Oct 09, 2024 Case C-237/22 of the CJEU – Clarification of the concepts of “Significant Benefit” and “Clinical Superiority” By Marc Martens Benedicte Mourisse The CJEU brings clarity, on the concepts of “Significant Benefit” and “Clinical Superiority” with respect to Orphan Medicinal Products...
Oct 02, 2024 Navigating the Complex Landscape of Merger Control and Foreign Direct Investment in Life Sciences in the EU and UK By James Baillieu Dr Saskia King In the rapidly evolving world of life sciences, merger control and foreign direct investment (“FDI”) regimes have emerged as key...
Sep 30, 2024 EU VAT: Novo Nordisk ruling unlocks VAT refund benefits for pharma companies – key takeaways By Andy van Esdonk On September 12, 2024, the Court of Justice of the European Union (CJEU) delivered a ruling in a case involving Novo Nordisk AS...
Sep 19, 2024 EU Parliament Adopts Position on Pharmaceutical Reform: implications for the Environmental Risk Assessment By Hester Borgers Emma Stok In our earlier article, we discussed the implications of the European Commission’s legislative proposal from 26 April 2023 for the...
Sep 17, 2024 The DNA of Life Sciences Deals By James Baillieu Maria John The life sciences sector, comprising of sub-sectors like pharmaceuticals, medical devices, diagnostics and services, aims to cure disease...
Sep 11, 2024 EU Pharmaceutical Reform: Update on the proposed changes to marketing authorisation procedures By Sally Shorthose Sophie Vo This article is part of our series covering the proposed reforms to the EU pharmaceutical legislation. To view the entire series, click...
Sep 05, 2024 What do the Political Guidelines for the Next European Commission bring to the life sciences & healthcare industry? By Hester Borgers Ana-Maria Barbu-Nyström On 18 July 2024 President Von der Leyen laid down the path for the next European Commission in her Political Guidelines for the next...
Aug 27, 2024 Clinical Trial Update in Ireland: New model Clinical Trial Agreement for Tripartite Clinical Trials in Ireland By Kelly Mackey Earlier this summer, the Irish Pharmaceutical Healthcare Association (IPHA), which represents the international originator...
Aug 08, 2024 New EU Pharmaceutical Reform: Key Changes and Impacts on Orphan Medicinal Products By Anna Koster Hester Borgers Introduction to the EU Pharmaceutical Reform After the European Commission published the proposed regulation regarding the EU...
Jul 30, 2024 New UK government’s plans for life sciences: the people and policies explained By Sally Shorthose Heidi Hurdle Charlotte Getz The UK life sciences industry takes centre-stage in two of the new Labour government’s “Five Missions For National Renewal”: economic...
Jul 30, 2024 New Draft Cybersecurity Act in the Netherlands: What you need to know By Wilfred Steenbruggen Puck van den Bosch In May 2024, the Dutch government published the draft bill for the new Cybersecurity Act (Cyberbeveiligingswet – “CSA”) for consultation...
Jul 15, 2024 EU Parliament Adopts Position on Pharmaceutical Reform: Focus on Regulatory Data and Market Protection Rules By Benedicte Mourisse Marc Martens This article is part of our series covering the proposed reforms to the EU pharmaceutical legislation. To view the entire series, click...
Jul 11, 2024 EU Pharmaceutical Law Revision: Re-Boxing Set to Become the New Normal for Parallel Imports? By Christian Lindenthal, LL.M. Annelie Säurig In April 2024, the European Parliament voted to adopt a revised version of a new Pharma Directive, part of the European Commission’s...
Jul 09, 2024 EU Parliament Adopts Position on Pharmaceutical Reform By Benedicte Mourisse Marc Martens On 10 April 2024, the European Parliament adopted its position at first reading on two European Commission proposals to revise the EU’s...
Jun 18, 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...
Jun 18, 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...