Tag Archives: France

French Supreme Court upholds Sanofi’s generic denigration fine

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. 102 of the Treaty on … Continue Reading

French Pilot on Mandatory Country of Origin Labelling (COOL) for Dairy and Meat in Processed Foods

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 … Continue Reading

European Court to Clarify Responsibilities and Liability for Medical Devices

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 … Continue Reading

French Sunshine Rules and the Medical Devices Industry

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 … Continue Reading

French Competition Authority Issues Preliminary Assessment of Pharmaceutical Sector

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 … Continue Reading

French Competition Authority Launches Pharmaceutical Sector Inquiry

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 … Continue Reading

France – Prior Approval for Advertising for Medical Devices and IVDs

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 for medical devices (MDs) and in vitro … Continue Reading

France – A Revolution for the Medical Devices Industry

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 to new advertising rules, sunshine-like … Continue Reading

France – A ‘Sunshine Act’ for the Healthcare Industry

Originally published as Covington E-Alert on January 20, 2012 Law No 2011-2012 of 29 December 2011 on the Strengthening of Health Protection for Medicinal and Health Products (“loi relative au renforcement de la sécurité sanitaire du médicament et des produits de santé”) (the “New Law”),creating Articles L. 1453-1 and L. 1454-3 to L. 1454-5 of … Continue Reading
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