The legal perspective. Today we discuss medical devices and social media, discovering that the combination, although difficult, is sometimes possible. What about testimonials? Here's how and when.

by Alberto Crivelli, founding partner of AMTF Avvocati

In the age of social networks, usingthem for advertising purposes guarantees wide visibility for the products and services offered to users from time to time. However, this form of advertising has been the subject of numerous regulatory interventions, which vary greatly depending on the product sector and activity involved.

In recent years, in particular,advertising via social media channels for medical deviceshas become increasingly common, including, for example, invisible dental aligners.

But is this form of advertising, aimed at such a wide audience, always to be considered lawful?

Article 21 of Legislative Decree 46/1997 and subsequent amendments establishes a total ban on advertising to the public of all devices that can only be sold on prescription or used, where applicable, with the assistance of a doctor or other healthcare professional, while advertising of devices other than those mentioned above is subject to prior authorization by the Ministry of Health following a specific procedure.

After obtaining ministerial authorization, therefore, the devices in question may be advertised in accordance with the new guidelines published by the Ministry of Health on online advertising of medical devices, which may also be disseminated via: company websites promoting institutional advertising, company-owned and non-company-owned websites, advertisements containing clickable links, emails, SMS and MMS messages, toll-free numbers, and social networks.

With particular reference to the latter,the Ministry of Health, while highlighting how promotion viasocialnetworks risks compromising the essential requirement of the static nature of the promotional message disseminated, given that these platforms are generally open to users who are free to express and manifest their opinions, has nevertheless decided to allow this form of advertising promotion, limiting it to the following social networks: Facebook, Instagram, and YouTube, the use of which is permitted, however, subject to significant limitations on certain typical functions, including, for example, the "comment" or "share" functions.

With regard to the use of email, SMS, and MMS messages, the most significant change is the possibility of sending advertisements for authorized products directly via SMS,subject to consumer consent and only where the minimum legal requirements are met (i.e., that the advertised product is a medical device and that the instructions for use must be consulted, all expressed in a maximum of 160 characters).

With regard to the possibility of disseminating advertising messages for authorized devices through the use of testimonials, such as individuals who are widely known to the public, the new Guidelines, while reiterating that advertising to the public must not contain any direct recommendation of the product, allow for certain exceptions, in particular:

• if the testimonial plays an active role in endorsing the product and clearly encourages consumers to purchase it, or expresses, even implicitly, a preference for the product, the message is not permitted;
• The message is not permitted even if thetestimonial presentsthe symptoms of the condition for which the product is indicated or if the message suggests that thetestimonialuses the product.

In all other cases, however, the use of testimonials may be considered legitimate, except for the Ministry's right to prohibit the mere presence of the testimonial where there is a risk of inappropriate use of the product with damage to consumer health.

What happens in the event of a violation of the above provisions?

When browsing online, it is easy to come across advertisements that do not take the above provisions into account, the violation of which may result in administrative penalties of up to €15,493.71 for the person responsible. For example, the owner of a website that hosts an advertisingbannerfor a medical device must expressly request that it be authorized by the Ministry of Health in order to avoid incurring the aforementioned penalties, as they have no possibility of intervening on the content of the banner itself.

Source: Youmark