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 (TOV) 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(ITA).
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 compliance experts provide guidance on the most effective ways to meet 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 with no Italian office, we offer tailored solutions to ensure compliance through your local distributors.
Why Choose Us?
Expert Guidance:
We provide up-to-date insights into Italian and global transparency regulations.
Tailored Solutions:
Our services are customized to meet your specific needs.
End-to-End Compliance:
From data gathering to final reporting, we handle every step.
Proactive Approach:
With us, you’ll be ready for full compliance when the Sanità Trasparente portal launches.
How the Italian Sunshine Act Impacts You
Under the Italian Sunshine Act, companies that provide products or services to the healthcare industry must disclose all financial relationships with HCPs and HCOs. This includes everything from payments for services to gifts and travel expenses.
If you’re a global company without an Italian office, you’re still required to report, but we’ll help streamline the process by managing your disclosures through your local partners(ITA).
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.
FAQs
1. What is the Italian Sunshine Act?
The Italian Sunshine Act mandates that companies disclose financial relationships with HCPs and HCOs to promote transparency and prevent conflicts of interest(ITA).
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(ITA).