Italy – Sunshine Act Introduces Broad Disclosure Obligations Across Healthcare Relationships

The Italian Sunshine Act (Law No. 62/2022), in force since June 2022, introduces mandatory transparency obligations for transfers of value between healthcare companies and healthcare professionals or organizations.

While the legal framework is established, full implementation remains pending the activation of the public electronic reporting register, making early preparation a key focus for in-scope entities.

Regulatory Background

The Act applies to a broad range of “producing companies” operating in the healthcare sector, including those involved in the development, manufacture, or commercialization of medicines, medical devices, and related services. It also captures entities organizing healthcare-related events and activities.

Disclosure obligations are triggered where transfers of value exceed defined thresholds:

• Healthcare professionals: €100 per transaction or €1,000 annually
• Healthcare organizations: €1,000 per transaction or €2,500 annually

In addition to financial and in-kind benefits, the Act requires disclosure of agreements that generate direct or indirect value, regardless of monetary amount. This includes arrangements such as:

• Participation in conferences or training events
• Membership of advisory or scientific committees
• Consultancy, teaching, or research engagements

All disclosures must be submitted electronically to the public register in accordance with Ministry of Health requirements. Where a producing company is headquartered outside Italy, its local branch or appointed representative may fulfill the obligation on its behalf.

Applicability and Scope

The requirements apply to:

• Producing companies operating in the human or veterinary healthcare sector, including foreign entities with an Italian presence
• Healthcare professionals and individuals involved in decision-making, resource allocation, or advisory roles within healthcare organizations
• A wide range of healthcare organizations, including public and private institutions, research bodies, universities, professional associations, and patient organizations

Reporting Timeline

Once the reporting platform becomes operational, companies will be required to submit disclosures annually by the 31^st of January, covering all reportable transfers of value from the previous calendar year.

Practical Considerations and Ongoing Obligations

While the reporting system is not yet live, companies should begin preparing by:

• Mapping interactions with healthcare professionals and organizations
• Identifying reportable transfers of value and agreements
• Implementing internal processes to track and validate disclosure data

Producing companies are responsible for ensuring that all submitted information is complete and accurate, in line with statutory requirements.

Risks of Non-Compliance

The Act introduces a structured penalty framework for non-compliance, including:

• Fines for failure to submit required disclosures, calculated per omission and linked to the value of the transfer
• Penalties ranging from €5,000 to €100,000 for incomplete or false information
• Reduced penalties for smaller companies (turnover below €1 million), subject to certain conditions

Given the scale of potential penalties and the public nature of the register, early preparation is key to mitigating compliance risk.

How Mercator® by Citco (Mercator) Can Help

Mercator can assist with:

• Assessing applicability and identifying in-scope activities
• Designing and implementing disclosure tracking processes
• Monitoring the launch of the reporting platform and supporting timely submissions

For assistance, please contact mercator@citco.com