Between innovation and prohibition: the European legal and ethical framework on human germline genome editing and the role of criminal law as a safeguard

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Опубликован: Mar 30, 2026
DOI: https://doi.org/10.12681/bioeth.45065
Alessandro Buoncompagni
European Law Students’ Association (ELSA), Bologna, Italy and Intern, BioMedLex, Greece
https://orcid.org/0009-0002-5324-1265
Аннотация

This article examines the European legal framework governing human germline genome editing (HGGE) and critically assesses the role of criminal law as a safeguard within that framework. Moving beyond general ethical debates on safety, enhancement, and research integrity, it argues that the distinctive legal challenge posed by HGGE lies in its heritable and irreversible character, as well as in its transgenerational implications. These features strain conventional autonomybased and liability-based regulatory models and help explain the persistent resort to categorical criminal prohibitions across European jurisdictions.


The analysis first reconstructs the relevant international and European legal landscape, with particular attention to the Oviedo Convention and the indirect yet significant influence of EU sectoral regulation, including forms of “functional prohibition.” It then provides a comparative examination of Germany, France, Italy, and the United Kingdom. Despite differing constitutional traditions, these systems converge in prohibiting reproductive germline modification and attaching criminal sanctions to its clinical application, while allowing tightly regulated non-reproductive research in certain circumstances.


A central contribution of the article is the clarification of the normative distinction between embryo research and reproductive germline modification. It argues that criminal liability is justifiable only where genome editing enters clinical trials or reproductive use aimed at implantation, thereby triggering heritable modification. Extending penal sanctions to preclinical or non-reproductive research would undermine the principle of extrema ratio. Ultimately, the article conceptualises criminal law in this field as protecting a trans-individual and transgenerational conception of human dignity, with heritability operating as the decisive threshold for penal intervention.

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