Biological Entity
A Legal, Philosophical and Biological Analysis
B.F.H.J. Bouchaut (TU Delft - Safety and Security Science)
L. Asveld (TU Delft - BT/Biotechnology and Society, TU Delft - Ethics & Philosophy of Technology)
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Abstract
Recent advancements in synthetic biology fundamentally challenge the traditional definition of an ‘organism’ and the regulatory use of the term ‘biological entity’. Developments such as gene editing, organoids, DNA computing, and synthetic cells increasingly blur the boundaries between living and non-living systems, prompting critical reassessment of foundational biological and legal concepts.
Current European and Dutch legislation, including Directive 2009/41/EC and the GMO Decree, defines organisms as "biological entities capable of replication or of transferring genetic material". However, the term ‘biological entity’ itself remains undefined. Scientific advisory bodies like COGEM (the Netherlands Commission on Genetic Modification) have long recognized that synthetic biology renders current definitions inadequate. Their reports consistently highlight how novel biological constructs, such as synthetic cells and biohybrid systems, do not align with traditional concepts of life, yet demand regulatory oversight.
Additionally, while the terms ‘organism’ and ‘biological entity’ are both used in law, their meanings can diverge significantly in scientific discourse. Legal definitions are often structured around risk and containment rather than biological accuracy, creating friction between regulatory objectives and scientific realities. For example, while scientists often exclude viruses from the category of organisms due to their host-dependence, legal frameworks classify them as biological entities, and thus subsequently as organisms for risk management reasons.