Keeping pace with science and ethics – how IVF legislation tells the story of a legal system giving chase

On 25 July 1978 at Oldham General Hospital, a baby girl was born by caesarean section, weighing 5lbs, 12 ounces. Her parents, Lesley and John Brown, named her Louise. This was a normal birth, on a normal day, in a normal hospital on the outskirts of Manchester. However, even before Louise drew her first breath, she had cemented her place in history. On 10 November 1977, Lesley Brown had undergone a procedure whereby a fertilized ovum (zygote) was transferred into her uterus in the hopes it would establish a successful pregnancy. When Louise Brown was born, she became the first ever human to be born after conception by in vitro fertilisation (IVF).

The invention of IVF gave hope to millions of people desperate to have their own children. But it had been a long, heart-breaking path requiring the input of many scientists to get to that day in July 1978. Buoyed by the research of others, a British biologist, Robert Edwards, was determined to find out if it was possible to take a human egg, fertilise it with sperm outside of the body, and then implant this in the womb to create a viable pregnancy. In 1969, he was able to fertilise a human egg in a test tube for the first time. Frustratingly, this did not develop beyond single cell division. He suspected that eggs would need to mature further in the ovaries prior to being harvested, so began working with gynaecologist Patrick Steptoe and embryologist and nurse Jean Purdy. Together, the team developed the technique that led to modern IVF.

The process was not without its setbacks. Even before Louise was born, the team’s research was seen as controversial, causing moral consternation among religious leaders, ethicists and scientists who called for the project to be cancelled. Initial reaction after Louise’s birth was positive, with excited news headlines announcing the birth of ‘Superbabe’ ‘lovely Louise’. However, many others were concerned that the march of human innovation had strayed too far into the realms of ‘playing God’. Steptoe’s comment that ‘we’ve created a baby’ only helped to fan the flames of growing opposition.

Faced with the difficulty of balancing a medical advancement that could help millions and deeply held ethical concerns, the government stepped in and created the Warnock Committee, also known as the Committee of Inquiry into Human Fertilisation and Embryology. Chaired by moral philosopher Mary Warnock, the purpose of the committee was to advise ministers as to whether IVF should be allowed, and, if so, how it was to be regulated. The composition of the Warnock Committee was symptomatic of a growing movement towards providing greater accountability to the public by instructing members of autonomous professions - such as philosophers, lawyers and theologians - to advise on ethical concerns. Indeed, the appointment of an ‘outside chair’ for the Committee was championed by lawyer Ian Kennedy ^[1].

Aided by fellow Committee member Anne McLaren, a distinguished embryologist, the Committee developed the concept of ‘the 14-day limit’. This was seen as the latest period that embryos could be allowed to grow in a laboratory. Any longer than 14 days, and the first vestiges of a central nervous system begin to develop. Prior to this, the embryo cannot feel pain or pleasure in the way that we understand feeling. This was a certain and simple cut off point that had medical backing but could also be used to inform legislature.

Despite some members of the Committee remaining of the view that IVF should not be allowed to progress, their report was published in 1984 setting out their recommendations. One of these recommendations was the establishment of an authority to monitor all IVF births, whether through private providers or the NHS, to ensure that legislation was followed. Despite some continuing opposition from religious communities, the report ultimately led to the Human Fertilisation and Embryology Act 1990 (the 1990 Act), which permitted IVF and experiments on embryos for the first 14 days after fertilisation.

The 1990 Act made provision for the creation of the world’s first fertility regulator, the Human Fertilisation and Embryology Authority. Their role is to regulate fertility clinics, provide impartial information to those who need it, and to take enforcement action should a clinic fall below the standards required. They are an arm’s length body of the Department of Health, meaning that, although they work on behalf of the Government, they are independent.

As the technology behind IVF developed, so did the need to tackle new ethical issues. In 1993, the HFEA conducted a public consultation as to whether sex selection for non-medical purposes should be allowed. The consultation found public opinion was against this practice and non-medical sex selection was banned under HFEA guidance. ^[2] However, in the mid-1990s, a technique for increasing the chance of conceiving a child of a preferred sex was developed in the US. This did not involve the storage or creation of an embryo and so it fell outside of the HFEA’s remit. This legal loophole provided private, non-licensed clinics in the UK the ability to offer this technique for choosing a child’s sex. In October 2002, the HFEA therefore launched a second public consultation on sex selection and these new techniques. This second report, published in November 2003, confirmed the status quo, with HFEA making it clear that sex-selection for non-medical reasons should continue to be prohibited.

In 2005, the law changed to allow all donor conceived individuals (DCIs) who were conceived using a donor registered after 1 April 2005 to find out the identity of their donor upon turning 18. Prior to this, all donations were anonymous, although the HFEA was required by law to maintain a register of all licensed treatments, which included donations, since 1991. From October 2023, the first DCIs who were eligible to find out the identity of their donor began turning 18. However, should donors not keep their contact details up to date, either deliberately of accidentally, then there is little that the HFEA can do from a legal perspective to assist those wishing to identify their donor.

Over the last fifteen years, the law regarding fertility treatment has also developed to improve access to treatment for more individuals. In November 2008, the Human Fertilisation and Embryology Act 2008 (the 2008 Act) received royal assent, which ultimately allowed both partners in a same-sex couple and unmarried couples to be legal parents, without one parent having to legally adopt the child to achieve the same outcome. However, with these changes came a complex regime for consenting to legal parentage which could - and still does – allow for mistakes. The consequences of not properly dealing with legal parenthood are serious and can lead to someone maintaining legal parentage when this was not the intended outcome.

Continuing this improvement in access to treatment, in May 2024 the Government announced that the 1990 Act would be amended to allow same sex couples with non-transmissible HIV to undertake IVF in UK licensed clinics, and donate eggs or sperm to a known recipient. Medical advancements had shown this was safe, in circumstances where:

• The donor has a sustained, undetected viral load;
• They have received antiretroviral treatment for at least six months prior to donation; and
• The recipient is aware of their HIV diagnosis.

The need for female same sex couples to undergo expensive screening for various health conditions prior to receiving reciprocal IVF was also removed. ^[3] As this screening could cost upwards of £1,000, this dramatically increased the accessibility of this form of treatment to many women who had previously been unable to afford the screening. Heterosexual couples were not required to obtain these tests. These developments in the law are seen as a huge step forwards for HIV and LGBTQ+ rights, and further highlight the need for the law to continue to keep pace with scientific and ethical developments in the area of IVF treatment.

Although the law dealing with IVF treatment has been gradually updated over the years, the original 1990 Act is now over 30 years old. For legislation that governs a rapidly developing area, these laws need to be modernised. A consultation was launched by the HFEA to obtain public opinion on the areas of the 1990 Act that most needed modernisation. The consultation closed in April 2023 and a report ^[4] was published to provide recommendations to the Government in November 2023. The main recommendations focused on improving the law around patient safety and good practice, access to donor information, consent, and scientific developments.

Key recommendations included providing the HFEA with a broader range of regulatory powers and the power to impose financial penalties. The 1990 Act should be amended to include an over-arching focus on patient protection, with greater emphasis on counselling for donors and recipients to understand the implications of IVF before treatment starts. The consent regime within the 1990 Act should be overhauled, as this is currently complex and can lead to unexpected consequences and outcomes. Finally, the 1990 Act should be revised to ensure it is ‘future-proof’. This means amending the 1990 Act so that it is better able to accommodate and adapt to scientific developments and medical advances in IVF treatment.

The development of legislation relating to IVF is particularly interesting as an example of scientific innovation and ethical considerations driving the need for legal regulation. When the 1990 Act was drafted, it was based on the medical knowledge and ethical views that prevailed at the time. As can be seen by some of the amendments to the legislation over the last 30 years, changes in both scientific understanding and societal beliefs have demanded that the legal framework for protecting patients, donors and DCIs develop also. The recent recommendations for reform made by the HFEA will hopefully take this modernisation further, and ensure that IVF treatment continues to be safe, ethically responsible and accessible to all those who seek to start a family this way.

Jessica's article was published in Family Law Week, 1 November 2024, and can be found here.