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Response to Department of Health Consultation on Proposals to Transfer Functions from the Human Fertilisation and Embryology Authority and the Human Tissue Authority

28 September 2012
This policy document is a response by the Progress Educational Trust (PET) to the Consultation on Proposals to Transfer Functions from the Human Fertilisation and Embryology Authority and the Human Tissue Authority (.pdf 338KB) issued by the UK Government's Department of Health (DH).
This response is limited to comments on the Human Fertilisation and Embryology Authority (HFEA), and the response was formulated following a meeting of PET's Trustees and Staff. A draft response was circulated to the Trustees for comment before submission.

1. Do you agree with the option to transfer all HFEA functions to the Care Quality Commission (CQC) with the exception of HFEA functions relating to research that will transfer to the Health Research Authority (HRA) and abolish the HFEA?
We do not agree with the option to transfer HFEA functions to the CQC and the HRA, and to abolish the HFEA.
The nature of HFEA functions is such that, even assuming that they were transferred without impediment and with all of the necessary expertise transferred alongside them (both of which are very optimistic assumptions), it is likely that the HFEA would be recreated in all but name as a discrete unit within the CQC. One could argue that this has already taken place spatially (the HFEA having already moved into the CQC's offices), but for one organisation to be formally subsumed by the other would not, in our opinion, cut costs. Indeed, this exercise is likely to incur net costs because of the bureaucracy involved.
One argument that has been made in favour of transferring HFEA functions to the CQC is that because fertility treatment is now routine, it is therefore appropriate for it to be regulated by a generic body like the CQC, rather than by a specialist body like the HFEA. We have some sympathy with this view, but do not think it can be reflected meaningfully in regulation - except perhaps disingenuously via a form of deliberately engineered 'neglect', whereby it is hoped that HFEA duties will be lost from sight because the CQC has bigger fish to fry. The problem with shifting the HFEA or its functions into a bigger operation is the likelihood that it will be lost from sight. A dangerous corollary of this would be a loss of accountability.
Although this is an area in which procedures such as IVF are routine and have wide public support, a significant minority of people consider even IVF to be extremely controversial. It is therefore crucial that public confidence in the effective regulation of this area is maintained. It is an inconvenient truth that the CQC has an image problem, with public confidence in this body eroded following the recent care homes scandal.
Primary legislation in this area remains predicated upon a special moral status ascribed to the embryo, with the consequence that fertility treatment is the subject of deliberate regulatory exceptionalism. This arrangement is at the core of the Warnock settlement developed via the Warnock Report (.pdf 769KB) and the two Human Fertilisation and Embryology (HFE) Acts. It should not be undone without due political contestation, addressing matters of morality well ahead of financial cost.
The HFEA's role is small and specialised and should be circumscribed, and a big organisation will simply have other priorities. If (as seems likely) public money continues to be tight, there will also be an irresistible tendency to move staff from the broader CQC into the CQC's HFEA-equivalent department when vacancies occur. This niche area will then be vulnerable to getting staff at particular grades, solely because they are not useful elsewhere. By definition, they will be ignorant of the HFEA's role and its subject matter. Specialist work requires specialist staff.
Human resources at the HFEA have suffered since the announcement that it faced abolition. A number of staff have left and have not been replaced, or have been replaced by promoting other staff members who lack the requisite experience, expertise and gravitas.
The area the HFEA regulates is still developing apace, and provision needs to be made to cope with unforeseen developments, new breakthroughs and novel techniques. For example, the Government has commissioned the HFEA to run a public consultation on novel techniques for avoiding the transmission of mitochondrial disease, and if the law is changed to permit the use of these techniques in treatment, then the HFEA will be responsible for regulating their use.
If a development occurs with similarly far-reaching scientific, social and legal ramifications - say, the successful derivation of viable human sperm from induced pluripotent stem cells - will the CQC have sufficient resources to address this development? Or will the first question asked be what is going to be cut from the workload?
The areas which the HFEA regulates still capture the media's attention, often receiving front-page coverage in national newspapers. A press office with expertise in this field is needed, and a general press officer at the CQC without the necessary experience could easily exacerbate problems in the media rather than successfully managing them.

2. Can you quantify what impact this could have at a local level (either in relation to service providers or patients or both)?
Your consultation document (.pdf 338KB) outlines the considerable overlap between fertility clinics that are regulated by the HFEA, and centres that are regulated by the CQC. However, the savings that could be made by eliminating this overlap are likely to be limited, because fertility treatment is a sufficiently distinctive area of healthcare to require its own inspection regime. This remains the case, even if those who inspect a centre represent one organisation between them rather than two.
That said, an independent review of the inspection procedures by both organisations should be carried out, to avoid duplication where possible, to avoid potential conflicts and to streamline the processes of both the HFEA and CQC.

3. Do you agree that HFEA functions relating to research should be transferred to the HRA?
We do not agree that HFEA functions relating to research should be transferred to the HRA, for two reasons.
First, embryo research and fertility treatment are fields that are connected in several respects. They both involve embryological expertise and they both involve the use of donated gametes and embryos, not to mention the challenge of encouraging donation of these gametes and embryos. There is also a category of translational work that exists between laboratory research and clinical practice, making it still harder to distinguish the two (for example, if techniques to avoid the transmission of mitochondrial disease are legally permitted, they will pass through a translational phase). It is therefore illogical to separate embryo research and fertility treatment, when this has been performed by a single regulator for two decades.
Second, while we sympathise to some extent with the desire to reduce regulatory burdens upon researchers, there is no guarantee that the HRA will succeed in achieving this aim. The HRA is a new organisation still awaiting non-departmental public body status, and while it was established with the aim of reducing regulatory burdens, it is too soon to tell whether it can deliver.

4. Do you think that some HFEA functions might sit better with bodies other than CQC and the HRA? If so, which functions and which organisations and what do you see as the advantages of the alternative organisation?
There is an argument to be made against the existence of arm's-length bodies in general, on the grounds that by deriving authority from government while being separate from it, such bodies can never have accountability commensurate with the power they wield. According to this argument, all HFEA functions would sit better with central Government.
However, we do not currently have a political culture that would make this argument viable. The logical corollary of a reduction in the number of arm's-length bodies is an appetite on the part of Government for assuming rather than outsourcing responsibility, and for engaging in principled moral debate about relevant policies and practices. This appetite does not appear to exist. A desire simply to reduce costs and regulatory burdens is not sufficient to justify a return of functions to central Government, which is itself subject to cuts, and which has traditionally been slow in responding to issues arising in fertility treatment and embryo research. We are also concerned that staff at the Department of Health who have expertise in this area have been redeployed.

5. Do you believe the HFEA should retain existing functions but deliver further efficiencies?
We believe that the HFEA should retain existing functions but deliver further efficiencies by tighter focusing. This is because transferring these functions will not, in our opinion, lead to improvements in efficiency or effectiveness, whereas such improvements are eminently feasible if the HFEA remains.
Our small charity addresses the same areas which the HFEA regulates (fertility treatment and embryo research), and is almost as old as the HFEA. Like the HFEA, we were founded following the passing of the original HFE Act, while our precursor organisation (the Progress Campaign for Research into Human Reproduction) was founded in 1985 in response to the Unborn Children (Protection) Bill proposed by Enoch Powell. Over the past two decades, we have come to consider ourselves a 'critical friend' of the HFEA, supporting it or criticising it as appropriate based on our ongoing evaluation of its decisions and activities. We understand that some individuals and organisations are very critical of the HFEA (indeed, we offer several criticisms of our own below) but we do not believe that calling for the HFEA's abolition via a response to this consultation is the appropriate vehicle for this critical impulse.
Some of the frustration that individuals and organisations feel towards the HFEA is in fact sublimated frustration at the way its duties are defined in statute. The only honest and appropriate way to exercise this frustration is via Parliament. Inasmuch as the HFEA is a legitimate target of frustration, those who would like to see it abolished assume that its deficiencies are so severe that any alternative regulator would be better. From our perspective, this position is naïve. The CQC is a beleaguered organisation which the House of Commons' Public Accounts Committee' has specified (.pdf 454KB) 'should not take on the functions of the HFEA at this time', while the HRA is a new and untested organisation. It would be foolish to rely on presumptions that these organisations will regulate in ways that are more competent and/or less objectionable than the HFEA.

6. Do you think that retaining functions with the HFEA could deliver savings to the public purse?
The HFEA could deliver savings by adopting a more minimalist approach to its statutory duties. The best way to achieve this would be to audit the current activities of the HFEA, compare them to the organisation's statutory duties, and pare back the activities accordingly.
For example, the HFEA recently launched a National Donation Strategy Group, with the aim of identifying and addressing impediments to gamete donation. While we think this is a laudable aim (indeed, our Director is a member of the group) it takes a generous interpretation of the HFEA's duty to provide information to see this as being within the organisation's statutory remit. This is especially the case, when one considers that the DH has to date funded the National Gamete Donation Trust to perform what is ostensibly the same work.
The HFEA could also deliver savings by developing a more rigorous and disciplined organisational culture. For several years now, we have ensured that we attend every London-based HFEA open authority meeting, and we also attend various other HFEA events. The impression given at these meetings is that the HFEA's organisational culture is, at least in some respects, poor. Authority Members' views are curtailed by the Chair and decisions appear to be rushed through. Our perception of these open meetings is that the fact that the HFEA does not give a more professional impression of itself (whatever its shortcomings behind closed doors) suggests a lack of judgment, a poor understanding of public perception, and a contempt for the public and sometimes for the very Authority members themselves.
The phrase 'public purse' needs to be clarified in relation to the HFEA, because much of the organisation's income derives not from Government funding, but from licence fees. However, since these licence fees are passed on to the public in the form of fertility treatment fees, talk of the public purse is not entirely inappropriate. In fairness to the HFEA, there are restrictions on how it is permitted to use its cash surplus (which was revealed to be a remarkable £3.4million. earlier this year), and perhaps these restrictions create perverse incentives for inefficient and ineffective use of money. But whether the blame lies directly with the HFEA or with the policies that restrict its spending, a situation where HFEA staff talk openly at public meetings of the need for 'high-burn activities' to reduce the organisation's surplus (as we have witnessed) is unacceptable and must change.

7. Within the option of retaining the HFEA and the HTA as independent regulators, are there any of their functions you think should be transferred elsewhere and, if so, which and why?
We would like to see a reduction in HFEA activities via a more minimalist interpretation of the organisation's statutory duties, there are no functions as such that we think should be transferred elsewhere.
We entertained briefly the argument that the HFEA register of information might be better maintained elsewhere - for example the Health and Social Care Information Centre, as proposed in the consultation document - where there is appropriate technical expertise. We also considered this argument in light of the fact that no satisfactory answer has yet been given by the HFEA, DH or anyone else, to the question of who will manage new issues that arise, once people who were conceived with donor gametes after the era of donor anonymity ended are entitled to request information about the relevant donor(s).
However, on reflection we think it would be impracticable for the function of maintaining the register to be transferred elsewhere, because this function is not sufficiently discrete. The register incorporates data submitted by clinics to the HFEA, as a condition of their license, on a rolling basis. The register is also dynamic in its entirety, rather than being wholly or partially static - for example, a datum such as the number of genetic half-siblings that a donor-conceived person has, or the identity of such genetic half-siblings, will always be liable to change. Furthermore, the register contains data relating to both public and private sector fertility treatment, whereas the Health and Social Care Information Centre is dedicated to public health data. The handling of personal data and public health data requires very different approaches.
It remains the case that in 2023, the first people who were conceived with donor gametes after the era of donor anonymity ended will reach the age of 18. Consequently, they will be entitled in law to request that the HFEA, or its successor, provides them with information about the relevant donor(s). It is far from clear how and by whom the logistics of this, and the provision of any necessary counselling, will be managed and funded. This needs to be resolved.

8. Do you have any comments on our assessment of the efficiencies associated with the different options in paragraphs 154-158 above and in the accompanying consultation Impact Assessment?
We do not accept the assertion (unsupported by any evidence) that 'the option of transferring functions to CQC except for HFEA-related research functions would avoid fragmentation of expertise'.
Even if fragmentation of expertise is technically avoided, there will doubtless be attrition of that expertise, because not all HFEA staff and advisers will want to work for another organisation - especially not an organisation with as poor a recent reputation as the CQC. Indeed, attrition of expertise has already been taking place for two years at the HFEA, as a consequence of its uncertain future following the Government's review of arm's-length bodies (.pdf 272KB). Several staff members have left and have not been replaced, or have been replaced by promoting other staff members who lack the expertise desirable.

9. This consultation focuses specifically on where functions might sit and implementation will be at the discretion of the regulators. However, if you have any views as to how functions might be undertaken in future or other issues of concern that we could share with the bodies undertaking these functions as they plan for the future, please let us know.
In our response to Q6 above, we refer to the fact that the HFEA's organisational culture is, at least judging by the impression given at open meetings, poor. Signifiers of this include the Chair's frequent and inappropriate jocularity when discussing serious matters (we do not wish for the organisation to be po-faced but it deals with many areas where such levity is completely misplaced), and also her lavish praise for staff members for simply doing their job is disproportionate.
The HFEA's recent Donation Review and related public consultation attracted criticism from a wide range of stakeholders, not simply because of the conclusion that was reached, but because of the way the review was conducted. An especially good example of HFEA conduct was the fact that one of its decisions following the review was released to the media before Authority members had even voted on it at the relevant public meeting, thereby undermining the credibility of the proceedings. If the HFEA is spared abolition (as we hope it will be), these issues must be tackled by its recently appointed chief executive, Peter Thompson.
Much criticism has been levelled at the current Chair of the HFEA, Lisa Jardine. Most recently, she has attracted criticism for her intemperate comments to the press regarding the HFEA's public consultation Medical Frontiers: Debating Mitochondria Replacement. Given the sensitivity of the areas the HFEA regulates, its figurehead will always attract attention and criticism, but the point to be made here is that the chairmanship of the HFEA is emphatically not a role for a 'personality' - whatever their qualities, and however eminent they may be in their calling in other areas outside this one. The Chair is the public face of the Authority and not the Authority itself.

10. Do you have any other comments on the consultation proposals that you would like to share with us?
We believe that the government has carried out the wrong consultation.
The Government should have ordered a detailed review of the HFEA's functions and activities (to establish what the organisation is currently doing which is over and above that required by statute) and combined this with a stakeholder consultation about overly bureaucratic and burdensome regulation, and should have sought evidence, not just opinion. The findings from this review should have formed the basis for securing much-sought-after cost savings. Additional benefits of this strategy would have been curbing of HFEA 'mission creep', winning buy-in from stakeholders, and improving the HFEA so that it is fit for purpose for years to come.

11. Can you provide examples of costs and benefits of these proposals?
See our responses to questions above.

12. Do you have any comments on the consultation Equality Analysis?

PET has organised two public debates about the proposed abolition of the HFEA. Approximately 300 people attended the first event, and 150 people attended the second.

At PET's first public event - 'The End of the HFEA: Are We Throwing the Baby Out with the Bathwater?', held at the Royal Society on 17 January 2011 - we asked the audience to complete feedback forms. One of the questions we asked the audience was 'Should the HFEA continue to oversee assisted conception and embryo research?'. The responses were as follows.
Yes 65
No 22
Don't Know 30

We also asked 'Have your views changed as a result of attending this event?' The responses were as follows.
More in favour of HFEA 29
Less in favour of HFEA 48
No change 34

At PET's second public event - 'Quangoing', held at University College London on 11 September 2012 - we asked 'Which of the Government's three options for the future of the HFEA gets your vote?'. The responses were as follows.
Transfer all HFEA and HTA functions to CQC with the exception of HFEA functions relating to research that will transfer to the HRA; and abolish the HFEA and the HTA 4
Transfer all HFEA and HTA functions to CQC with the exception of HFEA functions relating to research that will transfer to the HRA and a limited number of functions that would transfer elsewhere; and abolish the HFEA and the HTA 11
HFEA and HTA retain their functions but deliver further efficiencies 38

The Progress Education publishes BioNews, a digital weekly news and comment service covering assisted conception, human genetics and stem cell and embryo research. Since the announcement that the HFEA faced abolition, we have published a number of related comment pieces from a range of authors. These are listed below.
The demise of the HFEA - don't lament (or celebrate) too soon, it may never happen
Dr Evan Harris, 2 August 2010
How not to save money: Unscrambling the HFEA
Baroness Ruth Deech, 9 August 2010
The demise of the Human Fertilisation and Embryology Authority
Professor Alison Murdoch, 16 August 2010
Wither the HFEA and the fate of donor registers?
Professor Eric Blyth, Dr Marilyn Crawshaw, Dr Lucy Frith, Dr Caroline Jones and Dr Jennifer Speirs, 23 August 2010
HFEA up for the axe?
Josephine Quintavalle, 6 September 2010
Is the Human Fertilisation and Embryology Authority fit for purpose?
Professor David Jones, 13 September 2010
Why we shouldn't abolish the HFEA
John Parsons and Michael Savvas, 4 October 2010
The end of the HFEA: Are we throwing the baby out with the bathwater?
Sarah Guy, 24 January 2011
Regulators and embryologists aren't buddies
John Gillott, 31 January 2011
HFEA must address its 'misconceived interventions'
James Lawford Davies, 21 February 2011
The error of our ways? The demise of the HFEA and the prevention of errors in assisted conception
Professor Anne Kerr, 7 March 2011
HFEA: time for rebirth or burial?
Ann Furedi, 14 March 2011
Gamete Donation Review - not the HFEA's finest hour
Professor Eric Blyth, 3 May 2011
Perhaps the Government is right to plan to abolish the HFEA
Walter Merricks, 24 October 2011
An embarrassment of riches
James Lawford Davies, 20 February 2012
£3.4 million is a heck of a lot of money!
Clare Lewis-Jones, 20 February 2012
Better regulation for fertility treatment: a review of the options
Professor Alison Murdoch, 9 July 2012
Concerns about the consultation on the future of the HFEA
Rachel Cutting, 16 July 2012
Who will look after donor conception if the HFEA goes?
Walter Merricks, 23 July 2012
Quangoing, going, gone: what should happen to the HFEA?
Cait McDonagh, 24 September 2012