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Focus on Regulation

The Italian Supreme Court rules on the liability of broadcasters for unlawful advertising of medical devices

By decision No. 10892 published on 7 May 2018, the Italian Supreme Court ruled on an appeal brought by the Ministry of Health against a decision of the appellate Court of Padua in a case concerning the administrative sanctions imposed by the Ministry of Health on the manufacturer and the editorial director of a TV broadcaster for the breach of the law on the advertising of medical devices. The manufacturer offered for sale a fitness device, a balance board, in a teleshopping broadcast that was addressed to the public at large. While the first instance decision confirmed the sanctions of the Ministry of Health in their entirety, the appellate Court lifted the sanction imposed on the broadcaster due to a lack of legal ground for an extension of the liability.

The appeal before the Supreme Court concerned only the point of the appellate decision that excluded the liability of the broadcaster, as the Ministry of Health was successful in the other points and no appeal was filed by the losing parties.

The qualification of a balance board as a medical device on the basis of the manufacturer’s advertising claims

The Supreme Court based its assessment on the appellate Court’s finding that the balance board, irrespective of the manufacturer’s classification, was a medical device in consideration of the promotional claims put forward by the manufacturer. The product was indeed advertised for the use in the physiotherapy rehabilitation, and as beneficial for the skeletal and respiratory systems.

Advertising of a non-prescription medical device

According to Article 21 of the Legislative Decree No. 46 of 24 February 1997 (the Italian law on medical devices), the advertising of non-prescription medical devices in Italy requires the prior authorisation of the Ministry of Health. The sanctions that may be imposed in case of breach of Article 21 are to be found in Article 201 of the Royal Decree No. 1265 of 27 July 1934 (consolidated text of the laws of the healthcare sector), as amended.

According to that provision, the advertising of a non-prescription medical device without the required ministerial authorisation may be sanctioned by the Ministry of Health with an administrative fine ranging from Euro 2,582.28 to Euro 15,493.71. The fine may be imposed for any breach of Article 21 of the law on medical devices.

The appellate Court found that the offer for sale of the balance board in the teleshopping program was a promotion of a medical device to the public at large that required the prior authorisation by the Ministry of Health. As the advertisement was not authorised, the administrative fine imposed on the manufacturer was legitimate. Although the manufacturer argued in the first instance that the sanction had to be lifted, as the relevant provision would have been repealed by subsequent legislative amendments, the appellate Court dismissed such argument and confirmed the applicability of Article 201 of the Royal Decree No. 1265 of 27 July 1934 in case of any breach of the law on the advertising of medical devices. That finding of the appellate Court’s decision was not further appealed before the Supreme Court.

The liability of the TV broadcaster

Although the breach does not amount anymore to a criminal offence as it was in the past, the Supreme Court observed that the administrative fine still has a similar purpose as it is intended to ensure the protection of the public with regard to the general interest of the consumers’ health. As also the broadcaster may put at risk that general interest by disseminating an unauthorised advertising, the Supreme Court found that there are no reasons for restricting the applicability of the sanctions only to the manufacturer. The Supreme Court further noted, in the light of the Legislative Decree no 177 of 31 July 2005 (the Italian Audiovisual Media Service Law), as applicable at the time of the relevant circumstances, that a teleshopping service should be considered a promotional activity. As a consequence, the person having the responsibility for the editorial contents and for the elaboration of television or radio programs, having included the advertising in the broadcaster’s programs, may be held liable for the breach of the law on the advertising of medical devices. The Supreme Court added also that its conclusions had not changed, had it to decide according to the law as amended in 2010, which identified the “provider of media services” as the natural person or entity that is responsible for the selection of the audio-visual contents of the audio-visual service.

Comment

The decision of the Supreme Court applies the Italian Audiovisual Media Service Law, which provides for the liability of the editorial director of the broadcaster in relation to the transmitted content. By contrast, the reasoning of the Supreme Court does not seem to be applicable to internet service providers as defined by the Directive 2000/31/EC (Directive on electronic commerce), since those subjects do not have editorial responsibility over content users create and publish via their platforms.