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The new Italian Sunshine Act

15/06/2022

The Social Affairs Commission of the Italian Chamber of Deputies recently approved the final version of the so-called Sunshine Act, bearing “Provisions on the transparency of relations between manufacturing companies, health care providers and health organizations”. The text of the new law will enter into force soon after its publication in the Official Gazette.
 
I. What are the objectives of the Sunshine Act?
 
The new law pursues the objectives of enhancing the sense of responsibility of healthcare professionals in their interactions with industry, as well as increasing public awareness through knowledge of the financial links between pharmaceutical companies and professionals.
 
To these purposes, the Sunshine Act guarantees the right to knowledge of relationships of economic relevance or of advantage, between companies producing drugs, instruments, equipment, goods and services, including non-health-related ones, and health professionals or health organizations.
  
II. Who are the stakeholders involved?
 
The Sunshine Act identifies three categories of stakeholders that are primarily impacted by the legislation:

  • manufacturing companies;
  • persons operating in the health sector; and
  • health organizations

In the case of a manufacturing company based abroad, communications will be made by its representative in Italy.
 
III. What does the Act provide for?
 
The Sunshine Act sets out an obligation for manufacturing companies to disclose:

  • affiliations and disbursements of money, goods, services or other benefits made by a manufacturing company in favor of (a) a person operating in the health sector, when they have a unit value of more than EUR 100 or a total annual value of more than EUR 1,000; and (b) a health organization, when they have a unit value of more than EUR 500 or a total annual value of more than EUR 2,500;
  • agreements between manufacturing company and persons operating in the health sector or healthcare organizations, which result in direct or indirect benefits, consisting in participation in conferences, training events, committees, commissions, advisory bodies or scientific committees or in the establishment of consultancy, teaching or research relationships;
  • where the manufacturing entity is incorporated as a company, the identification data of persons operating in the health sector and health organizations who (a) hold shares or quotas in the company's capital or bonds issued by the company, registered for the previous year in the shareholders' register or the bond register, respectively; or (b) have received from the company, in the previous year, consideration for the granting of licenses for the economic use of industrial or intellectual property rights.

IV. When will the Act apply?
 
The full implementation of the Sunshine Act requires some preliminary steps.
 
Within three months from the date of entry into force, the Minister of Health shall determine:

  • the structure and technical characteristics of the electronic public register;
  • the requirements and procedures for the transmission of communications and data entry;
  • the models for communications and any further elements to be indicated in the communications.

Within six months from the date of entry into force, the telematic public register called 'Sanità Trasparente' shall be set up and made available on the institutional website of the Ministry of Health, in which the data relating to the communications and sanctions governed by the Sunshine Act will be published.
 
The date of the register's start of functioning will be communicated by means of a notice published in the Official Gazette. This date marks a key step in the implementation of the Act. Indeed:

  • the disclosure requirements relating to disbursements, conventions and agreements will apply from the second half of the year following the six-month period in progress on the date of publication of the notice;
  • disclosure obligations relating to shareholdings, bonds and income from industrial or intellectual property rights will apply as from the second year following the year in progress on the date of publication of the notice.

V. What are the sanctions?
 
A manufacturing company that fails to comply with the new obligations under the Sunshine Act may incur a number of sanctions, which will be published in a special section of the electronic public register.
 
The conducts that will be sanctioned include:

  • the failure to notify disbursements, affiliations and agreements, for which a fine of EUR 1,000 is provided for, increased by twenty times the amount of the disbursement to which the omission refers;
  • failure to disclose shareholdings, bonds and income deriving from industrial or intellectual property rights, for which a fine ranging from EUR 5,000 to EUR 50,000 is provided for;
  • unless the act constitutes a criminal offence, the provision of false information in communications, for which a fine ranging from EUR 5,000 to EUR 100,000 is provided for.

Only if the manufacturing company has an annual turnover of less than one million euro and is not controlled, affiliated or bound by supply or subcontracting relationships with other manufacturing companies, the sanctions will be reduced by half the amounts provided for by law.

Authors

Portrait ofLaura Opilio
Laura Opilio
Partner
Rome
Portrait ofMaria Letizia Patania
Maria Letizia Patania
Partner
Rome
Roberto Plutino