After its passage in June 2022, Italy’s Sunshine Act (Law 62/2022) is finally moving toward implementation—marking a significant development in life sciences transparency. The law introduces mandatory reporting obligations for financial relationships between life sciences companies and healthcare professionals (HCPs) or healthcare organizations (HCOs), including transfers of value (ToVs), financial interests, and service agreements.

Key Milestones and Implementation Timeline

  • June 26, 2022 – Law 62/2022 entered into force.
  • August 17–September 24, 2023 – Ministry of Health conducted public consultation on technical specs and draft decree.
  • October 8, 2023 – Consultation feedback report published.
  • December 4, 2023 – Stakeholders formally met with the Ministry to present concerns.
  • March 20, 2025 – Ministry showcased the Sanità Trasparente (Transparent Health) register and reporting process.
  • March 24, 2025 – Stakeholders submitted written feedback highlighting outstanding concerns.

Based on a recent presentation provided by Confindustria Dispositivi Medici, the Italian trade association representing medical device companies, if the register goes live in December 2025, then the following represents the applicable reporting timeline:

  • Agreements, disbursements, and ToVs from:
    • Jan–Jun 2026 must be reported by Dec 31, 2026 (published Jan 1–7, 2027)
    • Jul–Dec 2026 must be reported by Jun 30, 2027 (published Jul 1–7, 2027)
  • Financial interests for the full year 2026 must be reported by Jan 31, 2027 (published in March 2028)

What Must Be Disclosed

  • Transfers to HCPs > €100/item or > €1,000 annually
  • Transfers to HCOs > €1,000/item or > €2,500 annually
  • Service agreements, consultancies, and participation in events, committees, or advisory boards
  • Shareholdings, bond ownership, and intellectual property royalties

Public Registry and Penalties

  • Data will be published on the Ministry of Health’s Sanità Trasparente portal for 5 years
  • Consent is implied upon acceptance of the benefit or agreement
  • Penalties include:
    • €1,000 + 20x the undeclared amount
    • €5,000–€100,000 for missing, false, or uncorrected disclosures
    • Publication of violating companies’ names for at least 90 days

Next Steps for Companies

With enforcement now within reach, companies should:

  • Align SOPs, contracts, and CRM systems with the law
  • Prepare for XML-based data submissions
  • Evaluate how overlapping international transparency requirements (EFPIA, MedTech Europe) interact with Italy’s regulations

As one of the most comprehensive transparency laws in the EU, compliance with Italy’s Sunshine Act will require companies to review all processes and systems involved with the capture of transfers of value to Italian HCPs and HCOs.

May 29, 2025

Tim Robinson
General Counsel & Privacy Officer