France

French anti-gift regulation is now complete!

Jeanne Fabre

The two long-awaited orders of the French anti-gift regulation were finally published on 14 August 2020 (see our previous blog post: Decree on French anti-gift regulation published): Order of 7 August 2020 setting the amounts from which an agreement provided for in Article L1453-8 of the Public Health Code and specifying the granting of benefits Read More

France: Extension of framework agreement between French Pharmaceutical Companies Association and Economic Committee for Health Products

Jeanne Fabre

At the end of the Conventional Policy Steering Committee held on 23 July 2020, the French Pharmaceutical Companies Association (Leem) and the French Economic Committee for Health Products (CEPS) agreed to an extension of their Framework Agreement, which is the reference framework for fixing and regulating medicines pricing in France. The agreement, which would have Read More

Covid-19 ā€“ Coronavirus: French Health Ministry publishes orders and decrees concerning serological tests assessments, listings and reimbursements

Eveline Van Keymeulen

Further to the previous publications by the French High Health Authority (HAS), the French Health Ministry published on 21 May 2020 the list of serological tests deemed reliable and validated by the National Reference Centre for respiratory infection viruses (CNR) on its Covid-19 platform (see our previous post here). On the same date, a new Read More

CJEU ā€“ The Grand Chamber reverses the Neurim decision

Charles Tuffreau

In a landmark decision dated 9 July 2020 concerning the Santen case (Cā€‘673/18), the Grand Chamber of the CJEU clearly reverses the Neurim decision (Cā€‘130/11) and ruled that a MA cannot be considered to be the first MA, for the purpose of Article 3(d), where it covers a new therapeutic application of an active ingredient Read More

Decree on French anti-gift regulation published

Jeanne Fabre

Recently on June 2020, Decree No 2020-730 of 15 June 2020 on benefits offered by persons manufacturing or marketing health products or services (Decree) was published. The long-awaited Decree issued for the application of Ordinance No 2017-49 of 19 January 2017 on benefits offered by persons manufacturing or marketing health products or services (see our Read More