Italy’s Sunshine Act is approaching its operational launch. With the “Sanità Trasparente” infrastructure ready and awaiting final regulatory clearance, foreign life sciences companies should prepare for a new wave of disclosure, privacy and compliance obligations.
Italy’s Sunshine Act (Law No. 62/2022) is approaching a decisive milestone. The infrastructure supporting “Sanità Trasparente”, the Ministry of Health’s public transparency register, is substantially ready for launch. Only the final regulatory green light remains outstanding, potentially arriving in the coming months. Although reporting obligations are not yet operational, a new and significant area of compliance is about to open for businesses operating in the Italian healthcare market.
The legislation introduces mandatory public disclosure of financial relationships between companies and healthcare professionals (HCPs) and healthcare organisations (HCOs). Its scope extends beyond pharmaceutical and medical-device manufacturers to businesses marketing healthcare-related products and services, including in human and veterinary health. Importantly, foreign companies may fall within scope even without an Italian subsidiary, where their activities involve Italian HCPs or HCOs.
Reportable transfers of money, goods, services or other benefits include those exceeding €100 individually or €1,000 annually for an HCP, and €1,000 individually or €2,500 annually for an HCO. Consultancy arrangements, research activities, sponsorships, conferences and advisory boards may also trigger disclosure obligations. Separate reporting requirements apply to certain shareholdings and intellectual-property income.
Non-compliance may result in substantial financial and reputational consequences. Failure to report a transfer of value attracts an administrative penalty comprising both a fixed amount and a variable component equal to twenty times the value of the unreported transfer. False reporting may result in fines of up to €100,000. The public accessibility of reported information further increases reputational exposure.
A particularly sensitive issue will be reconciling mandatory transparency with data protection and confidentiality obligations. Companies will need to carefully assess their compliance with the GDPR and applicable data-protection requirements, ensuring that the collection, processing and public disclosure of information concerning healthcare stakeholders are supported by appropriate legal safeguards, while also addressing contractual confidentiality commitments.
International groups should therefore act now to map relationships and transfers of value, review consultancy and sponsorship agreements, establish reliable reporting procedures and coordinate compliance, legal, finance and commercial functions. Particular attention should be paid to transactions involving affiliates, distributors and other intermediaries.
