France: Pharmaceutical Advertising

The rules governing advertising on medicines are laid down in the Public Health Code (PHC), Articles L.5122-1 and seq. and R.5122-1 and seq. (other legal provisions apply to medical devices which are not considered here).

In addition to the legal provisions that are specific to medicines, the general legal provisions governing unfair commercial practices, notably false advertising, apply. These are laid down in the Consumer Code.

Various guidelines and self-regulations frame the advertising of medicines. They are of different natures: some are recommendations of authorities, applicable to any company, other are self-regulatory rules applicable only to members of given industry bodies.

a. If there are any such codes, to whom do they apply (companies, or healthcare professionals, for example)?

i) Guidelines of the French Medicines Agency (ANSM):

The French Medicines Agency (herein after the “ANSM”), published recommendations on advertisement of medicinal products directed towards healthcare professionals¹ and to the general public², available on its website. Among the recommendations relating to advertisement towards the general public, there is notably a “Charter concerning communication and promotion of health products (medicines and medical devices) on the Internet and in the electronic media³”.

These recommendations are applicable in principle to any company advertising medicines.

ii) Self-regulation by the industry:

The LEEM (Les Entreprises du Médicament – the French professional organization of the drug companies) has its own ethical conduct rules applicable to its members gathered in the set of provisions entitled “Dispositions Déontologiques Professionnelles ⁴” (in English: Professional Ethical Provisions). These include rules governing the advertising of medicines, notably the EFPIA Code of Practice5 as well as the “Charter relating to information by canvassing or prospection aiming to the promotion of medicinal products⁶” signed between LEEM and the the Economic Committee for Health Products (“CEPS”).

iii) Agreements between the industry and the Economic Committee for Health Products (CEPS):

A “Charter relating to information by canvassing or prospection aiming to the promotion of medicinal products ⁷” has been signed between the LEEM and the CEPS, the Economic Committee for Health Products.

b. What is the legal status of the self-regulatory codes?

i) Guidelines of the French Medicines Agency:

The ANSM is a public entity placed under the supervision of the Ministry of Health. Its recommendations do not have a legal force but are very useful guidelines since authorities and courts do take them into account in their decisions.

ii) Self-regulation by the industry:

The ethical rules of the LEEM are of self-regulatory nature and do not have a legal force. They are binding on the LEEM members. The CODEEM (Comité de déontovigilance des entreprises du médicament), the ethical vigilance committee of the LEEM, is in charge of monitoring the implementation of these ethical rules and can pronounce sanctions in case of non-compliance by LEEM members. These rules also serve as good practice standards for non LEEM members companies.

iii) Agreements between the industry and the Economic Committee for Health Products (hereinafter CEPS):

The “Charter relating to information by canvassing or prospection aiming to the promotion of medicinal products ” signed between the LEEM and the CEPS is aimed to frame commercial and promotional practices.

On the basis of this Charter and in accordance with Article L.162-17-8 of the French Social Security Code, the CEPS has the power to set annual quantified objectives concerning promotional practices.

Failure to comply with the objectives set by the CEPS may result in financial penalties

Footnotes

1. https://www.ansm.sante.fr/Activites/Publicite-pour-les-medicaments/Recommandations-pour-la-publicite-aupres-des-professionnels-de-sante/(offset)/3

2. https://www.ansm.sante.fr/Activites/Publicite-pour-les-medicaments/Recommandations-pour-la-publicite-aupres-du-grand-public/(offset)/4

3. Charter on the communication and promotion of health products (medicines and medical devices) on the Internet and e-media : https://ansm.sante.fr/var/ansm_site/storage/original/application/f0175469fbeb1ea62b6e648a88b67fde.pdf

4. « Rules governing professional ethics applicable to pharmaceutical companies members of LEEM”, December 2019 : https://www.LEEM.org/sites/default/files/2020-02/20%2001%2013%20-%20DDP%20MAJ%20déc%202019%20-%20nouvelle%20charte%20graphique%20-%20modif%20page%20sommaire%20sans%20modification%20apparente%20vf%20ALLONGEMENT%20DELAI%20MSL.pdf

5. The EFPIA Code of Practice : https://www.efpia.eu/media/413022/efpia-code-2019.pdf

6. Charter on information obtained by canvassing or canvassing for the promotion of medicinal products, https://solidarites-sante.gouv.fr/ministere/acteurs/instances-rattachees/article/charte-de-l-information-promotionnelle

7. Ibid.

“Advertising of medicinal products” has a legal definition under Article L.5122-1 PHC – essentially the same as in Article 86 of EU Directive 2001/83 – as “any form of information, including door to door information, canvassing or inducement, designed to promote the prescription, supply, sale or consumption of medicinal products”.

a. What does the definition cover? – does it include patient information leaflets, for example, catalogues, disease awareness campaigns or correspondence, for example?

Anything falling within the broad definition of Article L.5122-1 PHC may constitute advertising regardless of the medium.

There are some exclusions listed in the same Article, which are the following (essentially the same exclusions as in Article 86 of the EU Directive):

• information provided, in the framework of their functions, by pharmacists managing hospital pharmacies;
• 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 pack changes, adverse-reaction warnings as part of general medecine precautions, trade catalogues and price lists, provided they include no product claims;
• information relating to human health or diseases, provided that there is no reference, even indirectly, to medicinal products.

Article R.5124-76 PHC also excludes informative documents, of scientific, technical or financial nature, prepared by a pharmaceutical company that are not designed to promote a medicinal product.

It does not include either patient information such as the labelling and the accompanying package leaflets⁸, which are subject to the provisions of Title V.

This definition includes all forms of promotion, including medical visits, sample delivery, advantages perceived by health professionals whether in kind (i.e. gifts, donations of equipment, invitations, catering costs, the payment of travel expenses) or in cash (i.e. commissions, discounts, rebates or reimbursement of expenses).

b. Does the definition apply equally to all target audiences?

The definition is the same for all target audiences.

However, the legal regime governing advertisement differ depending on whether the advertisement targets the public⁹ or healthcare professionals ¹⁰.

(i) Advertisement of medicinal products directed at the public:

Advertisement of medicinal products directed at the public is possible only for medicines not subject to prescription and that are non-reimbursable by the compulsory health insurance schemes. Prescription medicines (compulsory or facultative) as well as reimbursable products are excluded.

There is an exception with respect of vaccines and tobacco-weaning medicines which can be advertised, even if they can be prescribed or reimbursed.

Furthermore, the marketing authorization must not contain any prohibition or restriction on advertising to the public due to a possible risk to public health, in particular when the medical product is not suitable for use unless a physician is involved in the diagnosis, initiation or monitoring of the treatment.

The requirements as to the contents of the advertisement are specific depending on whether it is directed at the public or at healthcare professionals (see explanations in the sections below).

Details of the precise requirements in respect of content of such advertising are set out in Articles L5122-6 to L5122-8 and R5122-3 to R5122-7 PHC.

(ii) Advertisement of medicinal products directed at Healthcare Professionals:

Advertisement of medicinal products directed at healthcare professional should be possible for all medicines. These include requirements as to the content of such advertising, for example the requirement to include the pharmaceutical form of the medicine and its adverse reactions.

Detailed rules for advertising to healthcare professionals are set out in Articles L5122-9 to L5122-10 and R5122-8 to R5122-17 of the PHC.

Rules governing professional ethics applicable to pharmaceutical companies members of LEEM“, December 2019 p.9

Footnotes

9. Article L.5122-6 and seq. PHC

10. Article L.5122-9 and seq. PHC

Press release regarding medicines are allowed in France and should be regarded as advertisement. However, if the press release brought informative documents, of scientific, technical or financial nature, prepared by a pharmaceutical company and are not designed to promote a medicinal product, it won’t be considered as advertisement¹¹.

(i) Advertising to the general public

Provided that the advertising includes the mandatory information provided for by the Public Health Code in a legible manner under normal reading conditions, it may be carried in printed media and press announcements. There is no additional restriction further than those applying to advertisements made to the public¹².

(ii) Advertising to Healthcare Professionals

Similarly, when the advertisement includes the mandatory information, press, special issue and in-house magazine advertisements are generally allowed as advertising supports ¹³.

Footnotes

11. Article R5124-67 PHC

12. ANSM recommandation : https://www.ansm.sante.fr/Activites/Publicite-pour-les-medicaments/Recommandations-pour-la-publicite-aupres-du-grand-public/Recommandations-pour-la-publicite-aupres-du-public/Supports-publicitaires-GP-autorises-et-presentation-des-mentions-obligatoires-associees

13. ANSM recommandation: https://www.ansm.sante.fr/Activites/Publicite-pour-les-medicaments/Recommandations-pour-la-publicite-aupres-des-professionnels-de-sante/Recommandations-generales/Supports

Pharmaceutical companies must have a dedicated service in charge of advertisement, under the responsibility of the “responsible pharmacist” (“pharmacien responsable”) who is in charge of ensuring compliance with the rules governing advertisement and notably of the scientific validity of the information ¹⁴.

The company must keep a sample of all advertisements it makes during three years as of the last date of dissemination thereof and keep it available to the ANSM together with a statement indicating the addressees, the method of dissemination and the date of first dissemination¹⁵.

With respect to advertisements directed at the public, the applicant has to assign an internal reference number for all advertisement materials¹⁶ according to rules defined by a decision of the Director General of the ANSM ¹⁷. This number must be mentioned on the advertisement, except for advertisements made on radio broadcast.

Footnotes

14. Articles L5124-2 and R5122-2 PHC

15. Article R.5122-2 PHC / Art. 98 Directive

16. Article R.5122-6 PHC

17. Decision of April 25, 2013 setting the rules for the development of the internal reference number relating to advertisements for medicines and products mentioned in Articles L. 5122-14, R. 5134-11 and R. 5134-15 of the Public Health Code

Advertisement for medicinal products must be pre-approved by the ANSM ¹⁸. The approval by the ANSM is named an advertisement “visa”. Whilst previously advertising directed at health professionals did not require pre-approval, since 2012 the ANSM pre-approves all advertising for medicinal products, whether directed at the general public or healthcare professionals

The ANSM publishes each year a calendar indicating the yearly sessions during which visa applications can be filed ¹⁹. The visa is deemed granted in the absence of decision by the ANSM within two months as of the last day of the session during which the application was filed. A visa has a validity of period of two years, but cannot exceed the validity period of the marketing authorization.

The visa can be suspended or withdrawn in case of non-compliance with the applicable legal provisions ²⁰.

Footnotes

18. Articles L.5122-8 and L.5122-9 PHC, R.5122-5 to -7, R.5122-12 to -16 PHC

19. Articles R.5122-5 and R.5122-13 PHC

20. Articles L.5122-8 and -9 PHC

The ad ²¹ must not be misleading or undermine the protection of public health ²² . It must present the medicinal product objectively and promote its proper use.

However, an advertisement for a medicine to the public may not contain any element that “suggests that the effect of the medicine (…) is greater than or equal to that of any other treatment or medication. Therefore, comparative advertising to the public may not relate to the pharmaceutical qualities of the medicinal product, but only and possibly to the economic aspects ²³.

On the other hand, comparative advertising is possible for advertising addressed to healthcare professionals, and is regulated by ANSM recommendations²⁴.

Comparative advertising may concern two or more products, under their brand name, under their the international nonproprietary name where the brand is identifiable, as long as they have the same therapeutic purpose (non-drug therapy is not excluded from the scope).

Any ad comparing medicines should be based on relevant and comparable product characteristics. Also, comparative advertising must not be disparaging, misleading or exclusively favour favourable elements. It shall at least include criteria of efficacy and safety of use (elements of the risk-benefit balance), but may also include criteria of interest to the practitioner: dosage, duration of treatment, interactions, acceptability, etc.

Pursuant to Articles L122-1 et seq. of the French Consumers Code, comparative advertising is allowed but (i) shall not be misleading, (ii) shall cover products or services addressing the same need, (iii) shall objectively compare one or several relevant main features of the products/services which can be verified and which are essential to the concerned products/services.

On the other hand, when prices are unrestricted (in the case of specialities not reimbursed by social security) or negotiated (in the case of specialities for exclusively hospital use), the comparison of treatment costs serves no purpose

Footnotes

21. As defined in article L5122-1 PHC

22. Article L5122-2 PHC

23. Article R.5122-4 PH

24. ANSM recommandation https://www.ansm.sante.fr/Activites/Publicite-pour-les-medicaments/Recommandations-pour-la-publicite-aupres-des-professionnels-de-sante/Recommandations-generales/Publicite-comparative

(i) Providing information on unauthorized medicines or unauthorized indications

Only authorized medicines can be advertised, more precisely medicines that have a marketing authorization or benefit from a parallel import authorization²⁵.

Article L.5122-2 of the PHC provides that advertising must comply with the provisions of the marketing authorisation as well as the therapeutic strategies recommended by the French High Authority for Health (“Haute Autorité de Santé”). Thus, it is forbidden to anticipate the results of studies that have not yet been filed concerning possible changes to the marketing authorisation, or even during the examination by the marketing authorisation commission (properties, indications, dosage, etc.). This is the case for studies for which the indications, dosage or duration of treatment have not been validated and which cannot therefore be the subject of an advertising message²⁶.

However, information on unauthorised medicinal products or indications may be freely provided if it does not constitute advertising. The information must therefore not be intended to promote the prescription, supply, sale or consumption of medicinal products. In order to distinguish information from advertising, the criterion of “promotional intent” is decisive²⁷.

(ii) Providing information on unauthorised medicines or unauthorised indications during a scientific conference directed at healthcare professionals, or to send information to healthcare professionals

With regard to medical congresses with an independent scientific committee, or meetings organized under the aegis of scholarly societies or groups of experts mandated by them, which report on the progress of research, the publishers of the medical press publish special editions covering all or part of the work presented, in order to inform healthcare professionals.

When these special editions present data from research not approved by the French authorities, they must include a warning on the first page stating so. The publication of these special editions, and their content, is the responsibility of the publishers and their reading committee ²⁸.

These publications may contain advertising inserts (at the exclusion of advertisements for products mentioned in these documents and for which is given information outside the marketing authorisation).

The distribution of these special editions and the selection of the health care professionals who are concerned by the subject is ensured exclusively by the publishers and not repeated. Whenever articles in these special editions provide scientific information on pharmaceutical products outside of the marketing authorisation, their promotional use is prohibited (in particular through medical visit).²⁹

Footnotes

25. Article L.5122-3 PHC

26.  ANSM recommandation https://www.ansm.sante.fr/Activites/Publicite-pour-les-medicaments/Recommandations-pour-la-publicite-aupres-des-professionnels-de-sante/Recommandations-generales/Axe-de-communication

27. Art. L5122-1 CSP, commentaire sous l’article, Dalloz

28. Article 8, Editorial Advertising Charter, 2015 https://www.leem.org/sites/default/files/CHARTE%20UDA%20SPEPS%20LEEM%20r%C3%A9vis%C3%A9e%20en%202015.pdf

29. ANSM recommendation: https://www.ansm.sante.fr/Activites/Publicite-pour-les-medicaments/Recommandations-pour-la-publicite-aupres-des-professionnels-de-sante/Recommandations-generales/Reunions-et-congres

Medicines subject to medical prescription and medicines reimbursable by compulsory health insurance schemes may not be advertised to the general public (with an exception for vaccines or tobacco-weaning products).

Medicine advertising directed to the public must be designed so that the advertising character of the message is obvious and the product is clearly identified as a medicine. As a minimum, it must include the following information³⁰:

• The name of the medicinal product, as well as its common name;
• Essential information for the proper use of the medicine;
• An express invitation to read carefully the instructions on the leaflet or on the outer packaging, as the case may be;
• A cautionary warning, a recommendation to seek medical advice from a pharmacist and, if symptoms persist, an invitation to consult a physician;
• For a generic speciality, the indication of this status and, if the generic group to which the speciality belongs includes one or more reference specialities, the indication: “This speciality is a generic of”, followed by the name of the reference speciality or specialities, their dosage and their pharmaceutical form. In such case, the advertisement also includes the statement: “Medicine listed in the generics register. At the time of substitution, consult the list of excipients of known effect on the packaging as well as the generics directory to find out about any warnings that may exist.”

For an ad on a radio broadcast, the mention of the international nonproprietary name is only required when the medicine contains no more than two active ingredients. For generics it is not necessary to refer to the active ingredient, however the mention that the speciality is generic is required.

Furthermore, an advertisement for a medicinal product to the public may not contain any element that³¹:

1° Would make medical consultation or surgery appear unnecessary, in particular by offering a diagnosis or recommending treatment by correspondence;

2° Would suggest that the effectiveness of the medicine is guaranteed, is free of adverse effects, or is greater than or equal to that of another treatment or medicine;

3° Would suggest that a normal state of health can be improved by the use of the medicine;

4° 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 medicinal products mentioned in the third paragraph of Article L. 5122-6;

5° Would be targeted exclusively or primarily at children;

6° Would reference a recommendation from scientists, health professionals or persons who, although neither scientists nor health professionals, may, by their reputation, encourage the consumption of the medicinal product concerned;

7° Would assimilate the medicinal product to food, cosmetics or another consumer product;

8° Would suggest that the safety or efficacy of the medicine is due to the fact that it contains a natural substance;

9° Could lead, through a detailed description of symptoms, to a false self-diagnosis;

10° Would misuse frightening or misleading visual representations of changes to the human body due to disease or injury;

11° Would excessively or deceptively depict the action of the drug in the medicine;

12° Would reference certificates of recovery;

13° Emphasise that the medicinal product has received a marketing authorisation or has been the subject of a registration;

14° Contain offers of bonuses, objects or products of any kind or direct or indirect material benefits of any kind.»

Footnotes

30. Article R.5122-3 PHC

31. Article R.5122-4 PHC

The provisions of the “anti-gift law”³² apply. Specifically, they require transparency of the ties between the health industries and other players in the health field, in particular patients’ associations (but also healthcare professionals, students training to become healthcare professionals or associations regrouping healthcare professionals or students).

All agreements concluded with patients’ associations must be made public through their publication on the public database “Transparency – Health”. The same is true for all benefits in kind or in cash that companies would provide, directly or indirectly, to associations (i.e. for any benefit whose amount is equal to or greater than €10, including all taxes pursuant to article D.1453-1 of the PHC33).

Furthermore, the subject is addressed in the LEEM’s rules governing professional ethics, which include a section on relations with patient associations ³⁴ is notably forbidden for the pharmaceutical industry to request, and for patient associations to promote, any medicine subject to compulsory prescription.

The objectives and scope of any partnership between patient organisations and the pharmaceutical industry should be transparent. The financial and non-financial support provided by the pharmaceutical industry should always be clearly known and whatever they are, they should have been the subject of a written agreement specifying the amount of funding and its purpose or, where appropriate, include a description of any significant indirect support or non-financial support. Each drug company is expected to have an approval process in place for such agreements.

A drug company may not publicly use a patient organization’s logo and/or branded materials without the written permission of such patient organization. It should also not seek to influence the language of the materials of the patient organisations it funds in a way that would be favourable to its own commercial interests.

Each company must publish a list of patient organisations to which it provides financial support and/or significant indirect/non-financial support, together with a brief description of the nature of the support.

Concerning events and hospitality, all events subsidised or organised by or on behalf of a company must take place in an appropriate location (i.e. it must be in line with the objective and purpose of the event). All forms of hospitality provided by the pharmaceutical industry to patient organisations and their members must be reasonable. Extended hospitality, depending on the event, should be limited to transport, meals, accommodation and registration fees.

In principle, the company will not be able to organise or subsidise an event that takes place outside its own country.

Footnotes

32. Article L.1453-1 et seq. of the PHC

33. Transparency – Health database: https://www.transparence.sante.gouv.fr

34. Professional Ethics Provisions (page 39-42) – LEEM December 2019)

Advertising of a medicine to healthcare professionals must always be in accordance with the marketing authorization. It must contain information that is accurate, up-to-date, verifiable and sufficiently complete to allow the recipient to form a personal opinion regarding the therapeutic

value of the medicine ³⁵. It must specify the date on which it was last established or revised and include at least the following information³⁶:

1. The name of the medicine;

2. The name and address of the company exploiting the medicine;

3. The pharmaceutical form of the medicine;

4. The qualitative and quantitative composition of the active ingredients, with the common name, and the constituents of the excipient, whose knowledge is necessary for the proper administration of the medicinal product;

5. The marketing authorization or registration numbers;

6. Essential pharmacological properties with regard to therapeutic indications;

7. Therapeutic indications and contraindications;

8. The method of administration and, if appropriate, the route of administration;

9. The dosage;

10. The adverse effects;

11. Special warnings and special precautions of use;

12. Medicine and other interactions;

13. The classification of the medicinal product in terms of prescription and delivery mentioned in the marketing authorization;

14. The limit selling price to the public when such a price is determined in application of the laws and regulations in force, accompanied, in such case, by the cost of the daily treatment;

15. The situation of the medicinal product with regard to reimbursement by health insurance organisations or approval for public authorities provided for in article L. 5123-2 of the PHC;

16. For a generic speciality, the indication of this status and, if the generic group to which the speciality belongs includes one or more reference specialities, the indication: “This speciality is a generic of”, followed by the name of the reference speciality or specialities, their dosage and their pharmaceutical form. In such case, the advertisement also includes the statement: “Medicine listed in the generics register. At the time of substitution, consult the list of excipients of known effect on the packaging.” However, for an advertisement on a radio broadcast medium, only the statement that the product is generic is required.”

ANSM’s recommendations only require the following information to be included in the advertising document ³⁷ :

1. Name, common name(s);

2. Indication and, where appropriate, inclusion in the therapeutic strategy in accordance with the procedures described in the recommendation then in force;

3. Safety data as described in the recommendation in force;

4. Prescribing and dispensing conditions;

5. Status of the medicine with regard to reimbursement by health insurance organizations or approval for public authorities provided for in Article L. 5123-2 of the PHC.

The other information provided for in Article R.5122-8 of the PHC may be made available via a cross-reference to the product information sheet of the public database of medicinal products ³⁸

Any written mention must be perfectly legible³⁹. According to the recommendations of the ANSM, these entries must comply with six essential criteria to ensure good legibility: the background, characters adapted and contrasted in relation to the background, the highlighting of titles, headings and key words, the absence of breaks in titles, the arrangement of compulsory information in the reading direction, the size of the characters, which may not be less than 7 Didot points or 8 pica points (known as ‘8 point font’) for printed documents.

Furthermore, quotations, tables and other illustrations borrowed from medical journals or scientific books, used in advertising, must be faithfully reproduced and the exact source must be indicated⁴⁰.

It is not appropriate ⁴¹ to include in an advertisement for a medicinal product information relating to physiological or pathological conditions which would contraindicate the use of the advertised medicinal product.

It is permissible to use clinical studies as long as they have been published in a peer-reviewed journal, carried out under the conditions of use of the medicinal product as defined in the product’s marketing authorisation and other existing reference documents (according to an opinion of the Transparency Commission, recommendations of good practice),⁴². Communication must focus primarily on the results of the study’s primary rather than secondary criteria. Unpublished studies that may be used are:

• those from the marketing authorisation documentation which are in accordance with the wording of the marketing authorisation;
• and, where appropriate, those selected for the elaboration of the opinion of the Transparency Commission and which are in accordance with the conclusions of the Transparency Commission.

It must be possible to make these studies available to any practitioner who so requests. However, the presentation in an advertisement of an ongoing or future clinical study on one or more medicinal products is not acceptable⁴³.

Where a medicinal product is subject to restricted prescribing conditions, advertising may be carried out only to prescribers authorised to draw up prescriptions and pharmacists practising in structures likely to dispense the medicinal product⁴⁴.

Footnotes

36. Article R.5122-8 PHC

37. ANSM recommandation https://www.ansm.sante.fr/Activites/Publicite-pour-les-medicaments/Recommandations-pour-la-publicite-aupres-des-professionnels-de-sante/Recommandations-generales/Mentions-obligatoires

38. http://base-donnees-publique.medicaments.gouv.fr

41. ANSM recommandation https://www.ansm.sante.fr/Activites/Publicite-pour-les-medicaments/Recommandations-pour-la-publicite-aupres-des-professionnels-de-sante/Recommandations-generales/Axe-de-communication

42. ANSM recommandation https://www.ansm.sante.fr/Activites/Publicite-pour-les-medicaments/Recommandations-pour-la-publicite-aupres-des-professionnels-de-sante/Recommandations-generales/Source-de-donnees

43. ANSM recommandation https://www.ansm.sante.fr/Activites/Publicite-pour-les-medicaments/Recommandations-pour-la-publicite-aupres-des-professionnels-de-sante/Recommandations-generales/Etude-clinique-en-cours

44. Article R.5122-10 PHC

The regulatory framework governing transfers of value to HCPs is commonly named “anti-gift” regime. Pursuant to articles L. 1453-3 et seq. of the CSP, no gift, pecuniary benefit or benefit in kind of any value whatsoever may be granted, offered or promised to a healthcare professional by the pharmaceutical industry⁴⁵. There are however some derogations.

1) Article L.1453-6 of the PHC provides that the following do not constitute prohibited transfers of value:

• Remuneration, compensation and payment of expenses for activities provided for in an employment contract or a contract of practice;
• Proceeds from the exploitation or transfer of intellectual property rights relating to a health product;
• Commercial benefits offered under the agreements governed by Articles L. 441-3 and L. 441-9 of the French Commercial Code and whose purpose is the purchase of goods or services.
• Benefits in cash or in kind relating to the exercise of the beneficiary’s profession and of negligible value, which may not exceed the amounts provided for, by type of benefit and over a specified period, by order of the ministers responsible for the economy and health.

2) Transfers of value of negligible value remain possible. A regulation(“arrêté”) has been published on August 7th, 2020⁴⁶. It specifies the ceilings under which some categories of advantages in kind or in cash are considered to be of negligible value, and thus fall out of the scope of the “anti-gift” regime. It sets both the maximum amounts for such benefits and the maximum frequency per calendar year. Otherwise, such benefits are prohibited:

• unplanned meals and snacks related to the recipient’s professional occupation: 30€ within the limit of two occurrences per calendar year;
• book, publication or magazine, including subscription, relating to the professional occupation of the beneficiary: 30 € per book, publication or magazine and within a total limit, including subscriptions, of 150 € per calendar year.
• Sample of health products for health purposes or demonstration sample: 20€ within the limit of three per calendar year.

As a derogation the following samples of health products for health purposes and demonstration samples are authorized without a limitation of their amount:

• samples of medicinal products the supply of which is governed by articles L. 5122-10 and R. 5122-17 PHC
• samples and demonstration samples supplied for educational or training purposes to the healthcare professional and that cannot be used for the patient’s care
• samples and demonstration samples used by the healthcare professional for educational purposes with the patient or given to the patient exclusively for the purpose of testing or adaptation to the product and for temporary use.
• office supplies: 20€ in total per calendar year
• other product or service related to the professional occupation of the beneficiary’s profession: 20€ in total per calendar year.

As a derogation, products whose supply to professionals is requested by a public authority are authorized without a limitation of their amount.

Furthermore, certain transfers of value are subject to derogations, the terms and conditions of which are set out in Articles L1453-7 et seq. of the PHC. These include in particular:

• remuneration, compensation and reimbursement of expenses for research, exploitation of research, scientific evaluation, consultancy, services or commercial promotion, provided that the remuneration is proportionate to the service rendered and that the compensation or reimbursement does not exceed the costs actually incurred by the beneficiaries of the advantage;
• donations and gifts, whether in cash or in kind, intended exclusively to finance research, the promotion of research or scientific evaluation activities;
• donations and gifts intended for associations of professionals and students subject to the prohibition on receiving benefits, including those involved in the training of such persons, and in particular for scholarly societies and national professional councils, with the exception of associations whose purpose is unrelated to their professional activity ;
• hospitality offered, directly or indirectly, during events that are exclusively of a professional or scientific nature, or during events promoting health products II of Article L. 5311-1 of the Public Health Code or health services, provided that this hospitality is of a reasonable level, strictly limited to the main purpose of the event and is not extended to other persons;
• financing or participation in the financing of professional training or continuing professional development programmes.

These transfers of value must be declared to the competent authorities – the National Boards of the HCPs concerned (conseil national de l’Ordre) or ARS depending on the HCPs concerned -depending on the amounts at stake (see details below). They must be framed by a written agreement meeting the requirements set out in the PHC.

Non-compliance with these rules is subject to criminal sanctions.

All benefits in kind or in cash that companies would provide, directly or indirectly, to healthcare professionals, the amount of which is equal to or greater than €10, all taxes included, must be made public via the public database “Transparency – Health” (article D.1453-1 of the PHC), ⁴⁷.(see below concerning the transparency obligations).

Footnotes

45. Rules governing professional ethics (1.2.2.1. Prohibition of gifts – page 15) – LEEM December 2019):

46. https://www.legifrance.gouv.fr/jorf/id/JORFTEXT000042234007/

47. Transparency – Health database: https://www.transparence.sante.gouv.fr

In accordance with article L. 5122-10 of the PHC, complimentary samples of medication may only be given to health professionals at their request. These samples may not contain substances classified as psychotropic or narcotic, they must be identical to the pharmaceutical specialities concerned and bear the wording: “free sample”.

They may not be handed over in areas accessible to the public during medical or pharmaceutical congresses.

Furthermore, only new medicines may be subject to the submission of samples during the two years following the first actual marketing⁴⁸. In addition, the submission of samples must comply with the following conditions:

• each supply of samples must be in response to a written, dated and signed request from the recipient;
• only a limited number of samples, up to a maximum of four per year and per recipient, may be submitted, depending on the nature of the medicinal product and the need for the prescriber to become familiar with it;
• each sample must be identical to the smallest package on the market;
• each pharmaceutical establishment supplying samples must organise within its own organisation the control of this supply and the follow-up of the samples; and
• each sample must be accompanied by a copy of the summary of product characteristics.

In addition, the medical sales representative charter⁴⁹ specifies that the handing over of medical samples by medical sales representatives is prohibited. Failure to comply with these rules is punishable by criminal sanctions.

Footnotes

48. Article R.5122-17 PHC

49. Charter on information obtained by canvassing or canvassing for the promotion of medicinal products

(i) With regard to meetings or congresses organized/sponsored /hosted on behalf of a company

LEEM’s rules governing professional ethics⁵⁰ requires that the drug companies shall only act as a sponsor or participate in such events on the following cumulative conditions:

• The programme, in its presentation, its execution and its agenda, has a real scientific purpose;
• A preliminary version of the program is available and accessible 6 months before the congress and the final version at least 1 month before;
• The scientific sessions must not be of a promotional nature and must be placed under the supervision of the independent scientific committee (steering committee) of the congress;
• If sessions are to be sponsored by drug companies, this sponsorship should be explicitly identified in the programme; and;
• Speakers, when addressing the public, must publicly declare their ties of interest

ii) With regard to the sponsorship of HCP’s participation in such meetings or congresses

The “anti-gift” rules governing transfers of value apply (see question 12 above). The term “hospitality” covers transfers of value relating to invitation to events, including the payment of accommodation, travel and catering costs, as well as congress registration fees, in the context of promotional events or events of an exclusively professional and scientific nature.

Hospitality offered, directly or indirectly, during events of an exclusively professional or scientific nature, or during events dedicated to the promotion of products or services is authorised pursuant to article L.1453-7 of the PHC provided such hospitality remains reasonable, strictly limited to the main objective of the event and is not extended to ancillary persons. This hospitality, as any transfer of value under the anti-gift regime (see above) must be the subject-matter of an agreement between the company and the healthcare professional, and shall be the subject of a declaration or authorisation, depending on the amount at stake, to the relevant administrative authority or professional order ⁵¹.

The regulatory provisions (“arrêté”) specifying the thresholds above which an authorization is required have been published on August 14th, 2020⁵². Concerning hospitality, the amounts above which an authorization is required are the following:

• 50 € for a meal,
• 15 € for a break,
• 150 € for a hotel night,
• 2.000 € as a total hospitality per invitation (including the meals, breaks, hotel nights and transportation),
• – up to 1.000 € for the registration fees, in addition to the other above mentioned disbursements.

Hospitality towards students training to become HCPs is absolutely prohibited: there is no derogation for them.

Furthermore, under the transparency provisions of the PHC⁵³, all agreements concluded with HCPs must be disclosed on the Transparency.gouv website (see below).

The rules governing professional ethics provide that: “The reasonableness of hospitality is appreciated according to the main objective of the event, which must remain exclusively professional and cannot be quantified or calculated, its appreciation being multifactorial. The following are thus considered:

• the medical relevance of the event,
• the suitability of the invited health professionals,
• the type and extent of benefits provided and paid for in whole or in part (transport, hotels, restaurants), and
• the programme timetable during the event, the topics covered and the medical and scientific content”.

Reasonableness is also appreciated in view of the positions taken by the competent regulatory bodies or administrative authorities pursuant to the provisions of Articles L.1453-3 et seq. of the Public Health Code, particularly with regard to the recommendations they may make, the authorisations or refusals of authorisation issued or the report they publish every two years.

Furthermore:

• The duration of hospitality must be strictly limited to the duration of the scientific event.
• The terms and conditions for the sponsorship of these events are limited to all or part of the expenses relating to transport, meals, accommodation and registration fees.
• Sponsorship can only be offered to healthcare professionals who are eligible to be registered as full participants.
• The extent of the expenses covered for healthcare professionals must be “reasonable” and strictly related to the main objective of the event. It must not exceed what the healthcare professionals would normally have been willing to pay for themselves had they borne the cost. Meals, including drinks, offered in this setting may not exceed sixty (60) euros (inclusive of tax).
• Pursuant to the conditions provided for by the applicable legal or regulatory provisions, it is prohibited to grant any form of direct or indirect hospitality to students in initial training who are seeking to practise one of the health professions referred to in 1° of Article L. 1453-4 of the Public Health Code”.

(iii) Concerning events taking place abroad

The LEEM rules governing professional ethics⁵⁴ provide that a company may not organize or sponsor an event that takes place outside its country of incorporation unless:

• most of the guests are coming from a country different from the country where the company is incorporated; or
• given the geographical location of the relevant resources or expertise that are the object or subject of the event, it makes more sense, from a logistical point of view, to organise the event in another country (an “international event”).

Footnotes

50. Professional Ethics Provisions (page 13-14) – LEEM December 2019

51. Articles L.1453-8 and L.1453-9 PHC

52. https://www.legifrance.gouv.fr/jorf/id/JORFTEXT000042234024/

53. Articles R.1453-2 et seq. PHC

54. Ibid

The organisation of events of a cultural, sporting or other than scientific nature by the pharmaceutical industry is prohibited ⁵⁵.

These events must be exclusively scientific. The rules governing professional ethics ⁵⁶ specifies that the programme of the planned event, both in its presentation and in its schedule, must clearly indicate a genuine scientific purpose. Consequently, the non-scientific part of the programme must be reduced to the strict minimum.

Indeed, “drug companies should not sponsor or organise entertainment (e.g. sports or leisure events). They must avoid the use of venues that are renowned for their leisure facilities or that are sumptuous or eccentric. Companies must not finance meals and elements of the ostentatious or festive programme offered by the organiser to the participants (e.g. gala dinner, concert, etc.). On the other hand, they may finance the elements of social conviviality intrinsic to the Events (meals for session chairmen, members of the independent scientific committee, reviewers of the work submitted, coffee breaks) provided that these are not of an ostentatious, festive or sumptuous nature.

Footnotes

55. Professional Ethics Provisions (page 13-14) – LEEM December 2019 :

56. Professional Ethics Provisions (page 13-14) – LEEM December 2019 :

Payment for services fall under the “anti-gift” provisions (see question 12 above).

Transfers of value corresponding to remuneration, compensation and expenses for research activities, research valorization, scientific evaluation, consulting, provision of services or commercial promotion, are allowed provided that the remuneration is proportionate to the service rendered and that the compensation or expenses do not exceed the costs actually borne by the persons.

They must be declared to or authorized by the competent authorities – National Board (Conseil national de l’Ordre) or ARS – of the concerned professional.

They must be laid down in an agreement between the company and the concerned professional⁵⁷.

The amounts determining whether a declaration suffices or whether an authorization is necessary are specified by a regulation (“arrêté”) of August 7, 2020.

Concerning the remuneration, compensation and disbursements for activities corresponding to research, research valuation, scientific evaluation, consultancy, services or commercial promotion, the thresholds have been set but are different given the considered persons:

• For healthcare professionals, the hourly rate is 200€, 800€ for half a day, and a global amount of 2.000€ for the whole contract. Beyond that the agreement is subject to authorization.
• For students wishing to become health professionals, the hourly rate is 80€, 320€ for half a day, and 800€ for the whole contract. Beyond that the agreement is subject to authorization.
• For associations bringing together healthcare professionals or students, the hourly rate is 200€, 800€ for half a day and 2,000€ for the whole contract. Beyond that, the agreement is subject to authorization.

Over these amounts an authorization is required.

Footnotes

57. Art. L.1453-8 PHC

This falls under the “anti-gift” regime (see question 12 above), applicable to transfers of value either in cash or in kind. The PHC⁵⁸ provides for the following derogations to the prohibition on transfers of value when it comes to grants or donation:

• Donations and gifts, in cash or in kind, intended exclusively to finance research activities, the valorisation of research or scientific evaluation;
• Donations and gifts intended for the persons mentioned in 3° of article L. 1453-4, with the exception of the national professional councils mentioned in article L. 4021-3 and associations whose purpose is unrelated to their professional activity.

An agreement must be concluded between the beneficiary and the entity providing the benefit ⁵⁹.

They must be declared to or authorized by the competent authorities.

Under the regulatory provisions (“arrêté”) of August 7, 2020, pharmaceutical companies can benefit from the declaration regime for:

• Grants and donations intended exclusively to finance research, research valuation or scientific evaluation activities: up to an amount of €5,000 for health professionals, €1,000 for students who intend to become healthcare professionals, and €8,000 for associations of healthcare professionals or students. Beyond this amount, an authorization is required.
• Grants and donations intended for another health-related purpose: it is forbidden to finance a health professional or a student, for an association of health professionals or students, the maximum amount is 1.000€. Beyond this amount, an authorization is required.
• Grants and donations to associations recognized as having a public interest, including those intended exclusively to finance research, research valuation or scientific evaluation activities: it is forbidden to finance a health professional or a student, for an association of health professionals or students, the maximum amount is 10.000€.

Over these amounts an authorization is required.

Footnotes

58. Article L.1453-7 PHC

59. Article L.1453-8 PHC

Pharmaceutical companies are required to make public on a website called Transparence-santé, “the precise purpose, date, direct beneficiary and final beneficiary, and the amount of the agreements concluded”⁶⁰ with:

1° Healthcare professionals;

2° The associations of healthcare professionals;

3° Students training for the professions as well as associations and groups representing them;

4° Associations of users of the health care system;

5° Health care institutions;

6° Academies, foundations, learned societies and consulting companies or organizations involved in the products or services sector;

7° Legal entities publishing press, radio or television services and online communication services to the public;

8° bis Persons who, in the media or on social networks, present one or more health products in such a way as to influence the public;

9° Publishers of prescription and dispensing assistance software;

10° Legal persons providing or participating in the initial or continuing training or continuing professional development of health professionals.

The public database “Transparence – Santé” requires⁶¹ the following information:

• For agreements: the identity of the parties involved, the date of the agreement, its precise purpose, the amount and the organizer, the name, date and place of the event;
• For benefits in kind and in cash, whether direct or indirect: the identity of the parties concerned, the amount, nature and date of each benefit where the amount of each benefit is greater than or equal to €10 including tax.
• For remunerations: the identity of the parties, the date of payment, the amount whenever it is greater than or equal to €10. Where applicable, the final beneficiary of the remuneration or advantage is informed by the company.

This obligation⁶² therefore applies to foreign companies and companies that do not yet have a product on the market. Indeed, the information note explicitly states that “any company producing or marketing health products (…) whether or not its registered office is located in France and whether or not its products are operated or marketed in France, is required to make public the agreements it enters into with healthcare professionals practicing in France (and students studying for these professions) or with any organization or association located in France (…). The benefits or remuneration provided to these same persons must also be made public. »

Non compliance with these rules is subject to criminal sanctions.

Footnotes

60. Article L.1453-1 PHC

61.https://www.transparence.sante.gouv.fr/flow/main;jsessionid=552E0405CB684179917C74D670A45E1A?execution=e1s1

62. Information note No. DGS/PP2/2017/180 of May 29, 2017 on the transparency of benefits granted by companies producing or marketing products for human health and cosmetic purposes

(i) Authorizing advertising in France

It is up to the ANSM to issue advertising authorizations via a visa. In all cases, advertising must meet the following criteria (art. L5122-2 PHC):

• comply with the provisions of the marketing authorization and the therapeutic strategies recommended by the Haute Autorité de Santé.
• present the medicinal product objectively, promote its proper use
• not be misleading to the protection of public health.

If these criteria are not met, the ANSM will refuse the application.

Since June 1, 2012 ⁶³, advertising to healthcare professionals has been subject to prior control. In this case, a request for prior authorization called PM visa must be addressed to the ANSM by pharmaceutical companies⁶⁴.

Advertising to the public is also subject to prior control. It results in the issuance of a visa, known as the GP visa.

In addition, the ANSM must verify whether the medicine is subject to a risk/benefit reassessment procedure; there is a strict ban on advertising until the end of this procedure ⁶⁵.

There are 2 exceptions to this control of advertising authorization for public health reasons:

• vaccines may be the subject of promotional campaigns aimed at the general public if they appear on a list drawn up for public health reasons by order of the Minister of Health ⁶⁶.
• tobacco-weaning products can also be the subject of promotional campaigns aimed at the general public.

The ANSM must control the mentions of the advertising document⁶⁷. Advertising for a medicinal product to the healthcare professionals mentioned in article L. 5122-9 is adapted to its recipients. It shall in particular specify the date on which it was last drawn up or revised and shall include at least information on the name, pharmaceutical form, composition, these properties, the name of the generic.

(ii) Advertising on the internet

The ANSM draw up a Charter⁶⁸ in March 2014 that regulates advertising on the Internet. This document, which has no legal authority, reflects the provisions applicable to the pharmaceutical and medical device industries when they publish information on their websites ⁶⁹.

A website must present the information provided for in Article 6 of Law N°. 2004-575 of 21 June 2004 on confidence in the digital economy and must in particular show the identification of the operator as well as the intended recipients and the type of information disseminated. It must be structured and present, from the home page, the site map.

The information shall be updated regularly and the date of the last update shall be specified. The site must be designed in such a way that parts intended for the promotion of a health product are explicitly distinct from other non-promotional parts. Advertising must therefore be clearly identified, which may be done by any clearly perceptible means that makes the advertising nature of the message unequivocal to the public.

Each promotional page of a website must display the mandatory information provided for by the HPC for the product category presented and the public for which it is intended. This information must be immediately seen.

Concerning the access to the promotional pages, the advertising must be adapted to its recipients:

• for healthcare professionals, it must be presented on pages that are reserved for them.
• the HPC imposes restrictions on the distribution of certain advertisements, in which case real access restrictions must be put in place by the operators. This security is essential and the simple commitment of the Internet user, certifying that he or she is a professional, is insufficient to access promotional pages for a medicine for which advertising to the public is prohibited.
• for the public, no access restriction is necessary.

The promotional pages of a medicine’s website must be the subject of a request for authorization from the ANSM before being put online. The terms and conditions for requesting advertising authorization are described on the ANSM website⁷⁰.

(iii) Advertising on social networks

The Charter71 strictly regulates advertising on social networks. The functionalities inherent in open social networks (such as Facebook, twitter, youtube, etc.) imply “linking the content of pages to comments and messages whose content is free and not controllable”. Consequently, advertising for the general public, in the form of a products page, is not possible on social networks that do not allow moderation of users’ comments. In addition, the [x] people like feature, which displays the number of people who pressed the like button on the promotional page, can be interpreted as an attestation of cure by the public or a guarantee if it is the profile of a health professional and is therefore contrary to article R5122-4 6° PHC (for medicines to the general public cannot include any element that would refer to a recommendation from scientist, health professionals or persons who may, by virtue of their reputation, encourage the consumption of the medicine).

General consumer regulation and guidelines issued by the French advertising self-regulatory body (ARPP) applicable to general online advertising shall also apply.

The Charter ⁷¹ strictly regulates advertising on social networks. The functionalities inherent in open social networks (such as Facebook, twitter, youtube, etc.) imply “linking the content of pages to comments and messages whose content is free and not controllable”. Consequently, advertising for the general public, in the form of a products page, is not possible on social networks that do not allow moderation of users’ comments. In addition, the [x] people like feature, which displays the number of people who pressed the like button on the promotional page, can be interpreted as an attestation of cure by the public or a guarantee if it is the profile of a health professional and is therefore contrary to article R5122-4 6° PHC (for medicines to the general public cannot include any element that would refer to a recommendation from scientist, health professionals or persons who may, by virtue of their reputation, encourage the consumption of the medicine).

General consumer regulation and guidelines issued by the French advertising self-regulatory body (ARPP) applicable to general online advertising shall also apply

Footnotes

63.Law of December 29, 2011 relating to the reinforcement of the health safety of medicines and health products + decree 2012-741 of May 9, 2012

64. Article L.5122-9 PHC

65. Article L.5122-3 PHC

66. Regulatory provisions (“arrêté”) of September 28, 2012 establishing the list of vaccines mentioned in Article L. 5122-6 PHC https://www.legifrance.gouv.fr/jorf/id/JORFTEXT000026473702

67. Article R.5122-8 PHC

68. Charter concerning communication and promotion of health products (medicines and medical devices) on the Internet and in the electronic media

69. Art. L5122-1 CSP Dalloz commenté

70. https://www.ansm.sante.fr/Activites/Publicite-pour-les-medicaments/Effectuer-une-demande-de-visa-de-publicite/(offset)/3

71. Charter concerning communication and promotion of health products (medicines and medical devices) on the Internet and in the electronic media (2.4 Social networks)

The PHC frames the rules on bribery through 2 articles, the first one targets the persons who offers, the second one targets the person who receives.

The bribery of a healthcare professional is prohibited for the promotion of medicines⁷², this is aimed at the person who offers the benefit. It is provided that the granting, offering or promising of a pecuniary advantage or in kind to health professionals (unless of negligible value), for the purpose of promoting medicines, is punishable by 2 years imprisonment and a fine of €75,000.

The second one is aimed at the healthcare professional who accepts these benefits. Indeed, members of the medical professions who accept them may be punished with two years imprisonment and a fine of €75,000 “the fact, for members of the medical professions (…) to receive benefits in kind or in cash, in any form whatsoever, directly or indirectly, provided by companies providing benefits, producing or marketing products covered by the compulsory social security schemes”⁷³.

With healthcare organization, the subject is addressed in the LEEM’s rules governing professional ethics, which include a section on relations with patient associations⁷⁴ where it is notably forbidden for the pharmaceutical industry to request, and for patient associations to promote, any medicine subject to compulsory prescription.

When a company provides support, financial or otherwise, to an association, they must put in place a written agreement. In addition, each company must make public the list of patient associations to which it provides financial or non-financial support.

Article 17 of the Sapin II law provides that the presidents and managers of a company which:

• employ at least 500 employees or belong to a group of companies whose parent company has its registered office in France and whose workforce includes at least 500 employees;
• and whose turnover or consolidated turnover is greater than €100 million;
• are required to take measures to prevent and detect the commission, in France or abroad, of acts of corruption or influence peddling.

Sanctions can go up to a fine (€200,000 for an individual, €1,000,000 for a legal entity) and are proportionate to the seriousness of the breaches observed and the financial situation of the individual or legal entity sanctioned.

Footnotes

72. Article L5422-9 PHC

73. Article L. 4163-2 PHC

74. Professional Ethics Provisions (page 39-42) – LEEM December 2019:

See question 12 above concerning the “anti-gift” rules

Outside the legal framework, the LEEM (the French professional organization of the drug companies) has its own ethical conduct rules applicable to its members gathered in the set of provisions entitled “Dispositions Déontologiques Professionnelles ” (in English: Professional Ethical Provisions).

These include the “Charter relating to information by canvassing or prospection aiming to the promotion of medicinal products” signed between the LEEM and the CEPS, the Economic Committee for Health Products which aim to frame commercial and promotional practices. The Charter notably specifies the duties of the medical sales representatives, the quality standards to be met, in particular with respect to the presentation of information, the ethical standards of the representatives regarding patients, healthcare professionals, and monitoring of the representatives’ activities.

The ethical rules of the LEEM are of self-regulatory nature and do not have a legal force. They are binding on the LEEM members. The CODEEM (Comité de déontovigilance des entreprises du médicament), the ethical vigilance committee of the LEEM, is in charge of monitoring the implementation of these ethical rules and can pronounce sanctions in case of non-compliance by LEEM members. These rules also serve as good practice standards for LEEM non-members companies.

ANSM is the administrative authority responsible for authorizing, monitoring and sanctioning non-compliance with standards relating to the advertising of health products in general.

ANSM’s decisions imposing financial penalties, as administrative decisions giving rise to complaints, may be appealed before its Director General and before the administrative judge⁷⁵.

When the ANSM withdraws an advertising visa, the Economic Committee for Health Products (CEPS) may impose a financial penalty on the company⁷⁶.

The French Economic Regulation Authority (DGCCRF) can also initiate investigations and claims before French Courts in particular under French Consumers regulation.

Finally, there is the possibility of going before the civil and criminal courts since there may be a civil action for compensation for the damage suffered (unfair commercial practice) or criminal sanctions for violation of the general principles of medecine advertising.

See question 12 above concerning the “anti-gift” rules.

Footnotes

75. ANSM 2016 Report– Financial sanctions

76. Article L.162-17-4 Social Security code

Pharmaceutical advertising is only legal if it is not misleading; therefore the legal basis for companies is the article L.5122-2 PHC⁷⁷.

Moreover, the provisions of the French Consumer Code apply to medicinal products advertising. The French Consumer Code prohibits any advertising that is false or misleading.⁷⁸ The DGCCRF is authorised to establish breaches of Article L121–1 of the Consumer Code by means of statements, which are then sent to the Public Prosecutor.⁷⁹

The use of comparative advertising ⁸⁰ is permitted only for promotion to healthcare professionals and not to the public. Besides, it is prohibited to suggest to the general public that the effect of a medicine “is greater than or equal to that of another treatment or medicine”⁸¹.

The criterion put forward in the 2014 Charter ⁸² is that the information provided must be “exempt from any denigration”, even insisting that the person exercising an information activity by canvassing or canvassing refrains from denigrating the specialties of competing companies, including generic and biosimilar.

It was clarified what could be considered disparagement of a competing pharmaceutical product or company: “Even if it is possible (which in practice only concerns reimbursable medicines), such advertising may not, however, take undue advantage of the notoriety attached to a competitor’s trademark, bring it into disrepute or denigration, cause confusion between the advertiser and a competitor or between the trademarks, or between the goods of the advertiser and those of a competitor, or present goods or services as an imitation or reproduction of a good or service benefiting from a protected trademark”.

Footnotes

77. Comments under Article L5122-2 CSP, Dalloz.

78. This is assessed with regard to the product’s nature, composition, substantial-quality, origin, properties, conditions of use, results expected from its use, etc. See Art. L121-2 Consumer Code.

79. Article L 511-3 Consumer Code.

80. French Consumer Code, art. L. 122-1

81. Article R5122-4 2° CSP

82. Charter relating to information by canvassing or prospection aiming to the promotion of medicinal products

The ANSM may initially take administrative and financial sanction measures⁸³.

Can be subject to financial sanctions by the ANSM ⁸⁴:

• any advertising of a medicinal product that has not obtained a marketing authorisation, registration or parallel import authorisation;
• any advertising to the public that has not obtained the appropriate visa or that is carried out in spite of its suspension or withdrawal;
• any advertising carried out among health professionals who have not obtained the visa necessary or which is carried out despite its suspension or withdrawal;
• any advertisement to the public for a prescription drug medical (with the exception of campaigns to reduce tobacco addiction and for vaccines);
• any advertisement to the public for a medicine for which the marketing authorisation or registration includes restrictions on advertising to the public by reason of a possible risk to public health;
• any advertisement to the public or health professionals for a medicinal product benefiting from a temporary authorization for use;
• any advertising to the public for a medicinal product reimbursable by the compulsory health insurance schemes;
• any advertising for generators, kits or precursors;
• any non-institutional advertising campaign for vaccines.

The amount of the sanction cannot exceed €150,000 for a natural person. In addition, it may not exceed 30% of the turnover of the product(s) concerned during the last financial year, up to a limit of €1 million for a legal entity.

The sanction may be accompanied by a daily penalty payment which may not exceed €2,500 per day. In addition, for some of these infringements, the ANSM may issue a ban on the advertising concerned after the company has been given formal notice.

Financial penalties may be published on the ANSM website⁸⁵.

When a financial sanction pronounced by the ANSM is likely to be combined with a criminal fine imposed on the author for the same acts, the total amount of the fines and financial sanctions does not exceed the highest legal maximum⁸⁶.

When a withdrawal of advertising visa has been pronounced by the ANSM, the CEPS can pronounce, after the company has been given the opportunity to present its observations, a financial penalty against it.

This penalty may not exceed 10% of the company’s sales excluding tax in France of the specialties that were the subject of the prohibited advertising during the six months preceding and the six months following the date of withdrawal of the visa. Its amount is set according to the seriousness of the infringement sanctioned by the prohibition measure and the sales trend of the specialties concerned during the period⁸⁷.

Finally, there are criminal sanctions applicable in the event of violation of the general principles governing medicine advertising⁸⁸. It is punishable by 5 years’ imprisonment and a fine of €375,000 if an advertisement for a pharmaceutical specialty which has not been the subject of a marketing authorization or an import authorization, or whose authorization has been refused, suspended, withdrawn or lapsed, is produced or caused to be produced, broadcast or caused to

be broadcast. These penalties are increased to 7 years’ imprisonment and a fine of €750,000 for these offences:

• are likely to cause a serious risk to human health;
• were committed in an organized gang;
• were committed on a telecommunication network intended for a public not determined;
• were committed by licensed pharmaceutical companies, brokers, pharmacies.

Additional penalties, such as the closure of the establishment, are also provided for⁸⁹. It is punishable by one year’s imprisonment and a fine of €150,000 for the dissemination of an advertisement for a medicinal product marketed under a temporary authorization for use⁹⁰. The court may even go so far as to prohibit the sale and order the seizure and confiscation of the medicines concerned, as well as the seizure and destruction of the documents and advertising material relating to them⁹¹.

Under French Consumer Regulation, criminal fine of up to 1,500,000 EUR (or alternatively an amount equal to the benefit brought by the advert/10% of the average annual turnover during the past 3 years/50% of the expenses used to make the advert) and up to 2 year imprisonment and prohibition from doing business during up to 5 years or forced closure of the seller’s business. The sanction may also be displayed to the public.

Footnotes

83. https://www.ansm.sante.fr/Activites/Processus-d-inspection/Les-suites-de-l-inspection-mesures-administratives/(offset)/2

84. Article L5422-18 PHC

85. Article L.5471-1 PHC

86. Article L.5471-2 PHC

87. Article L. 162-17-4 Social Security code

88. Article L.5421-2 PHC

89. Articles L. 5421-7, L. 5421-9, L. 5421-10 and L. 5421-11 PH

90. Article L.5422-3 PHC

91. Article L.5422-14 PH

ANSM’s decisions⁹² are subject first of all to an administrative review before its director, and then if this does not succeed, a judicial review can be carried out before administrative courts. Sanctions may therefore be reduced, cancelled or increased, knowing that it has been specified that ANSM considers the company’s ability to pay its contributions when imposing sanctions.

Should the ANSM identify a breach, it shall inform the company concerned, which may make comments. Binding measures may be imposed by the ANSM on a pharmaceutical company to induce it to comply with its obligations or to put an end to the failure to comply. If the difficulties persist, the ANSM may take the company in question to court⁹³.

For unfair commercial practice, the procedure operates independently from others and is not dependent on the outcome of other reviews by other authorities or courts. It is necessary to go directly before the judicial judge, as for criminal sanctions.

Footnotes

92. ANSM 2016 Report: financial sanction imposed by ANSM

93. Article Geneste & Devulder, §11.4, p.2

ANSM has, in recent years, issued few decisions, and when it does, the grounds are usually not given. As an example ⁹⁴, in 2020 ANSM did not render any decision relating to the advertising of medicines. Both in 2018 and 2019, one sanction procedure did happen, but no motives were specified or published.

In 2017⁹⁵, ANSM wrote in their yearly rapport that “Proceedings initiated against breaches of advertising rules, medical devices and medicinal products combined, represent the majority of proceedings initiated in 2017. These proceedings mainly concern the broadcasting of advertising on the Internet without prior authorization from the ANSM. (…) 8 proceedings for breaches of advertising rules for health products were initiated this year, mainly in the sector of advertising for medicinal products, which saw a significant increase in the number of proceedings initiated. »

In 2016, there were no sanction proceedings relating to advertising. Before 2015, no information is available.

There is no publication of CEPS decisions, but courts’ decision against CEPS decisions may be published.

Concerning the case-law, whether administrative or judicial, no proceedings relating to infringements of advertising have been pronounced recently.

The last important case dates back to 2016, on a case that has been opposing Leclerc to the pharmacists’ monopoly on the sale of medicines for about ten years ⁹⁶.

Footnotes

94. https://ansm.sante.fr/Decisions/Injonctions-decisions-de-police-sanitaire-sanctions-financieres-interdictions-de-publicite-Interdictions-de-publicite

95. Sanctions financières : bilan 2017 des sanctions financières prononcées par l’ANSM

96. https://www.legifrance.gouv.fr/affichJuriJudi.do?idTexte=JURITEXT000032781366