Your Chance for Change: Shaping the UK's Fertility and Embryo Law

The latest public event from PET focused on the current Human Fertilisation and Embryology Authority (HFEA) consultation on the main UK law governing fertility treatment and embryo research (the Human Fertilisation and Embryology Acts 1990 and 2008).

Sarah Norcross, director of PET, opened with a reflection on what had been achieved – from early campaigns against proposals to ban IVF and human embryo research, leading to lobbying for regulation (and the formation of the Progress campaign, the precursor of PET) – culminating in the 1990 Act. Setting the scene, she explained that the last major update in law was the Human Fertilisation and Embryology Act 2008, and that now there are many respects in which the law fails to meet the needs of patients, practitioners, researchers, regulators and others.

First to speak was Peter Thompson, chief executive of the HFEA, who gave a whistlestop overview of the consultation, titled 'Modernising the regulation of fertility treatment and research involving human embryos'. The time is ripe for change, he said, because since 1990 we have seen significant changes in the fertility sector, society, science, patient expectations, attitudes and more, yet the law has not kept pace. Further, potential new developments on the horizon could bring new issues to which the existing legislation cannot adequately respond.

He explained that the consultation is structured around four themes:

• Patient safety and promoting good practice.
• Access to donor information.
• Consent.
• Scientific developments

And he provided some detail on what the consultation asks in each of these areas. Modernising the law, he said, will have benefits for patients, who should be at the heart of reforms, with treatments being safe, evidence based and of high standards. There are also proposed benefits to clinics, eg, longer times between inspections and quicker/smoother appeals processes, and to donors, recipients and donor-conceived individuals, as well as to researchers.

Overall, he explained that the idea behind the consultation is for the HFEA to get a sense of public consensus on the themes and 'to start a conversation'. However, he cautioned that even though the HFEA plans to make recommendations to government in the summer, realistically, Parliament is unlikely to consider changing the law until after the next general election.

The second speaker was Venessa Smith, quality manager for the Assisted Conception Unit at Guy's Hospital, London. Her presentation covered the consultation's section on 'patient safety and promoting good practice', and how this might impact clinical practice. She pointed out that while there have been some amendments to the legislation – eg, greater recognition for same-sex parenting – there has been limited change in relation to patient safety.

Commenting on the HFEA's proposal that new legislation should explicitly reference patient safety, and that the Authority should have greater powers to take 'proportionate action' in respect of this, Smith asked how this would actually change current practice. She explained that HFEA inspections seem already to have turned towards a focus on high quality care and patient safety, and patient feedback and the 'patient experience' is heavily featured.

Furthermore, she said, there are already sanctions that the HFEA can impose if it decides that a clinic is not fulfilling its obligations in this respect. In addition, clinic staff work within their own professional guidelines, adhere to the Code of Practice, and have opportunities to inform the HFEA if they think there is something wrong. So, she posed the question: what will the HFEA's recommendations do to improve this?

She finished using the example of the single embryo transfer policy following the 'One at a Time' campaign (launched in 2007), describing this as a 'collaborative' project between the HFEA and clinics to reduce multiple births. Using the HFEA's own graph illustrating the campaign's success, she asked whether it would be more appropriate, in terms of 'patient safety', to focus on such collaborative goals in the future rather than legislative change.

Dr Rachel Gregoire, scientific director of the Hewitt Fertility Centre, Liverpool, spoke next, discussing proposed changes relating to donor conception. She reminded us that these are some of the most sensitive and contested issues discussed in the consultation, and that patients, donors and donor-conceived people will have mixed and wide-ranging views, with the impact of potential change felt differently in different family circumstances.

She also explained that when the Act was originally passed, there was a presumption that anonymous donation was best. Attitudes have changed over time, and the law does not yet fully reflect this. Following on, she described how social media and the emergence of commercial/consumer DNA testing have given people different routes to discover donor relatives. Particularly in a context where births from donation tripled between 2006 and 2019, donation raises questions about parental choice and informed decisionmaking. She said that the HFEA's recommendations seek to provide patients and donors with options that recognise this changed landscape.

That said, Dr Gregoire urged consultation respondents to look carefully at the exact wording of each question, consider the implications of their answers, and also ask themselves why those questions are being asked. She gave as an example the statement in the consultation that 'Clinics should be required by law to inform donors and recipients of the potential for donor identity to be discovered through DNA testing websites'. Given that this is already in guidance and should be considered good practice, what is the reason for seeking to enshrine it in law?

Similarly, in relation to the 'opt in/out' of early identity release (along the way she asked 'What does "early" mean?'), she cautioned that this may be putting adults' needs before the needs of children, potentially creating a two-tier system where some donor offspring have more rights than others. Given the rigid nature of the multiple-choice questions in the consultation, she encouraged respondents to the consultation to make good use of the questions at the end of each section that allow for a free text response.

The fourth speaker, Dr Kay Elder, is senior research scientist at Bourn Hall Fertility Clinic, Cambridge – the birthplace of IVF, and one of the few clinics that provides embryos for research. She spoke about patients donating unused embryos for use in research, and how this process could be improved. As she explained, 'research is the bedrock for the development of new techniques in fertility' and 'without donation, some of the treatments we take for granted today wouldn't even exist'.

Current law requires that consent to donate embryos for research must be specific to the research project in which the embryos will be used. This is already limiting, but if for some reason that project doesn't go ahead, precious embryos can be wasted. Dr Elder explained that despite a 2016 HFEA survey finding that 58 percent of patients would prefer to donate embryos to research than discard them, this is often easier said than done, given the bureaucratic and other barriers that exist (including the fact that many prospective donors will have had successful treatment and therefore will have young families to prioritise).

For an embryo to be donated, both gamete providers must give consent. Where a gamete donor has been used this makes obtaining consent difficult if not impossible, and introduces ethical difficulties in relation to contacting past donors.

Dr Elder concluded that requiring specific consent from gamete donors is both impractical and irrational, especially as it leads to many embryos that could be used in research being allowed to perish, and she questioned whether this requirement is necessary. Furthermore, she argued, the need to consent to a specific research project - rather than being able to give more generic consent - should be reconsidered. Summarising, her final recommendation was that 'the process of donating embryos to research needs to be simplified/streamlined', or even centralised in the form a research embryo bank.

Solicitor James Lawford Davies spoke last. He asked whether IVF should still be regulated so differently from other medical treatments, now that it is no longer experimental, and is routinely provided by clinics. He said that it is unusual to find another area of medicine so heavily regulated. He also highlighted the high number of criminal offences that attach to the regulation, and said that the question missing from the HFEA's consultation was: 'Why are we regulating this treatment area so tightly? What justifies it?'

Following on from this, Lawford Davies argued that better regulatory tools already exist to tackle poor patient care. He pointed out that the HFEA was not an expert body and was, in fact, always intended to have a lay majority, a lay chair and a lay deputy. There is no requirement for experts in the sector to be on the HFEA or to sit its licence committee. Given this, he argued, allowing the Authority wider powers against clinics gives rise to concern, especially when the relevant remit – in terms of poor practice in patient care – is already covered by other regulatory bodies (such as the General Medical Council, Care Quality Commission, Competition and Markets Authority and Advertising Standards Agency). Overall, he argued, the consultation should be looking at relaxation of regulation, rather than expansion.

Following the lively Q&A session, the take-home message from the evening was that the HFEA's public consultation is an opportunity to review the complicated and outdated law on fertility treatment and embryo research, and to prioritise recommendations for change. Everyone with an interest in this area – whether because of lived experience, clinical experience, academic or professional interes,t or any other reason – should consider submitting their own responses. It is, as the title of the event suggested, your chance for change. The consultation closes at 5pm on 14 April 2023, and can be accessed here.

PET is grateful to Merck for supporting this event.

The next free-to-attend online event from PET will be Surrogacy Law: What Is Intended… For Parents? For Surrogates? For Children?, taking place on Wednesday 19 April 2023.

Find out more and register here.