From Open Payments to Sanità Trasparente: A Tale of Two Transparency Systems

Picture this: You have time-traveled to 2013, and you see pharmaceutical and medical device companies in the U.S scrambling to understand a new reality. The data collection process for the Sunshine Act has just started, and suddenly every consulting fee, speaking engagement, and research grant to healthcare professionals must be reported to the government and published for all to see.

Fast forward to 2025, and Italian life sciences companies are experiencing their own transparency awakening as Sanità Trasparente prepares for launch.
Two countries, one mission: illuminate the financial relationships between healthcare companies and the professionals they work with. But while the destination is the same, the journeys are strikingly different.

The Genesis of Transparency

Both systems emerged from the same fundamental question: When does financial support become undue influence? The answer isn’t to eliminate collaboration—innovation thrives on partnerships between industry and healthcare. Instead, transparency creates accountability. Patients deserve to know if their physician received $50,000 in consulting fees from the company making their prescribed medication. Policymakers need visibility into funding patterns when evaluating treatment guidelines.

In the US, Open Payments now captures over $13 billion annually in industry payments, creating the world’s largest database of healthcare industry relationships. Italy’s system, when fully operational, promises to be equally comprehensive—but with a distinctly European twist.

Who’s Watching Whom? The Scope Dilemma

Here’s where the paths diverge dramatically.

The American Approach: Surgical Precision Open Payments keeps it relatively simple. Drug and device manufacturers report payments to physicians, certain non-physician practitioners, and teaching hospitals. Individual payments over $13.46 or annual aggregates exceeding $134.54 must be disclosed (these thresholds adjust annually for inflation). It’s a defined universe with clear boundaries—think of it as a well-lit room where everyone knows where the walls are.

The Italian Expansion: Casting a Wider Net Sanità Trasparente takes a different philosophy entirely. The Italian system acknowledges that healthcare decisions aren’t made in isolation by individual physicians. Administrative leaders influence purchasing decisions. Patient advocacy groups shape treatment narratives. Professional societies set clinical standards. CME providers influence continuing education. All of these relationships matter, so all must be disclosed.

For compliance teams, this means your stakeholder mapping exercise just became significantly more complex. That patient association you sponsor? Reportable. The administrative director who influences hospital purchasing decisions? In scope. The professional medical society receiving your educational grant? Absolutely included.

The thresholds reflect this broader scope: €100 for individual transfers to healthcare professionals (with annual aggregates of €1,000), and €1,000 for organizational transfers (with annual aggregates of €2,500). It’s a wider net with a finer mesh.

The Rhythm of Disclosure: Annual vs. Semi-Annual

America’s Established Cadence By now, US companies have their Open Payments rhythm down to a science. Data collection flows throughout the year, submission happens by March 31st, recipients get their review period through mid-May, and the public release comes in late June. It’s predictable, allowing teams to build workflows around these fixed dates.

Italy’s Dual Timeline Challenge Sanità Trasparente introduces a more complex reporting schedule: semi-annual submissions for most transfers of value, with annual reporting for ownership interests and intellectual property payments. This means compliance teams must maintain two separate calendars and data collection cycles—a significant operational shift for companies accustomed to annual reporting rhythms.

Think of it as switching from one large annual report to a series of quarterly earnings calls—more frequent touchpoints requiring more consistent data hygiene throughout the year.

The Devil in the Data Details

Here’s where compliance professionals earn their keep: getting the categories right.

Classification Consistency Challenges A speaking engagement at a medical conference might be classified as “Consulting” in Open Payments but could fall under “Professional Services” or “Event Participation” in Sanità Trasparente. This isn’t just semantic hair-splitting—different categories carry different reputational implications and analytical weight.

The Documentation Depth Difference Open Payments focuses primarily on transactional data—who received what, when, and for what general purpose. Sanità Trasparente digs deeper into the agreement level, requiring documentation of roles, responsibilities, and contractual relationships. This means your contract templates, speaker agreements, and consulting arrangements need to capture more granular detail from the outset.

Privacy, Consent, and the GDPR Factor

This is where the Atlantic Ocean creates more than just geographical separation.

The American Transparency Default In the US, transparency is the default setting. Physicians can review and dispute their records, but CMS will publish the data by the deadline even if disputes remain unresolved, simply marking contested records as disputed. The system prioritizes public access over individual privacy preferences.

The European Balance Italy must navigate transparency obligations within GDPR’s framework. This creates additional procedural requirements, such as providing privacy notices to HCPs and HCOs. Companies need processes for handling access requests, correction demands, and potentially even erasure requests—all while maintaining transparency obligations.

Learning from Experience: What the Data Tells Us

After more than a decade of Open Payments, patterns have emerged that Italian companies can learn from:

The Reputational Reality Financial penalties, while meaningful, rarely match the reputational impact of transparency reporting errors. A single misclassified payment that suggests inappropriate influence can generate more negative attention than a regulatory fine. The lesson: invest in accuracy over speed.

The Consistency Imperative The most common problems trace back to data inconsistencies—the same recipient’s name spelled differently across systems, identical activities categorized differently by different business units, or events managed through third parties where attribution trails disappear. Companies with clean master data models and enforced taxonomies consistently outperform those with fragmented approaches.

The Proactive Communication Advantage While Italy doesn’t mandate a formal dispute resolution period like Open Payments, smart companies build their own recipient notification and verification processes. A simple email confirming details before publication prevents most disputes and demonstrates a good-faith effort at accuracy.

The Bottom Line: Transparency as Competitive Advantage

Done right, transparency reporting becomes a competitive differentiator rather than a compliance burden. Companies that can demonstrate clean, consistent, and proactive disclosure practices build trust with healthcare providers, regulators, and the public. Those that struggle with accuracy, timeliness, or stakeholder communication find themselves explaining defensive positions instead of highlighting collaborative achievements.

As transparency requirements continue to expand globally, the organizations that build robust, scalable, and stakeholder-friendly disclosure processes today will find themselves ahead of the curve tomorrow. The question isn’t whether transparency is coming to your markets—it’s whether you’ll be ready when it arrives. If your team already manages Open Payments effectively in the US and also operates in Italy, read our blog on the best ways to prepare for Sanità Trasparente and make global transparency a part of your competitive strategy.