BackgroundClustered Regularly Interspaced Short Palindromic Repeats-associated technology may allow for efficient and highly targeted gene editing in single-cell embryos. This possibility brings human germline editing into the focus of ethical and legal debates again.Main bodyAgainst this background, we explore essential ethical and legal questions of interventions into the human germline by means of CRISPR-Cas: How should issues of risk and uncertainty be handled? What responsibilities arise regarding future generations? Under which conditions can germline editing measures be therapeutically legitimized? For this (...) purpose, we refer to a scenario anticipating potential further development in CRISPR-Cas technology implying improved accuracy and exclusion of germline transmission to future generations. We show that, if certain concepts regarding germline editing are clarified, under such conditions a categorical prohibition of one-generation germline editing of single-cell embryos appears not to be ethically or legally justifiable.ConclusionThese findings are important prerequisites for the international debate on the ethical and legal justification of germline interventions in the human embryo as well as for the harmonization of international legal standards. (shrink)

Recent results from studies on animals suggest that functional germ cells may be generated from human pluripotent stem cells, giving rise to three possibilities: research with these so‐called artificial gametes, including fertilization experiments in vitro; their use in vivo for therapy for the treatment of human infertility; and their use in assisted reproductive technologies in vitro. While the legal, philosophical, and ethical questions associated with these possibilities have been already discussed intensively in other countries, the debate in Germany is still (...) at its beginning. A systematic and detailed analysis of the legal framework in Germany is provided with regard to the three possibilities, including the applicable statutory laws as well as the constitutional law. The question emerges as to whether the statutory laws as well as the constitution justify a distinction to be made between embryos of artificial and natural origin. This question is subject to philosophical analysis, discussing the distinction between person and thing, dignity and price, personality and property, and nature and technique. As a result, the criterion of naturalness alone may not be sufficient to differentiate between embryos of natural and artificial origin, and other criteria need to be identified. (shrink)

Innovative techniques of developmental biology facilitate the artificial creation of embryo-like entities. This contribution analyses, first, whether certain artificially created embryo-like entities are ‘embryos’ within the meaning of existing statutory law definitions laid down in the Embryo Protection Act, the Stem Cell Act and the Patent Act. These definitions are non-uniform and their interpretation and application with regard to artificially created embryo-like entities is not always conclusive. Accordingly, the legal definitions of the term ‘embryo’ should be harmonised and, thereby, adapted (...) to the state of developmental biology. Any such legislative efforts need to be in conformity with the constitution, primarily with the guarantee of human dignity (Article 1‍(1) of the Basic Law). However, said provision cannot provide guidance to the legislature because the constitutional status of both embryos and embryo-like entities in vitro is highly disputed. It is held that this irresolvable debate is due to a fundamental lack of a widely shared experience that such entities possess a supreme unique value. This article argues that in such a situation it is, in the first instance, for the legislature (i. e. parliament) to determine the legal status of embryos and embryo-like entities in vitro. This argument is based on a particular doctrinal approach according to which the individual right to respect of one’s human dignity arising from Article 1‍(1) BL depends on recognition of the relevant entity as being a ‘human’ or a member of ‘humankind’ respectively. Such recognition has, hitherto, not been accomplished with a view to embryos and embryo-like entities in vitro. Against this backdrop, for the time being, the legislature may determine the legal status of embryos and embryo-like entities in vitro, lay down rules regarding their creation and particular use, and, especially, define the legal term ‘embryo’, albeit within some outer constitutional limits. The article, finally, analyses several elements of, and submits a proposal for, a new legal definition of the term ‘embryo’. (shrink)