Radio Review: Revisiting the 14-Day Rule

Since the Human Fertilisation and Embryology Act 1990 was passed, it has been a criminal offence to keep human embryos alive in the laboratory for more than 14 days. Recent scientific advances, however, have reopened the debate, with suggestions that the time limit should be increased to 28 days.

Over the course of two programmes Matthew Hill explores the evolution of IVF, the origins of the 14 day rule and the new research that has led to a push for an extension to the time limit. Hill speaks to many of the key players involved in the story, including pioneering researchers, legislators and members of the public who have received IVF treatment.

During the first programme, Hill provides a comprehensive background to IVF and embryology research. He chats to Louise Brown, the first 'test tube' baby, and discusses the positive and negative reactions that her parents received. The extent of this achievement is documented by Professor Simon Fishel, who worked with Professor Robert Edwards, pioneer of the first successful IVF treatment. Professor Fishel describes the challenges faced in translating work in animal models to humans and just how extensive was the understanding required before eggs could be successfully collected and fertilised in the lab.

Early on, when the success rate for IVF was just 10 percent, there was scope for the remaining embryos to be used in research to help in the development of the IVF technique. The objections raised at the time to IVF and embryology research make for fascinating listening, given how IVF is now accepted as part of everyday life. Hill interviews Baroness Mary Warnock, who was put in charge of a committee to investigate – and advise how to regulate – the future of IVF and embryo research. The committee report advised that experimentation on embryos should not extend beyond 14 days, and in fact it would be a criminal offence to do so. Warnock considered 14 days an appropriate time limit, well before earliest beginnings of the nervous system and sensory organs.

The Bill was passed, but regulation was not enforced until 1991, during which time there was much public debate. Juliet Tizzard, Head of Strategy of the (Human Fertilisation and Embryology Authority (HFEA) believes that this 'breathing space' allowed progress to be made in terms of greater acceptance by the public of the the idea that IVF and embryology research are both ethical and beneficial.

The second programme discusses the recent scientific advances in embryology that have led to the current debate over extending the 14-day rule. Professor Magdalena Zernicka-Goetz at Cambridge University has shown that it is possible to culture embryos for 12–13 days in an environment that mimics the womb. As she explains to Hill in an informative description of embryo development during this vital period, this is particularly important, as it is at this point that the embryo moves on to the next stage of development. Cells begin to develop a form and structure, and can accordingly provide further insight into IVF, miscarriage, human health and disease.

Professor Fishel, whose patients donated embryos for use in Professor Zernicka-Goetz's research, says that this new development has great potential for understanding both normal and abnormal function. However, Baroness Warnock says caution should be exercised, giving the public time to understand the implications of extending the research limit. Otherwise, she says, there is a risk not only that the extension will not be granted, but that the whole of embryo research could be put in jeopardy.

A recent YouGov poll of the UK public showed that of 1,740 people asked, 48 percent were in favour of increasing the limit to 28 days (see BioNews 885). However, there is a real sense of potential opposition to the extension, even in these very early stages. Professor David Jones of the Anscombe Bioethics Centre discusses both his opposition to an extension of the rule, and the fact that he would prefer an outright ban. But Professor Fishel believes that a majority of the public will eventually favour the extension.

In December 2016, the Progress Educational Trust (PET) held a conference on the topic, and a recent workshop at the Nuffield Council on Bioethics highlighted many of the issues that need to be addressed before any progress can be made towards legislation. However, Professor Zernicka-Goetz says that now her protocols are publicly available, there is increasing urgency to deal with this issue to ensure that embryo research is not carried out in areas without regulation.

The HFEA could lead a consultation, if required, involving expert opinions in addition to wide-ranging public debate - the regulator performed a similar role in relation to mitochondrial donation. PET has recently submitted a proposal to the Science and Technology Committee of the House of Commons, proposing a new Parliamentary inquiry into the 14-day rule. Whatever the outcome, extension of the 14-day rule is likely to be a lengthy process.

The two-part programme provides a fascinating insight into the debate that could rage in the coming months and years. Matthew Hill adroitly places this debate in the context of 25–30 years ago, when the first legislation on the 14-day rule came into force, and the advances of science in the meantime. He also highlights how important progress in this field has been, both for those who are unable to have children naturally and for our understanding of heritable conditions.

Through discussions with key players in the IVF story, Hill provides real insight into how the field has grown scientifically, ethically and legally within the realm of the general public. For those not familiar with the IVF/embryology research story, or keen to understand more about the upcoming debates, this two-part programme is a must.