3. Appendix I

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