[co-author: Angelo Forte]

From June 26th, 2022, the “Italian Sunshine Act” entered into force. This is a piece of legislation aimed at preventing corruption and fostering transparency in the health sector by imposing disclosure obligations on companies in the pharmaceutical, medical devices, nutritional, and health care sectors. While awaiting its full implementation, in this article we describe the key aspects of the Italian Sunshine Act and its distinctive features from current sources of similar transparency obligations.

Introduction to the Italian Sunshine Act

On June 26^th, 2022, following a three-year-long legislative process, Law no. 62/2022 (“Italian Sunshine Act”) entered into force.

This Law establishes provisions for transparency in the relationships between the companies of the life sciences and healthcare sector (“Companies”), healthcare professionals (“HCPs”), and healthcare organizations (“HCOs”).

However, its full enforceability is subject to implementing regulations and other fulfilments (e.g. the establishment of the Telematic Public Register for disclosures publication, named “Transparent HealthCare – “Sanità Trasparente”), with the result that it will probably not be effective for another year.

The key takeaway points of this legislative development are:

• transparency is no longer the result of Companies' voluntary membership in industry associations (e.g. Farmindustria and Confindustria Dispositivi Medici).

• the range of players affected by this...

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