FRANCE Law and Practice Contributed by: Emmanuelle Trombe, Anthony Paronneau and Anne-France Moreau, McDermott Will & Schulte
McDermott Will & Schulte 23 rue de l’Université 75007 Paris France
Tel: +33 01 81 69 15 00 Fax: +33 01 81 69 15 15 Email: etrombe@mwe.com Web: www.mwe.com
1. Life Sciences Regulatory Framework 1.1 Legislation and Regulation Pharmaceuticals and medical devices are governed by various pieces of legislation and regulations aris- ing from different sources. There is no uniform body of law, although there is an increasing number of rules being set at the European 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 com- plements the EU Directive on the Community code relating to medicinal products for human use (Direc- tive 2001/83/EC) and the EU Regulation on the Com- munity procedures for the authorisation and supervi- sion of medicinal products for human and veterinary use and establishing a European Medicines Agency (Regulation 726/2004). A new directive and regulation (collectively known as the “EU Pharmaceutical Pack- age”) have been agreed by the Council of the Euro- pean Union and the European Parliament, with formal adoption and entry into force upon publication in the European Union’s Official Journal expected in 2026. Medical devices are also governed by the Public Health Code, which implements and complements the EU regulations on medical devices (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, with the recent publication of a proposal for a regulation to simplify the MDR and IVDR.
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 forgetting codes of conduct and guidelines set by trade associations and competent regulatory authorities. In correlation with this diversity of legislative and regu- latory sources, there are also several regulatory bod- ies that apply and enforce these rules. For pharmaceuticals, the European Medicines Agen- cy (EMA) and the French National Agency for Medi- cines and Health Products Safety ( Agence nationale de sécurité du médicament et des produits de santé , ANSM) are the key entities. The EMA is an EU institu- tion and the ANSM is a French public establishment under the authority of the French Ministry of Health. With respect to medical devices, “notified bodies” 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 independ- ent from central administration and must undergo a regulatory accreditation process. 1.2 Challenging Decisions of Regulatory Bodies Decisions made by the regulatory bodies are primarily 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
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