Keeping the research in an embryonic state

In this essay, John Gillott argues that in order for research using human embryos to move forward, with benefits for human reproduction and the understanding of disease, a more liberal approach to regulation is required. However, scientists have been far too pragmatic in adapting to the current regulatory framework rather than arguing vigorously for a more liberal system. Major political and ethical issues should be a matter for our elected representatives in parliament, says Gillott, while regulators should focus on technical and professional matters.

Background

Over the past six years, the House of Commons and the House of Lords, the latter in both its legislative and legal capacities, have addressed individual aspects of human reproduction and related technologies. Legislators have allowed scientists to derive stem cells from embryos to aid research into some human diseases. This change in the law also made it legal in principle to create an embryonic clone of a living person. A separate law made it an offence to place such an embryonic clone in a woman. The Courts have considered legal challenges to rulings from the regulator, the Human Fertilisation and Embryology Authority (HFEA), in the area of cloning. They have also considered challenges to the Authority’s decision to allow the creation of a ‘saviour sibling’ – the use of genetic testing by a couple to have a child who would be a tissue match and hence an ideal donor for a seriously ill existing child.

These legislative and legal developments, in parallel with other legal and regulatory developments outside of the immediate area of human reproduction, led to pressure for a more fundamental review of the law and policy. In 2002, the House of Commons Science and Technology Committee took a preliminary look at the area. Ruth Deech, who had just stepped down as chair of the HFEA, suggested that re-opening the law was a bad idea. She also told them that, as she saw it, one of the functions of the HFEA was to shelter Parliamentarians from controversial questions, to make difficult decisions on their behalf. In a brief report, the Committee included this response: ‘Parliament does not need protecting and democracy is not served by unelected quangos taking decisions on behalf of Parliament.’ (1)

Somewhat provoked by Ruth Deech’s comments, it would appear, the Committee soon launched a bigger inquiry into the whole area, the results of which were published as Human Reproductive Technologies and the Law in 2005 (2). Since then, the government has published a response to the Committee and, in December 2006, a White Paper setting out in broad outline its plans for updating the law – Review of the Human Fertilisation and Embryology Act (3). It is expected that a new law will be in place by 2008.

Schematically, law and policy in the area of human reproduction covers two distinct, if connected, areas: fertility treatment that aims to produce a live birth, and research using human embryos. When these issues were discussed prior to the passing of the law that governs this area, the Human Fertilisation and Embryology Act 1990, the research questions were by far the more controversial. Lady Warnock, as she now is, anticipated this in 1984 when the committee of inquiry that she headed reported. Research, she said, is ‘infinitely more important, in my opinion.’ (4)

The main reason for this is simple: while fertility treatment leads to the birth of smiling babies and happy mothers (or at least, aims to), research destroys embryos with no such short-term gain. Add on fears about a ‘slippery slope’ to genetically modified humans or clones at some future date arising from such research and there is every chance that research will be the major focus of debate this time around as well.

However, this time there will probably be a twist. If we track some of the changes in the ethics and ideology of this debate over the past 20 years, we see that concerns about the slippery slope have come to the fore. In the 1980s ‘pro-life’ views were influential in society, and were very well represented within Parliament. This constituency has less influence today, in part due to the decline in traditional conservative views. At the same time, worries about a runaway world, of science being out of control, have strengthened. Today, fears about the ‘commodification’ of embryos are as common as concerns about the sanctity of life.

A liberalising trend

The Science and Technology Committee’s 2005 report set the ball rolling in terms of the current re-examination of law and policy. It was a somewhat unusual report for a parliamentary committee, and was a little controversial. Indeed, the committee was split on some issues, and this division spilled over into the public domain with the publication of competing press releases from different groups on the committee at the time of the report’s launch.

What remains is that the committee, or the majority on it led by Ian Gibson and Evan Harris, pushed for a more liberal regulatory regime for both fertility treatment and embryo research; one which would allow researchers and clinicians greater freedoms, in terms of what they are allowed to do, and in terms of the regulatory burden under which they work. They also wanted to draw clear lines of demarcation between policy making, which they saw as being Parliament’s job, and regulation, which they wanted to make more technical and safety-focused in character. In this they were, tentatively, supported by some scientists.

In summary, issues highlighted as problematic by the Committee included:

• There is a lot of bureaucracy and delay, which acts as a disincentive to research.
• Some kinds of research are disallowed, for example, the genetic modification of human embryos, even though the existing law would prevent the development of such embryos beyond 14 days in the lab and prevent their implantation into a woman.
• There are always applications at the forward edge that are marginalised and delayed if not prohibited. For example, this was the case two years ago with nuclear substitution into a single cell embryo to study mitochondrial diseases.
• At a general level, the law is structured such that particular forms of research are forbidden if they are not explicitly permitted.

The government’s White Paper proposes to allow some things currently prohibited: altering the genetic structure of a cell while it forms part of an embryo, and replacing the nucleus of a cell of an embryo with another nucleus. However, the Science and Technology Committee had gone further, recommending that most or all conceivable research applications be allowed in principle, so long as the creations were destroyed by 14 days. The government does not propose to change the fundamental structure of the Act, whereas the Science and Technology Committee proposed a slimmed-down and faster system of regulation, with a greater emphasis on trusting professionals to follow the law without the need for detailed regulation. Indeed, in principle the Committee suggested that the law itself could be changed so that research using embryos should be broadly permitted except for specific prohibitions (to be decided). But, partly concerned not to endorse ‘frivolous’ uses of embryos, it left this somewhat open.

The broad thrust of the Committee’s proposals should be supported and encouraged. At a general level, scientists should be trusted to follow the law subject to the usual regulatory and other controls that other scientists follow (including research ethics committees and the process of peer review involved in gaining funding). Avoiding further regulation would be an expression of support and trust for the scientists and the field of research. Moving to a law based on specific exclusion of certain procedures rather than specific permission for them would reduce delays and increase confidence for those working in the area that they will not unexpectedly fall foul of the law.

Political pressures limiting liberalisation

Unfortunately, when controversy flares up around embryo research scientists and politicians often run for political cover and fall into line behind the government and the regulator, praising their record of supporting ethical research and treatment, and noting that other countries have adopted the UK model of regulation.

The recent furore surrounding the creation of hybrid embryos for research looks as though it might be another example of this. Scientists were hopeful the government would support this, under new legislation if necessary. However, the government instead proposed to ban it when it published the White Paper in 2006. At that point in time, two groups had lodged applications with the HFEA to conduct the work under existing law, and a third had expressed interest. Given the hint that the HFEA wouldn’t approve it in the run up to the licence committee meeting in January 2007, the scientists, assisted by Evan Harris of the Science and Technology Committee, launched a media campaign and conducted intensive behind the scenes lobbying to try to save their plans. This had some effect. The HFEA stalled; rather than giving a decision it decided to launch a public consultation of its own on the issue before considering any applications. The scientists and Evan Harris praised this move, especially the HFEA’s willingness to consider the applications at a future date, in apparent defiance of the government’s plans. Further to this, the Science and Technology Committee launched its own inquiry, which took evidence in January and February of this year from a wide range of scientists, campaigners and the minister responsible.

All this activity might seem very sensible. But the issue could have been approached in a different way, more consistent with the desire to liberalise policy in this area and leave policy-making to Parliament. What we have in the case of hybrid embryos (I call them this for convenience’s sake. The precise term that ought to be used is a source of some debate) is a collection of cells pretty much invisible to the naked eye. Most scientists think such cells are incapable of developing to the point of being an independent living creature even if they were to be implanted in a woman. As it happens, there is already a law forbidding such an implantation in any case, which carries a penalty of 10 years in prison if it is broken. The scientists could have pressed the HFEA for an immediate decision (which is a reasonable thing to do and within their rights). Or, after seeking legal advice, the scientists could have got on with their research without approaching the HFEA at all.

There are good reasons to think that hybrid embryos might fall outside the HFEA’s remit. One line of argument is that to be covered by the HFEA, the embryos would have to have the potential to be born as a live human being were they to be implanted in a woman. The HFEA’s own view a year ago was that they did fall within their remit, on the precautionary basis that they might possibly be viable. (Of course, no one was proposing to test this possibility.) Now they are not so sure, following more substantial scientific advice internally. In public Professor Winston told Radio 4’s Today Programme listeners that such an embryo would not be viable. Others agree with him. (For a detailed scientific explanation of why this is almost certainly the case according to one leading researcher, see Robin Lovell-Badge’s reasoning in evidence to the Science and Technology Committee (5).)

It is ironic, therefore, that it is some leading scientists and funders of research such as the Medical Research Council (MRC) who now seem most keen that it should fall within the HFEA’s remit under existing law and should certainly do so under any new law. In public debate David King, the chief scientific adviser to the government, called for work using such embryos to be strictly regulated (6). Rather than scientists getting on with the research, or as a second best the regulator being pressed to make a decision (which is its job), we have instead praise for the HFEA for taking a leading role concerning an issue that might well fall outside its remit.

The danger is that the liberalising impulse initiated by the Science and Technology Committee will dissipate, partly due to the Committee’s own activity. Everyone seems to be agreed that if the HFEA supports research using hybrid embryos, it would be hard for Parliament or government to reject it. So much, it would seem, for a more liberal regulatory regime and the idea that Parliament rather than the regulator should take the lead in setting policy.

Politico-ethical aspects

Thus far, I have emphasised the political factors that tend to build a consensus around the regulatory role of the HFEA or a similar body concerning research. A politico-ethical aspect should also be added to this. The existing pattern of regulation is underpinned by the work of the Warnock Committee. Pretty much everyone active in the policy debate accepts the Warnock framework, whether this is for genuine or tactical reasons. The government has picked up on this and used it to blunt criticisms of current policy and practice. The Warnock framework is now accepted as part of the intellectual furniture.

It is important to remember that it was not always like this. In the 1980s, a number of individual scientists, many eminent in the field, as well as scientific institutions and journals at an editorial level, opposed the framework outlined by Warnock. Robert Edwards, IVF pioneer, responded in this way: ‘I deny the argument that [the] scientific impetus will necessarily lead to silly experiments. It would be unwise to jeopardise future advances by short-term recourse to the criminal law.’ Another prominent researcher thought that ‘the first part of the report is practical and sensible because it was based on at least 10 years of experience [with IVF]. When you come to the regulation of research it draws on science fiction and so is tinged with hysteria.’ When the government brought forward a White Paper based on Warnock some argued in response that by basing regulation on such fears it would increase public anxiety (7).

What are the key aspects of the current framework, and what are its downsides?

Warnock argued that in-vitro embryos should be accorded some respect and protection in law, but not the absolute protection we grant human life after birth. In practice this meant, according to Warnock, that some destructive research should be allowed on human embryos, but that: (a) this research required justification, primarily that it was important and could not be done in a different way (such as using non-human embryos); and (b) some kinds of research should be prohibited (such as transferring a human cell nucleus from an existing person into an embryo), even if there was no intention to allow such embryos to develop.

In proposing to allow research Warnock rejected the pro-life position. Less well known is that she also rejected the argument from potential. She was fairly clear that the embryo had to be judged on what it is rather than what it would or could become. The Warnock Committee was split on this. A minority argued that embryo research should be forbidden because of the potential of the embryo to develop into a human life. Warnock and the majority disagreed: ‘The majority of the Committee was not moved by the argument that these cells could, if certain conditions were satisfied, become human beings. They did not rely, that is to say, as the minority did, on “potentiality”, but on the consideration of what the embryo was at a particular time, its actual mode of existence immediately after fertilisation.’ (8)

I agree with this. From this I draw the conclusion that there should be no limits on embryo research, so long as such embryos are destroyed rather than implanted into a woman. Warnock’s view however was that, and I paraphrase now, morality should be based on sentiment – in this case, the sentiment attached to such embryos. This view has been criticised by a number of philosophers, notably John Harris. How, they ask, is this a moral argument? And how is sentiment to be judged – should we respect prejudice on this basis? (9)

The key to Warnock’s success was that in the realm of practical politics it worked well; it facilitated and legitimated the process leading up to a vote insofar as the vote in Parliament was an expression of the sentiment of MPs and the conflicting desire to harmonise scientific advance with morality, specifically support for the family. As noted above, many scientists began by opposing the specific prohibitions and form of regulation proposed by Warnock. But when they saw the way the political wind was blowing they fell in behind Warnock in the hope and expectation that regulation of research would provide some political protection for their work. As one MP put it: ‘the Medical Research Council recanted and threw its full weight behind Warnock.’ (10)

If we accept that a similar process is in play today, and that ultimately a vote based on sentiment in Parliament will determine the parameters, it should not follow that those who wish for a more liberal regime should meekly accept existing opinion and thinking if they disagree with it. If some scientists and politicians view the early embryo as a collection of cells first and foremost, why not say so and try to shift sentiment and the terms of debate? This looks like a missed opportunity to question the Warnock framework.

There are further problems. Accepting Warnock without question leads to a less interesting and open debate. It also creates an incentive to hype the benefits of research. Indeed, the current system creates pressure to hype research benefits so as to balance ethical concerns.

Take for example the hybrid issue once more. Neither the scientists nor the politicians complained about the terms on which the HFEA set up its consultation. The Authority described the work as a ‘step-change’ (in terms of ethics) – adding, if anything, to the barriers already imposed under the Warnock framework – and stated that scientists had to demonstrate the merits of the work. The scientists could not simply give an honest appraisal of the potential of their work, which may or may not produce major benefits. Instead, Professor Chris Shaw, who was preparing an application to the HFEA with Ian Wilmut (the leader of the team that made Dolly the sheep), stated: ‘there are hundreds of thousands of patients in Britain with degenerative neurological conditions. We can use these cell lines to study them, and to see if drugs are going to be effective. To shut that down is a real affront to patients who are desperate for therapy. Of all these diseases none are really treatable. This is a very serious turning point in terms of science and medicine.’ (11)

If researchers do not speak up they risk a regulatory regime with similar defects to the existing one: strong disincentives to research through multiple and time-consuming regulatory hurdles, and prohibitions on certain forms of research. After all, if the embryo is to be accorded some respect, that must mean that there have to be barriers and limitations on research. For example, the government’s current position (ie, at the time of writing) on research using hybrids seems to be that perhaps they will allow cell nuclear transfer of a human cell nucleus into an enucleated animal egg cell, under strict control, but that the creation of other forms of hybrids and chimeras will be prohibited.

Winning support for embryo research

One of the troubling aspects of the way some supporters of research present their case is to say that opinion cannot be allowed to determine policy if it is wrongheaded. Graham Stringer MP, who is on the Science and Technology Committee, pursued this line of argument strongly during their inquiry into hybrid embryos. Where the opinion in question is not simply about facts but also values, the issue is not straightforward at all.

Because the concerns underpinning opposition to this work today are quite nebulous – based on fears about future applications, genetically-modified people for example, or beliefs about the dangers of ‘commodification’ – it means that opponents lack to some degree the clear arguments and power that the pro-life lobby had in the 1980s regarding particular applications. At the same time though, the research is itself less promising of immediate benefits. Back then, the focus of research was into Pre-implantation Genetic Diagnosis, which allows parents the chance to have healthy children through a relatively simple, definitive, test. When Robert Winston successfully achieved this in practice shortly before the key Parliamentary vote on research, the pictures of a happy mother and healthy baby had a big impact and most of the press, including the Daily Mail, came out in support of embryo research. Today, broadly, the hope is that embryo research will contribute towards developing therapies for currently incurable diseases, but the research is a slow, step-by-step business, without many concrete results to date.

As things stand, particular research applications are eventually allowed in most cases but without much enthusiasm. Opponents swim in a sea of public concern, but often lack enough focus or clout to win the day. This should not be taken for granted though, especially as things are opened up to political debate and voting. And nor should attempts be made to sidestep popular opinion. The upcoming Parliamentary debates are an opportunity not just to change the law in a slightly more liberal direction, but also a good time to state confidently the benefits of a more liberal policy and to attempt to win popular support for it. Doing this through engaging with contemporary fears would be to the long-term benefit of both the research and the culture that surrounds it.

John Gillott is co-author of Science and the Retreat from Reason and a freelance writer.

(1) House of Commons Science and Technology Committee, Developments in Human Genetics and Embryology, Fourth Report of Session 2001-02, p. 13.

(2) Fifth Report, Science and Technology Committee

(3) Review of the Human Fertilisation and Embryology Act, Department of Health

(4) Mary Warnock, A Question of Life; The Warnock Report on Human Fertilisation and Embryology, Blackwell, 1984, p. xii.

(5) Science and Technology Committee evidence

(6) Chief adviser backs human-animal embryos opposed by ministers, Guardian, 28 February 2007

(7) All quotes in this paragraph are from Michael Mulkay, The embryo research debate: the science and politics of reproduction, CUP, 1997, pp. 21, 34.

(8) Warnock, p. xv.

(9) In addition to the Warnock Report, Mary Warnock outlines her views on these issues in ‘Do Cells Have Rights?’, Bioethics, Volume 1, Number 1, 1987, pp. 1-14. John Harris’ arguments can be found in, among other places, Clones, Genes, and Immortality, OUP, 1998.

(10) Mulkay, p. 27.

(11) Medicine faces ban on rabbit-human embryos, The Times (London), 5 January 2007