The Sunshine Act (Law 62 of May 31st, 2022 published in the Italian Official Journal on June 11th, 2022), concerns the dispositions on the transparency of relations among manufacturers, subjects operating in the helthcare field and helthcare organizations.
The Sunshine Act aims at ensuring the right to knowledge of relationships between manufacturers (defined as the subjects that directly manufacture or participate in the commercialization of medicinal products, instruments, equipment, goods and services in the field of human or veterinarian health, or that participate in the organization of congresses concerning such matters) and subjects operating in the helthcare sector and health organizations.
Financial penalties are envisaged in cases of failure to communicate, communication of incomplete information and communication of false information by the manufacturers.
The information subject to disclosure is the following:
- Disbursements, conventions and agreements
- conventions and cash, goods, services or other utilities disbursements in favour of subject operating in the health field (unit value of more than EUR 100 or a total annual value of more than EUR 1,000) and of healthcare organization (unit value of more than EUR 500 or a total annual value of more than EUR 2,500)
- agreements between manufacturing companies and organizations that produce direct or indirect benefits, consisting in participation in conferences, training events, committees, commissions, consultative bodies or scientific committees or in the establishment of consultancy, teaching or research relationships.
The communication shall be sent within the semester following that in which the disbursements were made and / or the agreements and conventions were established. If the manufacturing company is based abroad, the fulfillment can be carried out by its representative in Italy.
- Shareholdings, bonds and income deriving from industrial and intellectual property rights
There is also an obligation for manufacturing companies to communicate, by January 31 of each year, the data of subjects operating in the health sector and health organizations that:
- are holders of shares or quotas in the capital of the company or of bonds issued by the same, registered for the previous year in the register of shareholders or in the register of bonds, or that
- have received from the company, in the previous year, fees for the granting of licenses for the economic use of industrial or intellectual property rights
Communications must be transmitted in electronic form and will be entered in the telematic public register called “Sanità trasparente”. Communications entered in the register will be available for 5 years.
The go live of the electronic register is expected within 6 months starting from the date of entry into force of Law 62 and will be available on the Ministry of Health website. The start date will be published in the Italian Official Journal.
In any case, a transitional period is foreseen before the application of the Law.
Regulatory Pharma Net is ready to provide further updates on this hot topic and to support on all regulatory needs related to the “transparent” communication provided for in the Sunshine Act.
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