Unlocking Progress: Italian Sunshine Act’s Path to Transparency

In the world of transparency reporting, the Italian Sunshine Act, established under Law 62/2022, has remained a significant topic of discussion. Officially enacted on May 31, 2022, the progress has been relatively limited since its enforcement on June 26, 2022.

While the law was approved, the development of specific rules and the technical infrastructure for a dedicated platform were pending. The Ministry of Health was granted a six-month window to create and implement a Telematic Public Register known as “Transparent Healthcare” or “Sanita Transparente.”

Initially, the law enjoyed unanimous support from parliament members. However, progress seemed to stall, possibly due to the election of a new government and other government priorities.

Recent developments have shed light on this situation. In July, a member of parliament requested information from the Ministry of Health, seeking an update on the Sunshine Act’s status.

The Ministry of Health, after consulting with various authorities, has identified the technical characteristics of the electronic public register and the requirements for data upload. A committee was formed, including representatives from the Ministry, the Italian Medicines Agency (AIFA), the Agency for Digital Italy (AGID), the National Anti-Corruption Authority (ANAC), and the Guarantor for the Protection of Personal Data (GPDP). This committee prepared the draft decree and related technical specifications for the platform.

An active public consultation is open on the draft decree and technical specifications from August 17 to September 17, 2023. The process involves collecting contributions from stakeholders through a confidential questionnaire, with contributions evaluated to refine the draft decree.

Industry experts anticipate that the process should now move relatively quickly, with the initial disclosure requirements coming into effect as early as July 2024.