18 Jun, 2024 EU Parliament Adopts Position on Pharmaceutical Reform: Focus on Combating Antimicrobial Resistance By Sarah Faircliffe Caroline Arrighi-Savoie Johanna Harelimana Nour Saab +1 more... Show less On April 10, 2024, the European Parliament voted to adopt a revised version of the European Commission’s proposed reforms to...
18 Jun, 2024 CJEU AG opinion: pharmaceutical company has EU VAT refund rights following ex lege payments to state health insurance body By Andy van Esdonk On June 6, 2024, the Advocate General (AG) at the Court of Justice of the European Union (CJEU) delivered an opinion in case C-248/23...
18 Jan, 2024 SOHO ALERT: A Comprehensive Guide to the Proposed Regulation on Substances of Human Origin – Preparation Authorisation under the SoHO Proposal By Marc Martens Lora Arifagic The SoHO proposal introduces the procedure for obtaining an authorisation for SoHO preparations by the introduction of an EU-wide...
04 May, 2023 What the replication crisis means for AI and drug discovery By Phillipus Putter Back in May 2016, the scientific publication Nature surveyed over 1,500 researchers to find out how reproducible their work was. This...
24 Apr, 2023 An international overview of the regulatory legislation concerning telemedicine By Katrina Dang Johanna Harelimana Emma Stok Christian Lindenthal, LL.M. Hester Borgers Enrique Rivas Pieter Erasmus Patrick Brown +5 more... Show less Telemedicine has been available to healthcare providers for several years. However, it was not until quite recently that the field of...
12 Dec, 2022 The Legal 500: Pharmaceutical Advertising Comparative Guide 2022 By Sally Shorthose Alexandre Vuchot Johanna Harelimana Christian Lindenthal, LL.M. +1 more... Show less The latest edition of the Legal 500: Pharmaceutical Advertising Comparative Guide is now online. The aim of this guide is to provide its...
25 Oct, 2022 Blood, cells and tissues: regulatory change is coming By Phillipus Putter Approximately twenty years ago, the regulation of Substances of Human Origin (“SHO”) in Europe was reshaped by the introduction of the...
18 Jul, 2022 Final(ly) Rules of Procedure of the UPC By Christopher de Mauny Domien Op de Beeck Apart from the Unified Patent Court Agreement and a large body of further treaties, regulations, directives and laws governing the...
01 Jun, 2022 To opt-out or not? The UPC will change the rules of the game in the European patent field possibly as soon as next fall By Henri Kaikkonen Mikko Nurmisto Early this year it became clear that the long-pending reform of the European patent system is finally coming to fruition. With the...
07 Apr, 2022 The UPC Committees rule! By Wouter Pors Start of the Provisional Application Phase and first committee meetings The Provisional Application Phase of the Unified Patent Court...
28 Mar, 2022 The Return of Biosimilar Substitution in France By Johanna Harelimana Every year the Social Security Financing Law for 2022 (LFSS 2022) introduces several measures resulting in important changes for the life...
17 Mar, 2022 International Comparative Legal Guide to Digital Health 2022 By Sally Shorthose Toby Bond Pieter Erasmus Emma Drake +1 more... Show less Our Life Sciences IP, Regulatory and Data Protection experts Sally Shorthose, Toby Bond, Emma Drake and Pieter Erasmus have written the...