欧盟《生物技术法案》正式发布

Core Viewpoint - The European Commission has officially released the Biotechnology Act and a series of accompanying measures aimed at addressing the competitive lag of the local biotechnology industry and enhancing the long-term resilience and core competitiveness of the medical industry [2][3]. Group 1: Industry Overview - The biotechnology sector in the EU has created over 900,000 jobs, with 75% concentrated in the medical field, contributing nearly 40 billion euros to the economy annually [2]. - Despite its growth, the EU faces challenges such as insufficient funding, regulatory bottlenecks, and barriers to innovation, leading to a noticeable lag behind major global competitors in this strategic emerging field [2]. Group 2: Key Measures of the Biotechnology Act - The core of the Biotechnology Act focuses on streamlining the critical link from "laboratory innovation to market application" by optimizing the regulatory framework at the EU level and establishing a unified approval channel for complex innovative products [3]. - The Act aims to accelerate multinational clinical trial approvals using artificial intelligence, data technology, and regulatory sandbox mechanisms, effectively reducing compliance costs and operational burdens for companies [3]. - A special initiative called "EU Biotechnology" has been launched, aiming to mobilize 10 billion euros in capital by 2026-2027, leveraging an existing 3.5 billion euros life sciences risk debt portfolio and an annual commitment of 800 million euros in venture capital to fill investment gaps [3]. Group 3: Industry Reactions - The German Biotechnology Industry Association (DIB) and EuropaBio have highly recognized the Biotechnology Act, believing it lays the foundation for collaborative industry development and will effectively enhance innovation vitality and scalability [4]. - The Spanish Biotechnology Association (AseBio) expressed appreciation for the foundational work established by the first phase of the Act, emphasizing that a solid legal framework is essential for unlocking the potential of biotechnology to benefit the economy and society [4]. - The European Biotechnology Association welcomed the initiative but noted that further work is needed, highlighting the urgency for ambitious actions to enhance the EU's competitiveness amid global geopolitical changes [5].