The EU Biotech Act: what it means for people living with lung cancer
A new piece of EU legislation could change how quickly people living with lung cancer in Europe gain access to new treatments. The EU Biotech Act, proposed in December 2025, sets out to close Europe's innovation gap by accelerating progress in health biotechnology. For lung cancer specifically, the implications are significant.
Lung Cancer Europe has produced a fact sheet setting out what the Act contains, how it could affect clinical trials, and what it means for people living with lung cancer. Download it using the button below.
What the EU Biotech Act is
The EU Biotech Act focuses on speeding up clinical trial approvals, reducing administrative barriers, expanding funding, growing biomanufacturing capacity, and simplifying regulatory pathways across EU borders. It also gives explicit support to AI as a tool for modernising how trials are designed, conducted and monitored.
For lung cancer, three elements of the Act are especially relevant. First, faster and stronger drug development pathways that shorten timelines and make cross-border trials easier to run. Second, explicit support for AI as a tool for improving trial design and patient recruitment. Third, coverage of the next-generation therapeutic platforms where many of the most promising new lung cancer treatments are emerging, including immunotherapies, cell and gene therapies and mRNA technologies.
Why clinical trial speed is a lung cancer issue
Clinical trials are often the slowest part of getting new treatments to people, taking six to ten years from start to finish. The EU's share of global clinical trials has fallen from 22 per cent to 12 per cent over the past decade. For people with lung cancer, delays in accessing new treatments have direct consequences.
The Act aims to cut the first approval step from 75 days to 47 days and reduce overall approval timelines from over 100 days to around 50 days. It also addresses recruitment, which is consistently the biggest bottleneck in cancer trials. AI-enabled tools supported by the Act can match people to trials using electronic health records, identify eligible individuals across EU countries, and reduce recruitment costs by up to 80 to 90 per cent.
What it means for people living with lung cancer
Only about one in ten drugs entering clinical trials eventually receives approval, and trials can cost hundreds of millions of euros. By reducing regulatory barriers and increasing funding, the Act makes it more realistic for companies to pursue complex lung cancer therapies, including treatments for aggressive or hard-to-treat cancers.
It also addresses the gap that sometimes opens between a treatment being proven effective and it reaching people. Scaling up manufacturing can slow down approval or rollout even after a drug works. The Act supports new biomanufacturing facilities, faster production of biologic medicines, and stronger EU-wide supply chains.
Where the Act is now
The Act is currently under review by Parliament Committees and the Council. Trilogue negotiations between Parliament, Council and Commission are expected in late 2026, with full adoption expected around early 2027. The Act would enter into force 20 days after publication in the Official Journal.
Lung Cancer Europe will continue to monitor the Act's progress and advocate for the interests of people living with lung cancer throughout the legislative process.
Source
European Commission. Proposal for a Regulation to establish measures to strengthen the Union's biotechnology and biomanufacturing sectors (European Biotech Act), December 2025.