In February 2023, the Human Fertilisation and Embryology Authority (HFEA), the UK government fertility regulator, launched a public consultation on "Modernising the regulation of fertility treatment and research involving human embryos”. The consultation document included questions about the regulation of new scientific developments, and explicitly named stem cell-based embryo models (SCBEMs) as one of these developments.
The G-SCBEM Working Group submitted a collective response to this consultation on 13 April 2023. We had two principal aims:
- To ask the HFEA – in the advice on law reform that it submits to the UK Government following its consultation, and also in its work more generally – to take account of our project, noting that we are developing a recommended governance framework for research involving SCBEMs.
- Make four broad preliminary recommendations for the HFEA to consider when making its recommendation to government:
- Future policy around research involving SCBEMs should take care not to contradict the ISSCR Guidelines (2021).
- Future policy in this area should, where possible, follow the definitions and terminological recommendations in the ISSCR Guidelines (2021).
- Policymakers in this area should keep open the possibility that a revised HFE Act could refer to SCBEMs in its wording, for the purpose of clarifying that SCBEMs are excluded from the categories of materials to which the legislation applies (and thus from the remit of the HFEA).
- If laws and regulations are changed to permit (or facilitate the permitting of) novel reproductive technologies, it should be kept in mind that SCBEMs – while potentially very useful for testing reproductive technologies prior to clinical use – are not themselves likely to become a candidate reproductive technology for direct clinical use in the near future.
Further detail about these recommendations and our rationale for making them is given in the document below.
