Europe's Biotech Act: A Regulatory Blueprint to Close the Innovation Gap and Anchor Biomanufacturing in the EU
核心洞察
The European Commission's Biotech Act I aims to reverse Europe's declining share of global clinical trials, which fell from 22% in 2013 to 12% in 2023, through streamlined regulation and stronger innovation support.
EU health-biotech venture funding reached only €25 billion over the past decade compared to approximately €219 billion in the US, highlighting a stark capital gap that the Act seeks to address.
Biotech Act II has officially launched with a focus on industrial biotechnology and biomanufacturing, led by DG Grow (搜索), while Biotech Act I remains under consultation ahead of formal scrutiny.
The European Union is mounting an ambitious regulatory response to its widening biotechnology innovation gap. The proposed European Biotech Act (搜索) — known as Biotech Act I — is designed to streamline the continent's fragmented biotech ecosystem, accelerate clinical development timelines, and anchor innovation within the EU. Following the European Commission's release of a detailed Staff Working Document on 27 May 2026, the evidential and analytical foundation for the initiative is now clear: Europe's biotech sector, despite its strong research base, is struggling to convert scientific output into commercially viable products.
The numbers tell a sobering story. The EU attracted €25 billion in health-biotech venture funding over the past decade, compared to approximately €219 billion in the United States. Virtually all EU biotech IPOs in recent years have taken place on non-EU exchanges. Most strikingly, the EU's share of commercial clinical trials fell from about 22% in 2013 to 12% in 2023, while China's rose from 5% to 18% over the same period.
Root Causes and the Commission's Diagnosis
The Commission's Staff Working Document identifies three root causes behind Europe's biotech underperformance. First, regulatory hurdles — slow, complex processes including lengthy multi-country clinical trial approvals — hinder timely development and delay patient access to new therapies. Second, fragmentation across the EU's biotech ecosystem, combined with limited late-stage capital, pushes many European companies to seek growth outside the Union. Third, regulatory frameworks have not kept pace with emerging technologies such as gene editing, mRNA, and AI-driven development, creating uncertainty that deters investment.
The analysis emphasises that Biotech Act I is designed to complement parallel EU reforms — including updates to pharmaceutical, medical device, substances of human origin, genetically modified organisms, and health data/AI frameworks — to avoid duplication and ensure coherence without weakening existing protections.
Practical Changes Under Biotech Act I
Biotech Act I is expected to deliver incremental improvements across the biotech lifecycle. Shorter timelines for clinical trials and more coordinated oversight, including regulatory sandboxes, aim to reduce red tape and accelerate time-to-market for new treatments. Enhanced EU-wide support networks, clearer signposting, and targeted funding mechanisms are intended to help biotech ventures develop and scale within the EU rather than relocating abroad.
Crucially, the Commission insists that streamlining will not dilute EU standards. New biosecurity safeguards and strict data governance requirements, in line with GDPR and the European Health Data Space, will ensure innovation progresses alongside robust safety and public health protections.
The Capital Gap and Strategic Autonomy
At a high-level discussion held at the European Parliament on 12 May, co-hosted by MEPs Wouter Beke and Vytenis Andriukaitis in partnership with HIPRA (搜索) and The Parliament, the capital gap emerged as a central concern. US health-biotech companies attracted €220 billion over the past decade; European companies attracted one-ninth of that figure. As one speaker noted, Europe lost active pharmaceutical ingredient production to other regions thirty years ago and has struggled to rebuild it since. The analogy for biologics is pointed: once biomanufacturing capacity leaves, it tends not to come back.
Florika Fink-Hooijer, Director-General at DG HERA (搜索), pointed to EU FAB — the EU's network for vaccine and therapeutic manufacturing — as a model for the kind of robust, ever-warm manufacturing capacity Europe needs to address future pandemics and biological threats. She argued that keeping that network ready is not a cost but a strategic investment, citing the rapid and effective mobilisation around the recent Hantavirus outbreak as evidence of how far Europe's preparedness has come since COVID-19.
Fragmentation and the Call for Unity
MEP Andriukaitis introduced "One Europe, One Market!" as a refrain during the Parliament discussion, making clear his support for the Biotech Act to take the form of a regulation rather than a directive — ensuring uniform implementation across all 27 member states rather than fragmented national transposition. He went further, calling for Research and Innovation to become the single market's fifth freedom.
The stakes of fragmentation were illustrated with a striking example: a medicine can face an average approval wait of 127 days in Germany, compared to 531 days in Cyprus — more than a year's difference in treatment access for EU citizens living under the same flag. MEPs Paulius Saudargas and Inese Vaidere stressed the importance of the Biotech Act being inclusive across the full breadth of the Union, noting that Europe's next biotech breakthrough could come from a smaller member state or from one of the many mid-cap companies that currently struggle to scale.
Industry Asks and Strategic Projects
Carles Fàbrega, Managing Director of Human Health at HIPRA (搜索), put forward three concrete asks from industry: that contract manufacturers be clearly eligible for strategic project designations, given that they turn political ambition into real capacity; that vaccine platform technologies qualify as high-impact, since a platform is infrastructure enabling many future products; and that mid-cap manufacturers — the fastest contributors to strategic autonomy on a realistic timeline — qualify alongside the largest players.
Thomas Van Cangh, Head of the Biotech Task Force at DG SANTE (搜索), responded that strategic projects must make a systemic difference, while acknowledging that criteria could be calibrated to bring more players into the market. Andriukaitis offered his own definition: "High impact is when patients' lives are saved."
What Comes Next
Inter-institutional negotiations on Biotech Act I have not yet formally commenced. The main proposal, which takes the form of a Regulation, remains under a rolling period of consultation, awaiting official translation into all EU languages before proceeding to formal scrutiny in Parliament and Council. The Council has agreed its negotiating position on the Directive aspect of Biotech I, which focuses on placing genetically modified micro-organisms and the processing of organs on the market. A Joint Opinion of the European Data Protection Board (搜索) from March 2026 supports the Act's aims but insists on strong GDPR guardrails.
Meanwhile, the Commission has officially launched Biotech Act II, focused on industrial biotechnology and biomanufacturing. Biotech II is led by DG Grow (搜索), the Commission department on Internal Market, Industry, Entrepreneurship and SMEs, while Biotech I is led by DG SANTE (搜索). Ireland's Programme for the upcoming EU Council Presidency, commencing on 1 July, has specifically called out progression of Biotech Act I, suggesting momentum will build as 2026 progresses.
The decisions taken on this Act today will determine what patients can access tomorrow. As the Parliament discussion concluded, the risk is not what Europe loses now — it is what it fails to build next.