This chapter considers the legacy of the 1984 Warnock Report, and its continued impact on the regulation of assisted conception, embryo research and surrogacy in the UK. On the one hand, it is extraordinary that a regulatory system grounded in recommendations made only six years after the birth of the first ‘test tube baby’ has stood the test of time so well. The HFEA regulatory model – in which an ‘arm’s-length body’ issues licences, backed up by criminal sanctions, and in which primary legislation is supplemented by regularly updated codes of practice – has proved remarkably resilient, and has since been used to regulate other areas of medical practice. On the other hand, there may be disadvantages in trying to regulate a twenty-first-century industry using tools that were designed for a very different age. The chapter looks at two developments that the Warnock Report did not anticipate and hence did not make provision for in its recommendations: the emergence of a lucrative market in fertility services; and the increasing acceptance that fertility treatment should be available to would-be parents who do not conform with the ‘two-parent family, with both father and mother’ model.

Our account of moral status embraces equal consequentialist consideration for all sentient beings while ascribing the stronger protection of rights to those with narrative capacity. Individuals with the capacity to have narrative self-conceptions or identities have full-strength rights, while individuals with nontrivial temporal self-awareness that falls short of narrative capacity have partial-strength rights. This account of moral status is neutral with respect to species, which means that membership in Homo sapiens is neither necessary nor sufficient for moral status or rights. The final three sections explore ethical implications for research involving human embryos, rodents, and great apes. We defend a very liberal position with respect to embryo research, a relatively restrictive approach to rodent research (granting equal consequentialist consideration to rodents’ interests while permitting their use on utilitarian grounds), and a prohibition of invasive, nontherapeutic research involving great apes.

When the use of embryos in vitro for research was regulated under the Human Fertilisation and Embryology Act 1990 (as amended), regulators tried to navigate the various thresholds that occur in embryonic and research processes through providing clear-cut boundaries – the most well-known of these being the 14-day rule. This chapter offers an examination of this rule as a contemporary example of an existing mechanism in health research that is being pushed to its scientific limits.  This steadfast legal boundary, faced by a relatively novel challenge, requires reflection on appropriate regulatory responses to embryo research, including the revisitation of ethical concerns, and an examination of the acceptability of carrying out research on embryos for longer than 14 days ? I argue that recognising the inherent link between processes and the regulation of the margins of human life, enables us to ask us to ask more nuanced questions about what we want for future frameworks, for example, ‘when is human?’, one that legal discussion often shies away from. Instead I will argue that viewing regulation of embryo research as instance of both processual regulation and regulating for process has the potential to disrupt existing regulatory paradigms in embryo research, and enable us to think about how we can, or perhaps whether we should, implement lasting frameworks in this field.

This chapter considers how a liminal lens help inform contemporary discussions surrounding embryos in vitro and beyond using three case studies: 1) the 14-day rule, 2) in vitro gametogenesis, and 3) ectogenesis. The first case study is important as it is the principal manifestation of law’s attempt to reflect ‘special status’ on the embryo, and because it is also an example of legal attempts to deal with embryonic processes. This example is used to examine what the context-based approach developed in this book could bring to contemporary debate about the nature of such a rule, as well as its retention, reduction, or extinction. The second example enables us to consider what the analysis offered in this book says about these relatively new technologies in relation to their regulation, and the key biological and legal thresholds involved. The final case study focuses specifically on partial ectogenesis, a technology which not only introduces new thresholds, but leads us to question our existing understanding of meaningful legal thresholds, most notably birth as the moment in which the foetus/baby attains personhood. By these means, the analysis engages with the entire trajectory of embryonic development as this is driven by scientific possibilities, both current and near future.

In this introduction, McMillan introduces key concepts and definition discussed throughout the book, including: liminality, ‘the embryo’, process, and ‘legal status’. The regulation of emerging technologies may be described as the governance of processes in persistent flux, and in some cases, it is the regulation of what we do not yet know or fully understand. Reconciling process with progress, therefore, has not been easy. Nonetheless, the regulation of the embryo in vitro, and all the practices that law currently allows are, in essence, regulating for processes of change. Considering that it has been over 30 years since the 1990 Act was passed in its original form, is it time to legally reconceive ‘the embryo’? In this book McMillan calls for, and considers, the basis for a more coherent and robust intellectual defence of the ways in which we justify the different manners in which law treats different types of embryos created purposively towards different ends. The main questions that this analysis seeks to answer are the following: Overall, does law reflect and embody processual regulation, if so, what does this look like? And if not, what form could it take if reform were thought to be desirable?

The analysis in this chapter emphasises that there can only ever be two places that law, in its present state, can lead embryos to: a woman’s womb, or its own destruction and disposal. Ultimately, this chapter has been developed with a view to answering: how might we use a liminal lens to bring lessons from ‘the gothic’, from conceptualisation to realisation? This chapter addresses the latter in four sections. First, it briefly takes stock of the analysis and ‘lessons’ highlighted by the book so far, before going on to synthesise this analysis, and in doing so, considering the ways in which law can lead embryos out of liminality. Second, it focuses on the roles of persons in embryonic processes in vitro; and Third, it draws out the contours of a context-based approach, including what the approach is not; Finally, it, discusses the potential effects of a context-based approach for the issues (i.e. the contours of the ‘legal gap’) discussed in Part One of this book. It suggests that a context-based approach has the potential to justify affording embryos in vitro different ‘statuses’ depending on the relationally guided and defined pathway on which it is, or onto which it is put.

This analysis traces the history of the 1990 Act (as amended) and summarises the present regulatory framework governing the embryo in vitro with reference to its legal ‘special status’. It briefly summarises some of the key arguments put forward in the Warnock Report relating to the moral and legal status of the embryo in vitro and the enactment of these arguments in law, including subsequent amendments of the framework. The Chapter finds that, like its historical counterparts, embryonic, moral, scientific, and other forms of process were important considerations for the Report, which provided the intellectual basis for the 1990 Act.

This book, concerned with the regulation of human embryos in vitro, and their use for reproduction and research, has explored the ways in which law does, and can regulate processually. As we have seen, the 1990 Act is static and unchanging with respect to the moral status of ‘the embryo’, yet our societal understandings and perceptions of embryos are not. The 1990 Act is, as we have seen, permanently liminal. A ‘gothic’ framing of embryos and the use of a liminal lens have each revealed a key facet of embryo regulation. All of the practices that law currently allows are regulating for: uncertainty, process, and change. Here, the truism coined by Thomassen that ‘liminality is’ has been explored and unpacked with reference what this means for embryos that are subject to our legal architecture. The reality of liminality still has much to say about the way we regulate in vitro embryos. This book has provided the reader with ways to think about the ways we navigate law, and processes governed by law into, through and out of liminality in ways that bring greater insights into the sensitive enterprise of regulating for uncertainty, when our focus of attention is an entity as fluid and remarkable as the human embryo.

Chapter 4 examines the case of the EU controversy on the funding of embryo research,arguing that the mobilisation of ethics experts allowed policymakers to successfully bypass the conflict which had surfaced in the field. The mobilisation of the EGE facilitated the technicalisation of discussions on embryo research, by shifting the debate away from ‘either-or’ positions and presenting a range of intermediary scenarios. The EGE acted as a locus for the elaboration of a workable policy solution, in a context in which no agreement could be reached in the political arena. The position of ethics experts could then be invoked by policymakers in order to back their own position. The European Commission was able to mobilise expert bioethicists to such avail because policymakers and experts worked together in various crossing points and developed a similar approach to the issue. Experts also calibrated the knowledge they produced, in order to make policy possible. When the debate reopened ahead of the adoption of FP7, EU policymakers carefully orchestrated theknowledge production process by strictly delineatingthe question experts were asked.

Australia was at the cutting edge in the development of Artificial Reproductive Technology in the 1960s and 1970s. Regulatory responses were piecemeal: only a small number of the six states and two territories enacted legislation. The regulatory response to reproductive cloning and embryonic stem cell research has been more uniform, with nationally consistent legislation in the form of the Prohibition of Human Cloning for Reproduction Act 2002 and the Research Involving Human Embryos Act 2002, together with the Gene Technology Act 2000. This regulatory regime creates a prohibitory environment for germline genome therapy in Australia and provides little scope for genome editing research involving human embryos, even under licence. This chapter discusses the Australian regulatory regime, with particular focus on this triad of legislative instruments. Although Australia has made a commitment to science and health, and recognition of the right to found a family, the special status of the embryo is a paramount consideration. This chapter concludes that, as in many other countries, Australia is at a crossroads, and Australians must decide, collectively, how far genome editing research involving human embryos should be allowed to progress.

Belgium regulates research on human embryos, including germline modification, mainly through the 2003 Law regarding Research on Embryos In Vitro and the 2007 Law regarding Medically Assisted Reproduction and the Disposition of Embryos and Gametes. It allows the creation of embryos for research when the research goal cannot be reached by research on supernumerary embryos. The lawmaker only recognizes a gradual difference between embryos created for reproduction and later used for research and embryos specifically created for research purposes. The general rule in research is that no research can be performed for eugenic goals, i.e., selection or improvement of non-pathological characteristics of the human species. Everything that is not prohibited by the law is allowed. The conclusion, supported by the parliamentary debate, is that germline genome editing is permitted for corrective purposes (meaning elimination or correction of genetic diseases), if approval of the local ethics committee and the Federal Commission on scientific research on embryos in vitro is obtained.