The implementing Decree of the Act of January 26, 2016 (called Touraine Act) on health-related class actions was published on September 27, 2016.

Therefore, class actions may be initiated from September 28, 2016 onwards for health products commercialized before the entry into force of the Touraine Act.

In this context, health actors targeted by this new procedure, and in particular pharmaceutical laboratories, may face major financial (and reputation) losses.

I. Main features of the health-related class actions

The health-related class action procedure is based on a structure similar to the one created by the 2014 Consumer Act (called Hamon Act). Nonetheless, its scope has been substantially broadened by the lawmaker in order to facilitate its initiation.

  • A monopoly granted to approved associations of healthcare system users

The class action procedure is open to locally and nationally approved associations. Almost 500 approved associations of healthcare system users are entitled to bring health-related class actions, where only 15 consumer associations could do so under the procedure created by the Hamon Act.

  • A broad scope of application

The aim of the class action is to compensate for individual injuries resulting from bodily damage sustained by healthcare system users placed in a “similar or identical situation”. Those injuries must have been caused by the same person: a health product manufacturer/supplier, or a service provider using the health product.

The health products in question are those mentioned in the non-exhaustive list of Article L. 5311-1 of the French Public Health Code. Health products include, inter alia, drugs, medical devices, blood products, cosmetics, eye lenses, etc.

  • A two-phase procedure

Phase 1: The procedure will enable claimant associations to sue professionals on the basis of already existing liability regimes (ex: product liability; medical negligence; etc.).

The claim will be introduced before judicial or administrative courts on the basis of few “individual cases” described in the writ of summons. There is no certification phase as in the American class action system. This means that the admissibility of the claim and the professional’s liability are assessed at the same time by the judge.

As soon as the professional is found liable, the court will, in the same judgment, set the criteria to join the group and the relevant publicity measures. Once all appeals are exhausted, publicity measures will be carried out, and the compensation phase will start.

Phase 2: Once informed about the ruling, the concerned users will be able to choose to join the group (late opt-in system). The judge will decide on the cut-off date to join it; this period shall not be inferior to 6 months nor superior to 5 years.

If the professional refuses to compensate some users, the latter will have to bring an individual claim before the court that found the former liable in the class action proceeding.

II. Scope of the implementing Decree of September 26, 2016

  • An immediate application

Class actions in the health field may be initiated from September 28, 2016 onwards. They can concern health products commercialized and/or professional’s breaches committed before the entry into force of the Touraine Act (subject to limitation periods). This immediate application is obviously a great source of legal uncertainty for the concerned professionals.

  • An a minima Decree

The implementing Decree brings some precisions on the applicable procedure for class actions. Therefore, unless provided otherwise, ordinary procedural rules will apply, as provided for in the French Administrative Justice Code and the French Civil Procedure Code.

The implementing Decree also brings a derogation to appeal rules by expressly providing that the appeal procedure against class action judgments will be the one used in obvious and/or urgent matters (Article 905 of the French Civil Procedure Code). This is questionable as class actions are complex procedures.

The Decree also provides that the claimant association shall expose the individual cases justifying its class action in the writ of summon, on penalty of nullity.

  • The gaps in the Decree

The implementing Decree gives very few precisions on the applicable procedure to class actions, and does not address essential points.

For instance, the Decree does not provide any specific rule regarding the territorial jurisdiction issues. This is a major gap that brings about a high risk of forum shopping. There are currently 164 Tribunaux de grande instance (first-instance civil courts) and 42 first-instance administrative courts, all of which have jurisdiction to rule on class actions. Therefore, according to the options available under the ordinary jurisdiction rules, claimant associations will be able to make up their claim in a way as to choose the court before which they want to bring the action.

No limit has been set concerning publicity measures that can be ordered. Consequently, a court could order a professional to fund and carry out a publicity campaign on TV whose aim would be to inform the public of its liability and of compensation conditions. The consequences in terms of public image would be dreadful, and the cost of such measures would be very high.

To conclude, the broad scope of health-related class actions along with the incomplete nature of the Decree increase the risks of “procedural manipulation”. This is especially true given the sensitivity of public health cases and their significant public exposure.