A Compliance Professional’s Guide on Mastering Italian Sunshine Reporting

The Italian Sunshine Act (Legge 31 maggio 2022, n.62) marks a significant step forward in advancing transparency in Italy’s healthcare sector and aligning with global sunshine reporting standards. Enacted on June 26, 2022, the Act introduces a mandatory framework for life sciences companies and manufacturers of pharmaceutical and medical devices to disclose financial interactions with healthcare professionals (HCPs) and healthcare organizations (HCOs). These disclosures aim to reinforce public trust and ensure compliance within the healthcare ecosystem

The cornerstone of this legislation is the upcoming launch of the national reporting platform, Registro Pubblico Telematico (Sanità Trasparente), which is expected to go live later in 2025, with December 2025 as the projected date. This platform will serve as the centralized repository for all disclosures, allowing public access to financial relationships between life science industry and healthcare stakeholders. Prior to this legislation, only members of trade associations like Confindustria Dispositivi Medici were subject to voluntary self-regulatory codes, lacking legally binding enforcement

When the Italian Sunshine Act will come in force once the , companies must now prepare comprehensive transparency reports (rapporto di trasparenza) under the supervision of the Ministry of Health and regulatory bodies such as AIFA (Agenzia Italiana del Farmaco), supported by AGID (Agenzia per l’Italia Digitale). These reports must be submitted annually, with deadlines set for January 31st of each year for data collected in the previous semester

Reporting Obligations and Thresholds

Under Articles 3 and 4 of the Act, companies must disclose any transfers of value (ToVs) exceeding:

• €100 per instance or €1,000 annually to HCPs
• €1,000 per instance or €2,500 annually to HCOs

Covered interactions include gifts, payments, and agreements related to events, consulting, advisory services, and research. Each report must include a methodological note explaining how the data was collected and calculated, including tax and currency details and whether values are reported individually or in aggregate.

Importantly, the law assumes that HCPs and HCOs consent to the publication of their data when entering agreements with companies. However, companies are still required to notify recipients in advance about the planned disclosure, ensuring alignment with EU GDPR (Regulation 2016/679).

Sanità Trasparente: Features and Governance

Sanità Trasparente is an electronic public register being developed by the Ministry of Health in consultation with AGID to meet open data and accessibility standards. The platform will enable the public to search, view, and analyze reported data without restriction. This digital infrastructure supports Italy’s broader push towards healthcare transparency and digital transformation.

Once operational, Sanità Trasparente will override existing voluntary disclosure practices and enforce legally binding requirements across the pharmaceutical and medtech industries. The platform will be maintained by the Ministry of Health, with technical oversight by AGID and regulatory compliance monitored by AIFA.

A Compliance Professional’s Tips on Preparing for Italian Sunshine Act

If the Telematic Register is launched in December 2025, life sciences companies will be required to start collecting data on agreements, disbursements, and transfers of value (ToVs) from January 2026 onwards, to guarantee timely and accurate reporting of H1 2026 data in the initial submission cycle

To help life science companies prepare for the launch, below are some tips to help you navigate governance, processes, and technology for seamless Italian Sunshine Act compliance

• Maintain detailed and accurate records of all transfers of value, covering not only amounts but also transaction dates, recipients, and the specific nature of each payment or benefit. These comprehensive records are crucial for timely and compliant submissions to Registro Pubblico Telematico (Sanità Trasparente)

• Staying up to date with regulatory developments and evolving requirements of the Italian Sunshine Act and the launch of Sanità Trasparente is essential, as the Ministry of Health. We regularly answer the most pressing questions related to the Italian Sunshine Act and offer expert-led insights to help compliance professionals stay ahead of the curve and stay prepared for the Act at all times.

• Engaging local legal and compliance experts can help compliance professionals go through the complexities of the Italian Sunshine Act, especially for non-domestic companies new to the reporting landscape. Additionally, adopting automated, cloud-based solutions can streamline data management, reduce manual errors, and ensure that submissions to Registro Pubblico Telematico (Sanità Trasparente) are audit-ready, efficient, and fully aligned with the Italian Sunshine Act’s legal requirements

• Adopt an end-to-end managed transparency reporting solution that helps you gather data consistently and efficiently, gain end-to-end visibility, and track data smartly with advanced dashboards and analytics

Long-term Impact

We’re moving from a time where disclosure was mostly voluntary to one where it’s a legal requirement, and the stakes are higher than ever. Sure, avoiding fines is important, but let’s be honest: the real risk is to your reputation. One misstep in meeting these new transparency standards can do lasting damage to the trust we’ve built with regulators, partners, and the public.

As compliance professionals, you cannot afford to just tick the boxes. It is up to you to get into the details—making sure your data collection is solid, your processes are clear, and every transfer of value is captured and reported accurately. Plus, it is just as important to stay sharp on the legal side, especially around consent, data protection, and how you publish information, so that we’re always in line with both Italian and EU rules

As Italy moves closer to launching the Sanità Trasparente platform, many companies are asking: “Are we ready to meet the obligations of the Sunshine Act?” And more importantly: “What does readiness look like, and how much time does one need to be ready?”

With the deadline to collect data rumored to start in September 2025 — and August traditionally quiet — should you wait for your return in September or have one final conversation before it?

To help you prepare for the Telematic Register on time, we are hosting a free 45-minute webinar designed for legal, compliance, regulatory, and IT teams who know the law and are finalizIng the next steps:

Sunshine Act Obligations. How to Prepare?

To help companies prepare for the Telematic Register on time, we hosted a webinar on July 15, 2025 Sunshine Act Obligations: How To Prepare. Our experts spoke to compliance professionals from 40+ companies about how they can effectively address key legal obligations and set up responsibilities, timelines, and internal tools to avoid reporting mistakes and be legally and operationally “ready.”

Speakers included:

• Edoardo Lazzarini, Former Senior Ethics & Compliance Officer, Southern Europe (Italy, Spain, Portugal), Haleon and Takeda
• Roberto Cursano, Partner Delfino & Associates Law Firm Willkie Farr & Gallagher LLP
• Riccardo Ovidi, Counsel Delfino & Associates Law Firm Willkie Farr & Gallagher LLP

Read the full summary and explore exactly what your teams need to implement now to be ready for reporting under the Italian Sunshine Act.

Let’s lead the way in compliance and show our commitment to doing the right thing, for our business and for the people who count on us.