Governance and law reform proposals for stem-cell-based embryo models

Stem-cell-based embryo models (SCBEMs) should be distinguished explicitly from human embryos in UK law, according to a UK bioethics organisation.

SCBEMs are structures cultured in laboratory conditions, that mimic aspects or replicate features of early embryonic development. They are created entirely from stem cells, rather than from eggs and sperm. A review by Nuffield Council on Bioethics (NCOB), London, has recommended an amendment of the Human Fertilisation and Embryology Act to exclude SCBEMs from the legal definition of human embryo.

Professor Stephen Wilkinson, Lancaster University distinguished professor of bioethics and a member of the NCOB working group that conducted the review, said: 'Clear and informed debate about the ethical and regulatory status of these entities and the ways in which they might be used is vitally important for policymakers, the scientific community, and the public.'

There are many different varieties of SCBEM, some of which resemble aspects of the post-implantation human embryo (see BioNews 1259, 1234, 1229, 1221 and 1124). Research using SCBEMs could provide insights into early pregnancy loss, which could in turn pave the way for new approaches that improve IVF outcomes.

However, there are ethical questions concerning how far SCBEMs should be developed in culture, and how similar to actual human embryos SCBEMs might eventually become (see BioNews 1194). SCBEMs are not regulated in the same way as human embryos, which cannot be cultured for longer than 14 days from fertilisation (see BioNews 1213, 1152 and 885).

The NCOB review endorses, and builds upon, governance proposals set out earlier this year in the SCBEM Code of Practice (see BioNews 1246a and 1246b). The SCBEM Code of Practice was published jointly by Cambridge Reproduction (an interdisciplinary research centre at the University of Cambridge) and PET (the Progress Educational Trust, publisher of BioNews) and was informed by a public dialogue exploring the views and concerns of the lay public regarding SCBEMs (see BioNews 1234).

NCOB recommends a phased approach, focusing in the short term on embedding the SCBEM Code of Practice, including that document's prohibition on the transfer of a human SCBEM into the uterus of a human or animal. NCOB also recommends establishing new governance structures proposed in the SCBEM Code of Practice, including an Oversight Committee and a Register for research involving SCBEMs. NCOB recommends law reform in the longer term, and envisages a regime in which SCBEMs would continue to be regulated separately from human embryos, even if SCBEMs were to become so similar to embryos that the two things could not be easily distinguished.

'We are delighted that the new review from NCOB takes account of our public dialogue and supports our Code of Practice – not just in terms of endorsing those parts of the Code that can be complied with now, but also supporting our ongoing work to establish an Oversight Committee and Register for SCBEM research,' said Sandy Starr, deputy director of PET and project consultant for the SCBEM Code of Practice. 'We shall, of course, consider NCOB's longer-term recommendations carefully, but our immediate priority is to establish the governance structures proposed in our Code of Practice. This will be done in such a way to provide public reassurance that research is being conducted responsibly.'

Danielle Hamm, director of NCOB, said on the BBC Radio 4 Today programme that 'there is an opportunity here for the UK government to work with the sector to set a precedent that could be very influential, globally'.

The NCOB recommendations and the SCBEM Code of Practice will be discussed in presentations at the 2024 PET Annual Conference – 40 Years after the Warnock Report: What Is the Embryo's Special Status? – in central London this coming Wednesday (4 December 2024).

Conference registration will close shortly. Find out more, and register to attend, here.