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.
- With said law, the Italian legislators introduced, for the first time, disclosure and transparency obligations concerning relationships of economic relevance between companies manufacturing medicinal products, instruments, equipment, goods and services (even of non-health nature) (“Manufacturing Companies“), and healthcare professionals and organizations.
- Indeed, the approval of the Sunshine Act is of particular relevance since, until now, the disclosure of transfers of value between pharmaceutical and medical device companies and healthcare professionals and organizations was performed on a voluntary basis as a result of the participation of the company in the relevant trade association (e.g., Farmindustria, Confindustria Dispositivi Medici) and the consequent acceptance of the disclosure obligations provided for by the relevant Codes of Conduct.
- According to the Sunshine Act, reporting and disclosure obligations apply, among other things, to (i) agreements and disbursements of money, goods, services or other benefits performed by a Manufacturing Company in favor of healthcare professionals and/or organizations; and (ii) agreements between Manufacturing Companies and healthcare professionals and/or organizations providing direct or indirect benefits for the latter (participation in conferences, training events, committees, etc.).
- The new law introduces pecuniary sanctions for the nondisclosure and the late disclosure of data as well as for the submission of incomplete information.
- The Sunshine Act also provides for a public register that will be established on the institutional website of the Ministry of Health within six months from the entry into force of the law. Said register will include publication of the data submitted by Manufacturing Companies and those relating to sanctions, which will be accessible for a period of five years.