What Is the Embryo's Special Status in Ethics?

The fourth and final session of the 2024 PET (Progress Educational Trust) Annual Conference – '40 Years after the Warnock Report: What Is the Embryo's Special Status?' was sponsored by the European Society of Human Reproduction and Embryology (ESHRE), whose chair Professor Karen Sermon also acted as session chair.

Tackling ethical aspects of the status of the human embryo, the session revisited several themes that had emerged throughout the day, including an earlier session where Professor Sermon gave her own presentation (see BioNews 1268).

This time, the opening presentation – 'Donating Embryos to Others: The Ethical Challenges' – was given by Lucy Frith, professor of bioethics and health research at the University of Manchester's Centre for Social Ethics and Policy. Professor Lucy Frith is also a member of ESHRE's executive committee and ethics committee.

Several presentations earlier in the day had discussed the difficulties faced by patients who wish to donate unused IVF embryos to research. Here, however, Professor Frith discussed what happens when patients wish to donate embryos to others for use in treatment. This is comparatively rare in the UK, but seems to be increasing.

Figures from the Human Fertilisation and Embryology Authority (HFEA) show fewer than 50 births from embryo donation in 2010 and more than 200 by 2019. However, these figures incorporate 'double donation' births – where embryos are created from donor eggs and donor sperm, rather than being donated after their creation – and so the exact figures are unclear.

Either way, there is clear demand for double/embryo donation. With an estimated 130,000 human embryos stored in the UK having been allowed to perish since 1991, and another 500,000 embryos estimated to be in storage at present, if even a tiny fraction of the latter were to be donated then this would increase availability significantly. However, Professor Frith reported that there are reportedly few donor embryos available.

Professor Frith looked at different models for embryo donation, comparing the merits of using a similar system to gamete donation with the 'conditional embryo adoption' models seen in countries such as New Zealand, where the patients who created the embryos can vet and choose recipients. In some US models, there is also contact between the donor(s) and resulting child. Professor Frith argued that reproductive donation of unused embryos is a legitimate way to respect the special status of these embryos.

The second presentation – 'Changing Public Perceptions of Embryo Research' – was delivered by Sarah Franklin, professor of sociology and director of the Reproductive Sociology Research Group at the University of Cambridge.

We heard about the attitudes to IVF and embryo research that prevailed when the Committee of Inquiry into Human Fertilisation and Embryology (commonly known as the Warnock Committee) convened. Documents by show that as of November 1983, the Committee had received eight letters supporting IVF compared to 284 opposing embryo research, and a further 123 opposing embryo research, IVF and surrogacy.

Professor Franklin explained how the committee devised common-sense 'Warnockian' principles to navigate this controversial territory. Key to these were the ideas that people will have strong and differing views about human embryos (which should be respected), there will never be total agreement of the ethical status of the embryo (so compromise is the only option), and some regulation is better than none.

Professor Franklin also shared a quote from a Committee member – the late Professor Dame Anne McLaren – who said: 'If IVF and embryo research are clearly explained to the public, sensibly regulated, they will develop further, and most people will be convinced of their value and importance to society.' This proved to be true, and the 'Warnock Consensus' of clear regulation with public consultation enabled IVF and related innovations to become widely accepted.

The final two presentations both focused on stem-cell-based embryo models (SCBEMs), which had been discussed multiple times throughout the day. SCBEMs are not created from eggs and sperm, and are not (directly) regulated by the Human Fertilisation and Embryology Act. However, as methods for creating SCBEMs become more sophisticated, it has become necessary to consider how to govern related research and whether there could ever be circumstances in which human SCBEMs might be considered equivalent to embryos.

The third presentation – 'Futureproofing the Regulation of SCBEMs' – was presented by Emma Cave, professor of healthcare law at Durham University, who chaired the Working Group on SCBEMs at the Nuffield Council on Bioethics.

The content of Professor Cave's presentation was hot off the press, as this Working Group had published its report 'Human Stem-Cell-Based Embryo Models: A Review of Ethical and Governance Questions' just the previous week (see BioNews 1267a and 1267b). The report recommends that human SCBEM research should be regulated separately from human embryo research, and that SCBEM regulation in UK should be introduced in stages.

Stage 1 would embed the Code of Practice for the Generation and Use of Human Stem Cell-Based Embryo Models (SCBEM Code of Practice), published jointly by PET and Cambridge Reproduction earlier in the year (see BioNews 1246) as part of a 'soft law governance'. Stage 2 would involve a 'regulatory sandbox', where different approaches would be evaluated. Stage 3 would fix a type of regulatory control (which might involve licensing or certification) via legislation.

Although the Nuffield report is generally supportive of the SCBEM Code of Practice, one area of difference is whether SCBEMs should ever be viewed as human embryos. The Code of Practice says: 'Were it ever considered, as a matter of best scientific judgment, that a SCBEM very likely has the potential to develop fully within a human host, it would no longer be appropriate to refer to it as a "model"; rather, it should then be viewed as an "embryo", and would be governed as such.'

The Nuffield Working Group was not satisfied that it would be sufficiently clear when a SCBEM has acquired this potential, especially as it would be unethical (and prohibited by the SCBEM Code of Practice) to transfer a human SCBEM into a womb to gestate. As such, the Nuffield report argues that SCBEMs should remain under bespoke regulation even if such a point should be reached, while emphasising that this regulation will not necessarily be more lax than regulation concerning actual human embryos.

The last presentation – 'Do Stem-Cell-Based Embryo Models Have a Special Status?' – came from PET's own deputy director Sandy Starr, who was project consultant for the SCBEM Code of Practice (see BioNews 1234).

Starr examined the wording employed by the orginal Warnock Report when it first introduces the concept of the 'special status', and also considered Mary Warnock's introduction to the book version of the Warnock Report, which was entitled A Question of Life and was published the year after the report proper. In light of these, Starr suggested that the key question is not whether SCBEMs have a special status, but rather whether they ought to have such a status.

He concluded that the answer is relative. Compared to certain other human biological materials – unexceptional cells, tissues or stem cell lines – the answer is 'perhaps'. Compared to the established special status of human embryos, the answer is 'no' – unless and until certain SCBEMs are so sophisticated, that it becomes debatable whether they should be considered 'models' at all.

After the presentations, there were plenty of questions from the audience. Some questions concerned embryo donation, including the screening of donors and whether receiving couples could select embryos. If donors are able to select their recipients, does this constitute discrimination?

Many of the questions concerned SCBEMs, and their difference from (or similarity to) embryos. One questioner asked 'if it quacks like a duck' – if they become difficult to distinguish – will it be possible to maintain public confidence, while regulating them differently? Another contributor opined that the relevant question is not how similar SCBEMs are to embryos, but whether they are deserving of moral value in their own right.

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