Italian Government approve “Sunshine Act"

Objectives

The Sunshine Act is inspired by the legislation of the United States, where, in 2010, the Physician Payments Sunshine Act (PPSA) was approved in order to increase the transparency of financial relationships between healthcare related professionals, healthcare organisations and pharmaceutical manufacturers.

In Italy, prior to the approval of the Sunshine Act, there were only transparency obligations for companies operating in the health sector (medicinal products and medical devices) that were members of main industry associations (Farmindustria and Confindustria Dispositivi Medici).

Members of these trade associations were already obligated to follow a set code of ethics dictated by these associations, which directed member companies to disclose all transfers of value, directly or indirectly, between healthcare professionals, healthcare organisations and certain third parties on their websites.

Through the passing of the Sunshine Act into Italian law, this obligation is applicable to all companies, regardless of if they’re member to said trade association.

The aim of the Sunshine Act is to promote the transparency of “economically relevant or advantageous relations between companies producing medicinal products, instruments, equipment, goods and services, including non-health care ones, and those operating in the health sector or in health organisations”. (Article 1)

Obligations

Article 3 provides for a mandatory disclosure regime for:

• agreements and payments in cash, goods, services and other utilities carried out by a manufacturer in favour of:
  • of a person operating in the healthcare sector, when they have a unit value of more than 100 euros or a total annual value of more than 1,000 euros;
  • of a healthcare organisation, when they have a unit value of more than 1,000 euros or a total annual value of more than 2,500 euros.
• agreements between manufacturers and persons operating in the healthcare sector or healthcare organisations, which produce direct or indirect benefits, consisting in the participation in conferences, training events, advisory bodies or scientific committees or in the establishment of consultancy, teaching or research relationships.

If the manufacturer is based abroad, these obligations may be performed by its representative in Italy.

Article 4, on the other hand, provides that manufacturers having a corporate form shall, by 31 January of each year, notify the Italian Ministry of Health of the identification data of any person operating in the healthcare sector and healthcare organizations which:

• hold shares in the company's capital or bonds issued by the company, registered for the previous year, respectively, in the shareholders' register or in the bond register; or
• have received from the manufacturer, in the previous year, fees for the granting of licences for the economic use of industrial or intellectual property rights..

Stages of implementation

The Sunshine Act provides:

• within six months of the entry into force of the Sunshine Act itself, the creation of a public electronic register set up at the Italian Ministry of Health (the Transparent Healthcare Register). The register will be freely accessible for consultation according to open data standards and, in particular, the information contained therein will be accessible for a period of five years from the date of first publication;
• as from the semester following the date of publication of the Transparent Healthcare Registry, the application of the reporting obligations provided under Article 3 of the Sunshine Act will apply;
• as from the second year following the date of publication of the Transparent Healthcare Registry, the application of the reporting obligations provided under Article 4 of the Sunshine Act will apply.

Sanctions

The following sanctions apply in case of violation of the reporting obligations provided under the Sunshine Act (Article 6):

• in case of omission of the communication referred to in Article 3, a fine of 1,000 euros, increased by twenty times the amount of the payments to which the omission refers, shall be imposed on the manufacturing company;
• if the omission relates to the ownership of shares, bonds, industrial or intellectual property rights, the pecuniary administrative sanction shall be a minimum of 5,000 euros and a maximum of 50,000 euros;
• unless the act constitutes a criminal offence, if the manufacturer provides false information in relation to such communications, the sanction shall be a minimum of 5,000 euros and a maximum of EUR 100,000 euros.

Sanctions are reduced by half in case the violation is committed by manufacturers with an annual turnover of less than one million euros, provided that the concerned manufacturers are not connected, controlled or bound by supply or subcontracting relationships with other manufacturers.

Finally, sanctions imposed are made public in a special section of the Transparent Healthcare Register. This will list the names of manufacturers that have failed to comply or that have provided false information in their communications.