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The end of the HFEA: Are we throwing the baby out with the bathwater?

24 January 2011
Appeared in BioNews 592
'We trained hard, but it seemed that every time we began to form into teams we were reorganised. I was to learn later in life that we tend to meet any new situation by reorganising. And a wonderful method it can be for creating the illusion of progress while producing confusion, inefficiency and demoralisation' - quoted by Professor Robin Lovell-Badge.

The Progress Educational Trust and Anne Mclaren Memorial Fund organised a debate last week about the UK Government's plans for the Human Fertilisation and Embryology Authority (HFEA). The Government plans to divide the HFEA's functions between organisations, including the Care Quality Commission and the Department of Health, by the end of the current parliament. The debate asked: will something valuable be discarded in the haste to tackle some of the HFEA's perceived problems?

The debate seemed to highlight that - before abandoning the HFEA - its role needs to be examined and its function defined. It might need a 'lighter touch' when regulating 'routine' assisted reproductive technology (ART) procedures. It needs to keep up with scientific advancements. Above all, it needs to implement the law.

The Right Reverend Lord Richard Harries, crossbench peer in the House of Lords and Professor of Divinity at Gresham College was the first debate panellist. He said the 'draconian measures' proposed by the Government in its Public Bodies Bill are extremely foolish. The functions of the HFEA - unlike many other quangos under threat - are essential and cannot be duplicated by any other body.

Lord Harries said the 'umpteen days of parliamentary time' taken to establish the HFEA was a sign it deals with 'highly contentious issues on which there are very strong and very divided opinions'. One such issue is the moral status of the embryo. He explained the Government created a tight legal framework - the Human Fertilisation and Embryology (HFE) Act - to safeguard 'respect for the early embryo' (the phrase coined by the 1984 Warnock Report). The HFEA's main role is ensuring the Act is upheld.

Other 'key features' of the HFEA mentioned by Lord Harries are its 'horizon-scanning group' and the database it maintains. This database allows donor-conceived children to trace their biological parents and records 'incidents' - breaches of clinical and research protocols. If the accuracy of the database was threatened by the disbanding of the HFEA, Lord Harries felt 'this careful and integrated work would go by the board, and 'incidents' - which can be detrimental to the health and well-being of patients - would increase'.

Lord Harries finished by arguing the HFEA needs to develop 'lighter touch' regulation, particularly for IVF clinics and researchers. But there is 'no evidence that the careful work (the HFEA) does and ethical insights it is there to preserve will be preserved under any other system', he concluded.

Next to speak was Professor Robin Lovell-Badge who is a member of the HFEA's Scientific and Clinical Advances Advisory Committee. He's also head of Stem Cell Biology and Developmental Genetics at the Medical Research Council's National Institute for Medical Research. He could not imagine how the HFEA would be split into routine clinical and research components. He acknowledged there's 'some logic' to routine clinical IVF practice being managed like other routine clinical practice. But he questioned who would regulate non-routine cases of IVF where patients face, for example, genetic or environmental risks.

Professor Lovell-Badge argued there's a research element to 'routine clinical IVF practice'. IVF methods change constantly to improve implantation, pregnancy, and live birth rates. Some methods are constantly being refined, such as sperm freezing or the derivation of human gametes in vitro. 'This will one day not just be research, but will have clinical implications', he said. 'This would require a change in the HFE Act. And who would be best to tackle the issue: a small, focused body like the HFEA who are used to transferring research to clinical practice; or two large organisations with relatively little experience?'

Deriving human gametes in vitro could provoke public uncertainty. Professor Lovell-Badge claimed most early embryo research is routine ('no monsters in the lab', he said) and most scientists can be trusted not to 'do anything bad'. But he said the public probably wouldn't take his word for it. The HFEA is not always 'brave enough' to defend research, but he can't imagine larger, broad-remit organisations will want to 'rock the boat' either. He said the HFEA had a vital role in public engagement and explained it had launched a public consultation on sperm and egg donation the previous week.

Professor Lovell-Badge concluded by discussing the HFEA horizon-scanning group and how its work could be preserved by a large research organisation. He argued medical and scientific experts are essential for a Health Research Agency (HRA) to be knowledgeable and effective. But this would surely result in an 'HFEA within the HRA' - in which case, why disband the former?

Sheila McLean, Professor of Law and Ethics in Medicine and Director of the Institute of Law and Ethics in Medicine at the University of Glasgow, spoke next. She said she was surprised we're facing the end of the HFEA. She argued the HFEA is regarded worldwide as an example of 'best practice' in assisted reproduction. But three years ago, a parliamentary committee debated whether to combine the function of the HFEA with that of the Human Tissue Authority (HTA), to create the Regulatory Authority for Tissue and Embryos. The committee found the evidence was overwhelming that this would result in a 'significant loss of expertise'

Professor McLean was most concerned about the principles behind the delivery of assisted reproductive technologies (ARTs) under the HFE Act. The HFEA has 'set itself principles specific to its area of expertise' in addition to the standard regulatory principles governing all public bodies, Professor McLean said. The biggest loss from dividing the functions of the HFEA would be the loss of the principles behind service delivery.

The most serious consequences of disbanding the HFEA, according to Professor McLean, are 'a dilution of focus on ART-specific issues' and the inability of service users to challenge service providers. 'A generalist approach to regulation in this area seems to be an inadequate response to the needs of intended parents, future children, and scientists who work in this area', she said. She called the 'streamlining and cost-cutting without attention to human interest' a 'retrograde step'.

Professor McLean argued that - while some of the bodies proposed to take on the HFEA's remit may have relevant experience - they are not familiar with principles like concern for the welfare of future children. All the HFEA's work is held accountable to this principle. She questioned whether these principles are guaranteed to be followed if parts of the HFEA's work are 'hived off'.

Finally, it was time for a supporter of the HFEA's proposed reorganisation to speak. Professor Alison Murdoch, head of the fertility centre at Newcastle Centre for Life and Professor of Reproductive Medicine at Newcastle University's Institute of Human Genetics, was also the only panel member to hold treatment and research licenses from the HFEA.

Professor Murdoch combated arguments for retaining the HFEA. First, she said, the status society gives to the embryo is upheld in law. Nothing about the proposed reorganisation of regulation will alter this protection. Second, it's insulting to believe the HFEA keeps IVF treatment and clinics 'safe' for patients. This suggests centres would provide an unsafe service unless regulated. IVF is a safe procedure, said Professor Murdoch. She said the risks of dying from IVF are ten times lower than the risk of dying from pregnancy. 'It is not the HFEA that makes the procedure safe', she observed.

Clinicians face difficult decisions daily, Professor Murdoch said. She argued clinical practice cannot be dictated by 'rules which come from quangos, which do not have the flexibility to move with the variety of problems we deal with in clinical practice'. She mentioned the 'moral guidelines' provided by the HFEA to help clinicians make decisions. She emphasised the subtle but significant difference between guidelines and guidance: one is rules and regulations, the other is help.

Professor Murdoch said the 'isolation' of the HFEA from other authorities is a problem. Tackling this by regulating clinical IVF practice alongside other clinical areas would lead to greater consistency in regulation. She believes policy decisions should be based on expert advice from a professional body. Or advice could be provided by a Health Research Agency (HRA), as suggested by the Academy of Medical Sciences.

Professor Murdoch was also in favour of politicians getting involved in decision making because they're 'elected and accountable representatives'. Others have criticised this idea. They say embryology and fertility raises too many ethically and politically explosive issues for untrained parliamentarians and civil servants to deal with.

Professor Murdoch concluded by arguing the HFEA has 'lost sight of its main reason for existence; the provision of licences'. She recommends independent experts investigate the HFEA's existing regulatory processes, and legislative plans to ensure regulation is consistent with regulation in other areas of medicine. 'If that review supports the existence of the HFEA as it is at the moment, I will be happy to support it', she said.

The debate was opened up to the floor. Chair of the debate Emily Jackson, Deputy Chair of the HFEA and Professor of Law at the London School of Economics and Political Science, fielded numerous questions from the audience. One person asked what the HFEA's function should be and whether it might be more apt to ask 'what is it for?' Lord Harries reminded the audience the HFEA's primary function is to ensure the law is upheld.

Professor Murdoch said the HFEA must protect people's reproductive choices. She called it ironic that this right is protected in society in some ways. For example, we cannot be forcibly sterilised. But there's a body that intervenes over IVF 'not to the benefit of the couple at all', she said.

An audience member asked for clarification about what a 'lighter touch' to regulation would involve. Another person suggested a lighter touch could change the HFEA's outlook as well as removing red tape from clinics. He said the HFEA has been distrustful (in the case of saviour siblings) of parents' concerns about their children's welfare. The panel's view varied between Professor Murdoch's suggestion to 'go back to the beginning, to what is required by law, by good clinical care, and take regulation on that basis alone', to Lord Harries suggestion that it meant fewer and less onerous inspections.

Professor McLean said the attitude of distrust displayed by the HFEA originated, understandably, from the Warnock Report. This report erred on the side of caution because fertility treatment and embryology was new. It established safeguards, which may be unnecessary today. She agreed with Professor Murdoch that a regulatory body's default position should be respect for people's reproductive choices. But she admitted it is unclear how this would fit in with the research side - rather than the clinical side - of the HFEA's remit.

Other audience members sought reassurance from the panel that there is a role for a 'body' outside parliament to take decisions, harness public debate and keep at 'arm's length from Government'. One questioner was concerned that taking away the HFEA would leave researchers free to take on potentially dangerous and 'not wholly moral' work.

But the audience's overwhelming belief seemed to be that IVF, ART and other areas covered by the HFEA will remain regulated, not least by the provisions of the HFE Act. One audience member said the question is how regulation should be structured, not whether to do away with it.

One previous HFEA Chair, Baroness Ruth Deech said the public needs to know there are principles guiding decisions in fertility and embryology research and clinical practice. Suzanne McCarthy, a former chief executive of the HFEA and now an Human Tissue Authority (HTA) board member, echoed these concerns from the perspective of the HTA. Speaking on behalf of the HTA, which is also facing dissolution under the Public Bodies Bill, she said it was important the HTA's functions remain together to give the public and parliamentarians' confidence.

The panel finished by summarising their thoughts on the HFEA's future. Professor Murdoch reiterated that an independent body should examine what regulation is needed. Lord Harries agreed with her and said Government plans to dissolve the HFEA without proper scrutiny were foolish. Professor McLean said again that the HFEA's principles would be lost in other organisations. Professor Lovell-Badge simply said: 'if we keep the HFEA, then there's room for improvement. If its functions are moved elsewhere, we'll need something better'.

The Progress Educational Trust and Anne McLaren Memorial Fund would like to thank the Medical Research Council for their contribution to the costs of this event.

The End of the HFEA: Are We Throwing the Baby Out with the Bathwater?
Progress Educational Trust |  17 January 2011
19 December 2011 - by Sandy Starr 
The Public Bodies Bill - which empowers the UK Government to transfer the functions of the Human Fertilisation and Embryology Authority (HFEA), the country's regulator of fertility treatment and embryo research - has received Royal Assent and has become the Public Bodies Act. This Act represents the realisation in statute of the Coalition Government's longstanding plans for a 'bonfire of the quangos'...
31 October 2011 - by Sandy Starr 
The Public Bodies Bill - which, if passed, will allow the Government to abolish the UK's fertility regulator, the Human Fertilisation and Embryology Authority - has completed its report stage and third reading in the House of Commons...
14 October 2011 - by Sandy Starr 
The future of the UK's fertility regulator has been debated by a House of Commons committee. An amendment to the Public Bodies Bill that, if passed, would have prevented the abolition of the Human Fertilisation and Embryology Authority (HFEA), was proposed but ultimately withdrawn by Labour MP Valerie Vaz...
16 May 2011 - by Julianna Photopoulos 
The UK's House of Lords has voted for the first time on an amendment that, if passed, would have impeded the Government's power to abolish its fertility regulator. The amendment to the Public Bodies Bill, which said the cost-effectiveness of the Conservative-Lib Dem Government's abolition plans must be assessed first, was narrowly defeated...
14 March 2011 - by Antony Starza-Allen 
Health Minister Earl Frederick Howe has made reassurances that the Government has no intention of revisiting the ethical safeguards in the UK's fertility, embryology and human tissue legislation in the proposed arm's-length body reform process....
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