Europe’s Biotech Act: Faster Trials, Smarter Rules, and New Capital to Keep Innovation in the EU
January 2The European Commission has unveiled a health package centered on the proposed Biotech Act, aimed at cutting red tape, accelerating clinical trials, and mobilizing fresh investment, alongside targeted fixes to medical device rules and a new Safe Hearts Plan.
Why this matters
Biotechnology is one of Europe’s fastest‑growing sectors, contributing close to €40 billion to the economy and supporting 900,000+ jobs, about 75% of them in health. Yet Europe still struggles to translate science into market‑ready products, as funding gaps and complex regulation push start‑ups abroad. The Biotech Act tackles these bottlenecks head‑on.
What’s in the Biotech Act
The proposal focuses on health biotech (with some provisions touching food/feed) and updates a suite of EU rules to match the pace of modern science. It introduces regulatory sandboxes, harmonised requirements, and single pathways for complex products to shorten time‑to‑market. For multinational clinical trials, end‑to‑end authorisation could fall to ~47 days in straightforward cases, down from timelines that often exceed 100 days.
To help companies scale, the Commission will launch a health biotech investment pilot with the European Investment Bank in 2026–2027, aiming to mobilise up to €10 billion and provide a toolbox of financial products for start‑ups and SMEs. The Act also sets up strategic projects (e.g., ATMP centres of excellence, trusted testing environments, biodefence projects) that get fast‑tracked regulatory and scientific support.
Critically, the package embraces AI and data, from enabling AI‑driven clinical trials and smarter patient selection to improving data sharing via EU infrastructures, so developers can run more efficient studies without compromising safety.
Beyond biotech: devices and heart health
In parallel, the Commission proposes simplifying EU medical devices rules, boosting digitalisation, and strengthening the EMA’s coordination role, changes expected to save €3.3 billion per year (including €2.4 billion in administrative savings) while maintaining high safety standards. It also unveiled the Safe Hearts Plan, the first EU‑wide strategy to prevent, detect, and treat cardiovascular disease, Europe’s leading cause of death.
The bottom line
If adopted by the European Parliament and Council, the Biotech Act could mark a turning point: faster approvals, lower costs, stronger bio‑manufacturing, and better access to capital, all designed to keep European breakthroughs developed, produced, and delivered in Europe.