On 24 May 2022, the bill on ‘Transparency rules on relationships between manufacturing companies, healthcare professionals and organizations’ (“Sunshine Act“) was finally approved. The Sunshine Act will enter into force after its publication in the Official Gazette.
The Law promotes the transparency of public interest data regarding financial transactions between companies and health care entities. The objective of the new regulations is to prevent and counter corruption and improper administrative actions. Companies that produce drugs, instruments, equipment, goods, and services (including non-medical ones) and entities operating in the health sector, including medical organizations, now must declare all relationships “having economic significance or advantage” between them. A public electronic register shall be open for consultation for the public, called “Transparent Healthcare”.
The Law draws from similar U.S. legislation adopted in 2010, the Physician Payments Sunshine Act, a name also used in the rest of the world to refer to such regulations. Similar legislation are there in countries like France, Denmark, Belgium, Greece, Latvia, Portugal, Romania and Slovakia, as well as in the UK.
The rationale behind this legislation is to empower health care professionals in their relationships with the industry and to increase public awareness of the financial ties between pharmaceutical companies and professionals.
The Law identifies three categories of entities affected by the new legislation regarding the reporting requirements:
i) companies active in the field of human and veterinary health, any entity that carries on an activity aimed at the production or marketing of drugs, instruments, equipment, goods or services that can be marketed in that field;
ii) entities active in the health sector who are responsible for the management and allocation of resources or who participate in decision-making processes regarding drugs, devices, technologies and other goods; iii) health care organizations (such as health care companies, hospitals and inpatient or nursing institutions)
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.
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 favour 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.