Sylvie Gallage-Alwis, Alice Decramer, and Nikita Yahouedeou author chapter in ICLG’s Drug & Medical Device Litigation Comparative Guide 2024

By Sylvie Gallage-Alwis & Alice Decramer & Nikita Yahouedeou

Partner Sylvie Gallage-Alwis and Associates Alice Decramer and Nikita Yahouedeou have authored the French chapter in the ICLG’s latest Drug & Medical Device Litigation Comparative Guide.

Their chapter explores regulatory frameworks, manufacturing, transactions, advertising, promotion and sales, data privacy, clinical trials and compassionate use programmes, product recalls, litigation and dispute resolution.

The ICLG Drug & Medical Device Litigation Comparative Guide 2024 was published 19 April 2024, and Sylvie, Alice and Nikita’s chapter can be found in full here.

Please list and describe the principal legislative and regulatory bodies that apply to and/or regulate pharmaceuticals, medical devices, supplements, over-the-counter products, and cosmetics.

At the French level, the health sector is mainly governed by the Public Health Code (“PHC”), the Social Security Code, the Intellectual Property Code and the Consumer Code, but also by Regulations and Directives from the EU (“Regulation” and “Directive”).  Indeed, French law must comply with European Law either through transposition or direct application.

There are a variety of sources, depending on the product and issue at stake.  Pharmaceutical products are, for example, governed by Directive 2001/83/EC, as amended by Directive 2004/27/EC and Regulation No. 726/2004.  These statutes provide for the legal framework which has been amended and enhanced over time for the authorisation, manufacture and distribution of medicines in the EU.  On 26 April 2023, the European Commission adopted a proposal for a new Directive and a new Regulation on pharmaceutical products, to revise and replace the existing framework.

Specific Regulations also exist for orphan medicinal products for the treatment of rare diseases (Regulation No. 141/2000), paediatric medicines (Regulation No. 1901/2006), advanced-therapy medicines (Regulation No. 1394/2007) and in vitro diagnostic medical devices (Regulation No. 2017/746).

Regulation No. 2017/745 sets general rules for the marketing of medical devices.

Compliance with pharmaceutical and medical devices Regulations is ensured by the European Medicines Agency (“EMA”) at the European level and by the French Agency for the Safety of Medicines and Health Products (“ANSM”) at the national level, whose role is to maintain access to health products, while ensuring their safety.  Regarding medical devices only, the powers of the ANSM are shared with the General Directorate of Competition, Consumer Affairs and Fraud Control (“DGCCRF”).  They notably have the power to investigate and issue warnings.

Supplements generally fall under provisions of food law.  At the European level, supplements are governed by Directive 2002/46/EC, transposed into French law by Decree n° 2006-352.  The DGCCRF and the French Agency for Food, Environmental and Occupational Health and Safety (“ANSES”) are in charge of controlling supplements.

Cosmetic products are mainly regulated by the PHC, Regulation No. 1223/2009 and French Law No. 2014-201.  The competent authorities authorised to control cosmetic products are the DGCCRF and the ANSM.

The sale of over-the-counter products is authorised in France and controlled by the PHC.  The ANSM establishes a list of medicines that can be directly accessible in pharmacies.

How do regulations/legislation impact liability for injuries suffered as a result of product use, or other liability arising out of the marketing and sale of the product? Does approval of a product by the regulators provide any protection from liability?

Regulatory approval of a product does not exonerate the manufacturer and/or the marketing authorisation holder of its liability, as specified in Article L.5121-8 of the PHC.

The health sector has been the topic of several highly publicised cases over the years which gave rise to civil, criminal and administrative proceedings.  The Levothyrox or Mediator cases are examples of liability incurred despite the approval of the product by the authorities.  In cases of an authorised product, in addition to the liability of the manufacturer, plaintiffs may seek the liability of the State.  In January 2022, Sanofi was found liable for a lack of vigilance and information on the effects of Depakine, marketed since 1967 to treat unborn children diagnosed with epilepsy.  An appeal was lodged against this decision.

Articles 1245 et seq. of the Civil Code provide for a regime of strict liability against the producer of a defective product regardless of its authorisation.

What other general impact does the regulation of life sciences products have on litigation involving such products?

Given the sensitive nature of the issues surrounding life sciences products, the Regulations applicable to these products are very restrictive, which reinforce regulatory controls and put life sciences products under high scrutiny.  If compliance with the Regulations is always an important topic in product litigation, this is even more true for life sciences products.  Litigation also tends to be more complex as it lasts many years and is widely covered by the media.

As it may sometimes be very difficult for victims to identify the liable stakeholder, French law has established a compensation mechanism supported by the State, i.e., the French Office for the Compensation of Medical Accidents, Iatrogenic Affections and Nosocomial Infections (“ONIAM”), which is a public administrative body entrusted to compensate victims of medical accidents under certain circumstances pursuant to Article L.1142-22 of the PHC.  This does impact litigation as, when applicable, victims may prefer to file a claim before the ONIAM rather than against a manufacturer/health professional only, or may prefer to file a claim against both of them.

Are there any self-regulatory bodies that govern drugs, medical devices, supplements, OTC products, or cosmetics in the jurisdiction? How do their codes of conduct or other guidelines affect litigation and liability?

There are several self-regulatory bodies that govern health products, such as the Health Industry Federation, which is an umbrella federation comprising among its members the LEEM (Les Entreprises du Médicament), dedicated to the whole of the pharmaceutical industry, the GEMME (Générique Même Médicament), dedicated to producers and distributors of generics and the SNITEM (Syndicat National de l’Industrie des Technologies Médicales), the SYNADIET (Syndicat National des Compléments Alimentaires), which represents several actors in the supplements sector, the FEBEA (Fédération des Entreprises de la Beauté) and COSMED in the cosmetics sectors.

Their codes of conduct and/or opinions may be relevant in litigation to illustrate the position taken by the actors of the relevant sector.

Are life sciences companies required to provide warnings of the risks of their products directly to the consumer, or to the prescribing physician (i.e., learned intermediary), and how do such requirements affect litigation concerning the product?

Pursuant to Articles R.5121-147 to R.5121-149 of the PHC, life sciences companies are required to warn both healthcare professionals and users of the product of the risks of their products, through a package insert.  This insert must be written in French and must contain a certain number of indications for the user, such as a list of excipients, therapeutic indications, contraindications, interactions likely to affect the action of the medicine, instructions for use and adverse effects.

These companies can be held liable if the information regarding the risks of the treatment is insufficient.

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