Provisions on transparency of relationships between manufacturers, health-related entities and health organizations
On 24th May 2022, the so-called “Sunshine Act” has been definitely approved by the Social Affair Commission of the Italian Parliament and will formally enter into force 15 days after its publication on the Official Journal.
The law consists of 9 articles and pursues the “objective of transparency and the prevention and combating of corruption and the degradation of administrative action”, imposing transparency obligations on those defined “manufacturers”, i.e. “any person, including a member of the Third Sector, who, directly or as an intermediary or related undertaking, carries out an activity directed to the production or placing on the market of medicines, tools, equipment, goods or services, whether or not sanitary, including nutritional products, which may be marketed in the context of human and veterinary health or the organization of conferences on the same subjects.”
The law, therefore, establishes mandatory transparency obligations, which will be applied together with the transparency principles and requirements provided for by the Farmindustria and EFPIA Codes of Ethics.
- Scope
Transparency obligations relate to some relations between the manufacturers, on the one hand, and “entities operating in the health sector” and/or “health organizations”, on the other, as in article 2 of the law.
In particular, transparency requirements shall apply to:
(a) agreements and payments in cash, goods, services and other utilities carried out by another manufacturer in favor of: (i) an entity operating in the health sector, where they have a unit value above 100 euros or a total annual value greater than 1,000 euros; or (ii) a health organization where they have a unit value above 1,000 euros or a total annual value above 2,500 euros.
(b) agreements between manufacturing companies and entities operating in the health sector or health organizations that produce direct or indirect benefits through participation in conferences, training events, advisory bodies or scientific committees or in the establishment of research, advice and teaching relationships.
(c) In addition, by 31 January of each year, manufacturers shall provide identification of any health professionals and health organizations which: (i) hold shares in the company’s capital or bonds issued by the company; (ii) have received from the company in the previous year fees for the granting of licenses for the economic use of industrial or intellectual property rights.
2. Procedure
Transparency notices must be entered in a public electronic register held by the Ministry of Health (“Sanità Trasparente”), which will be established within 6 months from the date of entry into force of the law.
3. Final regime
Transparency notices shall be issued from the second semester following the ongoing one at the date of publication of the notice, in the Official Gazette, of the start of the operation of the register and, regarding the obligations of the point sub c), from the second year following that in progress to the date of publication in the Official Gazette of the notice of the start of operation of the register.
4. Sanctions
Non-compliance with the transparency requirements shall lead to the application of an administrative fine:
- equal to 1,000 euros increased by twenty times the amount of the payment, in the event of failure to notify;
- up to an amount of 50,000 euros, in the event of failure to notify the information of the point sub) c above;
- up to an amount of 50,000 euros, in the event of incomplete communication;
- up to 100,000 euros, unless the fact constitutes a crime, in the case of false notices.
These sanctions will be applied to the extent of 50% for companies with a turnover of less than 1 million euro.
25 May 2022
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The above note is for information only and may not be intended as a substitute for a considered and specific legal opinion.