Life Sciences: What's new in France ?

Competition Law | Sanofi’s appeal in Plavix® case dismissed by French Supreme Court

The dismissal of Sanofi’s appeal by the French Supreme Court on 18 October 2016 marks the end of proceedings initiated by the French Competition Authority (FCA) against Sanofi following a complaint by Teva in November 2009. About two weeks after Teva launched its generic version of Sanofi’s blockbuster drug Plavix®, Teva submitted that Sanofi was abusing its dominant position in the market for the distribution of the molecule “clopidogrel” to pharmacists. 

In a decision of 14 May 2013, the FCA found that Sanofi had infringed Article 102 of the Treaty on the Functioning of the European Union and Article L. 420-2 of the French Commercial Code by engaging for five months in disparaging practices against Teva’s generic. Sanofi had implemented a “structured communications strategy” towards both the health authorities and health professionals in order to support sales of Plavix® and of its own generic version, Clopidogrel Winthrop®, which was launched just a few days before Teva’s generic. 

Sanofi notably relied on the fact that there was a difference between the clopidogrel salt used in third-party generics and that used in Plavix® and Clopidogrel Winthrop®, plus a patented additional therapeutic indication distinguishing Clopidogrel Winthrop® from its competitors. The FCA found that Sanofi mentioned these features in such a way as to make doctors and pharmacists doubt whether third-party generics were bioequivalent with/substitutable for Plavix® and Clopidogrel Winthrop®.

According to the FCA, Sanofi was able to do this in particular because health professionals did not know enough pharmacology and were risk averse about treatments where patients’ lives were at stake. Sanofi’s message, which one could consider as a “disguised truth” or a “lie by omission”, had a negative impact on the sales and market entry of Teva’s generic for several months, even after Sanofi stopped its campaign. As a result, the FCA imposed an exemplary fine of €40.6 million on Sanofi. 

The conclusions of the FCA and the fine were upheld by the Paris Court of Appeal in a judgment of 18 December 2014, which was criticized by Sanofi before the Supreme Court. 

The Supreme Court’s judgement confirms the very strict approach of the FCA and the Paris Court of Appeal towards communications made by originator companies to promote their products in the face of generic “new entrants” which can be seen as unduly disparaging the generic product, even if such messages are implicit and are not necessarily intended to openly criticize competitors’ products (as opposed to merely defending the benefits of tried and tested products).

By approving the approach of the FCA and the Paris Court of Appeal, the Supreme Court sends a strong message to originator companies and reinforces their “special responsibility” as dominant firms not to abuse their position in the face of competition. 

In practice, this means originator companies face a risky path affording them limited scope to promote their drug once a generic enters the market. 

More specifically, originator companies should: 

• avoid questioning directly or indirectly the bioequivalence of generics, once this has been scientifically established;
• avoid exploiting health professionals’ fears and risk averse approach to support the sales of their own products over generics, especially for treatments where patients’ lives are at stake; and
• be very clear in their communications so as to limit the risk of conveying a truncated message that could be regarded as not entirely true and therefore unduly detrimental to generics.

One other major takeaway of the judgment is that originator companies now face a significant risk of increased fines, since the Supreme Court confirmed that the Paris Court of Appeal may take how long the effects of disparaging communications last in assessing how long the communications lasted. 

The impact on the level of the fine is even greater given that the Supreme Court upheld the FCA’s approach that the effects of a disparaging message do not stop when the practice ends, but rather when medical or legal grounds for stopping the practice are established. 

 As a result, in the Plavix® case, the duration taken into account as a multiplying factor for the calculation of the fine was one year, as opposed to five months (the duration of the disparaging practices).

Product liability | Snapshot of health-related class actions in France

Key Points

Recent high-profile public health scandals have led to the introduction of health-related class actions (actions de groupe) into French law, with the aim of better compensating claimants and deterring wrongdoing in health-related matters.

More than a year after the Hamon Law provided for the first French class actions limited to consumer protection and antitrust claims, the 2016 National Health Law (the "Health Law"), enacted on 26 January 2016, introduced class actions in health-related cases to redress bodily injuries caused by health and cosmetic products. The new health class action system entered into force on 28 September 2016 pursuant to Ministerial Order No. 2016-1249 enacted on 26 September 2016. The key features of this new system are now available and are set out below.

Who?

Who may bring such class actions?

Only registered associations representing users of the health system, at both national and local levels, can bring actions on behalf of users before the civil and administrative courts. Previously, these associations could only bring criminal actions in the collective interest of the users of the health system without representing individuals as such and for personal injuries.

Moreover, to be authorized to bring class actions, an association must meet certain criteria and must not, for instance, have side activities involving the marketing of health products. There are currently just over 500 registered associations, as compared to only 15 consumer associations entitled to launch class actions in consumer and antitrust-related matters.

On behalf of whom?

Registered associations are mandated by users of the health system placed in a similar or identical situation to seek compensation for individual damages for the physical injury users allegedly suffered.

Against whom?

Potential defendants include manufacturers and suppliers of health and cosmetics products; entities prescribing these products (such as hospitals or healthcare professionals); and such entities’ civil liability insurers. Any relevant natural or legal person, whether private or public, such as pharmaceutical companies, medical device manufacturers, pharmacists, wholesalers, healthcare facilities and healthcare professionals, may therefore be liable under the framework for health class actions.

One of the distinctive features of health class actions is that claimants may bring an action directly against the defendant’s insurer. This is because one specific aim of the new system is to facilitate access to compensation for victims of similar injuries.

What?

Which products?

The aim of the new health class actions is to provide compensation for physical injuries caused to users of the healthcare system by products within the competence of the French National Agency for Medicines and Health Products, which are referred to in a non-exhaustive list in Article L.5311-1 II of the French Public Health Code. The list includes medicinal products, raw materials for pharmaceutical purposes, contraceptives, medical devices, products derived from human blood, cellular products, organs and tissues, in vitro diagnostics, software, non-corrective lenses, tattoo products and cosmetics.

What damages?

The scope of French health class actions is broad and allows users of the health system to seek redress for personal injury claims, when placed in identical or at least similar situations.

Where?

There are no specific rules as to territorial jurisdiction, which may increase the risk of forum shopping. Relevant registered associations may bring class actions on behalf of users of the health system before civil or administrative courts, depending on the private or public nature of the defendants.

When?

Health-related class actions relate to all relevant products, whether commercialized before or after the entry into force of the Health Law. 

The time allotted to join the claimant class, as defined by the relevant court, ranges from six months to five years from the date of completion of the publicity measures.

How?

What are the main steps of the procedure?

The Health Law provides for a two-step opt-in procedure with an optional mediation phase.

To initiate the first step, the association must file a claim on behalf of at least two users of the health system, detailing each user’s claiming order to avoid any lack of representation.

The court then reviews the admissibility of the action and proceeds to examine the liability of the defendant towards the claimants.

The court may appoint experts to consider scientific and medical issues, including reviewing users’ medical records and relevant scientific literature, as well as regulatory assessment of the product.

Subject to the parties’ approval, the court may also appoint a mediator. In such cases, a mediation committee of at least nine individuals appointed by a court order can assist the mediator. The mediator is appointed for three months – renewable once – to help the parties reach a settlement agreement specifying, in particular, the type of bodily damages, the method and funding for providing opposing expert witnesses, the conditions for submitting individual settlement offers and for carrying out advertising.

The court defines the proposed class of users of the health system who may seek to impose liability on the defendant, sets out the criteria that the users must meet to be included into the claimant class and determines what damages resulting from physical injuries may be indemnified. This judgment may be subject to appeal. 

Once there is no longer any appeal available and the judgment becomes final, the criteria for joining the class and other prescribed information are made public under the conditions ordered by the court. The court defines the time allotted to join the class as well as the conditions that the claimants must meet and the nature of the damages to be redressed.

The second step of the procedure is the implementation of the judgment in the form of compensation for individual damages.

Claimants may either attempt to obtain compensation directly from the defendants or through the relevant association. If the defendant refuses to compensate any victim, such victims may each file an individual claim to obtain compensation with the court initially assigned to the case. 

What about other actions?

Besides class actions, the victims may use other mechanisms, such as individual civil cases, criminal cases or alternative dispute resolution processes.

Moreover, several class actions may be introduced in relation to the same products, provided that they do not relate to the same facts, breaches or damages.

Regulatory | HAS issues mobile health good practice guide

Key Points

The French National Authority for Health (Haute Autorité de Santé; the "HAS") issued on 7 November 2016 a good practice guide (the “Guide”) relating to mobile health apps and connected devices. The Guide is a non-binding document intended to help developers, manufacturers and those wishing to appraise mobile health apps and connected devices; promote the use of computerised mobile health technology; and raise standards in the sector.

Scope of the Guide

The Guide covers apps and connected devices with no intended medical purpose, which fall within the “grey area” of apps and connected devices having a potential effect on health without being medical devices per se. 

Medical devices subject to the requirements of European Council Directive 93/42/EEC – such as the CE marking – are therefore excluded.

The Guide does not override applicable provisions of any law or regulation relating to medical devices in the meaning of Directive 93/42/EEC; to the protection of personal data; or to consumer protection.

Contents of the Guide

The good practices in the Guide cover:

• information provided for users (description of information to be provided and optimal user consent model);
• health content (how the original content is gathered and presented; degree of standardization; 
• criteria governing both generation and intepretation of data);technical conception (design and data flows);
• security (cybersecurity, reliability and confidentiality); and
• usage (usability, user acceptance and ease of integration).
  

In addition to good practices, the Guide provides a risk matrix described below, which allows readers to understand how applicable each good practice is. This depends on the nature and risk profile of the app or connected device in question.

Main criteria

In the 101 standard practices identified in the Guide, the HAS recommends in particular that any health app or connected device:

• provide reliable, high-quality health information. Health-related content must be prepared by healthcare professionals or competent professional bodies; data presented must be updated and based on precise and reliable bibliographical references; any potential relationships between the authors and the sources of funding of the app or connected device must be disclosed; and the contents must remain neutral;
• be technically efficient. For example, this means that if the app or connected device measures data, this measurement must be precise, be configured according to a recognized calibration model and must specify the level of accuracy or the possible error rate; appropriate measures must prevent any breakdown; the app or connected device must not cause adverse effects on users and any contraindications and potentical side effects must be clearly stated;
• ensure the confidentiality and security of personal data. The type and amount of data collected must be relevant and strictly confined to the purpose of the app; the data must be anonymised upon collection and encrypted from collection to transmission to the data host; if a data breach or any other security incident occurs, the competent authorities (the Agence Nationale de la Sécurité des Systèmes d’Information (ANSSI), the Commission Nationale de l’Informatique et des Libertés (CNIL) and any judicial authorities) must be informed; and
• be ergonomic and easy to use.

The requirements may apply differently to apps or connected devices depending on:

• the main purpose of the technology (ranging from general health information to primary, secondary or tertiary intervention to data collection or analysis); and 
• the target audience: the general public, patients, healthcare professionals communicating with their patients or healthcare professionals communicating with their peers.
  

Depending on these parameters, each good practice is compulsory, recommended or advisable, and the app or connected device has to meet a low, moderate or high level of requirement for each.

Next steps

The HAS describes the Guide as a first step in the assessment and design process of apps and connected devices in the mobile health sector. It has already announced that it will supplement the Guide with other documents for healthcare professionals and users.

At European level, a similar guide for health apps and connected devices – as proposed by the Green Paper on mobile health published in 2014 – is expected for 2017. This European guide will supplement the code of conduct and the ongoing standardization and interoperability process envisaged in the European eHealth Action Plan 2012–2020.

A question remains as to whether the compliance with the Guide will lead to a certification or other “rating” assisting purchasing or product development decisions.