Life Sciences 2025

FRANCE Law and Practice Contributed by: Emmanuelle Trombe, Anthony Paronneau, Anne-France Moreau and Lorraine Maisnier-Boché, McDermott Will & Emery

1. Life Sciences Regulatory Framework 1.1 Legislation and Regulation for Pharmaceuticals and Medical Devices Pharmaceuticals and medical devices are gov- erned by various pieces of legislation and regu- lations arising from different sources. There is no uniform body of law, although there is an increasing number of rules being set at the Euro- pean Union (EU) level, which tend to harmonise – although not completely – the regime applicable across EU member states. In France, pharmaceuticals are mainly governed by the Public Health Code, which implements and complements the EU Directive on the Com- munity code relating to medicinal products for human use (Directive 2001/83/EC) and the EU Regulation on the Community procedures for the authorisation and supervision of medicinal prod- ucts for human and veterinary use and establish- ing a European Medicines Agency (Regulation 726/2004). A new directive and regulation (col- lectively known as the “EU Pharmaceutical Pack- age” ) are currently being discussed to revise the EU regime of pharmaceuticals. Medical devices are also governed by the Pub- lic Health Code, which implements and com- plements the EU regulations on medical devic- es (Regulations 2017/745 called “MDR” and 2017/746 called “IVDR” and, to some extent, the previous Directives). The medical device regulatory framework is also in the midst of a significant legislative reform. Beyond the Public Health Code, relevant rules are also included in the Social Security Code, Environmental Code, and more generally the Civil Code, Commercial Code and Consumer

Code, not to forget codes of conduct and guide- lines set by trade associations. In correlation with this diversity of legislative and regulatory sources, there are also several regula- tory bodies that apply and enforce these rules. For pharmaceuticals, the European Medicines Agency (EMA) and the French National Agen- cy for Medicines and Health Products Safety ( Agence nationale de sécurité du médicament et des produits de santé , ANSM) would be key enti- ties. The EMA is an EU institution and the ANSM is a public establishment under the authority of the French Ministry of Health. With respect to medical devices, “notified bod - ies” are also essential as they are in charge of assessing compliance of medium- to high-risk medical devices prior to and post-market. These bodies are independent from central administra- tion and must undergo a regulatory accreditation process. 1.2 Challenging Decisions of Regulatory Bodies That Enforce Pharmaceuticals and Medical Devices Regulation Decisions made by the regulatory bodies are pri- marily administrative acts that can be challenged through the following avenues. • Administrative appeal. This involves filing an objection with the regulatory body that issued the act ( recours gracieux ) or with its higher authority ( recours hiérarchique ). This admin- istrative appeal is a complaint addressed to the authorities asking them to change a decision they have taken, whether explicitly (eg, refusal) or implicitly (eg, lack of reply). In certain cases, this appeal may be compulsory prior to lodging a judicial claim.

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