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Transparency of health industries'

conformité réglementaire

Transparency of health industries' interactions with health professionals and organizations

August 23, 2023

Since April 2014, in France, the Transparence Santé database allows everyone to consult, in free access, all the information declared by companies on the links of interest maintained with health actors.7

A review of the main texts that have contributed to setting up this very specific system.

In France

Law n°93-121 of January 27, 1993 about various social measures

Although many of the articles of the so-called "DMOS" law have now been repealed, it was when it came into force in 1993 that the law laid the foundations for the system of benefits.

Among the main principles initiated by the law, two still appear in the background: the prohibition for companies to grant illegal advantages, and the prohibition for health professionals to receive such advantages.

Moreover, as early as 1993, the law provided for a regime with sanctions in the event of non-compliance with the prohibition. The former article L. 376-3 of the Public Health Code provided that "violations of the provisions of article L. 365-1 will be punished by a fine of 500,000 francs and two years' imprisonment". This is now found in articles L. 1454-1 and following of the same code.

Law n°2011-2012 of December 29, 2011 relating to the reinforcement of the sanitary safety of medicines and health products

Also known as the "Bertrand" law, named after the Minister of Health at the time, the law came into force on December 31, 2011. It completes the existing system by introducing a transparency mechanism for links of interest.

Among the contributions, Article 2 of the "Bertrand" law imposes an obligation of transparency on companies. This obligation, codified in Article L.1453-1 of the Public Health Code, resulted in the launch in 2014, of the Transparence Santé database. A website piloted by the Ministry of Solidarity and Health, it makes available all the information declared by companies on the links of interest they have with actors in the health sector.

Decree n°2013-414 of May 21, 2013 on the transparency of benefits granted by companies producing or marketing products for health and cosmetic purposes intended for humans

Intended to implement the terms of Article 2 of the "Bertrand" law, the decree was published in the Official Journal on May 22, 2013. Its main objective was to determine the nature of the information to be published by companies. As such, the following must be made public: agreements between companies and health actors, benefits and remuneration of an amount exceeding €10 including tax.

The first publication took place on June 1, 2013. It is now biannual, and takes place on March 1 and September 1.

Law n°2016-41 of January 26, 2016 on the modernization of our healthcare system

Also known as the "Touraine" law, named after the Minister of Health at the time, the 2016 law significantly strengthened the provisions of the "Bertrand" law. In the press kit published by the Ministry of Solidarity and Health in 2016, it is stated that "it is a question of getting out of the era of suspicion: transparency as well as health democracy (...) are the key to regaining trust".

It is in this spirit that the law sets out the following two principles: to strengthen the transparency of links of interest between laboratories and actors in the health system; and to improve the availability of this information.

Ordinance n°2017-49 of January 19, 2017, on benefits offered by persons manufacturing or marketing health products or services

Also known as the "Touraine" ordinance, the ordinance was issued on the basis of the eponymous law of January 26, 2016. Allowing for consistency in the perimeter between Transparency and the supervision of benefits, it also provides several important clarifications on the regime of the second. In particular, it specifies the recipients of the prohibition on receiving or offering advantages; the characteristics inherent in the notion of advantages; and the exemptions from the prohibition.

Law n°2019-774 of July 24, 2019 on the organization and transformation of the healthcare system

Also known as the "Ma santé 2022" law, the main objective of the 2019 law was to propose comprehensive responses to the challenges facing the French healthcare system. The framework for benefits and the transparency regime fall within this scope. Thus, it is now forbidden to offer hospitality to students in initial training and to associations representing them. In the same way, donations and gifts for national professional councils are excluded. Concerning the publication of links of interest, this now covers influencers.

Decree n°2020-730 of June 15, 2020 concerning benefits offered by persons manufacturing or marketing health products or services

Published in the Official Journal on June 17, 2020, the decree only came into force on October 1, 2020. This decree, which is essential, specifies the terms and conditions relating to benefits offered by persons manufacturing or marketing health products or services. It determines the natural or legal persons concerned, the nature and conditions of the exemptions to the prohibition on offering benefits. As well as the terms and conditions of the declaration and authorization system for exemptions.

Order of August 7, 2020 setting the amounts above which an agreement provided for in article L. 1453-8 of the public health code and stipulating the granting of advantages is subject to authorizationOrder of August 7, 2020 setting the amounts below which benefits in kind or in cash are considered to be of negligible value pursuant to 4° of article L. 1453-6 of the Public Health Code

Both published in the Journal Officiel on August 14, 2020, these decrees clarify the thresholds of the new regime for the supervision of benefits. More specifically, they determine the applicable thresholds from which an agreement must be submitted for authorization. As well as the threshold below which certain benefits are considered to be of negligible value.

At the international

At the international level, there is also a trend towards greater supervision and transparency. This can be seen through the laws dedicated to transparency that have been put in place in several States, and also through the consolidation of codes of practice disseminated by European and international federations (EFPIA, IFPMA, MedTech).

March 23, 2010, Sunshine Act, United States

An integral part of the Patient Protection and Affordable Care Act, the Physician Payment Sunshine Act, or "Sunshine Act" for short, aims to bring more transparency to decisions made by the US government and federal administration. Specifically, the Sunshine Act requires manufacturers of drugs, devices and medical equipment to report any cash or in-kind payment in excess of $10 to a physician or teaching hospital.

2014, EFPIA's first publication

The European Federation of Pharmaceutical Industries and Associations (EFPIA) published in 2013 the "Code on disclosure of transfers of value from pharmaceutical companies to healthcare professionals and healthcare organizations" to provide, from 2016 onwards, for the annual publication by pharmaceutical companies of all their financial transfers of hospitality, remuneration and donations to healthcare professionals and associations. This publication applies to members of the Federation.

June 14, 2017, Royal Decree implementing the Sunshine Act, Belgium

The text came to impose a transparency obligation on pharmaceutical and medical device companies. Since 2017, the latter must document and make public annually, the bonuses and benefits granted directly or indirectly to healthcare professionals, healthcare organizations or patient organizations.

Law No. 22.921 of January 12, 2018, Brazil

Brazil's 2018 law is part of a package of legislation implementing a disclosure of interest regime. Specifically, the 2018 law provides for the obligation of health product and health interest companies to inform the competent state agency of the sponsorship of a scientific event.

2021, ABPI Code of Practice, United Kingdom

The Association of the British Pharmaceutical Industry (ABPI) has published a code of practice aimed at ensuring the transparency of relationships in the healthcare sector. Manufacturers in the sector are now obliged to publish the links of interest they have with healthcare professionals, among others, on a dedicated website. Among the new features of the 2021 version of the code, we note an expansion of the persons to be published in transparency. From now on, relationships with journalists will have to be published.

15 October 2021, Farmindustria Code of conduct, Italy

The association of Italian pharmaceutical companies also has a code of conduct for manufacturers in the sector. This code of conduct governs the relations between healthcare companies and healthcare professionals. This code is itself based on the code of conduct issued by the European Federation of Pharmaceutical Industries and Associations (EFPIA). A dedicated bill is currently being studied by the Italian Parliament; new developments are expected in 2022.

Thus, over the years, a significant legal arsenal has been put in place to guarantee the transparency of links of interest with healthcare professionals and organizations and patient associations. Nevertheless, its interpretation is not always obvious, which does not alleviate the heavy and time-consuming workload of regulatory compliance teams. It is therefore strongly recommended to go digital.

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