Rewriting the Rules: Is it Time to Simplify Fertility and Embryo Law?

In the 32 years since the Human Fertilisation and Embryology Act 1990 was passed, the world, and our society, have changed immensely. PET's event 'Rewriting the Rules: Is it Time to Simplify Fertility and Embryo Law' on 5 October 2022 asked whether the legislation which regulates IVF and fertility treatment is still fit for purpose, and how this legislation might be improved.

The first speaker to unpick the titular question was Professor Alison Murdoch, president of the British Fertility Society. She outlined how the Human Fertility Embryology Authority (HFEA) was established, and its role defined, by the Human Fertilisation and Embryology Act 1990 (updated by the Human Fertilisation and Embryology Act 2008).

She sketched out the rules that fertility clinics must navigate, including the legislation itself plus the HFEA Code of Practice, as well as guidance from learned societies and professional bodies, such as the Royal Colleges. As part of this, she explained why some areas of regulation need to be more flexible to accommodate individual patient needs and keep up with changes in technology, whereas other areas require fixed regulation, such as requirements for record-keeping.

Professor Murdoch outlined sections of the Code which appeared vague or at odds with other legislation. Part of the Act refers to keeping information about the development of embryos and the provision of services under review. However, this is nonspecific and gives unlimited scope for data collection, which does not seem to be consistent with the Data Protection Act. The Act also states it should give advice to recipients, but in practice, advice must be individually tailored.

The Code of Practice also repeats and references guidelines produced elsewhere. The repetition is inefficient, and requires the HFEA to keep these guidelines under constant review. Professional guidelines can evolve based on academic study and society's views, and what was considered appropriate in 1990 may need to be removed today to benefit patient care.

For these reasons, Professor Murdoch suggested that the HFEA should continue to uphold the strictest and most specific parts of the law, but that areas requiring flexibility and discretion (such as where standards like 'proper' or 'suitable' are used in the legislation) should be determined by the relevant professional societies instead.

The second speaker was Dr Ippokratis Sarris, director of King's Fertility, London, who started by explaining how commonplace fertility treatment has become. There are now more than 60,000 IVF cycles a year, resulting in just under three percent of babies born in the UK.

His presentation focused on consent. Fertility medicine involves more levels of consent, from more different people, than other areas of medicine.

Over 50 separate consent forms must be completed to comply with licence conditions, and in addition, fertility centres today have their own specific tailored consent forms. By Dr Sarris' calculation, a straightforward IVF cycle requires the patient to read 42 pages of HFEA consent forms, then there are another 44 pages of in-house forms to satisfy inspectors.

Despite all this paperwork, the HFE Act does not distinguish between consent to medical treatment and consent to parental responsibility. This can lead to problems, because the question of who can and will be recognised as a legal parent is part of a highly complex field of law, and clinics do not have the appropriate expertise to give advice on this.

Dr Sarris recommended that there should be a clear distinction between consent for medical treatment, consent for storage of gametes, and consent for parental responsibility. He also added that using multiple separate consent forms is needlessly conflicting and confusing, and there should be a single form signed by both members of a couple.

The third speaker was Emily Jackson, professor of law at the London School of Economics, who also picked up on issues concerning legal parenthood.

Most children born following IVF are conceived with the gametes of the intended parents, and so parentage is relatively unproblematic. Issues arise, she said, when donor gametes are used.

The parentage provisions in the HFEA Acts are among the most complex and confusing aspects of the statute, not least because there are two sets of rules. The 1990 Act sets out the parentage of children born between 1991 and 2009, while the 2008 Act sets out the rules which apply to children born after 2009.

Professor Jackson gave a quick outline of the many different scenarios the legislation is intended to provide for: a mother who is married or in a civil partnership with a man; a mother who is unmarried but wants a man to be the legal father of her child; a mother who is married or in a civil partnership with a woman; a mother who is unmarried but wants a woman to be the legal parent of her child.

These rules are based on the idea of legitimacy within marriage, which is considered outdated today. The definition of a 'mother' in the law also struggles to accommodate scenarios such as trans men who have been able to give birth, or same-sex female couples where one woman is a child's genetic mother while the other woman is the child's gestational mother.

The more complex the rules, the more paperwork is required, and the greater the likelihood of human or administrative error. This results in families having to go to court when mistakes cast doubt over the legal parenthood of children.

The plea here for reform of the act is simplification, said Professor Jackson. She argued that the key factor defining whether a person is or can be a legal parent should be that person's intention, rather than consent, a term which (as Dr Sarris had already observed) gets muddled with medical treatment.

Stuart Lavery, divisional clinical director of Women's Health at University College London Hospitals, took aim at a single issue – the 'Person Responsible' (PR) for a fertility clinic.

A key requirement under the 1990 act is each clinic must have a single named person, with overall responsibility for compliance with law, data collection, and health and safety. No distribution or delegation of these responsibilities is possible, and failings can result in criminal liability.

Lavery said he did not know of any other branch of medicine in the UK or reproductive services around the world that placed the same weight of responsibility on one person. Now that IVF is part of mainstream medical treatment, this fact should be reflected in the way it is regulated.

The PR model was designed when clinics were much smaller, and it was easier to understand who should lead them. Now, 60 percent of IVF provision in the private sector is by clinics which form part of larger groups or chains. We need to move from individual responsibility to corporate responsibility, said Lavery, both in the private sector and within the NHS.

Members of the audience who asked questions noted the difficulty of linking valuable data on assisted conception with later health outcomes, since the Act currently impedes the release of the relevant data.

Further examples were also given of incompatibilities between legal parenthood and practical reality. For example, if a stored embryo is used to conceive a child after a couple has separated, the law does not currently allow one half of the couple to transition to a legal status of gamete donor rather than parent.

The panel agreed that although revision of the Act would take a long time and we are still in the earliest stages, interested parties need to start making the case for change. Now is the time to collect evidence of problems with the current legislation, and propose solutions.

PET is grateful to the British Fertility Society and CooperSurgical for supporting this event.

The next free-to-attend online event from PET is taking place this coming Wednesday (12 October), and is entitled 'From AI to CRISPR: How Should Emerging Reproductive Technologies Be Regulated?'.

Find out more and register here.