France

New measures on advertising and information of health products take effect in France

Eveline Van Keymeulen

In October 2018, Decree No. 2018-864 on the presentation, information and promotion of health products and related services entered into force, which was adopted pursuant to Article 58 of the Social Security Financing Bill. The decree introduces measures that aim to provide quality information to assist healthcare professionals in their therapeutic choices for health products, Read More

French Senate issues recommendations to tackle pharmaceutical supply disruptions

Eveline Van Keymeulen

In October 2018, the French Senate published a reportĀ on supply disruptions of medicinal products and vaccines. The report provides recommendations to combat the causes of such disruptions, which have increased by 30% since 2016, and to secure sufficient stock. In particular, the report proposes to: Set up tax exemptions for companies investing in French manufacturing Read More

French regulator (ANSM) introduces fast-track authorisation procedures for clinical trials

Eveline Van Keymeulen

On 15 October 2018, in preparation for the application of the EU Clinical Trials Regulation, the National Agency for Medicines and Health Products Safety (ANSM) introduced two fast-track procedures to allow faster patient access to innovations. The Clinical Trials Regulation is expected to become applicable in 2020. Fast-track procedure 1, “access to innovation”, aims to Read More

French Courts also want the CJEU to clarify the criteria laid down in the Neurim landmark decision

Charles Tuffreau

While Article 3(d) of the SPC Regulation (No. 469/2009) was thought to prevent the grant of an SPC covering a new therapeutic application of a product which had already received a MA for a medicinal product, the CJEU ruled in its Neurim decision (C-130/11) of 19 June 2012 that “the mere existence of an earlier Read More

French antitrust watchdog launches public consultation regarding distribution of OTC medicines

Patricia Carmona Botana

On 18 October 2018, the French Competition Authority (FCA) announced the opening of a public consultation relating to its sector inquiry into the distribution of medicines and biomedical laboratories launched in November 2017. Interested parties (such as healthcare professionals, pharmaceutical and health product distributors, retail pharmacies, etc.) are invited to submit comments to a set Read More