De nouveaux modèles de convention unique pour la recherche clinique ont été publiés le 5 aout 2024. Ceux-ci mettent à jour les précédents modèles en prenant en compte les nouvelles tendances de la pratique en matière de...more
Two updates to the French national clinical trial template agreements (Convention Unique) were published on August 5, 2024. They update the previous templates to take into account evolving practices in clinical trials. In...more
Un nouveau dispositif, porté par le projet de loi de financement de la sécurité sociale pour 2024, pourrait aboutir à imposer aux entreprises exploitant un médicament mature d’intérêt thérapeutique majeur qui souhaiterait en...more
A new draft measure, included in the Social Security Financing Bill for 2024, aims to require companies operating a mature medicinal product of major therapeutic interest (MITM) that wishes to suspend or cease marketing it,...more
The French law n° 2023-378 of 19 May 2023 on the supervision of health care centers has finally been published in the Journal Officiel. The text, which has reached a consensus, was adopted without major changes. This text is...more
A new bill of law has been proposed to improve the regulation of health care centers in France. While limited in scope as currently drafted, the bill contributes to the establishment of a regulatory framework applicable to...more
Une nouvelle proposition de loi est en cours d’adoption, visant à améliorer l’encadrement des centres de santé en France. Ce texte participe à la construction du cadre réglementaire applicable à la mise en place de ces...more
Répondant aux critiques émanant de la pratique, un arrêté en date du 20 janvier 2023 a modifié l'arrêté du 24 septembre 2020 portant sur la typologie thématique des avantages et des conventions en application de l'article...more
More than two years after the publication of the ministerial order of 24 September 2020 establishing a “thematic typology” of benefits and agreements provided for in Article R1453-14 of the French Public Health Code, a...more
La loi du 23 décembre 2022 de financement de la sécurité sociale pour 2023 a entériné l’adoption d’un nouveau régime d’agrément applicable aux sociétés de téléconsultation afin de favoriser la prise en charge des services de...more
The social security financing act for 2023, dated 23 December 2022, has endorsed the adoption of a new accreditation regime applicable to teleconsultation companies to facilitate the reimbursement of the teleconsultation...more
Analysis and update on a possible major evolution of the regulation applicable to telemedicine, currently borne by the Social Security Financing Bill for 2023 and being discussed by the French Parliament.
The Social Security...more
Analyse et point d’étape concernant une possible évolution majeure de la règlementation applicable aux actes de télémédecine qui est actuellement portée par le PLFSS 2023 et en cours de discussion devant le Parlement -
Le...more
A new French Decree on the legal guarantee of conformity of goods, digital content and digital services was published on June 30th, 2022. A new French Decree no. 2022-946 on the legal guarantee of conformity of goods, digital...more
Un nouveau décret relatif à la garantie légale de conformité pour les biens, les contenus numériques et les services numériques a été publié le 30 juin 2022...more
A new French template agreement for clinical trials (Convention Unique) was published on April 9, 2022. This new version was much awaited since the initial version, dated back to 2016, was missing some key provisions...more
L'arrêté ministériel fixant la Charte relative à la qualité des pratiques professionnelles de présentation, d'information ou de publicité des dispositifs médicaux à usage individuel, des autres produits de santé et de tout...more
The French ministerial order laying down the Charter on the quality of professional practices for the presentation, information or promotion of medical devices for individual use, other health products and any associated...more
Decree no. 2020-730 of 15 June 2020 and the ministerial orders of 7 August 2020 have completed and specified the new anti-benefits regulations which will come into force on 1 October 2020...more
The ministerial orders setting the thresholds for the determination of the notion of negligible value of benefits provided in kind or in cash, as well as the thresholds for the agreements triggering the authorization...more
2020 marks a further milestone in stricter controls on HCPs interactions in France. French government has laid the remaining bricks for the new (and stricter) regulatory framework for interactions between the industry and...more
On June 27 the third edition of our new global series, Life Sciences and Health Care Horizons, took place in Paris with discussions focused on the pricing and financial regulation of health products after the latest reforms....more
On 14 March, we organized alongside the Association française des juristes d’entreprise (AFJE) a workshop regarding the implementation of the Trade Secret Law in France, which was voted into force on 30 July 2018 and...more
On 22 February 2018, the French Health Authority (ANSM) published on its website its "Recommendations to applicants and holders of marketing and registration authorisations" on the names of medicines....more
On November 21, 2017, the French Competition Authority (“FCA”) announced the launch of a new sector inquiry relating to the functioning of competition in the pharmaceutical sector....more