The Italian healthcare landscape has undergone a significant turning point with the enforcement of Law No. 62 of May 31, 2022, commonly known as the “Sunshine Act.” This legislation aims to introduce transparency and clarity in the relationships among various entities involved in the healthcare sector. By fostering integrity and accountability, this law represents a crucial step towards ensuring the highest standards of ethical conduct in healthcare practices.
Indeed, the primary objective of the Sunshine Act is to prevent corruption and counteract conflicts of interest that may compromise the interest in collective and individual health, as protected by the Italian legal system.
The law provides a series of clear definitions, outlining who manufacturing companies, entities in the healthcare sector, and involved healthcare organizations are.
One of the most significant innovations introduced by the Sunshine Act is the establishment of the Public Telematic Registry called “Transparent Health.” This telematic platform, set up by the Ministry of Health, will collect all information related to economic transactions among healthcare operators, such as:
- agreements,
- cash payments,
- shareholdings, etc.
To ensure compliance with the law, sanctions are provided for companies that fail to meet communication obligations.
Finally, although the Sunshine Act has already come into force, communication obligations timings have not yet been clarified. However, it is important for companies and other affected operators to begin evaluating the adoption of appropriate measures to comply with the new provisions.
Regulatory Pharma Net is available to provide your company with any updates on the Sunshine Act regulatory framework and to assist on all regulatory needs related to this specific activity.
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.
Do not hesitate to contact us at info@regulatorypharmanet.com