14 June

HEALTHCARE

Sunshine Act: the law was published in the Italian Official Gazette

14/06/2022

Law no. 62 of 31st May 2022, containing “Provisions on the transparency of relations between manufacturing companies, subjects operating in the healthcare sector and health organizations” (so-called “Sunshine Act”) was published in the Official Journal no. 135 of 11th June 2022.

With reference to the contents of the new law, please see the Highlight published on 25th May 2022 (https://www.studiolegaleastolfi.it/in-primo-piano/en_695_sunshine-act-the-text-of-the-draft-law-has-been-approved-by-the-italian-parliament).

Sunshine Act will come into force on 26th June 2022, but for its application it’s necessary to take into account the transitional period outlined by the law.

First of all, it will be necessary to wait for the notice published in the Official Journal on the starting date of the operation of the public electronic register called “Sanità Trasparente” (on which company communications will be published for transparency purposes), which must be set up within 6 months from the entry into force of the law.

Furthermore, according to art. 9 of the new law:

(i) as from the second six-month period following the one in progress on the date of publication in the Official Journal of the communication of the starting date of the operation of the “Sanità Trasparente” Register;

(ii) the disclosure obligations of shareholdings (Article 4) shall apply as from the second year following the six-month period in progress on the date of publication in the Official Journal of the communication of the starting date of the operation of the “Sanità Trasparente” Register.

It is therefore necessary now to wait for the implementation of the Register and then begin the countdown to the application of the law.