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
The Q2/24 Life Science and Health Care Law Update covers key trends in the EU and Big Five (France, Germany, Italy, Spain, UK) in life sciences regulatory, corporate, compliance, competition, and privacy....more
We were pleased to welcome industry leaders to our Life Sciences and Health Care Horizons event in Zurich, where co-head of Hogan Lovells Life Sciences and Health Care sector Jane Summerfield, and partners Melissa K. Bianchi,...more
The current European legislation for in vitro diagnostic medical devices (IVD) (Regulation 2017/746 or the IVDR) has created challenges not only for IVD manufacturers but also for pharmaceutical companies....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
Industry is revising its models in clinical development: new collaborative research between the industry and investigators is becoming more important, resulting in an in-between approach between industry sponsored studies and...more
We were pleased to welcome industry leaders to our Life Sciences and Health Care Horizons event in Zurich, where co-head of Hogan Lovells Life Sciences and Health Care sector Jane Summerfield, and partners Melissa K. Bianchi,...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
La loi n° 2023-378 du 19 mai 2023 relative à l’encadrement des centres de santé a enfin été publiée au Journal Officiel. Ce texte qui a fait consensus, a été adopté sans modification majeure par rapport au projet initialement...more
We were pleased to welcome industry leaders to our Life Sciences and Health Care Horizons event in Boston for the first time since the pandemic. At the event, Hogan Lovells attorneys Eliza Andonova, Ina Brock, Kristin...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
In August 2022, the European Commission published a revision to Annex 1 “Manufacture of Sterile Medicinal Products” in EudraLex - Volume 4 - Good Manufacturing Practice (GMP) guidelines that will significantly impact...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
The online gaming sector is characterized by various regulatory frameworks, that may or may not overlap depending on the type of games and means of distribution. There are a number of stakeholders on the value chain...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
Speaking at the World Stem Cell Summit hosted by the Regenerative Medicine Foundation, Hogan Lovells partners Mike Druckman, Ernesto Algaba, Mandi Jacobson, Lu Zhou, Mikael Salmela, Charlotte Damiano, and Lowell Zeta, along...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