HFEA Chief Executive, Peter Thompson, on the special status of the embryo, 40 years after the Warnock Report

The Embryo and the Regulator: Where do we go from here?

It was the Warnock Report that gave the human embryo a ‘special status’. But in an important sense Warnock was only giving a name to what was understood by society more generally. The defining feature of the human embryo is that it has the potential to become a person. And for that reason, Warnock thought it was deserving of a degree of protection which no other human cells warranted.

Of course, not all embryos have the potential to develop successfully. Time lapse photography has demonstrated to all of us what only embryologists once saw: that the embryo can change radically in the first days of development. We also know that many ‘good’ embryos fail to implant. So, we have a regulatory regime where every embryo counts and, in turn, must be accounted for.

My aim today is to give a brief account from the regulator’s perspective of the human embryo in UK law and to look ahead to the ways in which scientific development is pushing against the boundaries of what is allowed.

It goes without saying that any decision to change the law is a matter for government and Parliament. But as the expert regulatory body in the UK, the HFEA equally has a duty to provide advice on such questions.

The embryo in UK law

Although the HFE Act closely follows the outlines of the Warnock Report, the Act doesn’t use the phrase ‘special status’. Nonetheless, the human embryo is at the very core of the Act - it appears roughly 300 times!

• The Act offers a definition of the embryo in law - though it is vague and now arguably inadequate.
• The Act sets out the circumstances in which the embryo can be lawfully created and the circumstances by which its creation would be unlawful.
• The Act sets out the length of time an embryo can be stored for.
• The Act sets out the purposes for which an embryo can be tested – for the avoidance of serious inherited illness.
• And the Act sets out the uses to which research on the embryo can be undertaken and the period for which that research can take place – up to 14 days or the appearance of the primitive streak.

The statutory framework for the embryo is also reflected in HFEA regulatory tools; not just inspection and licensing, but also consent, patient information, data collection and research.

Most of those essential statutory building blocks remain as they were first introduced in 1990. But aspects of the legal framework have developed as new science allowed or social views changed.

Some of these developments seemed initially promising but have turned out to be scientific ‘dead ends’ – the Parliamentary time spent on so-called ‘admixed’ or hybrid embryos in 2008 has not been repaid by scientific promise.

Other developments have fared better.

• It is, for example, now possible to store embryos for far longer than originally allowed – up to a maximum of 55 years.
• And following regulations in 2015 it is now possible to alter an embryo for the purpose of avoiding the transmission of serious inherited mitochondrial diseases.

Taken together, the UK statutory framework governing the embryo was intended to be all encompassing. It has proved to be both permissive and robust, and flexible - to a degree. Warnock’s essential bargain that scientists and clinicians could undertake their work so long as it was tightly regulated remains intact and widely supported.

Pushing against the boundaries

However, in recent years several scientific developments have begun to push against the boundaries of the Act.

The fact that something is scientifically possible is not of course a sufficient reason to change the law - questions of ethics and public acceptably also apply - but it does require us to ask the question: should the law be changed?

That is why when the HFEA published its proposals for law reform in November last year, one of our key themes focused on improving the HFEA’s ability to handle rapidly changing scientific developments. And as many of you will know, we do think that the mismatch between the demands of science and the law means that the regulatory framework would benefit from greater flexibility.

In recent months we have begun to look in more detail at three issues: in vitro- derived gametes, stem cell-based embryo models, and the so-called 14-day rule on embryo research.

Let me briefly consider each in turn.

In vitro-derived gametes are some years off, but their potential is considerable. This could be a genuinely disruptive technology. If safe and acceptable, IVGs could allow the infertile to have a genetically related child and remove the need for donated gametes and embryos. At present, the law in the UK prohibits the use of in vitro-derived gametes in treatment as it requires that eggs or sperm permitted for treatment are ‘produced by or extracted from the ovaries of a woman / testes of a man’.

Stem cell-based embryo models are not currently explicitly regulated by the HFE Act and the concern is their very ‘embryo-like’ qualities. Just how like an embryo would they need to be to warrant some kind of regulatory oversight? Recent developments in stem-cell based embryo models have attracted considerable media coverage and the UK SCBEM Code of Practice published earlier this year provides a welcome and proportionate starting point to govern the creation and use of such models.

The Nuffield Council on Bioethics has recently added its voice with an ethical and governance review of SCBEM research published last week. It concluded that a phased approach, that moved from ‘soft’ governance in the short term to ‘hard’ law in the medium term, would strike the right balance of encouraging innovation, respecting ethical boundaries and delivering public benefit. That ‘hard’ law could take a variety of forms, and it need not replicate the way in which the law currently treats bone fide human embryos.

The HFEA’s Scientific and Clinical Advances Advisory Committee recently considered IVGs and SCBEMs and our Board will discuss the arguments for and against some form of regulatory oversight in the new year.

The HFEA Board considered the case for extending the 14-day limit on embryo research at its meeting in November, following a discussion by SCAAC. The papers are available on our website, as usual, and the minutes will be available in due course. YouTube recording is available on our website.

Unlike IVGs and SCBEMs the arguments for and against the 14-day rule are well known.

There remain some who are opposed to any embryo research and would therefore be opposed to any extension. Others accept the current settlement but think the time is not right, believing that more research should be undertaken on the period up to 14 days before any extension is considered.

The Authority acknowledged those arguments but concluded that on balance, looking at the scientific and ethical issues in the round, there was a case for recommending to the government that the limit on embryo research should be extended.

• The Authority took the view that while there was more research to do up to 14 days, it was not necessary to exhaust all possible research avenues as research after 14 days would lead to different insights - an understanding of early embryo development in the ‘black box’ period, which could, for example, identify early pregnancy problems or improve our understanding of how congenital diseases start to develop. The hope of course is that such discoveries would in turn lead to new treatment options.
• The Authority also took the view that research post 14-days was consistent with the ‘special status’ of the embryo and that as embryo research was lawful it was ethical to extract the maximum research value out of every precious embryo.
• The Authority was also mindful of evidence of public opinion which suggests that a majority are supportive of an extension provided it continues to be robustly regulated.

In reaching its decision, the Authority also agreed that the principle of an upper time limit on embryo research remained important and that there were good arguments to suggest that research should be allowed up to 28 days. This echoes the findings of the other international bodies, most notably the Heath Council of the Netherlands in its 2023 report.

However, the Authority took the view that unlike the current regime, should embryo research be allowed from 14 to 28 days, it should take place on a case-by-case basis, requiring each research application to make the case to an HFEA licence committee as to why it was necessary to culture embryos to x days. The general principle should be that embryos are cultured for the shortest period of time to achieve the desired research outcome.

Conclusion

What happens next? We will continue to make the case for law reform, including these latest Authority recommendations, but this is only the next step on what could be a long process of reform. At the risk of repetition this is a decision for the government and ultimately Parliament. There will no doubt be other contributions to the debate along the way. The UK has long been a thought leader in the regulation of fertility services and human embryo research and our bio-science sector is one of the growth sectors identified in the recent Invest 2035 White Paper. There is much to be gained in the UK showing once more that it can lead the way.