The “Sunshine Act,” a bill establishing transparency requirements for interactions between manufacturing firms and healthcare organizations and specialists, was finally passed on May 24, 2022. As soon as the Sunshine Act is published in the Official Gazette, it becomes operative.
Italian Government Approve “Sunshine Act”
With the aforementioned law, Italian legislators for the first time imposed disclosure and transparency requirements on relationships of economic importance between businesses producing medical devices, instruments, equipment, goods, and services (even those not related to health) (hereinafter referred to as “Manufacturing Companies”) and healthcare organizations and professionals.
Indeed, the approval of the Sunshine Act is particularly significant because, up until now, the disclosure of value transfers between pharmaceutical and medical device companies and healthcare organizations and professionals was done voluntarily as a result of the company’s membership in the pertinent trade association (such as Farmindustria or Confindustria Dispositivi Medici) and the ensuing acceptance of the disclosure obligations stipulated by the association.
According to the Sunshine Act, agreements and disbursements of money, goods, services, or other benefits made by a Manufacturing Company in favor of healthcare professionals and/or organizations, as well as agreements between Manufacturing Companies and healthcare professionals and/or organizations providing direct or indirect benefits for the latter, are among the things that require reporting and disclosure (participation in conferences, training events, committees, etc.).
The new law adds financial penalties for failing to disclose information, doing so after the deadline, and submitting inadequate information.
The Sunshine Act also calls for the creation of a public register, which will be posted on the Ministry of Health’s official website within six months of the law’s enforcement. The data given by Manufacturing Companies and information about punishments will both be published in the aforementioned register and available for five years.
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