Ministry of Health Opened the Public Consultation for the Italian Sunshine Act

In recent developments, progress on the Italian Sunshine Act has come into focus. A member of parliament made a significant move in July by requesting an update on the Sunshine Act’s status from the Ministry of Health (MOH).

The MOH, after consultations with key entities including the Agency for Digital Italy (AGID), the National Anti-Corruption Authority (ANAC), and the Guarantor for the Protection of Personal Data (GPDP), has formulated a framework outlining the technical aspects of the electronic public register. This includes the requirements and procedures for data upload.

A dedicated committee, comprising representatives from the Ministry, the Italian Medicines Agency (AIFA), AGID, ANAC, and GPDP, was formed to craft a draft decree and corresponding technical specifications for the platform.

Furthermore, the public has been actively engaged in the process. A public consultation period was initiated from 17 August to 17 September 2023, enabling stakeholders to provide input through a confidential questionnaire. These valuable contributions will be evaluated by the committee to refine the draft decree and specifications, setting the stage for the Act’s full implementation.