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Nouveaux modèles de convention unique pour la recherche clinique: plus de standardisation, moins de simplification

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

New French template agreement for clinical trials: more standardization, less simplification

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

Nouvelle contrainte à la charge de l’industrie pharmaceutique dans la lutte contre les pénuries de médicaments

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

New offensive against the pharmaceutical industry in the fight against medicinal product shortages

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 law aimed at improving the framework for French health care centers has finally been published!

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

6/2/2023  /  France , Healthcare

Regulation of health care centers: a limited reform on the way

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

La réforme de l’encadrement des centres de santé, une réglementation attendue mais dont les contours restent encore limités

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

Dispositif Encadrement des avantages : actualisation de la liste des typologies thématiques des avantages et des conventions

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

French anti-benefits regulation: update of the list of thematic typologies of benefits and agreements

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

Loi de financement de la sécurité sociale pour 2023 : cadeau de fin d’année pour les sociétés de téléconsultation

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

Social Security Financing Law for 2023: a year-end gift for teleconsultation companies

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

Teleconsultations in France: a (r)evolution coming for commercial companies?

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

Téléconsultations : (r)évolution à venir pour les sociétés commerciales ?

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

France - E-merchants, don’t forget to update your T&Cs of sale!

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

France - E-commerçants, n’oubliez pas de mettre à jour vos CGV !

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

Long-awaited update of the French “Convention Unique” for clinical trials finally published

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

Publicité et communication sur les dispositifs médicaux : la Charte française tant attendue enfin publiée !

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

Advertising and communication on medical devices: France’s long-awaited Charter finally published!

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

Anti-benefits regulations: the last piece of the regulatory puzzle published

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

New French anti-benefits regulations - the thresholds finally published

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

Strengthening of the French anti-benefits regulations: the wait is over! (almost)

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

View from the Horizon: Pricing and financial regulation of health products in France

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

EU – Trade Secrets Law: practical implementation by businesses

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

Tell me your name and I'll tell you… if you comply with the French Health Authority's recommendations!

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

The French Competition Authority Wants to Lower Prices of Pharmaceuticals

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

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