The question of what is a 'permitted embryo' under the legislation governing assisted reproduction in the UK has received increasing scrutiny as technological progress challenges the concept of embryohood. As illustrated at Progress Educational Trust (PET)'s event, 'Fertility Frontiers: What Is a 'Permitted' Embryo in Law?', the answer is not solely concerned with the scope of what is permissible in assisted reproduction but goes to the very core of the UK's legislative approach to emerging reproductive technologies.
Introducing the debate, Sarah Norcross, director of PET, highlighted that while UK fertility law gives confidence and security during scientific change, the definition of an embryo, introduced under the Human Fertilisation and Embryology (HFE) Act 2008, is not fully scientifically aligned. Under the HFE Act 2008, an embryo for use in assisted reproduction must have been created by the fertilisation of an unaltered 'permitted egg' with a 'permitted sperm'. It must have no cells added to it from other sources or have its DNA altered (an exception exists for mitochondrial donation). Recent technological developments have, however, challenged this legal construct, giving rise to questions such as: Should artificially-created sperm qualify? Is there a use for genome editing tools? Should in vivo technologies be included under the legislation?
Now that the Human Fertilisation and Embryology Authority (HFEA) has been tasked by Government to advise what changes should be made, if any, to the HFE Act, there is, said Norcross, a 'once in a generation opportunity to revise and modernise the legislation'. To address these questions, PET is holding a series of events considering what changes should be considered; and the topic for the speakers at this event was whether the concept of the 'permitted embryo' should remain and, if so, should it be changed?
The first speaker was Nick Hopwood, professor of history of science and medicine at the University of Cambridge. Professor Hopwood started by explaining that the term 'permitted embryo' is a relatively new construction. The original HFE Act 1990 did not use the word and it was not until the HFE Act 2008, once it had become apparent that embryos had become the object of greater technical and social innovation, that the term was invented. The phrase emerged when it became necessary to distinguish between those embryos permitted for use in reproduction and those permitted for use in research. In this way, perhaps testament to the underpinning progressive nature of the legislation, Professor Hopwood explained how the 'permitted embryo' allowed research on non-permitted embryos.
Next to speak was Professor Robin Lovell-Badge, chair of trustees at PET and group leader in stem cell biology and developmental genetics at the Francis Crick Institute, London. Professor Lovell-Badge outlined the developments challenging the construction of the permitted embryo, including in vitro derived gametes. Progress in this area has been rapid, Professor Lovell-Badge said, and researchers are expected to succeed in producing human in vitro derived gametes soon. Such technologies present further opportunities for people to have genetically related children, but fall outside the legal definition of a 'permitted egg' or 'permitted sperm' (meaning that any embryos created from them fall outside the definition of a 'permitted embryo'), and their use in reproduction is therefore currently prohibited. Even with heritable genome editing or stem cell-based embryo models, where methods are not yet safe enough to be applied to human reproduction, you just never know what's around the corner, said Professor Lovell-Badge.
The need for 'future-proofing' in legislation was further illustrated by Mary Herbert, professor of reproductive biology at Newcastle University. Professor Herbert outlined the recent developments around mitochondrial replacement techniques. She said there are now additional possibilities to increase the efficiency and efficacy of mitochondrial replacement. Some of these possibilities were envisaged before the legislative changes to allow mitochondrial donation, but were not accounted for in the text to allow their permissibility once developed, showing how quickly even seemingly progressive legislation can become out of date.
The final speaker was Julian Hitchcock, solicitor and of counsel at Bristows, London. He commented that in 2008 Parliament was thinking ahead to the future when it made provisions to allow the Secretary of State to extend the definition of a 'permitted embryo' to allow for techniques to prevent mitochondrial disease. Since the purpose of such provisions was to remove serious disease, argued Hitchcock, it may continue to be possible to amend the HFE Act in a relatively straightforward manner to prevent heritable transmission of serious disease. Furthermore, it may be possible to come up with a threshold for 'serious diseases' in a similar fashion to how the HFEA current approaches PGT-M. Fundamentally, Hitchcock pointed out, to be democratically legitimate the law should reflect social attitudes and respect technological progress.
The questions that followed sought to examine the boundaries of what is considered an embryo. For example, when is it possible to know if a technique is sufficiently safe to go from the dish to the clinic? The law refers to placing an embryo in a 'woman' – what about people with womb transplants? How does the law account for changing gender norms? How (if at all) does the development of artificial womb technology need to be considered in revising the definition of 'permitted embryos'?
The panel were finally asked what changes to the HFE Act they would like to see. Professor Herbert wanted to see legislation operate on general principles, rather than strict specific definitions, and to use an approval body to determine what techniques are allowed. Professor Hopwood likewise agreed that specific technical points do not necessarily need high-level political input. In broad agreement was Professor Lovell-Badge, saying that it was nonsense to regulate technique or process, as change is so rapid. Much better to regulate the purpose or the outcome, he said. Finally, Hitchcock advocated a more responsive legal framework, but one which would be trusted and includes a degree of transparency. With reform on the agenda, it's likely that such questions will receive much consideration going forward. This debate helped illustrate the pace of scientific progress in reproductive technologies, and showed that progressive legislation can benefit from both forward thinking and clever drafting.
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