Corporate report

Independent review of the Human Fertilisation and Embryology Authority (HFEA): final report and recommendations

Published 23 November 2023

Foreword

The Human Fertilisation and Embryology Authority (HFEA) is a small and focused body, but it is an important one: it regulates assisted human fertility treatment and scientific research involving human embryos.

Since HFEA was established in 1991, scientific understanding of human development has changed, as have societal attitudes to family formation. The provision of fertility treatment has become more common and is now a commercial and often privately funded activity. HFEA plays a major role in ensuring this activity and related research is conducted safely and with positive outcomes for those involved and affected by it.

I hope this report helps HFEA and the government to continue to regulate this area effectively and efficiently.

I would like to thank HFEA and its stakeholders, and agencies in other countries, for being so open and generous with their time to help us conduct this review, and the arm’s length body (ALB) review team for the time and effort they have put into completing the review. 

Roland Green, Independent Lead Reviewer

Introduction

The Public Bodies Review programme was announced by written ministerial statement on 26 April 2022.

This programme of public body reviews is underpinned by Cabinet Office guidance, which delivers against the government’s commitments in its Declaration on Government Reform, to increase the effectiveness of arm’s length bodies (ALBs) and make them work better for the public it serves. 

Departments are expected to conduct regular reviews of their ALBs. Cabinet Office guidance sets out the process that departments are expected to follow when conducting public body reviews, to ensure that each ALB remains useful and its functions are necessary, and that each ALB is accountable, effective, efficient and aligned with the government’s priorities.

Within the Department of Health and Social Care (the department), public body reviews are conducted by the ALB review team, which is independent of the department’s policy teams. For each review, the department appoints independent lead reviewers to oversee these reviews.

Background

HFEA is the department’s second public body to be reviewed under this programme. HFEA was last reviewed in 2017 under the Cabinet Office’s Triennial Review programme, and prior to that jointly with the Human Tissue Authority (HTA) in 2013.

Since that review, the profile of activities in the fertility sector has evolved, with:

• growth in the proportion of treatment which is privately funded
• the development of ‘groups’ of private clinics
• 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 and influencing genetic development
• developments in emerging technologies like artificial gametes
• an increased focus on providing donor-conceived individuals (DCIs) with information about their genetic parentage

Review scope

Cabinet Office guidance requires that ALBs should be scrutinised against 4 main quadrants and outlines the minimum expectations that ALBs should meet. These quadrants are listed below:

• accountability
• efficacy
• efficiency
• governance

Additionally, Cabinet Office guidance requires each review to identify where savings can be made of at least 5% in nominal terms, to resource departmental expenditure limits (RDELs), of financial year 2022 to 2023 budgets.

HFEA completed a self-assessment before the review commenced against the 4 quadrants mentioned above. Having regard to the HFEA self-assessment return, the ALB review team decided that the review should primarily focus on accountability, efficacy and efficiency in line with the above list. However, due to the ongoing concerns of HFEA with the adequacy of the legal framework under which it operates, and requests by ministers for HFEA to make recommendations for change to the legal framework, the review further determined that this also should be considered. HFEA has good governance arrangements, so this was not an area of focus for review. The terms of reference, which set out the full scope of the review, can be found in annex A.

The chief executive of HFEA will be responsible for agreeing a plan to implement the review’s recommendations in partnership with its departmental sponsor team. For recommendations that fall outside the remit of HFEA, the sponsor team will work collaboratively with relevant leads within the department to oversee and enable the delivery of those recommendations. The review’s recommendations are set out in the ‘Summary of recommendations’ section.

Methodology

The research methods relied upon for this review consisted of a combination of semi-structured interviews, observations, workshops, desk-based research and a clinic visit.

HFEA’s senior leadership team provided the ALB review team with presentations and a wide range of documents to support the review, including its:

• board papers (otherwise known as authority papers)
• performance report
• annual business plan
• strategy paper for 2020 to 2024

In addition, HFEA provided its response to the joint consultation on surrogacy from the Law Commission of England and Wales and the Scottish Law Commission (‘the Law Commissions’). Legislation underpinning HFEA’s regulatory functions was critically analysed by the ALB review team.

Previous reviews

HFEA has been subject to several reviews over the past decade, most recently the Triennial Review in 2017 and the McCracken Review (which also involved HTA) in 2013. These reviews assessed the functions being carried out by HFEA, whether these functions still needed to be carried out and, if so, whether its delivery model is the most appropriate to deliver such functions.

Since then, the government’s position on public bodies has shifted and departments have been encouraged to review their ALBs to rationalise and improve efficiency, where possible. There have also been numerous changes to the health landscape at a local and national level, such as the introduction of integrated care boards (ICBs) and the merger of NHS Digital and Health Education England (HEE) into NHS England in 2022.

The functions of ALBs and their delivery is one of the core elements of the Public Bodies Review Programme, and therefore the review has explored whether there are opportunities to streamline or merge activities, structures or services with other health ALBs. Regard was given to the work of previous reviews, alongside analysis of the costs and benefits of merging or transferring functions, and the legal difficulties of doing so.

Stakeholder engagement

The ALB review team met the HFEA senior leadership team (SLT) in online meetings and at in-person meetings in the HFEA’s office in Stratford, London. An HFEA board (known as ‘the authority’) meeting, a Statutory Approvals Committee meeting, an Executive Licensing Panel meeting and an Audit and Governance Committee meeting were observed. The lead reviewer also held separate meetings with the majority of authority members.

Cabinet Office guidance specifies that reviews should aim to take no more than 6 months and be conducted in a proportionate manner. Bearing this in mind, and that HFEA was already in the process of conducting a public consultation on the reform of fertility law, it was decided that a public consultation as part of the review would not be the most effective or proportionate way of seeking input from interested parties. Instead, a roundtable event, with patient groups and professionals, was held at the department’s offices in Westminster, London on 19 May 2023, to gain different perspectives on HFEA’s functions and activities.

HFEA, on behalf of the department, informed its stakeholder groups of the opportunity to participate in the event. In total, 18 stakeholders were engaged, covering patient, consultant, nursing and provider interests. For those unable to attend, their views were elicited through one-to-one interviews online, including stakeholders providing the perspective of donor-conceived individuals (DCIs). The ALB review team and lead reviewer also visited the clinic Create Fertility in St Paul’s, London.

Interviews were conducted with departmental teams, health bodies and representatives from international institutions and governments. These included:

• NHS England (NHSE)
• Competition and Markets Authority (CMA)
• Human Tissue Authority (HTA)
• Care Quality Commission (CQC)
• Health Research Authority (HRA)
• National Institute for Health and Care Excellence (NICE)
• University of New South Wales (also known as UNSW Sydney)
• American Society for Reproductive Medicine
• Fertility Center Berlin
• Ministry of Health and Social Services, Ministry of Quebec, Canada

The complete list of stakeholders consulted can be found in annex B.

Executive summary

HFEA performs important functions. It regulates a discrete and specialised area of medical practice and scientific research, which can raise sensitive clinical, legal and ethical issues.

As the sole UK-wide fertility and embryology regulator, it ensures that all establishments undertaking research or providing treatment that involves human gametes and embryos, meet and maintain standards to ensure safe and ethical practice. It achieves this primarily by:

• administering a licensing scheme
• undertaking regular inspections
• producing guidance for industry professionals

It also provides substantial information for the public about the provision of fertility services and maintains a register that is a database of every fertility treatment carried out in the UK.

Some of the activities that HFEA performs are analogous to those of other health regulatory bodies. The Medicines and Healthcare products Regulatory Agency (MHRA), HTA and CQC all also carry out inspections and issue licences, as part of regulatory activities in their respective fields. However, a merger or transfer of functions would be unlikely to yield any significant cost-saving benefits and could lead to a loss in the public’s confidence in the effective oversight and regulation of this area. Additionally, despite some similarities in regulatory activities carried out in their respective fields of focus, there are clear risks - each ALB regulates a highly discrete and specialised area, with insufficient overlap to justify a complex merger or transfer of functions.

Departmental oversight of HFEA is effective. This is achieved through regular and frequent engagement and collaborative working between HFEA and the sponsorship team. The sponsorship team has detailed knowledge of HFEA, including the issues and challenges it faces. The sponsorship team has good arrangements in place to hold HFEA’s executive and board to account on their delivery on financial, policy and delivery commitments. However, the review notes that the team is small, and this makes the department heavily reliant on the expertise and knowledge of a few key individual sponsors and HFEA.

Similarly, HFEA has a small, highly experienced and capable executive management team to support its chair and members. The effectiveness of HFEA is dependent upon the breadth of skills and experience its members bring as well as the quality of support they receive from the management team.

HFEA’s financial position has been generally stable post-COVID-19, with income and expenditure remaining at a steady level. HFEA has agreed plans to deliver short-term efficiencies from April 2024 by raising the fees it charges for the in-vitro fertilisation (IVF) treatment cycle and for donor insemination (DI). This will enable HFEA to remove most of its grant in aid (GIA), resulting in significant non-cashable efficiency savings each year. HFEA has also agreed to reduce its capital departmental expenditure limits (CDEL) allocation, which has been reflected in its revised 2023 to 2024 financial year allocation.

In terms of medium-term efficiencies, HFEA has a long-standing commitment to undertake a complete review of its fee structure and look at possible alternative models of fee raising. In addition, the introduction of more shared services with other ALBs could enable the realisation of further efficiencies and improve the effectiveness of HFEA, by identifying opportunities to improve capacity and capabilities. This could introduce a welcome degree of resilience to HFEA, by allowing it to access functions from ALB partners in areas such as finance, legal, people and digital, data and technology. Improving recruitment and retention through greater collaboration could also help provide more fulfilling career paths, create a more attractive employment offer and reduce contractor spend.

HFEA’s regulatory activities are wide ranging, and a key element relates to inspections. Inspections of clinics and laboratories are mandated in the Human Fertilisation and Embryology Act 1990 (the 1990 Act) to uphold the required standards. Following the COVID-19 pandemic, a hybrid approach to inspections was adopted. Currently, HFEA combines remote evaluations and risk-based on-site inspections. The combination has been deemed by the Government Internal Audit Agency (GIAA) as ‘effective’ (GIAA’s highest rating).

Stakeholders place value on inspections maintaining standards and encouraging communication between clinics and HFEA, and the new inspection methodology has drawn positive feedback from many clinics. Some have, however, raised concerns about the length of the inspection process and apparent duplication between the desk-based and in-person assessments. The review recognises that some of these issues may abate as clinics develop experience of the hybrid regime. However, it is important to note that the direction of travel towards a more risk-based approach to inspection is limited by the current law. Nonetheless, a focus on poor performing clinics should be maintained, with a recognition that enforcement activity is important to the overall delivery of improved safety outcomes.

An area where HFEA has had notable success in improving outcomes of fertility treatment is in securing a reduction in multiple births following IVF treatment. It has done so through revising its code of practice over time to reflect best practice. In addition, it has worked closely with medical professional bodies to ensure that professionals and patients are aware of the evidence that multiple embryo transfers have limited benefits in terms of increasing birth rates, as well as having associated health risks.

Fertility clinics often offer additional treatments beyond basic IVF (‘add-ons’). However, the effectiveness of many of these in promoting fertility divides opinion and lacks a robust evidence base. HFEA, in collaboration with other professional bodies, has produced guidance on treatment add-ons to promote responsible use and published its advisory system which rates the effectiveness of add-ons based on approved scientific evidence. However, if patients have been advised on the risk of add-ons, HFEA cannot prevent clinics offering them, and red-rated add-ons are still routinely offered in some clinics. HFEA has tried to address the issue by developing its rating system to improve the information available to clinics and patients on the risks of add-ons, as well as the limited evidence on the likelihood of their improving the chances of treatment succeeding. HFEA will need to find ways to monitor whether its new rating system influences the uptake of add-ons, to see whether additional - possibly legislative - intervention is needed.

HFEA can play a key role in helping patients navigate fertility treatment by providing trusted independent advice on its website, social media platforms and advisory material to clinics. However, stakeholder feedback highlighted the need for HFEA to increase its visibility among patients. HFEA stated that it has to compete with paid-for advertising, which dominates internet search results. This often can mean its website is not the first port of call for patients. The review recognises that, as a public body, HFEA is limited in what it can pay for and do through online channels, particularly when compared to other organisations in the fertility area. Nevertheless, with the importance of social media and digital channels in influencing behaviour, the review considers that HFEA should continue to focus resources on optimising its social media presence.

HFEA has been required by law to maintain a register of all licensed treatments, including those involving donation, since 1991. Pre-2005 donation was anonymous. However, in 2005 the law changed to allow DCIs conceived using a donor registered after 1 April 2005, to apply for identifiable donor information from the age of 18. In October 2023, the first cohort of DCIs will be able to apply for identifiable donor information.

However, HFEA has experience of releasing identifiable information, as some pre-2005 donors have reregistered as identifiable. For those who were born pre-2005 from anonymous donors, they will only be provided with non-identifiable information. HFEA expects around 766 individuals to be eligible to apply by end 2024, and this number could rise to 11,427 by 2030. HFEA is preparing to manage this sensitive process and has allocated resources to managing requests. It has also put in place arrangements for counselling of DCIs and continues to publicise the need for donors to keep their details up to date and awareness that, if donors do not do so, DCIs may seek to use other methods, such as DNA testing and genealogy websites, to trace them. It is not clear to the review what more HFEA could do to manage this process under the current law. However, it is apparent that some donors have not kept the information in the register up to date. The impact is that HFEA is constrained, both legally and in resources, in managing expectations. The review notes that, in the long term, some legislative reform might assist HFEA in ensuring that accurate information is released to applicants (such as email addresses). HFEA may also need to charge clinics more to resource the register.

Given the sensitive nature of the personal data that HFEA holds, it needs to be alert to cyber security risks. The review notes that HFEA is aware of this issue and has identified areas of improvement to ensure that it is fully compliant and meets the National Data Guardian’s data security and protection standards. HFEA has developed an accepted improvement plan, with work ongoing in all areas to ensure it continues to improve in meeting standards. A summary of required actions is provided in the ‘Cyber security’ section of this report (in the ‘Effectiveness’ section).

Much of the law governing assisted fertility treatment and research in the UK is over 30 years old. HFEA and many stakeholders are in favour of law reform in several areas. HFEA has made various recommendations for change to ministers, which are considered in the ‘Legal framework’ section of this report. The review agrees that most of HFEA’s proposals would improve the regulation of clinics and service providers. They would also improve its ability to regulate more effectively. However, the review recognises that some of these could only be made by primary legislation, which is subject to available parliamentary time. The review also notes that some of the changes could alternatively be pursued by the use of secondary legislation, in particular by making an order under section 2 of the Legislative and Regulatory Reform Act 2006 (LRRA). These powers will not be sufficient to make all HFEA’s proposals relating to licence enforcement, but they could be used to make a number of useful changes, such as to inspection powers and the management of clinics.

The Law Commission of England and Wales, in March 2023, issued a joint report with the Scottish Law Commission, recommending HFEA be given new responsibilities to regulate organisations that supervise surrogacy arrangements and the making of payments to surrogates, and to create and maintain a bespoke surrogacy register. If such a regulatory arrangement were adopted, HFEA would be the most appropriate body to perform these functions, and its funding and resource allocation would need to be considered by the department. However, the review agrees with HFEA that it should not assume a direct role in regulating conduct in individual cases, if and when proposals are brought forward.

In accordance with the review’s key findings, a summary of its recommendations has been set out below.

Summary of recommendations

The review acknowledges that HFEA is a small body with limited resources and a significant number of competing pressures and priorities in the near term. The purpose of the public body review is to ensure that all of the department’s ALBs operate as efficiently and effectively as possible. With this in mind, the review has proposed a number of recommendations which, with the support of the department, it is confident that HFEA could deliver.

Efficacy

1. HFEA should remain an executive non-departmental public body.

Efficiency

2. HFEA should continue to learn from the effectiveness of regulators in both the UK and overseas, and set objectives in this area linked to its business priorities as appropriate.

3. Subject to HM Treasury approval, the department and HFEA should implement the proposed fee increase from the 2024 to 2025 financial year.

4. Within the next 18 months, HFEA should establish plans to allow it to conduct a review of its fee model.

5. The department should work with its ALBs to scope the merits of shared service functions to determine whether there is opportunity for improved overall efficiency in the areas identified by this review.

6. Within 12 months of all the functionalities of the Patient Register Information System (PRISM) being embedded, HFEA should review the efficiency of PRISM.

Effectiveness

7. The department should include the fertility sector in any evaluation of cross-border healthcare services, for example the costs, benefits and risks to UK citizens.

8. Over the next 18 months, HFEA should evaluate the PRISM data it now holds with the aim of improving the use of technology and data to enable a more risk-based approach to inspection.

9. As resources allow, now that HFEA has published the updated code of practice, it should engage with stakeholders to determine whether there is scope for the code of practice to be shorter and more user-friendly. The review notes that the timing of this work will also depend on progress on law reform.

10. HFEA should review how it would use any new powers to delegate the responsibilities of the person responsible, including to improve the effectiveness of regulation of fertility centres with common ownership.

11. Now that HFEA’s adapted add-on rating system has been published, it should work with the department and professional bodies to determine how best a voluntary data collection programme for treatment add-on usage in clinics could be introduced.

12. Within the next 18 months, the department should, with the assistance of HFEA, put in place arrangements to regularly review the potential implications of recent research and innovations, for example, the use of synthetic tissues, in the context of the current regulatory framework.

13. HFEA should review its digital capability and identify options to enhance its digital offering, including working with the wider ALB community to share resources.

14. The department should consider how it could further support HFEA’s communication function to improve the impact of trusted and evidence-based information when it reaches patients.

15. The department should work with HFEA and NHSE to collectively review its current approach to joint working and propose options to strengthen collaboration to improve delivery on fertility and wider women’s health priorities.

Legal framework

16. As part of its response to HFEA’s proposals, the department should explore whether some of the areas for law reform could be pursued through secondary legislation. The department should also explore the merits of designating HFEA as a consumer law enforcer.

Accountability

17. The sponsor team should seek to ensure that annual ministerial accountability meetings are reinstated from 2024.

18. The department should, in the next 18 months, develop and consider succession plans within the sponsorship team to mitigate risk and maintain the effectiveness of its sponsorship arrangement.

19. The department should, within the next 12 months, develop improved arrangements for co-ordinating responses from its ALBs to information requests from across government.

Health regulatory landscape

The department’s ALBs come in a number of different forms. These can be described as follows:

• executive agency - while operationally independent, executive agencies are legally part of the department and are normally staffed by civil servants. They are at the least ‘arm’s length’ from the department
• special health authority (SpHA) - special health authorities are set up using secondary legislation, to carry out functions on behalf of the Secretary of State for Health and Social Care. They are legally separate entities from the department but are subject to directions from the Secretary of State. They are considered mid-level ‘arm’s length’ and are unique to the department
• executive non-departmental public body (NDPB) - NDPBs are set up using primary legislation and are considered the most ‘arm’s length’. They are both operationally and legally independent of the department but are subject to departmental oversight

The department sponsors 5 ALBs, including HFEA, that are responsible for regulating different elements of the health and care system. The other 4 are CQC, HTA, MHRA and HRA, and their functions are outlined below.

Care Quality Commission

CQC is an executive NDPB of the department. As an independent regulator, it regulates all health and adult social care service providers in England. As a regulator, CQC ensures the quality and safety of care provided by services registered with it, for regulated activities such as those provided in hospitals, GP practices and care homes. CQC achieves this by monitoring and assessing providers and local systems, providing independent assurance to the public of the quality of care in their area and tackling inequalities in health and adult social care.

CQC’s regulatory functions include:

• registering health and care providers
• monitoring, inspecting and rating services
• taking enforcement action to protect people who use services that fall below the fundamental standards
• publishing its views on major quality issues in health and adult social care

CQC has new responsibilities to assess how well local authorities are meeting their duties under Part 1 of the Care Act 2014, for people accessing care and support. It will also be looking at how services are working together within an integrated care system, and how these systems are performing overall against the 4 key aims of:

• improving outcomes
• tackling inequalities
• enhancing productivity and value for money
• helping the NHS to support broader social and economic development

It is important to note that CQC does not perform these functions in the devolved nations. Similar functions are performed in Scotland by Health Improvement Scotland, in Wales by the Healthcare Inspectorate, and in Northern Ireland by the Regulation and Quality Improvement Authority.

Human Tissue Authority

HTA is an executive NDPB of the department. It is the independent regulator across most of the UK, of organisations that remove, store and use human tissue for research, medical treatment, post-mortem examination, education and training, and display in public. HTA also approves organ and bone marrow donations from living people. Its regulatory functions include:

• licensing organisations that remove, store and use human tissue for certain activities under the Human Tissue Act 2004
• licensing organisations involved in preparing tissues and cells for use in patient treatment, as required by the Human Tissue (Quality and Safety for Human Application) Regulations 2007
• licensing organisations involved in organ donation and transplantation, as required by the Quality and Safety of Organs Intended for Transplantation Regulations 2012
• monitoring and inspecting or auditing organisations to ensure they comply with the requirements of the legislation and its codes of practice

Medicines and Healthcare products Regulatory Agency

MHRA is an executive agency of the department. It regulates medicines, medical devices and blood components for transfusion in the UK. MHRA uses science and data to inform its decisions, enable medical innovation and to make sure that medicines and healthcare products available in the UK are safe and effective. Its regulatory functions include:

• promoting international standardisation and harmonisation to assure the effectiveness and safety of biological medicines
• securing safe supply chains for medicines, medical devices and blood components
• educating the public and healthcare professionals about the risks and benefits of medicines, medical devices and blood components, leading to safer and more effective use
• enabling innovation and research and development that is beneficial to public health
• collaborating with partners in the UK and internationally to enable the earliest access to safe medicines and medical devices and to protect public health

Health Research Authority

HRA is an executive NDPB of the department in England, although it has some powers for UK-wide research and an obligation to work with devolved nations. It is responsible for ensuring that research in health and social care is of high quality. It operates with the aim of improving people’s health and wellbeing by protecting and promoting the interests of the public through health research. It achieves this by:

• ensuring that research is ethically reviewed and approved
• promoting transparency in research
• co-ordinating and standardising research regulatory practice
• providing independent recommendations on the process of identifiable patient information where it is not always practical to obtain consent, for research and non-research projects

Separate to the review, departments have been asked to look at the regulatory landscape, to see if there are opportunities to improve efficiency in how their ALBs deliver public services, and where possible improve the quality of service they provide while reducing the regulatory burden on businesses.

Overview of HFEA

HFEA is an executive NDPB of the department. It was established in 1991 under the Human Fertilisation and Embryology Act 1990 (‘the 1990 Act’) and performs functions under that act, as subsequently amended, and secondary legislation made under it. Its remit is UK-wide. Its functions include:

• licensing and inspecting clinics that carry out fertility treatments
• licensing and inspecting establishments undertaking human embryo research
• licensing embryo testing to provide options for treating serious inherited illnesses for affected families
• maintaining a register of all treatment services provided by licensed establishments to named patients and their outcomes. The register also contains details of all gamete and embryo donors and children born as a result of IVF and DI
• regulating the storage of human gametes (eggs and sperm) and embryos for treatment or research
• producing and maintaining a code of practice, which sets out quality and safety standards for treatment and research
• providing relevant advice and information to DCIs, donors, clinics, research establishments and patients
• providing advice to government, when asked, about the development of human embryo research and fertility related services regulated by the 1990 Act

HFEA employs approximately 76 staff, with a single office in London, and has a mix of office or home-based staff, and regionally located inspectors. Its SLT comprises 4 individuals, including the chief executive and a finance director, who is shared with HTA.

The authority currently comprises 14 members, including the chair and deputy chair. The 1990 Act dictates a strict balance of lay and professional board members, who chair and sit on a range of statutory committees, which undertake licensing and audit functions.

Efficacy

This section considers whether HFEA’s functions should continue to be performed by an ALB, and whether these functions could be merged with or transferred to other ALBs or remain with HFEA. 

Public body assessment

Cabinet Office guidance requires reviews to consider whether there is a case for a body to continue to exist. To determine this, the body must satisfy at least one of Cabinet Office’s 3 tests.

Test 1: it performs a technical function

The fertility sector is a discrete and specialised area of medical practice and research that can raise complex clinical, legal and ethical issues. HFEA’s business is therefore technical at its core and relies on specialists to perform its functions, and expertise among authority members. For example, HFEA needs to take decisions on whether to permit pre-implantation genetic testing for serious inherited diseases to enable people to avoid passing on such diseases to their children. The review, therefore, concludes that the requirements of this test have been satisfied.  

Test 2: its functions require delivery with political impartiality

Effective regulation of fertility treatment and embryo research requires HFEA to be free of undue influence from both industry professionals and ministers. It needs to act and be seen to act in an unbiased and objective manner for the benefit of the public as a whole. For example, it is important that the public has confidence in the quality of the advice and information published on its website for patients, donors and DCIs. The political impartiality that HFEA operates under is key to engendering the confidence and trust of service users. If its activities were not politically impartial, it would likely not be seen as an objective and authoritative voice on these matters. This would undermine the confidence of service users - many of whom are vulnerable - who need assurances that they are being provided with objective and accurate information relating to the issues that affect them. The review, therefore, concludes that HFEA has met the requirements of this test.

Test 3: it needs to act independently to establish facts

NDPBs have a role in the process of national government despite not forming part of a government department. As a NDPB, HFEA delivers important regulatory functions on behalf of the government, to ensure that standards are met and maintained across all establishments that undertake treatment and research involving human gametes and embryos. It is, therefore, essential that HFEA operates independently to ensure it can establish the facts when assessing whether clinics and researchers operate to an acceptable standard. This is paramount to ensuring that the public receive the best and safest fertility treatment possible, and that there is confidence in the way that embryo testing and research using embryos is conducted. The review, therefore, concludes that this test has been satisfied.

Conclusion

HFEA satisfies all 3 of the Cabinet Office tests and should therefore remain at arm’s length from the government.

Delivery model

It is important to then analyse the delivery model of the functions to decide if it is the most appropriate. The review notes that the ALB landscape has evolved over time since HFEA was formed and any reorganisation of delivery comes with its own challenges. Therefore, the benefits of any of the 5 possible delivery redesigns outlined below would need to outweigh these risks.

1. Abolish

The activities regulated by HFEA have a unique public profile and importance, because they concern human reproduction and the use of human embryos for medical advancement - an area of great complexity and sensitivity. Without regulation, there would be no independent safeguard for patients regarding the quality and safety of the fertility clinics offering them the chance to conceive. Additionally, there would be no central repository of trusted data on treatments and outcomes, gamete and embryo donors and children born as a result of IVF, for example, and no regulatory framework to consider the legal, ethical and scientific aspects of advances in testing and treatment.

The continuing potential for innovation and change in this area makes the case for reliable regulation and a scientifically well-informed regulator even stronger. This was illustrated by a number of developments that received considerable publicity during the course of this review. First, the reporting of the first baby born with DNA from 3 people through mitochondrial donation, a new IVF procedure that can prevent children from inheriting incurable mitochondrial diseases. This followed HFEA’s regulation of research enabling the process to be developed. Second, the development of so-called synthetic human embryos designed for the purposes of research without the use of human eggs or sperm. This is outside HFEA’s remit (and the legislative framework in the UK) because HFEA only regulates embryos derived from the use of human gametes. It is currently the subject of self-regulation by the scientists involved, raising important questions about the future of early embryo research and reinforcing the need for active surveillance.

These developments have highlighted the continuing importance of having a regulatory body with oversight over the regulation and development of science, research and clinical practices. This is to ensure that practices are being provided safely and ethically, to drive better outcomes for patients and to mitigate the significant personal and psychosocial costs that can arise from unregulated practices.

As the regulator in these areas, HFEA supports the fulfilment of health outcomes and enriches the wider development of policy, such as in the field of women’s health. For example, its work and partnership with professional bodies has helped to deliver a decrease in multiple births from 23% in 2007 to 5% in 2021. This has led to a significant reduction in risks for mothers and children, of pregnancy and birth complications and significant cost savings for the NHS. There have also been year-on-year improvements in IVF birth rates for patients under the age of 43. In 1991, for those aged 35 to 37, the birth rate per embryo transferred was only 7%. This had increased to 25% as of 2021 - see section 2 (Average IVF pregnancy and birth rates using frozen embryo transfers increased over the past 30 years) of HFEA’s Fertility treatment 2021: preliminary trends and figures.

The areas regulated by HFEA are dynamic - not only as scientific knowledge of what is possible develops, but also as societal understanding of that changes, along with attitudes to family formation. For example, there is not only a developing scientific awareness of, and ability to, identify genes that influence our health, but also increased societal awareness of the importance of an individual knowing their genetic origins. This has been reflected in changes to the law to allow DCIs to access more information, when aged 16 or 18, about their donors and donor-conceived siblings. The change in law in 2005 regarding donor anonymity, resulted in donors who registered post 1 April 2005 consenting to identifiable information being provided to DCIs, by applying to HFEA. The balance has changed to improve and protect the rights of children to know their genetic origins. This work highlights the need for a regulator with expertise to oversee not just clinical procedures and research, but also information management and the delivery of sensitive information, while signposting to where appropriate support, such as specialist counselling, can be sought. For example, HFEA currently commissions a post-donation support service with the Hewitt Fertility Centre. The review, therefore, recommends against abolishing this body.

2. Move out of central government

The department supports ministers in leading the nation’s health and social care system. HFEA is responsible for regulating activities within the areas set out in the 1990 Act. HFEA and the department have a shared interest in ensuring that clinical and scientific activities involving human embryos and gametes are carried out in a safe and ethical manner. Oversight of this area by an organisation able to advise central government independently and objectively is of strategic benefit and importance to government. The review notes that this is particularly the case in an area where the majority of treatment is now provided by the private sector in the UK. It would not be appropriate for providers to self-regulate. There is also no obvious non-governmental third-party provider. HFEA’s specialist focus on assisted reproduction activities, whether privately or publicly funded, means that it is well positioned to unite the sector and ensure that clinics are maintaining high standards. The review, therefore, recommends against moving the functions carried out by HFEA out of central government.

3. Commercial models

Outsourcing activities to the private sector can bring benefits. These can include efficiency savings, lower costs and resources, and improved performance, particularly where activities are being delivered in a competitive environment. However, HFEA does not deliver services itself. Rather, it acts in the public interest to ensure that fertility treatment and research are ethical, safe and in compliance with the law. It would be inappropriate to move HFEA’s functions to a private provider. Doing so would make it difficult to instil confidence in the objectivity of the new body, and its ability to effectively manage conflicts of interest, which could undermine trust in the regulator. The review, therefore, recommends against any commercial models that would include the outsourcing of HFEA’s activities to the private sector.

In saying this, the review does not preclude the possibility that certain activities of HFEA could be outsourced by it, to be more efficiently delivered by a commercial entity. The administration of the Donor Conceived Register (DCR), or HFEA’s research functions, for example, are activities which, in other jurisdictions, are not carried out by the body that regulates fertility clinics. The review believes, however, that the current set of functions that sit under the remit of HFEA produces good internal synergies and should remain.

4. Bring in-house

In order for the department to perform HFEA’s functions, specialists would need to be employed with the knowledge and expertise to keep up to date with a fast changing scientific and clinical landscape. Moreover, effective regulatory inspection procedures require their own skills. The department currently does not have this level of expertise as it is predominantly a policy department. The benefit of having a NDPB carry out these functions is that it ensures that the policies of government are implemented, while operating at arm’s length from ministers. This helps facilitate effective governmental process as these functions are discharged on behalf of the department. The review, therefore, recommends against bringing the functions performed by HFEA in-house.

5. Merge or transfer powers

There can be benefits from merging 2 or more ALBs that deliver similar or complementary functions. These may include potential savings through the removal of some governance and central costs, such as senior management, property, finance, HR and commercial services, as well as simplifying the public body landscape more broadly by removing organisational siloes. The potential benefits of merging ALBs should be balanced against risks or challenges of doing so at any given time, such as the requirement for consultation and changes to legislation. Although there may be opportunities to streamline or co-ordinate some functions, such as inspections, there should be sufficient synergies for a clear cost benefit outcome.

Proposals to merge or transfer some or all of HFEA’s functions have been consulted on in the past and have been subject to 2 prior reviews. This review’s assessment of whether HFEA should be merged with another ALB draws on those earlier appraisals. It also considers, in the current context, the merits of merging with bodies that perform similar functions to those of HFEA. These bodies are HTA, MHRA and CQC.

HTA

HTA acts to ensure that human tissue is used safely and ethically, with full and proper consent. It does this by regulating any organisation involved in the removal, storage and use of human tissue for research, medical treatment, post-mortem examination, education and training, and display in public. It also gives approval for the donation of organs and bone marrow from living people. HTA ensures compliance within its area of focus through inspections of premises or facilities, which may be announced or unannounced, to ensure the integrity of the human tissue or organ.

The main area of potential synergy between HTA and HFEA is that both bodies conduct licensing and inspection functions. This is only occasionally, in relation to the same establishments, such as laboratories, that require a licence from both regulators. Given the limited size of the 2 bodies, the potential overlap in terms of regulatory skills and infrastructure, and the potential for minimisation of regulatory burdens on establishments, previous reviews have considered a merger or transfer of functions between these 2 bodies to deliver efficiencies.  

In 2010, the department published Liberating the NHS: report of the arm’s-length bodies review, which considered the possibility of both HFEA and HTA transferring functions to other ALBs, including CQC and a research regulator (now HRA). However, this was not progressed as part of the Health and Social Care Act 2012 due to the complexity of the legal framework and the work associated with ensuring the smooth transfer.

A proposal was later put to public consultation in 2012 to transfer functions from HFEA and HTA to CQC and HRA. A majority of respondents (75%) disagreed with the proposal to transfer powers due to the risks posed to the expertise and specialism embedded within each organisation and the level of trust established within the regulated sectors. It was felt the functions of the smaller bodies could be ‘subsumed’ by the core business of the CQC. The subsequent McCracken Review in 2013 concluded in favour of keeping the 2 bodies as separate NDPBs with distinct remits, in order to uphold focus and specialist expertise and “maintain public confidence in the activities they regulate” but did point to improved co-operation and shared services, including through the introduction of a shared director of finance and resources, which is considered later in this review. The 2017 Triennial Review later found no evidence to suggest that the position had changed and concluded that no clear benefits could be achieved without incurring the significant risks posed by merging the organisations.

In considering the evidence, the review supports the broad conclusions of previous work in this area. HTA and HFEA regulate within discrete and specialist areas with little overlap. A merger would be unlikely to yield a cost saving that would outweigh the well documented risks and could drive additional costs in the short to medium term. HFEA performs well and offers stability. Organisational change could risk destabilising the sector and weakening regulatory oversight in an important period in the organisation’s history, as it focuses on possible legislative reform, new digital regulatory developments, and the release of identifiable donor information to DCIs conceived after 1 April 2005.

Alternative models, which stop short of full merger (such as having a single board), would carry similar risks and are also not recommended at the present time. However, further sharing of services and back-office functions, and efforts to minimise the burden on organisations that both organisations regulate and inspect, warrants further consideration. This has been set out in the ‘Efficiency’ section of this review. The review, therefore, recommends against merging HTA and HFEA into a new single ALB.

MHRA

MHRA is the UK-wide regulator of medicines, medical devices and blood components for transfusion. It grants licences for the manufacture, sale and supply of medicines, medical devices and blood components, and undertakes inspections of organisations involved in these areas to ensure that the applicable standards of safety, quality and efficacy are met. HFEA and MHRA both, therefore, carry out inspections and issue licences based on compliance with the required standards of safety, quality and efficacy in their areas. They also both have research functions, as MHRA is also responsible for authorising clinical trials research into the safety and efficacy of medicinal products in humans.

Despite these similarities, there are limited areas of overlap between these organisations. MHRA is focused on monitoring safety standards of all medicinal products and devices. The activity of HFEA, on the other hand, centres around the regulation of treatment and research specifically in the areas of embryology and fertility. A merger or transfer of functions between these 2 bodies, therefore, would be unlikely to produce significant efficiencies due to the differences in remit. Transferring some of HFEA’s functions to MHRA would also represent a significant risk, as MHRA would likely struggle with having to absorb this additional capacity. In the event of a merger or transfer of functions, inspectors would also need to learn to inspect to different specifications, which would take time and incur costs. The lack of clear synergies and areas of overlap between these 2 organisations leads the review to recommend against a merger.

CQC

CQC, established under the Health and Social Care Act 2008, is responsible in England for the registration, assessment, inspection and monitoring of health and adult social care providers, including independent providers. It has over 3,000 employees, which is considerably more than that of HFEA. Similar functions in Scotland are performed by Healthcare Improvement Scotland, in Wales by the Healthcare Inspectorate and in Northern Ireland by the Regulation and Quality Improvement Authority. Both HFEA and CQC carry out licensing and inspecting functions as part of their statutory duties to ensure the quality and safety of care of both private and NHS providers.

As with HTA, previous reviews suggested that a transfer of HFEA functions to CQC and HRA could create a more coherent and integrated approach to licensing and inspecting across the health landscape. Like HTA, this recommendation was not progressed immediately due to the complexities of the legislative framework and the amount of work that would be required to ensure an effective integration of the newly transferred functions.

The review has again considered the potential benefits and risks of such a transfer. It does not underestimate the degree of specialisation and skills required from staff for the performance of the tasks of HFEA. However, the review does not consider that there would be no benefits from such a transfer. There could be some benefits from transferring HFEA’s licensing and inspection functions in England to CQC, such as focussing responsibility for the quality of care across health and social care institutions in one body. For inspections and record-keeping requirements, it could allow a common set of regulatory powers capable of being adapted as risks change (CQC already possesses the ability to impose civil fines that would be beneficial for HFEA).

There could also be some advantage in enabling more flexible use and development of staff - including senior staff - and board time, to give HFEA access to more resources during pressurised periods, due to changes in regulatory activities or when key staff leave. HFEA has indicated that dealing with poorly performing clinics, and concerns about the continuity of care for patients at them, can be distracting and take a lot of management time - this is similarly the case for CQC. There could be learnings between them in managing such cases, although the statutory regimes are very different.

It has previously been suggested by some stakeholders that, as IVF has become accepted as a common treatment, it should come to be regulated in the same way as other healthcare interventions. In theory, it would be possible for specialist arrangements to be established in a merged body under which the most sensitive decisions HFEA takes - for example, approval of the use of pre-implantation genetic testing for serious conditions, mitochondrial donation, or research activity - to still be taken by an independent specialist committee.

However, the review was not persuaded that such a transfer would be advisable. None of the stakeholders interviewed for this review were in favour of it. The central risk would be the loss of the concentration of expertise and specialist focus that HFEA currently has, both in the members it has attracted and its staff. The activities it regulates are highly specialised and focused on human reproduction, and the risks around them are, in many respects, different from those in other areas of healthcare. For example, the laboratories and storage facilities for gametes and embryos and arrangements for their movement, are highly specialised and need an intensity of scrutiny and record keeping far greater than most healthcare.

Moreover, the regulatory cultures of the 2 bodies are not the same: HFEA has a more compliance-based approach to inspection, whereas CQC has a broader remit focused on quality assurance. HFEA noted that its inspection regime is technical, and thus would require CQC inspectors to undertake specialist training to inspect fertility and embryology facilities. Any efficiencies would take time to realise.

Finally, a major complication of any merger would also be that HFEA has a UK-wide remit, whereas CQC is England only and does not perform its functions in the devolved nations. In theory, new arrangements could be consulted upon and legislated for, in order to regulate activities, in each of the devolved nations, currently performed by HFEA. This would clearly be time consuming and would lose the considerable synergies that come from having a UK wide regulator.

A transfer of functions or merger would not be a simple legislative process. The legislation that permits the transfer of functions between health bodies, in the Health and Care Act 2022, does not contemplate such a merger and did not include CQC in the transfer of functions power. Therefore, primary legislation would be needed to allow for a transfer of functions from HFEA to CQC.

Given the complexity and the risks involved, the review recommends against a merger. The review also notes the proposal from the Law Commissions’ report that functions related to surrogacy should sit with HFEA, given its focus on IVF regulation. This proposal has been considered in the ‘Legal framework’ section.

Summary

A summary of the options considered is set out in table 1.

Table 1: assessment of alternative delivery models

Delivery option	Assessment
Abolish	Rejected - functions are needed
Move out of central government	Rejected - could undermine independence; no obvious alternative providers
Commercial models	Rejected - as above
Bring in-house	Rejected - requires specialist expertise; may undermine independence requirement
Merge or transfer powers	Rejected - risks loss of expertise; limited benefits to mitigate potential risks
Continued delivery by a NDPB	Accepted - HFEA meets the tests for NDPB status

Conclusion

The review finds that HFEA’s status as a NDPB represents the most appropriate model for delivering the functions it carries out. This model allows HFEA to advise the department as necessary on sectoral developments while also affording it the operational independence to establish facts and regulate commercial entities independently of political interference. As a NDPB, HFEA is in a position to speak with objectivity and authority on issues relating to fertility treatments and research. A change in the delivery model may risk undermining the public’s confidence in the safe and ethical regulation of treatment and research involving human embryos and gametes. A merger or transfer of functions between HFEA and another ALB would carry similar risks and involve complex legislative processes, without yielding cost-saving benefits.

Recommendation 1

HFEA should remain an executive non-departmental public body.

Efficiency

This section will examine HFEA’s financial management performance over the past 3 years. It also considers HFEA’s benchmarking performance to assess its efficiency and performance against comparators and considers how it could improve proficiency through innovative approaches, such as shared services. This section further assesses whether there is scope for HFEA to deliver efficiencies, including both short term and medium term, through changes in its funding arrangement and fee structure. It also provides a high-level assessment of its data submission system, PRISM.

Financial performance

HFEA’s financial performance from 2019 to 2023 has been considered as part of the review.

HFEA has generally enjoyed a stable financial position post-COVID-19. The fertility sector was the first elective health service to resume treatment in May 2020. Fertility treatment is almost unique in the UK in that the majority of patients self-fund their treatment. The UK fertility sector is around 35% NHS and 65% privately funded, although clinic licence fees to HFEA are the same irrespective of patient funding arrangements. Eighty per cent of HFEA’s funding is derived from licence fees, with the remaining 20% from GIA from the department.

There was a dip of 18% in income from clinics for the 2020 to 2021 financial year, which was at the height of the pandemic, compared to 2019 to 2020. HFEA’s 2021 to 2022 position presents a healthier financial picture, with revenue from clinics recovering and surpassing pre-COVID-19 figures at £5.6 million. Its yearly expenditure on staffing costs and purchasing of goods and services also remains stable with no visible cause for concern. The increase in depreciation, amortisation (the process of reducing a cost or total in regular small amounts) and credit losses can be attributed to its data submission system, PRISM, which is discussed in more detail below. PRISM incurred additional and unexpected costs in 2021 to 2022 of £266,000 due to the need for additional third-party support. However, HFEA’s accommodation costs decreased by 42%, which were realised from savings in rent of £173,000. This was following HFEA’s relocation to a government-owned building in Stratford in 2021, co-locating with 4 other health ALBs.

HFEA’s 2022 to 2023 financial position is also positive. While the overall operating expenditure has increased by 7%, partially due to the adoption of international financial reporting standards (IFRS 16) and the recognition of leases on financial statements and subsequent amortisation of said leases, overall operating income has further increased by 5%. The increase in purchases of goods and services for 2022 to 2023 can be attributed to further legal expenses incurred in-year.

HFEA reported a small overspend at year end that was covered by reserves. This was driven in the main by a high turnover rate. Staffing levels have also increased to support work arising from a change in the law that will allow DCIs the right to access their donor’s full name, date of birth and their last known address. HFEA reports continued pressures on legal spend as its regulatory decisions and regime continue to be the subject of legal challenge.

Staffing costs remain HFEA’s biggest expenditure, although its pay award is in line with the department’s pay remit. HFEA has made further savings on accommodation in line with the previous year’s trajectory. Travel and subsistence costs have decreased as the move has allowed larger authority and committee meetings to be held onsite, rather than at external venues. In addition, HFEA’s adoption of hybrid inspections has lowered travel and subsistence costs by 36%.

HFEA’s income and expenditure for financial years from 2019 to 2023 are set out in tables 2 and 3.

Table 2: comparison of income for financial years from 2019 to 2023

Income source	2022 to 2023 (£’000)	2021 to 2022 (£’000)	2020 to 2021 (£’000)	2019 to 2020 (£’000)
Revenue from contracts with customers	−5,875	−5,581	−4,281	−5,230
% change	+5%	+30%	−18%	not applicable
Other operating income	−90	−111	−149	−218
% change	−19%	−26%	−32%	not applicable
Total	−5,965	−5,692	−4,430	−5,448
% change	+5%	+28%	-19%	not applicable

Table 3: comparison of expenditure for financial years from 2019 to 2023

Expenditure	2022 to 2023 (£’000)	2021 to 2022 (£’000)	2020 to 2021 (£’000)	2019 to 2020 (£’000)
Staff costs	5,198	4,820	4,958	4,629
% change	+8%	−3%	+7%	not applicable
Purchase of goods and services	510	299	220	189
% change	+70%	+36%	+16%	not applicable
Depreciation, amortisation and expected credit loss	471	554	201	321
% change	−15%	+176%	−37%	not applicable
Other operating expenditure	1,062	1,095	1,411	1,624
% change	−3%	−22%	−13%	not applicable
Total	7,241	6,768	6,790	6,763
% change	+7%	negligible	negligible	not applicable

Benchmarking

Benchmarking exercises can be useful guides to identify standards and best practices. They can be used to determine where an organisation ranks on comparative cost and performance. There may be external factors or internal processes which explain why an organisation performs particularly well or poorly through benchmark comparisons.

HFEA does not regularly produce any benchmarking data against other organisations. It has stated that this is due to the difficulties in finding comparable organisations and the resource that is required to collect and analyse comparative data. The review agrees that the unique nature of many of HFEA’s regulatory activities, such as the provision of information to patients and the regulation of the storage of gametes and embryos, make those difficult to benchmark. Nevertheless, the review considers that HFEA should continue to explore ways of comparing its work with that of other regulators both in the UK and abroad. The review is aware that the European Society of Human Reproduction and Embryology (ESHRE) collects comparative data, to which HFEA contributes.  

Recommendation 2

HFEA should continue to learn from the effectiveness of regulators in both the UK and overseas, and set objectives in this area linked to its business priorities as appropriate.

The review considers that there is value in benchmarking corporate functions. Such data can be used to monitor performance and highlight some of the potential issues that HFEA faces, by drawing on the comparison with well-managed functions of other organisations. Cabinet Office is considering ways to benchmark the corporate functions of small ALBs and the review supports this initiative.

Internally, HFEA does assess performance through its KPIs. Its Audit and Governance Committee recently revised its KPIs and plans to undertake a deep dive to consider the effectiveness of performance management and risk. The review supports this approach and feels there is value in HFEA conducting an internal exercise to see how far this data could be used in taking internal prioritisation decisions. This might be on a regional basis or to see whether more or less frequent inspection produces better results and would enable better allocation of resources. It would enable inspections to be focused on centres needing more in-person or online support to improve. The review therefore recommends that HFEA looks to systemise an approach to improving performance by increased internal benchmarking of its inspection regime.

Short-term efficiencies

Cabinet Office guidance requires reviews to identify where efficiency gains, both cashable and non-cashable, can be made within the ALB. As per the terms of reference for this review, HFEA is required to deliver at least 5% in resource RDEL funding from its 2022 to 2023 financial year budget. These efficiency savings should be delivered within one to 3 years following the review and can take into account inflation and also savings that have already been delivered under the last spending review. 

The department’s ALB Reform and Efficiency Programme, which considered ways to improve efficiency across health public bodies, identified savings of more than 5% of HFEA’s RDEL funding from its 2022 to 2023 financial year budget onwards. The review considered that, given the pre-existing efficiency savings identified, an additional 5% in efficiency savings on the total budget would be challenging for a small public body like HFEA.

Eighty per cent of HFEA’s income comes directly from clinic licence fees for IVF treatment cycles. HFEA has agreed to increase clinic licence fees from April 2024 for the IVF treatment cycle and for DI. A fee increase would remove most of HFEA’s GIA, resulting in non-cashable efficiency savings in the region of £0.7 million a year. HFEA will continue to receive GIA in the region of £0.4 million a year to cover statutory duties in respect to its opening the register service, which is specifically excluded from being funded by fees under provisions in the 1990 Act. The near removal of GIA and a greater reliance on fees will increase HFEA’s income volatility and would require some year-end flexibility, including a more active use of current reserves, to ensure HFEA can break even.

HFEA also receives £0.08 million each year in CDEL allocation (excluding IFRS 16). This funds the replacement of IT equipment, although demand varies year on year. HFEA has agreed to reduce its CDEL allocation, which has been reflected in its revised 2023 to 2024 financial year allocation of £0.04 million. In the medium term, HFEA will require access to capital funding to ensure its IT remains fit for purpose.

Recommendation 3

Subject to HM Treasury approval, the department and HFEA should implement the proposed fee increase from the 2024 to 2025 financial year.

Medium-term efficiencies

HFEA generates revenue from a range of activities that it can charge for under its current fee structure. HM Treasury rules allow HFEA to charge the bodies it regulates only for the cost of being regulated.

HFEA charges clinics for their licensed activity, which includes single fees, such as for a new licence application or a licence renewal, in addition to recurring activity fees, such as the cycle of IVF or intracytoplasmic sperm injection (ICSI) treatment. For financial year 2022 to 2023, the total income generated from all fees was £5.8 million. The biggest revenue driver is the recurring fees per treatment cycle, which accounted for £5.79 million of the financial year 2022 to 2023 total. A full list of fees can be found in table 4.

Table 4: breakdown of fees paid by centres

Chargeable activities	DI and IVF treatment and storage centres (fee £)	Storage centres (fee £)	IUI treatment centres (fee £)	Research centres (fee £)
New licence application	500	200	975	500 or 750
Renewal licence application	250 or 500	200	500	500 or 750
Third party agreement (with centres not licensed by HFEA)	250	250	250	not applicable
Chargeable IVF treatment (recurring fee)	85	not applicable	not applicable	not applicable
DI treatment (recurring fee)	37.50	not applicable	not applicable	not applicable
Annual activity	not applicable	not applicable	2,950	not applicable
Chargeable variations to licence - change of premises	500	500	500	500

HFEA has only raised its fees once in the last 7 years - representing a counterfactual saving to licence fee payers of around 20% compared to the consumer prices index over the same period. In recent years, it has used internally generated efficiencies to absorb inflationary pressures to keep fees down.

The review, however, notes that HFEA has a long-standing commitment to undertake a complete review of fee structure dating from before the COVID-19 pandemic. This commitment was to look at possible alternative models of fee raising, such as:

• flat rates according to clinic size or networks of clinics
• different rates for IVF cycles or donor cycles
• charging for storage licensing
• fees for research data applications
• fees for providing other information, including information pertaining to DCIs

HFEA said that this was appropriate to ensure its fee structure properly reflects recent changes in clinical practice, such as the greater use of freezing and the increasing cost of regulating the sector. The department previously agreed that HFEA should defer this review until after the COVID-19 pandemic, when activities had normalised. The review agrees with HFEA that the fee review should now be prioritised for the financial year 2024 to 2025.

Recommendation 4

Within the next 18 months, HFEA should establish plans to allow it to conduct a review of its fee model.

Shared services

There are clear benefits that can be achieved through sharing services. Cabinet Office Shared services strategy for government indicates that sharing services can reduce costs and deliver better services through modern systems by removing system inefficiencies and improving effectiveness. The review has assessed the extent to which a shared service approach would be beneficial to HFEA. The areas considered are:

• finance
• people
• digital, data and technology (DDaT)
• legal

Finance

Finance is an area where shared services have already been investigated as a cost-saving measure for HFEA. Following the recommendations of the McCracken Review in 2013, a shared director of finance and resources between HFEA and HTA was inaugurated, with time and costs split evenly between the 2 ALBs.

HFEA’s finance and resources team is made up of 3 additional FTE posts:

• head of finance (also shared with HTA)
• finance and accounting manager
• accounts officer

The director of finance and resources is part of both organisations’ SLTs, with responsibility for all financial planning, reporting and statutory accounts production, as well as management of the estates and facilities functions. The role has additional responsibilities for other functions, including as senior information risk owner, audit and risk committee lead, owner of organisational strategic and operational risk, and for programmer management or senior responsible owner (SRO).

There are further areas where the review considers support in finance through shared services would be beneficial to HFEA. This includes in financial management, as the review noted the lack of resilience that HFEA had in providing some financial information about its activities to the review, during a period when its director of finance and resources post was vacant. HFEA has also suggested that transactional support (payroll, accounts receivable) and alignment of its financial systems with other ALBs, would benefit an organisation of its size. The department’s commercial team should support HFEA in exploring options for upgrading finance systems and processes as a more explicit shared service with HTA, with a view to increasing efficiency and resilience within respective finance teams.

People

For smaller ALBs like HFEA, retaining talent is challenging as people move to the private sector or elsewhere within public service to seek not just improved pay or employment terms, but also a clearer development-focused career pathway. HFEA reports that on average it loses between 5% and 10% of inspectors each year. This amounts to further economic loss due to the necessity to recruit, hire and train new inspectors. According to HFEA, many outgoing members of staff comment that, although they like the organisation, the lack of opportunity for career development and the superior pay available in the private sector are factors that influence their decisions to leave.

DDaT

Another area where HFEA has experienced difficulty in recruitment and retention is in the DDaT profession. HFEA has a high turnover of staff in areas such as IT, which has led HFEA to rely on contracted staff to cope with the demands of change projects. This carries associated risks around loss of corporate memory and longer-term system resilience and cost. HFEA has averaged a turnover of 3 members of staff per year for the last 5 years, which equates to a turnover of approximately 20% of staff in this area. HFEA states that an organisation of its size is unable to offer much in the way of career development or opportunities for promotion and, like much of the public sector, it cannot offer pay in line with what IT professionals can command in the private sector. In addition, the review has identified additional areas of DDaT which it feels the shared service offering of another ALB, with large-scale digital and technology transformation capabilities, could support HFEA to deliver improved outcomes. These areas are:

• website development
• search engine optimisation
• data analytics on clicks to track usage
• data reporting (national and international)

Legal

For more than 10 years prior to June 2022, HFEA had an in-house permanent head of legal but appointing a new permanent in-house lawyer is a difficult task. This is due to the small size of the organisation, with the lack of a supporting team, and little opportunity for internal progression. External legal advisors are used to support licensing decisions to ensure appropriate separation of functions, and there is ad hoc use for particular litigation cases.

As a result, since June 2022, HFEA has instead employed lawyers for 6 months at a time on secondment from a law firm to see if this arrangement would work going forward. According to HFEA, these legal secondments have cost HFEA around £50,000, more per year than when it relied on a single in-house legal counsel.

While the review makes no criticism of the quality of the advice being obtained at present, it notes the potential advantages of an in-house legal function, that is able to access legal support networks within the wider ALB community. Many of the issues of public law and statutory interpretation affecting the work of HFEA, are similar to those faced by other ALBs. Accordingly, the review understands that HFEA will review the merits of other arrangements for internal and external legal support, which could provide a saving over the longer term and enhance the resilience of the organisation. The review suggests that these might include a shared legal service with other ALBs.

Conclusion

The review notes that the department is working closely with its ALBs to look for solutions in these areas by identifying opportunities to improve capacity and capabilities through improved collaboration. Improving functional capabilities, recruitment and retention through shared services could help provide more fulfilling career pathways, improve resilience, and help bring down contractor spend. This is welcomed, as increased shared services could enable the realisation of further efficiencies in the medium term and improve the effectiveness of HFEA.

As per Cabinet Office guidance, efficiency targets for each review must be quantified. However, at the time of this review, the quantification of efficiency savings has not been possible, as any estimate is based on future workstreams that have not been fully scoped. Therefore, the department should quantify potential efficiency savings for the short and medium term once scoping is complete.

Recommendation 5

The department should work with its ALBs to scope the merits of shared service functions to determine whether there is opportunity for improved overall efficiency in the areas identified by this review.

PRISM

The Patient Register Information System (PRISM), HFEA’s new data submission system, was launched in September 2021, and roll out began in January 2022. It was intended to improve the quality of data submitted to HFEA, enabling it to improve the effectiveness of its regulation of clinics and embryo research establishments. HFEA hopes that, in time, PRISM will deliver savings to HFEA and the fertility clinics that use it by reducing the administrative burden of its statutory duties on clinics while delivering improved data. HFEA is now close to completing its roll out and is conducting checks to validate the data being received.

Prior to PRISM, data was submitted to HFEA by one of 2 methods:

• a standalone data submission system that had been built by HFEA many years ago and installed in licensed clinics that did not have a third-party patient record system. Clinics manually entered data which was then sent direct to HFEA
• clinics used an electronic patient record system (EPRS) to manage their own data and there was an interface which allowed a subset of that data to be submitted to HFEA

The data received by HFEA was often of poor quality (anecdotally around 10% of data submitted had errors) and required validation by the HFEA register team and clinic data staff, to remove errors before publication on its website. Error rates for data submitted directly through PRISM are at around 1% and that through EPRS, between 3 and 4%. PRISM therefore minimises this administrative burden as, by design, it improves the quality of the data submitted. This is through improved validation rules, which restrict establishments submitting incorrect data in the first place and provide better visibility of incorrect data for action.

However, the development and implementation of the wider IT programme, of which PRISM is a part, was over budget (around £2 million more than the initial estimate) and took longer than planned. It was approximately 3 years longer if measured from the initial launch estimate. HFEA has stated that both the delivery date of PRISM and its budget were over-optimistic and should have been subject to thorough reassessment as part of its business plan commitments in 2018 to 2019. Given how recent the roll out has been, the review was unable to assess:

• the impact of PRISM on HFEA efficiency or data use
• HFEA’s plans to benefit from this in terms of its own staff reduction and data use
• the extent PRISM reduces costs to, and burdens on, establishments inputting the data

The review finds that there is sufficient ongoing corporate and authority oversight of the programme, along with engagement with users to work through any issues. The review, however, considers that once PRISM is embedded, HFEA should prioritise a review of the efficiency benefits both for HFEA and clinics.

Recommendation 6

Within 12 months of all the functionalities of PRISM being embedded, HFEA should review the efficiency of PRISM.

Effectiveness

This section provides a high-level overview of the arrangements for the provision and regulation of assisted reproduction technologies (ART) - primarily IVF in the UK (the review focused on IVF rather than other ART as it is the most common) and a number of other countries. The considerable differences between the regulatory regimes and funding arrangements in different states provide helpful context when evaluating the role of HFEA. It further assesses the overall effectiveness of HFEA as a regulatory body in protecting the public interest, including:

• ensuring clinics and laboratories (licensed centres) set and maintain high standards
• improving safety standards for patients
• regulating research
• regulating the provision of information to potential patients
• maintaining various registers
• its working relationship with other ALBs

It also considers HFEA’s internal processes for managing conflicts of interest and cyber security capabilities.

The provision and funding of IVF services

In the UK, ART (primarily IVF) can only be provided in facilities licensed by HFEA. HFEA does not determine how ART is funded, nor does it regulate the pricing of provision of ART. However, the funding arrangements for ART in the UK do provide important context for its regulatory activities, in part because of the financial pressures on patients and clinics in the UK.

The funding of ART across the UK varies considerably. Some ART is funded by the NHS, but the majority is privately funded. To be funded by the NHS, certain conditions need to be met. In England, these conditions, such as a woman’s health and age and whether there has been previous ART, are set having regard to clinical guidance from the National Institute for Health and Care Excellence (NICE), but funding varies between local integrated care boards (ICBs), depending upon their overall priorities and resources. Both NHS-owned and private clinics compete for contracts to provide treatments for ICBs. In Scotland, Wales and Northern Ireland, health commissioning and funding for ART by the NHS is determined by the relevant devolved administration. According to HFEA statistics, for patients under 35 years old, private funding has increased from 52% in 2019 to 63% in 2021.

International comparisons

According to the World Health Organization (WHO), infertility is a global public health issue that has widespread consequences on health and wellbeing. WHO estimates that around 17.5% of the adult population experience infertility. WHO notes that treatment for infertility is still largely unavailable, inaccessible and unaffordable in many parts of the world, particularly in low and middle-income countries. Consequently, there are few regulatory systems in place in these countries. The review therefore looked to other higher-income countries to compare their regulatory arrangements with those in the UK. For the purposes of this review, comparative analysis was carried out on fertility regulation in Canada, the USA, Australia, Germany and elsewhere in Europe.

Canada

Canada has a publicly funded healthcare system, which regulates IVF treatment provincially. Since 2021, the Canadian government funds one cycle of IVF for couples, including same-sex couples. Over half of all clinics in Canada are privately funded, and the average cost of an IVF cycle is approximately CAD$7,000 (£4,200).

The federal health department, Health Canada, regulates fertility clinics through its Regulatory Operations and Enforcement Branch, which produces guidance for clinics and laboratories. It sets out safety standards that all donor gametes are required to meet before they can be used for treatments. Accreditation Canada is an independent non-profit organisation that reports to Health Canada and carries out regular inspections of all social care and healthcare settings, with specialist inspectors for fertility laboratories and clinics.

Medical services, which include fertility services, are regulated provincially under medical college guidelines. While there is no officially regulated national donor registry, there is interest in mandating provincial donor registries that would be searchable through a federal system. Currently donors can remain anonymous, but legislation is planned to remove anonymity.

Health Canada also maintains a centralised mandatory data collection system. The Canadian Fertility and Andrology Society collects data on a voluntary basis. Provinces can use the central data to better understand risks and outcomes of treatments.

United States of America (USA)

In the USA, fertility service provision is regulated on a number of levels. At a federal level, fertility services are regulated by 3 agencies:

• the Centers for Disease Control and Prevention (CDC) collects and publishes data on assisted reproductive procedures
• the Food and Drug Administration (FDA) controls approval and use of drugs, biological products and medical devices. This includes regulation of infections, disease screening and testing of donated reproductive tissue including donor egg, sperm and donor embryos. It has the power to fine or shut down clinics if they are non-compliant with FDA regulations related to screening and testing of donated reproductive tissue
• The Centers for Medicare and Medicaid Services is the agency responsible for implementation of the Clinical Laboratory Improvement Act to ensure the quality of laboratory testing

There is self-regulation by medical boards and professional agencies, including:

• the American Board of Obstetrics and Gynecology, which certifies reproductive endocrinologists
• the American Society for Reproductive Medicine (ASRM), which produces both practice and ethics guidelines through their Practice Committee and Ethics Committee and provides guidance for all aspects of reproductive care
• the Society for Assisted Reproductive Technology, an affiliate of the ASRM, which monitors fertility clinics for adherence to the ASRM guidelines and accredits their embryology labs

The number of IVF cycles that an individual may receive varies considerably due to their resources and, in particular, insurance coverage, which is often dependent on employment status. Some states have mandates that require insurers to cover the provision of fertility services to varying degrees. Overall, availability of assisted fertility services, even in states that have insurance mandates, varies widely. For those individuals without insurance coverage, the costs of fertility services are often high and, in many cases, limit access to care.

There is no central donor registry in the USA. Information about gamete and embryo donors and recipients is held locally at fertility clinics, donor agencies and egg and sperm banks. There is no federal law governing donor record keeping or donor identification. Therefore, it falls to individual states to determine their public policy, and the vast majority of states do not address these issues, leaving private industry to set standards. To date, 3 states have laws governing record keeping and identification. The states of Washington and California passed laws in 2011 and 2018 respectively requiring donors to decide at the time of donation whether to opt in or out of identity disclosure. If a donor opts-in, the DCI may request identifying information about their donor after age 18. Both states require banks and clinics to maintain records. The state of Colorado passed a law in 2022, which will take effect in 2025, requiring disclosure of donor identity if the DCI requests disclosure after age 18. The law further requires banks and clinics to maintain records.

Australia

Australia’s healthcare system is publicly funded through Medicare, which pays half the cost for each IVF cycle provided by a private clinic (around the equivalent of AUS$4,800 (£2,500). In public clinics, patients are only required to pay a smaller contribution (approximately AUS$1,000 (£500)). There are no restrictions on the number of IVF cycles funded by the government, and no caps on the age of men or women for Medicare rebate eligibility.

A code of practice was established by the Reproductive Technology Accreditation Committee (RTAC), which is managed by the Fertility Society of Australia. Annual on-site inspections by specialised inspectors are paid for by clinics through the Fertility Society of Australia. Any serious issues raised with RTAC could result in insurance payments being reduced or ultimately a clinic’s licence being withdrawn, although this is unusual. The Embryo Research Licensing Committee (part of the National Health and Medical Research Council) and federal legislation around research and provide governance in the areas of licensing, inspections and the database.

The University of New South Wales runs the federal database (ANZARD) and publishes an annual report. Clinics pay a fee to cover the costs of the database and researchers can request data. Donor registers - and whether or not donors are permitted anonymity - are devolved to individual states. In New South Wales and Victoria, with the lifting of anonymity for individuals conceived before 2011, donors must agree to any requests to meet individuals after they reach the age of 18. The state of New South Wales is considering how to support those who wish to access donor information. In Western Australia, individuals aged 16 or over can request their donor’s identifying information.

Germany

Most treatment clinics in Germany are privately funded. Germany has a state-run public health insurance scheme, funded by taxpayer contributions, which sets out the federal criteria for the funding of fertility treatments in Germany. Under this scheme, funding is only available for married couples and, even then, not in circumstances when donor sperm is used. One IVF cycle costs approximately €4,500 (£3,800), half of which is funded publicly for up to 3 cycles.

Clinics are required to comply with standards set through the Federal Institute for Drugs and Medical Devices (FIDMD). Inspections are carried out every 2 years by regional inspectors on behalf of FIDMD. There is mandatory regional reporting for success rates and multiple births. FIDMD also holds and maintains a national sperm donor register, which allows for data to be kept for 110 years.

While there is no mandatory national register, data from nearly all fertility centres in Germany is held by the German IVF Registry. This data can be used for medical research, although embryo research and pre-implantation genetic testing is banned.

German law does not allow egg donation, although it does allow sperm donation, and anonymous donation is not allowed.

Other European states

There are considerable differences in public funding, legislation and regulation between European countries, the extent of which were shown in a 2023 study on equal access by ESHRE.

ESHRE has produced guidelines promoting best practice for IVF across Europe, including on the use of treatment add-ons, and is encouraging more harmonisation of data between registries across Europe. ESHRE has noted that the extent of cross-border movement of patients seeking treatment makes comparison of activity between different states very difficult. Potential patients’ decisions to seek treatment across borders may be for a variety of reasons, such as cost, availability of gametes, or regulatory differences, for example anonymity of donors or allowing for sex selection of embryos.

Conclusion

Different countries, and areas or regions within them, adopt a variety of approaches to regulation of ART. In some jurisdictions, standards regulation is left to professional bodies alone, while in others like the UK, this is supplemented by the activity of regulators. In the countries compared, regulation and the extent of publicly provided or supported funding that is available for it also varies widely. Given these differences and the limited harmonisation and reliability of available data to make comparisons, the review did not try to benchmark the comparative performance of HFEA against regulators in other states. While precise comparisons are difficult, there is scope for HFEA to learn lessons from overseas jurisdictions in terms of regulatory approaches, where appropriate comparisons can be made. This could in part be through maximising HFEA’s engagement with ESHRE.

The international landscape is important when considering the role of HFEA in relation to cross-border activity. HFEA regulates the quality and safety of arrangements for import and export of gametes and embryos. It also publishes general guidance on its website for potential patients on the risks of travelling abroad for treatment, although this does not deal with risks from treatment in particular states. The review considers there would be value in evaluating the impact and risks of cross-border activity, where it is likely to indirectly impose costs on the NHS, such as resulting from multiple embryo transfers. With HFEA’s support, the department should ensure this area is monitored as part of any evaluations of cross-border healthcare impacts.

Recommendation 7

The department should include the fertility sector in any evaluation of cross-border healthcare services, for example the costs, benefits and risks to UK citizens.

Regulation of clinics and laboratories

Inspections

In the UK, fertility treatment services and research involving human embryos can only be provided or conducted in facilities licensed by HFEA. The 1990 Act requires that clinics are inspected by HFEA to ensure that they meet certain standards. HFEA must inspect premises before issuing a licence, which can last for 5 years but is usually issued for 4. During the licence period, HFEA must inspect the premises within a 2-year period.

With the development of digital technology and communications generally, it has become possible to conduct more regulatory activities remotely. Since the COVID-19 pandemic, inspections have been conducted through a risk-based hybrid approach of remote, desk-based assessment and on-site inspection. This approach was reviewed by the GIAA in 2022, which deemed its hybrid approach to be effective, the highest rating.

Where HFEA identifies non-compliance during the inspection process, its inspectors aim to work with clinics and laboratories to address those issues where practicable. HFEA has regard to its compliance and enforcement policy to assess resulting risk and determine what regulatory action should be taken. If an incident is reported to HFEA, its clinical governance team uses an incident grading matrix to assess the seriousness of the incident, including the likelihood of it happening again, when deciding what action to take. Monitoring ongoing remedial actions and improvements can work well but can be slow and divert considerable HFEA resources. HFEA has suggested it would assist them if they had a wider range of sanctions to apply in cases of non-compliance, including fining powers. The review discusses this possibility in the ‘Legal framework’ section.

All those interviewed, including stakeholders, staff and members of HFEA, placed value on inspections to maintain standards and encourage good communications between the person responsible for each clinic and HFEA. Some stakeholders said that the initial desk-based assessment could be lengthy and duplicative, with clinics asked the same questions during the in-person inspection.

The review encourages HFEA to keep the requirements of the hybrid approach under review, and to ensure duplication between the desk-based and physical elements of inspection is minimised where possible. The ‘Legal framework’ section considers HFEA proposals to change the law relating to the frequency of inspections and length of licences.

Recommendation 8

Over the next 18 months, HFEA should evaluate the PRISM data it now holds with the aim of improving the use of technology and data to enable a more risk-based approach to inspection.

Code of practice

HFEA’s statutory code of practice provides guidance on licensed activities and the discharge of functions to the person responsible at fertility centres and other persons to whom licences apply. The code of practice is divided into provisions setting out mandatory requirements, how HFEA interprets those, and additional advice on best practice.

Amendments to the code of practice must be approved by the Secretary of State before publication. To date, it has been developed through 9 editions and a number of updates within each of these editions. The current version has been updated to reflect recent legislation around the storage of gametes and embryos.

The code of practice is treated by responsible persons as a “go-to document.” HFEA considers that its surveys suggest stakeholders value the structure and detail in it. However, some feedback received from stakeholders was that it has “grown much too long” and it would benefit from a “major overhaul” since they find it complex and sometimes difficult to navigate.

Updates to the code of practice have focused on adding material on new developments (such as legal changes), rather than the overall continuing effectiveness of the guidance in delivering improved outcomes. Given the importance of the code of practice in maintaining and raising standards, HFEA should consider the feedback from its users on how it could be improved. The review therefore recommends HFEA engages with stakeholders to review whether there is scope to make it more concise and user-friendly for clinics.

Recommendation 9

As resources allow, now that HFEA has published the updated code of practice, it should engage with stakeholders to determine whether there is scope for the code of practice to be shorter and more user-friendly. The review notes that the timing of this work will also depend on progress on law reform.

Person responsible

The 1990 Act requires that all fertility clinics must identify a person (known as the person responsible) who has overall responsibility for ensuring the clinic complies with its legal responsibilities as a licensed centre. This is a non-delegable responsibility for an individual and obliges them to take responsibility for supervising the conduct of all the people working at the clinic.

Some individuals act as the person responsible for more than one clinic. The review acknowledges the potential benefits of this in ensuring consistency of standards and behaviour between them, but also the difficulties because of risk of individual overstretch, given the need for a personal presence to perform the role.

Both HFEA and representatives of clinics see potential value in allowing for more delegation of responsibility by the person responsible. For example, allowing for a deputy to be appointed who can perform the role in certain circumstances, particularly where several clinics have the same licensee.

The review considers that having an identified individual, with formal responsibility for standards of conduct, should continue to be a pre-condition for a clinic being licensed. The role of a person responsible is well understood, is taken seriously by individuals and helps to maintain standards across the sector. However, the review recognises that over-reliance on one individual can itself create risks and inflexibility, and may not always be the best model, particularly in the case of regulation of chains of clinics performing very similar tasks.

HFEA has proposed that the law be reformed to permit more scope to vary the role of person responsible. The review comments further on this proposal in the ‘Legal framework’ section.

Recommendation 10

HFEA should review how it would use any new powers to delegate the responsibilities of the person responsible, including to improve the effectiveness of regulation of fertility centres with common ownership.

Improving safety standards for patients

Multiple births

Some IVF procedures increase the risk of multiple pregnancies. There is often a belief among patients and some health professionals that the success rate of IVF treatment is higher following the transfer of 2 embryos or more. As a result, despite the risks to mothers and babies, there has been a practice of transferring multiple embryos. Studies show that a single embryo transfer generally does not reduce the chance of having a baby. However, transferring multiple embryos does increase the risk of multiple pregnancies. These are associated with higher rates of stillbirth and premature births, causing significant pressures to healthcare systems and health risks to the woman carrying more than one embryo.

In the UK, HFEA has worked closely with the sector to develop several policy initiatives to reduce multiple births following IVF. In 2003, HFEA introduced measures to restrict the use of triple embryo transfers in fertility patients under 40 years of age. Its sixth edition of the code of practice stated that a maximum of 2 embryos could be transferred to women under the age of 40 - with no exceptions - and a maximum of 3 transferable to women aged 40 and over.

Following an independent expert group’s review of multiple births and outcomes worldwide in 2007, HFEA introduced its ‘One at a Time’ campaign, which set a multiple birth target of 10%. This campaign has had considerable success. Data shows that single embryo transfers increased in use from 13% of IVF cycles in 1991 to 75% in 2019. While birth rates from IVF have continued to rise, the multiple birth rate has fallen. Between 2007 and 2021, data shows that the number of multiple births resulting from IVF has reduced from 23% to 5%.

There is now a noticeable variation in IVF practices compared to other jurisdictions, in terms of the number of embryos transferred in an IVF cycle. For example, in Germany, clinicians can transfer up to 3 embryos during an IVF treatment, resulting in Germany having the highest multiple birth rate in Europe. Single embryo transfers are not, however, mandatory in the UK. Despite current guidance from HFEA and other professional bodies, clinics can use clinical discretion and transfer more than one embryo, provided they have advised patients of the potential risks. The review notes that the alternative might be to give HFEA stronger licensing powers to restrict clinics from offering multiple embryo transfers (see the ‘Legal framework’ section).

Treatment add-ons

Treatment add-ons is a term commonly used in the sector to describe a variety of additional treatments offered by fertility clinics, over and above ‘routine’ IVF. Views vary across the sector about the potential effectiveness of some of these treatments. There is often little high-quality evidence from clinical trials to show that they improve outcomes, including in terms of live birth rates, and limited evidence on their safety.

HFEA has sought to influence the responsible use of add-ons by collaborating with professional bodies and patient groups to produce guidance for the sector. Additionally, using evidence from high-quality randomised controlled trials (RCTs), its Scientific and Clinical Advances Advisory Committee (SCAAC) developed a ‘traffic light’ rating system for selected add-ons, which was published on HFEA’s website. Until recently, this rating system indicated whether an add-on treatment is effective at improving the chances of conception when undergoing fertility treatment, as follows.

• amber indicated that there is conflicting evidence from RCTs to show that an add-on is effective. As evidence is not conclusive, further research is required and therefore it is not recommended for routine use. An example is endometrial scratching
• red indicated that there is no evidence from RCTs to show that an add-on is effective to improve the chances of conception. An example is the use of immunological tests and treatments

However, despite HFEA’s work, some of the red rated add-ons are still being offered to patients by some clinics. The review notes the limited regulatory powers the HFEA has in this area and that the advice HFEA has been able to give to clinics and patients is inhibited by the lack of peer-reviewed scientific evidence.

HFEA has since developed an adapted rating system that will provide more information to clinics and patients on the likelihood of a treatment increasing the chances of success and other outcomes as well as raising any safety concerns. The new rating system went live in October 2023 and its effectiveness will be dependent on patients accessing it either directly from the HFEA website, or indirectly through clinics and clinicians. It will be important for HFEA to gauge the impact of the new advice by monitoring website traffic, the use of the guidance by clinics, and any continuing take up of add-ons.

Recommendation 11

Now that HFEA’s adapted add-on rating system has been published, it should work with the department and professional bodies to determine how best a voluntary data collection programme for treatment add-on usage in clinics could be introduced.

Other licensing activities

HFEA has various other related licensing functions involving human gametes and embryos. These include licensing their storage, their use in scientific research, and their import and export. There are also certain sensitive procedures involving embryos, where HFEA has special licensing arrangements, such as where pre-implantation genetic testing is proposed for new genetic disorders. The following 4 areas have been considered as part of this review:

• storage limits
• embryo research
• genetic testing
• collection and use of data

Storage limits

Embryos and gametes that are not used or transferred in an IVF cycle can be cryogenically preserved for future use, subject to written consent from those supplying them. After storage, as well as being used by the patient, they could be donated for someone else’s treatment or used for research.

Preservation techniques have improved over time. This means that preserved embryos now have the same potential for a successful pregnancy when used in IVF treatment as fresh embryos. There has been a steady increase in the practice of storing embryos and an increase in the duration of storage. Since the law was changed in July 2022, embryos and gametes can be stored for up to 55 years from the date that they were placed in storage. However, for storage to lawfully continue, patients are required to renew their consent every 10 years. Prior to this, embryos and gametes could only be stored for 10 years except where patients were at risk of becoming, or had become, prematurely infertile.

This change in the statutory storage limits should result in increased availability of embryos and gametes for research purposes. Although some stakeholders stated that they felt that HFEA had not prepared well for this change in regulations, the change of law, through the Health and Care Act 2022, meant limited time for HFEA to implement changes. According to one stakeholder, this change has resulted in practical problems for NHS clinics who have been disproportionately affected compared to private clinics, due to the number of gametes they already hold for medical purposes, for example while patients are undergoing certain treatments for cancer. The review notes that the implementation date for the Health and Care Act 2022 was set by Parliament.

Embryo research

The 1990 Act set a 14-day limit for the use of an embryo during research. This limit was introduced to recognise the ethical and religious concerns around conducting such research. Some scientists have raised the possibility that the limit may need reconsideration in the light of scientific innovation. The review has noted competing articles in the British Medical Journal considering the merits of such a change, but this is ultimately a matter for Parliament. The review makes no comment on the substantive merits of any such change. However, it notes that such a fundamental change to the 1990 Act may give rise to further complex ethical and religious issues, which would require a widescale consultation.

During the course of this review, there has been considerable media publicity about the potential use of human stem cells to create ‘synthetic’ ‘embryo-like’ structures, and speculation that such modelling techniques could potentially reduce the need for involving the use of human embryos and gametes in research. However, the nature and legal status of these structures is unclear. The 1990 Act, and hence HFEA, only regulates activities, including research, involving human embryos and gametes. It was not intended to deal with genetic research or the creation of human-like structures that do not involve the use of human eggs and sperm.

The review notes the potential significance of these developments but does not consider this review to be the appropriate place to assess their implications, beyond noting that they could affect the justification for some of the research HFEA approves. The department should, however, with the assistance of HFEA, keep under review the potential implications for the current framework regulating research involving human embryos. The review notes that HFEA anticipates recommendations on this subject later this year, from a University of Cambridge project. The department should ensure that it is kept updated on developments so that it can consider pursuing regulations if deemed necessary.

Recommendation 12

Within the next 18 months, the department should, with the assistance of HFEA, put in place arrangements to regularly review the potential implications of recent research and innovations, for example, the use of synthetic tissues, in the context of the current regulatory framework.

Genetic testing

One of the most sensitive and important activities of HFEA is regulating proposals for research and the use of embryo testing and treatments for people who have serious inherited diseases. HFEA has been at the forefront of work in this area. In 2015, HFEA was the first regulator in the world to license gene editing research on human embryos.

Pre-implantation genetic testing (PGT-M and PGT-SR)

It is now possible to use PGT, combined with IVF, to check for certain specific genetic, chromosomal abnormalities in embryos. Such testing can only be carried out in combination with IVF because cells from a developing embryo can be removed and tested. Embryos with abnormalities would be identified as being unsuitable for transfer during IVF. Embryos that have been tested and are free of the condition will be placed into the womb. The 1990 Act permits HFEA to approve such testing for conditions that make it likely to result in a baby being born with a serious physical or mental disability, a serious illness or other serious medical condition.

Over time, an increasing number of conditions have been identified by HFEA as suitable for such testing, as medical knowledge develops about these conditions. Where the decision has been to permit testing, HFEA lists these on its website so that other clinics may be permitted to conduct such tests. It now lists more than 600 medically defined conditions (although the number should not be exaggerated as many of the conditions are similar in terms of their practical effect on the health of the baby). HFEA reviews this list every 5 years to determine whether a condition should still be listed. For example, to take account of the possibility that a new treatment for a listed condition may have become available.

The review finds that careful, reliable, evidence-led decision taking by HFEA, around the risks of different conditions, is playing a central role in enabling the development of embryo testing. This is where embryo testing meets the statutory requirements and is scientifically and ethically justifiable for beneficial purposes in terms of the health of the baby. The review notes that the identification of genetic conditions is growing, and as a result the number of conditions listed by HFEA is likely to rise over time. HFEA will need to keep under review whether it may require increased resources with time to properly evaluate and support the volume of licence applications in future.

Mitochondrial donation

Mitochondria are present in almost all human cells, including eggs, and abnormalities in mitochondrial genes can be the cause of severe medical disorders. The UK has been the first country worldwide to license mitochondrial donation of genetic material from third parties to prevent such conditions arising.

HFEA initially licensed the Newcastle Fertility Centre to conduct mitochondrial research, and subsequently their use of a new technique they developed so that the mitochondria of another woman to be substituted in an embryo from the baby’s genetic mother. This enables a woman with mitochondrial disease potentially to have a baby without that condition. This technique is attractive because, although the mitochondrial DNA is donated from a third person, the egg provider is still in all other respects, genetically the baby’s mother. As with pre-implantation genetic testing for monogenic disorders (PGT-M) and pre-implantation genetic testing for chromosomal structural rearrangements (PGT-SR), HFEA must approve all individual uses of mitochondrial donation. The technique has received significant media interest recently, when it was reported that the first baby in the UK had been born using the technique.

A stakeholder commented on the positive role that HFEA, with its expertise, has played in this process. For example, HFEA has assisted government to draft workable legislation to enable regulation of research to develop new medical techniques. They thought HFEA’s careful approach has helped to build greater public confidence in this work.

HFEA’s successful approach in licensing the Newcastle Fertility Centre has been seen by other countries as an exemplar of well-regulated research. Representatives from Australia, China and Mexico have consulted HFEA on how to achieve better quality research and how to effectively regulate this area. HFEA has clearly worked effectively to enable such treatment to proceed in a well-monitored environment.

Collection and use of data

HFEA collects data about fertility treatment and outcomes, storage of eggs and embryos, and donation in clinics across the UK. Its register holds information about treatments, patients, partners, donors and children born as a result of these treatments. It is the longest-running database of its kind in the world, although some of the categories of data held in its register have changed since 1991.

Reports interpreting this data are published by HFEA and provide reliable information on the growth and changes in the use of IVF and DI since 1991. They give helpful granular detail on areas such as:

• average pregnancy and subsequent birth rates following IVF
• how these rates decline with age
• the growth in egg storage and the extent to which frozen embryo storage and transfer prior to IVF affects pregnancy rates
• average multiple birth rates
• the average age of patients receiving DI and IVF treatment
• the number of donor treatments undertaken by single women and female same sex couples
• how much of this activity was privately funded and how much by the NHS

HFEA makes data available in an anonymised form, in line with the Information Commissioner’s Office code of practice. For non-anonymised data, regulations set out that this can only be provided in specific circumstances, which is overseen by an internal panel with legal advice and subject to receiving a favourable opinion from an HRA-approved Research Ethics Committee. Identifiable data can only be accessed from abroad if the researchers are working with a UK research establishment, but in such cases is potentially available to support researchers worldwide. There is a direct benefit in making such data available for research since it furthers understanding and expands the evidence bases for decision making.

Provision of information

In accordance with its statutory duty to provide information, HFEA has a key role in supporting patients to make informed choices about fertility treatment. As outlined in its strategy for 2020 to 2024, HFEA aims to ensure that people can access high-quality information at the right time with a focus on improving access at the earliest (pre-treatment) stage, and to support decision making during and after treatment or donation. Its website provides a range of information to support both prospective and current patients in their decision making. This includes information about fertility treatment options, treatment add-ons, and performance and outcome data for each clinic.

The review notes feedback from some stakeholders that HFEA needs to “raise its profile.” When individuals approach charities for support with fertility treatment “almost all haven’t heard of HFEA,” and “are not aware of their resources.” Stakeholders also said that while HFEA’s website has “great resources, it isn’t well laid out or accessible.” The review recommends that, subject to resources, HFEA should review and update its website to optimise accessibility for patients, professionals and researchers. Given the importance of digital capability in delivering HFEA’s statutory duty, and the challenges associated with attracting and retaining DDaT specialists within a small ALB, the review notes the potential to enhance HFEA’s offer in this area through a shared service approach. This is further explored in the ‘Efficacy’ section.

Recommendation 13

HFEA should review its digital capability and identify options to enhance its digital offering, including working with the wider ALB community to share resources.

Social media presence

There has been a shift in where patients and consumers turn for information about fertility treatment. Discussion forums and social media platforms have become the norm. As part of this review, HFEA’s social media presence was benchmarked against 4 chains of clinics, noting that all will use paid for advertising and that HFEA has no budget for this. The data in figure 1, collected in May 2023, provides an example of HFEA’s social media following compared to the clinics (anonymised for these purposes).

Figure 1: bar chart to illustrate social media benchmarking

Figure 1 shows that HFEA had the highest numbers of X (formerly Twitter) followers, with 8,736, surpassing the 4 clinics. However, it ranked lowest in the number of Instagram followers, with 1,826, whereas clinic 3 led with 10,200 followers. Similarly, on Facebook, HFEA ranked lowest, with 2,010 followers, while clinic 3 ranked highest with 16,524 followers. HFEA had the highest number of followers on LinkedIn with 10,109, this was closely followed by clinic 2, which had 9,689 followers.

The review acknowledges the limitations of such comparisons as it is impossible to benchmark against paid for advertising but notes the following. Different platforms perform different roles - the number of X followers, for example, may be a positive reflection of the number of people interested in policy issues. LinkedIn following may reflect those interested in careers, rather than potential service users. Nevertheless, the data does suggest that HFEA is not necessarily the feed of choice on some social media, which is likely to be a result of the inability of HFEA to compete with paid for advertising or personal platforms. Given the vulnerability of potential patients, it is important that HFEA aims to become the ‘go-to’ place for potential service users to get reliable information on all platforms.

The review recognises that this is not an easy task as HFEA is inhibited by regulatory and financial constraints. In addition, it competes with paid adverts and promoted ‘success stories’ from individual clinics. HFEA considers its current social media strategy is as effective as its resources allow and it has made an impact despite its resource constraints. Nevertheless, the review considers that the vulnerability of potential patients increases the importance of HFEA increasing its profile and following on social media, to ensure that patients have access to independent and corroborated advice. The review notes the significant challenges in this area, given the limitations in how public bodies may use social media, coupled with consumer preferences for information, particularly in such an emotive space. However, the review recommends that the department explores with HFEA what additional resources, including access to specialist expertise, might further enhance the impact of its communications so that the message lands with the intended audience.

Recommendation 14

The department should consider how it could further support HFEA’s communication function to improve the impact of trusted and evidence-based information when it reaches patients.

Provision of misleading information to consumers

HFEA has no powers to enforce consumer law in relation to fertility treatment. However, it has assisted consumer law regulators - the Competition and Markets Authority (CMA) and the Advertising Standards Authority (ASA) - to produce advice on the application of consumer protection law to the advertising and provision of fertility treatments. Consumer protection law does not directly regulate pricing or the provision of treatments, but it does prohibit the provision of misleading information by private clinics to potential patients. This includes in relation to pricing and the ‘success’ rates of clinics in providing particular treatments, including add-ons.

CMA has taken an interest in the sector because of the particularly vulnerable position potential patients may be in when considering fertility treatment. For example, it has published guidance for fertility clinics and for patients in the UK to ensure that they understand their obligations and rights under consumer law, including in relation to the offering of add-ons. It also published an open letter to overseas-based fertility clinics that advertise their services to UK consumers, about their obligations under UK consumer law. However, CMA and ASA - and other consumer regulators - have limited resources and expertise to devote to the fertility sector and do not expect to be playing a regular ongoing role in monitoring the fertility sector.

The government has recently introduced potential legislation (the Digital Markets, Competition and Consumer Bill) to improve the powers of regulators, such as CMA and ASA and trading standards, to enforce consumer law. The bill would also enable a number of other regulatory bodies to enforce consumer law, including various sectoral regulators like Ofcom, and contains powers under which additional regulators could be designated by ministers. At present, none of the health regulators are listed for this purpose. However, the review notes that, as it is the main regulator of the provision of fertility services by private clinics, it is possible that HFEA could be given such powers in relation to businesses offering fertility treatment. The review considers the merits of this further in the ‘Legal framework’ section.

Opening the register

One of the functions of HFEA since 1991 has been to maintain a register containing information about the donors of gametes of DCIs. Initially, DCIs aged 18 or older on application were only permitted to obtain non-identifying information about their donors from the register. This gave them some information about their genetic origins of relevance, including physical characteristics, as well as more personal information such as occupation and interests. Donors could also provide a goodwill message and further non-identifiable information in the form of a pen portrait. However, HFEA was obliged to keep the identities of the donors within the register confidential, unless the donors reregistered as identifiable after the law changes in 2005 (see below). This created an expectation of anonymity on the part of the donor, which it was thought would encourage donation.  

However, in 2005, the law was changed so that most DCIs conceived using a donor who registered after the law was changed, who made a request upon or after reaching 18 years of age, would also be able to obtain information about the identity of their donors. The code of practice was changed to advise clinics that prior to donation, donors should be made aware of this possibility, and that clinics must give patients, when seeking treatment with donor gametes, information about the importance of telling any resultant children at an early age, of their donor-conceived origins. In 2008, further amendments to the 1990 Act were made to allow the disclosure of non-identifying information about donor siblings at age 16 and identifying information about them at 18.

The first individuals able to apply to HFEA for identifiable donor information will be able to do so from October 2023. People born through donation prior to 2005 will only be able to access non-identifying information about the donor from HFEA at the age of 16 unless their donor has reregistered as identifiable. By the end of 2024, around 766 donor-conceived individuals will be eligible to apply, and this number will rise to 11,427 by 2030. HFEA is preparing to manage this sensitive process, although it has identified a number of challenges.

First, it is not clear how much demand there will be, considering that DCIs may be unaware that they are DCIs. The policy of the department has been that it is for parents to choose how and when to tell their children that they are donor conceived. Also, many DCIs may not wish to trace their genetic parents or siblings, even if they are aware they are DCIs. Therefore, HFEA has been reviewing what resource may be needed in future years.

Second, the disclosure of identification information is clearly a highly sensitive process for the donor, the DCI and affected families. The review has heard arguments from DCI support groups that HFEA needs more resource to respond in a timely manner to the increase in enquiries and provide counselling arrangements and intermediary services for the people affected.

Third, there may be unrealistic expectations of what information HFEA is able to provide, in 2 respects:

• the legislation specifying what information can be disclosed is unhelpful - it refers to the name and last known address of the donor recorded in the register. However, many addresses have not been updated since the relevant gametes were donated, and many donors are likely to have since moved
• there is a cohort of DCIs conceived before the law was changed in 2005 who will be unable to benefit from the opening of the register. The review notes that they and other DCIs may decide to seek to identify their genetic parents and siblings by other less formal means, for example the use of commercial DNA testing websites

The review recognises that HFEA is taking sensible action, where it can within the current law, to mitigate these risks. This includes:

• trying to update the register by publicising the desirability of donors keeping their details up to date
• planning to increase staff available to manage requests
• putting in place arrangements for what future support services may look like given the likely increase in applicants.

However, the review is concerned that HFEA is inhibited in taking further action in updating the register and keeping it up to date (such as with current addresses, mobile phone numbers or electronic addresses) by legislative constraints in the 1990 Act and the general data protection legislation.

Working relationships with other ALBs

It is important that public bodies that are performing functions with or alongside others, have in place arrangements for effective information flow between them. While such arrangements are generally more effective where there is regular contact between the SLTs of bodies, there is also a place for structured memoranda of understanding (MoUs) setting out mutual responsibilities to help mutual understanding and assistance. This is particularly the case where there is a need to manage the sharing of sensitive personal data between them, as in the case of the information held by clinics and HFEA that is subject to strict statutory limits on sharing data. There are useful MoUs in place between HFEA and several bodies across government including CQC, HTA and MHRA, and the devolved administrations. For example, HTA and HFEA have taken steps to avoid duplication in inspection arrangements, and the MoU between CQC and HFEA includes a joint working protocol, which sets out the detailed arrangements for sharing information between the parties. This has improved working relationships between health regulators.

HFEA and the Confidentiality Advisory Group of the Health Research Authority (HRA) have put in place co-ordinated arrangements for the processing of applications to access identifiable HFEA research register information without consent. These standard procedures exemplify a shared commitment to a streamlined and efficient process so as to provide a proportionate, collaborative and transparent approach to scrutiny and a timely service to facilitate research. HRA also agreed that when it updates the Integrated Research Application System (IRAS), those IT systems will signpost researchers to HFEA’s services.

In contrast, HFEA and NHSE (and the NHS in Scotland, Wales and Northern Ireland) working relations are not set out in a MoU. This is primarily because HFEA acts as the formal regulator licensing those fertility clinics which are provided by NHS bodies. However, where asked, HFEA may also have a policy role, acting as an adviser to ministers on assisted fertility services and the matters regulated by the 1990 Act. It did so, for example, in providing information to develop the Women’s Health Strategy, which provides commitments to improve information provision regarding fertility and address the current geographical variation in access to NHS-funded fertility services across England. The impression of the review is that these interactions are not formally structured and may not be a priority for NHSE. The review considers that more regular contact between HFEA and NHSE (and NHS bodies in devolved areas) would be beneficial, such as the recent work with NHSE to share information about regulatory actions on fertility centres.

Finally, there have been some concerns regarding the inability to transfer sensitive personal data between fertility clinics, and the wider health system, that have been drawn to the review’s attention. For example, that this potentially inhibits the effective provision of NHS care to patients who have received fertility treatment in a clinic.

Recommendation 15

The department should work with HFEA and NHSE to collectively review its current approach to joint working and propose options to strengthen collaboration to improve delivery on fertility and wider women’s health priorities.

Internal processes

HFEA’s board and its committees are made up of a chair, deputy chair and other members that are appointed by the Secretary of State. There are currently 14 members. The 1990 Act ensures that a proportion, but not the majority of the members, are medical practitioners, embryologists or researchers in this field. Neither the chair nor deputy chair can be such persons. The committees similarly contain a ‘lay’ majority. The members provide oversight, challenge and expertise, in particular through the committees, which take key and often sensitive regulatory decisions, including relating to licensing and the authorisation of testing for certain severe genetic disorders. The overall arrangements are designed to ensure HFEA takes informed decisions while receiving lay oversight, and hence maintaining public confidence in its activities.

There is a clear process for making these appointments, set out in the Governance Code for Public Appointments and regulated by the independent Commissioner for Public Appointments. Some of the appointments process is statutory, with the 1990 Act setting out what the Secretary of State must have regard to when making appointments, and disqualifying criteria. The department’s Public Appointments Team leads the process and works with its arm’s length bodies, including HFEA, to recruit board members.

One important issue for both the department in appointing members, and then the operation of HFEA, is the management of actual, or potential conflicts of interest of board members. As with any public body, it is important HFEA policies and decisions are not impacted by any conflicts of interest among its members or staff.

The department says it is alert to the potential for conflict risks and takes this into account during the process of appointing members. All applicants are required to declare potential interests of concern.

There is ongoing, transparent declaration and management of interests once members take up post. Potential interests that are disclosed by members are published on HFEA’s website. If the interests of a board member change, members should inform HFEA so that the impact of any change can be considered. HFEA says it takes account of the potential interests of members when selecting them for appointment to particular committees. HFEA also has standing internal processes, which require members of the board or committees to remove themselves from a meeting when they may have an interest in a matter to be discussed. The review recognises that these arrangements provide scope to mitigate risk, while enabling HFEA to benefit from the membership and expertise of professionals in the areas it regulates. The review therefore recommends that both the department and HFEA continue to be alert to the risk of conflicts of interest arising and the need to manage them carefully.

Cyber security

Due to the sensitivity of the personal data held by HFEA, and the likely increased media attention around donor anonymity issues, there is the potential for increased cyber security attacks.

HFEA has completed the data security and protection toolkit (DSPT). The DSPT is a mandatory self-assessment tool used to measure a public body’s performance against the National Data Guardian’s 10 data security standards. The DSPT, submitted annually, includes an independent audit and organisations are expected to achieve the compliance level of ‘standards met’. If not, they must provide an improvement plan to address any issues and, once that plan is accepted, their status will change to ‘approaching standards’. HFEA’s 2022 to 2023 DSPT return included an improvement plan that was accepted by the DSPT team and the status is currently ‘approaching standards’. A summary of the required actions to meet standards is as follows:

• completion of information asset register work
• spot checks on security awareness training and compliance (phishing awareness campaign to be launched plus competency questionnaire and training reminders issued to staff)
• a business continuity exercise, which includes security incident response plan improvement
• implementing a specific technical control (Microsoft Windows Operating System ‘AutoRun’)

To further assist HFEA in its readiness to deal with cyber security threats, the department and NHSE Transformation Directorate’s Joint Cyber Unit (JCU) team and NHSE Cyber Operations recently met HFEA as part of its ‘Defend as One’ cyber security strategy, to consider how best to monitor and protect against such threats. HFEA outlined the protection already in use, including for the PRISM application, but is considering additional capabilities to further enhance its cyber security. In addition, the HFEA Cyber Security Lead has attended the newly constituted ‘JCU ALB Forum’, which is chaired by the National Chief Information Security Officer for Health and Social Care. The forum will meet at least 6 times a year with the objective of strengthening the department and ALB intelligence and management of cyber security to develop greater collective resilience across health and social care, as per the government and department’s cyber security strategy.

Legal framework

This section considers whether the legal framework is fit for purpose. It assesses whether it could be improved, by making a number of the legislative changes proposed by HFEA in the light of its recent consultation on modernising the regulation of fertility treatment and research involving human embryos. It also comments on the recent proposal of the Law Commissions that certain functions related to surrogacy should be performed by HFEA. 

Legal context

The main piece of legislation underpinning the functions of HFEA is the Human Fertilisation and Embryology Act 1990 (the 1990 Act), as amended over time. A chronology of key developments is at annex C. Other legislation that affects HFEA in performing its functions includes the Human Rights Act 1998 (the protection of family and private life under Article 8 of the European Convention on Human Rights (ECHR) is particularly relevant to HFEA), the Equalities Act 2010 and the Data Protection Act 2018. The clinics HFEA regulates must also comply with other regulation, including consumer law. 

Modernising fertility law

Between February and April 2023, HFEA conducted a stakeholder public consultation on whether the 1990 Act should be changed with a view to improving patient safety, access to data and supporting beneficial innovation. The areas of focus in its consultation were as follows:

• patient safety and promoting good practice
• access to donor information
• consent
• scientific development

On 14 November 2023, HFEA published its report on modernising fertility law, which makes proposals for the reform of the 1990 Act. This review provides brief commentary on these proposals below. This review suggests that the department should consider whether some of the changes proposed by HFEA should be made by an order under section 2 of the LRRA. These powers permit amendments to legislation for the purpose of removing or reducing the overall burden resulting from legislation provided certain conditions are met.

Patient safety and promoting good practice 

HFEA proposes that a range of patient safety issues could be more effectively improved if it had more extensive regulatory powers. This review agrees that some changes to HFEA’s regulatory powers would be desirable.

Proposal 1

HFEA should have greater freedom to decide the regularity and form of inspections 

Review response

The review agrees that removing the mandatory requirement to physically inspect premises at least every 2 years would generate both efficiency and effectiveness benefits.

Proposal 2

There should be more flexibility in the appointment of clinic leaders, for example introducing the option of a deputy person responsible and broadening the criteria for the qualifications and experience required to be a person responsible.  

Review response

The review considers that it remains essential to have an identified individual personally responsible for ensuring standards of treatment are met at a clinic. However, it also considers that amending the 1990 Act to allow for a greater degree of formal delegation, for example, allowing for the appointment of a deputy person responsible, would be desirable. 

Proposal 3

HFEA should have a broader, more effective range of powers to tackle non-compliance.

Review response

The review supports this proposal, although noting HFEA has, on occasion, effectively tackled non-compliance by suspending and revoking licences and should continue to do so where necessary.

Proposal 4

HFEA should have a broader range of powers to impose financial penalties across the sector. 

Review response

The review supports this proposal and agrees that broader powers to impose financial penalties on licensees would assist HFEA, particularly where one-off breaches have occurred. Any penalties should be dissuasive, while remaining proportionate and giving weight to all relevant factors. The review suggests any new powers should be capable of taking into account not just the behaviour of the relevant licensee at one establishment, but also the overall behaviour of groups of licensees. Any such powers should be seen as a supplement, not as an alternative to HFEA’s existing powers, and should be developed alongside published guidance with an appropriate appeal mechanism to ensure any new fining powers were being exercised fairly and for the right purpose.

Proposal 5

There should be an explicit duty on HFEA and clinics to act to promote patient care and protection.  

Review response

The review agrees that HFEA should promote patient care and protection. However, whether an explicit duty would be the most effective way of doing so is less clear. The review suggests that consideration additionally be given to HFEA having more specific powers to target licence conditions where there could be improvements by, for example, restricting the ability of some clinics to provide particular treatments or add-ons.

The review notes some stakeholders expressed concern at the risk of over regulation by HFEA intervening in individual cases and deterring innovation or the take up of new treatments. The review was not convinced these were significant risks and considers that there is a risk of competition between clinics lowering standards of care if HFEA does not regulate and sanction potentially unsafe practices. 

Proposal 6

The 1990 Act should be revised to accommodate developments in the provision of fertility-related services, in order to have a broader range of powers to tackle fertility services and potential treatments not taking place in licensed clinics. 

Review response

The review agrees that reform to the law in this area should be explored further. It recognises that there are risks to potential consumers from the activities of both licensed and unlicensed service providers online, in particular, the provision of misleading advertising and advice, and inappropriate encouragement of treatment that is self-administered. Such activities may already be in breach of consumer or criminal law on activity outside licensed premises in the 1990 Act, however, there is little enforcement of these provisions. One possible regulatory change would be to give HFEA powers to act as a consumer law enforcer in relation to the activities of both licensed providers and other persons offering assisted fertility related services outside clinics. Although this area falls inside the remit of existing consumer law enforcers (in particular the CMA and ASA), they have limited resources to devote to enforcement of consumer law to this sector and therefore this would have some potential benefits.

The Digital Markets, Competition and Consumers Bill lists the public authorities which will be able to enforce consumer law and creates powers for new authorities to be added. The bill does not currently designate any of the health regulators. HFEA could be designated to use these powers. Such a change could appeal to licensees as all regulation of their fertility-related activities would sit with one regulator. However, the review notes that designating HFEA as a consumer law enforcer would require it to developing expertise in a new area of law and become more closely involved in the commercial activities of clinics in individual cases. A preferable and more targeted alternative would be for legislation to extend the scope of the activities requiring a licence from HFEA to include certain activities online, for example information provision related to the provision of services in licensed premises.

The review recommends that the department conducts further work with HFEA and across government to identify the best way of improving the regulation of commercial fertility-related services outside clinics.

Proposal 7

The 1990 Act should be amended to allow HFEA to determine and set a more proportionate appeals process. 

Review response

There needs to be an appropriate appeal process in relation to any decision of HFEA to refuse to grant a licence, to take enforcement action suspending or revoking a licence. However, it is not clear to the review that the 1990 Act needs to be changed to enable the current overall process to be made more efficient. The review suggests HFEA and the department review further the scope for expediting decision taking within both HFEA and the Independent Appeals Committee (which in practice has rarely met).

Recommendation 16

As part of its response to HFEA’s proposals, the department should explore whether some of the areas for law reform could be pursued through secondary legislation. The department should also explore the merits of designating HFEA as a consumer law enforcer.

Access to donor information

There has been a growth in the popularity and accuracy of accessible direct-to-consumer DNA testing and matching services, which has made it much easier for a DCI to find genetic relatives. HFEA is therefore planning to propose several measures relating to access to donor information.  

Proposal 8

The 1990 Act should be amended to enable the removal of donor anonymity from the birth of any child born from donation.

Proposal 9

Clinics should be required by law to inform donors and recipients of the potential for donor identity to be discovered through DNA testing websites. 

Proposal 10

The 1990 Act should require all donors and recipients to have access to information about the implications of their decision before starting treatment.

Review response to proposals 8, 9 and 10

The review agrees that the law enabling DCIs to be informed about their genetic heritage needs reform. The review suggests that in framing any changes, lessons can be learnt from other jurisdictions, such as Australia, where there is no anonymity. Current legislative restrictions prevent the sharing of donor data. More thought is needed as to what legislative change would allow DCIs to have access to more up-to-date donor contact details.       

Consent 

Proposal 11

HFEA is proposing to simplify the current consent regime.

Review response

The current law requires patients to provide explicit and informed consent on future matters before receiving fertility treatment, which can be complex and burdensome for patients. While the review recognises the importance of having effective procedures for obtaining informed consent, it considers that an overhaul of the current consent regime would need to weigh up the benefits and risks of a change to the current framework.

Proposal 12

The 1990 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.

Review response

The review agrees that it should be possible for information about the fertility treatment that a person has received to be made available to their subsequent medical advisers in the same way as information about any other healthcare treatment, although it is not clear how frequently in practice such disclosure has been inhibited by the 1990 Act.

Proposal 13

Consent for donating embryos should be extended to allow patients who wish to, to give consent to research embryo banking. 

Review response

The current law requires that patients give consent to the use of their unused embryos for research purposes. HFEA has identified that there are sometimes shortages of embryos available for ethically approved and licensed research projects. The review recognises that these shortages could be reduced by changing the law to specifically allow patients to give more generic consents to unspecified future research. However, the principle that patients should be able to refuse or withdraw consent to particular uses of embryos containing their genetic material is important and so any change would require careful consideration. 

Scientific development

The 1990 Act has provided a robust but flexible framework that has helped to generate public trust in a sometimes-contested area of scientific and clinical work. This has created conditions and boundaries within which research and beneficial innovation in treatment can more easily flourish.  

Proposal 14

The 1990 Act should explicitly give HFEA greater discretion to support innovation in treatment and research. 

Review response

The review considers this proposal should be developed further. The 1990 Act requires new procedures to be necessary or desirable before they can be approved by HFEA. These requirements have not been considered by HFEA to have been met in the past, in certain cases where it considered the proposed procedures could have been beneficial to patients. It is not clear to the review how prevalent this issue is or how significant it may be for patients.

The review has no objection to giving HFEA greater discretion in this area.

Proposal 15

HFEA proposes amending the 1990 Act to ‘future proof’ it to accommodate scientific developments and new technologies.

Review response

The review notes that the UK currently has a reputation for permitting desirable research relating to human development in a well-regulated and ethical environment and agrees that the UK should not lose this through an inability to swiftly respond to scientific development or technological change. However, it is concerned that these proposed amendments are vague and without clarity as to the particular changes that might be approved under them. It also notes that the creation of powers to allow change to the current regulatory regime without extensive Parliamentary debate of sensitive issues could give rise to concern as to how they might be used in future. For example, the current ‘14-day rule’ which limits research on fertilised embryos, has long been seen by some as unduly inhibiting research. Others regard it as setting a clear boundary which has broad public support and many other jurisdictions have followed suit.

Any revision to the current regime to give HFEA additional discretion to permit new areas of research would therefore require careful framing to ensure it retained these boundaries and broad public support.  

Surrogacy 

The Law Commissions have published proposals for reforms to the law relating to surrogacy arrangements that could extend the functions of HFEA. They propose that HFEA be given 2 new roles in England, Wales and Scotland. 

Proposal 1 

They propose HFEA become the regulator of non-profitmaking regulated surrogacy organisations (RSOs), who would oversee a new ‘pathway’ for prospective parents of surrogate children. This would allow intended parents who have entered into a surrogacy agreement, to become the legal parents of a child upon his or her birth without having to apply to a court.

It is proposed RSOs could place a surrogacy agreement on this new pathway where they were satisfied that certain critical pre-conception screening and safeguarding checks were met. RSOs would also be responsible for monitoring the making of payments to the surrogate mother. In doing so, it would be acting as an arm of the state (by creating an alternative mechanism to parenthood other than declaration by the court).  

The Law Commissions propose that RSOs would operate under a licensing scheme overseen by HFEA, modelled on that for fertility clinics under the 1990 Act, that HFEA be given enforcement powers in relation to RSOs and that HFEA should provide statutory guidance to the new RSOs through a new bespoke code of practice for surrogacy.   

Proposal 2

The Law Commissions propose the creation of a surrogacy register modelled on the register of donor conception maintained by HFEA. The purpose would be to enable surrogate-born people to access information about their origins. They suggest this would have practical value in helping such people to understand their genetic and gestational heritage for health reasons, and positively contribute to the quality of family relationships.  

Currently, a surrogate-born person can find out some information about their origins from a number of sources. First, they can access their parental order certificate, which will tell them that a parental order was granted in relation to them. Second, they can access information from the court in relation to the parental order. Third, they can access the register of information on donor conception operated by HFEA, which regulates fertility clinics.

Review response 

The review has not considered the merits of changing the law relating to surrogacy. However, if ministers wish to proceed with the reforms proposed by the Law Commissions, the review can see no other existing body that would be a better candidate for taking on the functions proposed.

The review notes that the proposed new RSOs would not be performing scientific or clinical tasks of the kind in which HFEA currently has expertise. Additionally, if HFEA were to be required to formulate a code of practice, this would be a significant management distraction that could inhibit HFEA from improving the effectiveness of its existing functions. Taking on such functions would require additional resources and legislation to enable HFEA to be able to charge fees for performing them. In consideration of the proposed reforms, the department should assess resource and funding arrangements to ensure that HFEA can take on such functions. 

Finally, the review notes that the Law Commissions have highlighted one area requiring further thought. This concerns the regulation of unlawful payments between prospective parents and surrogates. The review does not consider that giving HFEA a direct enforcement function in relation to such payments would be consistent with its existing licensing roles. It would also reduce the incentive on the RSO to carry out this function well.

Accountability

This section sets out the accountability arrangements between HFEA and the department, with a focus on the reporting lines to the department and ministers. It examines HFEA’s relationship with its sponsorship team to assess whether the accountability arrangements could be enhanced. It also outlines HFEA’s engagement with the department’s policy teams to ensure that health policy and regulation are being developed to improve outcomes and how HFEA responds to requests for information.

Departmental oversight

The Secretary of State for Health and Social Care has overall responsibility to Parliament for all matters concerning HFEA, including its delivery and performance. The Secretary of State’s statutory powers in respect of HFEA are set out in the 1990 Act, and include:

• to appoint the non-executive members of the authority, including the chair and the deputy chair
• to set objectives for HFEA in line with statutory duties
• to determine the funding and resourcing of HFEA
• to hold HFEA to account

The Secretary of State is supported in their function by the department. Within the department, the Permanent Secretary has appointed the department’s director for NHS Quality, Safety and Investigations as the senior sponsor for HFEA. The senior sponsor acts as HFEA’s designated point of contact within the department. The senior sponsor meets frequently with the chair and the chief executive of HFEA as part of the department’s accountability arrangement. The senior sponsor is responsible for agreeing the objectives of HFEA and ensuring that there is sufficient oversight at department level to support the Secretary of State in holding HFEA to account.

HFEA’s chief executive reported that the senior sponsor “always finds time” to interact with HFEA if required and described the relationship as responsive and supportive. However, while the engagement with the senior sponsor is effective, ministerial engagement with HFEA has been infrequent over recent years, with the last formal ministerial annual accountability meeting being held in 2017. The review believes that ministerial engagement is important to both ensure that ALBs have a shared understanding of and are delivering ministerial priorities, and that ministers are aware of the current challenges facing ALBs. The review, therefore, concludes that annual ministerial accountability meetings should be reinstated to increase ministerial awareness of HFEA’s work.

Recommendation 17

The sponsor team should seek to ensure that annual ministerial accountability meetings are reinstated from 2024.

Sponsorship team

The sponsorship team is the primary contact between the department and HFEA. Its role is to support the senior sponsor by liaising regularly with HFEA to ensure effective corporate relationships and co-ordinate assurance and accountability functions. The sponsorship team liaise regularly with HFEA to review its performance against plans, achievement against targets and expenditure against its departmental expenditure limit and allocations.

Both the sponsorship team and HFEA itself told the review that they believe there is a good level of communication and trust between the sponsorship team and HFEA. HFEA commented that “there is an open and strong sponsorship relationship which has been built over time”. Engagement is frequent and interactions regular, through the sponsorship team’s attendance at authority meetings, Science and Clinical Advances Advisory Committee meetings and Audit and Governance Committee meetings. The sponsorship team also holds quarterly accountability meetings with the chief executive and SLT, chaired by the senior sponsor. Annual meetings are held between the senior sponsor and the chief executive and chair of HFEA. The meetings provide a structured platform to monitor progress and address issues, and regular ad-hoc interactions further strengthen the department’s accountability arrangements.

The sponsorship team possesses in-depth knowledge of HFEA, which is important from a departmental perspective in understanding how wider policy developments might impact the regulatory functions of HFEA. However, the size of the sponsorship team is small and dependent on the expertise and knowledge of a few key individuals. This poses a risk to the long-term effectiveness of HFEA’s sponsorship arrangement if these individuals leave the department. The review, therefore, considers succession planning paramount to maintaining the resilience and effectiveness of the sponsor team.

Recommendation 18

The department should, in the next 18 months, develop and consider succession plans within the sponsorship team to mitigate risk and maintain the effectiveness of its sponsorship arrangement.

Risk

Risk is regularly reported to the authority through the Audit and Governance Committee. In addition, risk management is discussed at the authority meetings, which occur 6 times a year. This allows authority members to seek more detailed assurance from senior leaders within HFEA. The sponsorship team reviews HFEA’s risk register at the quarterly accountability meetings and discusses key risks and mitigation plans.

The proactive nature of the sponsorship arrangement allows for emerging risks to be appropriately addressed, managed or mitigated by the department. The sponsorship team can escalate risk to the department through multiple channels, including the central risk team and the ALB Oversight Team. Risks are dealt with appropriately and in accordance with the department’s risk management strategy.

All ALBs including HFEA are invited to attend the department’s Audit and Risk Committee on a rotational basis to discuss its key risks and the problems they are currently facing, before answering questions from the Committee about their papers to ensure consistent governance is maintained. Furthermore, high-level quarterly risk updates are provided by the sponsorship team to the department’s Performance and Risk Committee.

Key performance indicators (KPIs)

HFEA has generally had a high level of performance in meeting its KPIs, having met 90% or more of KPIs agreed with the department in recent years. The department has recognised this in each annual accountability report.

HFEA agree a business plan with their sponsoring department annually. The plan includes KPIs that cover delivery of its strategic plan. Performance is then recorded against these KPIs on a monthly basis, and the achievements and actions needed are then reviewed at the Corporate Management Group (CGM) meeting. A report is also submitted to the authority every 2 months and to the department every quarter.

HFEA has several KPIs. These include:

• sickness absence rates
• rolling annual turnover versus target range (5 to 15%)
• emailed public and telephone enquiries
• opening the register performance
• Parliamentary questions
• freedom of information requests
• end-to-end licensing
• inspections per month
• inspection reports to person responsible
• inspection reports to committee
• licensing items
• social media followers
• social media engagement
• debt collection within 40 working days
• average debtor days
• percentage of invoices paid within 10 working days

KPIs are reviewed by the department during the quarterly accountability meeting and by the authority at each authority meeting. Where HFEA’s delivery of a KPI is rated red, the chief executive will advise on the cause and set out its mitigation. The senior sponsor and the authority can challenge the chief executive on the steps taken to address a red rating where it is persistent and seek further reassurance about taking action to address the issue. The relevant action is then reviewed at the next scheduled meeting, unless it is high risk, in which case the sponsor teams work with HFEA at a working level and an update is provided at the next scheduled meeting.    

Policy engagement

Due to the specialised area in which HFEA operates, it has had limited engagement with the department’s wider policy teams. However, when asked, HFEA said that it has worked closely with the department on the development of policies, including providing information during the development of the Women’s Health Strategy for England and responding to its call for evidence. The strategy was published in August 2022 and includes a chapter on fertility, pregnancy, pregnancy loss and postnatal support with actions being taken forward by the department, HFEA and other ALBs. Following the publication of the strategy, HFEA now meets quarterly with the department’s women’s health team to update on progress against some of the strategy’s ambitions and commitments. The team described HFEA’s engagement with the work as “very positive” and noted that it was “keen to discuss areas of alignment, for example work to improve information for individuals and healthcare professionals on infertility and different treatment options.” HFEA has also met with the government’s Women’s Health Ambassador, Professor Dame Lesley Regan.

HFEA provides information to the department when required to support Parliamentary and public engagement, including in responding to requests made under the Freedom of Information Act, Parliamentary questions and ministerial correspondence. This working relationship is governed by a Public and Parliamentary Accountability Protocol between HFEA and the department.

As the department’s policy and sponsorship capacity in this area is currently limited, it is reliant on HFEA’s policy expertise. This arrangement works well in periods when there are limited policy issues under discussion, However, there can be resource challenges during the development of major law and policy, demonstrated with the current review of HFEA’s current powers. This work was commissioned by the department to HFEA, which posed challenges due to HFEA’s size and limited capacity, although this has been compounded by other competing pressures. The review suggests the department reviews its policy capacity in this area to ensure it has adequate resources to critically assess such developments and take appropriate action.

Requests for information

HFEA is obligated to provide information upon request from the department, either for internal use or for use by the Cabinet Office, HM Treasury or other relevant bodies. Both the sponsorship team and HFEA identified instances where they had received duplicative requests for information within a short timeframe and emphasised that this requirement could place a significant burden on HFEA due to the small size of the organisation. An example of this is very similar requests for financial information and potential savings opportunities coming from different parts of the department. The review notes that efforts should be made within the department to ensure HFEA is not overburdened with duplicative requests, or requests where the information is already held by the department. The review suggests that requests to the ALBs are filtered by the central ALB Oversight Team and sponsorship team before reaching HFEA but recognises that this may require increased capacity within these teams.

Recommendation 19

The department should, within the next 12 months, develop improved arrangements for co-ordinating responses from its ALBs to information requests from across government.

Annex A: terms of reference of the review

Background

The Human Fertilisation and Embryology Authority (HFEA) is an executive non-departmental public body of the Department of Health and Social Care.

HFEA regulates fertility clinics and research using human embryos, which involves licensing, inspections, setting standards and the provision of information to aid patient choice. It is required by law to hold a register of all licensed treatments and outcomes and to make information available on request to those affected by donor conception or for the purposes of research. HFEA’s remit is UK-wide and covers services provided by the NHS or the private sector. In carrying out its statutory functions, HFEA aims to:

• ensure the best care is provided to patients by well-led clinics; that care is effective and ethical, scientifically robust and accompanied by excellent support; that clinics provide transparent evidence so that patients can make informed choices; and there is more research and innovation to improve the evidence base
• provide the right information that is accurate and useful, and provided at the right time; that improved information is available at the earliest (pre-treatment) stage, with new information flows to support primary care professionals and patients; and provide access and impartial information for all - particularly about the evidence base, add-ons and treatment options
• help shape the future, through proactively embracing new developments in the changing fields of modern family creation, genetics and artificial intelligence; engage with and facilitate debates on changes in science, law and society, and integrate new developments into its work; and prepare for future legislative and operational changes to ensure that it remains a modern, effective and responsible regulator

HFEA has been subject to a number of reviews, most recently in 2017 when the Triennial Review was published. That review set out 17 recommendations, which were implemented by the time the report was published. Since that review, the profile of activities within the fertility sector that HFEA regulates has changed significantly, including:

• a higher proportion of privately funded treatments - fertility treatment is a unique area of healthcare in the UK where the majority of patients are paying for their own treatment
• an increase in the range of serious inherited conditions that can be tested for in embryos and considered by HFEA together with mitochondrial donation treatment
• more treatment involving donor gametes and a wider range of people accessing fertility treatment
• more investment in clinics by private equity firms changing the nature of clinics from largely owner managed to group operated
• an increased provision of sensitive information to donor conceived individuals from 2023 onwards
• an increase in attention to offers of unproven add-ons to basic treatments
• an increase in the provision of information and services on social media competing with free unbiased information from HFEA
• emerging technologies like artificial gametes

HFEA has also changed its own regulatory practices, including introducing a hybrid of desk-based and physical inspections, during the pandemic, which need to be evaluated in a post pandemic climate. The effectiveness of the inspection process was evaluated in a 2022 GIAA audit and received a ‘substantial’ rating that the framework of governance, risk management and control is adequate and effective.

Scope and purpose of the review

Public bodies are a critical delivery arm of government. The Public Bodies Review Programme aims to ensure public bodies have appropriate governance and accountability as well as being effective and efficient.

As the first stage of the review process, HFEA has conducted an initial self-assessment with the department’s HFEA sponsor team to help the department decide whether a review is required and the scope of that review. It covers 4 areas:

• governance
• accountability
• efficacy
• efficiency

This process has provided good evidence that HFEA has an effective governance structure. While the evidence provided by HFEA shows it also has good accountability arrangements, the review will determine whether there is any scope to enhance the accountability arrangements between HFEA and the department.

The primary focus of this review will be efficacy, efficiency and effectiveness. In addition, the review will consider the legislative framework underpinning the role and functions of HFEA and whether it remains fit for purpose.

Efficacy

In accordance with Cabinet Office guidance, a review should examine the functions of the body and assess whether there is a case for the body to continue to exist in its current form. While there have been no significant changes to HFEA’s core regulatory functions since its last review, this review shall consider opportunities to streamline or merge activities, structures and services. In addition, the review will consider whether HFEA could share expertise with the department, ALBs and other regulatory bodies. Any changes should deliver clear benefits such as reduced costs or improvements in service and resilience further to previous recommendations and accounting for the changing nature of the sector outlined in the ‘Background’ section above.

Efficiency and effectiveness

It is expected that a public body review should identify efficiency savings of at least 5% within a 1- to 3-year timescale. The 5% target takes into account inflation and those savings that have already been delivered under the last spending review. This review will therefore consider where efficiency could be generated in accordance with this request and what further efficiencies could be realised.

It is important to note that HFEA is a relatively small body, however the review should probe hard the efficiencies savings possible. This review will, concurrently, have regard to the impact on the sector it regulates, of any efficiencies under consideration.

The review will also examine the effectiveness of the current funding model for HFEA which is primarily based on charging clinics for fertility treatment activity (privately funded or funded by the NHS). It will do so having regard to the wider context of regulation of such clinics and fertility services, and public funding in relation to these services, across the UK, and having regard to the effectiveness of approaches to regulation in this area taken by other (non-UK) jurisdictions. Ministers, as part of the ALB review discussions, have recently asked for as much of HFEA’s remaining GIA to be charged as fees. HFEA is working up a proposal that would minimise GIA.

HFEA’s income is currently dependent on the amount of treatment cycles performed by clinics each year. The review will examine alternative funding models that may allow more flexibility, such as enabling any unaccounted surplus to be available across financial years, and the benefits to HFEA including strategic planning and investment. As part of reviewing this model, the review will examine how the fees are set and the process for reviewing fee levels.

The review will also review when and why HFEA charges for information access. Currently, HFEA does not directly charge users for the provision of information. It is expecting an increase in applications for donor information from late 2023 onwards, due to a change in legislation in 2005. This will lead to the opening the register service having to provide identifying information of gamete donor to donor conceived children who have reached 18.

Additionally, current regulations restrict HFEA’s ability to charge full cost for register data provided for research purposes to researchers and institutions. The case for adopting a full cost recovery model will be examined within the more general probe of HFEA’s charging model discussed above. 

Legal framework

The healthcare sector, regulated by HFEA, has changed significantly since it was established over 30 years ago. As a result, HFEA started looking at where legislative change could be most helpful in 2020. It has recently launched a public consultation on modernising the legal framework regulating its activities with a view to improving patient safety, access to data and supporting beneficial innovation. It suggests that existing legislation is sometimes inhibiting HFEA to regulate effectively.

The review will provide an independent perspective on the extent to which legislative reform could enable HFEA to make more efficient and effective use of resources in relation to the fertility sector. This review will thus provide a light touch assessment on the merits of legislative reform.

Department and public body arrangements for review

Second Permanent Secretary

The Second Permanent Secretary will oversee the public body review. Generally, this will involve:

• deciding on and appointing the lead reviewer
• deciding whether a body merits an in-depth review or not
• if appropriate, requesting a challenge panel is established
• accepting or rejecting the recommendations suggested
• holding to account the department and public body for the implementation of the recommendations

Principal Accounting Officer (PAO)

The PAO is responsible for ensuring that the organisation operates effectively, as set out in Managing public money. The PAO’s role in the review process is to advise their ministers:

• on which bodies should be prioritised for review
• of suitable lead reviewer candidates
• on the depth of review required
• whether to accept recommendations or to reject with good reason, with particular regard to value for money
• to ensure timely implementation of recommendations

The PAO will also ensure there is suitably skilled resource to support the lead reviewer through the review team, and support from the functions.

HFEA (‘the body’)

The role of HFEA is to work openly and transparently with the review team to ensure all relevant data is shared in an ‘open book’ approach. This will help the review team gather an accurate picture, understand the challenges and issues, and make evidence-based recommendations that can add value to the body.

Sponsor team

The senior sponsor is supported by sponsor team, which role is to provide the link between the review team and the body. The key focus is to support sponsored bodies in being accountable, high-performing organisations, delivering value for money services as outlined in their business plan and supporting the parent department in achieving its objectives.

Lead reviewer

The appointed lead reviewer is Roland Green. The lead reviewer is responsible for the direction and findings of the review, and provide assurance to ministers, the department and the public body that it has been conducted with a level of independence. The role of the lead reviewer is to ensure that the review is proportionate and objective, and that the recommendations will facilitate the continuous improvement of the public body.

The key responsibilities of the lead reviewer are as follows:

• to agree the terms of the review with the department, considering:
  • the scope for the review, based on early findings from the self-assessment model carried out by the review team and the body
  • priorities and objectives of departmental ministers
• to work with the review team to complete the review in a timely, efficient and proportionate manner, ensuring public body reviews guidance is adhered to
• to provide an independent and objective voice to the review, while bearing in mind departmental priorities and sensitivities
• to ensure a clear communication channel between themselves, the department and HFEA, raising concerns where necessary
• to report regularly into senior departmental leadership structures, with regular conversations with HFEA senior sponsor to update on progress. The lead reviewer will also communicate the outcome of the review to the second permanent secretary and ministers, where appropriate.
• to engage with HFEA’s senior leadership and keep them sighted on progress, emerging findings and recommendations
• to ensure a strong focus on value for money throughout, including the use of HM Treasury guidance as appropriate
• to ensure a representative and proportionate number of stakeholders are engaged and given the opportunity to feed into the review (this could include overseeing public consultation if deemed necessary)
• to oversee the development of evidence-based recommendations to form the review
• to develop hypotheses and clearly articulate evidence-based findings in a clear, objective and proportionate report to the department
• to deliver a set of feasible and risk-based findings and recommendations
• to complete a ‘lessons learned’ template to help shape future reviews

Review team

The review team will be supported by the lead reviewer in undertaking the review.

The responsibilities of the review team will include:

• seeking approval for the different stages of the review via submissions to ministers
• supporting the handling of the review within the department, ensuring that the PAO, sponsors, ministers and HFEA are engaging, as needed, with the review
• appointing an appropriate lead reviewer with relevant experience and expertise, and with enough capacity to commit fully to the review
• managing appropriate engagement between the lead reviewer, HFEA, key stakeholders and other key officials
• co-ordinating in person evidence gathering process, including interviews with the body and relevant stakeholders
• ensuring that the review is done in a timely manner and following the Cabinet Office’s public body reviews guidance
• contributing to cross-government groups to share learning and ensure the department’s reviews are in line with wider governmental review work
• independent evidence gathering and analysis
• drafting the final report and recommendations collaboratively with the lead reviewer

Challenge panel

As part of the review process, a challenge panel shall be established to hear the findings from the lead reviewer, understand the evidence base, challenge emerging thoughts and inform recommendations in a rigorous and constructive manner. The challenge panel shall consist of a chair and panel members with suitable skills and sector experience. The panel may have representation of senior civil servants from the sponsor’s department, and other departments as well as non-executive directors (NEDs) from other arm’s length bodies.

Annex B: stakeholder engagement

The review team and or the lead reviewer conducted online or in-person interviews with a range of representatives from the department, HFEA, other public bodies and the private sector. The review team also offered 2 concurrent in-person roundtable sessions for professional stakeholders and, separately, patient stakeholders, to discuss areas of interest. These were held on 19 May 2023. Other stakeholders that were unable to attend the roundtable event were interviewed on-line separately. The review team also visited the Create Fertility clinic in St Paul’s, London and were hosted by Professor Geeta Nargund, Medical Director, for a tour of the fertility clinic and laboratories.

Interviews

HFEA

Julia Chain, Chair

Peter Thompson, Chief Executive

Clare Ettinghausen, Director of Strategy and Corporate Affairs

Richard Sydee, Director of Finance

Rachel Cutting, Director of Compliance and Information

Geeta Nargund, non-executive member

Frances Flinter, non-executive member

Alison McTavish, non-executive member

The Rt Revd Graham James, non-executive member

Tim Child, non-executive member

Jonathan Herring, non-executive member

Catharine Seddon, non-executive member

Alison Marsden, non-executive member

Jason Kasraie, non-executive member

Other organisations interviewed as part of the review

Health Research Authority

Human Tissue Authority

Care Quality Commission

National Institute for Health and Care Excellence

NHS England

Competition and Markets Authority

Government Legal Service

Representatives from international institutions

William Ledger, University of New South Wales

Sigal Klipstein, American Society for Reproductive Medicine

Andreas Tandler-Schneider, Fertility Center Berlin

Solene Lemay, Ministry of Health and Social Services, Ministry of Quebec

Workshop attendees

Jane Denton, Director of Multiple Births Foundation

Veronique Berman, Chana Charity

Sarah Norcross, Progress Educational Trust

Olivia Montuschi, Donor Conception Network

Marta Jansa Perez, British Fertility Society

Laura Carter-Penman, Peppy Health

Debbie Evans, Herts and Essex Fertility Centre

Stuart Lavery, University College Hospitals NHS Foundation Trust

James Hopkisson, TFP Nurture Fertility

Other stakeholder interviews

Rachel Gregoire, The Hewitt Fertility Centre

Laura-Rose Thorogood, LGBT Mummies and Proud Foundations

Abha Maheshwari, Aberdeen Fertility Centre

Nina Barnsley, Donor Conception Network

Jackson Kirkman-Brown, Association of Reproductive and Clinical Scientists

Jane Blower, Association of Reproductive and Clinical Scientists

Jane Stewart, Newcastle Fertility Centre

Dominic Curran, Donor Conceived Register

Laura Bridgens, Donor Conceived Register

Annex C: chronology

1978

Birth of the first IVF baby (Louise Brown).

1984

The Report of the Committee of Inquiry into Human Fertilisation and Embryology, chaired by Mary Warnock, is published. It recommends the creation of HFEA and that it should not primarily be a medical or scientific body but should take a broader view and protect the public interest.

1985

Surrogacy Arrangements Act 1985 makes commercial surrogacy unlawful (other surrogacy arrangements are unenforceable).

1990

The Human Fertilisation and Embryology Act 1990 (the 1990 Act) is passed.

1991

The 1990 Act is commenced and HFEA established with powers to:

• regulate by a licensing regime and advisory code of best practice:
  • the creation of human embryos outside the body and their use in treatment and research
  • the use of donated gametes and embryos
  • the storage of gametes and embryos
• keep a database of IVF treatment carried out from 1991, relating to all cycles and use of donated gametes
• review information and provide advice to the government about:
  • human embryos and developments in research involving them and the provision of treatment services and activities governed by the 1990 Act
  • promote compliance with the 1990 Act and the code of practice
  • provide advice and information to potential donors, donors, clinics, research establishments and to DCIs

The 1990 Act also created a legal mechanism (parental orders by the court) for ratifying retrospectively agreed surrogacy arrangements. 

2001

Regulations (2001/188) extend the therapeutic purposes for which embryo research can be licensed. These include: 

• increasing knowledge about the development of embryos
• increasing knowledge about serious disease
• enabling any such knowledge to be applied in developing treatments for serious disease

Following a first instance decision in a judicial review the Human Reproductive Cloning Act 2001 is passed to prohibit cloning of human embryos.

2004

The Human Tissue Act 2004 sets out standards of quality and safety for the donation, procurement, testing, processing, preservation and storage of human tissues and cells intended for human application (including but not limited to reproductive cells). This enables compliance with the EU Tissues and Cells Directives (including their regulation of import and export in or out of the EU).

Regulations (SI 2004/1511) permit more disclosure of information about donors, to individuals conceived from donated gametes or embryos. Therefore:

• more non-identifying information for those born since 2001 available to them as adults from 2010
• more identifying information for those conceived from gametes or embryos donated after April 2005
• the government emphasises “that the commitment to past donors has been that they will not be identified retrospectively. We respect and will uphold that commitment”

2008

The Human Fertilisation and Embryology Act 2008 (‘the 2008 Act’) amends the 1990 Act to: 

• ensure that the creation and use of all human embryos outside the body are subject to regulation
• ban selection of the sex of offspring for social reasons
• accommodate the growth of single sex families, while emphasising taking account of “the welfare of the child” and the need for “supportive parenting” following treatment, allowing for the recognition of both partners in a same-sex relationship as legal parents of donor conceived children
• make it easier for data collected by HFEA to be used to conduct research (implemented through regulations in 2010)
• clarify the scope of legitimate embryo research activities, including regulation of “human admixed embryos” (embryos combining both human and animal material) and allow for mitochondrial donation
• oblige HFEA to observe good regulatory practice principles and act effectively, efficiently and economically
• provide for an appeals committee that can reconsider licensing decisions made by HFEA (under which the current appeals regulations SI 2009/1891 were made)
• modify the 1990 Act to implement the 4 EU Human Tissue and Cell Directives

The 2008 Act also modifies surrogacy laws, so that non-profit making surrogacy is allowed, and creates new provisions within the 2008 Act to determine legal parenthood in cases involving assisted reproduction, and also to enable same-sex and unmarried couples to apply for a parental order. Under new provisions in the 2008 Act, a court must be satisfied that a surrogate mother has given consent freely and unconditionally to the making of a parental order.

2009

Regulations (SI 2009/1891) establish a licence appeals committee to reconsider licensing decisions on the merits.

2010

Regulations (SI 2010/995) permit some disclosure of protected information for research purposes.

2015

Regulations (SI 2015/572) allow for mitochondrial donation.

2018

Amendments to the 1990 Act to enact EU withdrawal (leaving minor differences to application of the 1990 Act in Northern Ireland from the rest of the UK).

2019

Amendment to the 2008 Act in 2018 allows for single parents to apply for parental orders in surrogacy cases.

2022

The Health and Care Act 2022:  

• extends the time periods for which gametes and fertilised embryos can be stored (for up to 55 years, subject to various consent requirements)
• enables the transfer of functions and or powers, using subsequent secondary legislation, between HEE, HRA, HFEA, HTA and NHSE