Unauthorised advertising of medical devices: the content distributor is also subject to penalties

As known, at least among the insiders, the Manufacturer or the company responsible for the placing on the market of a medical device, must request an authorization to conduct advertising on those devices from the Italian Ministry of Health. A complete application has to be submitted, containing all the information concerning the company, the advertised product, the type of advertising and the means of diffusion that will be utilized (television, radio release, daily and periodic press, flyers, booklets, road signs, etc...).

It is also well known that the unauthorised advertising of medical devices implies, for the manufacturer or person responsible for placing the product on the market, administrative sanctions that range from € 2,582.28 to € 15,493.71 (pursuant to Article 201, paragraphs 3-5, of Royal Decree No. 1265/1934).

 

However, the Italian Cassation introduced, with Order n. 10892/2018, an extension of liability: not only the manufacturer of the device, the owner of the means of communication that the manufactuer uses to spread the unauthorised advertising message, is to be sanctioned as well.

The case in question concerns an ad campaign that was broadcasted by a private television, describing an oscillating platform as a "device that can produce positive effects on physiotherapic rehabilitation, and bring benefits to the skeletal and respiratory system" (and other statements that can be included in the definition of what is a Medical Device, provided by Legislative Decree 46/1997), without obtaining prior authorisation from the Minister.

 

The Court of Cassation stated that "in case of administrative offense concerning the advertising of medical devices without the required ministerial authorization, responsibility lies not only with the manufacturer of the device, but also with the content distributor ".

 

The Court motivated its decision by recalling two previous rulings (in 1993 and in 1996) that date back to the time when an unauthorised advertising of medical devices constitued a criminal offence. On the basis of these rulings, unauthorized advertising is also attributable to the director of a newspaper or the administrator of a radio and television broadcaster. Consequently, it was considered that, even after the decriminalisation of this offence, the owner of the means of communication that was used for the diffusion of the ad to the public, should be included among the entities held liable for the offence.

 

It is likely that from now on, this principle will be applied to all media, including internet and social networks. Therefore, attention should be paid to advertising content, because both manufacturers of medical devices and broadcasters can be sanctioned.