Lesser-Known Reporting Scenarios and Key Exemptions Under the Italian Sunshine Act
Author
May Khan leads the Compliance Services team at Vector Health, a SaaS company specializing in life sciences compliance. Her experience includes global transparency reporting, Sunshine Act strategy, and HCP risk monitoring. At Vector, she coordinates cross-functional teams dedicated to data integrity, customer service, and regulatory alignment.
Vector Health Compliance
Il principale partner in Italia per la conformità al Sunshine Act
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.
Let’s unpack some of these less obvious reporting scenarios, alongside a few key exemptions, so you’re not caught off guard in your disclosure cycle.
Peer-to-peer honoraria
Peer-to-peer honoraria refer to payments given to healthcare professionals for services provided as peer reviewers or in other similar roles within an organization.
While these may appear to be professional-to-professional transactions, they are not exempt if facilitated or financially supported by a manufacturer. Even if the manufacturer is not directly involved in the interaction, these are considered indirect transfers of value under Article 3 of the Italian Sunshine Act, and hence must be disclosed.
If you’re sponsoring an event, covering an honorarium, or even just facilitating logistics, it is reportable.
Academic stipends and public grants
Academic stipends are financial support provided to individuals in training or research settings, and public grants refer to funding often issued through public institutions for research, education, or program development.
These forms of support are not automatically exempt under the Italian Sunshine Act and become reportable when:
- The funds are channeled through or funded by a manufacturer, or
- There is a reportable agreement between the manufacturer and the recipient HCP or HCO.
This requirement ensures transparency even when influence is exercised indirectly through academic or institutional channels.
In short: if the funding benefits a named HCP or is linked to a manufacturer-driven agreement, it must be disclosed.
Third-party interactions
If a third-party or an intermediary interacts with an HCP or HCO on your behalf, would the accountability lie on that intermediary, or the company?
A distinctive feature of the Italian Sunshine Act is its inclusion of intermediaries. Whether it is:
- Your internal teams managing HCP relationships
- A contracted event planner
- A distributor or partner agency
— anyone acting on your behalf in transferring value to an HCP or HCO must be included in your reporting.
Moreover, you are required to name the individual responsible for managing each relationship in the Ministry of Health’s Sanita Trasparente, reinforcing personal accountability and proper documentation across your organization.
Food and beverages
Meals, beverages, and hospitality-related expenses are among the most frequently overlooked transfers of value and are often viewed as minor or inconsequential. However, under Article 3 §1(a), these are considered reportable if:
- They exceed established monetary thresholds
- They are provided outside standard hospitality contexts
- They take place during educational or promotional events
Even something as simple as a coffee or lunch can trigger a reporting obligation, context and value matter.
Key exemptions under the Italian Sunshine Act
While the default assumption is that all transfers of value are reportable, the law provides some clear-cut exemptions:
- Salaries or payments to employees of the manufacturer are not subject to disclosure
- Non-individualized commercial discounts or rebates, i.e., those not targeted at a specific individual, are also exempt.
Does support for student training or scholarships need to be reported?
Reporting may be required if the support is directed towards individuals who are enrolled in accredited medical training, while already practicing in a clinical or advisory role. On the other hand, scholarships provided to institutions without earmarking are typically exempt.
Conclusion
For companies operating in Italy or selling into its healthcare system, the Italian Sunshine Act requires organizational alignment, rigorous intermediary tracking, and proactive compliance workflows, which goes beyond just data collection. Ignoring third-party involvement or assuming you’re exempt as a foreign entity could expose your company to penalties and brand risk.
Curious how your structure holds up under the law? Dive into our FAQs where leading legal and compliance specialists regularly address the most relevant and timely questions. If you don’t see the answer you need, simply submit your query, and our experts will get back to you with a tailored response.
Let’s unpack some of these less obvious reporting scenarios, alongside a few key exemptions, so you’re not caught off guard in your disclosure cycle.
Peer-to-peer honoraria
Peer-to-peer honoraria refer to payments given to healthcare professionals for services provided as peer reviewers or in other similar roles within an organization.
While these may appear to be professional-to-professional transactions, they are not exempt if facilitated or financially supported by a manufacturer. Even if the manufacturer is not directly involved in the interaction, these are considered indirect transfers of value under Article 3 of the Italian Sunshine Act, and hence must be disclosed.
If you’re sponsoring an event, covering an honorarium, or even just facilitating logistics, it is reportable.
Academic stipends and public grants
Academic stipends are financial support provided to individuals in training or research settings, and public grants refer to funding often issued through public institutions for research, education, or program development.
These forms of support are not automatically exempt under the Italian Sunshine Act and become reportable when:
- The funds are channeled through or funded by a manufacturer, or
- There is a reportable agreement between the manufacturer and the recipient HCP or HCO.
This requirement ensures transparency even when influence is exercised indirectly through academic or institutional channels.
In short: if the funding benefits a named HCP or is linked to a manufacturer-driven agreement, it must be disclosed.
Third-party interactions
If a third-party or an intermediary interacts with an HCP or HCO on your behalf, would the accountability lie on that intermediary, or the company?
A distinctive feature of the Italian Sunshine Act is its inclusion of intermediaries. Whether it is:
- Your internal teams managing HCP relationships
- A contracted event planner
- A distributor or partner agency
— anyone acting on your behalf in transferring value to an HCP or HCO must be included in your reporting.
Moreover, you are required to name the individual responsible for managing each relationship in the Ministry of Health’s Sanita Trasparente, reinforcing personal accountability and proper documentation across your organization.
Food and beverages
Meals, beverages, and hospitality-related expenses are among the most frequently overlooked transfers of value and are often viewed as minor or inconsequential. However, under Article 3 §1(a), these are considered reportable if:
- They exceed established monetary thresholds
- They are provided outside standard hospitality contexts
- They take place during educational or promotional events
Even something as simple as a coffee or lunch can trigger a reporting obligation, context and value matter.
Key exemptions under the Italian Sunshine Act
While the default assumption is that all transfers of value are reportable, the law provides some clear-cut exemptions:
- Salaries or payments to employees of the manufacturer are not subject to disclosure
- Non-individualized commercial discounts or rebates, i.e., those not targeted at a specific individual, are also exempt.
Does support for student training or scholarships need to be reported?
Reporting may be required if the support is directed towards individuals who are enrolled in accredited medical training, while already practicing in a clinical or advisory role. On the other hand, scholarships provided to institutions without earmarking are typically exempt.
Conclusion
For companies operating in Italy or selling into its healthcare system, the Italian Sunshine Act requires organizational alignment, rigorous intermediary tracking, and proactive compliance workflows, which goes beyond just data collection. Ignoring third-party involvement or assuming you’re exempt as a foreign entity could expose your company to penalties and brand risk.
Curious how your structure holds up under the law? Dive into our FAQs where leading legal and compliance specialists regularly address the most relevant and timely questions. If you don’t see the answer you need, simply submit your query, and our experts will get back to you with a tailored response.
Author
May Khan leads the Compliance Services team at Vector Health, a SaaS company specializing in life sciences compliance. Her experience includes global transparency reporting, Sunshine Act strategy, and HCP risk monitoring. At Vector, she coordinates cross-functional teams dedicated to data integrity, customer service, and regulatory alignment.
Vector Health Compliance
Il principale partner in Italia per la conformità al Sunshine Act
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.