3. Appendix I
1. Appendix I
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.
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).