'Inherited regulation for advanced ARTs: comparing jurisdictions’ applications of existing governance regimes to emerging reproductive technologies' by Walter G Johnson and Diana M Bowman in (2022) 9(1) Journal of Law and the Biosciences comments
Over the past 5 years, advanced assisted reproductive technologies (ARTs), such as mitochondrial replacement therapies (MRTs) and heritable human genome editing (HHGE), have raised global policy concerns and fears of ‘unregulated’ proliferation. Yet, few innovations are ever truly unregulated and more often fall within the scope of one or more pre-existing regulatory regimes, a process referred to as ‘inherited regulation’. While the United Kingdom has enacted new legislation to specifically authorize and closely regulate MRTs, many jurisdictions will likely default to current oversight systems to manage advanced ARTs. This article evaluates and compares how several jurisdictions have already used four types of inherited regulatory regimes to manage MRTs and HHGE. Cases are drawn from jurisdictions where inherited regulatory interventions on advanced ARTs have taken place (USA, Greece, Ukraine, China, and Russia) and include jurisdictions closely connected with those cases (Mexico and Spain). When accounting for political, cultural, and religious contexts, many of these inherited regimes offer promise as starting points for governance of advanced ARTs, yet each will require further adjustments and tailoring to adequately manage the benefits and risks of these powerful innovations.
The authors argue
Technology has long influenced how and when human reproduction can occur, transforming and being transformed by everything from social values to economic structures in the process. Yet, over the past four-and-a-half decades, the actual or potential role of technology in reproduction has rapidly expanded. The birth of Louise Brown in 1978 through in vitro fertilization (IVF) catalyzed the clinical application of assisted reproductive technologies (ARTs) around the world as well as ethical and policy debates around their use. Incremental innovation in ART methods now occurs continuously, aiming to increase the success rates of pregnancy and live births through established fertility treatments. However, more radical or ‘seismic’ innovations in ARTs have also occurred since the turn of the millennium, making novel reproductive options possible with corresponding policy implications.
These advanced ART techniques move beyond IVF and related methods by manipulating gametes, embryos, or even somatic cells at the organelle, genomic, or gene expression levels, ultimately producing a viable embryo biologically related to the intended parents. Advanced ART techniques began to arise over two decades ago with reproductive cloning and ooplasmic transfer, although the controversies they provoked resulted in legislative and regulatory actions to block their use in many jurisdictions. Unlike earlier advanced ARTs, which lack direct health benefits for the resulting children, newer advanced ARTs promise significant benefits to at least a small number of families who otherwise would be unable to have a healthy, biologically related child. Such techniques, including mitochondrial replacement therapies (MRTs) and heritable human genome editing (HHGE), have not yet achieved widespread use. Yet, the healthy births of multiple children from MRTs across a handful of jurisdictions and a single use of HHGE yielding three children in China foreshadows a coming time where the technologies may become more widely adopted.
In this article, we trace how multiple states have already used available regulatory systems to steer the use of, or prohibit, certain advanced ART techniques. Scholars have already begun to make comparisons of several states’ approaches to one type of advanced technique, MRTs, addressing the matters of how jurisdictions conceptualize and categorize the technology or whether states have or will enact novel regulatory regimes. This article takes a different approach by comparing oversight responses to both MRTs and HHGE that are grounded in existing rules and regulatory authorities (rather than novel frameworks) and examining the type of regulatory regime applied in each case, assuming that the regulation of one form of advanced ART will undoubtedly inform decision-making around others. By focusing on how jurisdictions can use existing oversight mechanisms, conceptualized here through the lens of inherited regulation, we aim to illustrate how these advanced ARTs are not truly ‘unregulated’ and explore the normative dimensions of wielding inherited regulation in this space. As global debates continue over how states and the international community should respond to MRT and HHGE, comparative analysis and a recognition that advanced ARTs can trigger inherited regulatory regimes may offer insights relevant to policymakers and stakeholders more broadly.
In this article, we find evidence of jurisdictions taking multiple different approaches to using existing regulatory structures and instruments to manage advanced ARTs, and we argue that effectively using these regimes will require policymakers to thoughtfully, and incrementally, tailor their requirements to advanced ARTs. For some jurisdictions, this will require coordinating multiple inherited regimes, potentially at multiple levels of government. Section II provides an overview of two nascent advanced ARTs, which have already seen clinical use, before Section III introduces the theoretical framework of inherited regulation. Five case studies of inherited regulatory interventions on advanced ARTs are presented in Section IV, followed by a comparison and discussion of these cases in Section V. Concluding thoughts and implications for policy strategies around advanced ARTs and inherited regulation are set out in Section VI.
