Italian Sunshine Act: transparency in the Healthcare & Life Science Sector
The Italian Sunshine Act was adopted in 2022 and is becoming effective in the next few months. The purpose of the Sunshine Act is to promote the transparency of financial transactions and relations of interest between companies, professionals and entities operating in the Healthcare and Life Science Sector, but also to protect patients from an anti-corruption perspective.
The Sunshine Act (Law no. 62, May 3, 2022) requires the establishment of a public register called ‘Transparent Healthcare‘ on the institutional website of the Ministry of Health, freely accessible for consultation, which gathers declarations on relations of economic significance or advantage between people operating in the health sector and health organizations; imposing sanctions in the event of non-compliance with transparency obligations.
With the establishment of the public register the healthcare companies will be obliged to give all the information pertaining agreements and disbursements in cash, goods, services or other benefits made in favor of a person operating in the health sector, when they have a unit value of more than 100 euros or a total annual value of more than 1,000 euros; if the disbursement or agreement is made to a health organization, the figures rise to 1,000 euros and 2,500 euros respectively. Agreements that produce direct or indirect benefits connected with ‘participation in conferences, training events, committees, advisory bodies or scientific committees or in the establishment of consultancy, teaching or research relationships must also be declared.
All communications (with the exception of some sensitive data) will be freely accessible, for consultation, search and extraction of data, for five years from the date of publication: at the end they will be deleted. With regard to the consent for processing personal data, the law provides that this is understood to be given by the individuals or health organizations at the time of accepting the agreements or entering into conventions. Companies are, however, obliged to specify the communication obligations.
The Act establishes monetary sanctions in the event of:
- omission of telematic communication;
- delay in the communications required by law; or
- incomplete or false information, unless the act is a criminal offence.
In order to make the Sunshine Act effective, the Ministry of Health shall release an implementing regulation in the next few months. On 17 September 2023, the public consultation on the draft regulation and the related technical specifications for the creation and management of the public register was concluded; the consultation was open to stakeholders, understood as companies producing products of health interest, voluntary associations, healthcare companies and professionals, in general all subjects operating in different capacities in the human and veterinary health sector. Thirty stakeholders participated in the public consultation, highlighting shortcomings and impacts of the proposed regulation: the Ministry is expected to take these into account when drafting the final version of the regulation.
Once the public consultation phase is over, the ‘Transparent Healthcare’ public register in expected to see the light of day relatively soon: it will be crucial for companies to use the next few months in order to be prepared.