Sunshine Act
LAW No. 62 of 31 May 2022
Provisions on the transparency of relations between manufacturing companies, healthcare providers and health organizations
The implementing decree of the Sunshine Act is expected in the year 2024, and thus Law 62/2022 will come into operation. This law introduces the obligation for companies producing health goods and services to make public all transfers of value to entities operating in the health sector and health organizations, to prevent corruption and ensure transparency.
Article 3, the heart of the law, specifies that:
“Agreements and disbursements in money, goods, services or other benefits made by a producing company” exceeding €100 for health professionals and exceeding €1,000 for health organizations are subject to disclosure.
MZ Events is equated with a producing enterprise for this rule.
- Also subject to the publication (publicity) of transfers of value are ‘agreements between producing companies and health professionals or health organizations, which produce direct or indirect benefits, consisting in the participation in conferences, training events, committees, advisory bodies or scientific committees or the establishment of consultancy, teaching or research relations’.
All Italian and foreign health professionals, whatever their degree or specialization, are involved in this regulation.
- The ‘operational arm’ of the Sunshine Act will be the Italian Ministry of Health’s ‘Sanità Trasparente‘ platform, a public telematic register that will be put online when the law comes into force.
- The data to be entered are many and very detailed.
This will increase the bureaucratic workload for organizers of medical and scientific congresses. In addition, the cooperation of health professionals receiving goods and services will certainly also be needed to enter the data correctly.
- Reporting must be entered into the ministerial portal every six months.
The Sunshine Act introduces an important positive novelty: CME providers, both public and private, are equated with healthcare organizations (such as Hospitals and Universities), therefore among the potential beneficiaries of value transfers, which could also be among those subject to publicity obligations.
Therefore, MZ Events when acting as CME Provider no. 966, accredited by the Ministry of Health, will not be obliged to publish any data, whereas when the Company acts as PCO organizing medical-scientific congresses, it will have to publish, for example:
– Fees and expense reimbursements to speakers, moderators, committee members, etc.
– Hospitality, travel, and registration are granted free of charge
– Gifts, including gifts of services, of a value exceeding 100€
– Expense reimbursements incurred for invitations under the Educational Grant procedure
– Contributions and financial compensation to public and private Associations, Foundations or Bodies.
The Sunshine Act also applies to foreign professionals operating in the health sector in Italy or doing business with Italian entities in the health sector. This means that if a foreign-producing company has business dealings with healthcare entities or organizations in Italy, it must comply with the transparency and reporting requirements of the Act.
MZ Event will have to handle expense reimbursements and fees given to Italian and foreign professionals and organizations equally.
Certainly, the application of the regulation will require further investigation, which we will be happy to share with you.