Clifford Chance

The public consultation on the draft executive order and guidelines governing the public electronic register called “Transparent Health System” introduced by Law 62/2022 (the 'Italian Sunshine Act') has now been concluded.

The Italian Sunshine Act promotes the transparency of data of public interest relating to financial transactions between the healthcare industry and healthcare professionals/organisations by setting up a public electronic register called 'Transparent Health System' which will be available on the website of the Ministry of Health. The register will be fed with the information that operators are obliged to communicate to the Ministry. The purpose of the new law is to prevent corruption and combat conflicts of interest that plague the sector to the detriment of the public interest in collective and individual health.

Although the law has been passed, the register is not yet operational, pending the enactment of the executive order and relevant guidelines that will regulate the operation of the register. In particular, the draft order regulates the type of data collected, their transmission and publication, reports of conduct in breach of the law and the timeframe for publication and storage of data. The related technical regulations, on the other hand, define in detail the entities required to transmit the data to the Ministry of Health, as well as the processes for authenticating and authorising them, the data to be transmitted, the means of consultation of the electronic public register and the infrastructural features of the register.

Most companies in the healthcare sector which are members of the Italian Association of Pharmaceutical or Medical Devices Companies have long since complied with the transparency obligations laid down by EFPIA, Medicine for Europe or Medtech Europe. With the introduction of the Italian Sunshine Act, transparency obligations will apply to all companies in the healthcare sector regardless of whether or not they belong to a trade association, thereby ensuring uniformity of behaviour in relations between healthcare companies and healthcare professionals/organisations.

Although the system is not yet operational the entry into force of the order and the roll out of the register are now imminent. Companies must therefore prepare themselves for the potentially huge number of transfers that could fall within the scope of the Sunshine Act (e.g. disbursements in cash - or in kind -, shareholdings and income from industrial or intellectual property rights, etc.).