House of Lords debate: Adequacy of the law on the regulation of fertility treatment: 4 June 2026

1.1.        The Human Fertilisation and Embryology Authority (HFEA) is responsible for the regulation of fertility treatment, like IVF, and scientific research involving human embryos across the UK. It regulates according to the Human Fertilisation and Embryology Act 1990 (as amended).

1.2.        Much of the original 1990 Act remains fit for purpose and provides a flexible framework for the regulation of a fast-developing area of medicine and research. However, in other respects the regulatory framework is increasingly out of date.

·    It is out of step with modern thinking about patient safety;

·    It is incapable of dealing with the shift to elements of fertility services being provided online;

·    It is inflexible and does not allow the HFEA to match its regulatory oversight to the risks involved.

1.3.        The HFEA proposals for reform relate to three areas: patient protection and safety; effectively regulating a changing sector; and effective and proportionate sanctions.

2.1.        Patient protection should be an explicitly stated principle of the Act, with a requirement that HFEA decision-making and compliance by licensed clinics should have reference to it.

2.2.        The majority of clinics are now operating in a competitive market using advertising and other tools to attract new customers. Patients are having to make very difficult and expensive choices about medical care – in contrast to most medical interventions in the UK which can be accessed on the NHS. The current regime does not always allow the HFEA to act when failures of care arise.

2.3.        In recent years healthcare regulation has moved to put the needs and interests of patients at the centre. The absence of any specific statutory reference to patients in the Act is therefore out of step and can make it harder for the HFEA to take proportionate action where patient protection or safety is at risk. 

2.4.        The HFEA has no interest in intervening in the relationship between doctor and patient. However, patients expect the HFEA to act where they feel they are at risk of being mis-sold treatment add-ons or other services which may have a financial or other cost.

2.5.        A broader duty on patient protection would enable the HFEA to act in the best interests of patients where it has very limited or no powers at present.

3.1.        Bringing all related UK services, whether offered in physical premises or online, within a broad definition of regulated fertility services would recognise the changing nature of wider fertility treatment.

3.2.        For some time, a range of activities marketed as fertility treatments have taken place outside of HFEA licensed clinics in a variety of settings. More recently, the fertility market has started to move online, in settings which are outside of the regulated scheme – i.e. physical licensed premises. Some of these online services act as ‘networks’ introducing patients to fertility treatment and offering all services except for those that are legally required to take place in licensed clinics, such as egg collection or embryo transfer. Some of these services only exist as a collection of different online parts, brought together under a single brand. A high profile example of this was Apricity which closed suddenly in December 2024.

3.3.        For some patients this may well offer more flexibility and personalisation than a traditional fertility clinic. Other patients have however reported that when they find a service provider offering ‘fertility services’, they assume that all aspects of the service are regulated.

3.4.        Some virtual clinics do give a misleading impression that they are regulated, including citing a ‘HFEA regulatory fee’ in their price lists, even though they are not a HFEA clinic and licensed treatments take place elsewhere in other HFEA licensed clinics. Some virtual clinics publish their own success rates; from a patient perspective, they would appear to fall under the HFEA regime, yet they do not. In some cases, the quality of those services is covered by a ‘third party agreement’ with a HFEA licensed clinic; in other cases it is not.

3.5.        As far as patients are concerned, where ‘fertility services’ are offered, the HFEA should be acting in their interests. While there is no desire to double up on any regulation falling within other healthcare regulators’ remits, the HFEA should ensure patients are clear, when fertility-related services take place outside of licensed clinics, that they are not covered by the oversight of the HFEA.

3.6.        The HFEA is often approached by patients who feel it should be able to do more on a range of issues, from what is said on a clinic website, to the offer of treatment add-ons, to services offered outside of licensed clinics. The Act should be revised to ensure it remains relevant to today’s – and the developing – fertility market.

4.1.        In an increasingly commercial fertility sector, the power to levy a financial penalty could be a useful and proportionate tool to shape clinic behaviour, or to address serious or repeated non-compliance, and to incentivise compliance across the sector.

4.2.        Today’s regulatory challenges are increasingly out of step with the HFEA’s powers. A regulatory scheme that encourages a positive culture of best practice wherever possible, and effective sanctions where necessary would be more effective. Today fertility treatment is provided predominantly through self-funding by patients, although this varies across the nations and regions of the UK. The majority of clinics are privately owned, many as part of large groups with external finance. Elements of fertility care and associated treatments are increasingly offered online or outside of HFEA regulation.

4.3.        At present the HFEA has no flexibility to adjust its powers according to regulatory performance. It wants to reduce the regulatory burden for compliant clinics and focus our oversight on those that are not meeting the required regulatory standards.

4.4.        Good regulation should try to achieve the greatest impact with the most proportionate sanction. For example, it would often be more proportionate to impose a financial penalty, which the HFEA is unable to do at present, rather than to remove or suspend a licence. The former would encourage a clinic to improve their compliance whilst minimally impacting existing patients, whereas the latter could possibly require the clinic to close which would significantly impact patients and their treatment. The regulator’s power to impose financial penalties would also act as an important and effective deterrent for poor compliance across the sector.

5.1.        The HFEA was established in 1991 by the Human Fertilisation and Embryology Act 1990 and was the first regulatory body of its kind in the world. Since then, scientific understanding of human development has changed markedly, as have societal attitudes to family formation. The provision of fertility treatment has become more common and unlike most medicine in the UK is now largely commercial and privately funded. The HFEA ensures this treatment and related research is conducted safely and with positive outcomes for those involved and affected by it.

5.2.        The Human Fertilisation and Embryology Act was last amended in 2008, updating the law to accommodate a number of social and scientific developments - such as enabling single patients to be the legal parent of a child and a ban on sex selection for social reasons. There have also been various changes made since 1990 through regulations, such as changing the statutory storage period for embryos and gametes; enabling disclosure of information for research purposes and disclosure of donor information. However, there have been no changes to the way the HFEA regulates since 1990, despite the significant changes to the structure of the UK fertility sector.

6.1.        Much of the original 1990 Act remains fit for purpose and provides a flexible framework for the regulation of a fast-developing area of medicine and research. However, in other respects the regulatory framework is increasingly showing its age: it is inflexible and does not allow the HFEA to match its regulatory oversight to the risks involved; it is out of step with modern thinking about patient safety; and it is incapable of dealing with the shift to elements of fertility services being provided online. Many UK regulators have a wider and more effective range of powers to improve compliance and protect patients and consumers than those available to the HFEA.

6.2.        Having treatment in a UK licensed fertility clinic continues to be very safe. In 2024/25, out of more than 100,000 cycles of fertility treatment, storage or donation, incidents occurred in less than 1% of cycles. Around 1 in every 32 UK births is now from IVF.

6.3.        In pushing for change one element of the existing statutory regime should remain: the special status of the embryo in both fertility treatment and research has remained a guiding principle. The potential of the human embryo does make it different from all other human tissue and even if fertility treatment is much more commonplace than it was in 1990, that potential continues to justify a distinct regulatory regime.

7.1.        The UK fertility sector has changed significantly over the last 30 years, with changes accelerating in the last decade. The major changes can be summarised as:

·    growth in the proportion of treatment which is privately funded to now 73% across the UK

·    the development of ‘groups’ of private clinics funded by private finance

·    growth in the cryogenic storage of gametes and embryos

·    changes to the profile of services related to fertility being offered online

·    recognition that consumer law applies to the supply of fertility-related services

·    new techniques for identifying embryo development

·    developments in emerging technologies like artificial gametes

·    changes in the volume donor-conceived individuals (DCIs) applying for information about their genetic origins.

7.2.        There is now roughly one IVF child in every classroom with IVF births making up around 1 in 32 of UK births. The number of patients having fertility treatment has increased over the last 30 years with just over 6,000 IVF patients in 1991 compared with over 52,000 in 2023. The types of families using fertility treatment have also changed, with single patients increasing from under 500 in 2000 to over 3,600 in 2023, and female same-sex couples increasing from 210 in 2000 to over 2,500 in 2023. There has been a significant improvement in the average birth rate from IVF using fresh embryo transfers, which has increased from 8% per embryo transferred in 1991 to 31% in 2023.

7.3.        Patients are increasingly looking for advice from charity websites, social media, online forums, and clinic websites. The types of treatment being sought is also changing, with increased options bringing more complex choices for prospective and existing patients. For example, there has been a large increase in the number of patients storing eggs from 15 in 2000 to nearly 7,000 in 2023.

7.4.        The fertility sector itself has also changed considerably. In the 1990s, the typical fertility clinic was either in the NHS or owned and run by the clinicians themselves. Today, the majority of clinics are in the private sector, and many are increasingly part of larger commercial groups.

The changing context in which fertility treatment takes place is most evident when considering the increase in the number of patients who are privately funding their treatment. Overall, HFEA figures show that NHS funding for IVF cycles varies across the UK with 24% of cycles funded in England, compared to 54% in Scotland, 49% in Northern Ireland, and 33% in Wales in 2023.  This has led to widespread discussion as to whether such patients are also consumers. The Act applies to all fertility services (NHS and privately funded), and the HFEA expect licensed clinics to provide the same standards of care regardless of how a patient is funded. But the growth in private provision has changed the relationship between patient and clinic and within clinic teams themselves. It has also highlighted where the HFEA lacks powers to act in the interests of patients, whether it is questioning the use of add-ons or the provision of ‘online fertility clinics’. The work of the Advertising Standards Authority (ASA) and the Competitions and Market Authority (CMA) in this area has highlighted the lack of powers the HFEA has in relation to patient experience and where its powers could be improved in the interests of the patient.

8.1.        The HFEA have been considering what legislative changes are needed in response to the developments in the fertility sector set out above since 2021. The proposals were developed through a series of Authority (Board meetings) discussions and a wider advisory group with experts from the field; small, targeted roundtables with stakeholders and wider public consultation.  All background documents and information can be  found on the HFEA website:

·    Full HFEA report and proposals published Autumn 2023

·    Report summarising responses to public consultation published Autumn 2023

·    Papers and minutes from HFEA Authority (Board decisions) on law reform February 2022, May 2022, July 2022, September 2022, March 2023, May 2023, July 2023 and September 2023.

·    Papers and minutes from the HFEA Legislative Reform Advisory Group 2022-2023

·    Public Body Review 2023 assessment of HFEA legislative reform proposals

·    Competition and Markets Authority recommendations on HFEA reform

For more information:

enquiriesteam@hfea.gov.uk

www.hfea.gov.uk