Italian Sunshine Act: Transparency Reporting Requirements

Adhering to the Italian Sunshine Act’s Transparency Reporting Obligations

The Italian Ministry of Health established transparency reporting requirements for businesses engaged in the production and promotion of healthcare services and products with the enactment of Law No. 62, dated May 31, 2022, also referred to as the Italian Sunshine Act. Although it is similar to regulations in other countries, the law expands its reach as the legislation with a broad scope of reporting companies, strict deadlines for disclosing ‘transfers of value’, which will take effect once the Sanità Trasparente platform becomes operational, and several unique compliance requirements.

Who Must Report?

Before the law was introduced, transparency requirements regarding value transfers in the pharmaceutical and healthcare sectors in Italy only applied to members of trade associations such as Farmindustria and Confindustria Dispositivi Medici. Other companies that weren’t members of trade associations were voluntarily adhering to these regulations.

The law broadens the list of reporting entities that must comply with the updated transparency reporting requirements. Manufacturing firms that directly or indirectly produce or market medical goods or services, including non-healthcare goods that can be sold in the human and animal health sectors, are included in the law’s extremely broad definition of reporting businesses.

Because of this expansive definition, the Italian Ministry of Health conducted a public consultation to gather feedback and input from impacted companies. The Ministry used the outcomes of the consultation, which took place from August 17 to October 8, 2023, to develop a decree that clarified the duties of various players.

What Needs to Be Reported?

Healthcare manufacturers and other relevant companies are required by the Italian Sunshine Act to report on a wide range of transactions that benefit healthcare organizations (HCOs) and healthcare professionals (HCPs). In particular, it is required by law to report on:

• Transfers of value, including donations of cash, products, services, or other benefits
• Agreements that result in either direct or indirect benefits, such as involvement in training sessions, conferences, committees, commissions, and consultative bodies, as well as the development of teaching, research, or consulting partnerships,
• Ownership interests, such as bonds and shares in manufacturing companies or other applicable entities, including those held in full or in part as remuneration.
• Fees paid to HCPs or HCOs for intellectual property rights licensing

Any “transfers of value” in favor of medical professionals must be reported if the overall annual value of the transfers exceeds 1,000 EUR or if the value of the individual transfers exceeds 100 EUR. If the payment is done in support of a healthcare organization, the overall yearly value threshold is equivalent to 2,500 EUR, while the individual transfer amounts are 1,000 EUR.

Where Do I Need to Report the Data?

Information about value transfers, agreements, shares, and bonds will be submitted by reporting entities to the Ministry of Health’s Sanità Trasparente database, where it will be made publicly accessible. The database’s records will contain separate sections for each kind of transfer, disbursement, and agreement, as well as details on the penalties imposed on manufacturers who do not comply. For at least five years after publishing, the public will be able to freely search and sort the data kept in the database.

Timeline for Reporting

The structure of the database Sanità Trasparente, including its technical features and the process by which businesses will submit their data online, will be decided by the Ministry of Health, in cooperation with the Agency for Digital Italy (AgID), the National Anticorruption Authority (ANAC), and—most importantly—the Italian Data Protection Authority (Garante Privacy). In practice, privacy features are built into the system by default and by design.

Once the Sanità Trasparente platform becomes operational, medical product manufacturers and other reporting entities will be required, under Article 3 of the Italian Sunshine Act, to disclose transfers of value and agreements with healthcare professionals (HCPs) and healthcare organizations (HCOs) by the end of the semester following the one in which the transfer or agreement occurred. This reporting schedule is based on a semester system rather than a fixed number of days or months.

According to Article 4 of the Italian Sunshine Act, reporting entities must submit information by January 31st of the following year on shares, bonds, or other ownership interests held by HCPs or HCOs in the company, as well as any payments made to them for the licensing of intellectual or industrial property rights.

If the Ministry of Health activates the Sanità Trasparente platform in June 2025, reporting obligations would begin in early 2026.

• Transfers of value and agreements made in the second half of 2025 would need to be reported by June 30, 2026.
• Ownership interests and IP-related payments made in calendar year 2025 would need to be reported by January 31, 2026.

Privacy Concerns

A significant provision addressing privacy concerns pertaining to information reports can be found in the Italian Sunshine Act. The Sunshine Act makes it clear that individual disclosure is required, even if the previous laws permitted disclosure on value transfers in aggregate form in some circumstances, such as when obtaining consent for such disclosure was not possible.

In order to do this, the law stipulates that when there is a value transfer, agreement signing, or the receiving of shares or other advantages, healthcare professionals and organizations- this is
considered implied consent for the disclosure of their information. Despite the fact that HCP or
HCO consent is considered implied, businesses still have a responsibility to notify them of the disclosure by sending them a privacy notice that must, at the very least, explain that their information will be posted on the Ministry’s database Sanità Trasparente.

Penalties for Failure to Comply

Manufacturers and other reporting businesses that violate the Italian Sunshine Act are subject to severe penalties for each instance in which they do not fulfill their transparency duties. In addition to that, fines will be publicly available and freely searchable on the Sanità Trasparente database for at least 90 days after they are published.
The following penalties for non-compliance are included in the law’s text:

• €1,000, plus 20 times the value of each unreported transfer of value or other disbursement
• Between 5,000 and 50,000 euros for failure to report transfers of shares, bonds, or payments related to intellectual property licenses to HCPs or HCOs.
• 5,000 to 100,000 euros for giving incorrect details about agreements, value transfers, share transfers, or licensing payments.

Simultaneously, the Sunshine Act lessens penalties for reporting organizations with yearly turnover under one million euros. A defaulting manufacturer must be an independent business with no contractual or affiliation ties to other manufacturing companies in order to be eligible for reduced penalties.

Find Out More With Vector Health

The Italian Sunshine Act’s Transparent Healthcare database (Sanità Trasparente) is still in the planning stages, but once the register is up and running, medical product manufacturers and other reporting organizations included in the law must be fully prepared to ensure compliance. Now is the time for relevant manufacturers and entities to review their internal policies regarding their interactions with HCPs and HCOs and implement internal frameworks.

Given the extent of reporting, tight deadlines, and severe fines outlined in the Italian Sunshine Act, using digital technologies is essential to enable data collecting, data storage, and timely submission.

Get started by booking a discovery session with Vector Health. In this session, we’ll walk you through the five essential stages for preparing for the Telematic Register. We’ll also outline the roadmap and timeline, explain the level of effort required, and guide you on the key steps you’ll need to take to ensure you’re fully ready before the platform goes live.

Italian Sunshine Reporting Readiness Blueprint

A Clear, Practical Start to Sunshine Compliance

Preparing for Italy’s Sunshine reporting requirements can feel overwhelming — new rules, strict deadlines, and the pressure of getting every detail right.

Vector Health’s Italian Sunshine Reporting Readiness Blueprint is a free, expert-led service that gives you a clear view of your current compliance status — and exactly what needs to happen next. It will help you understand where your company stands today and what you’ll need to do to become fully compliant. It’s the essential first step before investing time, money, or panic into remediation.

We’ve delivered this blueprint to multiple international organizations, and the results consistently provide clarity, direction, and measurable value.

What’s Included in the Readiness Blueprint:

• A full mapping of your reportable spend — cash, in-kind, hospitality, services.
• A system-by-system inventory of where your Sunshine-related data currently lives.
• Clear identification of gaps in your data — missing HCP info, manual logs, inconsistent records.
• A prioritized, actionable next-steps plan to address risks and ensure compliance.
• A departmental readiness diagram that visually shows strengths, gaps, and risk zones.

All findings are delivered in a structured report — ready to be used by your Compliance, Legal, and Finance teams.

Think of it as a compliance x-ray: we show you what’s working, what’s missing, and how to fix it — before you spend a euro.