Italy – The New Italian Sunshine Act: What Companies Should Know And How To Get Ready

On 31 May 2022, the Italian Parliament approved Law 62/2022, also known as the Sunshine Act.  The Sunshine Act entered into force on 26 June 2022.  However, it will become fully enforceable once the Ministry of Health sets up the Public Register where companies will have to disclose their data and issues the necessary implementing acts.  This means that realistically the new transparency system will not be operational before 2023.  Nonetheless, it is critical that companies operating in Italy make sure that they are ready when the time comes.  Here, we outline some of the key features of the new Sunshine Act and the steps that companies could take in preparation.

Main differences with the transparency rules of the industry codes

Prior to the approval of the Sunshine Act, only member companies of trade associations, such as Farmindustria or Confindustria Dispositivi Medici, were under the obligation to disclose the transfers of value made to healthcare professionals (“HCP”) and organizations (“HCO”).  Non-member companies of those trade associations had no corresponding obligation, although many of those companies disclosed their transfers on a voluntary basis, following the provisions of the trade associations’ Codes of Ethics as best practice…