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

In general, to modify the human germline is prohibited. However, regulating the use of HHGE might be a more efficient method than the actual ban. Indeed, when genome editing is safe for introduction in clinical practices, it is frequently proposed that the prohibition is lifted solely for therapeutic purposes, i.e., to eliminate serious genetic diseases. Definitions of the concepts of health and disease are controversial and may only be reached by adopting a value-laden approach, which may rise concerns about legal certainty and have possible discriminatory effects. Nor the threshold of the seriousness of the disease might be used to solve these issues. A different model might then be adopted for the assessment of the permissibility of HHGE, i.e., the PGD model. However, such model should not be implemented as the only criterion, but should rather be a “minimum threshold”: HHGE should be allowed whenever used to correct a genetic defect for which PGD is possible.