Navigating the Changes: Updates on the Italian Sunshine Act

Ever since the Italian Sunshine Act came into force on June 26, 2022, it has remained a hot topic in the world of transparency. However, it’s important to note that the legislation has yet to become fully enforceable due to the Ministry of Health’s delay in implementing the Telematic Public Register.

The original plan was for the platform to go live in January 2023, but this has not materialized, leaving companies uncertain about when the Ministry of Health will introduce the register. Under the previous rules, companies only disclosed data on a voluntary basis if they were part of a national association, and non-compliance had no legal consequences. However, Law 62/2022 is a parliamentary legislation, making non-compliance subject to sanctions.

Companies are closely monitoring the latest developments related to the telematic register to understand how the new requirements will impact them. Key differences between the old and new rules that companies should be aware of include:

1. Expanding transparency obligations to cover various Transfer of Value (TOV) types within specific thresholds.
2. Extending transparency obligations to cover information on healthcare professionals and organizations with shareholdings, bonds, or income from intellectual property rights.
3. Requiring data to be submitted on an individual basis, disallowing aggregated data.
4. Allowing the public to make whistleblowing reports to the Ministry of Health in case of act violations.
5. Imposing heavy financial sanctions on companies for non-compliance or providing incomplete or incorrect information.
6. Publishing details on the Ministry of Health’s website for at least 90 days and entering them into the Telematic Public Register for reputational sanctions.
7. Determining monetary sanctions based on the nature of violations, the amount of TOV or agreements, and the violating companies’ revenue.