France

French “anti-gift” rules strictly regulate the relationship between the life sciences industry and healthcare professionals (“HCP”) and the possibility for companies active in the health sector to offer benefits, in cash or in kind to healthcare professionals, medical students or associations representing them.  This includes a general prohibition against offering…
Continue Reading Regulatory Watch: How has recent Law No 2019-774 of 24 July 2019 on the organization and transformation of the health system changed the anti-gift rules?

France’s medicines regulator, the Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM), has released draft guidelines, currently subject to a public consultation, setting out recommendations for manufacturers designed to help prevent cybersecurity attacks to medical devices. Notably, the draft guidelines are the first instance of recommendations released by a national regulator in Europe that apply cybersecurity considerations specifically to medical devices. The full ANSM draft guidelines, ‘Cybersécurité des dispositifs médicaux intégrant du logiciel au cours de leur cycle de vie’ (‘Cybersecurity of medical devices integrating software during their life cycle’) published 19 July 2019, is available in French here, and in English here.

The draft guidelines note that while the European regulatory framework (the Medical Devices Regulation 2017/745 and In Vitro Diagnostic Medical Devices Regulation 2017 /746) has been modified “in line with technological developments” (e.g. “data exchange, monitoring, risk prediction and control software”) to include software within the definition of a medical device, and accompanying security and performance requirements specific to such medical devices incorporating software, the “[medical device and in vitro diagnostic medical device r]egulations do not explicitly refer to or elaborate on the notion of cybersecurity”. For the purposes of the guidelines, ‘cybersecurity’ is described as “the full set of technical or organisational measures set up to ensure the integrity and availability of a [medical device] and the confidentiality of the information held on or output by this [medical device] against the risk of targeted attacks.” 
Continue Reading French medicines regulator produces first in Europe medical devices cybersecurity guidelines

In its 18 October judgment the French Cour de Cassation upheld the €40.6m fine imposed on Sanofi-Aventis (“Sanofi”) by the French Competition Authority (“FCA”) in May 2013 and affirmed the judgment of the Paris Court of Appeal. The FCA found that Sanofi abused its dominant position in violation of Art.

Continue Reading French Supreme Court upholds Sanofi’s generic denigration fine

On 19 August 2016, France adopted Decree No 2016-1137 introducing mandatory country of origin labelling (COOL) for dairy and meat in processed foods.  The national measures strengthen the regulatory framework that exists at the EU level, which already imposes COOL requirements on specific foodstuffs, such as unprocessed and pre-packed swine, poultry, sheep and goat meat (Art. 26(2) of EU Regulation 1169/2011 of 25 October 2011), unprocessed beef and beef products (EU Regulation No 1760/2000 of 17 July 2000), fruit and vegetables, honey, etc.  After receiving the green light from the French State Council (“Conseil d’Etat”) and the European Commission, the trial period will now run for a period of two years, starting on 1 January 2017 until the end of 2018.
Continue Reading French Pilot on Mandatory Country of Origin Labelling (COOL) for Dairy and Meat in Processed Foods


A more detailed analysis of the impact of the work at the CJEU is featured in Clinica Medtech Intelligence.


Liability Spotlight now on the Notified Bodies

Background and Context

The so-called PIP-Breast-implant scandal now reaches the Court of Justice of the European Union (CJEU). As last week a German court referred a liability case to the CJEU, it is now upon the CJEU to provide further clarity on the responsibilities and liability scheme for medical devices in the EU. The key questions relate to the responsibility of the Notified Bodies which are in charge of granting the CE mark which again is required to place medical devices on the EU market. The CJEU’s answer will have an impact on the work of Notified Bodies and will be relevant for the liability of medical device manufacturers in the EU.

In the current case, the plaintiff has sued the German Notified Body TÜV Rheinland for damages as she had been implanted a PIP breast implant. PIP stands for the company name Poly Implant Prothèse which, for years, was illegally selling breast implants containing industrial silicone instead of the medical silicone for which they had received the CE mark. The founder of PIP and several former executives and managers were convicted of fraud and sentenced to jail by a court in France.
Continue Reading European Court to Clarify Responsibilities and Liability for Medical Devices

This post originally appeared on our sister blog, InsideMedicalDevices.  

At the end of May 2013, the French government released the long awaited Decree implementing the 2011 French Sunshine Act.  The Decree requires companies to publicly disclose — in French — any benefit over 10 Euros and agreements (except commercial ones) concluded with healthcare professionals or other actors active in the health sector in France.
Continue Reading French Sunshine Rules and the Medical Devices Industry

The French Competition Authority (“FCA”) is currently investigating the intensity of competition in the supply of pharmaceuticals.  The investigation was launched in February 2013 and concerns all levels of the medicinal distribution chain (pharmaceutical suppliers, wholesalers and retailers).

In July 2013, the FCA submitted to public consultation its initial assessment of the pharmaceutical sector.  The FCA raised multiple concerns at every level of the distribution channel.  The main areas of concern identified by the FCA are as follows:
Continue Reading French Competition Authority Issues Preliminary Assessment of Pharmaceutical Sector

In February 2013, the French Competition Authority (“FCA”) launched an inquiry into the pharmaceutical sector, examining each level of the medicinal distribution chain (pharmaceutical suppliers, wholesalers and retailers).  The FCA is likely to focus on a broad range of issues, including:

  • Generic entry: The inquiry will likely examine pay-for-delay arrangements and other issues relating to generic entry.  Both the FCA and the European Commission are currently investigating several cases relating to practices allegedly aimed at disrupting generic entry.   The FCA has also indicated that, following the sector inquiry, it may publish specific guidance on practices affecting generic entry.
  • Parallel trade: In 2007, the FCA cleared  (subject to certain commitments) the quota systems implemented by several major pharmaceutical companies.  Quota systems are aimed at rationalising wholesale distribution and limiting parallel trade.  The FCA may use the sector inquiry to revisit the issue of parallel trade and re-examine the quota systems.
    Continue Reading French Competition Authority Launches Pharmaceutical Sector Inquiry

Originally published as Covington E-Alert on October 3, 2012

French Law No 2011-2012 of 29 December 2011 on the Strengthening of Health Protection for Medicinal and Health Products has been inserted into the Public Health Code (‘Code de la santé publique’ or CSP). It includes new advertising rules…
Continue Reading France – Prior Approval for Advertising for Medical Devices and IVDs

Originally published as Covington E-Alert on February 13, 2012

New Advertising Rules

Medicinal and Health Products (“loi relative au renforcement de la sécurité sanitaire du médicament et des produits de santé”) (the ‘New Law’) will have a tremendous impact on the medical devices industry. The industry will now be subject…
Continue Reading France – A Revolution for the Medical Devices Industry