FAQs
FAQs
This section contains frequently asked questions related to the Italian Sunshine Act for your ease. If you have any more questions that you feel should be added please let us know and we’ll add them after reviewing.
Q. What is the Italian Sunshine Act?
Answer: The Italian Sunshine Act, or “Legge 124,” is an Italian transparency law that mandates the public disclosure of financial relationships between healthcare providers and pharmaceutical or medical device companies to increase transparency and prevent conflicts of interest. It promotes accountability and ethical practices within the healthcare sector.
Q. How does the Italian Sunshine Act change the current scope of transparency?
Answer: The Italian Sunshine Act expands the scope of transparency in Italy’s healthcare industry by requiring disclosure of financial interactions between pharmaceutical companies, medical device manufacturers, and healthcare professionals or organizations. This law enhances transparency, ensuring that payments, benefits, and other transfers of value are reported and publicly disclosed, creating greater accountability and trust within the healthcare sector.
Q. What type of personal details will need to be disclosed?
The date of birth and qualification of the intermediary and the place of birth, date of birth, and qualification of the beneficiary.
Q. Will personal details be disclosed to the public?
No. The personal details will be required to be disclosed on the Sanita Transparente but these will not be published.
Q. Are there any Transfers of Value (TOVs) excluded from reporting?
The MOH’s Technical Specification and the Law encompass payments in money, goods, services, or utilities, along with agreements for participation in conferences, training events, committees, and more. While a comprehensive list is pending, it’s advised to collect details of all TOVs to ensure thorough compliance.
Q. My small global company lacks an office in Italy. Do we need to report, or does our software distributor bear the responsibility?
If you’re a global company without an Italian office but have a software distributor partnership, you’re required to make the disclosure. Clearly indicate on the portal that the TOV was facilitated through your distributor, and disclose their details accordingly.
Q. What about indirect beneficiaries? Like an educational grant given to HCO to support the attendance of HCP to a congress (MedTech requirement). Do we need to disclose the attendees?
Answer:
Absolutely. Both the law and Draft Decree emphasize transparency in both direct and indirect benefits. Consequently, all details, including attendee information, will be disclosed as part of our unwavering commitment to compliance
Q. Is a transparency template, like the former Modello Trasparenza, already available for internal testing?
Answer:
The Ministry of Health has released a technical specification outlining the types of data companies may need to capture. This document is not final and may change, but it provides a useful starting point for preparing internal systems.
The Ministry of Health has released a technical specification outlining the types of data companies may need to capture. This document is not final and may change, but it provides a useful starting point for preparing internal systems.
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