Italian IAP finds that claims on medical devices are unlikely to be misleading if pre-approved based on scientific evidence
14 April 2017
The Italian self-regulatory advertising body (Istituto di Autodisciplina Pubblicitaria – IAP) recently held that promotional claims made in relation to CE-marked medical devices are unlikely to be misleading if those have been pre-approved by the Ministry of Health on the basis of scientific evidence pursuant to the rules pertaining to the promotion of medical devices.
Under Italian law, the promotion of medical devices to the public – when permitted – is subject to prior authorisation by the Ministry of Health (Article 21 of Legislative Decree 46/1997, implementing Directive 93/42/EEC in Italy). The IAP separately enforces a (general) advertising self-regulatory code (IAP Code) which, among other things, prohibits misleading advertising (Article 2). In principle, there is no interconnection between the regulatory framework pertaining to the promotion of medical devices and the self-regulatory prohibition of misleading advertising enforced by the IAP.
With Decision No. 89/2016 dated 21 March 2017, the Jury of the IAP reversed an injunction issued by the IAP Supervisory Committee and held that the advertising message “Kilocal Magra, useful to fight excess weight and reduce waist” does not violate Article 2 of the IAP Code (nor Article 23-bis, which relates to the promotion of food products and not of medical devices). The product Kilocal is a CE-marked medical device and the claim had been authorised by the Italian Ministry of Health pursuant to Article 21 of Legislative Decree 46/1997.
The Jury, consistently with previous decisions, reiterated that no equivalence or automatism can be assumed between the authorisation granted by a governmental authority in relation to an advertising message and compliance with the IAP Code. However, the two proceedings cannot be regarded as completely independent and, where the ministerial authorisation was not granted per silentium but as a result of investigations and actual evaluations supported by adequate scientific studies on the merits, it can be reasonably held that the claim is sufficiently reliable and not misleading.