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.

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?

We have seen thus far that the intellectual underpinning of the 1990 Act (as amended) - the embryo’s rather vague ‘special status’ - has not changed since the Act’s inception. Moreover, we have seen that any attempts change the intellectual basis of the Act, for example the 2008 Act, have been cautious at best. Thus, as a way of mapping the landscape to date, and also of clearing a path towards novel approaches to regulating the embryo, this chapter undertakes two important tasks: (1) an academic analysis of the caution mentioned above - a fade from discourse - which has only intensified the confusion surrounding the ‘special’ legal status of the embryo; and (2) an exploration of some of the ways in which the unclear nature, source, and extent of the legal status of the embryo could be clarified by exploring two key normative legal tools that are often employed to provide certainty: binding objects within a regulatory space, and drawing boundaries. Ultimately, this chapter posits that the root of the vague nature of the embryo’s ‘special status’ is a prevailing uncertainty regarding how we ought to treat embryos in vitro, because, by its very nature, it does not easily fit into normative social, moral or legal categories.

This chapter examines the regulatory framework governing the use of human embryos and gametes in treatment and research in the United Kingdom.This framework, overseen by the Human Fertilisation and Embryology Authority (HFEA), permits the use of germline genome modification in human embryos for specific research purposes, but it does not currently allow such modified embryos to be used in treatment.The chapter goes on to consider how germline genome modification may become a licensable treatment in the future, building on the recent experience of regulating research into mitochondrial donation and its clinical application in the United Kingdom.The legal and ethical challenges raised against the use of mitochondrial donation (and likely to be raised against the clinical use of germline genome modification) are also considered, including concerns arising out of EU legislation.