Where Do We Go Next? The Case for Change

Law reform is in the pipeline – in the UK and elsewhere – in relation to fertility treatment, embryo research, surrogacy, and related areas of science and medicine, making the second session of the PET (Progress Educational Trust) 2023 Annual Conference second timely and important.

The session began with Julia Chain, chair of the Human Fertilisation and Embryology Authority (HFEA), speaking on 'The HFEA's Law Reform Proposals: Regulating for the Future' (her presentation is available in full online). Linking back to the first session (see BioNews 1219), she explained that the HFE Act was the first of its kind globally and that she is proud of the UK as a world leader in this area. However, she cautioned, science, medicine and attitudes have moved on 'in leaps and bounds' since the law was first passed in 1990. For that reason, the HFEA has now published new proposals to update the legislation, focusing on key areas where 'there is more to do' and seeking to 'future-proof' it (see BioNews 1216).

She also explained how the context of the regulation has changed since its inception, including a nine-fold increase in patients. Over half of these patients access treatment at private clinics, which are often part of large clinic groups funded by private equity, rather than clinician-led as they were at their inception. Technical changes, such as the move of some aspects of patient care online, also do not match the original model of law which is focused on the regulation of large, licensed premises. The HFEA's 15 proposals cover four areas – patient protection, access to donor information, consent, and scientific developments.

Chain went on to say that the move towards private treatment means fertility patients are now consumers. HFEA proposals therefore include extended regulatory powers to promote patient safety, such as greater latitude to impose financial penalties on clinics. By contrast, she said, the most compliant clinics could enjoy a lighter regulatory burden, perhaps with less frequent inspections.

She noted that recommendations on access to donor information, where it is proposed that the donor's identity will be released from birth, have gained the most media attention. She explained that things have changed since the legislation was first passed, when there was a presumption of anonymity. The move to identity release donation in 2005 makes 2023 a 'landmark year', as it marks the first time when some donor-conceived individuals will be old enough to ask for that information. Not only has understanding of the importance of children knowing their genetic origin from an early age changed, but direct-to-consumer genetic testing means that anonymity can no longer be guaranteed, even if desired. She acknowledged that the recommendation would be a 'significant departure from current practice' but that this needs to be balanced against 'what is taking place on the ground in reality'.

Consent to treatment, as well as consent to donation of embryos to research and to embryo banking, are also the subject of proposed reforms. Even though fertility consents are more complex than some other medical consents, because additional persons are involved, nonetheless she said it could be 'simpler than at present'.

In terms of scientific developments, it was noted that some research – for example, involving in vitro-derived gametes and stem-cell based embryo models – is developing at pace. It is there important that the legislation is 'future-proofed', to avoid the whole Act needing to be reopened each time a new technique comes around. Additionally, she acknowledged that there needs to be debate around the '14-day rule' for embryo research.

Following on, Ephia Yasmin, secretary elect of the British Fertility Society asked: 'Patients, Practitioners and Fertility Law: What Change Is Needed?'. Yasmin began by arguing that it is actually 'a privilege' to be regulated, because it means that patients feel safe and practitioners feel empowered. However, she argued that the Act does not always serve patients well. As one example, she mentioned donation of embryos for use in treatment. When donation is to a couple, they become the legal parents according to the law. But if an embryo is donated to a single woman, the law is not clear on the status of the male gamete provider, and the best advice clinicians can give is to seek legal advice. She said this was not good enough. Another example she gave was child and adolescent patients, in relation to fertility preservation. The HFEA Code of Practice Code of Practice does not really acknowledge these patients in its wording, she said, and clinicians have had to adapt by using general medical principles such as 'Gillick competence' when providing services.

Yasmin explained that change in the fertility sector has always been rapid, but that this has been especially noticeable in recent years, with changes in how people understand families and the different technologies available. She said consent rules needed to be aligned with working practice, and that e-consenting in particular must be thought about. We must learn from history she said, giving the example of gamete storage, and not constrain ourselves with law.

Dr Rachel Gregoire, deputy chair of the Association of Reproductive and Clinical Scientists, next presented on 'Donation Law Reform: Less Is More'. She explained that she was pleased to see the HFEA's proposals to release the identity of donors at birth, and the other proposals that 'naturally follow'.

Dr Gregoire also explained why she was glad there had been no recommendation of an opt in/out, where donors and/or parents could decide what information was disclosed and when. This, she said, would have meant that some donor-conceived people would have known more than others, when it was not them who had consented to treatment using donor gametes in the first place. Fewer restrictions on access to identifying information means more equitable choices available to the donor-conceived.

But she said, 'Let's go further!', arguing that what is missing from the HFEA recommendations is a proposal to set a global limit for the number of families that can be created from a donor recruited and/or used in the UK. In relation to the current ten-family limit (within the UK), she said that 'We're not very good at this', and we have a social and moral obligation to consider the impact on donor-conceived individuals.

Finally, Dr Peter Rugg-Gunn – scientific lead at the Human Developmental Biology Initiative (HBDI) – led us through 'Future Opportunities for Human Embryo Research'. He started from the premise that research matters, because it creates benefits for patients by advancing treatment success rates and safety, and providing new treatment options. Right now, he said, was an exciting time to be working in this area, especially because of recent advances in human embryo research which are opening up new opportunities.

Nevertheless, there are key open questions in embryo research. How are early cell lineages specified? How can advanced imaging and AI tools be used to better predict treatment success? How are epigenetic patterns established? What are the effects of environmental signals? How does the embryo implant and interact with the endometrium? Furthermore, there are ways that research can be supported to deliver new benefits to patients – for example, by removing impediments so as to enable more patients to donate embryos to research. He said that an agile regulatory framework would be welcomed, and argued that the 14-day rule should be reviewed now rather than later.

Using excellent graphics to show the stages of embryo development (up to day 35), Dr Rugg-Gunn went on to explain what we could learn, and might be able to fix, if we were permitted to culture embryos beyond 14 days. He said that a recent public dialogue project involving HBDI indicated substantial public support for embryo research (see BioNews 1213). Most participants supported some extension of the 14-day limit, as long as the research continues to be robustly regulated. Concluding, he said that the dialogue highlighted the need for national conversations on reviewing and changing the 14-day rule, informed by greater transparency and public awareness of human embryo research. The first step, he said, should be to conduct wider-ranging work seeking the views of other groups in society.

After the talks, there was lively discussion with input from the audience. There was a particular focus on setting boundaries within families in response to increased access to donor information, what sort of counselling should be offered and who should provide it, what additional protections fertility patients need if they are generally to be considered 'consumers', and how best to engage people in debates about early embryo research.

PET would like to thank the sponsors of this session (the Edwards and Steptoe Research Trust Fund) and the other sponsors of its conference (the Anne McLaren Memorial Trust Fund, ESHRE, Hertility, Born Donor Bank, Carrot Fertility, Ferring Pharmaceuticals, Merck, Theramex, the Association of Reproductive and Clinical Scientists, and the Institute of Medical Ethics.).

Register now for PET's next free-to-attend event, Fertility Treatment for Single People: Who Should Pay?, taking place in Edinburgh on Wednesday 10 January 2024.