A firm dedicated to the healthcare industry, ELSI assists its French and foreign clients, pharmaceutical companies, biotech companies, operators, manufacturers and distributors of DM, cosmetic products and other players in the strategy and legal and regulatory security of all aspects of the life cycle of their products and activities, whether commercial or regulatory.
From our experience in human and veterinary health companies as well as with our clients, we have acquired a practical and pragmatic approach to the implementation and legal security of the anti-kickback and transparency policies and processes of pharmaceutical companies, in the broadest sense. This is why we have developed a complete range of subcontracting services for the outsourcing of all or part of DMOS and transparency activities.
Entrust us with the management of your anti-gift and transparency activities, in complete serenity and according to your needs.
A complete offer for outsourcing all or part of your anti-gift & transparency activities:
Contract generation and management
Representation to professional bodies (IDAHE 2 transmission)
The scope of the provisions of the anti-gift law (formerly the DMOS law) or now the law governing benefits (LAC) since the entry into force of Order No. 2017-49 of 19 January 2017 relating to benefits offered by persons manufacturing or marketing health products or services, laying down a principle of prohibiting the offering or proposing of benefits to members of the health professions and associations grouping them, has continued to expand over the years.
Although this provision initially concerned only activities relating to reimbursable products, it is now applicable to all health products, such as those listed in Article L. 5111-1 of the Public Health Code (CSP), as well as to all those involved (manufacturers, operators, distributors, health professionals, students, influencers, etc.).
The former article L. 4113-6 of the CSP has therefore been replaced by a new system, introduced by the order of 19 January 2017 and its implementing regulations, which modified the procedures for drawing up agreements, defining benefits and remuneration and the procedures for monitoring them by introducing a dual declaration and authorisation system. In fact, the granting of certain benefits and agreements whose amounts exceed the thresholds set by decree is now subject to prior authorisation by the relevant professional bodies (CNOP, CNOM, etc.). For other agreements, the amounts of which are below the thresholds, they are subject to a declaration regime with these same bodies.
The modification of these processes has forced operators to adapt the terms and conditions of their relations with health professionals as well as their internal implementation process, such as the management of contracts, boards, transmission of requests and declarations to the orders, and above all, schedules.
As a corollary of the anti-gift mechanism since the law of 29 December 2011 on the reinforcement of the sanitary safety of medicines and health products, the transparency of links of interest, also known as the "Sunshine Act", and the obligation to make public the advantages granted, as well as the existence of agreements concluded with health actors and the remuneration paid, are also imposed on the health industries.
Veterinary medicines and products are not exempt from this either, as Law No. 2014-1170 on the future of agriculture, food and forestry (LAAAF) of 14 October 2014 subjects its actors (producer, manufacturer, GIE, etc.) to the same reporting and transparency obligations.
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An investigation by the DGCCRF in 2021 led to the penalization of 6.6 million euros for illegal practices by the URGO group.
Medical device law
An amendment to the WDR has just been proposed by the European Commission to postpone the entry into force of the WDR.