Are You Recording Everything Italy’s Sunshine Act Expects?
Table of content
- Scenario 1: You Co-Sponsor a Training Bootcamp – Who Declares What?
- Scenario 2: Your Event Agency Books Flights and Dinners — Who Declares?
- Scenario 3: A Surgeon Records a Short Testimonial Clip — Is It Reportable?
- Scenario 4: Your Medical Team Pays an APC for a Manuscript — What Happens Next?
- Scenario 5: You Give a Hospital Free Access to a Software Tool — Is It Considered a Transfer?
- Scenario 6: A Physician Receives Royalties or Stock Awards — When Are They Declared?
- Scenario 7: An HCP Is Paid After an Informal Email Agreement — Does It Count?
- Final Thoughts
- Want more clarity?
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.
Compliance teams across the life sciences industry are discovering the same uncomfortable truth: Italy’s Sunshine Act doesn’t just capture payments, it captures situations.
Not just invoices, not just contracts, not just honoraria. Situations.
- A shared sponsorship.
- A flight booked by an agency.
- A software plugin added as a “gesture.”
- A testimonial filmed for a launch event.
- An APC paid months after the research team has moved on.
These everyday moments, far more than the major financial transfers, are where the majority of reporting errors are born. And because the Italian Sunshine Act (Law 62/2022) is one of the most granular transparency frameworks in Europe, the compliance risks often hide inside operational routines that no one has thought to classify as “reportable.”
To help teams pressure-test their processes, below is a scenario-based audit guide built from real Italian Sunshine Act obligations. If any scenario feels familiar, it’s a sign your reporting workflow may be missing a required disclosure.
Scenario 1: You Co-Sponsor a Training Bootcamp – Who Declares What?
Your company teams up with two other manufacturers to fund a surgical bootcamp for early-career specialists. One sponsor handles logistics, another pays the speakers, and you finance the facilities and cadaver labs.
Risk:
Teams often assume the “primary sponsor” will declare everything. Under Article 3, however, each manufacturer must disclose its proportionate share, specifying beneficiaries and the value transferred. If both identifiable HCPs and an HCO benefit, the reporting must distinguish between the two.
Audit question:
Do you have a process that automatically breaks down shared activities into reportable shares, even if another company or organizer manages the event?
Scenario 2: Your Event Agency Books Flights and Dinners — Who Declares?
Your HCP speakers have their travel and meals booked through an external event organizer. Internally, teams sometimes believe that because the agency pays the vendor directly, only the agency carries reporting obligations.
Reality:
Intermediaries do not shield manufacturers. If you fund the activity, you must disclose each identifiable beneficiary and the hospitality provided, whether it’s airfare, a hotel room, or a networking dinner.
Audit question:
Does your agency contract include mandatory data-capture and transparency reporting workflows?
Scenario 3: A Surgeon Records a Short Testimonial Clip — Is It Reportable?
Marketing asks a respected surgeon to film a 90-second testimonial for a product launch. The surgeon’s travel, honorarium, or even small items like studio refreshments are covered by your company.
Reporting trigger:
Participation in company-sponsored content such as testimonial, interview, booth presentation, social campaign, may constitute a reportable agreement/transfer under Art. 3 when it produces an advantage and meets the reporting conditions. If compensation or benefits are provided and thresholds are met, it becomes a reportable transfer of value.
Audit question:
Are marketing-driven HCP engagements fully integrated into your transparency workflow, or are they handled in isolation?
Scenario 4: Your Medical Team Pays an APC for a Manuscript — What Happens Next?
Your publication team submits a manuscript to a journal and pays the article processing charge. Later, they pay for translation of the accepted manuscript into Italian.
Under the law:
APCs, submission fees, expedited review charges, medical writing services, translation, and editing can be reportable where they constitute a transfer of value or an agreement that benefits a covered recipient/counterparty and meets the law’s reporting conditions.
Audit question:
Does your publication team know which expenses are considered transfers of value, and is there a mechanism to capture the beneficiary accurately?
Scenario 5: You Give a Hospital Free Access to a Software Tool — Is It Considered a Transfer?
Your company provides a clinical decision-support module to a hospital as part of an educational initiative. There is no commercial contract; it’s simply “support.”
Compliance truth:
When software, digital tools, or platforms are provided free or at a discount outside standard procurement, they are transfers of value. Platform access, upgrades, plugins, and IT services must all be declared if they have measurable value.
Audit question:
Does your IT or medical affairs team track when digital services are gifted or discounted?
Scenario 6: A Physician Receives Royalties or Stock Awards — When Are They Declared?
A physician you collaborate with holds equity in a product line or receives royalties for licensed IP. The contract was signed last year, but payments only started this year.
Key rule:
Only benefits actually realized in the calendar year are declared. This includes royalties, share awards, stock options, and any accrued income.
Audit question:
Does your system track realized vs. deferred benefits, and does finance feed that data into transparency reporting?
Scenario 7: An HCP Is Paid After an Informal Email Agreement — Does It Count?
A quick email chain between your team and an HCP leads to a small consulting engagement. The agreement isn’t formalized in a signed contract until later, but the work begins.
What the law says:
The formality of the agreement doesn’t matter. If the interaction produces a financial benefit, compensation, travel, or project participation, it becomes reportable once the thresholds are met.
Audit question:
Do informal engagements get picked up in your current reporting system, or can they slip through?
Final Thoughts
Italy’s Sunshine Act is not simply a reporting requirement, it’s a recognition process. It forces teams to look beyond transactions and into the structure of day-to-day interactions. The question is no longer “Was a payment made?” It’s “Did value move?”
And value moves in more ways than most teams expect.
Want more clarity?
If you have questions about any of the scenarios above, or want to validate your own workflows, visit our FAQ page and submit your question directly to our experts.
Table of content
- Scenario 1: You Co-Sponsor a Training Bootcamp – Who Declares What?
- Scenario 2: Your Event Agency Books Flights and Dinners — Who Declares?
- Scenario 3: A Surgeon Records a Short Testimonial Clip — Is It Reportable?
- Scenario 4: Your Medical Team Pays an APC for a Manuscript — What Happens Next?
- Scenario 5: You Give a Hospital Free Access to a Software Tool — Is It Considered a Transfer?
- Scenario 6: A Physician Receives Royalties or Stock Awards — When Are They Declared?
- Scenario 7: An HCP Is Paid After an Informal Email Agreement — Does It Count?
- Final Thoughts
- Want more clarity?
Compliance teams across the life sciences industry are discovering the same uncomfortable truth: Italy’s Sunshine Act doesn’t just capture payments, it captures situations.
Not just invoices, not just contracts, not just honoraria. Situations.
- A shared sponsorship.
- A flight booked by an agency.
- A software plugin added as a “gesture.”
- A testimonial filmed for a launch event.
- An APC paid months after the research team has moved on.
These everyday moments, far more than the major financial transfers, are where the majority of reporting errors are born. And because the Italian Sunshine Act (Law 62/2022) is one of the most granular transparency frameworks in Europe, the compliance risks often hide inside operational routines that no one has thought to classify as “reportable.”
To help teams pressure-test their processes, below is a scenario-based audit guide built from real Italian Sunshine Act obligations. If any scenario feels familiar, it’s a sign your reporting workflow may be missing a required disclosure.
Scenario 1: You Co-Sponsor a Training Bootcamp – Who Declares What?
Your company teams up with two other manufacturers to fund a surgical bootcamp for early-career specialists. One sponsor handles logistics, another pays the speakers, and you finance the facilities and cadaver labs.
Risk:
Teams often assume the “primary sponsor” will declare everything. Under Article 3, however, each manufacturer must disclose its proportionate share, specifying beneficiaries and the value transferred. If both identifiable HCPs and an HCO benefit, the reporting must distinguish between the two.
Audit question:
Do you have a process that automatically breaks down shared activities into reportable shares, even if another company or organizer manages the event?
Scenario 2: Your Event Agency Books Flights and Dinners — Who Declares?
Your HCP speakers have their travel and meals booked through an external event organizer. Internally, teams sometimes believe that because the agency pays the vendor directly, only the agency carries reporting obligations.
Reality:
Intermediaries do not shield manufacturers. If you fund the activity, you must disclose each identifiable beneficiary and the hospitality provided, whether it’s airfare, a hotel room, or a networking dinner.
Audit question:
Does your agency contract include mandatory data-capture and transparency reporting workflows?
Scenario 3: A Surgeon Records a Short Testimonial Clip — Is It Reportable?
Marketing asks a respected surgeon to film a 90-second testimonial for a product launch. The surgeon’s travel, honorarium, or even small items like studio refreshments are covered by your company.
Reporting trigger:
Participation in company-sponsored content such as testimonial, interview, booth presentation, social campaign, may constitute a reportable agreement/transfer under Art. 3 when it produces an advantage and meets the reporting conditions. If compensation or benefits are provided and thresholds are met, it becomes a reportable transfer of value.
Audit question:
Are marketing-driven HCP engagements fully integrated into your transparency workflow, or are they handled in isolation?
Scenario 4: Your Medical Team Pays an APC for a Manuscript — What Happens Next?
Your publication team submits a manuscript to a journal and pays the article processing charge. Later, they pay for translation of the accepted manuscript into Italian.
Under the law:
APCs, submission fees, expedited review charges, medical writing services, translation, and editing can be reportable where they constitute a transfer of value or an agreement that benefits a covered recipient/counterparty and meets the law’s reporting conditions.
Audit question:
Does your publication team know which expenses are considered transfers of value, and is there a mechanism to capture the beneficiary accurately?
Scenario 5: You Give a Hospital Free Access to a Software Tool — Is It Considered a Transfer?
Your company provides a clinical decision-support module to a hospital as part of an educational initiative. There is no commercial contract; it’s simply “support.”
Compliance truth:
When software, digital tools, or platforms are provided free or at a discount outside standard procurement, they are transfers of value. Platform access, upgrades, plugins, and IT services must all be declared if they have measurable value.
Audit question:
Does your IT or medical affairs team track when digital services are gifted or discounted?
Scenario 6: A Physician Receives Royalties or Stock Awards — When Are They Declared?
A physician you collaborate with holds equity in a product line or receives royalties for licensed IP. The contract was signed last year, but payments only started this year.
Key rule:
Only benefits actually realized in the calendar year are declared. This includes royalties, share awards, stock options, and any accrued income.
Audit question:
Does your system track realized vs. deferred benefits, and does finance feed that data into transparency reporting?
Scenario 7: An HCP Is Paid After an Informal Email Agreement — Does It Count?
A quick email chain between your team and an HCP leads to a small consulting engagement. The agreement isn’t formalized in a signed contract until later, but the work begins.
What the law says:
The formality of the agreement doesn’t matter. If the interaction produces a financial benefit, compensation, travel, or project participation, it becomes reportable once the thresholds are met.
Audit question:
Do informal engagements get picked up in your current reporting system, or can they slip through?
Final Thoughts
Italy’s Sunshine Act is not simply a reporting requirement, it’s a recognition process. It forces teams to look beyond transactions and into the structure of day-to-day interactions. The question is no longer “Was a payment made?” It’s “Did value move?”
And value moves in more ways than most teams expect.
Want more clarity?
If you have questions about any of the scenarios above, or want to validate your own workflows, visit our FAQ page and submit your question directly to our experts.
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.