Olivér Várhelyi presents Biotech Act I to parliamentary committee

https://control.eup.glcloud.eu/content-manager/content-page/20260319-1100-COMMITTEE-SANT?audio=fr&lang=fr&logo=true&multicast=true On 19 March, during a joint meeting of the SANT and ITRE committees, Commissioner for Health and Animal Welfare, Olivér Várhelyi, presented part one of the Biotech Act, followed by an exchange with Members. Published in December 2025, Biotech Act I aims to strengthen Europe’s biotechnology and biomanufacturing sectors by supporting innovation, simplifying regulatory frameworks and boosting investment. The discussion highlighted growing concerns about Europe’s declining competitiveness in biotechnology, particularly in clinical trial activity. The EU’s global share has fallen from 18% to 9%, while China’s has risen to around 30%. The proposed Act seeks to address these challenges by accelerating clinical trial approvals, especially for multi-country trials, streamlining regulatory procedures, and promoting the use of health data and artificial intelligence. It also aims to close the investment gap, with the European Investment Bank expected to mobilise up to €10 billion to support biotech scale-ups. MEPs also stressed the decline in the share of orphan medicines developed by EU-based companies, reinforcing calls to strengthen Europe’s capacity to deliver innovative treatments more rapidly and equitably across Member States. The next steps include committee reports (by both SANT and ITRE),  that will shape the Parliament’s position, while the Council carries out its own parallel examination. https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/14627-Biotech-Act_en