The key facts about regulatory reforms in Italy. Prepared in association with Baker Mckenzie, a leading law firm in Italy, this is an extract from The Pharma Legal Handbook: Italy, available to purchase here for GB 119.
1. Are there proposals for reform or significant change to the healthcare system?
The most recent changes in legislation relate to the clinical trial sector, where Legislative Decree No. 52/2019 and the Decree of the MoH dated November 30, 2021, which was published in the Italian Official Gazette on February 16, 2022, have introduced new rules according to which data and results obtained from non-profit clinical trials funded by the Italian NHS can be assigned to third parties for registration and marketing purposes provided that either the sponsor or the assignee refunds and reimburses any direct or indirect associated costs (please see Chapter 2).
Also, on June 26, 2022 Law No. 62/2022 on ‘Transparency rules on relationships between manufacturing companies, healthcare professionals and organizations’ (“Sunshine Act”) entered into force. With said law, the Italian legislators has 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.
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.). Law No. 62/2022 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 (i.e. by December 26, 2022). Said register will be used to publish data submitted by Manufacturing Companies and those relating to sanctions, which will be accessible for a period of five years.
2. When are they likely to come into force?
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