Medical products and services: the Sunshine Act sets new provisions for the companies that operate in Italy

published on 10 October 2024 | reading time approx. 6 minutes

In June 2022, law no. 62/2022 (also known as “Sunshine act”) entered into force. Such a law heavily impacts the healthcare sector by strengthening provisions regarding transparency and those aimed at preventing and combatting corruption in healthcare. The law intends to shed light on relationships between companies producing drugs, instruments, equipment, goods and services, and entities operating in the healthcare sector or health organisations which have an economic significance or advantage.

Given that the new provisions will also impact non-Italian companies, all businesses must adequately be informed to avoid sanctions.

Entities impacted by the new transparency provisions

Domestic and non-domestic manufacturers, workers in the healthcare sector, and healthcare organisations are all subjected to the provisions of the Sunshine Act. The new obligations must also be fulfilled by non-Italian manufacturers, that must also appoint a representative located in Italy.

Companies should not be misled by the language used by the Italian legislator: in fact, the term “manufacturer” is to be understood as “any entity, including those belonging to the Third Sector, which, either directly or in the role of an intermediary or related enterprise, engages in an activity directed at the production or marketing of drugs, instruments, equipment, goods or services, including non-health products, including nutritional products, marketable in the field of human and veterinary health, or at the organisation of conventions and congresses concerning the same objects” (art. 2, par. 1, lett. a)). This definition falls right in line with the objective of the new law, which aims to obtain the highest degree of transparency possible. To achieve this goal the new provisions apply to a large number of entities.

However, manufacturers are not the only players involved: for the Sunshine Act to be applicable, manufacturers must have a business or otherwise advantageous relationship with entities operating in the healthcare sector or health organisations. According to article 2 of the Sunshine Act, the latter can be public or private legal entities providing health services (e.g. hospitals) as well as, for example, university departments, specialiased schools, private research institutes, public and private entities that organise continuing medical education activities and societies, patients' associations, foundations and other entities established or controlled by these entities or that control or own them or act as intermediaries for health organisations. By “entities operating in the health sector”, the Sunshine Act means “individuals belonging to the health or administrative area and other individuals who work, in any capacity, within a health organisation, public or private, and who, regardless of the position held, exercise responsibility in the management and allocation of resources or intervene in decision-making processes regarding drugs, devices, technologies and other goods, including non-health, as well as research, experimentation and sponsorship” (art. 2, par. 1, let. b)).

Transparency obligations

The Sunshine Act requires manufacturers to communicate any agreement and disbursement of money, goods, services or other benefits in favour of entities operating in the healthcare sector and health organisations. In the first case, the unit value must amount to more than 100 euros or the total annual value must amount to more than 1.000 euros; in the second case, the unit value must be greater than 1.000 euros or the total annual value must be greater than 2.500 euros (art. 3, par. 1).

Agreements that make for direct or indirect benefits, such as conferences, training events and scientific committees are also subjected to disclosure (art. 3, par. 2).

By January 31st of every year, manufactures in corporate form must communicate to the Italian Ministry of Health the identifying data of individuals holding shares or units of the company's capital or bonds issued by the company registered for the previous year or individuals that, in the previous year, have received compensation from the company for granting licenses for economic use of industrial or intellectual property rights (art. 4).

The electronic public register “Sanità trasparente”

The communication of data required by articles 3 and 4 of the Sunshine Act must occur through the electronic public register “Sanità trasparente” (art. 6), which, however, is still in the making. The register is being developed following the indications of the Italian legislator that, for example, requires the public registry to be freely accessible for consultation and to be provided with functions that enable the search and extraction of the data in accordance with open data standards (art. 5, par. 3).

It must be noted that with the stipulation of the agreements or the acceptance of the disbursements, consent is understood to be given by the subjects and organisations involved to the publication and processing of data for the purposes of article 5 of the Sunshine Act. In any case, manufacturing companies are required to provide notice to health subjects and health organisations, specifying that communications are subjected to publication on the institutional website of the Ministry of Health. These provisions do not affect the rights of data subjects outlined in Regulation (EU) 2016/679 (GDPR).

Consequences of the adoption of the Sunshine Act

Manufacturers will have to comply with the provisions of the Sunshine Act as soon as the electronic public register “Sanità trasparente” goes live. The operations’ starting date shall be announced by a notice published on the Official Journal for the publication of laws currently applicable in Italy (“Gazzetta Ufficiale”).

Companies can, however, already start adjusting to the new provisions. Non-domestic companies should especially start reflecting on the opportunity of nominating a representative in charge of the collection of data and registration process as well as of the communication with the Italian Authorities. Taking early action in order to be prepared when the terms for the applicability of the reporting requirements begin is particularly important given the sanctions which could be applied in case of non-compliance. For example, a manufacturer that fails to file the necessary data within a specific time frame (art. 3), could be subjected to an administrative sanction, which imposes the payment of a sum of 1,000 euros increased by twenty times the amount of the disbursement to which the omission refers to for each omitted communication (art. 6, par. 2).

Overview of obligations and sanctions

Obligation	Punishable conduct	Administrative fine*
By the end of the following semester, telematic communication regarding conventions and disbursements of money, goods, services or other benefits made to: of a health-related entity, when they have a unit value greater than 100 euros or a total annual value greater than 1,000 euros; of a health care organization, when they have a unit value greater than 1,000 euros or a total annual value greater than 2,500 euros.	Failure to execute telematic communication. Art. 6, par. 2. Incomplete provision of information not corrected within 90 days of deadline. Art. 6, par. 4.	1,000 euros increased by 20 times the amount of the disbursement to which the omission relates.
	Provision of false information. Art. 6, par. 5.	Unless the act constitutes a crime, from 5,000 to 100,000 euros.
By the end of the following semester, communication of agreements with health-related entities or health organizations that produce benefits consisting of participation in conferences, training events, committees, advisory body commissions or scientific committees or the establishment of consulting, teaching or research relationships.	Failure to execute telematic communication. Art. 6, par. 2. Incomplete provision of information not corrected within 90 days of deadline. Art. 6, par. 4.	1,000 euros increased by 20 times the amount of the disbursement to which the omission relates.
	Provision of false information. Art. 6, par. 5.	Unless the act constitutes a crime, from 5,000 to 100,000 euros.
Transmission of the communication of the enterprise established as a corporation by the deadline of January 31st of the communication of entities operating in the health sector and health organizations for which one of the following conditions is met: are shareholders or unit holders of the company's capital or bonds issued by the company, registered for the previous year in the register of shareholders or bond register, respectively; have received fees from the company in the previous year for licensing the economic use of industrial or intellectual property rights.	Omission. Art. 6, par. 3. Incomplete provision of information not corrected within 90 days of deadline. Art. 6, par. 4.	From 5,000 to 50,000
	Provision of false information. Art. 6, par. 5.	Unless the act constitutes a crime, from 5,000 to 100,000 euros.
By January 31st, indication in the disclosure of the total value of shares or units constitutes a qualified participation in the disclosure of entities operating in the health sector and health organizations for which one of the following conditions is met: are shareholders or unit holders of the company's capital or bonds issued by the company, registered for the previous year in the register of shareholders or bond register, respectively; have received fees from the company in the previous year for licensing the economic use of industrial or intellectual property rights.	Omission. Art. 6, par. 3. Incomplete provision of information not corrected within 90 days of deadline. Art. 6, par. 4.	From 5,000 to 50,000
	Provision of false information. Art. 6, par. 5.	Unless the act constitutes a crime, from 5,000 to 100,000 euros.

*To the manufacturing enterprise with an annual turnover of less than one million euros, the penalties shall be applied in an amount equal to one-half of the amounts defined by the aforementioned subparagraphs, provided that such enterprise is not controlled, affiliated or bound by supply or subcontracting relationships with other manufacturing enterprises.