Italian Sunshine Act: Long-Awaited Implementation Now Underway
Author
May Khan guida il team Compliance Services di Vector Health, società SaaS specializzata nella compliance per il settore life sciences. La sua esperienza include il reporting sulla trasparenza a livello globale, la strategia legata al Sunshine Act e il monitoraggio dei rischi relativi agli HCP. In Vector coordina team interfunzionali dedicati all’integrità dei dati, al servizio clienti e all’allineamento normativo.
Vector Health Compliance
Il principale partner in Italia per la conformità al Sunshine Act
The journey toward full enforcement has involved several important steps:
- June 2022: The Sunshine Act was officially enacted, setting the stage for sweeping changes in how healthcare industry interactions are disclosed and reported.
- Late Summer 2023: The Ministry of Health invited public input on the technical specifications of the Act, culminating in the release of a feedback report in October.
- December 2023: Stakeholders and the Ministry engaged in direct discussions to address outstanding concerns.
- March 2025: The Ministry of Health presented the Sanità Trasparente register, outlining the process for reporting and publication of data, with stakeholders providing further feedback shortly after.
Projected Reporting and Publication Timeline
According to recent industry updates, if the Sanità Trasparente register goes live by the end of 2025, the reporting process is expected to follow the following timeline:
- First Half of 2026: Companies must disclose relevant transactions by December 31, 2026, with public access granted in early January 2027.
- Second Half of 2026: Reports are due by June 30, 2027, and will be published in early July 2027.
- Annual Financial Interests for 2026: These must be reported by January 31, 2027, with publication scheduled for March 2028.
What Must Be Disclosed?
The Italian Sunshine Act sets clear thresholds and categories for mandatory reporting:
- For Healthcare Professionals (HCPs): Any single transfer of value over €100 or annual total exceeding €1,000.
- For Healthcare Organizations (HCOs): Individual transactions above €1,000 or annual totals over €2,500.
- Additional Disclosures: Service contracts, advisory fees, event participation, equity holdings, bond ownership, and royalties from intellectual property must all be reported.
Sanità Trasparente Public Portal and Penalties
All submitted data will be made available to the public for five years on the Ministry’s Sanità Trasparente portal. Importantly, HCPs and HCOs are considered to have consented to disclosure by accepting the benefit or agreement.
Non-compliance can result in substantial penalties, including:
€1,000 + 20 times the undeclared amount.
€5,000–€100,000 for false, missing, or uncorrected disclosures.
Public listing of violating companies’ names for at least 90 days.
What To Get Right Before the Telematic Register Goes Live
With the Italian Sunshine Act’s requirements set to become enforceable soon, healthcare, pharmaceutical, and medical technology companies that engage in financial interactions with HCPs and HCOs should take proactive measures such as:
Reviewing and updating internal policies, contracts, and digital systems to ensure alignment with the law.
Preparing for the technical aspects of data submission, including XML formatting.
Assessing how these Italian Sunshine reporting requirements intersect with broader European transparency initiatives, such as those from EFPIA and MedTech Europe.
Looking Ahead
Non-compliance with the Italian Sunshine Act is not only expensive but also has the potential to leave a significant mark on the reputation of life sciences companies. It is high time for companies to prepare for reporting that is accurate, safe, and audit-ready. Vector Health is offering a free discovery session for a limited time for manufacturers to assess where they stand today in terms of sunshine reporting.
Trusted by Compliance, Legal, and Regulatory teams, Vector Health helps life science companies with audit-ready Italian Sunshine reporting through its QA-first methodology.
At our recent event in Milan, we discussed 7 key capabilities required for excellence in reporting that are based on our QA-first methodology. Request your copy here.