Page URL: https://www.progress.org.uk/dhtrhfea

Response to a Call for Evidence issued by the Department of Health as part of its Triennial Review of the Human Fertilisation and Embryology Authority

31 August 2015
This policy document is a response submitted by the Progress Educational Trust (PET) to a Call for Evidence issued by the UK Government's Department of Health (DH), as part of the latter's Triennial Review of the Human Fertilisation and Embryology Authority (HFEA).

1. Is there a continuing need for the functions undertaken by the HFEA?
Yes
No
Don't know
Explain your answer, addressing the following questions:
Are there any functions you believe could be dropped or undertaken by another organisation?
Are there any functions that you think are needed but are not currently being undertaken?
Are there gaps or overlaps in the HFEA's role which should be addressed?
Could the functions be merged with those of another public body?
Yes, there is a continuing need for the functions undertaken by the HFEA. One could argue that there are functions that are needed but are not currently being undertaken, but these require prior clarification in statute (surrogacy law is an obvious example where reform of the law is long overdue, as applying the Surrogacy Arrangements Act 1985 to scenarios now arising is proving difficult at best). Meanwhile, the past decade has seen various proposals to abolish the HFEA and/or to transfer its functions to the Human Tissue Authority, Care Quality Commission (CQC), Health Research Authority, Health and Social Care Information Centre and other bodies. These proposals somewhat miss the point, which is that the most useful approach to assessing the functions of the HFEA would be to conduct a thorough audit of the regulator's activities, and then compare this with what is strictly required in statute.
Granted, parts of the 1990 and 2008 Human Fertilisation and Embryology (HFE) Acts are open to interpretation. Even so, such an exercise would undoubtedly help DH and other interested parties understand which HFEA functions and activities are necessary, and which might constitute 'mission creep'. For example, the HFEA has for a long time published details of clinic success rates for the benefit of patients, but is now considering going further - the regulator has said 'we believe we could do more to collect and publish patient feedback about their experience of a particular clinic'. It is currently examining various proposals for publishing patient feedback which have drawn comparisons with TripAdvisor, the popular travel website which pioneered the use of customer reviews. It is worth asking whether and how such initiatives relate to the HFEA's statutory remit, and how much they cost.

2. How well do you think the HFEA fulfils each of its functions at present?
Very well
Well
Average
Poor
Very poor
Don't know
Explain your answer.
The HFEA's performance is variable across its different functions and activities. It does a good job of producing a Code of Practice and of licensing and monitoring, if this is judged by the number of major adverse incidents, but the burdens it imposes are sometimes disproportionate (see the response to Q6 below).
The HFEA's provision of information to patients is currently being reviewed and revised through the Information for Quality programme, and this should hopefully lead to some improvements, although some of the initiatives proposed under the auspices of this programme are open to criticism (such as the 'TripAdvisor' proposal discussed in the response to Q1 above). The HFEA's provision of information to donors has benefited from its Lifecycle initiative, but this too is open to criticism (see the response to Q5 below).
When the HFEA provides information to fertility clinics, it has an unfortunate tendency to identify problems - systemic or otherwise - and then step back. One example would be problems with parenthood consent forms that were identified following a recent legal case. Clinics which identified these problems were given no further support or advice by the HFEA at the time.
The design and production of consent forms for IVF treatment and gamete storage by the HFEA has posed difficulties over the years, with a multitude of different versions of these forms produced and introduced, sometimes with unreasonably short timescales. PET has heard from clinicians in its orbit that a new consent form which clinics had to start using this year did not arrive until very shortly before its use became mandatory, leaving clinics struggling to train staff in the use of the new form.
There has been debate about the role of the HFEA in regulating adjuncts to treatments that appear not to have an evidence base. The HFEA keeps these under review, as required by statute, while refraining from undue interference in clinical practice. This is a balance that the HFEA seems to be maintaining reasonably well at present (see the response to Q8 below).

3. Recent reviews have considered and rejected possible merger of the HFEA with both the Human Tissue Authority and a combination of the Care Quality Commission and the Health Research Authority. Outside of the options outlined above that have previously been considered and rejected, which of the following organisational forms would you support?
Remain as a non-departmental public body
Merge with another public body
Undertake the functions within the Department of Health
Become a mutual
Voluntary sector organisation
Don't know
Explain your answer.
On no account should the statutory regulator of research and treatment involving human embryos become a mutual or a voluntary sector organisation, as such a body would be too far removed from the responsibilities of the state. As for a merger with another public body, this is impractical - not least because the enduring Warnock settlement, as promulgated through the 1990 and 2008 HFE Acts, ascribes a special moral status to the embryo. As a consequence, fertility treatment is the subject of deliberate regulatory exceptionalism.
In an ideal world it might be preferable for HFEA functions to be undertaken within DH - thus avoiding the political problem, endemic to arm's-length bodies, of a body wielding state authority without having commensurate state accountability - but PET does not believe there is any appetite in central government to assume such responsibility for a complex, fast-moving and sometimes contentious area of science and medicine. PET therefore believes that the HFEA must remain as a non-departmental public body.
Nonetheless, DH - as the HFEA's sponsoring body - could sometimes be bolder and take more of a lead in giving the regulator instruction.

4. How would you rate the performance of the HFEA?
Very well
Well
Average
Poor
Very poor
Don't know
Explain your answer, addressing the following questions:
In what areas, if any, could the HFEA improve its performance?
What key indicators should be used to effectively measure the HFEA's performance?
As explained in the response to Q2 above, the HFEA's performance is variable across its different functions and activities.

5. Does the HFEA have a positive impact on patient and donor care?
Yes
No
Don't know
Explain your answer.
The HFEA obviously has a positive impact on patient and donor care inasmuch as it licenses fertility treatment, makes the granting of licenses conditional upon various standards being met, and inspects against these standards. In short, the HFEA regulates a field that warrants regulation, and does so fairly competently. Whether the HFEA can be said to have a positive impact beyond this is questionable, but whether it ought to have a positive impact beyond this is also questionable - if the HFEA were to cleave strictly to its functions as defined in statute, the issue would arguably be moot. As it transpires, the HFEA does aspire to do more for patients and donors, with initiatives such as Lifecycle - a campaign to find new ways of improving sperm and egg donation in the UK.
Lifecycle is run by the HFEA's National Donation Strategy Group, of which PET's Director Sarah Norcross is a member. In the two years since the launch of this campaign, its activities have amounted to producing five leaflets and five flowcharts, all aimed at patients and donors. These have had a positive impact and have been met with a positive response, but there is a sense that the campaign has been impeded from achieving more. One could question whether these activities needed to be part of a campaign with its own brand identity, availing itself of outsourced design and consultancy work, rather than simply being an organic part of the HFEA's broader work.

6. Do you think that the functions of the HFEA, regulatory or otherwise, impose burdens that are:
Proportionate
Disproportionate
Don't know
Explain your answer, addressing the following questions:
Are risks managed appropriately?
How does the approach compare to other regulators?
The HFEA's regulation of in vitro fertilisation (IVF) is disproportionate, in that some aspects are overregulated and some aspects may be underregulated. Routine IVF is overregulated, in light of the fact that it is a commonplace procedure (around 2% of babies born in the the UK are now conceived via IVF) and is a known quantity. At the same time, one specific IVF technique - a ICSI (intracytoplasmic sperm injection), which is now used in around half of all IVF treatments in the UK - may be underregulated.
ICSI addresses specific aspects of male infertility, and should not be offered unless these aspects are present. PET is especially concerned about reports of ICSI being used to fertilise eggs with donor sperm, and of donors are being recruited whose sperm is labelled 'for ICSI only'. With the exception of 'known donor' treatments (which PET suspects are a minority of cases), screening guidelines by the relevant professional bodies make it clear that donors should not be recruited specifically for use in ICSI.
There are various possible reasons why such poor practice might occur. It is possible that ICSI is being misconstrued by clinics, and/or misrepresented to patients, as a way of optimising pregnancy rates across the board. It is also possible that ICSI is being used to compensate for the use of substandard donor sperm, or for the overdilution of quality donor sperm so that the sperm can then be used in more treatments. And it is possible that decisions are simply being made by the wrong personnel.
Whatever the truth, it is a matter that warrants attention by the HFEA. PET is aware that professionals have written to the HFEA about the problem, but PET is not aware that the HFEA has changed its inspection practice accordingly.

7. How effectively does the HFEA operate within and support the rest of the health and care system?
Very well
Well
Average
Poor
Very poor
Don't know
Explain your answer.
The HFEA has worked collaboratively with CQC to reduce the burden of inspection on clinics, and to avoid duplication of activity so as to benefit the health and care system. This is a good idea in principle, but some clinicians question whether it has indeed had any effect in reducing the burden of inspection.
Beyond such arrangements, it is difficult to see how the HFEA could play more of an integrated role, as it regulates very specific sectors. It could be argued that by playing a role in licensing treatment based on safety and effectiveness, and by keeping a register of incidents from which clinics can learn, there may be beneficial consequences in terms of avoiding incidents and complications that could impact upon the wider health sector.
As the HFEA was established to implement and administer a specific Act of Parliament, lack of integration with the broader health and care system should not necessarily be seen as a problem.

8. Could the HFEA do more to support innovation and new approaches in the area of human fertilisation and embryology?
Yes
No
Don't know
Explain your answer.
The HFEA could do more to clarify, for the benefit of patients in particular, whether or not new approaches have a strong evidence base. It has equivocated on this question in the past - for example, in relation to preimplantation genetic screening - but recently there have been indications that it may be adopting a more robust stance, and this is welcome.
The HFEA has done good work on one high-profile pioneering approach in recent years, namely mitochondrial donation, but one of its policies has hindered rather than helped the advent of this innovative new technique. For the past few years, the scientists appointed to the HFEA's independent scientific review panel on mitochondrial donation were told not to answer media queries or speak to journalists without explicit permission from the HFEA - permission which was infrequently granted.
This has had a number of perverse consequences, which are discussed in the response to Q14 below. The basic point is that in PET's view, and in the view of others, independent scientists who are among the most prominent in their fields should not be subject to a media gag as a consequence of sitting on a regulator's independent scientific review panel. These scientists could legitimately have spoken to the three reports on mitochondrial donation they wrote for the HFEA, and to their work on the subject more generally, without it thereby being implied that they were speaking for the regulator.

9. How effectively does the HFEA maintain public confidence that the area of human fertilisation and embryology is regulated appropriately?
Very well
Well
Average
Poor
Very poor
Don't know
Explain your answer.
There are several indications that the HFEA does a good job of maintaining public confidence. For example, the HFEA - like PET - exhibits at the annual Fertility Show at Olympia London, where thousands of members of the public seek information and advice. Clinics and businesses from around the world - ranging from the reputable to the decidedly disreputable - exhibit at this event, and it is important for the regulator to have a presence. There was one recent year when the HFEA did not exhibit at the event, and PET exhorted the regulator to resume exhibiting there. To its credit, it did.
Another indication that the HFEA maintains public confidence is that while the Human Fertilisation and Embryology (Mitochondrial Donation) Regulations 2015 were passing through both Houses of Parliament earlier this year, a number of MPs and Peers paid fulsome tribute to the HFEA and its work. This confidence in the HFEA was important in persuading Parliamentarians that mitochondrial donation would be regulated effectively, if they made it legal - which indeed they did.

10. How well does the HFEA communicate and engage with stakeholders?
Very well
Well
Average
Poor
Very poor
Don't know
Explain your answer, addressing the following questions:
Are relationships with stakeholders (including regulators and professional bodies and other organisations in the health and care system) effective?
How effective is engagement with the public and wider stakeholders?
How well does the HFEA influence nationally and internationally?
The HFEA engages with stakeholders in a number of different ways, including two meetings a year with the Association of Fertility Patient Organisations, of which PET is a member. The HFEA has also resumed its annual conferences, at which PET exhibits, after suspending these for several years while the regulator's future was cast in doubt by the Government's review of arm's-length bodies. The two HFEA conferences held since annual conferences resumed have been good examples of stakeholder engagement, although the first of these conferences had some profligate aspects (most notably, a group of artists being commissioned to draw a mural during the course of the day which documented the proceedings - an absurd exercise, in PET's view). Happily, the most recent HFEA conference was a slightly more restrained affair.
HFEA representatives often speak at PET's public events. The most recent example was 'A TripAdvisor for Fertility Clinics - Would You Recommend It?', a public debate held earlier this year which focused on a specific HFEA initiative (the 'TripAdvisor' patient feedback initiative discussed in the response to Q1 above). A 70-minute podcast of this event can be listened to here - the HFEA gave a good account of itself at the event and promised to take people's views on board, but audience feedback suggested that many attendees regarded the HFEA's proposals a fait accompli. This view was not dispelled when the HFEA's representative on the speaker panel invited attendees to email her with their views (PET sent follow-up emails to all attendees encouraging them to do precisely this), only for the HFEA to take several weeks even to acknowledge receipt of people's emails (whether and how the regulator will take on board the views that it received remains unclear).
On a more positive note, at PET's most recent annual conference 'The Commercialisation of Life' the HFEA's Chief Executive Peter Thompson not only gave a presentation, but also stayed for and contributed to the remainder of the conference. This included him responding with good grace to direct criticism of the HFEA by Professor Lord Robert Winston. This is much to the credit of Peter Thompson and the HFEA, and will have impressed the many professional stakeholders who attended the conference.

11. Is the HFEA sufficiently forward-looking and responsive to new challenges and opportunities?
Yes
No
Don't know
Explain your answer, addressing the following questions:
Does the HFEA have the capability and capacity to respond to future challenges?
Does the HFEA have a robust and effective strategy for responding to changing demands and technologies?
The HFEA is forward-looking - it has an effective Horizon Scanning Panel - but is not always responsive to the new issues that it identifies. When it does respond, it is more inclined to regard new issues as problems rather than opportunities, and can give the appearance that its decisions are predicated largely on a fear of legal action being taken. As discussed in the response to Q8 above, and detailed in the response to Q14 below, the HFEA's handling of mitochondrial donation was overly controlling and risk-averse, in that it resulted in a media gag on independent scientists which proved unhelpful.
Looking ahead, genome editing is a subject that should definitely be on the HFEA's radar, as an application for embryo research using genome editing could already be submitted under the HFE Acts. The use of genome editing in treatment is a more distant prospect, and is likely to be prohibited by law for the foreseeable future, but this possibility is already dominating public discussion - see, for example, a the cover story of the 22 August edition of The Economist - and the HFEA needs to be attentive to this.
PET is pleased to see that an HFEA member, Dr Andy Greenfield, is currently chairing the Nuffield Council on Bioethics' Working Group on Genome Editing. But PET notes that this work is taking place outside the auspices of the HFEA.

12. Are there any measures you believe the HFEA could take to deliver further efficiencies (whether reduced costs or improved use of resources)?
PET is aware that the Deregulation Act 2015 provides for a duty on regulators to 'consider the importance for the promotion of economic growth of exercising the regulatory function'. When this legislation was passing through Parliament, concern was expressed from some quarters that this provision would be applied to the HFEA and would compromise its functions. PET shares this concern.
The Government offered reassurance in Parliament that 'in a very large number of areas of medical and biomedical concern, the question of economic growth - let alone of commercialisation - will have to be treated either as not relevant to the subject, or as one of the factors but certainly not one of the most important ones'. In PET's view, the HFEA should have no duty to consider economic growth when exercising its functions.
Setting aside the question of economic growth (which should not apply in this instance), there is certainly scope for the HFEA to be more efficient in the way it allows and arranges for researchers to use its data. Data needs to be accessible to a variety of researchers who have different financial resources (and in some cases few or no resources) at their disposal, but there should also be a mechanism that permits the HFEA to be paid from research grants to provide quality data in a timely manner.
PET has heard from researchers in its orbit that complicated data linkage studies requiring HFEA input are made prohibitively difficult to complete in the time required by the terms of a grant, because of delays on the part of the HFEA. The HFEA clearly struggles to handle a diverse range of requests with few IT staff, and with an arrangement whereby researchers are charged £250 per half working day spent on dealing with requests, with a cap of £5,000 per request.
It should be possible to pay more to the HFEA to expedite such work, as long as two caveats are observed.
First, existing arrangements for researchers should continue for the benefit of those researchers who do not have specific grant funding to cover this expense - in fact, there should be an option to apply to use data for a lesser fee, or even completely for free. This is important so that more junior researchers, or researchers from less obvious disciplines, can access HFEA data. Some of the best and most revolutionary research takes place when data is approached from a fresh perspective.
Second, any revenue raised from fees should be used specifically for dedicated staff time, on a not-for-profit basis. Such fees should not be exploited as a source of profit, as this would be to the detriment of the accessibility of the data to researchers.

13. Does the HFEA follow best practice governance arrangements?
Yes
No
Don't know
Explain your answer, addressing the following questions:
Is the HFEA sufficiently open and transparent?
Are effective financial management processes in place?
Does the HFEA recruit through open and fair processes?
One of the ways in which the HFEA is commendably open and transparent is that it holds Open Authority Meetings, which can be attended by members of the public and other interested parties, and it publishes the minutes of these meetings on its website. This transparency was further enhanced when the HFEA recently began making audio recordings of Open Authority Meetings available on its website.
At the same time, however, the HFEA recently - and without explanation - discontinued its long-established practice of allowing members of the public to pose questions at the end of these meetings. PET attends most Open Authority Meetings, and previously used this opportunity on many occasions to pose questions to the HFEA.
Another factor that detracts from the impression of openness and transparency - although realistically speaking, this may be unavoidable - is that often at an Open Authority Meeting in the afternoon, it becomes obvious that a matter is being alluded to that was settled clandestinely at a closed meeting that morning.

14. Does the HFEA follow best practice governance arrangements?
As discussed in the response to Q8 above, in recent years the HFEA has effectively placed a media gag on the scientists appointed to the HFEA's independent scientific review panel on mitochondrial donation. This has had a number of perverse consequences.
The independent scientists advising the HFEA are often well known to journalists, and have often earned their reputation for independence by being open and available to journalists to comment on contentious issues for a number of years. Placing any controls or restrictions on these independent scientists risks undermining the very reputation for independence that made them so useful to the HFEA in the first place. A journalist who finds that their requests for comment are suddenly being declined will be given more reason (not less reason, as the HFEA seems to believe) to think that the HFEA is presumptuously seeking to manipulate coverage.
The objectives and priorities of a regulator at arm's length from government are not the same as the objectives and priorities of scientists, or of journalists, or of the media-consuming public. Allowing the communications team of the HFEA to have final sign-off on media appearances by independent scientists means that decisions about science communication risk being made on political grounds or for corporate strategic reasons, when they should in fact be made on the basis of scientific accuracy and improving public understanding.
Scientific experts such as those who advise the HFEA have many different professional affiliations and roles, are associated with media spokespeople for multiple organisations, and are accustomed to recognising, managing and declaring conflicts of interest. These scientists often have close working relationships with press officers at their university or institution, their learned society, their funding body, medical research charities, and the UK's Science Media Centre. These relationships are established over the course of many years, and it is wrong that as soon as such a scientist joins an HFEA expert panel, final decisions about media strategy that involve them should suddenly rest with the HFEA communications team alone.
In the case of mitochondrial donation, the scientists appointed to the HFEA's expert panel have been extremely senior in their fields, and have had considerable experience of working with the media. Together with trusted press officers, such scientists regularly make judgments about which media to work with, which interviews to agree to, and which misrepresentations to challenge. Such scientists often know particular journalists well, and can be trusted to conduct media work in a way that will enhance public understanding of complex and contentious science.
The problem raised by the HFEA's approach in this instance is not going to disappear, now that the Mitochondrial Donation Regulations have been passed. For one thing, the HFEA may need to reconvene an expert panel on mitochondrial donation to consider the latest evidence of safety and efficacy, before the first license to use mitochondrial donation in treatment can be issued. For another thing, the problem may arise again, whenever the HFEA has to deal with a similarly complex and contentious area (for example genome editing, as discussed in the response to Q11 above).
The HFEA has done much good work in relation to mitochondrial donation, but this aspect of its approach is wrongheaded - inimical to free and open discussion, and inimical to scientific and medical progress.