Sheetal Soni

Rapid advances in stem cell science have generated stem cell-based embryo models (SCBEMs), multicellular structures derived from pluripotent stem cells that recapitulate key features of early human development without originating from fertilization. Although the literature also refers to these entities as “human embryo models” or “embryoids,” this article adopts the term SCBEM to reflect their stem cell derivation and to maintain terminological precision. Originally presented as an alternative research platform to embryos, SCBEMs are increasingly exhibiting embryo-like structural and developmental organization. Their trajectory raises a familiar ethical warning about scientific creation outpacing responsibility and exposes significant gaps in legal definitions that rely on origin-based criteria (fertilization, cloning, parthenogenesis) instead of functional characteristics and demonstrated developmental potential. This article develops a South African-centred analysis within a comparative frame, arguing for a bespoke governance framework that is principled, proportionate, and adaptive. It proposes: (i) revised statutory definitions that are tethered to potential and organization; (ii) specialist oversight and a national register; (iii) a culture-limit policy that is aligned with resemblance (and distinct from the fourteen-day rule which applies in relation to embryos); (iv) bright-line prohibitions on any reproductive use or transfer into human or animal hosts; and (v) mechanisms for public trust, transparency, and cross-border harmonization. The aim is to enable socially valuable research while closing loopholes that could erode ethics oversight and public confidence. This article clarifies the legal-ethical problem through the lenses of potentiality and developmental resemblance, maps the comparative governance of SCBEMs with lessons for South Africa, and offers a model framework which includes definitions, oversight architecture, culture-limit policy, prohibitions, and transparency that are designed to be future-ready. A doctrinal analysis of primary law and authoritative guidance was adopted, supplemented by comparative review and governance design principles (proportionality, accountability, transparency). Where formal sources are silent, policy-ready rules were derived from best-practice codes and ethics literature.

Preterm birth, defined by the World Health Organization as any birth occurring before 37 weeks of gestation, remains a significant global health challenge, contributing to high rates of neonatal mortality and long‐term complications. In this context, artificial womb technology – or ectogenesis – offers a transformative intervention capable of sustaining extra‐uterine gestation and improving outcomes for extremely preterm infants. This article explores the legal, ethical and societal implications of introducing artificial wombs in South Africa, where existing laws regulating pregnancy, birth and personhood are ill‐equipped to address this technological shift. In particular, the definitional limits of the Choice on Termination of Pregnancy Act, the conditional nature of the nasciturus fiction, and the ambiguity surrounding parental authority and legal guardianship over gestatelings, is analysed. I argue for the development of a bespoke legal framework to regulate ectogenesis, rather than amending existing pregnancy or birth legislation, and propose a set of principles to guide future regulation. Additionally, I highlight how access to artificial wombs may reinforce healthcare inequality if limited to private medical settings. By proactively addressing the legal and policy challenges posed by ectogenesis, South Africa can advance a rights‐based approach to reproductive healthcare while preparing for the ethical and legal complexities of this emerging technology. This article utilised a qualitative, doctrinal research methodology based on desktop analysis. The research involved the critical examination of primary legal sources such as constitutional provisions, statutes and relevant South African case law. Secondary sources included scholarly articles in medical law, bioethics and reproductive justice, particularly those addressing emerging technologies, e.g. ectogenesis. Comparative perspectives from jurisdictions such as the United Kingdom, the Netherlands, and the United States were also consulted to contextualise the legal challenges within broader international debates. Sources were selected using targeted searches of legal databases and peer‐reviewed journals, with priority given to academic work that engages directly with the ethical, legal and regulatory dimensions of artificial womb technology.

In 2018, the Chinese scientist He Jiankui presented his research at the Second International Summit on Human Genome Editing in Hong Kong. While it was intended that he facilitate a workshop, he was instead called on to present his research in heritable human genome editing, where he made the announcement that he had taken great strides in advancement of his research, to the extent that he had gene-edited human embryos and that this had resulted in the live births of two children. While his research ethic and methodology was interrogated, he insisted that two children, twin girls, had been born healthy and that there was another pregnancy (at the time) where birth of a third gene edited child would be imminent. This announcement generated a ripple effect in the scientific community and exposed the gaps in regulation and absence of law relating to the technology. This resulted in a flurry of activity and conversation around regulation of the technology, which scientists stated was not ready for human trials. This article reviews the Third Summit which was held in London in March 2023 and comments on the latest developments in the regulation of heritable human genome editing.