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...
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)...
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...
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...
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...
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...
26 Jul, 2023 What does the European Commission’s proposed reform of EU pharmaceutical legislation mean for Paediatric medicines? By Phillipus Putter Sarah Faircliffe This article is part of a series that covers the proposed reforms to EU pharmaceutical legislation. To view our first article and the...
10 Jul, 2023 Reform of the EU pharmaceutical legislation: proposals to fight against antimicrobial resistance By Sarah Faircliffe Nour Saab Johanna Harelimana This article is part of a series that covers the proposed reforms to EU pharmaceutical legislation. To view our first article and the...
04 Jul, 2023 Increased interest in the use of psychedelics as mainstream therapies By Josh Price Psychedelics have been under investigation by academics, clinicians and pharmaceutical companies for some time and the momentum and...
23 Jun, 2023 Strengthened Environmental Risk Assessment requirements under the proposed new directive on medicinal products for human use By Emma Stok Hester Borgers Sarah Faircliffe This article is part of a series that covers the proposed reforms to EU pharmaceutical legislation. To view our first article and the...
22 May, 2023 AI as a Medical Device By Sophie Vo To add to all the chatter about AI, let’s talk about AI as a medical device. Last month, the Medicines & Healthcare products Regulatory...
26 Apr, 2023 Single-arm clinical trials: EMA launches consultation By Phillipus Putter In contrast to randomised controlled trials (RCTs), single-arm clinical trials (SATs) are relatively simple by design: a sample of...
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...
24 Apr, 2023 The Netherlands: Tolerance policy on online prescribing of medication now embodied in new policy rule By Emma Stok Hester Borgers On 11 April 2023, the Dutch Ministry of Health, Welfare and Sport announced a new policy rule for the online prescription of medication,...
21 Feb, 2023 LFSS 2023: creation of a new accreditation system for teleconsultation companies By Nour Saab Johanna Harelimana Alexandre Vuchot Article 53 of the Social Security Financing Act for 2023 (LFSS) created a new accreditation system for teleconsultation companies. The...