Modernising fertility law

Table of contents

• Introduction
• Summary of recommendations
• The case for change
• Law Reform activity
• Section 1 - Patient protection and safety
• Section 2 - Access to donor information
• Section 3 - Consent
• Section 4 - Future scientific developments and innovation
• Next steps
• Annex 1 - Authority members 2020-2023, Legislative Reform Advisory Group members and consultation information

Introduction

The UK has long been a world leader in the regulation of fertility treatment and research involving human embryos. The Human Fertilisation and Embryology (HFE) Act 1990 (the Act) was the first law of its kind in the world. It established the Human Fertilisation and Embryology Authority (HFEA) and the regulatory regime which we oversee. In the 33 years since, there have been significant changes in the size and structure of the fertility sector, in popular attitudes to fertility treatment, and in clinical and scientific developments.

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. But the Act has only been updated once, in 2008. The 2008 changes removed potential barriers to licensed treatment for female same-sex couples and widened the scope of who could become a parent. However, with it came a complex consent regime to ensure legal parenthood. The 2008 Act also paved the way for regulations which provided new treatment options for parents seeking to avoid serious inherited mitochondrial disorders. And there have been other changes through regulations or secondary legislation, such as to enable the provision of complex data to researchers to explore infertility and the impact of IVF, or to change the storage period for gametes and embryos.

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. In looking at those areas of the law that require modernisation we do not seek to break with the broad settlement set out in the original Warnock Report which balanced medical need and scientific developments with what was socially acceptable. Rather our aim is to update the settlement for the needs of today and to ‘future-proof’ it as far as possible. Therefore, the proposals that follow are a mix of focused reforms aiming to decrease unnecessary regulatory burden or fix a range of significant ‘technical’ issues, combined with more radical changes to meet the challenges of new scientific possibilities or shifts in social attitudes.

In all our work, 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.

The HFEA first began to speak publicly about concrete proposals for law reform in 2020, our 30th anniversary. While we are happy that successive government ministers have acknowledged the need for change, we recognise that the process to achieve law reform is not a quick one and we will continue to work with ministers and our sponsors in the Department for Health and Social Care (DHSC) to achieve timely changes.

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Summary of recommendations

Patient safety and promoting good practice:

1. The HFEA should have greater freedom to decide the regularity and form of inspections.
2. There should be the possibility of appointing Deputy PRs and PRs with a broader range of qualifications or experience.
3. The HFEA should have a broader and more proportionate range of regulatory enforcement powers.
4. The HFEA should have the power to impose financial penalties.
5. The Act should be revised to include an over-arching focus on patient protection.
6. The Act should be revised to accommodate developments in the way fertility services are provided.
7. The appeals process in the Act (and associated Regulations) should be amended to allow for challenges to licensing decisions to be resolved in a more efficient and proportionate way.

Access to donor information:

8. The Act should be amended to enable the removal of donor anonymity from the birth of any child born from donation.
9. Clinics should be required by law to inform donors and recipients of the potential for donor identity to be discovered through, for example, DNA testing websites, social media or further means other than the HFEA Register.
10. The Act should require all donors and recipients to have implications counselling sessions before starting treatment.

Consent:

11. There should be an overhaul of the consent regime in the Act.
12. The Act should be updated to require automatic record-sharing between clinics and the NHS central records systems as the default position. This would support more joined-up and safer patient care at hospitals and within primary care. Patients would be able to opt out of this record-sharing.
13. The Act should be amended to allow patients donating embryos to consent to research embryo banking.

Scientific developments:

14. The Act should explicitly give the HFEA greater discretion to support innovation in treatment and research.
15. The Act should be amended to ‘future proof’ it, so that it is better able to accommodate future scientific developments and new technologies.

The case for change

Attitudes to fertility treatment have changed over the last 30 years, with increased understanding of infertility and assisted reproduction now more openly discussed in the media and popular culture. Many of today’s patients are comfortable with sharing their experiences, including on social media. Fertility treatment today offers a growing number of different family types an option to have their own much-wanted child and also provides a way (through pre-implantation genetic testing for monogenic disorders or chromosomal structural re-arrangement (PGT-M and PGT-SR)) for families to avoid passing on serious inherited illnesses.

The number of patients having fertility treatment has increased almost ninefold over the last 30 years with just over 6,000 IVF patients in 1991 compared with nearly 52,000 in 2021. The types of families using fertility treatment have also changed, with single patients increasing from 490 in 2000 to over 4,300 in 2021, and female same-sex couples increasing from 221 in 2000 to over 3,750 in 2021. 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 22% in 2021.¹ There has also been an increase in the number of surrogacy treatments in licensed clinics, with around 66 surrogacy cases recorded in 2000 compared with around 250 in 2021.²

Patients are increasingly looking for advice from charity websites, social media, online forums, and clinic websites while decreasingly using their GP for information. 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 14 in 2000 to over 3,000 in 2021.³

The fertility sector itself has also changed considerably in the past 33 years. 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, our figures show that NHS funding for IVF cycles varies across the UK with 24% of cycles funded in England, compared to 30% in Wales and 58% in Scotland in 2021.⁴

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 we 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 our powers could be improved in the interests of the patient.

Clinic staff, whether they work in the NHS or the private sector, are concerned with the quality of care every patient receives and want to ensure they have a positive experience, whatever the outcome of their treatment. However, in an increasingly commercialised market, where investors are understandably seeking profitable return, it is only right that questions are asked about clinic pricing structures, sale of treatment add-ons and marketing and advertising techniques used to attract patients. The change from patient to consumer has been well documented by researchers and as the sector regulator we need to ensure we have the appropriate powers to oversee these changes in the sector.

The science surrounding research on embryos and gametes, as well as new assisted reproductive technologies, continues to develop at pace, bringing potential new treatment options as well as new ethical issues. How new treatments are best introduced into clinics is the subject of widespread debate, as the controversies around IVF treatment add-ons over the last few years demonstrate. The recent wider media interest in embryo models (also known as stem cell-based embryo models) is further evidence of the speed of change.

The 1990 Act was shaped by the understanding of the scientific possibilities, ethical and societal views at that time. All have moved on. Our proposals are designed to ensure the law remains relevant going forward.

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Law Reform activity

As noted above, the 30^th anniversary of the HFEA in 2020 offered an opportunity to reflect on how far the fertility sector had changed since the regulatory regime was first set up. It was clear that although the sector and patient population had changed dramatically since then, the ability of the HFEA to be a modern, agile regulator was in many ways hampered by an outdated law. 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.

The COVID-19 pandemic meant that our law reform work was delayed in 2020-21 and the recommendations in this report have been developed during 2022-23 following a series of Authority discussions and decision-making; meetings of a broader Legislative Reform Advisory Group drawn from experts in the field; small, targeted roundtables with stakeholders; and a wider public consultation. The results of the public consultation are set out in a separate report.

The proposals in this report focus on the key changes that the HFEA believes should be made to the current law. The government asked the HFEA to make recommendations for change; however any further updates to the Act are decisions for government and ultimately parliament. We would expect that there would be further government consultation on some of these areas before legislative change.

This report sets out recommendations under four key themes where we think change is most needed:

• Patient protection and safety
• Consent
• Donor anonymity
• Scientific developments

In each of these themes we set out the case for change, the issues with the current legal framework, and our recommendations for change.

The range of recommendations presented here do not cover discrete reforms that may be taken outside of a revised Act.⁵ Nor do we cover those which may relate to all subsequent regulations, such as the 2010 Disclosure of Information for Research Purposes where there are a number of areas we would like to see change.

Throughout this report we use the term ‘patients’ to include a wide range of those involved in assisted reproduction: current and former patients and their partners, donors, donor-conceived individuals, intended parents, and surrogates. We also consider the future children resulting from treatment.

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Section 1 - Patient protection and safety

Case for change

Patients should be assured that the treatment they are offered is safe, evidence-based and of a high standard. To provide this assurance, the HFEA wants to put patients at the heart of a revised law.

Fertility treatment is unique in modern healthcare - there is no comparable area of healthcare where a potential new life is created in a laboratory. But many of the regulatory issues we face are common to healthcare more generally - the Cumberlege report on women who suffered avoidable harm from private and NHS healthcare described a system that did not adequately recognise that patients are its primary purpose. Like all healthcare regulators, the HFEA needs to put patient protection and safety, alongside the long-established concern for the special status of the embryo, at the heart of its regulatory actions.

Today’s regulatory challenges are increasingly out of step with our powers. We want a regulatory scheme that encourages a positive culture of best practice wherever possible, and effective sanctions where necessary.

The fertility sector in the UK has changed significantly since the HFEA was set up. 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 our regulation.

This is not to say that the interests of patients are not uppermost in the minds of clinic staff wherever patients are treated. However, 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 us to act when failures of care arise. This can be seen in respect of two key aspects of patient protection and safety. First, multiple births, the biggest risk to the health of patients and babies born from IVF. Although we have managed to significantly reduce the incidence of multiple births by working with professional and patient groups, we lack the powers to directly tackle the small number of clinics who have high multiple birth rates. Second, the offering of unproven treatment add-ons, where we have no enforcement tools at our disposal and can only recommend that the benefits and risks are discussed with each patient with reference to the HFEA add-ons rating system. The Women’s Health Strategy from 2022 notes that changes to the HFEA’s regulatory powers may be needed to cover fertility treatment add-ons.

In arguing for better patient protection and safety we do not wish to suggest that most clinics are putting patients at risk. They are not. Overall, the fertility sector has a good level of compliance with the law and our guidance, as our annual State of the Sector report demonstrates, with a low level of incidents per the number of cycles every year.⁶ But that does not diminish the need for appropriate regulatory tools where serious non-compliance occurs, however infrequently. At present the HFEA has no flexibility to adjust its powers according to regulatory performance. We want to reduce the regulatory burden for compliant clinics and focus our oversight on those that are not meeting the required regulatory standards.

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Better patient protection through risk-based inspection and licensing

Current situation

The law currently allows the HFEA to issue treatment and storage licences for up to five years after which the clinic needs to apply to renew its licence if it is to continue to offer licensed activities. The renewal process involves a renewal inspection. The HFEA typically issues licences for a maximum of four years because the Act also requires us to inspect the licensed premises at least once every two years and we have also sought to reduce the regulatory inspection burden.

Issues

1. The law is inflexible and is out of step with modern risk-based regulation.

The requirement to inspect premises at least every two years means there is no scope to exempt clinics from an inspection even when they are fully compliant. A more risk-based inspection cycle would vary the frequency of inspection according to the risk of non-compliance and allow the HFEA to devote more of its resources to those clinics where the risk is greater. More flexibility would also allow the HFEA to vary the proportion of an inspection which is conducted on-site and the proportion which is undertaken remotely. It would enable those clinics who are compliant to reduce their regulatory interactions.

This is not about moving away from on-site inspections; the evidence suggests that on-site inspection can be a vital tool in ensuring that standards are met and provides an opportunity to speak to patients and clinic staff. But a robust inspection regime draws on a variety of evidence whether from performance data, clinic documents (policies and protocols) or direct observation. At present, we are required to inspect the premises of a clinic at regular intervals regardless of its level of compliance. A more flexible approach would also be more closely aligned with the Regulators’ Code principle that regulators should base their regulatory activities on a proportionate approach to risk.

2. The requirement to renew a licence creates unnecessary uncertainty.

Even if the HFEA were to have greater flexibility over when and how it inspected, this would not remove the necessity of a periodic licence renewal. In many other regulated sectors, including much of healthcare, providers are awarded ongoing licences provided they meet the required standards.

Proposal 1: The HFEA should have greater freedom to decide the regularity and form of inspections.

This could be done via periodic licences (whether five years as now, or longer) or an ongoing licence, subject to ongoing monitoring and periodic risk-based inspection. This would take away the artificial ‘cliff edge’ of a licence renewal. We would expect that a clinic will continue to meet the required standards unless their performance shows otherwise. Where there appears to be significant non-compliance, the HFEA should retain the power to shorten, suspend or revoke a licence (in addition to being able to impose additional conditions).

Changes to the regulatory regime are not intended to introduce a system that is more lenient or arbitrary. Inspections should remain rigorous and standardised and follow policies that reflect the statutory framework.

A move to ongoing licences should not be seen as a removal of regulatory oversight and it may be that a minimum frequency of inspections should be agreed to ensure that patients continue to have a recent assessment of the quality of care provided. Current regulatory thinking is not just about taking action to tackle non-compliance, it is also concerned with incentivising compliance and a one size fits all approach to regulatory activity is therefore often not appropriate. Our proposal would allow us to approach licensing and inspection in a more targeted way.

It may be possible to make changes to the requirement to physically inspect licensed premises every two years through an order under the Legislative and Regulatory Reform Act 2006 (LRRA). A Legislative Reform Order (LRO) can only be made for the purpose of removing or reducing any burden, or to ensure that regulatory functions comply with better regulation principles. LROs are de-regulatory and can be used to remove or reduce burdens resulting from legislation as well as to improve the way regulatory functions are carried out.

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Better supporting clinic leaders to deliver high quality care

Current situation

The regulatory focus of the Act largely falls on one individual: the ‘Person Responsible’ (PR). This individual is accountable for the conduct of all activities in the clinic. The PR in a clinic setting is required to have certain qualifications and experience, which limit the range of potentially suitable people who could be a PR. Given the importance of the PR’s role, the HFEA runs an entry programme to support new PRs and provide continuous learning, which requires all PRs to understand the legal requirements of the role.

Under the Act, licences are granted to a ‘Licence Holder’ (LH, who may or may not be the same person as the PR). The LH can be a corporate entity - such as a health trust, a private business, or an individual.

The LH and the PR must both be considered ‘suitable’ and the Authority must be satisfied as to the character of the PR, but the current test does not provide an adequate regulatory tool.

The Act also sets out the powers and duties of the PR, though these fall short of a formal job description. The HFEA has issued a key behaviours and role description document, which sets out what is expected of a PR in their role as clinic leaders, and has developed the PR Entry Programme to support PRs. There is no formal provision for deputy PRs or for the role to be shared. And the law does not permit a PR to delegate their responsibilities.

Issues

1. The responsibilities of the PR are significant.

There is no provision for the role to be shared, or for there to be deputy PRs. This is increasingly out of step where licensed clinics are part of a larger commercial group, and indeed one PR may be the PR for several clinics within the group. The possibility to share the responsibilities of the PR could improve resilience and allow for a second opinion in dealing with complex cases.

The Act places onerous responsibilities on the PR but provides her/him with no formal powers/influence to facilitate change – there are several existing models which may be relevant: for example, the Care Quality Commission (CQC) registration process designates a ‘Registered Manager’ who is legally responsible and accountable for meeting the CQC’s fundamental standards for quality and safety. While the Act could be amended to ensure that the PR has the authority to make decisions (and consideration could be given as to whether there should be any exemptions for NHS providers), that level of detail is probably better left to the criteria for approving a PR, rather than legislation.

Proposal 2: There should be the possibility of appointing Deputy PRs and PRs with a broader range of qualifications or experience.

Good regulation should aim to support those who provide services as well as challenge them to improve.

Although much will depend on the circumstances and size of the clinic, the appointment of a deputy PR (or deputies) might provide a more sustainable and flexible model, especially where clinics are part of a wider commercial group structure. Additionally, broadening the criteria of qualifications and experience required to be a PR would improve the range of people suitable for the role.

There should be clear lines of responsibility with the appointment of any Deputy PR(s) to ensure there is no ambiguity between individuals.

If changes are made to the PR role, the role of the Licence Holder (LH) should also be reviewed. The Act does not define what sort of person or entity can be a Licence Holder – and therefore it is not clear who is ‘suitable’ to be a LH or how this is assessed. As noted above, the holders currently vary from private business entities to hospital trusts to individuals who may also be PRs. There are no requirements for private providers to be financially viable or any formal restrictions on who can be involved in the ownership or governance of a fertility business and, consequently there is no scrutiny of the owners/shareholders of a private clinic or its financial viability, unlike in the school or care sectors.

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Better regulatory tools to support and protect patients

Current situation

The HFEA has a limited range of powers and sanctions to enforce its regulatory requirements. The HFEA can suspend a clinic’s licence with immediate effect, take away (revoke) the licence, or change the licence to impose additional conditions – for example, we could require a clinic to temporarily stop donor treatment if we had concerns about that aspect of the clinic’s service, but it could continue to provide other treatments.

The Act is drafted in such a way that the HFEA can only consider varying (e.g. by adding a condition) or suspending a licence if it has the power to revoke, or if it suspects that there are grounds to revoke. There are no other formal sanctions available.

Furthermore, the Act is focused on the special status of the embryo, not the patient, when the focus should be on both. As such it reflects the concerns of the time that Warnock was drafted and pre-dates the move toward more patient-centred health care. In response the HFEA’s enforcement documents do refer to actual or potential risks to the safety of patients, gametes or embryos, but there is no statutory reference to the patient. And there is nothing in the Act that puts the patient or patient protection as a focus – as is evident from the periodic calls for a ‘welfare of women’ test to match the existing ‘welfare of the child’ – to inform the work of the HFEA.

Issues

1. The range and order of regulatory sanctions make proportionate action difficult.

At present, the HFEA must show that the requirements for taking away a licence are being met (the most serious sanction we have) before we can opt to impose alternative sanctions, such as conditions or a temporary suspension. This is a very high bar for any regulatory action, with the result that non-compliant services might continue to operate while not meeting the required standards for longer than they should, increasing the risks to patients. Earlier, more targeted, regulatory action would better protect the patient and mean that the complete (temporary or permanent) closure of a clinic, which is rarely in patients’ best interests, is less likely.

2. The range of regulatory sanctions available to the HFEA are limited.

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.

3. The Act is silent on patients.

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.

We saw responses to the consultation that patients were already protected under other legislation or regulation but find that hard to reconcile with our experiences where patients can be at risk. The issue can be illustrated by the examples of multiple births and treatment add-ons, where patients can be at risk, in some cases physically, in other cases because of the impact on their financial or mental health. But the HFEA has no regulatory powers to act in the interests of patients in either case.

The HFEA has no interest in intervening in the relationship between doctor and patient. However, patients expect us 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.

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.

4. More fertility services are being offered that fall outside the remit of the Act.

For some time a range of activities marketed as fertility treatments have taken place outside of HFEA licensed clinics in a variety of settings, including ‘wellness’ clinics. 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. For some patients this may well offer more flexibility and personalisation than a traditional fertility clinic. Other patients have however reported to us that when they find a service provider offering ‘fertility services’, they assume that all aspects of the service are regulated. And 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.

As far as patients are concerned, where ‘fertility services’ are offered, the HFEA should be acting in their interests. While we have no desire to double up on any regulation falling within other healthcare regulators’ remits, we 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.

Additionally, there has also been a growth in private arrangements, including online sperm donation where the risks to a woman’s health, future children born and lack of clarity about legal parenthood can be serious. However, it is difficult to see how any regulatory regime could effectively tackle such arrangements.

Proposal 3: The HFEA should have a broader and more proportionate range of regulatory enforcement powers.

A re-ordering and restructuring of our enforcement options so that we could take earlier, more proportionate, action would allow for a more effective response based on the seriousness of the non-compliance. This would better align the Act with the Regulators’ Code and the expectation that regulators should act proportionately, which is usually taken to mean the least necessary action to address regulatory risks and non-compliance.

Although we saw some concerns over a wider range of powers for the HFEA, we heard others who were strongly in favour of more regulation in this area for patients undergoing fertility treatment. A broader and more proportionate range of powers would enable us to act more effectively rather than result in greater oversight for clinics.

Proposal 4: The HFEA should have the power to impose financial penalties.

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. In comparison, the CQC can fine a service provider when it fails to provide safe care or provides treatment that results in avoidable harm to a service user or exposes them to a significant risk of exposure to harm. As when other UK regulators impose fines, any monies collected through such financial penalties by the HFEA would be passed to HM Treasury.

We heard some concern in consultation responses that financial penalties may be viewed by wealthier clinics as ‘the cost of regulation’ and this is something that has resonance with other regulated sectors that impose financial penalties. In addition, there was concern that the cost of financial penalties may be passed onto the patient. Based on evidence from other sectors, used appropriately, we believe that financial penalties are highly likely to be effective in improving compliance. Any change to allow for financial penalties should be in addition to other powers that would enable us to act quickly when regulatory action is needed.

It was also stressed that non-financial penalties may be as important, for example powers to enforce information provision, or a penalty when information was seen to mislead patients.

Proposal 5: The Act should be revised to include an over-arching focus on patient protection.

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.

A lack of focus on the needs and protection of patients is out of step with modern healthcare – an over-arching objective regarding patient protection could be inserted into the Act with a requirement that HFEA decision-making and compliance by its LHs/PRs should have reference to it. There is then an open question of the nature of that reference, which could range from a flexible but ill-defined ‘have regard’, to something more concrete and capable of evidencing, e.g., being included as one of the statutory responsibilities of the PR.

Alternatively, the CMA have recommended that this (and some other) aspects of the HFEA Code of Practice should be directly enforceable to help incorporate protection of patients’ consumer interests.

This proposal is intended to reflect the wider context of fertility treatment in the UK today, where the majority of patients pay for the treatment themselves (which is very unusual in UK healthcare) and consideration is not only about medical care and treatment, but as others have noted, about patients as consumers.

This duty therefore is not about duplicating what exists elsewhere but acknowledging the distinctive nature of fertility treatment service and provision in the UK today.

Proposal 6: The Act should be revised to accommodate developments in the way fertility services are provided.

The HFEA is often approached by patients who feel we 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.

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.

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Making licensing decisions more efficient

Current situation

The Act specifies how the HFEA should handle appeals from clinics against licensing decisions. Such decisions are, rightly, subject to a statutory right of challenge by clinics. In practice these challenges are rare.

In most cases the Act sets out a multi-stage process: the initial licensing decision can be subject to a "representations process" whereby the proposed decision is notified to a clinic who can then make written or oral submissions. If the proposed licensing decision is upheld then there is a right to a "reconsideration" undertaken by an external and independent Appeals Committee.

With the exception of a suspension, which has immediate effect, if a clinic makes a written or oral submission, the decision cannot take effect until the reconsideration process has been completed, or the clinic accepts the proposed decision. This can take many months and creates uncertainty for the clinic and patients.

The same regulations and rights of appeal apply whether the proposed licensing decision is specific to only one clinic’s licence, arising from a non-compliance issue, or if it the HFEA wishes to revise the standard licence conditions to bring about a simultaneous change for all UK clinics. This might be done following a change in the law, for example, after EU exit or the recent gamete and embryo storage changes from the Health and Care Act 2022, or as a result of a policy change. The risk of an expensive and protracted challenge from even one clinic, can be a deterrent in making such changes mandatory by inclusion in the licence conditions, even where the change is widely accepted as needed and supported by the vast majority of the sector.

Issues

1. The legal process for resolving challenges to HFEA licensing decisions is slow, costly and out of step with other regulators’ practice.

The Act requires a protracted, overly legalistic and costly process for resolving challenges to licensing decisions. At each stage the process can effectively resemble a court case. It is also very expensive for the clinic and the HFEA.

Other regulators offer a more proportionate, quicker, less quasi-judicial procedure at the first step of a challenge by clinics.

Proposal 7: The appeals process in the Act (and associated Regulations) should be amended to allow for challenges to licensing decisions to be resolved in a more efficient and proportionate way.

The aim would be to ensure that a clinic’s ability to challenge regulatory decisions remains, and that the process for challenging is transparent and fair, but that the process is quicker and more cost effective for both the HFEA and clinics. In any revised scheme the right of appeal remains an essential requirement, but there is scope to simplify the process, for example by cutting out the ‘representations’ stage and allowing a clinic to go straight to the Appeals Committee reconsideration of the decision or having this appeal heard by a judicial tribunal as is the process for challenging decisions made by other regulators such as the Care Quality Commission. The details of any amended appeals system should be further developed with engagement from licensed clinics as a swifter, more efficient process would benefit the clinic and any patients affected.

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Section 2 – Access to donor information

Case for change

The sharing of information around donor conception raises sensitive, challenging and complex questions.

When the Act was first introduced there was a general presumption that donation should be anonymous. Over time attitudes have changed, but the law does not fully reflect those changes. The current professional advice is that children benefit from learning from a young age that they have been conceived using donor gametes.

The issue of accessing donor information and identifying donors has become more urgent with the growing popularity of easily accessible, relatively affordable direct-to-consumer DNA testing and matching services, which have revolutionised our ability to find our genetic relatives, as well as the growth of social media groups to help individuals find their donor or donor siblings. Looking ahead, the future development of facial recognition software may make this process easier still. Mainstream media and social media have shone a light on how these services can provide information to those who previously had no way of finding out their full genetic origins.

Current situation

Currently, children resulting from donation are unable to find out identifiable information from the HFEA until they are 18. After the birth of a donor-conceived child, parents can apply to the HFEA for non-identifying information and a donor-conceived individual can also apply for this information once they are 16. People conceived from donations made post-April 2005, can request identifying information about their donor from the HFEA via the Opening the Register service, based on verified data held in our Register. This information can include the donor’s full name, date of birth, and last known postal address. Donors are able to find out from the HFEA the number, sex and year of birth of any children born as a result of their donation.⁷

Issues

1. The availability of direct-to-consumer DNA testing and matching websites and social media challenges assumptions about anonymity and the release of information about donors.

The Act designates the HFEA Register as the central repository for verified donor information and as the single access point to it. However, the easy availability and increased use of direct-to-consumer DNA testing and matching websites, and the availability of identifiable personal information on social media and the wider internet, have combined to allow many donors and donor-conceived people to be identifiable to each other, whether directly or by inference, outside of any information from the HFEA.

Third parties can also find out information about genetic relatedness between other people via these routes - whether this information is sought intentionally or is discovered unexpectedly. For example, someone may find out that they are donor-conceived because of a genetically related family member using a DNA testing website. Additionally, some groups offer DNA testing and matching between donor-conceived siblings who would like to make contact with each other, without trying to identify the donor.

Anonymity in relation to donor conception can therefore no longer be assured to donors or to donor-conceived people and to their genetic relatives, regardless of when donations were made, or relevant consents given, and whether this information is sought intentionally or is discovered unexpectedly. This undermines the integrity of the current legislative framework.

2. The parental response to the possibility of commercial websites, social media groups or other ways of helping to reveal identities will vary.

Some parents of donor-conceived children are pleased that identifiable donor information is now more easily discoverable earlier and through channels other than the HFEA. They will actively seek out information in their child’s early years because they want their child to have contact with the donor during childhood. They may also, or alternatively, seek out their child’s donor-conceived siblings who share the same donor in early childhood, so that social relationships can be made. Other parents may value the 18 years in which the donor(s) are not identifiable to their child and use the time to prepare their child to decide for themselves what information they might want to access in future. And other parents may never inform their child that they are donor-conceived. Donors will also have a range of responses regarding when donor-conceived individuals and their parents should receive this information.

3. Donation raises questions about choice and informed decision making.

The decision to use donated gametes can have significant implications for the donor(s), the parent(s) and the donor-conceived individual(s). The decision might impact on existing and new personal relationships and family dynamics. Making sure that prospective parents have access to the right information on the use of donor gametes within their treatment is an important element of the treatment pathway to ensure that they can come to a properly informed decision.

Proposal 8: The Act should be amended to enable the removal of donor anonymity from the birth of any child born from donation.

It was generally recognised by respondents to our consultation that the current system, where identifiable information is disclosed to the donor-conceived person at 18 and only on request, is being overtaken by other means (e.g. DNA consumer tests, social media) currently accessible to parents and donor-conceived individuals at an earlier age.

The question is how to balance what is in the law with what is taking place at present and to recognise that any change to the current law may have consequences, some of which may be less advantageous than the system we have now. In effect, the ability for people to trace their donors through a combination of DNA testing and social media means that at present an informal twin/dual track system already exists, albeit outside of the formal legal framework.

In recognition of this, we suggest that the Act is amended to allow the provision of identifiable information on donors after the birth of a child. This proposal is designed to ‘future proof’ the Act to recognise the increasing accessibility of information that parents are already able to find out about their donor should they choose to do so.

It is recognised that this is a significant departure from current practice and therefore a gradual approach to reach this position may be appropriate.

Before any change to the law is implemented, there would need to be in-depth discussions with interested parties: professional bodies, patient and donor groups, donors and donor-conceived individuals, and licensed centres within the fertility sector.

Any revised system for releasing donor information should uphold the following existing principles:

• That there remains a need for an official ‘record of truth’ and the law should continue to require the HFEA to collect data about children born through donation.
• That consent should be properly obtained, and donors and recipients fully informed about the potential challenges to anonymity from DNA testing and matching services.
• That parents should not be legally required to disclose to their children that they are donor-conceived. But patients should continue to be encouraged by clinics to be open with their children about how they were conceived.

The HFEA’s proposal on the removal of anonymity is subject to further consideration of the following points:

• Identifying donor information is available from birth if requested by parents but that a wholly ‘open’ system of donor selection, where identifying personal details of the donor are available before treatment, is not recommended at this stage, while recognising that it does occur in other countries.
• Removal of anonymity should take place following legislative change with an implementation date to be agreed.
• Access to the donor sibling registry for non-donor-conceived offspring of donors is considered as part of any further work on consequences of the changes above.
• Continued respect of donor anonymity for pre-2005 donors and no retrospective early removal of anonymity for post-2005 donors.

Consideration should be given to whether a child, once they are ‘Gillick competent’, should also be required to give consent before their parents could apply for identifiable information about their donor. This would reflect the general legal framework in the UK which accords greater legal rights to the child as they move towards adulthood.

Proposal 9: Clinics should be required by law to inform donors and recipients of the potential for donor identity to be discovered through, for example, DNA testing websites, social media or further means other than the HFEA Register.

As part of the consent process, clinics should be legally required to inform donors and recipients about the possibility that any children born from donation could discover their donor’s identity before they are 18. This would change what is currently HFEA guidance into a legal requirement.

If proposal 8 to remove donor anonymity is adopted, then the wording of this new statutory requirement should be reviewed.

Proposal 10: The Act should require all donors and recipients to have implications counselling sessions before starting treatment.

The complexity of donation and the potential impact that it can have over a lifetime on wider personal relationships makes it unusual among medical treatments. Therapeutic counselling must at its heart be a voluntary decision. However, there is a good case that the principle of properly informed consent requires all donors and recipients to have access to implications counselling sessions. This would allow the consideration of the long-term implications of their decision to provide or use donor gametes before starting treatment. This should be enshrined in law.

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Section 3 – Consent

Case for change

Informed consent is one of the most important principles in healthcare and is a fundamental feature of the Act. The consent requirements of the Act are far more detailed and stringent than for any other types of human tissue, particularly in cases involving donation or surrogacy. Consent to fertility treatment involves more than one person, and needs patients to consider potentially challenging scenarios, including making decisions about what might happen in the future to their gametes and any embryos in the event of their death (or loss of mental capacity). The conversation between clinic and patient is therefore crucial in ensuring consent is appropriately informed, and both clinics and patients report difficulties with obtaining properly informed consent. In some cases, poorly taken fertility consents have had to be resolved by the courts which can be upsetting, time consuming and expensive. There are therefore good grounds for considering whether and if so how, elements of the consent regime should be changed in a modernised Act.

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Consent to treatment and storage

Current situation

Like all medical treatment, fertility treatment requires the consent of the participants. The Act requires informed consent for a range of treatment and storage scenarios: what sort of treatment to have, whether gametes are to be stored and for how long, whether donated sperm, eggs or embryos are involved, whether a surrogate will carry the child, who will be the legal parent if donor gametes are used and the person seeking treatment is not married or in a civil partnership, what might happen in the event of death, loss of capacity, or if one of the parties changes their mind. Those consents are captured in the clinic on HFEA consent forms that patients, partners (if relevant) and donors are required to complete.

For many patients, the range of consents they need to give by law is relatively straightforward, but consent can be a particularly complex process where donation or surrogacy is involved. The requirements of the law can also be inflexible, particularly when circumstances change for patients, for example in the posthumous use of gametes.

Consent to legal parenthood can be particularly complex and mistakes have given rise to cases having to be resolved by a court. Consent to legal parenthood currently takes place in a fertility clinic as part of the necessary discussion of treatment options. Some have argued that this element of the consent regime might be better dealt with by changes to family law rather than as part of the HFE Act. But patients will still need advice to reach a properly informed decision and if that is no longer provided at the clinic, it will involve more time and expense for the patient.

Issues

1. Consent to treatment and storage can be complex and that complexity can lead to mistakes.

There are a range of issues with the current consent regime. The examples set out below are not exhaustive and sometimes only occur in a small number of cases. The consequences can be significant, however.⁸

• Where a civil/married partner of a woman receiving treatment using donor sperm/embryos does not agree to the treatment this is not a guaranteed route out of legal parenthood.
• Where a man donates embryos created from his sperm (rather than only donating sperm) for the treatment of a single woman (e.g., the donation of their unused embryos), the sperm provider could potentially be considered the legal father.
• The requirements for clinics to store parenthood consent forms for 30 years is not long enough to allow future queries or disputes about parenthood to be resolved easily although the widespread move to digital consent may resolve this in future decades. Clinics are also not always set up for long term record keeping over the decades ahead, especially if they close or change ownership.
• It is not possible under the Act to change parenthood consent after treatment has taken place, which has caused issues for patients.
• There is overlap between the HFE Act and Human Tissue Act regarding the consent (and regulation in general) for storage and use of testicular and ovarian tissue.
• The current provisions of the Act give rise to a number of problematic scenarios in respect of posthumous use.

In recognition of the complexity of the current consent regime we consulted on a type of ‘opt out’ model, with the aim of simplifying consent for the largest single patient group (i.e., those patients in a legally recognised relationship who wish to use their own gametes). Under this proposal, patients that were not in a recognised relationship or used donor gametes or a surrogate would still require more complex consent arrangements.

A small number of free text responses to the consultation supported the ‘opt out’ proposal, citing that such a model would minimise errors when completing the consent forms and that this model would give patients a choice on how to provide their consent. Others, however, expressed concern that an ‘opt out’ model could lead to more complexities in some cases that would require resolution in court, and that such a model may not guarantee that patients received sufficient support and that therefore informed consent would not be taking place. Additionally, the inherent complexity of fertility treatment was noted as a reason as to why such an ‘opt out’ may not be suitable. It is of note that the consultation responses showed no agreement for any other model.

There was, nonetheless, general agreement as noted above that the current consent regime needs simplifying. The consent forms were viewed by some as lengthy and difficult to complete because they replicate what is in the current law. Posthumous consent for the use of gametes and embryos was thought to be particularly complex.

The proposal below outlines the principles of any new consent regime and the HFEA will work with others in the coming years to design a revised consent regime within these principles.

Proposal 11: There should be an overhaul of the consent regime in the Act.

Our view is that the principles of informed consent must remain but we propose to work in collaboration with the sector and interested stakeholders to overhaul the consent regime within those principles.

The present system requires each participant to actively ‘opt-in’ to consent to each element of treatment or scenario. The HFEA consider ‘deemed consent’ to not be appropriate in the case of fertility treatment or donation. A different way to approach consent might be to view consent as a series of ‘packages’ which an individual could choose; this has been successfully adopted in some other areas of medicine. Under this model a future consent regime could be built around a small number of ‘standard consent’ packages. People would then be asked whether they wished to adopt this package or make tailored choices. This would greatly simplify the current system.

When considering the simplification of consent, it is important to ensure that all elements of treatment and possible scenarios are explored during the consent process to ensure patients are fully informed and supported in their decision-making when completing consent forms through oral and written information.

An area that is often considered to be particularly complex is consent to legal parenthood, particularly for patients whose treatment involved donated gametes. This is currently being considered by academics and organisations including the British Fertility Society (BFS), and collaborative work should continue to take place.

Any revised consent regime, should uphold the following principles (in no particular order):

• Reflect current best practice and guidance, for example the GMC principles of consent
• The importance of free and informed consent
• Dynamic consent – whereby any party involved can change their mind
• Simplification
• Recognition of modern families
• The special status of the embryo

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Consent to disclosure and the sharing of patient data in a medical setting

Current situation

The Act requires that fertility patients’ treatment details are kept confidential from their other medical treatment data. This contrasts with most other areas of wider medical practice, where relevant patient information is often shared for the purposes of individual care without seeking the patient’s express consent. Data sharing of this kind for specified purposes can enable improvements in the individual’s care and speed up diagnoses.

Issues

1. The law is out of step with modern medical practice and presents a potential risk to patient safety.

Under the Act the disclosure of information about an individual’s fertility treatment, within the normal bounds of medical confidentiality, could result in identifying information about their partner, or child born from treatment, being disclosed to other healthcare professionals without their consent.

The difficulty of sharing fertility treatment details within other clinical settings makes joined-up patient care more difficult. This can have a direct negative effect on patient care. At present, obtaining consent from each patient can be complex, and may cause a delay when urgent treatment might be necessary.

One example is with Ovarian Hyperstimulation Syndrome (OHSS) a potentially serious side effect which some patients develop in reaction to the drug treatment necessary for IVF. Due to the gravity of OHSS, the HFEA requires licensed clinics to report all ‘severe’ and ‘critical’ cases of OHSS to us. The confidentiality provisions of the Act mean that fertility clinics may not know about all such cases. They must rely on building relationships and data sharing agreements with their local hospitals to get a clear picture of the number of OHSS cases amongst their patients. This is inadequate as not all patients with OHSS will attend a local hospital that has a data sharing agreement with their clinic.

More generally, if health professionals are unable to find out about a patient’s fertility treatment, access their medical notes or contact their GP, patients may not receive the right ongoing care or follow-up support for their fertility treatment outcome.

Proposal 12: The Act should be updated to require automatic record-sharing between clinics and the NHS central records systems as the default position. This would support more joined-up and safer patient care at hospitals and within primary care. Patients would be able to opt out of this record-sharing.

The sharing of fertility patient data in a non-fertility medical setting should be brought in line with the current regulations for the sharing of other patient/medical data between healthcare providers. Comparable provision would also need to be made for record-sharing with private providers where fertility patients are receiving other medical treatment. Emphasis would need to be placed on the fact that the sharing of medical data would only take place within regulated medical care in line with the rules that govern the sharing and confidentiality of other medical data and that it would be possible to opt out.

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Consent to research

Current situation

The Act currently requires consent to the use of embryos in research to be donated to specific, named projects. This makes it difficult to use research embryos efficiently through initiatives like research embryo banking.

Issues

1. The law can act as a barrier to embryo research.

Some patients will not want to donate embryos that they do not use in treatment to research. Others may place a lot of importance on being able to do so. Because the current system means any embryos donated have to be suited to the needs of the specific project(s) that their clinic has links to, not all embryos will be suitable, or some clinics may not have links to any projects for embryo donation.

There is also considerable variation in embryo donation consent rates at clinics, which suggests that while some clinics may be actively promoting research projects to patients, others may not be discussing the option of research donation with patients fully. This may be in part because not every clinic has links to a research project (whether actively recruiting or not). Overall, these factors can mean that licensed and ethically-approved research projects may lack access to a timely supply of suitable embryos, and that patients who would like to donate their embryos to research are not always able to do so. In turn, this can hinder progress in embryo research and development necessary to improve fertility treatment for future patients.

Proposal 13: The Act should be amended to allow patients donating embryos to consent to research embryo banking.

This would enable patients to donate to a research bank to store embryos, whether or not their clinic is currently linked to any research projects itself. The research embryo bank could then allocate the stored embryos to a suitable research project(s) when needed, in line with the patients’ consent. This could improve the timely supply of available embryos for research projects, as embryos are a valuable and limited resource with limited donation opportunities for many patients. This proposal would allow more patients who wish to support embryo research to do so, and it would make it easier for patients whose clinics do not have links with research projects to donate their embryos to research if they wish to do so.

Embryos would then only be used in research in line with the donating patients’ consent given to the embryo bank, and with the benefit of continued oversight of the embryo bank’s governance. The HFEA would regulate both the facility storing the embryos and (as currently) each research project using donated embryos. Scientists could gather more knowledge in advance of which stored donated embryos may be available, which could help them when setting up new research projects.

Some patients will welcome the opportunity to donate embryos to any research project. Others would only want to donate to a project that resonates with them personally. Patients should continue to be allowed to donate their embryos directly to specific research projects only if that is their preference. Likewise, any changes to embryo donation consent should permit patients to place restrictions on their consent, for example, some patients may prefer not donating their embryos to projects resulting in embryonic stem cell lines. Additionally, if patients wish to revoke their consent to donation for research of embryos being stored at embryo banks, this should also be available.

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Section 4 - Future scientific developments and innovation

Case for change

The Act has provided a robust yet flexible regulatory framework that has helped to generate public trust in a sometimes-contested area of scientific and clinical work and in turn created the conditions where innovation can flourish. The restrictions in the Act reflect the social consensus of the time, as well as the scientific limitations. Over 30 years on, there is a case for re-examining elements of that consensus.

Many leading-edge developments have occurred since the passing of the Act in 1990, including, in 2015, the world-first decision by the UK Parliament to make lawful treatments to help avoid the inheritance of serious mitochondrial DNA diseases, under the regulatory oversight of the HFEA. Also in 2015, in another regulatory world first, the HFEA licensed the Francis Crick Institute in London to undertake research in human embryos involving the new gene editing technique CRISPR-Cas9.

However, demand for new treatments continues. Patients’ expectations of treatment possibilities have risen, partly due to the increase in self-funded treatment and the wider access to information about possible improvements that are covered frequently in the media and on social media. Furthermore, the link between fertility treatments and advances in genetics and genomics offers hope for families affected by serious genetic conditions. In future these may present prospective parents with new reproductive options.

Research in this field continues at pace and is now pushing against, or going beyond, the boundaries of what would be legally permitted in the UK. There is now a risk that the UK could lose its world-leading status in this area if changes are not considered.

Any new recommendations designed to support scientific development and innovation need to reconcile the certainty that comes from setting out clear rules in law with the ongoing and, at times, fast changing nature of scientific and clinical research. Clear legal rules can provide a publicly agreed framework in which scientific and clinical activity can take place and the mere fact of setting limits on what is and is not permissible can generate public trust, which in turn can create the conditions for further innovation. However, those same rules can also be a barrier to beneficial innovation.

In order for such rules to be effective over time they need to focus on principles and objectives rather than process, and they need to recognise that safety in medicine is never absolute. The question is not whether a new treatment is ‘safe’, but whether the evidence suggests it is ‘sufficiently safe’ given the potential benefits to the patient. Making a new more flexible system work will require a new framework that combines greater regulatory discretion with the potential for greater parliamentary accountability.

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A regulatory model to better support innovation

Current situation

At present, the HFEA has a procedure for authorising new processes. It was introduced to meet the UK’s obligations under an EU Directive on the quality and safety of tissues and cells (the “2006 Directive”). The current legal test for authorising a new process is that the process must not render the tissues or cells clinically ineffective or harmful to the recipient.

There is some ambiguity over processes that fall outside of the scope of this test, such as processes that do not affect the tissues or cells but may affect the patient. In addition, it is a test designed to ensure the safe and easy movement of tissues and cells between member states, rather than one that encourages innovation specifically in the context of fertility treatment.

The HFEA is already looking at how we can update and improve the existing procedure for authorising new processes. This includes looking at whether and how the HFEA can authorise a new process on a pilot basis, with the ability to add restrictions on a case-by-case basis together with tighter reporting and monitoring. However, it would be preferable to have a clear, statutory framework for the HFEA to approve pilots of unproven processes with appropriate safety nets in place.

Issues

1. The Act does not provide a legal framework specifically designed to encourage the development of potentially useful clinical innovations.

Regulating emerging techniques or technologies, or new uses of established techniques or technologies, requires a balance to be struck between what is written in law and what is subject to regulatory discretion.

A clear emphasis on the principles to be used rather than the process, and an explicit provision on the face of the Act, that the regulator can implement processes in line with those principles as determined by the regulator, would allow new research or treatments to be introduced in a controlled and timely way.

Proposal 14: The Act should explicitly give the HFEA greater discretion to support innovation in treatment and research.

One way of enabling the Act to better encourage innovation would be through the use of trial or conditional approvals. There are a variety of models which could be drawn on. The best known of these is the clinical trial regime, but it can be slow and expensive and is better suited to some treatments than others. More promising is ‘managed access’ an option used by the National Institute for Health and Care Excellence (NICE) when they want limited use, ongoing monitoring and real-world data. Regulatory ‘sandboxes’, is another flexible approach to regulation increasingly used by regulators to encourage innovation while minimising risks. Sandboxes have been described as ‘controlled experiments in which new products, services, or ways of doing things can be placed into a real-world environment’.

A clear regulatory framework for approving sandboxes or pilots could mean that a greater number of novel processes could be offered in the clinic under closer, real-time regulatory oversight. This could allow more patients to be offered new clinical developments, while generating more evidence which could then be used to decide whether to authorise the process more widely.

Trials or sandboxes would not be appropriate for all innovations, for example those presenting unacceptable safety risks to patients. Without express provision in the Act, trials or sandboxes would not be able to extend what is currently prohibited by the law, but they could provide a more responsive framework for closely supervised introductions and trials of new technologies in this area. In practice, the regulatory oversight of individual technologies would vary considerably, given the risks involved and the extent to which efficacy had to be assessed over time. However, any new legislative provision should allow the HFEA to approve such technologies/treatments provided there were no safety concerns, limit their use to specified centres for a period of time, require licensed entities to provide specified information as a condition of any approval, and allow for assessment of the technique at the end of the trial period, with the ability to allow the widespread adoption of the technology or a limited extension or revocation of the original approval as appropriate. In the case of trial or sandbox research taking place within clinical treatment, it would be important for clinics to make clear to patients the experimental nature of such interventions. We propose that the government consider revising the Act to allow the HFEA to approve new technologies using regulatory ‘sandboxes’ or some similar flexible trial mechanism.

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Improving the HFEA’s ability to handle rapidly changing scientific developments

Current situation

The Act sets out several significant limitations on scientific research and possible future assisted reproductive technologies. For example, the Act sets limits on the length of time that a human embryo can be developed in vitro or used in research (currently up to 14 days) and it does not permit interventions in the nuclear DNA of gametes or embryos for use in reproduction. The Act also predates the new ‘categories’ of cells that have been developed in recent years, such as in vitro derived gametes, embryo like entities and stem-cell based embryo models, which pose a challenge for the current regulatory scheme. Significant advances have been made across these scientific developments, and these advances may soon be limited by current restrictions set out in the Act.

These developments give rise to two different types of questions. First, whether the Act should be more flexible so that it can better accommodate such developments over time, subject to the social consensus of the day. Second, whether the Act should be revised to accommodate any of these new developments in the next few years. We only sought views on the first question in our consultation; nonetheless we did receive a range of comments both for and against these new developments.

Issues

1. The regulation of certain scientific advances in the Act means that our rules can be slow to adapt, to the detriment of patients.

At present the entire Act needs to be re-opened to accommodate some developments in research or clinical practice. The pressure on parliamentary time inevitably means that such change happens rarely, which can restrict the development of novel research and new clinical techniques for use in assisted reproduction. The greater use of secondary legislation in these areas could combine parliamentary oversight with greater flexibility. The aim would be to have an adaptable regulatory mechanism that could command public support while allowing treatment and research advances to be considered in a more timely way.

2. The Act places limits on the use of human or human admixed embryos in research which are now being challenged by scientific developments.

At present the Act limits the use of human or admixed embryos in research to 14 days or the appearance of a primitive streak (if earlier).⁹ It is now increasingly possible for researchers to keep embryos alive beyond 14 days. If this were permitted in the UK for research purposes, it would lead to improved understanding of early embryo development and the possibility of new or improved treatments. There is a window of very early pregnancy between 14 – 28 days of embryo development which is not currently well understood. Increasing the 14-day rule would allow scientists a valuable insight into embryonic development and the study of disease processes, such as miscarriage and the development of congenital abnormalities. Extending this limit has been proposed by some international organisations. For example, the International Society for Stem Cell Research recently proposed guidelines to remove the 14-day limit on embryo research, and replace this with strict case-by-case oversight of any research past 14 days where justified, and after extensive public engagement.

In order to ensure that such a change could be dealt with in a timely and flexible manner a new mechanism could be introduced into law to allow for parliamentary consideration of issues like the 14-day rule in the future, outside of reopening the HFE Act. This could be similar to the regulation making power written into the Act in 2008 that required positive approval of the resulting statutory instrument of the Mitochondrial Regulations of 2015.

3. The Act does not permit interventions in the nuclear DNA of gametes or embryos for use in reproduction.

The Act does not permit interventions in the nuclear DNA of gametes or zygotes for the purposes of germline genome editing. This technique might be useful for some patients to avoid passing on a serious heritable condition. Embryo testing for such a purpose has long been allowed in the UK by means of PGT-M (preimplantation genetic testing for monogenic disorders), but this can only be used in certain circumstances. It is possible that genome germline editing technology combined with PGT-M may eventually be more efficient than use of PGT-M alone. At present there are significant safety and efficacy issues raised by the application of nuclear germline genome editing in treatment and there are of course serious ethical considerations given the long-term impact of altering the germline. Since the First International Summit on Human Genome Editing of 2015, there has been significant legal and ethical debate, resulting in many reports and papers from international bodies and national ethics committees. Most reports consider that heritable applications of human genome editing may be acceptable in the future in certain circumstances, while noting that there remains significant concern about the safety and efficacy of the technique.¹⁰

However, scientific work in the field of genome editing continues to advance, as do novel techniques of genome editing. Should these issues be resolved, the technique could be a safe and effective treatment option for the avoidance of passing on heritable conditions in certain defined circumstances.

There is also the possibility of genome editing in-vivo whereby genome editing reagents could be delivered directly to the reproductive tracts. In this way it may be possible to edit the nucleus of gametes without the need for in-vitro manipulation, thereby circumventing the Act. As with regards to genome editing in-vivo, consideration should be given to the possibility of bringing such applications under the Act.

4. Scientific advances are creating new 'categories' of cells such as in vitro-derived gametes and stem-cell based embryo models which are outside the regulatory categories of the Act.

The Act currently specifies that research involving gametes and embryos is regulated by the HFEA. At present the Act governs human embryos and gametes. The legislation in the UK prohibits the use of in vitro-derived gametes in treatment. Section 3ZA requires that eggs or sperm permitted for treatment are ‘produced by or extracted from the ovaries of a woman/testes of a man’.

Despite their biological similarity to in vivo-derived gametes or embryos, these new categories of cells including in vitro derived gametes, and stem cell-based embryo models are not currently regulated by the Act. These entities are becoming increasingly similar to bona fide human gametes and embryos, and research on these could offer significant benefits.

Recent developments in stem-cell based embryo models in particular have attracted considerable media coverage and work on a voluntary framework to govern the creation and use of such models in the UK is well advanced.¹¹

Proposal 15: The Act should be amended to ‘future proof’ it, so that it is better able to accommodate future scientific developments and new technologies.

Ongoing policy work should take place with relevant interested parties among professional bodies, scientific researchers, patient groups and licensed centres within the fertility sector to agree to a set of regulatory changes to address the challenge posed by novel scientific developments.

Any revised regime should uphold the following principles:

• Public engagement and discussion before authorisation. Consideration of significant scientific advances and any changes in the regulation of those advances should be preceded by broad and meaningful public debate and engagement, as appropriate to the issues raised. It should be recognised that the views of scientific researchers are not the only important ones, and that the examination of ethical issues should form part of any additional future work.
• Have a clear but flexible framework to accommodate scientific developments in an ethical and safe way. This might include a clear legislative authorisation to adapt licence conditions for this purpose. It should also include continuous monitoring and a method for deauthorisation.
• Ongoing scrutiny of regulatory decisions. It is essential that any changes to the regulation of scientific developments is open to scrutiny. For example, if it was considered appropriate for the HFEA to permit developments and the use of innovative technologies, ongoing parliamentary scrutiny would be beneficial, so that the HFEA is not seen to be ‘writing its own rules’ on a range of matters. This could, for example, be through an amendment to the Act that requires regular updates by the HFEA to a relevant parliamentary select committee.
• Balance of different interests. Considering the balance of scientific and clinical innovation alongside the ethical, social, and philosophical issues in any new regime.

We did not seek specific views on the merits of the various developments set out above and given the controversial nature of all three we would therefore not recommend that they be adopted into a revised HFE Act without further detailed consideration. We would however note that given the time it will inevitably take to have a revised Act ready for Parliamentary consideration, the Department may wish to consider whether such work be started in the interim on any or all of these developments.

Of the three developments in question, we note that the debate on the merits of the 14-day rule and on embryo like entities are most pressing; research is advancing quickly on both.

On the 14-day rule it is clear that science would be able to move beyond this limit, with potentially significant benefits to our understanding of early embryo development. However, given the importance of putting some limit on embryo research a consensus on any new limit would need to be reached and we need a mechanism for doing that. It is important that any possible amendment of the Act would continue to have a clear time limit for embryo research.

On stem cell-based embryo models, the work underway to establish non-statutory guidelines referred to above is welcome and may be sufficient. However, it may not assuage concerns about inappropriate research or use of stem cell-based embryo models and it may therefore be proportionate to amend the Act to permit some form of statutory regulation of stem cell-based embryo models in the future. Any future regulation would need to be proportionate to the issues at stake, rather than replicating the regulatory scheme that exists for human embryos. Research involving such stem cell-based embryos will still need to use bone fide human embryos as reference models.

Work on heritable nuclear germline genome editing is least advanced at present. However, research rarely proceeds in a linear fashion and there may be a significant breakthrough which might mean that nuclear germline genome editing becomes a realistic prospect. Nevertheless, given the important issues involved at this point, we do not recommend that the Act is revised to permit its use in assisted reproduction at this time.

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Next steps

The HFEA will be publishing the proposals in November 2023. These will be available on our website and we look forward to discussing the detail of them with interested parties going forward.

We note that this report focussed on areas where we think that change is the most needed. However, the HFEA continues to work on other areas that require secondary legislative reform including register research regulations, and current restrictions in donor regulations (e.g., the requirement to provide a postal address rather than an email address).

Legislative reform is likely to take some time and in the meantime, the HFEA will continue to regulate effectively within the current law. We look forward to working with other regulators, relevant stakeholders, and research groups.

Updates to this work will be available on our website.

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Annex 1 - Authority members 2020-2023, Legislative Reform Advisory Group members and consultation information

Authority members

• 2020
  • Sally Cheshire (Chair)
  • Kate Brian
  • Jonathan Herring
  • Gudrun Moore
  • Ruth Wilde
  • Anita Bharucha
  • Margaret Gilmore
  • Emma Cave
  • Yacoub Khalaf
  • Ermal Kirby
  • Anne Lampe
  • Anthony Rutherford (until 11 Nov)
• 2021
  • Julia Chain (Chair) (from 1 April)
  • Catharine Seddon (from 18 January)
  • Jonathan Herring
  • Gudrun Moore
  • Tim Child (from 18 January)
  • Jason Kasraie (from 18 January)
  • Alison Marsden (from 1 April)
  • Ruth Wilde
  • Anita Bharucha (until 31 Dec)
  • Margaret Gilmore
  • Emma Cave (until 30 September)
  • Yacoub Khalaf (until 31 December)
  • Ermal Kirby
  • Anne Lampe
  • Sally Cheshire (Chair) (until 31 March 2021)
  • Kate Brian (until 31 March 2021)
• 2022
  • Julia Chain (Chair)
  • Catharine Seddon
  • Prof Jonathan Herring
  • Prof Gudrun Moore
  • Tim Child
  • Jason Kasraie
  • Alison Marsden
  • Ruth Wilde (until 31 March)
  • Margaret Gilmore (until 31 March)
  • Ermal Kirby (until 30 April)
  • Anne Lampe (until 30 April 2022)
  • Geeta Nargund (from 1 April)
  • Alex Kafetz (from 1 April)
  • Alison McTavish (from 1 April)
  • Professor Dame Frances Ashcroft (from 1 April)
  • Zeynep Gurtin (from 1 April)
  • Graham James (from 1 May)
  • Frances Flinter (from 1 May)
• 2023
  • Julia Chain (Chair)
  • Catharine Seddon
  • Jonathan Herring
  • Gudrun Moore
  • Tim Child
  • Jason Kasraie
  • Alison Marsden
  • Geeta Nargund
  • Alex Kafetz
  • Alison McTavish
  • Frances Ashcroft (until 30 April 2023)
  • Zeynep Gurtin
  • Graham James
  • Frances Flinter
  • Christine Watson (from 1 May 2023)

Legislative Reform Advisory Group members

• Julia Chain (Chair HFEA) – Chair
• Tim Child (Chair SCAAC)
• David Archard (Nuffield Council on Bioethics)
• Nina Barnsley (Donor Conception Network)
• Gwenda Burns/Catherine Hill (Fertility Network UK)
• Emily Jackson (LSE)
• Jackson Kirkman Brown (Association of Reproductive and Clinical Scientists)
• Robin Lovell Badge (Francis Crick Institute)
• Raj Mather (British Fertility Society)
• Eddie Morris / Adam Balen (Royal College of Obstetricians and Gynaecologists)
• Francesca Steyn (Royal College of Nursing)
• Peter Thompson (HFEA)

Consultation

The public consultation ran from 28 February to 14 April 2023.

Respondents could respond via an online survey or email using the questionnaire in an accessible Word document. A separate annex provides an overview of the responses.

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Footnotes

1. Fertility Trends 2021
2. See underlying data sets for Fertility Trends 2021
3. See underlying table 1 Fertility Trends 2021
4. See underlying table 18 Fertility Trends 2021. We are unable to report values for Northern Ireland for comparison due to technical issues in reporting from their largest clinic.
5. For example, in ‘shared motherhood cases’ where the current legislation (deriving originally from the EUTCD), does not acknowledge or accommodate the option of two women being ‘treated together’ i.e., where a female partner provides her eggs for the treatment of her female partner. This disparity has resulted in partners being screened and recorded as ‘donors’. The UK government have announced that this law will be changed and therefore we do not propose to cover this issue further here. Additionally, areas of regulation that are currently being considered by the UK Government such as Artificial Intelligence, are outside the scope of this report.
6. See the latest State of the Sector report here.
7. More information on who can access donor information is available on the HFEA website.
8. More detail on these examples can be found in this paper.
9. See further in the LRAG discussion paper ‘The regulation of scientific developments – part 2’
10. See recent UK work into heritable nuclear germline genome modifications including: Genome editing and human reproduction: social and ethical issues – Nuffield Council on Bioethics, UK Citizens’ Jury on Genome Editing – Wellcome Connecting Science
11. See: Governance of Stem Cell-Based Embryo Models (G-SCBEM) project.