How Legal Teams Can Support Accurate XML Reporting

Legal teams are often pulled into Sunshine Act reporting at the last minute, reviewing data extracts they didn’t create and trying to interpret XML errors they didn’t cause.

And they’re the ones who can be asked to explain why an “agreement” didn’t match a disclosure, why a clause was interpreted differently, or why a seemingly minor data error might expose the company to public scrutiny.

But here’s the truth: legal teams don’t need to get lost in data models or XML schemas to make a critical impact on transparency reporting. Their role isn’t to build files, it’s to build defensibility.

As Italy’s Sunshine Act is rumoured to enter full enforcement soon, the collaboration between compliance and legal has never been more essential. XML accuracy may be technical, but the accountability behind it is legal.

The Legal Function’s Real Role in Sunshine Reporting

Under the Italian Sunshine Act, every reported transaction that meets the thresholds described in the law, from a €200 conference sponsorship to a multi-year consultancy, becomes a public legal declaration. It represents a statement of fact that could be audited, contested, or cited.

That’s where legal adds value. By ensuring that:

• Contracts align with disclosure definitions, so that payments classified as “conventions” mirror their legal purpose.
• Consent and data protection obligations are properly embedded in agreements with healthcare professionals and organizations.
• Interpretive consistency is maintained, so one affiliate doesn’t label a research honorarium “consulting” while another calls it “sponsorship.”

In short: compliance controls the data, but legal defines the meaning.

Four Ways Legal Can Strengthen XML Accuracy — Without Doing the Data Work

1. Interpret the Grey Zones

Many XML errors stem from uncertainty about what to report, not how to report it. For example, when does an educational grant become a “transfer of value”? Should travel paid through a third party be disclosed? Legal teams can issue interpretation memos or guidance notes to help compliance classify spend consistently across the organization.

2. Embed Transparency in Contracts

If reporting fields like “purpose,” “value,” and “duration” are built into your standard contract templates, the right data is captured at source. Legal teams can revise templates to reflect the Italian Sunshine Act terminology, reducing rework when compliance later extracts spend data.

3. Govern Exceptions, Not Every Record

Legal shouldn’t be buried in spreadsheets. Instead, define a tiered review process, compliance handles routine filings; legal intervenes only in exceptions (late submissions, unusual payments, or high-value relationships). This ensures oversight without overload.

4. Anticipate Disclosure Risks

Once published, transparency data becomes a reputational artefact. Legal can work with communications and compliance to identify potentially sensitive disclosures, for example, unusually high consulting fees or patterns that may draw external scrutiny, and prepare proactive messaging or documentation.

Collaboration Without Overlap

The strongest compliance frameworks are built on role clarity. Compliance owns the operational pipeline: collecting data, validating XML, and managing submissions. Legal provides interpretation, governance, and protection.

Teams that blur those lines often struggle, either legal becomes a bottleneck, or compliance proceeds without sufficient legal context. A better model is structured collaboration: quarterly alignment meetings, predefined escalation triggers, and shared dashboards that give legal visibility without the burden of data handling.

From Data Accuracy to Legal Assurance

As XML reporting evolves from a pilot to a fully public disclosure regime, the role of legal will continue to expand. Every file submitted on the Sanità Trasparente portal carries legal implications, from how a transaction is defined, to how exceptions are justified, to how corrections are logged.

For forward-looking organizations, empowering legal isn’t about pulling them into data work, it’s about building a compliance ecosystem that’s legally sound, transparent, and future-ready.

How Vector Health Can Help

At Vector Health Compliance, we help life sciences companies simplify global transparency reporting,  from XML submissions in Italy to disclosure portals across Europe and beyond. Our integrated solution brings data, compliance, and legal oversight together in one platform, so your teams stay aligned without getting buried in spreadsheets.

Discover how we can help you streamline your reporting process and reduce risk — book a discovery session with our team today.