4/9/2026 2:07:26 PM New US Tariffs on Pharmaceutical Imports: What Life Sciences Companies Need to Know By Phoebe Greybanks The United States has introduced sweeping new tariffs targeting patented pharmaceutical products and their ingredients, with duties set...
4/9/2026 9:58:05 AM France to impose new tax on pharmaceutical companies “unduly delaying” generic entry through patent filing and litigation strategies By Anne-Charlotte Le Bihan Audrey Naturel Marylis Clerc Following our recent coverage of the new US tariffs on pharmaceutical imports, it is worth noting that Europe is also seeing significant...
3/17/2026 2:49:04 PM The EU Pharma Package Reaches a Milestone: Formal Adoption on the Horizon By Mette-Marie Henrichsen On 6 March 2026, the European Council published its “compromise texts of the provisional agreement” (the “Compromise Text”), setting out...
2/13/2026 9:54:14 AM CJEU to revisit Santen doctrine: German court challenges SPC interpretation for veterinary medicinal products By Manuel Lobato Intellectual property rights created by European Union regulations (such as supplementary protection certificates (SPC)) can give rise to...
1/19/2026 5:16:05 PM What is the statute of limitations for personal injury claims in France? By Charles-Henri Caron Lînah Bonneville Our foreign clients often ask us about the statute of limitations for personal injury under French law. While the question may appear...
1/15/2026 1:56:33 PM Understanding the impact of the European Accessibility Act on Medical Devices By Kelly Mackey Deirdre Kilroy Understanding the impact of the European Accessibility Act on Medical Devices The European Accessibility Act (Directive (EU) 2019/882)...
12/16/2025 6:10:23 PM Provisional agreement on the EU Pharma Package before 2025 comes to an end By Sarah Faircliffe Sophie Vo Hester Borgers On 11 December 2025, it was announced that the Council of the European Union and European Parliament reached an agreement on the EU...
10/27/2025 11:54:53 AM Navigating the interplay of MDR and AIA: New MDCG Guidance on Medical Device AI Under the EU AI Act: EU and UK perspectives By Pieter Erasmus Maud van Haaren Hester Borgers The EU regulatory landscape for medical devices making use of artificial intelligence (MDAI) has become significantly more complex with...
9/25/2025 2:34:28 PM Fit for the Future: England’s 10 Year Health Plan and Implications for US Companies By Sally Shorthose England’s National Health Service (NHS) is seen as one of the world’s most ambitious and comprehensive healthcare systems, but has been...
9/4/2025 4:43:11 PM Navigating Digital Health: When Software Becomes a Medical Device – Critical Legal Considerations for Technology Suppliers in the Healthcare Sector By Henri Kaikkonen As digital health applications become increasingly sophisticated and telemedicine (the distribution of health-related information and...
8/18/2025 3:47:55 PM EU Pharmaceutical Law Reform: New Framework for Combination Products By Christian Lindenthal Annelie Säurig As part of its pharmaceutical law reform, the EU legislator has proposed a modernised framework for combination products – products that...
8/14/2025 9:55:42 AM EU Pharmaceutical Law Reform: Council advances paediatric medicine reform with more flexible investigation plan proposals By Clarissa Junge-Gierse This article is part of our series covering the proposed reforms to the EU pharmaceutical legislation. To view the entire series, click...
8/4/2025 9:40:31 AM Council adopts its position on EU pharmaceutical law reform: focus on antimicrobials and transferable data exclusivity vouchers By Caroline Arrighi-Savoie Nour Saab Margot Pietri This article is part of a series covering updates to the proposed European Union (EU) pharmaceutical legislation reform, known as the...
7/16/2025 12:09:27 PM The European Commission’s draft for a Critical Medicines Act (CMA): Disruptive Changes in Public Procurement? By Clarissa Junge-Gierse Introduction On March 11, 2025, the European Commission introduced the Critical Medicines Act (CMA), a legislative proposal that...
7/8/2025 8:00:47 AM EU Pharmaceutical Law Reform: Key Changes on Advertising of Medicinal Products By Kevin Munungu In 2023, the European Commission proposed a comprehensive update of the key EU pharmaceutical legislation (the "Pharma Package") to...
6/20/2025 11:08:08 AM Council of the European Union adopts position on EU Pharma Package By Benedicte Mourisse Marc Martens Sarah Faircliffe On 4 June 2025, the Council of the European Union adopted its mandate for negotiations with the European Parliament on two European...