The Role of an Intermediary or Third-Party 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
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Imagine discovering, five years after you’ve left a company, that your name is still tied to a financial transaction with a healthcare professional. This is not a hypothetical scenario, it’s exactly how the Italian Sunshine Act treats intermediaries. For compliance teams, this raises an immediate question: who should be identified as the responsible party when transfers of value are disclosed?
The Italian Sunshine Act (Law 62/2022) has introduced a new level of transparency in the relationships between life sciences companies and the healthcare sector. While the obligations around reporting transfers of value (ToVs) are relatively clear, one area that continues to raise questions is the role of intermediaries. Who exactly is considered an intermediary, and how should companies manage this responsibility in practice?
Intermediaries: Broader Than You Thinks
When the law was first published, the term “intermediary” was often assumed to mean only external agents or third parties acting on behalf of a company. However, the legislation makes it clear that intermediaries are not limited to outside entities. In fact, employees of the company can also fall into this category.
An intermediary is anyone involved in arranging, managing, or executing the interaction that results in a ToV. This could be the person who organizes a consultancy, the staff member who calls and invites a healthcare professional to an event, or the individual who facilitates budget approval for a sponsorship. Once an intermediary is identified, their name remains linked to the transaction in the Transparency Register for five years, even if they later leave the company.
Responsibility Rests With the Company
Although intermediaries must always be identified, the responsibility for reporting ultimately rests with the company. This is true even when third parties are directly involved in the transaction. Consider the example of a company paying €100,000 to a travel agency, which then contracts services in the company’s name. In this case, the travel agency is the intermediary, but the company remains the responsible reporting party.
Authorities have consistently emphasized this point: what matters is the visibility of the company behind the transaction. Allowing disclosures to be made only by agents or service providers would undermine the purpose of the law, which is to provide transparency about the role of manufacturers in financial relationships with healthcare professionals and organizations.
Navigating Corporate Complexity
Identifying intermediaries can be straightforward in simple cases, but today’s corporate structures often complicate the picture. It is no longer just a sales representative who chooses a consultant and signs a contract. Instead, there may be a proposer, a review committee, and a separate team approving the budget. In such cases, pinpointing the “responsible” intermediary can be challenging.
To address this, companies are advised to develop a detailed internal reference table. This table should specify, for each type of interaction, who the beneficiary is and who the intermediary is. It should also account for the fact that if a person not listed as an intermediary ultimately receives value, that individual becomes the beneficiary and must be disclosed as such. Even if this approach results in duplicate entries, the key principle remains that all relevant data must be reported.
Industry Guidance vs. Ministry Expectations
Industry codes, such as those from Farmindustria and MedTech Europe, offer practical guidance for managing intermediaries and disclosures. They can help companies develop consistent internal processes. However, experience shows that the Ministry of Health does not always align with these frameworks. In fact, official FAQs often diverge from industry interpretations in a significant proportion of cases.
This divergence underscores why companies should adopt a cautious, conservative approach. Even when a legal-entity agent may technically be able to report, the safer and more transparent practice is for the company itself to upload the disclosure, listing the agent as the intermediary.
Conclusion
The concept of the intermediary under the Italian Sunshine Act is broader than many initially thought. It includes not only external third parties but also company employees involved at any stage of the transaction. The company must always remain the accountable reporting party, ensuring that beneficiaries and intermediaries are clearly identified and disclosed.
While the complexity of modern organizations makes this challenging, the underlying principle is simple: transparency. By adopting structured internal processes and keeping the responsibility for reporting firmly in-house, companies can manage this obligation effectively and align with both the spirit and the letter of the law.
Imagine discovering, five years after you’ve left a company, that your name is still tied to a financial transaction with a healthcare professional. This is not a hypothetical scenario, it’s exactly how the Italian Sunshine Act treats intermediaries. For compliance teams, this raises an immediate question: who should be identified as the responsible party when transfers of value are disclosed?
The Italian Sunshine Act (Law 62/2022) has introduced a new level of transparency in the relationships between life sciences companies and the healthcare sector. While the obligations around reporting transfers of value (ToVs) are relatively clear, one area that continues to raise questions is the role of intermediaries. Who exactly is considered an intermediary, and how should companies manage this responsibility in practice?
Intermediaries: Broader Than You Thinks
When the law was first published, the term “intermediary” was often assumed to mean only external agents or third parties acting on behalf of a company. However, the legislation makes it clear that intermediaries are not limited to outside entities. In fact, employees of the company can also fall into this category.
An intermediary is anyone involved in arranging, managing, or executing the interaction that results in a ToV. This could be the person who organizes a consultancy, the staff member who calls and invites a healthcare professional to an event, or the individual who facilitates budget approval for a sponsorship. Once an intermediary is identified, their name remains linked to the transaction in the Transparency Register for five years, even if they later leave the company.
Responsibility Rests With the Company
Although intermediaries must always be identified, the responsibility for reporting ultimately rests with the company. This is true even when third parties are directly involved in the transaction. Consider the example of a company paying €100,000 to a travel agency, which then contracts services in the company’s name. In this case, the travel agency is the intermediary, but the company remains the responsible reporting party.
Authorities have consistently emphasized this point: what matters is the visibility of the company behind the transaction. Allowing disclosures to be made only by agents or service providers would undermine the purpose of the law, which is to provide transparency about the role of manufacturers in financial relationships with healthcare professionals and organizations.
Navigating Corporate Complexity
Identifying intermediaries can be straightforward in simple cases, but today’s corporate structures often complicate the picture. It is no longer just a sales representative who chooses a consultant and signs a contract. Instead, there may be a proposer, a review committee, and a separate team approving the budget. In such cases, pinpointing the “responsible” intermediary can be challenging.
To address this, companies are advised to develop a detailed internal reference table. This table should specify, for each type of interaction, who the beneficiary is and who the intermediary is. It should also account for the fact that if a person not listed as an intermediary ultimately receives value, that individual becomes the beneficiary and must be disclosed as such. Even if this approach results in duplicate entries, the key principle remains that all relevant data must be reported.
Industry Guidance vs. Ministry Expectations
Industry codes, such as those from Farmindustria and MedTech Europe, offer practical guidance for managing intermediaries and disclosures. They can help companies develop consistent internal processes. However, experience shows that the Ministry of Health does not always align with these frameworks. In fact, official FAQs often diverge from industry interpretations in a significant proportion of cases.
This divergence underscores why companies should adopt a cautious, conservative approach. Even when a legal-entity agent may technically be able to report, the safer and more transparent practice is for the company itself to upload the disclosure, listing the agent as the intermediary.
Conclusion
The concept of the intermediary under the Italian Sunshine Act is broader than many initially thought. It includes not only external third parties but also company employees involved at any stage of the transaction. The company must always remain the accountable reporting party, ensuring that beneficiaries and intermediaries are clearly identified and disclosed.
While the complexity of modern organizations makes this challenging, the underlying principle is simple: transparency. By adopting structured internal processes and keeping the responsibility for reporting firmly in-house, companies can manage this obligation effectively and align with both the spirit and the letter of the law.
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.