In the footsteps of the Bertrand law of December 29, 2011 (in France), the Italian Parliament has been working for several years on a bill dedicated to the transparency of relations in the health sector.
The project on the transparency of relations between producing companies, health actors and health organizations was approved on April 4, 2019 by the Chamber of Deputies of the Italian Parliament. It aims to regulate interactions between companies producing or supplying medicines, tools, equipment or providers of health goods and services; and professionals and public or private organizations operating in the health sector.
A year and a half later, the text, entitled "Bill 1201", has been sent to the Italian Senate and is in the process of being approved. More exactly, the ten pages that make up the bill and the eight articles that compose it, aim to make professional relations transparent and to encourage the prevention and the fight against corruption in the health sector.
This approach is part of a larger trend, led by France and then by the United States, but also reflects a certain public desire for transparency. The non-governmental organization "Transparency International" has published an annual corruption perception index since 1995. In 2020, Italy was ranked 52nd out of 179 countries and France 23rd. This ranking shows that there is room for improvement. At the European level, this importance is underlined by the inclusion in the EFPIA (European Pharmaceutical Industries Association) code of the obligation for its members to declare transfers of value between companies and healthcare professionals and organizations.
The Italian Sunshine Act is part of this trend. The text in the making, which is accessible on the Italian Senate's website, sets up a system dedicated to the disclosure of benefits. More specifically, it will be up to the company that granted the benefit to ensure that it is published in a free electronic register that can be consulted. The disclosure will have to be made annually, at the latest on January 31.
The following are some of the main features of the scheme introduced by the Bill :
First, the regulated benefits are : payments, sponsorships, and benefits in the broadest sense. That is, they may involve any type of health care professional or organization.
Secondly, in addition to applying to the above-mentioned actors, the law also concerns manufacturers of health products and cosmetics, and all service providers involved in direct or indirect relations with health professionals. The scope of the actors is understood lato sensu and concerns these various actors as soon as there is a direct or indirect benefit.
Finally, the thresholds for publication differ from the French threshold of €10. Indeed, for any benefit from a healthcare professional whose unit value exceeds €50, or whose total annual value exceeds €500, there will be disclosure. In the same way, for health organizations, if the unit value exceeds 500€, and the total annual value exceeds 2 500€, there will be publication.
In short, the highlighting of the relations between health industrialists and health professionals, puts the patient's interest back at the center. The latter can consult the digital register in order to find out about the health services received.
The platform "Sanità trasparente" (Transparent Health) should be established within 6 months after the entry into force of the law.