The EU’s proposed European Biotech Act (“Biotech Act I”) is intended to close Europe’s biotechnology innovation gap. Following publication of the legislative proposal in December 2025 (see our briefing) the European Commission has now released a detailed Staff Working Document (27 May 2026) setting out the evidential and analytical basis for the initiative. This analysis outlines how the EU plans to boost its biotech ecosystem through simpler regulation and stronger innovation support, balanced by strict safety, public health and data safeguards. With the starting gun having been fired on Biotech Act II, we also look at the focus of the second phase.

Despite Europe’s strong research base, there is a perception that the EU is struggling to convert innovation into products and scale up commercially. The EU attracted €25 billion in health-biotech venture funding over the last decade (versus around €219 billion in the US), and virtually all EU biotech IPOs in recent years took place on non-EU exchanges. According to the Commission, 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%.

The Staff Working Document is the Commission’s evidence-based blueprint for Biotech Act I. It is health biotech-led, reflecting the Act’s initial focus, but also covers targeted measures in industrial, food and agricultural biotech. The analysis recaps Europe’s biotech challenges and outlines how a new EU framework could streamline regulation, support innovators and build capacity.

The Commission’s  analysis identifies underperformance in Europe’s biotech sector and points to three root causes:

• Regulatory hurdles: Slow, complex processes – e.g. lengthy multi-country clinical trial approvals – hinder timely development and delay patient access to new therapies.
• Fragmentation: A disjointed EU biotech ecosystem and limited late-stage capital push many European companies to seek growth outside the EU.
• Pace of change: Regulatory frameworks have not kept pace with emerging technologies (e.g. gene editing, mRNA, AI-driven development), creating uncertainty and deterring 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

Biotech Act I is expected to deliver incremental improvements across the biotech lifecycle. Key areas include:

• Simpler, faster processes: Shorter timelines for clinical trials and more coordinated oversight (such as regulatory sandboxes) aim to reduce red tape and accelerate time-to-market for new treatments.
• Better support for innovators: Enhanced EU-wide support networks, clearer signposting and targeted funding mechanisms are intended to help biotech ventures develop and scale within the EU instead of relocating abroad.
• Maintaining high standards: Streamlining will not dilute EU standards. New biosecurity safeguards and strict data governance requirements (in line with GDPR/EHDS) will ensure innovation progresses alongside robust safety and public health protections.

Recent developments & What’s Next

Inter-institutional negotiations on Biotech Act I have not yet kicked off in the fullest sense. 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 it proceeds to formal scrutiny in Parliament and Council, although it is already under review.

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. EU data protection authorities have also weighed in. Separately, a Joint Opinion of the EDPB (March 2026) supports the Act’s aims but insists on strong GDPR guardrails, reinforcing that strict privacy and data rules will apply.

Meanwhile, the Commission has officially launched Biotech Act II, which is focused on industrial biotechnology and biomanufacturing.  To underscore the difference, Biotech II is led by DG Grow, the Commission department on Internal Market, Industry, Entrepreneurship and SMEs. Biotech I is led by DG Sante.

Looking ahead, Ireland’s Programme for the upcoming EU Council Presidency, which commences on 1 July, has specifically called out progression of  Biotech Act I. We expect much more momentum behind these files, in particular Biotech Act I, to pick up as 2026 progresses.

For further information contact our Life Sciences Group.

With thanks to Eseroma Matebalavu for his assistance with this piece.