Regulating germline editing in assisted reproductive technology: An EU cross-disciplinary perspective

Area of Science:

• Bioethics
• Reproductive Medicine
• Genetics

Background:

• Assisted reproductive technology (ART) applications of genome editing elicit strong public and expert opinions.
• Concerns often stem from scientific misunderstandings and misconceptions about current legal frameworks.
• A multidisciplinary approach is needed to navigate these complex issues.

Purpose of the Study:

• To analyze national, European, and international regulatory responses to genome editing in ART.
• To contribute to the global regulatory debate on gene editing technologies.
• To advocate for a balanced approach that permits responsible research while preventing misuse.

Main Methods:

• Review and synthesis of medical, legal, and ethical expertise.
• Analysis of existing regulatory frameworks at multiple governance levels.
• Comparative assessment of regulatory approaches.

Main Results:

• Genome editing in ART should not be subject to autonomous regulation.
• Existing, general legal frameworks, potentially referencing equivalent technologies, are more appropriate.
• Overly broad moratoria risk hindering essential basic research.

Conclusions:

• Flexible regulations are recommended to facilitate responsible research and development.
• An open, inclusive debate is crucial to counter misinformation.
• Global governance should be fostered through cross-disciplinary collaboration and stakeholder involvement.