What Is the Embryo's Special Status in Law?

The third session of the 2024 PET (Progress Educational Trust) Annual Conference – '40 Years after the Warnock Report: What Is the Embryo's Special Status?' – was chaired by Professor Emily Jackson, professor of law at the London School of Economics and Political Science.

Sponsored by Burgess Mee, this session – 'What Is the Embryo's Special Status in Law?' – focused on human embryos from a legal perspective, with a panel comprising leading experts who were well-placed to answer this question from several perspectives and across numerous jurisdictions.

First to speak was Peter Thompson, chief executive of the Human Fertilisation and Embryology Authority (HFEA). He argued during his presentation, 'The Embryo and the Regulator: Where Do We Go From Here?', that the defining feature of an embryo deserving special attention is its potential to develop into a person. Nonetheless, the legal definition of the embryo is vague. Regulation was intended to be all-encompassing – permissive, robust and allowing tightly regulated research. However, scientific developments – including stem cell-based embryo model (SCBEMs) and in vitro gametogenesis – have pushed the boundaries of what is possible, creating a mismatch between science and law and raising the need to consider regulatory reform.

The 14-day limit on culturing human embryos in the laboratory is currently under scrutiny. Thompson announced at the conference the HFEA has recommended extending the limit to 28 days, to allow research that could improve our understanding of embryo development (see BioNews 1268). The UK has been a thought leader in embryo research, he said, and must once more lead the way.

The second presentation – 'Defining the Embryo: Do We Need a More Meaningful Legal Definition?' – was given by Julian Hitchcock, consultant at Biolawgy. Hitchcock was a member of the Working Group that produced the SCBEM Code of Practice, published jointly by PET and Cambridge Reproduction (see BioNews 1234, 1246 and 1258).

Hitchcock explained how, under the original version of the Human Fertilisation and Embryology Act, embryos were defined as products of fertilisation. Following legal challenges brought in the wake of cell nuclear replacement, this was amended to mean live human embryos, irrespective of the means of production.

Meanwhile, under UK patent law, an embryo was at one point defined as an entity that commences the process of human development. This definition was challenged in relation to its applicability to parthenotes, leading to clarification that commencement assumes an inherent capacity to develop into a human being.

Hitchcock also discussed definitions of an embryo in Australia and Germany, as well as a recent, scientifically informed attempt to 'propose a refined legal definition of an embryo'. He concluded that although the UK's current legal definition 'embryo means a live human embryo' may seem unhelpfully circular, it actually has much to recommend it.

The third presentation – 'Regulating Moral Intuitions: Reflections on the 'Special Status' of the Embryo in Law' – was given by James Lawford Davies, partner at LDMH Partners.

He said that the Warnock Report afforded the embryo some measure of respect, but this was not absolute, and was weighed against the benefits of research. This resulted in the recommendation that the embryo ought to have some protection in law, leading to the 14-day limit and other restrictions. In both the Warnock report and the Parliamentary debates that followed, there was a heavy focus on the use of embryos in research.

Lawford Davies argued that the 'special status' afforded to the human embryo in and after the Warnock Report is somewhat nebulous – for example, there is no actual 'special status clause' in the legislation. The courts have held that some related materials (specifically sperm) are capable of being owned in very limited circumstances, but legislation on human embryos does not adopt a property model. To do so, Lawford Davies said, would be in tension with consent and raises questions about the sale of gametes. He also pointed out there is dissonance between the special status of the embryos and the requirement to dispose of embryos once a legal limit on storage has been reached.

The final presentation offered a perspective from outside the UK. 'Embryos and Legal Gymnastics: A German Tale of Rules, Red Tape and Tiny Troubles' was presented by Dr Verena Nordhoff, senior clinical embryologist at the University of Münster's Centre of Reproductive Medicine and Andrology, Germany.

Dr Nordhoff explained that in Germany, embryos are protected under legislation, with criminal sanctions of a fine or imprisonment. This means it is difficult to dispose of embryos, which are stored even when patients do not want them anymore. Preimplantation genetic testing and research using human embryos are generally forbidden, but there are important (if complex) exceptions. Dr Nordhoff highlighted the problems that can result from overly restrictive legal definitions – the lesson to take away was 'don't do it like the Germans', Dr Nordhoff said.

A question and answer session followed, with all four speakers returning to the stage. The audience's questions included whether an extension to the 14-day rule could lead to requests beyond 28 days in the future, and whether a quasi-property model of the embryo would work in regulation. Thompson was sceptical of slippery slope arguments, saying these often become a pretext for doing nothing. The Parliament of the day makes a decision, he said, and if it should make a different decision in 20 years' time then that is democracy in action. Society should be allowed to reach a view that is appropriate at the time.

On the quasi-property model, Lawford Davies said that given the state of UK law, it would be difficult to adopt this model now. However, where there are patients who wish to use embryos but are being compelled to dispose of them, then a different model might be an appropriate way to avoid them having to resort to court.

Overall, the session highlighted how defining an embryo in law depends not only on making scientific, ethical and social judgments on the value that should be afforded to human embryos, but also involves policy decisions on what is most appropriate in relation to research and treatment. As Lawford Davies said, the embryo is neither a person nor property, but rather is something different altogether. How we choose to define this unique entity has significant implications for all involved.

PET would like to thank the sponsor of this session (Burgess Mee) and the other sponsors of its conference (the Anne McLaren Memorial Trust Fund, the British Fertility Society, the European Society of Human Reproduction and Embryology, Born Donor Bank, Merck, Ovoria Egg Bank, Theramex, TMRW Life Sciences and the Institute of Medical Ethics).