Italian Sunshine Reporting: Ensuring Transparency and Compliance

Overview

The Italian Sunshine Act (Law 62/2022) is a critical step toward enhancing transparency in Italy’s healthcare sector. The law mandates that all transfers of value (TOVs) between healthcare professionals (HCPs) and organizations (HCOs) must be reported publicly, ensuring greater accountability. Though the law came into effect in June 2022, full implementation will not occur until the Ministry of Health establishes the Sanità Trasparente portal, which is expected in 2025.

What We Offer

Our Italian Sunshine Reporting service simplifies the compliance process, helping organizations like yours navigate these new requirements with ease. Whether you’re a pharmaceutical company, medical device manufacturer, or healthcare service provider, our expert team ensures that your transfers of value are accurately recorded and reported on time. We take care of everything from data collection to report submission, ensuring you remain compliant with all legal requirements.


Key Services

1. Data Collection & Reporting

We assist in gathering, organizing, and validating all the necessary information for your TOVs to covered recipients. We manage the entire process, ensuring that every detail is accurate and complete.

2. Legal and Compliance Advisory

Stay informed about the latest changes to the law and how it applies to your organization. Our experts provide guidance on meeting these new transparency obligations.

3. Training & System Integration

We help your organization set up internal policies, conduct training, and integrate necessary systems to capture and report TOVs efficiently.

4. Cross-Border Compliance

For global companies without an Italian office, we offer tailored solutions to ensure compliance through your local distributors.


Why Choose Us?

FAQs

1. What is the Italian Sunshine Act?

The Act mandates that companies disclose financial relationships with HCPs and HCOs to promote transparency and prevent conflicts of interest.

2. Who needs to report?

Drug and device manufacturers, companies providing healthcare services, and global companies working through distributors must report all transfers of value to covered recipients.

3. What are the penalties for non-compliance?

Non-compliance may lead to significant financial penalties for incomplete or missing reports.

4. Do we need consent from HCPs to report?

No, consent is not required to report financial transactions under current regulations.

5. How often do we need to report?

Reporting is biannual, with exact dates pending confirmation from the Ministry of Health.

Take the Next Step

Ready to ensure full compliance with Italian Sunshine Reporting? Book an appointment with our experts today to discuss how we can support your organization’s needs.

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