Italy Implements New Transparency Reporting Regulations

Italian Sunshine Act


In May 2022, Italy approved a new national transparency law regulating relations between pharmaceutical & medical device manufacturers and people operating in the healthcare sector, including healthcare organizations.

Unofficially dubbed the ‘Italian Sunshine Act,’ the law takes inspiration from US Federal Open Payments reporting (colloquially referred to as the ‘Sunshine Act’) and aims to shed more light on the financial relationships between manufacturers and the healthcare sector to guard against corruption.

Prior to the law taking effect, pharmaceutical and medical device manufacturers (‘Manufacturing Companies’) in Italy were only subject to disclosure laws if they were members of a voluntary industry association (e.g., EFPIA/Farmindustria and MedTech Europe/Confindustria Dispositivi Medici).

Now, these entities must disclose reportable transfers of value granted to various entities in the healthcare sector on a central public platform.

Preparing for Change:

Despite the law going into effect in June 2022, the implementation process will be a phased approach to provide Italian lawmakers & agencies the time to establish the disclosure parameters and reporting mechanisms – meaning much of the regulatory scheme has yet to be announced.

However, the current language of the law does provide some salient information for Compliance Officers to start utilizing in preparing their organization for the upcoming changes now:

  • The new law enjoins drug and device ‘Manufacturing Companies’ who have marketable products in the health sector for humans or veterinary use
  • Reportable recipients include ‘Persons Operating in the Healthcare Sector’ and ‘Healthcare Organizations’ (HCOs)
  • A central platform for filing and viewing disclosures, called the Transparency Healthcare Registry (‘Sanità Trasparente’), will be released in stages:
    • Within three months from the date of entry into force of this law, the Minister of Health must disclose the technical characteristics of the public electronic register, as well as the requirements and procedures for the transmission of communications and data entry
    • The platform itself must be operational within six months from the entry into force of the Italian Sunshine Act
  • The first set of transfers of value that must be reported the semester following the release of Sanità Trasparente include:
    • Agreements and payments in cash, goods, services, and other utilities.
      • Only if they have a unit value of more than €100 euros or a total annual value of more than €1,000 given to Person Operating in the Healthcare Sector
      • For HCOs, only when they have a unit value of more than €1,000 or a total annual value of more than €2,500
    • Agreements which produce direct or indirect benefits, including participation in conferences, training events, advisory bodies or scientific committees, or the establishment of consultancy, teaching or research relationships
  • During the second year following the release of the reporting platform, the second set of transfers of value that must be disclosed are:
    • Shares in the company’s capital or bonds issued by the company, registered for the previous year, in the shareholders’ register or in the bond register held by reportable recipient
    • Fees for the granting of licenses for the economic use of industrial or intellectual property rights

Insight to Planned Enforcement:

The current language also provides insight into the comprehensive enforcement guidelines. Interestingly, the penalties for violating the law vary depending on the types of transfers of value that were misrepresented.

Under the law, any sanctions will be made public in Sanità Trasparente as well as the Ministry of Public Health website, which will publish the enforcement action along with the name of the Manufacturing Company.

In short, compliance officers can take action right now to prepare their organizations to file their first reports, but they also need to carefully monitor developments and further clarifications.

Road Mapping Success:

For a look deeper into these changes and how to start getting your compliance department prepared, we encourage you to check out Italian Sunshine – New Transparency Act is Now in Force appearing in the August 2022 edition of Policy & Medicine. Authored by MedPro Systems’ Senior Compliance Advisor, Elan Schefflein, Elan breaks down specifics of the law, key takeaways, and what to start putting in place now.

For additional information on the Italian disclosure requirement, please visit the Italy Transparency Navigator in RegulatoryID. Don’t have RegulatoryID? Please contact or submit a contact us to learn more!

Similar Posts