Italy is finally poised to get a law on transparency in the healthcare sector

Transparency in the pharma sector is currently mainly based on self-imposed obligations on the part of  the pharmaceutical companies. This self-regulation is generally in the form of an internalisation of the transparency principles existing in the codes of ethics of the main trade associations, such as Farmindustria, Egualia and Confindustria Medical Devices, which already provide for the obligation of associated companies to publish information on their websites regarding transfers of value made, either directly or indirectly, in favour of healthcare professionals (HCPs) to healthcare organisations (HCOs) and third parties. 

Bill for transparency

If the Sunshine Act is passed, the internal rules of the pharma sector will be transposed into and integrated by  primary legislation that bases its rationale in the transparency of the relationships of "value" between the manufacturing companies operating in the pharmaceutical sector (including the production of nutritional products marketable in the field of human and veterinary health), the subjects operating in the healthcare sector and the HCOs (see article 2). The proposed legislation also seeks to clarify some uncertainties in the interpretation of codes of ethics. 

Disclosure obligations

Article 3 provides for a mandatory disclosure regime for conventions and disbursements of money, goods, services or other utilities made by a manufacturing company in favour of:

• a subject operating in the health sector, with a unit value exceeding €100 or a total annual value exceeding €1,000;
• a HCO, for a unit value exceeding €1,000 or a total annual value exceeding  €2,500.

Agreements between manufacturing companies and subjects operating in the health sector or with HCOs that produce direct or indirect benefits, consisting in participation at conferences, training events, committees, advisory bodies or scientific committees, or in the establishment of consulting, teaching or research relationships, are also subject to disclosure requirements.

Article 4 envisages that manufacturing companies will be required to file an annual communication with the public telematic register stating details of:

• the ownership of shares or quotas of its share capital by parties operating in the health sector or one or more HCOs; or 
• any payments made for the granting of licences for the economic use of industrial or intellectual property rights in favour of entities operating in the health sector or one or more HCOs.

Disclosure requirements will be implemented through an online public register established by the Italian Ministry of Health within six months from the entry into force of the law: The information recorded will remain accessible to the public for a period of five years.

Sanctions

In order to strengthen the efficiency of the law, fines are envisaged for manufacturing companies that fail to comply with the disclosure obligations. Supervisory powers will be attributed to the Ministry of Health, supported by the dedicated police department (Comando Carabinieri per la tutela della salute).

Osborne Clarke comment

The Farmindustria and Confindustria Medical Device Code of Ethics contain provisions regarding the modalities, duration and content of the publication required for their associated companies, which are  similar to the provisions of the Sunshine Act. Therefore, the real gap that the legislator intends to fill with this new legislation concerns both the subjects required to meet the obligations of transparency – the compliance of which will no longer be left to the members of trade organisations and their commitment to comply with the respective codes of ethics – and the enforceable nature of the relevant provisions, the violation of which would entail the application of heavy fines. 

The existing code of ethics mainly envisage sanctions of a reputational nature (including the exclusion of the pharmaceutical company from the relevant association in case of violation), with the residual possibility of potential fines that are proportionate to the gravity of the infringement. The Sunshine Act on the other hand, once adopted, will oblige all companies in the sector to respect the obligations of transparency – regardless of any expressions of adhesion or consent to industry codes. Moreover, through the intervention of the authorities in charge, which will also have inspection powers, the law will lead to an easier verification of any violations, thus promoting a virtuous growth and uniformity of the entire sector towards the highest levels of transparency and legality.

If you would like to discuss any of these issues further, please do not hesitate to contact the authors or your usual Osborne Clarke contact.