Based on the model of the American “Sunshine Act”, the law n°2011-2012 of 29 December 2011 relative to the reinforcement of sanitary security of medicinal and health products, known as the “Bertrand law”, imposes greater transparency on consented advantages to those working in the field of healthcare services, especially advantages offered by manufacturers of medical devices. This “moralization” of practices aims to prevent conflicts of interest.
Since 1st October 2013, certain manufacturers of medical devices must therefore publish their contracts concluded and advantages consented to certain people. This obligation does not only apply to health professionals but also to health professionals’ associations, students in the health profession and their representative associations, healthcare establishments, foundations, scholarly companies and consulting companies or organisms intervening in health products or the healthcare service area. In this way, the Bertrand law marks an extension of the provisions of the “anti-gift” Act (known also as the DMOS Act) of 29 January 1993.
The manufacturers of medical devices are also obliged to make public all of the direct or indirect advantages that they consent to certain persons, in-kind or in cash, of a value equal to or higher than 10 euros (TTC).
Although the law does not define the notion of “advantage”, it is understood as something from which an interest, a profit, or a benefit is obtained. Therefore, for example, the remuneration of a radiologist for a consulting mission, an invitation for a formation meeting, the cover of costs of subsistence for the hospital staff, or a lunch invitation could be considered as an advantage to be made public. However, a tangible object which does not have a market value will not constitute an advantage.
Conventions and advantages must be published every semester on a unique public website, the implementation of which will be specified by a bylaw from the Health Minister, expected in spring 2014. The health company will have to communicate the required information to the authority responsible of this website.
While awaiting its the creation, the necessary information will be published on each company’s website, on a common website for two or more companies or on the professional union’s website, to which where the company has adhered. It is thus imperative that the manufacturers of medical devices, or more generally, the companies which produce or market sanitary products for human use, respect this obligation of publication.
A company which fails to do so risks punishment and fines of up to 45.000 euros. This fine can be increased fivefold for legal entities.
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