The provisions of the 2019 Budget Law on health services advertising
The main regulatory measures introduced by the 2019 Budget Law regarding the field of health services advertising are contained in sections 525 and 536 of Article 1.
In accordance with section 525, informative communications published by private healthcare facilities and healthcare professionals (enrolled in the relevant registries) shall not contain any promotional or suggestive elements. According to the law, this limitation aims to encourage the patient’s free and conscious decision and dignity, while still safeguarding public health, and his or her right to accurate information on health services. We can clearly see that public healthcare facilities are excluded from the scope of this provision and thus not subject to such restrictions.
According to the 2019 Budget Law, health services advertising may only include information about professional qualifications and specializations and the characteristics and prices of the services offered (as per Article 2 of the Bersani Decree). In any case, the 2019 Budget Law states that such information may only be provided for the purpose of ensuring the safety of the health services being advertised and may not contain any promotional or suggestive content (the actual meaning of this wording is unclear and subject to interpretation).
Additionally, section 536 of the 2019 Budget Law establishes sanctions to be applied if the provisions on health services advertising are breached. It specifies that local healthcare associations have the authority to take disciplinary action against professionals or companies and to report any violations to the Italian Communications Authority (Autorità per le Garanzie nelle Comunicazioni – AGCOM).
Recent judgments on health services advertising
The provisions of the 2019 Budget Law concerning health services advertising address an issue that has recently been the subject of controversial judgments and public debate.
More specifically, two recent judgments issued by the Liguria Regional Administrative Courtand the Italian Council of State and a previous judgment of the Court of Cassation all addressed the issue of whether, following the Bersani Decree, the more restrictive rules contained in the previous Italian Law no. 175/1992 regarding health services advertising were still in force. These court proceedings had opposing outcomes, creating confusion about the application of the relevant provisions.
In particular, while the Court of Cassation stated that the entire Italian Law no. 175/1992 had been repealed by the Bersani Decree, according to the judgments of the administrative courts, the Bersani Decree only repealed the provisions regarding the limitations on informative communications published by professional services and the rules contrary to the principles of freedom, transparency and truthfulness in advertising, while the other provisions remained in force, such as the obligation to indicate the health director in the advertising message (considered one of the minimum requirements).
The risks of restricting competition in the healthcare sector
Although the 2019 Budget Law does not clarify the specific issue addressed by the court proceedings mentioned above (the validity of Italian Law no. 175/1992), it reveals a particularly restrictive approach to health services advertising, limiting the permissible contents of communications published by private healthcare facilities to the information referred to in Article 2 of the Bersani Decree. In addition, it provides that such information shall be functional to ensuring the safety of treatments and without any promotional or suggestive content. This provision threatens to undermine the liberalization of health services communications brought about by the Bersani Decree.
In this regard, the Italian Competition Authority (Autorità Garante della Concorrenza e del Mercato – AGCM) published an opinion when these provisions were still in draft form, stating that these new limitations are so strict as to constitute almost a complete ban on advertising health services, contradicting the Bersani Decree and the principles of European competition law.
Furthermore, the fact that control of these advertising messages is the responsibility of the AGCOM is quite unusual, since the monitoring on the advertising to public is generally the responsibility the AGCM, the authority which protect a fair competition between economic operators. This could be seen as another sign that shows a political intention to restrict as much as possible the healthcare operators’ ability to advertise the services they provide and, under this perspective, the competition in the healthcare sector.