A few months ago, the Italian Ministry of Health ("Ministry") published new guidelines for the advertising of medical devices (the "Guidelines"), that updated the previous version, dated March 28, 2013.
The Guidelines provide for a comprehensive regulation of the advertising of medical devices through the main communication channels but, compared to the previous version, they particularly focus on online advertising. They introduce, for the first time: (i) a regulation of the advertising of medical devices through social networks, and (ii) a comprehensive regulation of advertising on the Internet, both through institutional sites and third parties' websites.
Advertising on social networks
The Guidelines reproduce almost literally the Ministry's guidelines of July 2017 concerning the advertising of the over-the-counter (OTC) medicinal products: (a) advertising is allowed only on the social networks expressly listed in the Guidelines, namely Facebook, YouTube and Instagram, so that advertising on any other social network is prohibited; (b) advertising on social networks must be previously authorized by the Ministry; and (c) messages on social networks must be "static", meaning that they cannot be changed by the advertising company or by any third party, therefore the functions that allow users to post comments under the posted advertising messages must be disabled.
Since it is technically impossible to restrict the ability of users to share messages on Facebook, it is possible therefore to add comments, the Guidelines provide that the advertiser shall insert the following disclaimer: "The Ministry of Health only authorizes the content of the advertising message. Any comments are the sole responsibility of the user and the company does not assume any responsibility for the users' comments".
According to the Guidelines the companies' websites that promote the company's image or logo (i.e., institutional websites) may publish the list of the medical devices commercialized by that company, as well as the image of their packaging with the brand, the trade names and the instructions for use, without any message regarding the health properties of the products. In such cases, as no specific properties of the medical devices are claimed, no prior authorization by the Ministry is required.
The advertising of medical devices on sites owned or controlled by the advertiser (but different from the institutional ones) is permitted subject to ministerial authorization, under condition that: (A) the advertising message is clearly identified within the website; and (B) a wording is included specifying that the authorization refers only to the advertising message (and not to the entire website).
For instance, in the case of websites relating to specific products (i.e., product-website), the site map must be sent to the Ministry with the indication of the advertising parts to be authorized.
The Guidelines represent a step forward in the regulation of the advertising of medical devices, with particular reference to certain communication channels, like the social networks, and put on the same level, in this respect, medical devices and OTC medicinal products. This is certainly a good signal and a concrete support for medical devices companies that needed instructions on how to carry out their advertising campaigns.
Nevertheless, medical devices companies that intend to strengthen their presence on the Internet have to take care of a number of grey areas that still remain to be addressed: the use of Google adwords, search engine marketing, virtual windows of medical devices to be sold online, etc.
In addition, certain requirements imposed by the Guidelines may be difficult to apply (e.g., the disclaimer on the messages posted on Facebook) and their implementation often requires a case by case analysis to assess whether any (also minimal) variation is still complaint with the Guidelines and does not expose the company to the risk of sanctions.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.