Italy’s Sunshine Act Is Almost Live. Is Your Company Ready?

After years of regulatory groundwork, Italy’s healthcare transparency regime is entering its final stage before becoming enforceable. The Italian Ministry of Health has confirmed that the technical and regulatory framework underpinning Law No. 62/2022 is substantially complete, and the Sanità Trasparente online portal is now accessible for company testing.

This is not a dress rehearsal you can skip. The Ministry has made clear that once the platform passes quality assurance, free of significant technical issues, mandatory disclosure obligations will activate immediately. All test data will be wiped, and real reporting begins.

“Once testing concludes and the platform is deemed ready, mandatory disclosure comes into force — with no additional grace period signaled.”

For applicable manufacturers — pharmaceutical, biotechnology, medical device, nutraceutical, and other healthcare-related companies — this means the compliance clock is running now, not when the law formally activates.

Covered transfers include consulting fees, speaker honoraria, sponsorships, educational grants, travel and hospitality, research funding, donations, and ownership interests. Scientific societies and patient organizations are also covered recipients — a scope that often catches teams off guard.

Activation Readiness Checklist

• Complete your Sanità Trasparente portal testing and report any malfunctions to authorities
• Audit transfer-of-value tracking systems for all covered recipient categories
• Implement reconciliation controls to catch cumulative threshold breaches across the calendar year
• Establish cross-functional transparency oversight (Legal, Medical Affairs, Commercial, Finance)
• Build audit-ready documentation packages for all direct and indirect transfers
• Train field teams on EUR 100 HCP single-transfer disclosure trigger — lower than many EU peers

Companies already operating under EFPIA disclosure frameworks will have a head start, but Italy’s scope and threshold structure differs enough to warrant a dedicated compliance review — particularly for companies with active medical education, advisory board, or patient advocacy programs.