- Email: [email protected]
The future of the Human Fertilisation and Embryology Authority
Reproductive BioMedicine Online (2013) 26, 305– 306
www.sciencedirect.com www.rbmonline.com
COMMENTARY
The future of the Human Fertilisation and Embryology Authority Veronica English Head of Medical Ethics, British Medical Association, United Kingdom E-mail address: [email protected]
Abstract The UK Government has proposed that the Human Fertilisation and Embryology Authority (HFEA) should be abolished and
its functions transferred to the Care Quality Commission. This commentary explores the problems with this proposal and suggests that an independent review of how the HFEA carries out its functions and a subsequent reform of some of its practices represent a better option for the UK. RBMOnline ª 2013, Reproductive Healthcare Ltd. Published by Elsevier Ltd. All rights reserved. KEYWORDS: HFEA, Human Fertilisation and Embryology Authority, Regulation, Care Quality Commission, Public Bodies Act 2011, Arm’s Length Bodies review
In July 2010 the UK Government published its review of arm’s length bodies, including a proposal to abolish the Human Fertilisation and Embryology Authority (HFEA) and to transfer its functions to the Care Quality Commission (CQC) (Department of Health, 2010). This proposal did not, as one might have expected, follow a detailed review of the current regulatory mechanism but rather it stemmed from the political goal of reducing the number of arm’s length bodies. The Government had come to power with the headline-grabbing mission of unleashing a ‘bonfire of the quangos’ (another name for arm’s length bodies) and the HFEA was one of a number of organizations that was rounded up for inclusion. In 2011 the Public Bodies Act was passed, allowing the transfer of functions through secondary legislation and the Department of Health has subsequently carried out a consultation exercise seeking views on how to proceed. There is, however, no obligation to use the powers in the Act and a growing number of organizations and individuals are now calling on the Government to think again. Given the political pressure to reduce the number of arm’s length bodies, the idea of having a single regulator for clinical practice (the CQC) and a single regulator for research (the newly formed Health Research Authority)
does not sound unreasonable in theory. But even a cursory review of how the changes would work in practice is sufficient to recognize the serious problems it presents. First, the CQC has had some serious problems which it is trying hard to overcome. Numerous critical reports have been written about its performance. The Public Accounts Committee, for example: (i) concluded that it had ‘failed to fulfil its core role effectively’; (ii) expressed ‘serious concerns’ about its governance, leadership and culture; and (iii) said the public lacks confidence that it is an effective regulator. The Committee explicitly warned the Government not to risk transferring the HFEA’s functions to the CQC (Public Accounts Committee, 2012). This is not the type of body that should be taking on the highly specialized and sensitive regulation of assisted reproduction. Also, to be clear, despite some of the comments that were made in Parliament and elsewhere, these proposals will not reduce the level of regulation in the UK. It will not mean that IVF will be regulated in the same way as other medical procedures. The Government has been clear that the fundamentals of the legislation will remain unchanged so IVF will continue to be a licensable activity and subject to specific regulation (House of Lords Hansard, 2011). It is simply a question of who regulates it – the HFEA or the CQC.
1472-6483/$ - see front matter ª 2013, Reproductive Healthcare Ltd. Published by Elsevier Ltd. All rights reserved. http://dx.doi.org/10.1016/j.rbmo.2013.01.002
306 Many people in the sector believed that the transfer of functions to the CQC would inevitably result in a reduction in the licence fees they pay. But tucked away in the impact assessment accompanying the Government’s consultation is a small paragraph indicating that fees might reduce if the functions are transferred to the CQC but that they might also increase if the Government decides to reduce the grant-in-aid (Department of Health, 2012). So those hoping for less regulation or significant financial savings as a result of the Government’s plans may well be disappointed. Those people working in the sector may not always like the HFEA nor agree with its decisions. They may believe it is too bureaucratic, makes too many demands, gets involved in things it should not and is too expensive. There are undoubtedly changes that are needed but the question is whether abolition or reform is the better alternative. I personally strongly believe the HFEA should be retained, but with improvements ideally identified through an independent review of its activities, so let me briefly explain why. First, it is difficult to identify any clear advantages of this proposal (except the abolition of one arm’s length body): all of the advantages of abolition set out in the impact assessment, such as reduced administrative burden through closer liaison and joint inspections can and should be achievable without abolishing the HFEA. It should never be the case that an IVF clinic is subject to two different inspections, by different bodies, on different days looking at the same thing. But it isn’t necessary to abolish the HFEA to achieve this outcome and work is already underway to streamline the regulatory process. There is also an issue of public confidence – over its life span of more than 20 years, the HFEA has managed to maintain public confidence in this area of practice. Although Parliament voted in the late 1980s to allow human embryo research to continue, this and related issues are still highly sensitive and controversial. Despite this, with the HFEA as a trusted, specialist regulator, the UK has been able to continue and develop research and to use innovative treatment options, such as human leukocyte antigen testing, without public disquiet. It is highly questionable whether the public would have the same level of confidence if the area were regulated by the CQC. Shifting the regulation of assisted reproduction treatment to the CQC undoubtedly in my mind represents a risk to public confidence in the sector. We would also lose what has been called the ‘HFEA brand’. Patients, prospective patients and donor-conceived individuals know where to go to get impartial advice and information. The HFEA is recognized and respected both nationally and internationally. There is also a real risk of loss of expertise with these proposals, both in terms of the accumulated knowledge that the HFEA has developed in relation to the sensitive ethical issues it regulates but also, on a very practical level, knowledge about how the sector operates so that sensible and proportionate decisions
V English can be made. The extent of this loss will depend on the way in which the proposals are implemented and, of course, we have no details at all of how this will work in practice. The HFEA could simply lose its name and transfer lock, stock and barrel under the CQC as an autonomous fertility directorate. Expertise would be maintained and things would continue pretty much as before, albeit with the added risk to public confidence of being seen as part of the CQC. For those who want major change, however, the transfer will not achieve it and it is questionable whether it would really constitute the ‘abolition’ of an arm’s length body. Alternatively, the HFEA’s functions could be assimilated into the CQC. This would introduce a very serious risk that decisions directly affecting clinical practice would be made by people who have absolutely no knowledge or understanding of the way the sector works. The CQC Board will, of course, need to appoint specialist committees to advise it. But this means that the body that is responsible and accountable for the regulation (the CQC Board) has no knowledge of the field, and the body or bodies that have the knowledge, and are therefore, in practice, making the decisions (the advisory groups) have no responsibility or accountability – not an ideal situation. The HFEA is not perfect and some change is needed. I believe it has served us well but it needs to move with the times and there are things that can be done better. But to transfer the regulation of this very specialized and sensitive area of practice to the CQC, which is already struggling with its existing workload, just makes no sense. Of course we all hope that the CQC will improve but it is a huge leap of faith to assume that these very significant and fundamental problems can be overcome by 2015 when the transfer is meant to take place. Even if the CQC does improve, the problems of lack of expertise and public confidence will remain.
References Department of Health, 2010. Liberating the NHS. Report of the Arms-length Bodies Review. DH, London. Department of Health, 2012. Consultation on proposals to transfer functions from the Human Fertilisation and Embryology Authority and the Human Tissue Authority. Impact Assessment. DH, London, para 128. House of Lords Hansard, 28 March 2011, col 1068. Public Accounts Committee, 2012. The Care Quality Commission: regulating the quality and safety of health and adult social care. Seventy-eighth Report of Session 2010–12. The Stationery Office, London. Declaration: The author reports no financial or commercial conflicts of interest. The views expressed are those of the author and not necessarily those of the BMA. Received 11 December 2012; accepted 3 January 2013.
www.sciencedirect.com www.rbmonline.com
COMMENTARY
The future of the Human Fertilisation and Embryology Authority Veronica English Head of Medical Ethics, British Medical Association, United Kingdom E-mail address: [email protected]
Abstract The UK Government has proposed that the Human Fertilisation and Embryology Authority (HFEA) should be abolished and
its functions transferred to the Care Quality Commission. This commentary explores the problems with this proposal and suggests that an independent review of how the HFEA carries out its functions and a subsequent reform of some of its practices represent a better option for the UK. RBMOnline ª 2013, Reproductive Healthcare Ltd. Published by Elsevier Ltd. All rights reserved. KEYWORDS: HFEA, Human Fertilisation and Embryology Authority, Regulation, Care Quality Commission, Public Bodies Act 2011, Arm’s Length Bodies review
In July 2010 the UK Government published its review of arm’s length bodies, including a proposal to abolish the Human Fertilisation and Embryology Authority (HFEA) and to transfer its functions to the Care Quality Commission (CQC) (Department of Health, 2010). This proposal did not, as one might have expected, follow a detailed review of the current regulatory mechanism but rather it stemmed from the political goal of reducing the number of arm’s length bodies. The Government had come to power with the headline-grabbing mission of unleashing a ‘bonfire of the quangos’ (another name for arm’s length bodies) and the HFEA was one of a number of organizations that was rounded up for inclusion. In 2011 the Public Bodies Act was passed, allowing the transfer of functions through secondary legislation and the Department of Health has subsequently carried out a consultation exercise seeking views on how to proceed. There is, however, no obligation to use the powers in the Act and a growing number of organizations and individuals are now calling on the Government to think again. Given the political pressure to reduce the number of arm’s length bodies, the idea of having a single regulator for clinical practice (the CQC) and a single regulator for research (the newly formed Health Research Authority)
does not sound unreasonable in theory. But even a cursory review of how the changes would work in practice is sufficient to recognize the serious problems it presents. First, the CQC has had some serious problems which it is trying hard to overcome. Numerous critical reports have been written about its performance. The Public Accounts Committee, for example: (i) concluded that it had ‘failed to fulfil its core role effectively’; (ii) expressed ‘serious concerns’ about its governance, leadership and culture; and (iii) said the public lacks confidence that it is an effective regulator. The Committee explicitly warned the Government not to risk transferring the HFEA’s functions to the CQC (Public Accounts Committee, 2012). This is not the type of body that should be taking on the highly specialized and sensitive regulation of assisted reproduction. Also, to be clear, despite some of the comments that were made in Parliament and elsewhere, these proposals will not reduce the level of regulation in the UK. It will not mean that IVF will be regulated in the same way as other medical procedures. The Government has been clear that the fundamentals of the legislation will remain unchanged so IVF will continue to be a licensable activity and subject to specific regulation (House of Lords Hansard, 2011). It is simply a question of who regulates it – the HFEA or the CQC.
1472-6483/$ - see front matter ª 2013, Reproductive Healthcare Ltd. Published by Elsevier Ltd. All rights reserved. http://dx.doi.org/10.1016/j.rbmo.2013.01.002
306 Many people in the sector believed that the transfer of functions to the CQC would inevitably result in a reduction in the licence fees they pay. But tucked away in the impact assessment accompanying the Government’s consultation is a small paragraph indicating that fees might reduce if the functions are transferred to the CQC but that they might also increase if the Government decides to reduce the grant-in-aid (Department of Health, 2012). So those hoping for less regulation or significant financial savings as a result of the Government’s plans may well be disappointed. Those people working in the sector may not always like the HFEA nor agree with its decisions. They may believe it is too bureaucratic, makes too many demands, gets involved in things it should not and is too expensive. There are undoubtedly changes that are needed but the question is whether abolition or reform is the better alternative. I personally strongly believe the HFEA should be retained, but with improvements ideally identified through an independent review of its activities, so let me briefly explain why. First, it is difficult to identify any clear advantages of this proposal (except the abolition of one arm’s length body): all of the advantages of abolition set out in the impact assessment, such as reduced administrative burden through closer liaison and joint inspections can and should be achievable without abolishing the HFEA. It should never be the case that an IVF clinic is subject to two different inspections, by different bodies, on different days looking at the same thing. But it isn’t necessary to abolish the HFEA to achieve this outcome and work is already underway to streamline the regulatory process. There is also an issue of public confidence – over its life span of more than 20 years, the HFEA has managed to maintain public confidence in this area of practice. Although Parliament voted in the late 1980s to allow human embryo research to continue, this and related issues are still highly sensitive and controversial. Despite this, with the HFEA as a trusted, specialist regulator, the UK has been able to continue and develop research and to use innovative treatment options, such as human leukocyte antigen testing, without public disquiet. It is highly questionable whether the public would have the same level of confidence if the area were regulated by the CQC. Shifting the regulation of assisted reproduction treatment to the CQC undoubtedly in my mind represents a risk to public confidence in the sector. We would also lose what has been called the ‘HFEA brand’. Patients, prospective patients and donor-conceived individuals know where to go to get impartial advice and information. The HFEA is recognized and respected both nationally and internationally. There is also a real risk of loss of expertise with these proposals, both in terms of the accumulated knowledge that the HFEA has developed in relation to the sensitive ethical issues it regulates but also, on a very practical level, knowledge about how the sector operates so that sensible and proportionate decisions
V English can be made. The extent of this loss will depend on the way in which the proposals are implemented and, of course, we have no details at all of how this will work in practice. The HFEA could simply lose its name and transfer lock, stock and barrel under the CQC as an autonomous fertility directorate. Expertise would be maintained and things would continue pretty much as before, albeit with the added risk to public confidence of being seen as part of the CQC. For those who want major change, however, the transfer will not achieve it and it is questionable whether it would really constitute the ‘abolition’ of an arm’s length body. Alternatively, the HFEA’s functions could be assimilated into the CQC. This would introduce a very serious risk that decisions directly affecting clinical practice would be made by people who have absolutely no knowledge or understanding of the way the sector works. The CQC Board will, of course, need to appoint specialist committees to advise it. But this means that the body that is responsible and accountable for the regulation (the CQC Board) has no knowledge of the field, and the body or bodies that have the knowledge, and are therefore, in practice, making the decisions (the advisory groups) have no responsibility or accountability – not an ideal situation. The HFEA is not perfect and some change is needed. I believe it has served us well but it needs to move with the times and there are things that can be done better. But to transfer the regulation of this very specialized and sensitive area of practice to the CQC, which is already struggling with its existing workload, just makes no sense. Of course we all hope that the CQC will improve but it is a huge leap of faith to assume that these very significant and fundamental problems can be overcome by 2015 when the transfer is meant to take place. Even if the CQC does improve, the problems of lack of expertise and public confidence will remain.
References Department of Health, 2010. Liberating the NHS. Report of the Arms-length Bodies Review. DH, London. Department of Health, 2012. Consultation on proposals to transfer functions from the Human Fertilisation and Embryology Authority and the Human Tissue Authority. Impact Assessment. DH, London, para 128. House of Lords Hansard, 28 March 2011, col 1068. Public Accounts Committee, 2012. The Care Quality Commission: regulating the quality and safety of health and adult social care. Seventy-eighth Report of Session 2010–12. The Stationery Office, London. Declaration: The author reports no financial or commercial conflicts of interest. The views expressed are those of the author and not necessarily those of the BMA. Received 11 December 2012; accepted 3 January 2013.