- Email: [email protected]
The role of the Human Fertilisation and Embryology Authority
Ethics/Education
The role of the Human Fertilisation and Embryology Authority
patients and the wider society and safeguards the individuals and establishments working within the sector (Table 1). The regulator provides two key assurances developed over the years to reflect many changes and advances. Firstly, a Code of Practice sets out the standards for all clinics to ensure they are following both HFEA policy and the law. This reassures clinics and patients alike that their treatment is measured against the same standards at all clinics across the UK, and applies equally whether they are National Health Service (NHS) or privately run. This is a source of confidence for the patients who walk through the door of any clinic in the UK – not least because most patients pay for their own treatment. To ensure these standards are workable and reflect best practice within the sector, the Code of Practice is now produced in collaboration with professional bodies – a way of working that the Authority plans to continue and develop. Colleagues from the British Fertility Society, the Association of Clinical Embryologists and other professional bodies worked jointly with the regulator to develop the latest Code of Practice, making the standards and guidance as effective and focussed as possible. Secondly, the HFEA is a regulator that is very closely linked with the day-to-day running of clinics. While contact with clinics is proportionate to how much support they need, the close link has a prospective impact as clinics drive their standards ever higher and benefit from the best practices of others. A key assumption underlying this system of regulation is that there will be willing compliance on the part of those whose activities are regulated.
Hossam I Abdalla
Introduction The birth of a longed-for child brings joy and happiness. Many thousands more people have been able to enjoy that experience in recent years thanks to artificial reproductive technologies (ARTs). A little over 30 years ago, no child had ever been born using in vitro fertilisation (IVF). Today, over 40,000 IVF cycles are carried out each year in the UK and more than 11,000 children are born,1 with over 3 million children born worldwide after ART. With these developments came ethical dilemmas brought to light by the changing expectations of patients and by possibilities unthought-of by previous generations. In response to the new ethical and social dilemmas that followed the science of assisted reproduction, the UK Government established the Human Fertilisation and Embryology Authority (HFEA). Since 1991, the HFEA has been placed firmly at the heart of developments in the field of assisted reproduction and embryo research. The regulator’s task is to find a balance between the needs of science and medicine and the concerns of patients and the public. With new legislation2 to renew the legal framework for IVF and embryo research regulation approaching the final parliamentary stages, the role of the HFEA and the ethically sensitive issues it deals with are being widely discussed.
The HFEA’s current role • To licence and monitor fertility clinics that carry out IVF and donor insemination • To licence and monitor clinics undertaking human embryo research • To licence and monitor the storage of gametes and embryos • To produce a Code of Practice that gives guidelines to clinics about the proper conduct of HFEA-licensed activities • To maintain a formal register of information about donors, fertility treatments and children born as a result of those treatments • To provide relevant advice and information to patients, donors and clinics • To review information about human embryos, the provision of treatment services and activities governed by the HFE Act • To monitor any subsequent developments in this area and, where appropriate, advise the Secretary of State for Health on developments in these fields • The HFEA’s remit does not include all infertility treatments (such as fertility drugs). It is not an ombudsman and is not involved in funding for treatment
Role of the HFEA The principle of a balanced approach was at the heart of the recommendations of the Committee of Inquiry into Human Fertilisation and Embryology (the 1984 Warnock Report).3 The Committee concluded that the unique status of the human embryo required special attention and recommended a regulatory framework for this area of sophisticated scientific and medical practice. It recognised that, while science needs to progress to improve treatments and understanding of disease, the public is concerned that the moral and personal dimensions of these advances are properly addressed. Parliament subsequently passed the Human Fertilisation and Embryology Act 1990 (HFE Act) establishing the HFEA in August 1991 – the first statutory body of its type in the world. Given the recent interest in human-animal embryo research, it may sometimes seem that the focus of regulation is dealing with public concerns over new technologies. In fact, regulation plays a key role in the running of the sector as a whole. It reassures
The Authority and licensing HFEA Authority members bring a broad range of expertise to the HFEA – from medicine to law and religion to philosophy. They are appointed by UK Health Ministers through the NHS Appointments Commission in accordance with guidance from
Hossam I Abdalla FRCOG is Director of the Lister Fertility Clinic, Lister Hospital, London, UK.
OBSTETRICS, GYNAECOLOGY AND REPRODUCTIVE MEDICINE 19:2
53
© 2008 Published by Elsevier Ltd.
Ethics/Education
UK National live birth data for fresh and frozen embryo transfers, 2006
All cycles Under 35 Fresh cycles Under 35 Frozen cycles Under 35
Success rate (%)
No. of patients
No. of cycles
No. of births
No. of babies
23.1 29.0 24.4 31.0 17.4 20.1
33051 14103 29304 12651 6894 2795
41827 17562 33916 14337 7911 3189
9655 5089 8280 4447 175 642
11884 6440 10248 5660 1636 780
Table 1
receives the inspection report. Each clinic is required to appoint a Person Responsible, a specific legal role defined by the HFE Act 1990. The role of the Person Responsible is to ensure both the quality of service provided and the effective management of the ethical issues encountered. The Person Responsible is subject to an assessment by a HFEA Licence Committee and there is an inspection of the premises where the activities are performed. What is required of clinics is set out in the Code of Practice. It is regularly reviewed and amended to keep up to date with the rapidly changing field of assisted reproduction and research. This, in conjunction with guidance in the form of Chair’s Letters, Directions and Chief Executive’s letters, provides the framework for clinics to carry out their work. To make this task easier, all the guidance issued by the HFEA is available on the organisation’s website. Inspection is not only about reporting back to a Licence Committee. The process benefits both individual clinics and the whole regulatory system by contributing to service improvement. It provides feedback to clinics about their work, promotes effective self-assessment and reduces the risk of under-performing establishments damaging the reputation of others in the industry. Inspection reports keep the public informed of the availability, safety and quality of licensed clinics, helping them choose providers on the basis of independent evidence of the quality of services.
the Commissioner for Public Appointments (the ‘Nolan’ Guidelines). To ensure that the HFEA has a balanced and independent view, the HFE Act requires that the Chair, Deputy Chair and at least half of the HFEA members are neither doctors nor scientists involved in human embryo research or providing infertility treatment. Members decide on HFEA policies and consider licence applications for treatment and research. Since 1991, the regulator has licensed clinics that carry out IVF, donor insemination and research using human embryos. Since the introduction of the European Union Tissues and Cells Directive in July 2007, the HFEA has had additional powers to regulate all practices that involve the procurement, testing, processing or distributing of eggs or sperm for human application. This has brought other fertility services – such as intra-uterine insemination and gamete intra-fallopian transfer – into its remit. Regulation for its own sake or unnecessary overlapping of inspection, benefits no-one, so the HFEA uses the key principles of the Government’s better regulation for streamlining the HFEA’s work. It has already made good progress on the five principles of good regulation – proportionality, accountability, consistency, transparency and targeting. In particular, it has been working closely with the Healthcare Commission to develop ways to integrate inspection programmes in a sensible and pragmatic way and to reduce the information demands on clinics. Regulation starts with a HFEA Licence Committee – the gatekeepers for all licensed activities. The Licence Committee examines applications from those wishing to carry out treatments and research alongside inspection reports, and makes decisions following the legal framework set out by Parliament. Each Licence Committee is made up of several members of the Authority and meetings take place about 30 times each year. Research applications are also peer reviewed by members of an expert panel to ensure that applications meet the requirements of necessity and purpose.
The Register The HFEA has a statutory duty to collect information about licensed treatments and their outcomes. This is held on the ‘Register’– a collection of records compiled from data provided by licensed clinics. The Register holds information on patients and partners undergoing treatment, donors, treatments, embryo creation, embryo use and pregnancy outcomes. It is this data that enables the HFEA to produce success rates as part of the online ‘Find a Clinic’ service. It also allows the HFEA to shed light on other trends such as the age of people coming forward for treatment or the type of treatments carried out. The information held in the Register is protected by the HFE Act’s own specific confidentiality regulations, over and above any other data law. This means that information can only be given to the individual concerned and cannot be given to parents, grandparents or anyone else unless a court order has been granted. It is a criminal offence for HFEA employees, or others whose
Inspections Inspections assess the quality and effectiveness of the clinic’s (or research centre’s) management of activities, including services and information to patients and donors, premises and equipment, clinical and laboratory processes and competence of staff. The most important question for a clinic’s inspectors is: ‘What is it like for a patient here?’ The licensing process starts with the submission of information by a clinic and concludes when the Licence Committee
OBSTETRICS, GYNAECOLOGY AND REPRODUCTIVE MEDICINE 19:2
54
© 2008 Published by Elsevier Ltd.
Ethics/Education
A recent example of this close collaborative work has already borne fruit. An Authority decision last year called for a professionally-led, coordinated national strategy to reduce the number of multiple births after fertility treatment. Over the past few months, professional and patient organisations and HFEA have come together to work on ways to develop the strategy and their work has led to the announcement of professional guidance, a series of professional workshops and a website providing information for professionals and patients (see www.oneatatime.org. uk). Having a strong stance from the relevant bodies on an issue such as this is important to the intrinsic quality of the Authority’s decisions and policies.
job involves handling information on the Register, to release the information to anyone not entitled to it. Information relating to treatment using donor sperm, eggs or embryos is particularly sensitive. The amount of information that can be provided is determined by who is requesting the information (parent, donor or donor-conceived person), their age and when the donor registered. Anonymity of donors was lifted in 2005 but a number of donors who registered before that date have re-registered so that they can be traced by their offspring.
Electronic data interchange Electronic data interchange (EDI) is an electronic system for reporting treatment and patient data. Clinics must now send their information to the HFEA instantly and securely, helping to make data more accurate and quicker to process. EDI should enable faster access to the rich data that the Register holds, allowing professionals to benchmark their practice. Licensed centres are now required to provide records to HFEA by EDI within 5 working days of a patient deciding to undergo treatment, and within 3 calendar days of the start of drug stimulation. The result of the pregnancy test must also be notified within 5 working days, and the early pregnancy outcome (presence of foetal pulsation being ‘positive’) within 8 weeks of cycle completion. EDI may have been the work of the regulator, but the contribution from the sector’s professionals has been crucial to its practical implementation.
Horizon scanning A panel of leading international scientists report to the HFEA on imminent developments in the field that could potentially change the way IVF is practised. This ‘Horizon Scanning’ programme enables the Authority and the sector to be aware of future possibilities and to highlight areas where the regulator may need to take action or investigate more thoroughly. Recent ‘Horizon Scanning’ has noted that it may soon be possible to find the genes expressed by the most viable embryos – the ones most likely to implant successfully. If this were so, it could entirely change the way embryos are selected for IVF, with a positive impact for both patients and doctors.
The public and patients Policy and guidance
It is important that the HFEA understands the mainstream of public opinion and that of other stakeholders before decisions about policy are made. Public concerns are not just about the most cutting-edge techniques or the ones that stretch everyday understandings of what is possible. According to market & opinion research international (MORI) research4 conducted by the Authority in 2005, the jury is still out on IVF itself. A total of 50% of people believe that the benefits outweigh the risks and 48% believe that IVF does have unknown consequences. One in five people believe that IVF is unethical and should not be allowed at all. More recently, the HFEA conducted a public consultation looking into research using cytoplasmic hybrid embryos.5 That research found the public to be generally in favour of innovative and ethically challenging research as long as it can be shown to be necessary and effectively regulated. The views and experiences of patients, particularly those collected through the HFEA’s independent patients panel, ‘Fertility Views’, also help the HFEA better understand how its work affects those who are actually undergoing treatment. The HFEA is legally bound to provide information to the public and all concerned stakeholders, although how this is done is left to the Authority to determine. For example, in its first 5 years, the Authority provided national results and trends regarding IVF and donor insemination (DI) treatments but refrained from publishing data about individual clinics. This policy changed in 1995 when individual clinic data started to be provided. In an attempt to provide a level playing field, the results were initially adjusted taking into account the size of individual clinics and the mix, type and age of patients treated.
The HFEA’s policy-making role goes to the heart of the many and various complex ethical issues raised by IVF and embryo research. Recent high profile examples include research using cytoplasmic hybrid embryos, in vitro maturation of eggs and reducing the proportion of multiple births following IVF. The regulator’s role requires it to keep abreast of developments across a number of disciplines including scientific development, clinical innovation, public health policy and the changing social context. HFEA policies are reviewed regularly, a task that involves extensive research, literature reviews, public consultations and open meetings, and often the commissioning of work from specialists in the field. Policy options are presented to the Authority, which then decides the regulator’s approach or course of action, based on the evidence. As well as respecting the framework set out in the HFE Act, policy development must be consistent with the Authority’s overall corporate strategy. It must also take account of other factors, such as the social context, specific ethical considerations, the evidence base (or lack of) and the risks, and the interests of those affected. Policy measures must be capable of being applied to classes of activity or event, and not merely provide for individual cases. The principles of good medical practice in this country are that it is evidence-based and professionally led. IVF and other fertility treatments are no exception – the profession needs to lead the way and the HFEA will do everything it can to support that. The HFEA is encouraging greater involvement from the professional bodies to help drive improvement and take a stance on best practice.
OBSTETRICS, GYNAECOLOGY AND REPRODUCTIVE MEDICINE 19:2
55
© 2008 Published by Elsevier Ltd.
Ethics/Education
This system had its weaknesses and was abandoned 2 years later. Since then, only raw data for clinics has been provided. Although, more recently, the data has been stratified into different age groups and made available electronically through the ‘Find a Clinic’ guide, other crucial data such as incidence of elective embryo transfers and cancellation rates has been omitted. This system of reporting has support from patients’ but also has its critics.6 The dilemma is simply how to present the data in a form that will be most useful for patients and at the same time encourage best practice. For these reasons, the HFEA has recently held a series of deliberative events and other work with stakeholders to look at the best way to present the data.
In addition to the HFE Bill currently going through parliament, the work of the HFEA is affected by other new legal and regulatory requirements including: the Hampton Review; the Legislative and Regulatory Reform Act; the Regulators Compliance Code; and the Regulatory Enforcement and Sanctions Bill. Together, these give the HFEA an opportunity to set an improved framework that will deliver benefits for patients and professionals. Regulation can be enormously valuable to the sector, providing public confidence, protecting the sector from external challenges, and supporting the smooth operation of a thriving market in IVF services through patient assurance. The rapid change in this sector over the past 30 years has required the HFEA to make decisions on issues that could not have been foreseen by the original legislation. That will continue to be the case – the law cannot and does not anticipate every eventuality or development, especially in such a fast-moving sector. However, it is through greater collaboration, drawing on the skills, expertise and experience of the HFEA and the professional bodies in this sector, that the full potential of this world-renowned regulatory system will be achieved. ◆
New legislation As the science of ART continues to expand the number and complexity of possible treatments, HFEA has had to change in order to keep abreast of new developments. In 2005, when the Government conducted its review of the current HFE law, the Authority submitted a detailed report suggesting a number of key changes, describing how the HFEA would like the new regulation to work. Key to this is a more collaborative, responsive way of regulating. For example, it is expected that the new law will give the HFEA greater flexibility in the way it carries out its work. The decision-making powers of the HFEA could be delegated more widely to its Executive and to separate committees with a mix of members who are not part of the HFEA. This would bring collaboration with professionals and the public to the forefront of HFEA decision-making. The new law should also provide greater clarity on crucial issues such as the definition of ‘embryo’ to aid decision-making in what promises to continue to be a controversial and rapidly developing area of science and medicine. This clarity would not be possible without the depth and quality of parliamentary inquiry, including the evidence given by many key members of the sector. The new Act is expected to take the improved electronic system for the HFEA Register to another level – with the possibility of sharing previously unseen information with bona fide researchers about implantation, live births, and very importantly, long-term outcome for IVF children. This would need much careful and informed work to operate, but ultimately could provide invaluable information to researchers, clinicians and ultimately IVF patients and their families.
OBSTETRICS, GYNAECOLOGY AND REPRODUCTIVE MEDICINE 19:2
References 1 HFEA success rates data 2005. London: Human Fertilisation and Embryology Authority, December 2007. 2 Human Fertilisation and Embryology [HL] Bill - 2007-08. 3 Report of the Committee of Inquiry into Human Fertilisation and Embryology. London: Her Majesty’s Stationery Office, July 2004. 4 HFEA-commissioned research from MORI. London: Human Fertilisation and Embryology Authority, March 2005. 5 Hybrids and Chimeras: A report on the findings of the consultation, London: Human Fertilisation and Embryology Authority, October 2007. 6 Jacobs HS, Abdalla HI. Guide to donor insemination and IVF clinics. A patient’s guide or a government league table? Hum Reprod 1996; 11: 1835–1836.
Acknowledgements Special thanks to Ms Paula Woodward of the HFEA who has been an immense help in the preparation of this article.
56
© 2008 Published by Elsevier Ltd.
The role of the Human Fertilisation and Embryology Authority
patients and the wider society and safeguards the individuals and establishments working within the sector (Table 1). The regulator provides two key assurances developed over the years to reflect many changes and advances. Firstly, a Code of Practice sets out the standards for all clinics to ensure they are following both HFEA policy and the law. This reassures clinics and patients alike that their treatment is measured against the same standards at all clinics across the UK, and applies equally whether they are National Health Service (NHS) or privately run. This is a source of confidence for the patients who walk through the door of any clinic in the UK – not least because most patients pay for their own treatment. To ensure these standards are workable and reflect best practice within the sector, the Code of Practice is now produced in collaboration with professional bodies – a way of working that the Authority plans to continue and develop. Colleagues from the British Fertility Society, the Association of Clinical Embryologists and other professional bodies worked jointly with the regulator to develop the latest Code of Practice, making the standards and guidance as effective and focussed as possible. Secondly, the HFEA is a regulator that is very closely linked with the day-to-day running of clinics. While contact with clinics is proportionate to how much support they need, the close link has a prospective impact as clinics drive their standards ever higher and benefit from the best practices of others. A key assumption underlying this system of regulation is that there will be willing compliance on the part of those whose activities are regulated.
Hossam I Abdalla
Introduction The birth of a longed-for child brings joy and happiness. Many thousands more people have been able to enjoy that experience in recent years thanks to artificial reproductive technologies (ARTs). A little over 30 years ago, no child had ever been born using in vitro fertilisation (IVF). Today, over 40,000 IVF cycles are carried out each year in the UK and more than 11,000 children are born,1 with over 3 million children born worldwide after ART. With these developments came ethical dilemmas brought to light by the changing expectations of patients and by possibilities unthought-of by previous generations. In response to the new ethical and social dilemmas that followed the science of assisted reproduction, the UK Government established the Human Fertilisation and Embryology Authority (HFEA). Since 1991, the HFEA has been placed firmly at the heart of developments in the field of assisted reproduction and embryo research. The regulator’s task is to find a balance between the needs of science and medicine and the concerns of patients and the public. With new legislation2 to renew the legal framework for IVF and embryo research regulation approaching the final parliamentary stages, the role of the HFEA and the ethically sensitive issues it deals with are being widely discussed.
The HFEA’s current role • To licence and monitor fertility clinics that carry out IVF and donor insemination • To licence and monitor clinics undertaking human embryo research • To licence and monitor the storage of gametes and embryos • To produce a Code of Practice that gives guidelines to clinics about the proper conduct of HFEA-licensed activities • To maintain a formal register of information about donors, fertility treatments and children born as a result of those treatments • To provide relevant advice and information to patients, donors and clinics • To review information about human embryos, the provision of treatment services and activities governed by the HFE Act • To monitor any subsequent developments in this area and, where appropriate, advise the Secretary of State for Health on developments in these fields • The HFEA’s remit does not include all infertility treatments (such as fertility drugs). It is not an ombudsman and is not involved in funding for treatment
Role of the HFEA The principle of a balanced approach was at the heart of the recommendations of the Committee of Inquiry into Human Fertilisation and Embryology (the 1984 Warnock Report).3 The Committee concluded that the unique status of the human embryo required special attention and recommended a regulatory framework for this area of sophisticated scientific and medical practice. It recognised that, while science needs to progress to improve treatments and understanding of disease, the public is concerned that the moral and personal dimensions of these advances are properly addressed. Parliament subsequently passed the Human Fertilisation and Embryology Act 1990 (HFE Act) establishing the HFEA in August 1991 – the first statutory body of its type in the world. Given the recent interest in human-animal embryo research, it may sometimes seem that the focus of regulation is dealing with public concerns over new technologies. In fact, regulation plays a key role in the running of the sector as a whole. It reassures
The Authority and licensing HFEA Authority members bring a broad range of expertise to the HFEA – from medicine to law and religion to philosophy. They are appointed by UK Health Ministers through the NHS Appointments Commission in accordance with guidance from
Hossam I Abdalla FRCOG is Director of the Lister Fertility Clinic, Lister Hospital, London, UK.
OBSTETRICS, GYNAECOLOGY AND REPRODUCTIVE MEDICINE 19:2
53
© 2008 Published by Elsevier Ltd.
Ethics/Education
UK National live birth data for fresh and frozen embryo transfers, 2006
All cycles Under 35 Fresh cycles Under 35 Frozen cycles Under 35
Success rate (%)
No. of patients
No. of cycles
No. of births
No. of babies
23.1 29.0 24.4 31.0 17.4 20.1
33051 14103 29304 12651 6894 2795
41827 17562 33916 14337 7911 3189
9655 5089 8280 4447 175 642
11884 6440 10248 5660 1636 780
Table 1
receives the inspection report. Each clinic is required to appoint a Person Responsible, a specific legal role defined by the HFE Act 1990. The role of the Person Responsible is to ensure both the quality of service provided and the effective management of the ethical issues encountered. The Person Responsible is subject to an assessment by a HFEA Licence Committee and there is an inspection of the premises where the activities are performed. What is required of clinics is set out in the Code of Practice. It is regularly reviewed and amended to keep up to date with the rapidly changing field of assisted reproduction and research. This, in conjunction with guidance in the form of Chair’s Letters, Directions and Chief Executive’s letters, provides the framework for clinics to carry out their work. To make this task easier, all the guidance issued by the HFEA is available on the organisation’s website. Inspection is not only about reporting back to a Licence Committee. The process benefits both individual clinics and the whole regulatory system by contributing to service improvement. It provides feedback to clinics about their work, promotes effective self-assessment and reduces the risk of under-performing establishments damaging the reputation of others in the industry. Inspection reports keep the public informed of the availability, safety and quality of licensed clinics, helping them choose providers on the basis of independent evidence of the quality of services.
the Commissioner for Public Appointments (the ‘Nolan’ Guidelines). To ensure that the HFEA has a balanced and independent view, the HFE Act requires that the Chair, Deputy Chair and at least half of the HFEA members are neither doctors nor scientists involved in human embryo research or providing infertility treatment. Members decide on HFEA policies and consider licence applications for treatment and research. Since 1991, the regulator has licensed clinics that carry out IVF, donor insemination and research using human embryos. Since the introduction of the European Union Tissues and Cells Directive in July 2007, the HFEA has had additional powers to regulate all practices that involve the procurement, testing, processing or distributing of eggs or sperm for human application. This has brought other fertility services – such as intra-uterine insemination and gamete intra-fallopian transfer – into its remit. Regulation for its own sake or unnecessary overlapping of inspection, benefits no-one, so the HFEA uses the key principles of the Government’s better regulation for streamlining the HFEA’s work. It has already made good progress on the five principles of good regulation – proportionality, accountability, consistency, transparency and targeting. In particular, it has been working closely with the Healthcare Commission to develop ways to integrate inspection programmes in a sensible and pragmatic way and to reduce the information demands on clinics. Regulation starts with a HFEA Licence Committee – the gatekeepers for all licensed activities. The Licence Committee examines applications from those wishing to carry out treatments and research alongside inspection reports, and makes decisions following the legal framework set out by Parliament. Each Licence Committee is made up of several members of the Authority and meetings take place about 30 times each year. Research applications are also peer reviewed by members of an expert panel to ensure that applications meet the requirements of necessity and purpose.
The Register The HFEA has a statutory duty to collect information about licensed treatments and their outcomes. This is held on the ‘Register’– a collection of records compiled from data provided by licensed clinics. The Register holds information on patients and partners undergoing treatment, donors, treatments, embryo creation, embryo use and pregnancy outcomes. It is this data that enables the HFEA to produce success rates as part of the online ‘Find a Clinic’ service. It also allows the HFEA to shed light on other trends such as the age of people coming forward for treatment or the type of treatments carried out. The information held in the Register is protected by the HFE Act’s own specific confidentiality regulations, over and above any other data law. This means that information can only be given to the individual concerned and cannot be given to parents, grandparents or anyone else unless a court order has been granted. It is a criminal offence for HFEA employees, or others whose
Inspections Inspections assess the quality and effectiveness of the clinic’s (or research centre’s) management of activities, including services and information to patients and donors, premises and equipment, clinical and laboratory processes and competence of staff. The most important question for a clinic’s inspectors is: ‘What is it like for a patient here?’ The licensing process starts with the submission of information by a clinic and concludes when the Licence Committee
OBSTETRICS, GYNAECOLOGY AND REPRODUCTIVE MEDICINE 19:2
54
© 2008 Published by Elsevier Ltd.
Ethics/Education
A recent example of this close collaborative work has already borne fruit. An Authority decision last year called for a professionally-led, coordinated national strategy to reduce the number of multiple births after fertility treatment. Over the past few months, professional and patient organisations and HFEA have come together to work on ways to develop the strategy and their work has led to the announcement of professional guidance, a series of professional workshops and a website providing information for professionals and patients (see www.oneatatime.org. uk). Having a strong stance from the relevant bodies on an issue such as this is important to the intrinsic quality of the Authority’s decisions and policies.
job involves handling information on the Register, to release the information to anyone not entitled to it. Information relating to treatment using donor sperm, eggs or embryos is particularly sensitive. The amount of information that can be provided is determined by who is requesting the information (parent, donor or donor-conceived person), their age and when the donor registered. Anonymity of donors was lifted in 2005 but a number of donors who registered before that date have re-registered so that they can be traced by their offspring.
Electronic data interchange Electronic data interchange (EDI) is an electronic system for reporting treatment and patient data. Clinics must now send their information to the HFEA instantly and securely, helping to make data more accurate and quicker to process. EDI should enable faster access to the rich data that the Register holds, allowing professionals to benchmark their practice. Licensed centres are now required to provide records to HFEA by EDI within 5 working days of a patient deciding to undergo treatment, and within 3 calendar days of the start of drug stimulation. The result of the pregnancy test must also be notified within 5 working days, and the early pregnancy outcome (presence of foetal pulsation being ‘positive’) within 8 weeks of cycle completion. EDI may have been the work of the regulator, but the contribution from the sector’s professionals has been crucial to its practical implementation.
Horizon scanning A panel of leading international scientists report to the HFEA on imminent developments in the field that could potentially change the way IVF is practised. This ‘Horizon Scanning’ programme enables the Authority and the sector to be aware of future possibilities and to highlight areas where the regulator may need to take action or investigate more thoroughly. Recent ‘Horizon Scanning’ has noted that it may soon be possible to find the genes expressed by the most viable embryos – the ones most likely to implant successfully. If this were so, it could entirely change the way embryos are selected for IVF, with a positive impact for both patients and doctors.
The public and patients Policy and guidance
It is important that the HFEA understands the mainstream of public opinion and that of other stakeholders before decisions about policy are made. Public concerns are not just about the most cutting-edge techniques or the ones that stretch everyday understandings of what is possible. According to market & opinion research international (MORI) research4 conducted by the Authority in 2005, the jury is still out on IVF itself. A total of 50% of people believe that the benefits outweigh the risks and 48% believe that IVF does have unknown consequences. One in five people believe that IVF is unethical and should not be allowed at all. More recently, the HFEA conducted a public consultation looking into research using cytoplasmic hybrid embryos.5 That research found the public to be generally in favour of innovative and ethically challenging research as long as it can be shown to be necessary and effectively regulated. The views and experiences of patients, particularly those collected through the HFEA’s independent patients panel, ‘Fertility Views’, also help the HFEA better understand how its work affects those who are actually undergoing treatment. The HFEA is legally bound to provide information to the public and all concerned stakeholders, although how this is done is left to the Authority to determine. For example, in its first 5 years, the Authority provided national results and trends regarding IVF and donor insemination (DI) treatments but refrained from publishing data about individual clinics. This policy changed in 1995 when individual clinic data started to be provided. In an attempt to provide a level playing field, the results were initially adjusted taking into account the size of individual clinics and the mix, type and age of patients treated.
The HFEA’s policy-making role goes to the heart of the many and various complex ethical issues raised by IVF and embryo research. Recent high profile examples include research using cytoplasmic hybrid embryos, in vitro maturation of eggs and reducing the proportion of multiple births following IVF. The regulator’s role requires it to keep abreast of developments across a number of disciplines including scientific development, clinical innovation, public health policy and the changing social context. HFEA policies are reviewed regularly, a task that involves extensive research, literature reviews, public consultations and open meetings, and often the commissioning of work from specialists in the field. Policy options are presented to the Authority, which then decides the regulator’s approach or course of action, based on the evidence. As well as respecting the framework set out in the HFE Act, policy development must be consistent with the Authority’s overall corporate strategy. It must also take account of other factors, such as the social context, specific ethical considerations, the evidence base (or lack of) and the risks, and the interests of those affected. Policy measures must be capable of being applied to classes of activity or event, and not merely provide for individual cases. The principles of good medical practice in this country are that it is evidence-based and professionally led. IVF and other fertility treatments are no exception – the profession needs to lead the way and the HFEA will do everything it can to support that. The HFEA is encouraging greater involvement from the professional bodies to help drive improvement and take a stance on best practice.
OBSTETRICS, GYNAECOLOGY AND REPRODUCTIVE MEDICINE 19:2
55
© 2008 Published by Elsevier Ltd.
Ethics/Education
This system had its weaknesses and was abandoned 2 years later. Since then, only raw data for clinics has been provided. Although, more recently, the data has been stratified into different age groups and made available electronically through the ‘Find a Clinic’ guide, other crucial data such as incidence of elective embryo transfers and cancellation rates has been omitted. This system of reporting has support from patients’ but also has its critics.6 The dilemma is simply how to present the data in a form that will be most useful for patients and at the same time encourage best practice. For these reasons, the HFEA has recently held a series of deliberative events and other work with stakeholders to look at the best way to present the data.
In addition to the HFE Bill currently going through parliament, the work of the HFEA is affected by other new legal and regulatory requirements including: the Hampton Review; the Legislative and Regulatory Reform Act; the Regulators Compliance Code; and the Regulatory Enforcement and Sanctions Bill. Together, these give the HFEA an opportunity to set an improved framework that will deliver benefits for patients and professionals. Regulation can be enormously valuable to the sector, providing public confidence, protecting the sector from external challenges, and supporting the smooth operation of a thriving market in IVF services through patient assurance. The rapid change in this sector over the past 30 years has required the HFEA to make decisions on issues that could not have been foreseen by the original legislation. That will continue to be the case – the law cannot and does not anticipate every eventuality or development, especially in such a fast-moving sector. However, it is through greater collaboration, drawing on the skills, expertise and experience of the HFEA and the professional bodies in this sector, that the full potential of this world-renowned regulatory system will be achieved. ◆
New legislation As the science of ART continues to expand the number and complexity of possible treatments, HFEA has had to change in order to keep abreast of new developments. In 2005, when the Government conducted its review of the current HFE law, the Authority submitted a detailed report suggesting a number of key changes, describing how the HFEA would like the new regulation to work. Key to this is a more collaborative, responsive way of regulating. For example, it is expected that the new law will give the HFEA greater flexibility in the way it carries out its work. The decision-making powers of the HFEA could be delegated more widely to its Executive and to separate committees with a mix of members who are not part of the HFEA. This would bring collaboration with professionals and the public to the forefront of HFEA decision-making. The new law should also provide greater clarity on crucial issues such as the definition of ‘embryo’ to aid decision-making in what promises to continue to be a controversial and rapidly developing area of science and medicine. This clarity would not be possible without the depth and quality of parliamentary inquiry, including the evidence given by many key members of the sector. The new Act is expected to take the improved electronic system for the HFEA Register to another level – with the possibility of sharing previously unseen information with bona fide researchers about implantation, live births, and very importantly, long-term outcome for IVF children. This would need much careful and informed work to operate, but ultimately could provide invaluable information to researchers, clinicians and ultimately IVF patients and their families.
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References 1 HFEA success rates data 2005. London: Human Fertilisation and Embryology Authority, December 2007. 2 Human Fertilisation and Embryology [HL] Bill - 2007-08. 3 Report of the Committee of Inquiry into Human Fertilisation and Embryology. London: Her Majesty’s Stationery Office, July 2004. 4 HFEA-commissioned research from MORI. London: Human Fertilisation and Embryology Authority, March 2005. 5 Hybrids and Chimeras: A report on the findings of the consultation, London: Human Fertilisation and Embryology Authority, October 2007. 6 Jacobs HS, Abdalla HI. Guide to donor insemination and IVF clinics. A patient’s guide or a government league table? Hum Reprod 1996; 11: 1835–1836.
Acknowledgements Special thanks to Ms Paula Woodward of the HFEA who has been an immense help in the preparation of this article.
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© 2008 Published by Elsevier Ltd.