3. Appendix I

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1. Appendix I


Comparison tables of national legal provisions for advertising and promotion of medicinal products, using sample questions from the information offered by three different law associates.


1.1. CMS Expert Guide

Advertising of medicines and medical devices
Provides high level information on life sciences and healthcare advertising in 27 jurisdictions and offers a quick and simple understanding of the applicable laws. The Expert Guide covers, amongst others, different types of advertising, regulatory aspects as well as legal consequences of non-compliance.

France

Germany

Question (11): Are there specific provisions for advertisement of medicines and medical devices on the internet/in social media postings?

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…).

There are no specific legal provisions for advertisements on the internet/in social media postings. However, the general restrictions apply (with certain peculiarities):

Access Restrictions on Websites:

Since advertising for prescription-only medicines is limited to HCPs, it is necessary to restrict access to comply with German law (if prescription-only medicines are involved). German law does not provide for a specific mechanism to restrict access. However, restricting access by providing a tick-box question (“Are you an HCP?”) is not sufficient. In practice, most companies use access control systems with registration requirements (such as DocCheck).

Mandatory Information (Pflichtangaben)

In advertisements for medicines, whether prescription-only or not, the mandatory information must be displayed (see question 7 above). However, on the internet and in social media postings a visible link that directly and without detours leads to such information is considered sufficient by German courts.

Social Media: Only OTC medicines

In practice, the advertising on social media is limited to OTC medicines (as advertising for prescription-only medicines is not allowed to the general public and an access restriction, as used for websites, is technically not feasible on social media).

https://cms.law/en/int/expert-guides/cms-expert-guide-to-advertising-of-medicines-and-medical-devices


1.2. Legal 500 guide on pharmaceutical advertising

The aim of this guide is to provide its readers with a pragmatic overview of the law and practice of pharmaceutical advertising law across a variety of jurisdictions.

Each chapter of this guide provides information about the current issues affecting pharmaceutical advertising in a particular country and addresses topics such as self-regulation, press releases, gifts, samples, grants or donations, anti-bribery rules, regulatory authorities and courts, as well as insight and opinion on the most common issues in their respective country.

The Q&A template for each chapter has been provided by Sally Shorthose of Bird & Bird.
2nd Edition | Published: December 2020

Question: When if at all do competent authorities have to get involved in authorising advertising? Is advertising on the internet (including social media) for medicinal products regulated, and if so, how? Should companies include access restrictions on websites containing advertising or other information intended for healthcare professionals?

Germany

 

There is no requirement for an authority to get involved in authorising advertising. No specific regulations for advertising on the internet apply, either. The general requirements as outlined above of course need to be observed.

Lastly, it is recommendable for companies to restrict access on websites containing information/advertisements on prescription medications to healthcare professionals only. A common tool for that is i.e. http://www.doccheck.ag/home/.

France

(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 companies.

Advertising to the public is also subject to prior control. It results in the issuance of a visa, known as the GP visa 64.

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.

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)

https://www.legal500.com/guides/guide/pharmaceutical-advertising/


1.3. 4.3 Chambers Pharmaceutical Advertising 2021


The new Pharmaceutical Advertising 2021 features 17 jurisdictions. The guide covers regulatory frameworks, advertising to the general public and healthcare professionals, transparency, inducement/anti-bribery and enforcement. Last Updated: March 04, 2021.

France

Germany

7. Advertising of Medicinal Products on the Internet

7.1 Regulation of Advertising of Medicinal Products on the Internet

Advertising on the Internet for medicinal products is governed by the common provisions applicable to the advertising of medicinal products contained in the Public Health Code, in particular Articles L.5422-1 et seq.

Advertising is therefore subject to an advertising endorsement and must in principle contain all the mandatory particulars (see 4.2 Information Contained in Advertising to the General Public and 5.1 Restrictions on Information Contained in Advertising Directed at Healthcare Professionals).

The ANSM does, however, provide for derogations for the compulsory information on certain media.

Authorised Advertising Media

Any media distributed in service (display, supports for the pharmacy counter, umbrella stand, wall thermometer), internet banners, internet pop-ups or various objects (material used by a health team at a sports event, a vehicle engaged in a sports race) constitute authorised advertising media with the compulsory reduced particulars. These particulars are as follows: the name of the medicinal product, the common name, the indication, the medicinal product, the age limit and specific warnings.

Internet promotion

The ANSM has drawn up a charter concerning the communication and promotion of health products on the Internet and on the e-media. The purpose of this charter is to clarify the advertising provisions of the Public Health Code in order to adapt them to this medium.

In practice, the charter requires that the Internet user be able to critically analyse the information received insofar as the sites of pharmaceutical companies will henceforth have to display a clear distinction between the information, services and advertising sections. The text also specifies the conditions under which pharmaceutical companies may offer certain services such as access to bibliographic databases, the dissemination of information relating to human health and diseases and access to other sites via hyperlinks.

The Charter allows an operator to set up discussion forums on their website under certain conditions. In particular, the operator is expected to moderate the discussions a posteriori in order to preserve the proper use of the health products referred to therein.

In addition, the operator must put in place sufficient means to ensure that remarks that do not comply with the regulations in force do not remain in place for more than 24 working hours.

For advertising on the internet the general rules and provisions on advertising apply. However, in accordance with German case law, certain peculiarities apply:

Mandatory Information (Pflichtangaben)

Certain pieces of information have to be displayed in an advertisement for medicinal products. According to German courts, there is an exception for advertising for medicinal products on the internet. To be in compliance with the rules of the HWG, it merely has to depict a visible link that directly and without detours leads to the mandatory information and that is labelled appropriately.

Advertising Restrictions Regarding the General Public and Publication of the Package Leaflet on the Internet

According to a verdict of the European Court of Justice (ECJ), it is permissible for companies to release information on prescription drugs on their websites if such information is only accessible to someone who is actively searching and demanding for it and if such information only consists of the accurate presentation of the packaging of the medicinal product, the literal and complete reproduction of the package insert or the summary of product characteristics as approved by the authorities. Thus, information released on company websites that is subject to a selection or rearrangement by the company and that has not been released to inform on but rather to promote the company’s products is still prohibited.

7.2 Advertising of Medicines on Social Media

Advertising of medicines on social networks is governed by the charter of the ANSM on the communication and promotion of health products on the Internet and on e-media.

This charter specifies that the inherent functionalities of social networks lead to linking page content to comments and messages whose content is free and not controllable.

Consequently, advertising of a medicinal product to the general public in the form of a “products” page is not possible on social networks, unlike the discussion forums available directly on the operator's website, as it is impossible to moderate the comments of Internet users.

In addition, the “like” option available on some social networks may be perceived as an attestation of healing by the public if it is the profile of a health professional, which is contrary to the Public Health Code.

However, a closed forum between health professionals on social networks is allowed if the operator intervenes through moderation of discussions.

Due to a lack of specific rules, the general restrictions apply. Unless an access control or access restriction is technically feasible, advertising of medicines on social media is limited to OTC products, as advertising for prescription-only medicinal products is not allowed to the general public

7.3 Restrictions on Access to Websites Containing Advertising Intended for Healthcare Professionals

Companies are required to implement access restrictions on websites containing advertising or other information intended for healthcare professionals.

For example, the attribution of a personal access code, given after checking the quality of the health professional, makes it possible to prevent unauthorised persons from accessing these sites.

Given the fact that any advertising for prescription-only medicines is limited to HCPs under German law, it is necessary to restrict access to websites which refer to prescription-only medicines. The HWG does not provide for a specific mechanism to restrict access. However, restricting access by providing a simple tick-box question (eg, “Are you a healthcare professional?”) would not be accepted as sufficient by courts. In practice, established access control systems with registration requirements (such as DocCheck) are used by most companies in Germany