Italy: Sunshine Act - The draft decree and related technical regulations on the "Transparent Healthcare" public register have been published

In brief

On 17 August 2023, the Ministry of Health published the draft decree, and related technical regulations, on the "Transparent Healthcare" public register and launched a public consultation to gather comments and contributions from stakeholders, including manufacturers of health products, healthcare professionals and organizations.


Key takeaways 

In such register, the establishment of which is provided for by Article 5 of Law No. 62 of 31 May 2022 ("Sunshine Act"), the Ministry of Health will publish the communications and data relating to relationships of economic importance between manufacturing companies, healthcare professionals and organizations, as well as the sanctions imposed for the violation of the disclosure and transparency requirements laid down in the Sunshine Act.

Specifically, the draft decree regulates the requirements and procedures for the transmission by manufacturing companies of communications and data related to the above-mentioned relationships, the disclosure by the Ministry of Health of the same data as well as the timing for their publication and retention. On the other hand, the technical regulations establish the internal organization of the register, its infrastructural features and the modalities for consulting the register.

Contributions from stakeholders will be assessed by the Ministry of Health and the other competent authorities to finalize the draft decree. From the date of activation of the register, which will be announced by a notice published in the Official Journal, the deadlines for the application of the disclosure obligations introduced by the Sunshine Act will start to run.

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