France: Enactment of new health law
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On 26 July 2019, France enacted Law No 2019-774 of 24 July 2019 on the organisation and transformation of the health system (New Health Law), which aims to establish a better organised health system in the French territories and strengthen access to care. Among other priorities, the New Health Law allows for the immediate initiation of a major overhaul to education requirements for medical students, as well as changes to the financing of local hospitals and an acceleration in the shift to digital by massively deploying telemedicines and allowing health care professionals to practise via telecare.
In addition, the New Health Law introduces further amendments to, and strengthens, the existing "anti-gift" regulatory framework (introduced by the "DMOS Law" in 1993, amended in 2011, and more recently, Ordinance No 2017-49 of 19 January 2017 inserting revised "anti-gift" rules). The provisions of the Ordinance were supposed to enter into effect on a date fixed by decree and no later than 1 July 2018, but the implementing decree has not yet been adopted and most provisions are yet to become applicable. The main amendments of the anti-gift framework concern:
- The ratification of the 2017 Ordinance (which now becomes law).
- The clarification of its scope.
In particular, the rules have been broadened and pharmaceutical companies are now subject to the anti-gift rules regardless of whether or not their products are covered by the health insurance system. All products included in the Public Health Code list, even if the French National Agency for Medicines and Health Products Safety does not regulate them, fall within the scope of regulation. In addition, and as stated by Leem, the French pharmaceutical industry association, some amendments are immediately applicable, such as the prohibition on offering hospitality to students and student associations during scientific or professional meetings or promotional events, to avoid any pressure on students and to stop influential practices. However, as pharmaceutical companies are still waiting for the implementing texts, they are currently operating in a grey zone. The future anti-gift rules are expected to become applicable in autumn 2019.
In addition, the transparency requirements have also been broadened by the New Health Law, by the inclusion of a new category of person to be covered by the requirements: influencers, who are persons who, in the media or on social networks, present one or more health products in such a way as to influence the public, are now also regulated persons.
A prior version of this post was originally published by the same authors in Practical Law – Life Sciences, September 2019 Issue (Thomson Reuters).