With the approval of the Italian Parliament last May, the so-called 'Italian Sunshine Act' (L. 62 of 31/05/2022) will soon officially enter into force (the date is set for 26 June 2022).
Law on Transparency; this act aims at introducing into the Italian legal framework specific provisions regarding interactions between manufacturing companies, healthcare professionals and healthcare organizations.
Such system is not new, as the U.S published the first "Sunshine Act" back in 2010 together with the “Open Payments” database for public consultation. Later in 2015, the European Federation of Pharmaceutical Industries and Associations ("EFPIA") published the EFPIA Code that requires member pharmaceutical companies to disclose payments made to healthcare professionals on local public platforms (where available) or on their own websites. Taking cues from similar models already in place abroad, the Italian law calls for the introduction of an online registry to monitor links of interest (benefit, compensation, agreement) between the healthcare industry and healthcare professionals and entities.
Within its nine articles, the Italian Sunshine Act's primary purpose is to promote greater transparency about the existing operations and relationships between companies and entities operating in the healthcare sector, in order to achieve a higher level of prevention and contrast corruption.
In order to achieve these objectives, the Italian Sunshine Act provides for precise requirements for the of agreements with, and transfer of value, both in cash and in kind (including transfer of money, goods, services or other benefits) from a manufacturing company to: disclosure
- healthcare professional ("HCP") – with unit value greater than 100 euros or total annual value greater than 1,000 euros);
- healthcare organization ("HCO") – with a unit value greater than 1,000 euros or annual total greater than 2,500 euros).
In addition, agreements between manufacturing companies and HCPs or HCOs, which produce direct or indirect benefits, such as sponsorship to attend meetings, conferences, training events, committees, advisory boards or scientific committees or the establishment of consultancy, teaching or research relationships, are also subject to disclosure.
Manufacturing company will have to transmit electronically to the Italian Ministry of Health specific details about the relationships between such companies and HCPs/HCOs, including the beneficiary's data, via the new public register "Sanità trasparente" in the manner yet to be further prescribed.
In addition to the obligation of publication, the Italian Sunshine Act provides that the electronic register must also include information on shareholdings, ownership of bonds and income deriving from industrial or intellectual property rights of manufacturing companies and held by healthcare professional and by healthcare organizations.
Regarding the privacy aspects, although the consultation of the Italian data protection authority will take place within 3 months from the date of entry into force of the law, the Italian legislator already anticipates potential interactions with the Regulation (EU) 2016/679 ("GDPR"). On the one hand, the Italian legislator requires manufacturing companies to collect the consent of data subjects, on the other hand, the law provides that such consent is considered as provided ‘by default’ by the said subject who signs the agreement, receives the compensation, or acquires shares, bonds and/or gets income from industrial or intellectual property rights. In any case, manufacturing companies shall provide a complete information notice to HCPs and/or HCOs’ representatives as per art. 13-14 of the GDPR.
It is also worth mentioning that, unlike the EFPIA Code, the Italian law does not expressly provide for the possibility for individuals to request manufacturing companies to publish their personal data in an aggregated, and therefore anonymized, manner.
Finally, there are specific provisions in the event of non-compliance with the above-mentioned disclosure duties, with sanctions ranging from a minimum of €1,000 (increased by twenty times the amount of the payment to which the omission refers) up to €100,000.