Abstract:

Genome editing technologies, particularly CRISPR, have rapidly changed the landscape of modern biomedicine,    and it has made it necessary to rethink ethical, legal, and security paradigms. Within the European Union (EU), somatic genome editing is widely accepted as a therapeutic practice, whereas germline interventions remain largely prohibited due to precautionary and moral considerations.    The article presents a two-pillar model for the governance of genome editing—object-based regulation, which aims to evaluate technological products and tools, and process-based regulation, which focuses on clinical applications and treatment processes.

The analysis reveals structural inconsistencies within the EU regulatory framework: long-standing moratoriums based on lack of knowledge hinder scientific progress, while morality-based patent limitations inadequately address real-world risks and may unintentionally incentivise technological development outside EU jurisdiction. We argue that future regulation must transit from precaution-driven prohibitions toward knowledge  and risk-based governance, emphasising safety, efficacy and responsible innovation.

We propose a division of regulatory responsibility in which the EU oversees object-level evaluation of genome-editing tools, while member states retain authority to decide on process-level clinical application based on ethical and societal context. Advancing this model requires coordinated research, harmonised assessment mechanisms, and ongoing interdisciplinary dialogue. A scientifically informed regulatory shift would not only improve policy coherence, but also foster public trust and facilitate future therapeutic breakthroughs.

 

 

 

Keywords:

CRISPR, EU regulation, somatic therapy, germline modification, bioethics, precautionary principle, policy development

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