5 Common Mistakes to Avoid in First-Year Sunshine Reporting
Table of content
- 1. Overlooking the Importance of Detailed “Nature of Spend” Categorization
- 2. Duplicate and Overlapping Transactions
- 3. Misaligned Reporting Periods
- 4. Currency and Value Errors in Cross-Border Scenarios
- 5. Incomplete Documentation and Missing Context
- Beyond Minimum Compliance: Preparing for the Future
- Final Thoughts
Author
Sabrina Morgan is the Head of Global Compliance & Customer Delivery at Vector Health. She oversees global transparency reporting and international disclosure requirements along with the Italian Sunshine Act strategy. She also leads the global client delivery team dedicated to data integrity, compliance solutions, and regulatory alignment for pharmaceutical and MedTech organizations.
Vector Health Compliance
Your Leading Partner in Global Sunshine Compliance
Cerchi supporto per la compliance al Sunshine Act?
Hai domande pratiche?
Dai un’occhiata alla nostra sezione Domande Frequenti per risposte chiare su scadenze, obblighi e strategie.
If you’re preparing to report under Italy’s Sunshine Act (Legge 62/2022), your first reporting cycle may expose gaps that can easily be avoided with foresight and structure.
While the Ministry of Health (MOH) in Italy may only require limited disclosure categories, compliance leaders know that a robust, detailed, and auditable system protects an organization far beyond minimum regulatory expectations. Here’s how to avoid the five most common first-year reporting mistakes — and why going “beyond compliance” matters.
1. Overlooking the Importance of Detailed “Nature of Spend” Categorization
One of the most common (and serious) mistakes in first-year Italian Sunshine reporting is treating the Ministry’s minimal categorization requirements as sufficient.
The MOH currently asks for only three broad “natura” categories, general, research, and ownership, with an optional open “causa” (cause) field. However, mature Sunshine programs (like in the U.S. and France) recognize that more granular categories, such as meals, travel, lodging, conference fees, consulting, and honoraria, are critical for compliance and audit resilience.
We consider maintaining such structured categories essential for:
- Sustaining robust audit trails over extended periods,
- Enabling effective spend monitoring, and
- Preparing for future regulatory developments that may expand reporting expectations.
Our gap remediation analyses for several companies consistently show that those who only meet the minimum requirements struggle later during internal or external audits.
When an auditor reviews a Sunshine report, they are looking for:
- Clear methodology behind data collection and categorization,
- Consistency across reporting periods, and
- The ability to identify the valid reason for each transfer of value (ToV).
To illustrate, imagine two reports that each list payments to the same healthcare professional. The first includes only the total amounts and labels them all “general,” while the second specifies the details, such as airfare, meals, lodging, conference fees, and honoraria.
Both reports technically meet MOH requirements, but only the second provides the context necessary for compliance teams to justify the spend during an audit. In practice, the more detail you provide, the more defensible your report becomes.
Therefore, crafting a standardized, detailed categorization structure (beyond what is mandated) ensures consistency, transparency, and defensibility — all hallmarks of mature compliance programs.
2. Duplicate and Overlapping Transactions
Duplicate entries often occur when different departments or systems record the same event, for example, one team logging a conference sponsorship and another recording an honorarium payment linked to the same physician.
Such overlaps inflate spending figures and can cause unnecessary audit triggers.
Avoid this by:
- Reconciling data through unique transaction IDs,
- Performing pre-submission duplicate checks, and
- Keeping a clear audit trail of any merged or excluded transactions.
3. Misaligned Reporting Periods
Under Italy’s Sunshine Act (Law 62/2022), companies must disclose transfers of value and agreements on a biannual basis, while financial interests such as shareholdings or royalties are reported annually. However, many companies track spend by fiscal year or internal accounting cycles, leading to missing or double-counted data.
To prevent errors:
- Clearly communicate the Sunshine reporting window internally,
- Define cut-off dates for accruals and late entries, and
- Conduct reconciliation between fiscal and calendar-year data before final submission.
4. Currency and Value Errors in Cross-Border Scenarios
For multinational operations, errors in currency conversion or recording payments made abroad in local denominations are common pitfalls. A transaction made in CHF or CZK, if not converted properly, can distort totals and misrepresent values.
To prevent this:
- Adopt a consistent exchange rate source (e.g. European Central Bank rate on the transaction date).
- Flag all foreign currency payments for conversion review.
- Maintain a currency log that records the rate, date, and rationale for transparency.
5. Incomplete Documentation and Missing Context
Missing data fields (like recipient IDs, payment purposes, or agreement references) are among the most frequent issues identified during post-submission audits.
Auditors routinely ask not just for the transaction itself, but for proof of purpose, documentation that connects a spend to a legitimate, disclosed activity. Without this, compliance cannot reasonably justify the reported ToV.
Best practices include:
- Using standardized data templates that capture all mandatory and contextual fields.
- Linking each entry to supporting documents (contracts, receipts, agreements).
- Performing mid-cycle spot audits to ensure data completeness before final reporting.
Beyond Minimum Compliance: Preparing for the Future
While Italy’s Ministry of Health currently requires only limited categorization, experienced transparency teams recognize that compliance maturity depends on systems, not forms. By maintaining detailed “natura” and “causa” fields, building structured data frameworks, and preserving audit trails, companies can position themselves not just to meet obligations, but to anticipate regulatory evolution.
In short, adding more detail today prevents greater risk tomorrow. The most successful compliance teams treat transparency as an investment in accountability — not just a reporting task.
Final Thoughts
The first year of Sunshine reporting is a learning curve. But avoiding the five key mistakes, poor categorization, duplicate entries, misaligned periods, currency errors, and incomplete documentation, sets a foundation for long-term compliance success.
To help you avoid these crucial mistakes, we’re hosting a full-day on-site workshop “Practical Training on Italian Sunshine Act Reporting” on 18th November in Milan, Italy. This is a hands-on, operational training program where you will test your systems, processes, and XML reporting capabilities against the Ministry of Health’s evolving requirements. Together, we will transform global best practices into concrete strategies for Italy—helping you strengthen governance, reduce reporting risks, and lead your organization with confidence.
Register today and get your early-bird discount.
Table of content
- 1. Overlooking the Importance of Detailed “Nature of Spend” Categorization
- 2. Duplicate and Overlapping Transactions
- 3. Misaligned Reporting Periods
- 4. Currency and Value Errors in Cross-Border Scenarios
- 5. Incomplete Documentation and Missing Context
- Beyond Minimum Compliance: Preparing for the Future
- Final Thoughts
If you’re preparing to report under Italy’s Sunshine Act (Legge 62/2022), your first reporting cycle may expose gaps that can easily be avoided with foresight and structure.
While the Ministry of Health (MOH) in Italy may only require limited disclosure categories, compliance leaders know that a robust, detailed, and auditable system protects an organization far beyond minimum regulatory expectations. Here’s how to avoid the five most common first-year reporting mistakes — and why going “beyond compliance” matters.
1. Overlooking the Importance of Detailed “Nature of Spend” Categorization
One of the most common (and serious) mistakes in first-year Italian Sunshine reporting is treating the Ministry’s minimal categorization requirements as sufficient.
The MOH currently asks for only three broad “natura” categories, general, research, and ownership, with an optional open “causa” (cause) field. However, mature Sunshine programs (like in the U.S. and France) recognize that more granular categories, such as meals, travel, lodging, conference fees, consulting, and honoraria, are critical for compliance and audit resilience.
We consider maintaining such structured categories essential for:
- Sustaining robust audit trails over extended periods,
- Enabling effective spend monitoring, and
- Preparing for future regulatory developments that may expand reporting expectations.
Our gap remediation analyses for several companies consistently show that those who only meet the minimum requirements struggle later during internal or external audits.
When an auditor reviews a Sunshine report, they are looking for:
- Clear methodology behind data collection and categorization,
- Consistency across reporting periods, and
- The ability to identify the valid reason for each transfer of value (ToV).
To illustrate, imagine two reports that each list payments to the same healthcare professional. The first includes only the total amounts and labels them all “general,” while the second specifies the details, such as airfare, meals, lodging, conference fees, and honoraria.
Both reports technically meet MOH requirements, but only the second provides the context necessary for compliance teams to justify the spend during an audit. In practice, the more detail you provide, the more defensible your report becomes.
Therefore, crafting a standardized, detailed categorization structure (beyond what is mandated) ensures consistency, transparency, and defensibility — all hallmarks of mature compliance programs.
2. Duplicate and Overlapping Transactions
Duplicate entries often occur when different departments or systems record the same event, for example, one team logging a conference sponsorship and another recording an honorarium payment linked to the same physician.
Such overlaps inflate spending figures and can cause unnecessary audit triggers.
Avoid this by:
- Reconciling data through unique transaction IDs,
- Performing pre-submission duplicate checks, and
- Keeping a clear audit trail of any merged or excluded transactions.
3. Misaligned Reporting Periods
Under Italy’s Sunshine Act (Law 62/2022), companies must disclose transfers of value and agreements on a biannual basis, while financial interests such as shareholdings or royalties are reported annually. However, many companies track spend by fiscal year or internal accounting cycles, leading to missing or double-counted data.
To prevent errors:
- Clearly communicate the Sunshine reporting window internally,
- Define cut-off dates for accruals and late entries, and
- Conduct reconciliation between fiscal and calendar-year data before final submission.
4. Currency and Value Errors in Cross-Border Scenarios
For multinational operations, errors in currency conversion or recording payments made abroad in local denominations are common pitfalls. A transaction made in CHF or CZK, if not converted properly, can distort totals and misrepresent values.
To prevent this:
- Adopt a consistent exchange rate source (e.g. European Central Bank rate on the transaction date).
- Flag all foreign currency payments for conversion review.
- Maintain a currency log that records the rate, date, and rationale for transparency.
5. Incomplete Documentation and Missing Context
Missing data fields (like recipient IDs, payment purposes, or agreement references) are among the most frequent issues identified during post-submission audits.
Auditors routinely ask not just for the transaction itself, but for proof of purpose, documentation that connects a spend to a legitimate, disclosed activity. Without this, compliance cannot reasonably justify the reported ToV.
Best practices include:
- Using standardized data templates that capture all mandatory and contextual fields.
- Linking each entry to supporting documents (contracts, receipts, agreements).
- Performing mid-cycle spot audits to ensure data completeness before final reporting.
Beyond Minimum Compliance: Preparing for the Future
While Italy’s Ministry of Health currently requires only limited categorization, experienced transparency teams recognize that compliance maturity depends on systems, not forms. By maintaining detailed “natura” and “causa” fields, building structured data frameworks, and preserving audit trails, companies can position themselves not just to meet obligations, but to anticipate regulatory evolution.
In short, adding more detail today prevents greater risk tomorrow. The most successful compliance teams treat transparency as an investment in accountability — not just a reporting task.
Final Thoughts
The first year of Sunshine reporting is a learning curve. But avoiding the five key mistakes, poor categorization, duplicate entries, misaligned periods, currency errors, and incomplete documentation, sets a foundation for long-term compliance success.
To help you avoid these crucial mistakes, we’re hosting a full-day on-site workshop “Practical Training on Italian Sunshine Act Reporting” on 18th November in Milan, Italy. This is a hands-on, operational training program where you will test your systems, processes, and XML reporting capabilities against the Ministry of Health’s evolving requirements. Together, we will transform global best practices into concrete strategies for Italy—helping you strengthen governance, reduce reporting risks, and lead your organization with confidence.
Register today and get your early-bird discount.
Author
Sabrina Morgan is the Head of Global Compliance & Customer Delivery at Vector Health. She oversees global transparency reporting and international disclosure requirements along with the Italian Sunshine Act strategy. She also leads the global client delivery team dedicated to data integrity, compliance solutions, and regulatory alignment for pharmaceutical and MedTech organizations.
Vector Health Compliance
Your Leading Partner in Global Sunshine Compliance
Cerchi supporto per la compliance al Sunshine Act?
Hai domande pratiche?
Dai un’occhiata alla nostra sezione Domande Frequenti per risposte chiare su scadenze, obblighi e strategie.