Non-Reportable Transfers of Value: 10 Scenarios You Don’t Need to Disclose Part 2/2

Non-Reportable Transfers of Value: 10 Scenarios You Don’t Need to Disclose Part 2/2
In Part 1 of this series, we covered 10 clear examples of non-reportable transfers of value (TOVs) under the Italian Sunshine Act (Law 62/2022), from anonymized payments to open-access webinars. In this follow-up, we go a level deeper, focusing on indirect, institutional, and operational scenarios that often raise questions during compliance reviews.
These nonreportable scenarios are particularly relevant for market access teams, public affairs leads, and compliance officers dealing with technology pilots, donations, or collaborative healthcare initiatives.
 

1. Donations to non-health NGOs

Corporate donations to NGOs operating outside the healthcare sector, such as those focused on education, the environment, or social development are not reportable, provided that the donations are not made at the request of, or for the benefit of, any identifiable HCP or HCO.

If the donation indirectly benefits or is connected to a specific HCP, then the TOV may become reportable.
 

2. Patient education materials co-developed with HCPs

If a healthcare professional collaborates on patient education materials without receiving honoraria, hospitality, or promotional benefits, the interaction is not reportable. Voluntary, unpaid contributions strictly for patient benefit fall outside the law’s scope.

The reportability may be reassessed if the HCP’s involvement leads to indirect benefits, such as increased visibility, professional promotion, or if the materials are used for branded marketing.
 

3. AI-based diagnostic tools for pilot use

When AI diagnostic tools are offered for pilot use in healthcare institutions, without being assigned to individual HCPs or involving exclusive access or compensation, the value is non-attributable and thus not a reportable TOV.

However if a pilot includes associated benefits like training, consultancy, or future licensing discounts, it may trigger reportability and should be assessed in context.
 

4. Institutional subscriptions to drug interaction checker

An institutional subscription—e.g., for a drug interaction checker—granted to a hospital or department (not individual HCPs) is not reportable. The law only applies when the TOV can be tied to a named HCP or HCO.

If exclusive access is granted to named HCPs, even within the institution, the TOV may need to be disclosed.
 

5. Transportation costs for hospital couriers

Logistical reimbursements for hospital couriers, when made for operational purposes and not structured to benefit any HCP or HCO, are not considered TOVs under the Italian Sunshine Act.

Reassessment is advised only if the courier service is owned or operated by an HCP, or if the fees are excessive.
 

6. Provision of aggregated, anonymized dashboards

Dashboards that are generated to support institutional decision-making, monitor population-level trends, or evaluate treatment outcomes, without identifying individual prescribers or clinicians, are considered non-attributable and therefore fall outside the scope of reportable TOVs.

However, if the dashboards include metrics that highlight the performance, prescribing behavior, or outcomes of specific HCPs and are used in a way that promotes or influences their standing, the TOV may become indirectly reportable and should be reassessed.
 

7. HCP Attendance at Company Townhalls

Mere attendance at a company-hosted townhall, without honoraria, hospitality, or travel reimbursement, is not a reportable TOV. The law requires a tangible benefit for disclosure to apply. If any value is conferred (e.g., meals, travel), then disclosure should be reassessed.
 

8. Discounts on product purchases to public hospitals

Volume-based discounts, tender pricing, or rebates offered to public hospitals through standard commercial negotiations are not reportable, unless they’re structured to benefit individual HCPs. However, discounts linked to prescribing behavior or conditional on clinical decisions could raise red flags.
 

9. Free pharmacovigilance software given to institutions

Volume-based discounts, tender pricing, or rebates offered to public hospitals through standard commercial negotiations are not reportable, unless they’re structured to benefit individual HCPs. However, discounts linked to prescribing behavior or conditional on clinical decisions could raise red flags.
 

10. Public sponsorship of disease awareness campaigns

Sponsoring a campaign aimed at the general public or patient communities is not a reportable TOV, unless it includes promotional activities involving identifiable HCPs or HCOs.

If a named physician is featured and receives honoraria or visibility benefits, reportability should be reassessed.
 

Conclusion

For businesses involved in Italy’s healthcare sector, grasping what falls outside the reporting requirements of the Italian Sunshine Act is as vital as understanding what must be disclosed.

Excessive reporting can lead to undue compliance strain, compromise data accuracy, and reflect weak internal coordination. Maintaining clear records of non-reportable TOVs, along with their justifications, is crucial for ensuring transparent, defensible, and streamlined compliance.

Wondering how your approach aligns with the law? Explore our FAQs, where Italy’s top legal and compliance experts routinely tackle the most pressing and relevant issues. 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.

Non-Reportable Transfers of Value: 10 Scenarios You Don’t Need to Disclose Part 2/2
In Part 1 of this series, we covered 10 clear examples of non-reportable transfers of value (TOVs) under the Italian Sunshine Act (Law 62/2022), from anonymized payments to open-access webinars. In this follow-up, we go a level deeper, focusing on indirect, institutional, and operational scenarios that often raise questions during compliance reviews.
These nonreportable scenarios are particularly relevant for market access teams, public affairs leads, and compliance officers dealing with technology pilots, donations, or collaborative healthcare initiatives.
 

1. Donations to non-health NGOs

Corporate donations to NGOs operating outside the healthcare sector, such as those focused on education, the environment, or social development are not reportable, provided that the donations are not made at the request of, or for the benefit of, any identifiable HCP or HCO.

If the donation indirectly benefits or is connected to a specific HCP, then the TOV may become reportable.
 

2. Patient education materials co-developed with HCPs

If a healthcare professional collaborates on patient education materials without receiving honoraria, hospitality, or promotional benefits, the interaction is not reportable. Voluntary, unpaid contributions strictly for patient benefit fall outside the law’s scope.

The reportability may be reassessed if the HCP’s involvement leads to indirect benefits, such as increased visibility, professional promotion, or if the materials are used for branded marketing.
 

3. AI-based diagnostic tools for pilot use

When AI diagnostic tools are offered for pilot use in healthcare institutions, without being assigned to individual HCPs or involving exclusive access or compensation, the value is non-attributable and thus not a reportable TOV.

However if a pilot includes associated benefits like training, consultancy, or future licensing discounts, it may trigger reportability and should be assessed in context.
 

4. Institutional subscriptions to drug interaction checker

An institutional subscription—e.g., for a drug interaction checker—granted to a hospital or department (not individual HCPs) is not reportable. The law only applies when the TOV can be tied to a named HCP or HCO.

If exclusive access is granted to named HCPs, even within the institution, the TOV may need to be disclosed.
 

5. Transportation costs for hospital couriers

Logistical reimbursements for hospital couriers, when made for operational purposes and not structured to benefit any HCP or HCO, are not considered TOVs under the Italian Sunshine Act.

Reassessment is advised only if the courier service is owned or operated by an HCP, or if the fees are excessive.
 

6. Provision of aggregated, anonymized dashboards

Dashboards that are generated to support institutional decision-making, monitor population-level trends, or evaluate treatment outcomes, without identifying individual prescribers or clinicians, are considered non-attributable and therefore fall outside the scope of reportable TOVs.

However, if the dashboards include metrics that highlight the performance, prescribing behavior, or outcomes of specific HCPs and are used in a way that promotes or influences their standing, the TOV may become indirectly reportable and should be reassessed.
 

7. HCP Attendance at Company Townhalls

Mere attendance at a company-hosted townhall, without honoraria, hospitality, or travel reimbursement, is not a reportable TOV. The law requires a tangible benefit for disclosure to apply. If any value is conferred (e.g., meals, travel), then disclosure should be reassessed.
 

8. Discounts on product purchases to public hospitals

Volume-based discounts, tender pricing, or rebates offered to public hospitals through standard commercial negotiations are not reportable, unless they’re structured to benefit individual HCPs. However, discounts linked to prescribing behavior or conditional on clinical decisions could raise red flags.
 

9. Free pharmacovigilance software given to institutions

Volume-based discounts, tender pricing, or rebates offered to public hospitals through standard commercial negotiations are not reportable, unless they’re structured to benefit individual HCPs. However, discounts linked to prescribing behavior or conditional on clinical decisions could raise red flags.
 

10. Public sponsorship of disease awareness campaigns

Sponsoring a campaign aimed at the general public or patient communities is not a reportable TOV, unless it includes promotional activities involving identifiable HCPs or HCOs.

If a named physician is featured and receives honoraria or visibility benefits, reportability should be reassessed.
 

Conclusion

For businesses involved in Italy’s healthcare sector, grasping what falls outside the reporting requirements of the Italian Sunshine Act is as vital as understanding what must be disclosed.

Excessive reporting can lead to undue compliance strain, compromise data accuracy, and reflect weak internal coordination. Maintaining clear records of non-reportable TOVs, along with their justifications, is crucial for ensuring transparent, defensible, and streamlined compliance.

Wondering how your approach aligns with the law? Explore our FAQs, where Italy’s top legal and compliance experts routinely tackle the most pressing and relevant issues. 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.