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New Italian Sunshine Act will have strong impact on life sciences companies operating in the European Union
Justin Will, Senior Principal, Commercial Compliance Consulting
M. Vittoria Caddeo, Sr. Consultant, Global Commercial Compliance
Aug 08, 2022

Four years after the bill was first proposed by the Italian Parliament, the Italian Sunshine Act (Law 62/2022) was finally approved and officially published in the Official Gazette. The law entered into force June 26, 2022.

With the aim of fighting corruption and enhancing transparency in the healthcare sector, the new law will require life sciences companies to disclose relations with healthcare professional and organizations.

Any entity which, directly or in the role of intermediary, carries out an activity aimed at the production or marketing of medicines, medical devices, equipment, goods or services, including non-sanitary products, including nutritional products, in the field of human and animal health, at the organization of conferences and congresses concerning the same areas, will be subject to Law 62/2022.

Life sciences companies will report and disclose on a biannual basis via a central reporting platform, called Sanità Trasparente, all Transfers of Value (ToVs) – including monetary payments as well as in-kind, goods, services or other benefits – to individuals that exceed €100 per transaction, or €1000 annually. The TOV threshold for each HCO interaction is €1,000 per ToV or €2,500 annually. Manufacturers will also have to disclose all agreements that confer direct or indirect advantages to HCPs or HCOs, including congresses and other educational event participation, scientific committee and advisory board participation, research, consulting and speaking engagements (Art.3).

According to the approved law, licensing fees and ownership – via shares or bonds – shall likewise be disclosed on an annual basis (Art.4).

It is expected that the platform Sanità Trasparente will be developed and go live within six months of the Italian Sunshine Act entering into force of law. Whether the timeline is respected, the first period for which healthcare industry companies would be required to submit all disclosures would be from June 2023 through December 2023, with reporting due by June 2024 (for Art.3 reporting).

The information published on the platform Sanità Trasparente will be available for five years. Consent from the recipient will not be required, but it will be necessary to inform the individual on the modalities of data processing.

Failing to follow these rules could result in serious penalties: For either omissions or incomplete reporting of engagements, companies could face fines as high as 20 times the amount of the ToV in question, plus an additional sanction of €1,000 per infraction. For either omissions or incomplete reporting related to IP licensing fees and ownerships – via shares or bonds – companies could face fines of €5,000 to €50,000. Instances of false reporting would trigger fines starting at €5,000 and up to €100,000. The Ministry of Health is ultimately responsible for the monitoring and the enforcement of the law; the enforcement may be also done by the Tax Police in the context of standard tax audit.

IQVIA Commercial Compliance team is already working on the interpretation and preparation for disclosures according to the Italian Sunshine Act. From automating and managing the entire HCP/O contracting lifecycle; to capturing, collecting, and reporting global spend; to planning efficient and compliant HCP meetings and engagements – discover how our solutions can make compliance easier for you.

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