NETHERLANDS Trends and Developments Contributed by: Hamza Zourakhti and Barbara van der Ven, Brande & Verheij LLP
EU Law Remains the Main Driver for the Dutch Life Sciences Sector One of the most anticipated developments in the phar- maceutical sphere is the overhaul of the pharmaceuti- cal legislation, the first significant reform in over two decades. In this respect, on 11 December 2025, the European Parliament and the Council of the European Union reached a political agreement on the aforemen- tioned overhaul, which consists of a new Regulation replacing the current Regulation No 726/2004 and a new Directive replacing the current Directive 2001/83/ EC (generally referred to as the “Pharma Package”). This agreement between the two European institutions was a long time coming, as the European Commis- sion’s initial proposal dates back to April 2023. This reform aims to foster innovation, improve access to medicines and address major public health challeng- es, and will have significant implications for a variety of topics, such as orphan market exclusivity, the Bolar exemption, antimicrobial resistance (AMR), shortages, the review timelines of the EMA, and regulatory data protection and market protection. A period of 24 months will apply, during which, inter alia, EU member states must update their national laws to reflect the new rules, and the EMA and nation- al competent authorities must develop implementa- tion guidelines. Furthermore, complementing the Pharma Package, the European Commission put forward a proposal for the Critical Medicines Act on 11 March 2025. The pro- posed Act seeks to improve the security of supply and the availability of critical medicines within the EU. On 2 December 2025, the Council of the European Union agreed on its position on the aforementioned Criti- cal Medicines Act. The next step is for the European Parliament to establish its position, after which it will enter negotiations with the Council in order to agree on a final text. Another notable development involves the biotech sector. Indeed, the European Commission has looked into ways to boost biotech and biomanufacturing in order to improve the European Union’s competitive- ness, strategic autonomy, and economic security. To that end, the European Commission published a pro-
posal for a new regulation, the Biotech Act, of which the first phase was published on 16 December 2025. In terms of medical devices, the European Commis- sion has identified that the current rules are creat- ing unnecessary costs, bottlenecks, uncertainty for companies, and delays for patients. Seeking to miti- gate some of these unfortunate consequences, the European Commission put forward proposals on 16 December 2025 that aim to simplify the MDR and IVDR (while maintaining the safety standards). Artificial Intelligence Artificial intelligence has significant implications for the life sciences sector and is found across vari- ous segments thereof, ranging from clinical trials to diagnostics and drug discovery. Indeed, the EU Arti- ficial Intelligence Act (Regulation (EU) 2024/1689), also referred to as the AI Act, entered into force on 1 August 2024 and is set to become fully applicable on 1 August 2026. It goes without saying that the AI Act has implications for the life sciences sector, as various AI systems used within the sector are classified as “high-risk” systems. For instance, AI chatbots used in the life sciences sec- tor may be subject to the transparency requirements as stipulated in the AI Act. Furthermore, the AI Act is also relevant to medical devices and in vitro diagnos- tic medical devices, as an AI system can also, under certain circumstances, qualify as a medical device. As the medical (and in vitro) devices landscape is already struggling with compliance in the context of the MDR and IVDR, the European Commission – rec- ognising this struggle as well as the increased dif- ficulty posed by the various compliance timelines (ie, the AI Act, MDR and IVDR) – extended, as part of the Digital Omnibus, the compliance deadline for high-risk AI systems in medical (and in vitro) devices to August 2028. Other targeted changes that the Digital Omnibus intro- duced concern, inter alia: • the European Health Data Space Regulation (which entered into force on 26 March 2025);
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