Law on the regulation of fertility treatment

Approximate read time: 15 minutes

The House of Lords is scheduled to debate the following motion on 4 June 2026:

Baroness Deech (Crossbench) to move that this House takes note of the adequacy of the law on the regulation of fertility treatment.

Baroness Deech chaired the Human Fertilisation and Embryology Authority (HFEA) between 1994 and 2002.^[1]

1. Fertility treatment

Infertility is defined as the inability to conceive after a year of regular unprotected sexual intercourse.^[2] It may be caused by a number of different factors in either the male or female reproductive systems. According to the NHS, around one in seven couples may have difficulty conceiving.^[3]

Infertility can be treated with medicines, surgical procedures and assisted conception methods.^[4] Medicines may include drugs to stimulate ovulation, while surgical procedures can include repairing damaged or blocked fallopian tubes or removing obstructions that prevent the release of sperm. Assisted conception methods include intrauterine insemination (IUI), where sperm is inserted into the womb via a plastic tube, and in vitro fertilisation (IVF), where the egg is fertilised outside the body.

Assisted conception also has uses other than treating infertility. For example, these methods can allow those in same-sex relationships to have children through egg or sperm donation, or surrogacy.^[5] Additionally, when combined with genetic testing, IVF can allow patients to have children without passing on serious inherited illnesses.^[6]

IVF also enables human embryo research in a laboratory.^[7] Following fertilisation, embryos can be ‘cultured’ where they are grown in a laboratory in a nutrient medium. Embryos intended for fertility treatment are transferred to a woman’s womb after two to six days, but embryos can be cultured for longer for research purposes.^[8] A majority of embryo studies in the UK use embryos destined for or originally intended for fertility treatment.^[9]

Stem cells which can develop into any type of cell in the body can also be used to develop models that mimic embryo development.^[10] These are known as pluripotent stem cells. In the UK, stem cell-based embryo models (SCBEMs) primarily use embryonic stem cells from surplus IVF embryos.^[11] Alternatively, other cell types, for example, skin or blood cells, can be reprogrammed into induced pluripotent stem cells to generate SCBEMs.^[12] Currently, the development of SCBEMs is limited to a few days and they cannot be used to form viable foetuses.^[13]

2. Law on the regulation of fertility treatment

The law on the regulation of fertility treatment concerns legislation regulating assisted conception methods and embryo research. This is set out in the Human Fertilisation and Embryology Act 1990. This primary legislation last had a systematic update in 2008, though other changes have been introduced in secondary legislation.^[14]

2.1 Warnock report

The first child conceived by IVF was born in 1978 in the UK, raising various legal, social, and ethical questions.^[15] This prompted the UK government to commission an inquiry chaired by Mary Warnock (later Baroness Warnock) in 1982 to recommend appropriate policies and safeguards.^[16] The resulting ‘Report of the committee of inquiry into human fertilisation and embryology’, also known as the Warnock report, was published in 1984.^[17]

The report included a total of 64 recommendations and set out principles for an ethical framework for embryo research.^[18] Importantly, the report recommended that “the embryo of the human species ought to have a special status”, enshrined in legislation. It argued that human embryo research should be permitted only under a licence from a regulator and that embryos may not be cultured for over 14 days.

2.2 Human Fertilisation and Embryology Act 1990

The Human Fertilisation and Embryology Act 1990 implemented many of the recommendations of the Warnock report. The act regulates the creation, keeping and use of human embryos outside the body and the storage and use of human sperm and eggs to create embryos.^[19] It prohibits certain activities, such as placing non-human embryos, sperm or eggs in women, and prohibits other activities from being carried out without a licence.

Under the act, licences can be granted for the purpose of fertility treatment, and for embryo storage and research.^[20] The act imposes conditions on each licence type and enables other conditions to be imposed.

The act also implemented other recommendations from the Warnock report, including provisions that defined parentage, ensured anonymity of donors and established an independent regulator to oversee the new regime in the form of the Human Fertilisation and Embryology Authority (HFEA).^[21]

2.3 Human Fertilisation and Embryology Act 2008 and other changes

Motivated by advances in reproductive medicine, the government announced a review of the 1990 act in 2004, conducted a public consultation in 2005 and published a white paper in 2006 containing policy proposals.^[22] These proposals were then implemented in the Human Fertilisation and Embryology Act 2008.

The 2008 act amended the 1990 act but maintained the same regulatory model. Some provisions aimed to make the IVF process more equal for same-sex and opposite-sex and married and unmarried couples.^[23] Other amendments were made to account for scientific developments, such as broadening the definition of a human embryo to include those not created by fertilisation and prohibiting the use of genetic modification in fertility treatment.^[24]

The 1990 act was last amended by schedule 17 of the Health and Care Act 2022, which extended the maximum time frozen sperm, eggs and embryos could be stored for. Prior to the 2022 act, the limit was 10 years or up to 55 years for people deemed to be “prematurely infertile”.^[25] The 2022 act allowed storage for 10-year renewable periods up to a maximum of 55 years, regardless of medical need.

2.4 Secondary legislation

While the 1990 act has been amended little since 2008, secondary legislation has introduced some key changes. For example, the Human Fertilisation and Embryology Authority (Disclosure of Donor Information) Regulations 2004 removed anonymity for sperm, egg or embryo donors for donations made after 1 April 2005.

The Human Fertilisation and Embryology (Quality and Safety) Regulations 2007 amended the act so that a licence is also required for non-medical fertility services, such as online services that provide donor sperm for self-insemination at home.

The Human Fertilisation and Embryology (Mitochondrial Donation) Regulations 2015, made under provisions introduced by the 2008 act, enabled mitochondrial donation to be used in IVF to prevent the transmission of serious genetic diseases from mother to child.^[26]

The regulatory framework was most recently amended by the Human Fertilisation and Embryology (Amendment) Regulations 2024. This allowed people living with HIV who are undergoing anti-viral treatment and have an undetectable viral load to donate to known recipients.^[27] It also created a new definition of partner-donated eggs so female same-sex couples have the same testing requirements as heterosexual couples.

2.5 Stem cell-based embryo models

Due to their novelty, SCBEMs are not explicitly referred to in any legislation.^[28] However, ethical concerns have been raised and there is debate on how they relate to human embryos.^[29]

In 2024, Cambridge Reproduction and Progress Educational Trust developed a UK SCBEM code of practice to fill the gap in legislation.^[30] Chief Executive of the HFEA Peter Thompson has spoken in support of this voluntary, sector-led code and repeated the HFEA’s proposal to “future proof” the law made in its 2023 report.^[31] This report is explored below.

3. Human Fertilisation and Embryology Authority report: Modernising fertility law

Between 2022 and 2023, the HFEA conducted a review of UK fertility law, publishing the resulting ‘Modernising fertility law’ report in November 2023.^[32] The report concluded that “while much of the original 1990 act remains fit for purpose, there are some areas where a new focus with up-to-date regulatory thinking could enable more efficient, effective regulation and a better service for licensed clinics and research centres, as well as the wider patient community”.^[33]

3.1 Case for change

The report made a case for change by highlighting various societal and scientific changes since the 1990s.^[34] Firstly, it argued that attitudes towards fertility treatment have changed, with increased public understanding and open discussion of infertility and assisted conception. It pointed to statistics demonstrating the increased popularity of these methods, including:^[35]

• the number of IVF patients rose from roughly 6,000 in 1990 to nearly 52,000 in 2021
• recorded surrogacy cases rose from 66 in 2000 to 250 in 2021
• the number of patients storing eggs rose from 14 in 2000 to over 3,000 in 2021

The HFEA also argued that the growth in private clinics has changed relationships between patients and clinics and between clinic teams.^[36] It reported that in the 1990s a typical fertility clinic was either in the NHS or owned and run by clinicians themselves, whereas by 2023 a majority of clinics were privately operated.

There have also been numerous scientific developments in this time.^[37] For example, between 1991 and 2021, the average birth rate per embryo transferred increased from 8% to 22%. Meanwhile, the increasing availability of direct-to-consumer DNA kits also poses challenges for donor anonymity. Additionally, in 2016, scientists managed to culture human embryos in a laboratory up to the legal limit of 14 days.^[38] While it is currently not technically feasible to culture human embryos beyond that limit, this may become possible in the near future.^[39]

3.2 Proposals

The report made 15 proposals for reform separated into the following themes:^[40]

• Patient safety and promoting good practice. The HFEA argued that it should have greater freedom to decide the regularity and form of inspections. It added that it should also have “a broader and more proportionate range of regulatory enforcement powers”.^[41] For example, a power to impose financial penalties may be required to enforce compliance in an increasingly commercial fertility sector. It also argued that the 1990 act should be “revised to include an over-arching focus on patient protection”.^[42]
• Access to donor information. The report argued that the 1990 act should be amended “to enable the removal of donor anonymity from the birth of any child born from donation”.^[43] It claimed that when the 1990 act was introduced it was generally presumed that donation should be anonymous but that social attitudes had changed. It also recommended reforms to ensure donors and recipients are aware of treatment implications, particularly related to the potential for donor identity to be discovered.
• The HFEA recommended that “there should be an overhaul of the consent regime in the act”.^[44] It also proposed automatic record-sharing between clinics and NHS central records to aid patient transfers from IVF units to maternity care. The report also proposed that patients donating embryos should be able to consent to embryo banking to support research.
• Scientific developments. The report recommended that the act should be amended to “explicitly give the HFEA greater discretion to support innovation in treatment and research”.^[45] This could include allowing the HFEA to pilot novel processes for a trial period. It also argued for greater use of secondary legislation to “combine parliamentary oversight with greater flexibility” and allow regulations to adapt to future developments without having to amend primary legislation.^[46] It also argued a need to future-proof legislation, for example, to ensure that new “categories” of cells and embryos, such as SCBEMs, are regulated.

As part of developing these recommendations, the HFEA ran a public consultation between February and April 2023.^[47] The HFEA reported that “there was support for the majority of the HFEA proposals across respondents” but noted that some respondents were from organised campaigns opposed to embryo research.^[48]

3.3 Reforming the 14-day rule

One recommendation from the HFEA report was to extend the 14-day rule for embryo research.^[49] This is a controversial topic with debates centred around the potential benefits of embryo research and the moral status of the human embryo.^[50]

The HFEA argues that raising the limit would “lead to improved understanding of early embryo development and the possibility of new or improved treatments”.^[51] Scientists claim that greater understanding of the window in early pregnancy between 14 and 28 days of embryo development could improve understanding of causes of miscarriages and congenital abnormalities.^[52] The HFEA proposed a mechanism to raise this limit similar to the regulation-making power written into the 2008 act that enabled the 2015 regulations to allow for mitochondrial donors. It argued that this would allow for flexibility.

3.4 Government response

The government has not yet published a formal response to the HFEA’s 2023 report. However, on 10 July 2025 Parliamentary Under Secretary of State for Women’s Health and Mental Health Baroness Merron reported that the government was considering the report’s proposals. She said:

Ministers have met with the HFEA chair and discussed the emerging regulatory challenges.

The government is considering the HFEA’s priorities for changing the law and will decide how to take this forward at the earliest opportunity.^[53]

The minister added that “no formal assessment has been made of the regulation of SCBEMs” and “the department has no current plans to extend the 14-day limit on human embryo research”.^[54]

On 29 January 2026, Baroness Merron said the government was “continuing to engage with the HFEA on their priorities for changing the law”.^[55]

4. Other calls for reform

4.1 British Fertility Society

In 2023, the British Fertility Society (BFS), a professional body for those working in fertility, stated that its members “demonstrated strong support for legislative reform in several areas” highlighted by the HFEA report.^[56] The BFS highlighted the following reforms in particular:

The BFS is pleased to see that the regulator [the HFEA] has proposed that the law be reformed to remove the undue need for secrecy which currently exists around fertility treatment. This is outdated and puts patient safety at risk. Further, current requirements for consent prior to treatment are impractical and cumbersome, and in need of modernisation.^[57]

4.2 Human Fertilisation and Embryology (Regulation) Bill

Dame Caroline Dinenage (Conservative MP for Gosport) introduced the Human Fertilisation and Embryology (Regulation) Bill in the House of Commons on 15 July 2025. This private member’s bill intended “to make provision about the regulation of online providers of fertility and certain ancillary services by the HFEA”.^[58] However, the bill did not progress beyond first reading.

Making the case for leave to bring in the bill, Dame Caroline cited the HFEA’s proposal that the 1990 act “should be revised to accommodate developments in the way fertility services are provided”.^[59] Dame Caroline used the example of the sudden closure of Apricity Fertility on 1 January 2025 disrupting treatments.^[60] As it was a concierge service connecting patients to clinics rather than a UK-registered fertility clinic, the company was not regulated by the HFEA.^[61]

4.3 International Society for Stem Cell Research guidelines

The International Society for Stem Cell Research (ISSCR), an independent US-based scientific society, has published ‘ISSCR guidelines for stem cell research and clinical translation’ (last updated in 2025).^[62] These guidelines call on national science academies and regulators to lead conversations on whether the 14-day rule should be extended. They also provide guidelines as to how this could be done, “should broad public support be achieved within a jurisdiction”.^[63] The document also recommends that an “iterative approval process should be established [for SCBEM research], requiring regular reporting to [an oversight] committee as experiments proceed”.^[64] It also asserts that there must be limits on how long SCBEMs can be cultured for.^[65]

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