The provision envisages the establishment, on the institutional website of the Ministry of Health, of an electronic public register freely accessible for consultation, where appropriate publicity will be given to the agreements and disbursements in cash, goods, services or other benefits made by a manufacturing company in favor of a subject operating in the health sector.
After four years of waiting the Sunshine act is law. In fact, it was definitively approved in the Commission 
Social affairs of the Chamber, the bill containing provisions on the subject of transparency of relations between manufacturing companies, individuals working in the health sector and healthcare organisations.
Already approved by the Chamber and modified by the Senate, the renamed text thus becomes law Sunshine act, which sees Massimo Baroni as the first signatory (in the picture). As the rapporteur explained to Ansa, Nicola Provenza (M5s), "this is an historic milestone with respect to a law that aims to prevent corruption in healthcare".
Indeed, the Sunshine act aims to guarantee a greater transparency in relations between manufacturing companies and subjects active in the health sector, thanks to a text in 8 articles. And establishes a whole series of innovations, from ad hoc electronic public register with the possibility of sanctions, including types of sanctions reputational.
But let's go in order: the provision is certainly not new for the sector. It had been presented on 10 April 2018 and assigned to the XII Social Affairs Commission, in the referring office, on 4 July 2018. The examination in the commission was concluded on 28 March 2019 and subsequently in the Chamber on 4 April 2019. The April 8, 2019, was approved with amendments on February 23, 2022 to be sent back to the Chamber, assigned to the XII Social Affairs Commission. After that it seemed to have disappeared from the radar. An articulated path, therefore, for a text that introduces provisions aimed at make disbursements/financing/benefits/advantages transparent that the manufacturing companies carry out towards subjects or organizations operating in the human and veterinary health sector.
Transparency is guaranteed through the establishment, on the institutional website of the Ministry of Health, of a electronic public register called 'Transparent Healthcare', where all the data resulting from the communications that the manufacturing companies will be obliged to forward to the ministry and concerning the disbursements or agreements involving benefits for those who work in the health sector will be published in separate sections. The communications system will be subject to supervision and a sanctions regime.
The law - strongly supported by the M5S - follows similar provisions introduced in other countries of the world, in particular in France and the United States, so much so that it has been renamed, precisely, the Sunshine act Italian, on the basis of the analogous provision introduced in the United States.
But let's see the most important details. Article 3 And the central provision of the measure so long as identifies disbursements, agreements (as amended in the Senate) and agreements subject to publicity and which, therefore, the manufacturing companies will have to communicate to the Lungotevere Ripa ministry for subsequent publicity in the electronic register.
In particular, they are subject to advertising le disbursements in cash, goods, services or other utilities made by a manufacturing company in favor of a subject operating in the health sector when they have a unit value greater than 100 (instead of 50 euros, as amended in the Senate) or when they have a annual value greater than 1,000 euros (instead of 500 euros, as modified in the Senate); these thresholds are instead respectively 1,000 euros (instead of 500 euros, as amended by the Senate) and 2,500, if the disbursements are made to a healthcare organization as defined in article 2.
The article in question also specifies that conventions are also subject to publicity (as amended in the Senate) and agreements between manufacturing companies and individuals operating in the health sector or health organizations, which produce direct or indirect advantages, consisting in the participation in conferences, training events, committees, commissions, consultative bodies or scientific committees or in the establishment of consultancy, teaching or research relationships.
The provision then sets out the methods of transmission of the communication containing the data relating to the disbursement, the convention or the agreement, to be carried out by the manufacturing company.
Article 6 regulates instead the supervision and sanctions related to the violation of the provisions. For the omission of the communication referred to in article 3 (disbursements or agreements), the manufacturing company is subject to a pecuniary administrative sanction of 1,000 euros increased by twenty times the amount of the disbursement to which the omission refers. If, on the other hand, the omission concerns the ownership of shares, bonds, industrial or intellectual property rights, the pecuniary administrative sanction will be a minimum of 5,000 and a maximum of 50,000 euros.
Unless the fact constitutes a crime, if the manufacturing company provides false information in relation to both prescribed communications, then the fine will be a minimum of 5,000 and a maximum of 100,000 euros. The sanctions are reduced by half if the violation is carried out by manufacturing companies with an annual turnover of less than one million euro, provided that the companies are not connected, controlled or bound by supply or subcontracting relationships with other manufacturing companies. In relation to the incompleteness of the communications provided, you are given the opportunity to regularize your position within a period of 90 days.
Publication of the imposition of sanctions is also provided.
One is also planned reputational sanction, as widely requested during the hearings, providing that the names of companies that have not sent the due communications or that have provided false information are also published on the front page of the ministry's website, together with the sanctions.
Supervision of compliance with the provisions is entrusted to the Ministry of Health which makes use of the Carabinieri Command for the Protection of Health (Nas), without prejudice to the verification of the obligations also by the financial administration and the Finance Police Corps, in the scope of their control activities on manufacturing companies.
AND' also foreseen also the wishleblowing, i.e. the possibility of reporting conduct in violation of the provision, delegating the relative discipline to the same decree envisaged for the establishment of the electronic Register.
