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Consultation on the Reform of the Human Fertilisation & Embryology Act Regulating Scientific Advance

This HFEA consultation, launched on Tuesday, is important not only for IVF clinics, but to all those working in the fields of embryological, developmental and reproductive science. It concerns the reform of the Human Fertilisation & Embryology Act 1990 to reflect changes in, among other things, advances in science, the social understanding of those advances, and modern attitudes.  A revision to the Act is likely to affect research into areas such as artificial gametogenesis, gonadal organoids, the use of embryo-like "stembryos" and the study of peri- and post- implantation stage human embryos. It will also affect the regulation of heritable genome editing, should the current prohibition be modified to permit such interventions in certain circumstances.

A key challenge in updating the Act is to improve regulatory responsiveness. The current law does not easily keep up with the rate of discovery, technical advance or public appreciation of new developments. Indeed, it even applies the brakes. The present Act requires that even technical matters which are devolved to a statutory instrument must be approved by both Houses of Parliament. In effect, a new Act of Parliament is required merely to add a new permitted procedure of mitochondrial transfer, thereby impeding public access to more effective procedures for the prevention of serious inherited mitochondrial disease.  Indeed, just such a technique was known about when Parliament debated mitochondrial donation in 2015. Unfortunately, because it did not find its way onto the draft legislation, it was not debated, so now remains prohibited until approved by MPs and peers. That takes time. For example, the last time the 1990 Act was updated was in 2008, a period during which Jupiter completed one and a half orbits.  Another majestic Jovian year later, during which so much has changed in the minds and laboratories of the pale blue dot, nothing has changed.  It's not just that the Act needs to be updated.  Of course it does.  It needs to be able to keep updating.  But how?

Suppose that the Act were updated to spell out exactly how we should regulate, say, the clinical use of organoid-derived sperm. Suppose also that two techniques were presented to Parliament that scientific and clinical authority held to be safe and effective. If Parliament were to approve these procedures, but provided that any new technique would require further, full Parliamentary debate, patients would be denied access until a slot could be found in the Parliamentary calendar. Setting science in regulatory concrete is an inherently bad idea. Flexibility is imperative.

There should be nothing exceptional about the regulatory mechanisms applicable to emerging embryological, developmental or reproductive science. In fields such as the law of medicinal products or in vitro diagnostic medical devices, Parliament is never called upon to debate whether product X is efficacious or product Y is sufficiently accurate. Such technical matters are, of course, devolved by Parliament to authorities of sufficient technical competence, such as the MHRA. Would it not be preferable for new mitochondrial transfer procedures to be rendered permissible by a competent authority delegated for the purpose?

But not all decisions in emerging reproductive biomedicine are technical.  Should we permit a limited degree of human genome editing? Should researchers be able to undertake licensed research on human embryos at the stage during and after which, in nature, implantation would take place? Or, to take up the example above, never mind how we might regulate the clinical use of organoid-derived sperm: should such use be allowed at all?

In finding a way to regulate such technologies, we have to distinguish the clinical from the non-clinical, and technical assessment from policy approval. We have to consider how to delegate legislative power relating to each of these areas so as to maximise access to emerging scientific knowledge and technological capacity, with proper regard to ethical concerns (and perhaps a statutory list of considerations to be taken into account) and so as to maintain public confidence.

Consider the question, "should we permit hereditable genome editing?"  Plainly has two components.  No-one wants to unleash technologies that cause harm to children who may be born as a result of an editing intervention (or their descendants), so we can say with confidence that no such use should be permitted unless it is technically approved. Equally, we may wave aside arguments that merely declare the unreliability of all such interventions as a reason for continued prohibition, because we can easily provide a technical quality assessment barrier, as we do for medicines and medical devices. The second component of the question is the one I raised before: whether (even if it were safe) it should be allowed at all.   These are serious questions of public policy, which demand a democratic mandate. Opinion polls suggest a strong level of support for making limited genome editing lawful. They also show support for extending the period for which human embryos may be cultivated in vitro. Currently, this ends just as the tiny cell ball is about to fold itself inwards to form the three embryonic layers, thereby precluding study of the stages of development at which most miscarriages take place: those before and shortly after implantation. But opinion polls don't cut the mustard. No legislative response would command respect if it hadn't successfully run the gauntlet of Parliamentary debate. However, if it succeeds in doing so, the governance of these areas should be facilitative: capable of accommodating and responding to scientific and technical advances, while ensuring that ethical oversight and approval is appropriate and (NB) timely.

Afterword.  Should the public interest in research be brought to the fore?

I will write more on the reform of the Act in due course.  For the present, however, I would ask you to pull focus on the research that makes any innovation possible. No-one is at clinical risk, so no technical or clinical assessment is required for projects involving human gametes and embryos. However, the benefits of such research provide incalculable human, and calculable financial, benefits. The social and economic value of this research is too easily neglected, and it may be argued that the Act itself neglects it too.  Most strikingly, researchers need access to human embryos while IVF patients, feeling the full emotional impact of embryo research, want to provide researchers with their unused embryos. Yet, despite this clear public interest, the effect of the Act currently is that the vast majority of surplus embryos are destroyed. This is an immense waste of human resource, made to no-one's advantage but those who do not have to store them for research purposes. Should the Act now recognise the public interest in supplying surplus embryos for research?

The consultation closes at 5pm on 14th April 2023.

See also An adaptive act: How should human fertilisation and embryology legislation respond to scientific and technological change? 

Setting science in regulatory concrete is an inherently bad idea. Flexibility is imperative.


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