EORTC welcomes EU Biotech Act and calls for refinements to enable patient-centred trials

Brussels, Belgium – 24 June 2025 – The European Organisation for Research and Treatment of Cancer (EORTC) welcomes the Biotech Act as an initiative to support clinical research by improving the European legal framework.

By committing to support clinical trial sponsors, and particularly non-commercial sponsors that conduct the majority of minimal- and low-intervention clinical trials in the Union, the Act sets forth the goal of simplifying regulatory requirements and reducing administrative burdens while preserving patient safety.

To fully realise this vision and provide the procedural certainty necessary for clinical trial sponsors to conduct treatment optimisation and other public-interest trials, we propose a targeted, two-step refinement to the current text. First, the definition of Low-Intervention Clinical Trials (LICTs) should be updated to pragmatically reflect established, real-world clinical practices. Second, we recommend harmonising the regulatory pathway for these low-risk trials with the newly proposed “Minimal-Intervention” category, centring their approval solely on Ethics Committee oversight.

By adopting this unified, risk-proportionate approach, the EU can eliminate administrative ambiguity, align with successful international practices, and safely accelerate the delivery of optimised cancer treatments to patients.

The European Organisation for Research and Treatment of Cancer (EORTC) is a non-governmental, non-profit organisation, which unites clinical cancer research experts, throughout Europe, to define better treatments for cancer patients to prolong survival and improve quality of life. Spanning from translational to large, prospective, multi-centre, phase III clinical trials that evaluate new therapies and treatment strategies as well as patient quality of life, its activities are coordinated from EORTC Headquarters, a unique international clinical research infrastructure, based in Brussels, Belgium.

Caroline Moulins
Head of Communications
caroline.moulins@eortc.org