Table 1 Summary of suggested substantive and procedural legal requirements of germline therapies

Substantive requirements

Treatment of, or prevention against, certain serious, hitherto incurable hereditary diseases.

Diseases to be defined in an abstract way or identified in a list which could be of an exhaustive (i.e. static) or only exemplary (i.e. dynamic) character

Interventions for other, e.g. enhancement or eugenic, purposes to be explicitly prohibited

Acceptable risk of the intervention

Unambiguous cure or prevention of the hereditary disease and unequivocal overall advantage for the embryo’s and its offspring’s health

No negative side effects such as a higher susceptibility of the genome edited embryo, or the resulting born human being and its descendants, to other kinds of diseases

Dependence of the permissibility of germline interventions on necessity

Preclinical scientific testing and evaluation using in vitro animal and human (e.g. stem cell) models as well as in vivo animal models

Procedural requirements

Drawing up, and updating, list of diseases by legislator or, on the basis of legislatively delegated powers, of an administrative authority and/or of a special committee composed of relevant stakeholders (e.g. scientists, ethicists, lawyers, medical doctors, patient groups)

Consent of the (future) parents of the embryo

Consent of the mother who will have to carry the genetically modified embryo

Thorough information about the risks by a medical doctor

Establishment of international body in form of “trustee” or “custodian” for the purposes of consent of future generations

Participation in the decision-making process of other institutions such as an ethics committee or a judge