The European Brain Council (EBC) welcomes the first part of the EU Biotech Act as proposed by the European Commission. It is indeed regarded as timely initiative to strengthen Europe's capacity to translate its excellence in science into tangible health solutions. In particular, its aims to strengthen the EU's biotechnology and biomanufacturing ecosystem, with an initial and explicit focus on health biotechnology, by reducing regulatory fragmentation, accelerating time-to-market and improving access to capital while maintaining high standards of safety, ethics and biosecurity, are very much welcomed in a context of increased tension and challenge.
Whilst addressing a somewhat longer focus, the proposal also focuses on a number of particular issues and methods to achieve their broader objectives. In particular, New Approach Methodologies (NAMs) are identified as one that could be applied in biological research, early discovery, preclinical development, and the regulatory and quality testing of medicinal products and medical technologies, and are said to have the potential to generate scientific and technological data that are comparable to, or in some cases more informative and generated more rapidly than, those obtained through current standard methods.
In the Pledge for Science: Brain Research and Innovation in the EU, the European Brain Council stressed that brain research is uniquely complex and intrinsically interdisciplinary, and that no single model can yet capture the full biological, cognitive and behavioural dimensions of the human brain. While the development and uptake of NAMs should be actively supported as complementary methods in science and research, the EBC calls for these to be investigated in a scientifically nuanced manner that recognises their complementarity with, rather than substitution for, existing models, including animal research, which remains essential in the absence of fully validated alternatives.
The Biotech Act should therefore ensure that regulatory incentives for NAMs are accompanied by sustained support for fundamental neuroscience, robust validation frameworks, structured dialogue between scientists, regulators and patients, and full compliance with the highest ethical standards, so that innovation in brain health is accelerated without narrowing the research toolbox needed to address the vast and growing burden of neurological and mental disorders in Europe.