Regulating Heritable Human Genome Editing: Drawing the Line between Legitimate and Controversial Use

Area of Science:

• Bioethics
• Genetics
• Reproductive Medicine

Background:

• Human germline genome editing (HHGE) is generally prohibited.
• Lifting the ban for therapeutic purposes to eliminate genetic diseases is often proposed.
• Defining health and disease is complex and can lead to legal and discriminatory issues.

Purpose of the Study:

• To explore alternative regulatory models for HHGE.
• To propose a framework for assessing the permissibility of HHGE.
• To address concerns regarding the definition of disease and its implications for HHGE.

Main Methods:

• Analysis of existing ethical and legal frameworks for genome editing.
• Evaluation of the limitations of disease severity thresholds for regulation.
• Proposal of the preimplantation genetic diagnosis (PGD) model as a regulatory benchmark.

Main Results:

• A complete ban on HHGE may be less efficient than a regulatory approach.
• Defining "disease" is subjective and poses regulatory challenges.
• The PGD model offers a potential criterion for assessing HHGE permissibility.

Conclusions:

• HHGE regulation should move beyond a simple ban.
• A value-laden approach to defining disease raises concerns.
• HHGE could be permitted if used to correct genetic defects identifiable through PGD, serving as a minimum threshold.