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Source: Policy and Medicine
On June 26, 2022, the so-called Italian Sunshine Act entered into force, cementing Law n. 62/2022 into law. The law establishes requirements for transparency in the relationships between life sciences and healthcare companies, health care professionals, and health care organizations. However, the full enforceability is subject to certain implementing regulations and other fulfilments (such as the establishment of the Telematic Public Register for disclosures publication), meaning it is likely not to be fully effective for another year or so. In the meantime, however, companies impacted by the new transparency law should familiarize themselves with the law and what will soon be required of them.
Even with certain factors outstanding, companies operating in Italy need to be aware of the law and consider certain takeaways. For one, transparency is no longer the result of companies’ voluntary membership in industry associations.
Additionally, the Italian Sunshine Act contains some relevant differences with respect to national industry codes of practice companies may be used to, such as:
- Transparency obligations will cover all kinds of transfers of value above certain minimum thresholds (individual transfers of €100 or more and annual total amount of €1,000 – for health care organizations, the minimum threshold increases to individual transfers of €1,000 and annual total of €2,500).
- Transparency obligations will cover information on health care providers and health care organizations who have shareholdings, bonds, or have received income from industrial or intellectual property rights
- Communication of data shall be made on an individual basis – the Italian Sunshine Act does not provide for aggregated disclosure
- Violation of the Italian Sunshine Act is a ground for whistleblowing reports to the Ministry of Health
- The administrative pecuniary sanctions issued for Italian Sunshine Act violations will be made available on the first page of the Ministry of Health website for at least 90 days.
Under the Italian Sunshine Act, there are three different transparency obligations for companies. First, companies must publicly disclose every semester: transfers of money, goods, services, or other values towards health care providers and health care organizations (subject to the exceeding of a specific threshold value). Second, companies must also publicly disclose each semester agreements that are entered into with health care providers and health care organizations that resulted in direct or indirect benefits, including the participation in seminars, training events, committees, commissions, consultive bodies, and scientific committees; or the establishment of consulting, teaching, or research relationships. Finally, companies must annually disclose – no later than January 31st each year, starting in January 2024 at the earliest – the identification details of health care providers and health care organizations that hold shares/quotas/bonds of the companies or consideration received from companies in the previous year, in relation to licenses for the economic use of industrial or intellectual property rights.
The law allows for administrative monetary sanctions, which vary depending on the violation, the amount of the transfer of value/agreement, and the violating companies’ revenue. Sanctions will be made public on the first page of the Ministry of Health website for at least 90 days and will be entered into the Telematic Public Registry.
The law also allows for whistleblowing reports by citizens. The whistleblowing reports must be addressed directly to the Ministry of Health and will be regulated in the future by the Ministry of Health with an implementing decree.
What to Do Now
Hogan Lovells outlined some ideas on what to do next while companies await full implementation, including assessing current compliance policies and setting up training activities for functions that may be impacted by the Italian Sunshine Act.