3. Appendix I

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)