medicines that have been authorised for marketing in France. Moreover, advertising for a medicine is prohibited when the benefit/risk ratio is reassessed. 

Advertising to the public for a medicine is permitted only on condition that (i) it is not subject to medical prescription, (ii) that none of its various presentations is reimbursable by compulsory health insurance schemes and (iii) that its marketing authorisation or registration does not include a prohibition or restriction on advertising to the public because of a possible risk to public health, in particular where the medicinal product is not suitable for use without the intervention of a doctor for the diagnosis, initiation or monitoring of treatment. 

By way of derogation, advertising campaigns for tobacco cessation products or for vaccines subject to medical prescription or reimbursable may address the general public (under certain conditions for non-institutional advertising campaigns for vaccines).

Advertising to the public for medicines or above-mentioned vaccine advertising campaigns are subject to prior authorisation by the ANSM (see section 3 hereabove).

The provision of free samples of medicines to the general public is prohibited.

In addition to the mandatory information that must be included in advertisements intended for the general public (see section 8 hereunder), an advertisement for a medicine may not contain any element that:

• Would make medical consultation or surgery appear superfluous, in particular by offering a diagnosis or recommending treatment by correspondence; 
• Suggests that the effect of the medicine is insured, that it is free of adverse effects, or that it is greater than or equal to that of another treatment or medicine; 
• Would suggest that a normal state of health can be improved by the use of the medicine; 
• Suggests that a normal state of health may be affected in the event of non-use of the medicinal product (this prohibition does not apply to advertising campaigns for vaccines or tobacco cessation products); 
• Would be addressed exclusively or mainly to children; 
• Would refer to a recommendation from scientists, health professionals or persons who, although they are neither scientists nor health professionals, may, by their reputation, encourage the consumption of the medicinal product concerned; 
• Assimilates the medicine to food, a cosmetic product or another consumer product; 
• Suggests that the safety or efficacy of the medicine is due to the fact that it is a natural substance; 
• Could lead, by a detailed description of symptoms, to a false self-diagnosis; 
• Would abusively, frighteningly or misleadingly use visual representations of alterations in the human body due to illness or injury; 
• Excessively or misleadingly presents the action of the medicine in the human body; 
• Would refer to certificates of healing;
• Would insist on the fact that the medicine has received a marketing authorisation or has been registered; 
• Would include offers of bonuses, objects or products of any kind or direct or indirect material benefits of any kind whatsoever.

5.2 Medical devices

Only medical devices that have a CE marking may be advertised.

• Reimbursed medical devices

In principle, advertisement to the general public of medical devices reimbursed, even partially, by compulsory health insurance schemes is prohibited.

However, by way of exception, advertising to the general public of reimbursed medical devices posing a low risk to human health (classes I and II,a) is authorised.

• Non-reimbursed medical devices

The advertising to the general public of non-reimbursed medical devices is authorised and subject to ex-post control.

However, advertising of certain medical devices posing a significant risk to human health is subject to prior authorisation by the ANSM.

• Prohibited statements

Advertising must not be misleading or pose a risk to public health.

In addition to the mandatory information that must be included in advertisements intended for the general public (see section 8 hereunder), an advertisement for a medical device (reimbursed or not) may not contain any of the elements listed hereabove for medicines in section 5.a.

• In vitro diagnostic medical devices

Advertising to the general public of in vitro diagnostic medical devices is authorised and subject to ex-post control. 

Nonetheless, advertising of in vitro diagnostic medical devices whose failure is likely to cause a serious health risk is subject to prior authorisation by the ANSM.

Only in vitro diagnostic medical devices that have received a certificate attesting their performance and compliance with essential requirements concerning the safety and health of patients, users and third parties (e. g. CE marking) may be advertised.

Advertising must not be misleading or pose a risk to public health.

In addition to the mandatory information that must be included in advertisements intended for the general public, an advertisement for an in vitro diagnostic medical device may not contain any element that:

• Makes medical consultation or surgery appear superfluous, in particular by offering a diagnosis by correspondence;
• Suggests that a normal state of health can be improved by the use of the in vitro diagnostic medical device;
• Suggests that a normal state of health may be affected if the in vitro diagnostic medical device is not used;
• Would be directed exclusively or mainly at children;
• Would refer to a recommendation from scientists, health professionals or persons who, although not scientists or health professionals, may, by their reputation, encourage the use of in vitro diagnostic medical devices;
• Could lead, through a detailed description of symptoms, to false self-diagnosis;
• Abusively, frighteningly or misleadingly uses visual representations of alterations in the human body due to illness, injury or disability;
• Would refer to certificates of healing;
• Insists that the in vitro diagnostic medical device has been certified;
• Would include offers of bonuses, items or products of any kind or direct or indirect material benefits of any kind.

6.1 Medicines

Advertising to HCPs for medicines or above-mentioned vaccine advertising campaigns is authorised but subject to prior authorisation by the ANSM (see section 3 hereabove).

Advertising may not mention the position taken with regard to a medicine by an administrative or advisory authority in a manner likely to alter the meaning or objectivity of that position.

Free samples of medicines may be given to persons authorised to prescribe or dispense medicines in in-house pharmacies but only at their request (and only for some products and in limited quantities).

These samples may not contain substances classified as psychotropic or narcotic drugs, or to which the regulation of narcotic drugs is applied in whole or in part.

They must be identical to the pharmaceutical specialties concerned and marked: “free sample”.

6.2 Medical devices

Advertising to HCPs of medical devices and in vitro diagnostic medical devices is authorised and subject to ex-post control. 

Nonetheless, advertising of medical devices and in vitro diagnostic medical devices whose failure is likely to cause a serious health risk is subject to prior authorisation by the ANSM.

Information contained in an advertisement shall be, readable, accurate, up-to-date, verifiable and sufficiently complete to enable the HCP to (i) form a personal opinion as to the therapeutic value of the medicine or (ii) appraise the characteristics and performance of the medical device. The advertisement shall indicate the date on which it was established or last revised. 

7.1 Medicines

The advertisement shall notably indicate (CSP, art. R.5122-8):

• The name of the medicine;
• The MA or registration numbers;
• Essential pharmacological properties in view of therapeutic indications;
• Therapeutic indications and contraindications;
• Method of administration;
• Dosage;
• Adverse effects;
• Special warnings and precautions for use;
• Drug interactions and other interactions;
• The limit price for sales to the public if such a price is fixed in accordance with laws and regulations in force, accompanied, in this case, by the cost of daily treatment;
• The situation of the medicine with regard to reimbursement by health insurance bodies or approval by public bodies;
• Specific mentions in case of generic medicines.

7.2 Medical devices

The advertisement shall notably indicate (CSP, art. R.5213-2):

• The commercial name or reference;
• The use, as well as the characteristics and performance claimed for such use;
• The medical device class;
• Essential information for proper use;
• An express invitation to read carefully the instructions displayed in the package leaflet or on the label given to the HCP;
• The situation with regard to reimbursement by health insurance bodies.

The advertisement shall be designed so as to render the advertising nature of the message obvious and the medicine/medical device clearly identified.

8.1 Medicines (CSP, art. R. 5122-3 and seq.)

The advertisement shall notably include the following information:

• The name of the medicine;
• The international non-proprietary name (INN);
• Essential information for proper use;
• An express invitation to read carefully the instructions on the package leaflet or on the outer packaging;
• A caution message, a reference to the advice of a pharmacist and, in the event of persistent symptoms, an invitation to consult a doctor;
• Specific mentions are to be displayed for generic medicines;
• Specific rules apply to radio advertising.

Please note that there are also elements which are prohibited from appearing in an advertisement for medicines (see section 5 hereabove).

8.2 Medical devices (CSP, art. R.5213-1)

The advertisement shall be designed so as to enable the GP to understand the use for which the medical device is intended.

The advertisement shall specify the date on which it was established or of its last modification and shall notably contain the following mentions:

• The name or commercial reference of the medical device;
• The intended use of the medical device;
• Essential information for proper use;
• An express invitation to read carefully the instructions in the package leaflet or on the labelling given to the end user;
• Depending on the degree of risk for human health, a message of caution and a reference to the advice of an HCP or any other competent professional;
• The following notice: “Ce dispositif médical est un produit de santé réglementé qui porte, au titre de cette réglementation, le marquage CE”.

Please note that, as for medicines, there are also elements which are prohibited from appearing in an advertisement for medical devices (see section 5 hereabove).

As a general rule, any quotation, table or other illustration from medical journals or scientific work used in an advertisement shall be faithfully reproduced and indicate the exact source.

The ANSM has issued additional guidelines which notably state (Recomm. ANSM, “Axe de communication”, “Source de données”…):

• Studies which may be used are those published in a peer-reviewed journal, carried out under the conditions of use of the medicine defined by the product’s MA and other existing standards.
• Unpublished studies may be used if they result from the MA file and are in accordance with the wording of the MA.
• The use of a clinical study in an advertisement shall be focused primarily on the results of the main criteria. The results of the secondary criteria may only be presented together with those of the primary criteria and provided that they have been published in the original article or abstract.
• If the main focus of an advertisement is about the effects of a medicine on a sub-population of patients, such communication is only acceptable if based on the results of clinical studies which are correct from a methodological standpoint and allow to make such an assertion.
• Explanatory studies are the most likely to underlie effectiveness or safety, particularly in comparative advertising. They must be prospective, controlled, randomised and, if possible, conducted blindly.
• The use of rigorous meta-analysis results is accepted.

With regard to referencing, any precise statement (excluding the technical characteristics of the device) shall be documented by a complete bibliographical reference clearly indicated.

In addition to general provisions of French Consumer law, specific rules such as those mentioned below are applicable to the advertisement of medicines and medical devices:

• Advertisements directed to GP:
  • It shall not suggest that the effect of a medicine or medical device is better or equal to that of another treatment, medicine or medical device. Thus, a comparison cannot be made as to the pharmaceutical qualities of the medicine or medical device but solely as to the economic aspects.
• Advertisements directed to HCPs:
  • It may concern two or more products, under their brand name or under their INN when the brand is identifiable, provided that they are from the same pharmaco-therapeutic class or, at least, have the same therapeutic purpose.
  • The comparison shall be as exhaustive as possible without focusing exclusively on favourable elements. It shall cover essential, significant, relevant and verifiable characteristics. At a minimum, the criteria of effectiveness and safety shall be included.
• Price comparison is possible, but comparison of treatment cost is more relevant. Price shall never be the sole criterion of comparison (except for generics). (Recomm. ANSM, Publicié comparative).

The Charter for Communication and Promotion of Health Products (Medicines and Medical Devices) on the Internet and e-Media published by the ANSM sets out the main principles applicable to advertisement on the internet /in social media.

Firstly, it is to be noted that the general rules applicable to advertisement are applicable.

Specific rules come in addition to such general framework and, for instance:

• Websites shall clearly distinguish promotional pages from institutional pages;
• Any operator who implements a discussion forum shall implement true discussion moderation services;
• The promotion of health products on open social networks is forbidden unless such networks allow to moderate the internet users’ comments and to deactivate certain modalities (e.g. “like”);
• Advertisements reserved to HCPs shall be displayed on sites that can only be accessed by HCP.

The downloading of mobile health applications on public platforms is not possible unless such applications allow to moderate the users’ comments and to deactivate certain modalities (i.e. comment, notation, recommendation of the application…).

The main body which supervises compliance with advertisement provisions is the ANSM.

12.1 Medicines

The main criminal and financial sanctions applicable in case of violation of advertisement regulations are the following:

Criminal penalties (CSP, art. L. 5422-3 and seq.):

Any advertising which has not obtained the visa or which is carried out in spite of its suspension or withdrawal is punishable by one year of imprisonment and a fine of € 150,000.

Any advertising to the GP of a medicine (i) requiring a  medical prescription, (ii) refundable by mandatory health insurance plans, or (iii) which authorisation or registration contains restrictions on advertising to the public because of a possible risk to public health is also punishable by one year's imprisonment and a fine of €150,000.

Additional penalties (such as the closing of the establishment) may also be applied.

Financial sanctions (CSP, art. L. 5471‑1 and L.5471-2.):

The ANSM may also apply financial sanctions in case of violation of general principles governing publicity (i.e. advertisement for a medicine which does not have an MA, advertisement towards GP for a medicine subject to medical prescription, advertisement towards GP or HCPs for a medicine which did not obtain a visa…).

The maximum sanction is of (i) 30% of the turnover achieved during the last closed financial year for the product(s) concerned, up to a maximum of € 1,000,000 for a legal entity and (ii) € 150,000 for a natural person. Such sanction may be accompanied by a daily penalty of up to € 2,500 per day.

Such sanctions are subject to a contradictory procedure and may be published on the Internet. They may be combined with criminal fines but, in such case, the total amount of the fine and financial sanction cannot exceed the higher maximum legal applicable amount.

Financial penalties may also be applied by the Economic Committee on Health Products (CEPS) in specific cases.

12.2 Medical devices

Criminal penalties (CSP, art L.5461-6):

The diffusion or creation of an advertisement regarding a medical device subject to prior authorisation when the ANSM did not deliver, refused to deliver, suspended or withdraw such authorisation is punishable by 1 year of imprisonment and a fine of € 150,000. Complementary penalties may be imposed.

Financial sanctions (CSP, art. L.5461-9):

The ANSM may also apply financial sanctions in various situations: advertisement to GP for medical devices reimbursed by health insurance mandatory regimes, advertisement for medical devices subject to prior authorisation but for which no such authorisation has been obtained… The same sanctions and upper limits apply as for medicines (CSP, art. L.5471-1).

Financial penalties may also be applied by the CEPS in specific cases.

EU medical device regulation 2017/745.

Such regulation should have been applicable from May 26th, 2020. Nevertheless, to allow EU countries and their authorities/institutions to give priority to the fight against the coronavirus pandemic, the entry into force of some provisions of this regulation has been postponed for one year (regulation (EU) 2020/561) and will solely be applicable as from May 26th, 2021.