On 16 December, the European Commission proposed the EU Biotech Act – an initiative aimed at strengthening Europe’s biotechnology ecosystem by accelerating innovation, improving regulatory efficiency, and enhancing access to cutting-edge therapies. The Act seeks to streamline approval pathways, support advanced therapies such as gene and cell therapies, improve manufacturing capacity within the EU, and foster investment in rare disease research. By reducing fragmentation across member states and promoting faster translation of scientific advances into clinical practice, the EU Biotech Act has the potential to improve timely patient access to innovative haemophilia treatments, reinforce supply security for plasma-derived and novel products, and ensure that patient needs and safety remain central to Europe’s life-science strategy.