EU Biotech Act: Opportunities and challenges for the rare disease community +... +++

https://www.eurordis.org/members-webinar-eu-biotech-act/ October 2025 The European Commission is consulting on its forthcoming EU Biotech Act – a flagship initiative of the European Life Sciences Strategy – that aims to strengthen Europe’s capacity to innovate, compete globally, and translate biotechnology into benefits for people and society. For the 30 million Europeans living with a rare disease, biotechnology has already proved transformative. Put in simple terms, biotechnology is the use of living systems and biological processes to improve health and the environment: from genetic testing and molecular diagnostics to life-changing gene and cell therapies, it continues to redefine what is possible in medicine. The EU Biotech Act seeks to build on this progress, helping Europe move more swiftly from scientific discoveries to new products such as treatments and diagnostic tools, while driving scientific excellence and industrial growth across the Union. While most debates have focused around competitiveness, EURORDIS works with the Commission and its partners to ensure the Act delivers meaningful progress for the rare disease community. In our recent webinar, we explored what the Biotech Act is expected to achieve, why it matters, what EURORDIS is calling for, and how patient organisations can help shape it through the Commission’s public consultation open until 10 November 2025. "With the EU Biotech Act, we have a real opportunity to strengthen Europe’s leadership in health innovation – not only for competitiveness, but above all for patients. We want innovation to happen in Europe, so that new therapies for rare diseases are developed, tested, and made accessible here. This means creating an ecosystem where research, regulation, and investment work together." – Fabio D’Atri, Policy Officer, European Commission (DG SANTE) About this initiative https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/14627-Biotech-Act_en Commission launches new strategy to make Europe a global leader in life sciences by 2030 https://ec.europa.eu/commission/presscorner/detail/en/ip_25_1686 About this consultation https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/14627-Biotech-Act/public-consultation_en