From Rome to the World: How Italian Transparency Obligations Extend Internationally
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
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If you work in life sciences compliance, you know that managing transparency obligations is already complex. Add international engagements, and the complexity multiplies. A speaker program in Paris, a clinical investigator in Milan working on a U.S.-funded study, or a digital health pilot with an Italian HCO but foreign sponsors, suddenly, the simple question arises: Which international transfers of value (ToVs) need to be reported under the Italian Sunshine Act (Law 62/2022)?
The answer is: you must disclose cross-border ToVs whenever the beneficiary qualifies under the law as a “soggetto che opera nel settore della salute” or an “organizzazione sanitaria”, even if the interaction or payment occurs abroad or the company is foreign. The law casts a wide net to ensure transparency not only in Italy, but also in any cross-border activity where Italian healthcare professionals (HCPs) or healthcare organizations (HCOs) are involved. Let’s unpack some of the most important scenarios companies need to anticipate.
Italian HCPs Interacting with Foreign Companies
One of the most common questions is whether non-EU manufacturers must comply. The law is clear: if you engage with Italian HCPs or HCOs, you must report their interactions in compliance with ( Art. 3 ) of the Italian Sunshine Act, regardless of where your headquarters are located. Foreign manufacturers may designate a legal representative in Italy to handle disclosures. Payment routed through third-party logistics or foundations does not eliminate the obligation. The responsibility always traces back to the originating company.
Foreign Professionals Operating in Italy
Cross-border does not always mean Italian professionals abroad, it also means foreign HCPs working in Italy’s healthcare sector ( Art. 2.1.b ). The law explicitly applies to non-Italian nationals who are involved in healthcare activities in Italy, whether in hospitals, universities, or private practice. If they operate within the Italian healthcare system, their benefits must be reported just like those of Italian colleagues.
Italian HCPs Abroad
What if an Italian-registered physician or participates in an international congress outside Italy? The Italian Sunshine Act applies in this case as well. If an Italian HCP falls within the law’s definitions, for example, is contracted to or affiliated with an Italian organizzazione sanitaria, or otherwise operates in the health sector as defined in ( Art. 2.1.b ), their benefits must be disclosed even when the activity occurs abroad. Activities can include travel, hospitality, or honoraria, etc.
This rule ensures that Italian HCPs remain visible in the transparency system, even if the transfer of value occurs in another jurisdiction.
Cross-Border Research and Trials
Another hotspot is multi-country clinical research. Payments or agreements to HCPs or HCOs in global trials are reportable in Italy if they are registered in Italy or affiliated with an Italian HCO as defined by ( Art. 2 ) of the law, regardless of where the funding originates. Funding routed via CROs or foreign partners remains reportable by the manufacturer, may be by listing the CRO/agency as intermediary.
Similarly, international collaborations with Italian universities require reporting if the ToV flows to identifiable Italian recipients. This closes potential loopholes where sponsors might otherwise channel funds through non-Italian partners.
Modern Engagements: Virtual and Hybrid
Cross-border no longer means just physical travel. Today, companies fund remote training from distance and international advisory boards. If an Italian HCP receives support for a hybrid ECM (Educazione Continua Medicina) session, a global product launch panel, or access to premium digital health solutions, those benefits are reportable under the Italian Sunshine Law.
Even seemingly intangible transfers, like access to proprietary software or long-term demo units, fall within scope if they deliver measurable value.
Charitable and Institutional Contributions
The law also extends to indirect or reputational benefits, including charitable donations. If a donation is made in honor of, or at the request of, an Italian HCP, it must be reported as per Italian Sunshine reporting obligations, listing the HCP as an intermediary under ( Art. 3.4.g ).
Equally important, multi-national board appointments (such as scientific advisory boards) involving Italian HCPs must be disclosed, even if the board is based abroad or funded by foreign affiliates of the same group. The same principle applies to advisory roles in global panels; if an Italian HCP is involved, it falls within the law’s scope.
The Bottom Line
Law 62/2022 makes one thing clear: national borders do not shield transfers of value from reporting when Italian HCPs or HCOs are involved in international engagements. Whether the support takes the form of a travel stipend for a foreign conference, a role in a global advisory panel, funding for an international trial, or access to cross-border digital platforms, the obligation to disclose remains.
For compliance teams, this means building systems that can track Italian recipients globally, not just domestically. Collaboration with affiliates, CROs, and third-party vendors is crucial, as is educating commercial teams that “out of country” does not mean “out of scope.”
Ready to put your global transparency knowledge into practice? Join us on 18th November in Milan for a full-day, hands-on workshop “Practical Training on Italian Sunshine Act Reporting.” Gain practical experience in managing complex cross-border reporting scenarios, building compliant XML files, and comparing Italy’s disclosure requirements with the U.S. and France.
Test your systems, align your reporting processes with Ministry of Health standards, and learn directly from real-world cases and peer best practices.
Secure your seat now and turn transparency compliance into operational confidence.
If you work in life sciences compliance, you know that managing transparency obligations is already complex. Add international engagements, and the complexity multiplies. A speaker program in Paris, a clinical investigator in Milan working on a U.S.-funded study, or a digital health pilot with an Italian HCO but foreign sponsors, suddenly, the simple question arises: Which international transfers of value (ToVs) need to be reported under the Italian Sunshine Act (Law 62/2022)?
The answer is: you must disclose cross-border ToVs whenever the beneficiary qualifies under the law as a “soggetto che opera nel settore della salute” or an “organizzazione sanitaria”, even if the interaction or payment occurs abroad or the company is foreign. The law casts a wide net to ensure transparency not only in Italy, but also in any cross-border activity where Italian healthcare professionals (HCPs) or healthcare organizations (HCOs) are involved. Let’s unpack some of the most important scenarios companies need to anticipate.
Italian HCPs Interacting with Foreign Companies
One of the most common questions is whether non-EU manufacturers must comply. The law is clear: if you engage with Italian HCPs or HCOs, you must report their interactions in compliance with ( Art. 3 ) of the Italian Sunshine Act, regardless of where your headquarters are located. Foreign manufacturers may designate a legal representative in Italy to handle disclosures. Payment routed through third-party logistics or foundations does not eliminate the obligation. The responsibility always traces back to the originating company.
Foreign Professionals Operating in Italy
Cross-border does not always mean Italian professionals abroad, it also means foreign HCPs working in Italy’s healthcare sector ( Art. 2.1.b ). The law explicitly applies to non-Italian nationals who are involved in healthcare activities in Italy, whether in hospitals, universities, or private practice. If they operate within the Italian healthcare system, their benefits must be reported just like those of Italian colleagues.
Italian HCPs Abroad
What if an Italian-registered physician or participates in an international congress outside Italy? The Italian Sunshine Act applies in this case as well. If an Italian HCP falls within the law’s definitions, for example, is contracted to or affiliated with an Italian organizzazione sanitaria, or otherwise operates in the health sector as defined in Art. 2.1.b ), their benefits must be disclosed even when the activity occurs abroad. Activities can include travel, hospitality, or honoraria, etc.
This rule ensures that Italian HCPs remain visible in the transparency system, even if the transfer of value occurs in another jurisdiction.
Cross-Border Research and Trials
Another hotspot is multi-country clinical research. Payments or agreements to HCPs or HCOs in global trials are reportable in Italy if they are registered in Italy or affiliated with an Italian HCO as defined by ( Art. 2 ) of the law, regardless of where the funding originates. Funding routed via CROs or foreign partners remains reportable by the manufacturer, may be by listing the CRO/agency as intermediary.
Similarly, international collaborations with Italian universities require reporting if the ToV flows to identifiable Italian recipients. This closes potential loopholes where sponsors might otherwise channel funds through non-Italian partners.
Modern Engagements: Virtual and Hybrid
Cross-border no longer means just physical travel. Today, companies fund remote training from distance and international advisory boards. If an Italian HCP receives support for a hybrid ECM (Educazione Continua Medicina) session, a global product launch panel, or access to premium digital health solutions, those benefits are reportable under the Italian Sunshine Law.
Even seemingly intangible transfers, like access to proprietary software or long-term demo units, fall within scope if they deliver measurable value.
Charitable and Institutional Contributions
The law also extends to indirect or reputational benefits, including charitable donations. If a donation is made in honor of, or at the request of, an Italian HCP, it must be reported as per Italian Sunshine reporting obligations, listing the HCP as an intermediary under ( Art. 3.4.g ).
Equally important, multi-national board appointments (such as scientific advisory boards) involving Italian HCPs must be disclosed, even if the board is based abroad or funded by foreign affiliates of the same group. The same principle applies to advisory roles in global panels; if an Italian HCP is involved, it falls within the law’s scope.
The Bottom Line
Law 62/2022 makes one thing clear: national borders do not shield transfers of value from reporting when Italian HCPs or HCOs are involved in international engagements. Whether the support takes the form of a travel stipend for a foreign conference, a role in a global advisory panel, funding for an international trial, or access to cross-border digital platforms, the obligation to disclose remains.
For compliance teams, this means building systems that can track Italian recipients globally, not just domestically. Collaboration with affiliates, CROs, and third-party vendors is crucial, as is educating commercial teams that “out of country” does not mean “out of scope.”
Ready to put your global transparency knowledge into practice? Join us on 18th November in Milan for a full-day, hands-on workshop “Practical Training on Italian Sunshine Act Reporting.” Gain practical experience in managing complex cross-border reporting scenarios, building compliant XML files, and comparing Italy’s disclosure requirements with the U.S. and France.
Test your systems, align your reporting processes with Ministry of Health standards, and learn directly from real-world cases and peer best practices.
Secure your seat now and turn transparency compliance into operational confidence.
Author
May Khan guida il team Compliance Services di Vector Health, società SaaS specializzata nella compliance per il settore life sciences. La sua esperienza include il reporting sulla trasparenza a livello globale, la strategia legata al Sunshine Act e il monitoraggio dei rischi relativi agli HCP. In Vector coordina team interfunzionali dedicati all’integrità dei dati, al servizio clienti e all’allineamento normativo.
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.