Building an Audit-Proof Transparency Program Before Italy’s Sunshine Act Goes Live

The question is: will your reporting withstand the audit, or will it become a cautionary tale like Novo Nordisk in the UK or the repeated errors flagged in the US under Open Payments?

Why Audit-Proofing Matters

Global audits have repeatedly shown that most reporting errors are preventable. Novo Nordisk, for example, voluntarily admitted that it had failed to disclose approximately £7.8 million in transfers of value over three years in the UK. This turned out to be a systemic failure in its internal disclosure processes that led to public reprimands and multiple findings of breach under the ABPI Code.

Similarly, US Open Payments experience shows that companies are at risk of underreporting when small, repeated payments are not correctly aggregated to the annual thresholds, or when key identifiers (such as NPIs or state license numbers) are missing or wrong, which are issues that CMS guidance and industry analyses repeatedly flag as common data-quality failures.

For Italian companies preparing for the Sunshine Act, these lessons are clear: an audit-proof program is not optional, it’s essential for avoiding reputational damage, financial risk, and regulatory scrutiny.

5 Foundations of an Audit-Ready Transparency Program

1. People: Train, Align, and Empower
   Compliance starts with people. Teams across finance, medical affairs, and compliance must understand their roles in transparency reporting. Standardized training ensures everyone speaks the same language regarding HCP/HCO identifiers, spend categories, and thresholds.
2. Process: Define Clear Workflows
   Map each step of the reporting process. From data collection to submission, every touchpoint should be defined, accountable, and monitored. Include internal quality checks and cross-department reconciliation before submission.
3. Systems: Use Technology Wisely
   Manual processes fail. Implementing a digital platform for transparency reporting ensures correct identifier validation, automatic categorization of payments, real-time aggregation, and alerts for missing or inconsistent data.
4. Controls: Build Compliance Into the Workflow
   Embed automated controls to catch errors early. Configurable business rules can flag misclassified payments, duplicate records, or threshold breaches before they reach regulators. This reduces the risk of costly rework or audit findings.
5. Documentation: Keep an Audit Trail
   Audit-ready documentation is your safety net. Maintain detailed notes on methodology, assumptions, data sources, and reconciliations. Under Article 5(4) of Italy’s Sunshine Act, data published in Sanità Trasparente remain publicly accessible for five years before deletion, so companies should retain their supporting documentation for at least that period, and longer where needed to defend against investigations or litigation.

Preparing for Italian Regulator Expectations

Italy’s Sunshine Act pursues the same transparency goals as EFPIA and Farmindustria Code of Conducts through public disclosure of ToVs, but is broader in scope and legally binding, with its own thresholds, timelines and sanctions.

Early preparation allows companies to adapt internal processes, align cross-functional teams, and adopt technologies that ensure smooth compliance from day one. Companies that proactively audit their own processes before submission will gain a competitive advantage and avoid the pitfalls seen globally.

Why Modern Compliance Teams Are Automating Early

Companies using advanced transparency platforms can:

• Validate identifiers against official registries automatically.
• Classify payments correctly and consistently.
• Aggregate transactions in real time to meet thresholds.
• Maintain comprehensive, linked documentation for audit readiness.

The result? Compliance teams focus on strategic oversight, not firefighting errors.

Final Takeaway

Italy’s Sunshine Act is inevitable, and its reporting obligations will be public and scrutinized. By learning from global audit failures and building an audit-proof transparency program, Italian life sciences companies can ensure that when the spotlight hits, it shines on preparedness rather than errors.

Build your audit-ready transparency program today. Discover how Vector Health Compliance can help automate, align, and future-proof your Sunshine Act reporting.