27 May 2022
The government has tasked the Human Fertilisation and Embryology Authority (HFEA) to review and make recommendations for fertility law reform in the UK. The HFEA hopes to reach an outline agreement with the Department for Health and Social Care before the end of 2022 on what needs to change. In doing so, the HFEA has identified three key areas of the Human Fertilisation and Embryology Act 1990 which are in need of reform to take better account of (1) patient protection, (2) scientific developments and (3) consent, data sharing and anonymity.
The Human Fertilisation and Embryology Act 1990
The Human Fertilisation and Embryology Act 1990 (‘HFE Act 1990’) is now more than 30 years old. Its origins date back to the 1980’s and the findings of the Warnock Report, which first looked at regulating fertility treatment and maintaining public confidence and security following the birth of the first IVF baby, Louise Brown, in 1978. A lot has changed since then and the law needs to be brought up to date to reflect rapidly evolving medical and scientific technologies, increased demand for fertility treatment and increasing commercialisation of the fertility sector.
The HFEA would like to overhaul existing fertility law in the UK to ensure better protection for patients undergoing fertility treatment. It would like to see a more patient-centred approach to fertility treatment delivery and regulation in what it sees as an increasingly commercialised area of medicine dominated by private fertility clinics. As such, the HFEA is looking to obtain greater and more flexible regulatory powers, for example to fine fertility clinics who are found to have sold ineffective “add-on” treatments or fallen short in their quality of care to better protect patients.
Rapid developments in science and technology are also increasingly challenged by existing fertility law in the UK. This has led to increasing calls to extend the current 14-day rule to enable more research around human embryos and specific regulation of embryo models using stem cells called ‘gastruloids’ and ‘blastoids’.
In 2008, the HFE Act 1990 was updated to introduce the concept of ‘permitted embryos, eggs and sperm’. This took account of some scientific developments and introduced regulation to ensure no alteration of DNA nor additions of cells from other sources in fertility treatment, except in very limited circumstances (i.e. subsequent introduction of regulatory updates in 2015 enabling 3-person IVF to prevent babies inheriting deadly genetic diseases). However, advances in science, medicine and technology have moved on at pace and law reform needs to take greater account of developments in genome editing, laboratory created/matured eggs and sperm and potential for in-vivo (in the body as opposed to in the laboratory) technologies.
Consent, data sharing and anonymity
Consent plays a fundamental role in fertility treatment delivery and fertility law in the UK. However, the HFEA feels that various aspects of the current rules are overly complicated. In addition, the HFE Act 1990 currently makes it difficult to share data and there are restrictive rules relating to the sharing of patient data, which can be problematic when a patient transfers from an IVF unit to maternity care.
The HFEA is also considering whether to change the current gamete donor identity-release system (enabling a donor conceived individual to obtain identifying information about their donor as from age 18) to take account of the growing popularity of direct-to-consumer DNA tests which are increasingly undermining donor anonymity in the UK.
The way forward
We have already seen some recent changes to fertility law in the UK. The government brought in regulations early on in the pandemic to extend storage of eggs, sperm and embryos by a further 2 years to take account of temporary delays in fertility treatment delivery in the UK. The government has also passed the Health and Care Bill in April 2022 which will from 1 July 2022 enable patients to store their eggs, sperm and embryos up to a maximum of 55 years without medical need. The government also tasked the Law Commissions of England and Wales and the Scottish Law Commission to make recommendations for surrogacy law reform and the are expected to publish their final report and draft legislation later this year.
However, there are still many complex issues which require careful thought and debate in terms of further fertility law reform in the UK. A balance needs to be struck to take greater account of rapid developments in science, medicine and reproductive technologies and the needs of patients, whilst at the same time does not produce overly onerous and restrictive fertility law and governance in the UK moving forward.
For my part, I would like to see a new Ministry for Genomics and Fertility, with a dedicated Minister providing unified future direction for the fertility sector. This would help develop new integrated national genomic and fertility policy and political strategy. This would help combat our growing fertility problem in the UK. It would also bring greater cohesion, promote and prioritise the fertility space which is increasingly influenced by the application of genomic technology including the ability to prevent genetic disease and much more. Additionally, it would help create an all-inclusive policy and strategy that encompasses fertility issues from pre-conception through to pregnancy and birth, as well as individual fertility and genetic legacy in the UK.
Specialist fertility and family law advice navigates many complex legal and wider issues associated with fertility treatment, donor conception, surrogacy, co-parenting arrangements, adoption and complex personal situations. It can create a bespoke family building legal and practical action plan to help preserve and maximise individual fertility, understand options and make better informed decisions about conception, family creation, biological identity and legacy. It also helps effectively navigate many complex fertility and family law issues, including:
- Legal issues and options where women face rapidly declining age-related fertility and loss of opportunity for conception (e.g. fertility preservation and maximisation, management of existing personal relationships and implications of using donor gametes).
- Delays in medical diagnosis and associated impact on individual fertility.
- Difficulties with storage and use of frozen eggs, sperm and embryos in fertility treatment in the UK (e.g. lack of consent).
- Issues associated with import of frozen gametes and embryos into the UK for use in fertility treatment and surrogacy (e.g. due to anonymous and commercially obtained gametes and embryos which engage UK public policy restrictions).
- Issues associated with the export of frozen gametes and embryos abroad for use in fertility treatment and surrogacy (e.g. lack of consent).
- Legal parentage disputes with an ex-partner, donor, co-parent, step-parent, surrogate.
- Legal parentage disputes with a UK fertility clinic (e.g. problems and omissions with HFEA consent forms).
- Acquisition of legal parentage following a domestic or international surrogacy arrangement.
- Acquisition of legal parentage following a known donor arrangement.
- Acquisition of legal parentage following a co-parenting arrangement.
- An application to bring or defend a Declaration of Parentage (e.g. following a direct-to-consumer DNA test or to re-register a birth certificate).
- An application to bring or defend a step-parent adoption order.
- An application for an order to recognise a foreign adoption under English common law.
- Unexpected death of a loved-one and related issues associated with posthumous storage and use of eggs, sperm and embryos in fertility treatment (e.g. due to an accident, illness including Covid-19).
- Care and upbringing of children following a dispute with an ex-partner, parent, donor or surrogate.
Need a fertility lawyer or a family lawyer? If you would like to discuss your situation or you require specialist fertility, surrogacy and family law advice and assistance please contact Louisa Ghevaert by email email@example.com or by telephone +44 (0)20 7965 8399.