How Medicrea’s Case Connects to the Italian Sunshine Act

Medicrea faced $2 million in penalties due to failures in transparency reporting and violations of anti-kickback laws—a scenario that could easily happen in Italy if companies are unprepared for the Italian Sunshine Reporting.
Here’s why your business should take note:

• Italy’s Transparency Rules Are Expanding – Just like in France and the U.S., Italy’s Sunshine Act requires detailed reporting on transfers of value to healthcare professionals (HCPs) and healthcare organizations (HCOs). Any failure to track, report, or comply can lead to financial and legal consequences.
• Global Compliance Isn’t Optional – Medicrea’s case proves that regulatory enforcement extends beyond borders. If your company operates in Italy, you need to be prepared now—waiting until the Telematic Register goes live could leave you exposed.
• Non-Compliance Comes at a Cost – Medicrea’s penalties weren’t just financial; they faced reputational damage and regulatory scrutiny. A failure to align with Italian transparency requirements could mean severe fines and investigations that impact your bottom line.
• Prevention is Better Than Penalties – Medicrea’s violations stemmed from gaps in reporting and oversight. Companies preparing for the Italian Sunshine Act must have strong systems in place to accurately track, report, and manage compliance—before it’s too late.

Don’t Wait for a Compliance Crisis—Prepare Now

Join us in Milan on February 26th for an exclusive Sunshine Act Compliance Dialogue—a networking event designed to help compliance and legal professionals stay ahead of Italian Sunshine Reporting requirements.

Hear from industry experts at Baker McKenzie & Vector Health

Engage in discussions with peers facing the same compliance challenges

Learn how to avoid costly missteps before the Telematic Register launches

Date: February 26, 2025

Location: Baker McKenzie, Milan

No fee for drug, device, veterinary & chemical manufacturers

Secure your spot today:

Avoid the Medicrea Mistake—Get Compliance Right from the Start

• If you do business in Italy, this law affects you.
• If you work with HCPs or HCOs, reporting is mandatory.
• If you wait until the last minute, you risk financial penalties.

Join us for an evening of compliance, conversations, and cocktails—and make sure your business is on the right track.

P.S. If you think this doesn’t affect you, think again. Help a colleague stay compliant—share this invite with your team.