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...
08 May, 2024 SOHO ALERT: A Comprehensive Guide to the Proposed Regulation on Substances of Human Origin - interplay with the ATMP Legislation By Marc Martens Lora Arifagic Legislative process On 19 July 2022, the European Commission (‘EC’) submitted a proposal for a Regulation on standards of quality and...
07 May, 2024 Italy: Originator to pay over €13.4 million for abusing its dominant position by misusing the patent system By Evelina Marchesoni In this article we look at a ground-breaking decision of the Italian Supreme Court dealing with the compensation for damages caused by an...
30 Apr, 2024 Developments in the Netherlands on preventing unwanted influence of healthcare professionals by medical companies By Hester Borgers Jephta Zantinge On 8 April 2024, the Dutch Minister of Medical Care (the Minister) sent a letter to the Dutch House of Representatives (Kamerbrief)...
27 Feb, 2024 Principle of Automatic Substitution by Biosimilars By Johanna Harelimana Nour Saab Caroline Arrighi-Savoie Like generic medicines, biological medicines that are very similar to another biological medicine (biosimilars) are included in a list...
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...
16 Jan, 2024 HMA-EMA publish multi-annual AI workplan: further guidance on the use of AI in the medicines lifecycle By Hester Borgers In December 2023, the joint HMA-EMA Big Data Steering Group (BDSG) published a multi-annual (2023-2028) AI workplan to guide use of AI in...
18 Dec, 2023 The Legal 500: Pharmaceutical Advertising Country Comparative Guide 2023 By Sally Shorthose Pieter Erasmus The latest edition of the Legal 500: Pharmaceutical Advertising Comparative Guide is now online. The aim of this guide is to provide its...
05 Dec, 2023 AI in healthcare: the World Health Organisation’s regulatory considerations By Hester Borgers Dr. Nils Lölfing The World Health Organisation (WHO) has published regulatory considerations on artificial intelligence (AI) for healthcare in October...
24 Nov, 2023 Polish government, business associations respond to EU pharmaceutical law reform By Andrzej Stelmachowski Following the EC’s announcement of the European Pharmaceutical Strategy[1], the Polish government and the country’s business associations...
28 Sep, 2023 Circular economy: what impact for healthcare players? By Alexandre Vuchot Johanna Harelimana Nour Saab Environmental awareness and the desire to limit or eliminate the impact of human activities on the environment have led to real political...
27 Sep, 2023 Public Procurement for Biological Medicines in Belgium By Lora Arifagic Marc Martens Introduction The Royal Decree of September 13, 2023 (‘RD’), implementing Article 71bis, § 1, of the Belgian Act on Compulsory Health Care...
14 Sep, 2023 EMA’s envisaged risk-based and human-centric approach to regulate AI By Hester Borgers Christian Lindenthal, LL.M. Dr. Nils Lölfing Bird & Bird’s international life sciences and healthcare team is at the forefront of the legal developments with regard to AI and the...
10 Aug, 2023 AI and the life sciences, navigating the complex legal landscape By Hester Borgers Christian Lindenthal, LL.M. Bird & Bird’s international life sciences and healthcare team is at the forefront of the legal developments with regard to AI and the...
09 Aug, 2023 EU Commission’s proposed changes to marketing authorisation procedures By Sophie Vo Sally Shorthose This article is part of a series that covers the proposed reforms to EU pharmaceutical legislation. To view our first article and the...