The Italian Sunshine Act

On June 26, 2022, Law No. 62 of 31 May 2022, concerning Provisions on transparency of relations between manufacturing companies, health care providers and health care organisations (the so called Sunshine Act) entered into force.

As a result of said law, transparency of direct and indirect transfers of value (ToV) in the Italian H&LS sector will no longer be a nice to have (on a voluntary basis) for manufacturing companies, but rather a legal obligation.

Indeed, according to the Sunshine Act, companies operating in the H&LS field are now required to disclose any disbursements of money, goods, services or other benefits performed in favour of healthcare professionals (HCPs) – when the individual value of the transfer exceeds €100 or the annual overall amount exceeds €1,000 – and/or healthcare organizations (HCOs) – when the individual value of the transfer exceeds €1,000 or the annual overall amount exceeds €2,500.

Furthermore, reporting and disclosure obligations apply also to agreements between manufacturing companies and HCPs and/or HCOs providing direct or indirect benefits for the latter and consisting in participation in conferences, training events, scientific committees, commissions, advisory boards or in the engagement for consultancy, teaching or research activities.

The information on both ToV and agreements producing direct or indirect benefits shall be published by manufacturing companies within the semester following the one in which they occur, on a public register – the so called Transparent Healthcare Register – which will be created within the next six months on the institutional website of the Ministry of Health (MoH). The obligation at hand will apply from the second semester following the official activation of the Transparent Healthcare Register (ie not before the second semester of 2023, at the earliest).

In addition, starting from the second year after the activation of the Transparent Healthcare Register (ie from January 2024, at the earliest), manufacturing companies shall communicate to the MoH, by 31 January of each year, the identification details of any HCPs and HCOs holding shares or quotas in the company, or bonds issued by the same, or that have received fees from the company, in the previous year, for the economic exploitation of industrial or intellectual property rights.

All the above data shall be published exclusively on an individual basis, as publication in aggregate form is not envisaged by the law. In this regard, the Sunshine Act clarifies that, even though consent to publication is to be deemed as implicitly given by HCPs and HCOs by means of their acceptance of the concerned ToV or agreement, companies are still required to inform them of the disclosure by providing them with a specific privacy notice.

Finally, the Sunshine Act introduces significant financial sanctions in the event of non-compliance with the transparency obligations provided thereunder, as well as for the provision of incomplete and/or incorrect information. The data relating to the sanctions applied will also be published on a dedicated section of the Transparent Healthcare Register, with the related possible consequences on a reputation level.