Although not revolutionary, these two new pieces of legislation are certainly of great interest to life sciences companies operating in Italy. They may, in fact, entirely change the quantity and quality of information available on and to life sciences companies, and perhaps even impact the cultural landscape in which such companies operate.

–> INFORMATION IN: the Whistleblowing Act is designed to encourage a flow of information to the company;

<– INFORMATION OUT: the Italian Sunshine Act will ensure that interactions with HCPs or HCOs are publicly disclosed, which will generate information from companies out to the public.

THE SUNSHINE ACT.

• Not yet applicable.  The Italian Sunshine Act (law number 62 of 2022) is not yet applicable because the website of the Italian Ministry of Health where data should be published is not yet ready.

• Aim.  The purpose of the Sunshine Act is to enhance transparency of relationships between companies and healthcare operators. Also, in the intention of the legislator, it also aims at fighting corruption even though the subject matters of the disclosure are entirely legitimate transactions.

• Reportable interactions.  Under the Sunshine Act, agreements and delivery of money, goods, services or other benefits to an healthcare professional (HCP) having a value above €100 or an annual aggregate value of more than €1,000 trigger the obligation to report the transaction. The threshold is higher if an healthcare organization (HCO) is involved, as the value must be above €1,000 individually or above €2,500 annually. Additionally, any agreements with HCPs or HCOs regarding the attendance to congresses, trainings, events, or any consultancy, research and teaching relationship must also be reported, as well as any equity or bonds in life science companies granted to HCPs or HCOs (even if granted for free) and any consideration for intellectual property licenses. Reporting must occur every 6 months and the information on the registry will be available for 5 years. Consent to disclosure by HCPs is (supposedly) implied.

THE WHISTLEBLOWING ACT.

• In force. The Whistleblowing Act (legislative decree no. 24 of 2023) is already in force for all companies to which it applies (including, but not limited to, life sciences’ companies). This means companies which have adopted a “231” model, as well as companies with more than 50 employees, or less if they are active in specific sectors.

• Aim.  The purpose of whistleblowing legislation is to protect the reporting person by prohibiting any retaliation against him or her, while ensuring confidentiality and compliance with data protection legislation. This should encourage reports, also anonymous, on any illicit activity happening within or outside the company. Companies must appoint a specific body or person to manage the reports so that they can be properly investigated (when relevant), and feedback can be provided to the reporting person.

Both laws rest on the assumption that corruption is inherent in businesses, especially in life sciences’ companies, and should be unearthed, even in an industry that is heavily regulated, self-regulated, and closely monitored by regulators and authorities.

Will the Sunshine Act and the Whistleblowing Act change the perception of life sciences companies? Will their efforts in terms of transparency and accountability be rewarded with a more positive reputation? That’s hard to predict, and probably unlikely.

Life sciences companies must balance the tensions between health and profit, the needs of buyers, users and patients, their products’ innovation and safety. They must do that ethically and generally invest a lot of resources into their compliance efforts. The two new laws may further strengthen such commitment.