LAWS
Law No. 93-121 DMOS of January 27, 1993, revised on October 11, 2019
This historic law regulates the benefits offered by healthcare companies to healthcare professionals. It requires the drafting of a written agreement for any service or benefit and prohibits any form of unsubstantiated gift or payment. The objective is to prevent conflicts of interest and ensure an ethical relationship between the industry and professionals. The 2019 revision strengthened the reporting requirements and clarified certain obligations.
Law No. 2011 - 2012 on Drug Safety of December 29, 2011
Adopted in the context of the Mediator scandal, this law aims to improve the health safety of medications. It strengthens pharmacovigilance procedures, more strictly regulates relationships of influence, and imposes transparency regarding conflicts of interest among health stakeholders. It has laid the groundwork for the transparency framework currently in effect.
DECREES
Human Health Decree No. 2013-414 of 05/21/2013
This decree establishes the public platform Transparency Health, on which companies must publish the signed agreements and the benefits granted to health professionals and organizations. It specifies the publication procedures and the information that must be included in the declarations.
Human Health Decree No. 2016-1939 of 12/28/2016
It broadens the scope of individuals affected by transparency (students, learned societies, patient associations, etc.) and specifies the requirements for content, format, and frequency of disclosures. This decree reflects a desire to make the system more comprehensive and better regulated.
Animal Health Decree No. 2016-1795 of 12/20/2016
This text transposes the transparency framework to the veterinary sector. It requires laboratories and animal health companies to disclose the benefits and agreements made with veterinarians and other stakeholders in the field.
Animal Health Decree No. 2017-89 of January 26, 2017
Complementary to the previous one, this decree establishes the reporting procedures specific to relationships in the field of animal health, ensuring traceability equivalent to that of human health.
Human Health Transparency Decree No. 2019-1530 of 12/30/2019
This amendment clarifies the outlines of the legislative framework, particularly the reporting obligations regarding compensation. It strengthens the coherence of the transparency system and consolidates the existing legal architecture.
ORDERS
Order of 03/22/2017 Operation of the Health Transparency Site
It establishes the operating rules for the Transparence Santé platform, including technical formats, publication deadlines, and data management. This decree ensures the accessibility and reliability of the public database.
Order of 07/08/2020 Benefits subject to authorization
These orders list the benefits that require prior administrative authorization before being granted. They clarify what can or cannot be offered to professionals, in a logic of preventing abuses.
NOTES
Information Note No. DGS/PP3/2018/217 of 09/18/2018 Animal Health
This note specifies the practical procedures for reporting for stakeholders in animal health, particularly the specifics related to veterinary products and the professionals involved. It accompanies the implementation of previous decrees.