France

French Competition Authority launches sector inquiry into medicinal products and biomedical laboratories

Patricia Carmona Botana

On 20 November 2017, the French Competition Authority (FCA) launched a sector inquiry into medicinal products and medical biology (biomedical) laboratories in France.  As previously announced, the inquiry aims to address the challenges that the sector entails for the French insurance system and public health and to assess the feasibility of more competitive conditions with Read More

France sets up committee to combat cyber-attacks on medical device software

Eveline Van Keymeulen

The French regulator for medicines and health products (ANSM) recently announced the creation of the first temporary specialised scientific committee (CSST) on cyber-security for medical device software.  The CSST is composed of external experts in information technology and cyber-security.  It provides recommendations to the ANSM’s general director, intended for manufacturers of medical device software, with Read More

France one step closer to biosimilar substitution: ANSM introduces first similar biologic groups

Eveline Van Keymeulen

The National Agency for Medicines and Health Products Safety (ANSM) has introduced the first “similar biologic groups” in the French biosimilar register (liste de référence des groupes biologiques similaires), pursuant to a decision dated 18 September 2017. The decision follows the amendment of the biosimilar substitution regime by the 2017 Social Security Financing Act, and Read More

French regulators provide guidance to prevent confusion between medicines and food supplements

Eveline Van Keymeulen

Earlier this summer, the French National Agency for Medicines and Health Products Safety (ANSM) and the French National Agency for Food, Environmental and Occupational Health & Safety (ANSES) published recommendations to help healthcare professionals and patients distinguish medicines from food supplements. The recommendations follow pharmacy reports about a risk of confusion between the medicinal product Read More

French Supreme Court confirms discriminatory abuse in market of medical information databases for pharmaceutical companies

Florence Ninane

Earlier this summer, the French Supreme Court (Cour de Cassation) rejected an appeal by Cegedim against a ruling of the Paris Court of Appeal, upholding a July 2014 decision of the French Competition Authority (FCA) that imposed a EUR 5.7 million fine on the company. The FCA had found that Cegedim’s refusal to grant a Read More