PUBLIC CONSULTATION RESPONSE – The Biotech Act must turn innovation into better cancer care for every patient
The European Cancer Organisation (ECO) has submitted its response to the European Commission’s public consultation on the proposed EU Biotech Act, welcoming its potential to strengthen European innovation and access for patients, while proposing needed additional measures.
The Biotech Act represents an important opportunity to create a European environment in which biotechnology research and innovation can flourish. For cancer care, this could accelerate progress in areas including advanced therapies, precision medicine, radiopharmaceuticals, and AI-enabled diagnostics, helping innovative treatments reach patients more quickly and equitably.
Following the publication of the European Biotech Act proposal on 16 December 2025, the European Commission invited stakeholders to provide feedback.
ECO’s response focuses on three priorities: improving the regulatory environment for clinical trials in Europe; strengthening access to Advanced Therapy Medicinal Products (ATMPs); and ensuring greater policy attention is given to health and oncology workforce needs.
Improving the regulatory environment for clinical trials in Europe
Europe’s share of global clinical trial activity has declined significantly over the past decade. In oncology, between 2013 and 2023, Europe’s share of commercial trials declined to 21% from 41%, while almost half of EU oncology trials are now concentrated in the same four countries: France, Italy, Spain, and Germany.
‘With Europe's share of oncology clinical trials continuing to decline, patients are losing access to innovative treatments and cutting-edge research. The Biotech Act is a welcome opportunity to reverse this trend by making Europe a more competitive, efficient and attractive environment to conduct cancer research, while maintaining strong protections for patients.’
Isabel Rubio, President, European Cancer Organisation
ECO therefore supports the steps to streamline and shorten clinical trial timelines, provided all safety and ethical measures are in place. In line with proposals from its member societies – the European Organisation for Research and Treatment of Cancer (EORTC) and the European Hematological Association (EHA) – ECO also calls for simpler, proportionate regulatory pathways for low-intervention clinical trials.
ECO further calls for investigation into centralised European ethical approval and policies to give patients in every region an equal opportunity to take part in clinical research. Yet a pressing concern remains: a growing number of therapies are winning approval without European patient populations represented in the trials that underpin them.
Strengthening access to ATMPs
On advanced therapies, ECO welcomes proposals to establish ATMP Centres of Excellence. Advanced therapy medicinal products are beginning to transform cancer care, offering therapies that can target cancers once considered very difficult to treat. Encouraging and sustaining their development and availability across Europe is therefore a priority.
This, however, comes with a variety of additional requests: centres must reduce geographical inequalities, and their governance should include patients, civil society organisations, healthcare professionals and hospital pharmacists, alongside researchers, regulators and industry.
Encouraging greater policy attention to health and oncology workforce needs
ECO also stresses that Europe’s biotechnology ambitions cannot be achieved without a sufficiently skilled healthcare workforce. Stronger multidisciplinary education, improved workforce planning, closer cooperation with European professional societies, and greater mobility and exchange of expertise between member states are all necessary elements towards fulfilling this goal.
The EU’s Professional Qualifications Directive should also be reviewed and updated to make the cross-border recognition of specialist qualifications more responsive to rapidly developing fields such as genomics, cell and gene therapies, molecular pathology, artificial intelligence and advanced diagnostics.
We invite you to read ECO’s consultation response here.
