The interaction between the pharmaceutical and the medical devices industries and doctors has always been reason of concern for the authorities and the population, due to the potential conflict of interests that can be established with the concession of advantages given by the industry, in form of scientific support, gifts, meals, etc… which could interfere especially in the doctor's judgment in choosing the best treatment for their patient.
One of the solutions found by the authorities and the industry itself, seizing its self-regulation, was the initiative of giving transparency to the transfers of value from the industry to healthcare professionals.
Some countries have laws, while other countries have industry codes that ensure the transparency of these transfers of value. In Brazil, for example, only the State of Minas Gerais has Laws MG 22,440/2016 and 22,921/2018, which, as a rule, compel the pharmaceutical and medical devices industry to issue annual reports for the transfers of value to registered healthcare professionals in the respective councils based in the State of Minas Gerais, while the State Health Department publishes on its website the list of healthcare professionals and how much each one has received from pharmaceutical and medical devices industries.
It so happens that, finally, Italy sanctioned Law 62 on May 31, 2022, which provides for the transparency of relations between manufacturing companies, professionals in the healthcare sector, and healthcare organizations.
First, the Law defines some concepts that are important for understanding its applicability:
Manufacturing company - any subject, including those belonging to the Third Sector, which, directly or as an intermediary or affiliated company, carries out a direct activity in the production or sale of medicines, tools, equipment, goods or services, including non-medical, including nutritional products, marketable in the human and veterinary healthcare sector, or the organization of conferences and congresses on the same objects.
Healthcare professionals - subjects belonging to the healthcare or administrative area and other subjects who work, for any reason, in the context of a healthcare organization, public or private, and who, regardless of the position held, exercise management responsibilities and allocate resources or intervene in decision-making processes relating to medicines, devices, technologies and other goods, including non-medical ones, as well as research, experimentation and sponsorship. They are compared to subjects who work in the healthcare sector and professionals registered in the mandatory national register for members of the judging committees in public procurement procedures, pursuant to article 78 of the code referred to in the legislative decree of 18 April 2016, #50, administered by the National Anti-Corruption Authority, and eligible for public procedures for the purchase and production of goods and services in the healthcare sector.
Healthcare organization – local healthcare authorities, hospitals, university hospitals, scientific institutes and any type of hospitalization and treatment of public or private legal entities, healthcare service providers, university departments, graduate schools, institutes and associations of public and private research and companies in the healthcare sector, professional associations of the healthcare professions and associations among healthcare professionals, also without legal capacity, public and private entities that organize continuing education activities in medicine, medical societies, patient associations, foundations and other entities established or controlled by the subjects referred above or whoever controls or owns them or performs them in the role of intermediary for said healthcare organizations.
According to the aforementioned Law, the following situations are subject to disclosure:
– agreements and transfers of money, goods, services or other utilities made by a manufacturing company in favor of a subject active in the healthcare sector, which have a unit value greater than €100 euros or a total annual value greater than €1,000 euros.
– agreements and transfers of money, goods, services or other utilities made by a manufacturing company in favor of a healthcare organization, which have a unit value greater than €1,000 euros or a total annual value greater than €2,500 euros.
– Agreements between manufacturing companies and healthcare professionals or healthcare organizations, which produce direct or indirect benefits, consisting of participation in conferences, training events, committees, commissions, advisory bodies or scientific committees or the establishment of consultancy, teaching or research.
The disclosure of the transfers of value described above must be made by the manufacturing companies by means of electronic data transfer, until January 31 of the next year, containing the following information:
a. 1) surname and name, business address and qualification, if the beneficiary or party is an individual; or 2) the name of the company, the registered office and the nature of the business, if the beneficiary or party is a legal entity;
b) the tax code or value added tax (VAT) number of the beneficiary or party;
c) the disbursement date or the reference period of the convention or agreement;
d) the nature of the disbursement or the convention or agreement;
e) the amount or cost of payment or remuneration for the convention or agreement; in the case of goods, services or other utilities, the market value must be indicated;
f) the cause of the disbursement, convention or agreement;
g) the subject, identified by means of the data referred to in letters a) and b), who, as an intermediary, defined the disbursement conditions, the terms of the conventions or agreements, or, in any case, who has maintained relations with the beneficiary or the party on behalf of the manufacturing company, even if he is an employee of the same company;
h) the registration number of the beneficiary or the party on its professional board.
An important point to highlight is that information on transfers of value must be individualized, not being allowed to disclose on an aggregate basis, without reference to the individual beneficiary.
Any violation of this Law can be reported by any citizen to the Italian Ministry of Health. Any sanctions applied by the Ministry of Health will be published on the front page of the Ministry of Health website for at least 90 (ninety) days and will be entered in the Telematic Public Registry.
