Human Genetics Alert submission to Science and Technology Committee enquiry into Human Reproductive Technologies and the LawSummary
This submission argues that the 1990 HFE Act is now outdated and inadequate in dealing with the challenges revised by genetic and reproductive science and technology (‘reprogenetics’). We argue, a) that scientific and technological developments have created a set of possibilities for manipulation of reproduction that go well beyond the original concern of the Act with the relief of infertility; and b) that (partly as a result of this) there has been a shift in the focus of public concern, away from the issue of the status of the embryo, towards a broader set of concerns, such as ‘designer babies’ and eugenics. These concerns are based on the long-term trend to mould human reproduction into an industrial/consumerist model. We see the advocacy of ‘reproductive liberty’ as a crucial ideological element in the advancement of this trend, and argue that the issues raised by the proliferation of reprogenetics raise such profound challenges for humanity as a whole that they cannot be left up to individual couples and their doctors, or dealt with on a case-by-case basis without adequate consideration of broader and long-term ethical issues.
In stating these concerns, we do not seek to deny the benefits brought by these technologies, or to suggest doctors or scientists are dedicated to advancing eugenics and the objectification of human beings. Indeed, the difficulty that we face as a society is precisely that in seeking to help people and relieve suffering we create these profound problems. However, we wish to emphasise that these issues and the public expressions of concern about them cannot be dismissed as ‘misunderstandings of science’, ‘irrationality’ or ‘fear of change’. These issues overspill the capacity of the Act to deal with them, but the attempt to do so within the wording of the original Act is leading both to litigation and to the need for the HFEA to take decisions which can be criticised as arbitrary, and for going beyond its remit as regulator and usurping the role of Parliament. We compare the position of the HFEA with that of the Advisory Committee on Releases to Environment in regulating GMOs: the source of the problem in each case lies in legislation which does not address the key issues, and the need for regulators to take legally defensible decisions within an overly-narrow set of rules. We therefore argue for a revision of the HFE Act to allow consideration of the issues raised by reprogenetics, and for a separation of the roles of regulation and of consideration of long-term policy, through the creation of a new commission. We conclude with a series of suggested changes to the Act to deal with specific issues.
1. Introduction to Human Genetics Alert
Human Genetics Alert (HGA) is an independent watchdog group, funded by leading British charities. It is a secular ‘pro-choice’ organisation that seeks to be a focus for public concern on issues related to human genetics.
2. The changing politics of reproductive technologies and the adequacy of the HFE Act
2.1 Scientific and technological change
As the call for evidence mentions, there have been many technological and scientific developments since 1990. The list omits one scientific development which may be more far reaching in its effects than the sum of the others: the sequencing of the human genome. These developments are opening radical new possibilities for the manipulation of human reproductive cells. Reproductive and genetic technologies are, as might be expected, interacting together in unexpected and unplanned ways, to create an almost endlessly ramifying cornucopia of possibilities. It is not enough to consider reproductive technologies in isolation from genetics, and there is now a huge literature on the interface of the two. It is not surprising that there is a common feeling that the science is progressing faster than our ability to deal with its ethical and social implications
One example of the way technological developments are exposing loopholes in the Act concerns gametes and their production. As the HFEA has recently pointed out in its report on sex selection, this allows social sex selection by sperm sorting.
However, the problem with gametes and their precursors goes deeper. ‘Gamete’ is defined in the Act as live eggs or sperm. However, in the last 15 years there have been considerable developments in the ability to grow and manipulate in vitro the cells of the germ line into eggs, and, especially, sperm. These cells can be used to create embryos through IVF and ICSI. For example cells, such as embryonic stem cells or embryonic gonad cells may be genetically engineered. They may be allowed to develop spontaneously into gametes or matured in the reproductive organs of animals. Somatic cells have been artificially ‘haploidised’ by nuclear fusion into immature eggs. Other techniques may eventually allow the creation of an embryo from two female cells and incorporate genetic material (including that in the mitochondria) from three parents.
The more important point, however, is that the science has moved beyond the mere relief of infertility. For example, it is now beginning to be possible to not merely prevent disease but to select desired characteristics in the child. It is also becoming possible to co-opt reproductive processes for other medical ends, such as creating ‘saviour siblings’ or tissues derived from embryonic stem cells. Here, reproduction is being used to generate customised tissues, raising concerns about the instrumentalisation of human life.
In summary, scientists now have powerful toolkit for the manipulation and control of all aspects of the growth and development of human reproductive cells and tissues, and thus of the origins of human beings.
2.2 Political changes
In the 1980’s, the key issue which framed the 1990 Act was the status of the embryo, and the key political alignments paralleled divisions on abortion. These traditional debates continue, and partly because they are based in established political constituencies and organisations, continue to dominate most of the public debate about new possibilities such as therapeutic cloning, particularly in the U.S. This polarisation is becoming increasingly unhelpful to an informed mature public debate on these issues, in a number of ways. Firstly it excludes other concerns and constituencies (such as women and disabled people) from the media debate and prevents discussion on the ethical middle ground, upon which the law is supposedly based. There is, for example, little discussion of what is meant by ‘respect’ for embryos, and what moral lines this concept allows us to draw. Secondly, the results of political mobilisation along these traditional lines are producing increasingly irrational and perverse results, such as the inability to agree on a ban on reproductive cloning, in the U.S and at the UN.
Meanwhile, the public has moved on. Confronted with an increasingly powerful set of reproductive and genetic technologies, the focus of public concern is now with ‘designer babies’ and the set of issues that this term encapsulates. It is important to understand what underlies these issues, in order to appreciate the degree of their significance for our society.
The increasing ability to intervene in human reproduction is part of a long-term trend of increasing technologisation and medicalisation of reproduction. In rough chronological order, this began with sterilisation in the era of state eugenics, and continued with family planning, artificial insemination, hormonal contraception, prenatal screening, IVF and PGD. In general the trend has been for greater technological intervention and the separation of sex from reproduction. It is often predicted that the culmination of this trend will be an entirely artificial reproduction, involving gestation in artificial wombs, and selection/genetic engineering for 'enhancement'.
One way that concern about this trend is often expressed is in the expression ‘Playing God’, or, in secular terms, ‘interfering with nature’. Advocates of these technologies often reply that our whole society, including medicine is based on controlling nature. However, the concern about control is more the way we tend to control nature in our industrial-market society. The tendency is to subject natural processes to the criteria of industrial production: efficiency, uniformity and quality control, and thereby to create objects/commodities that can be sold to consumers. This can be seen in many areas, including, particularly clearly, in agriculture.
The anxiety about ‘designer babies’ and eugenics is in essence about the application of this industrial model to the natural process of human reproduction. This is seen most starkly in cloning, with its potential production of genetically identical copies of an original. With the ability to select the characteristics of and even genetically engineer children according to consumers’ desires comes the concern that human beings are becoming just another designed object/commodity within the industrial market system. This is the reason for opposing sex selection for example: it is simply not appropriate to choose human beings in the same way that we choose washing machines. For most people the commodification of humanity both offends against their deepest existential sense of who they are, and against the dignity of human beings. Ultimately, objectification undermines the basis of human rights. It also raises questions about parent-child relationships and children’s rights when the parent selects/designs the child. In the case of so-called ‘saviour siblings’, the objectification of the child leads to its being used as a tool, albeit for good ends.
A related set of concerns stems from the quality control imperative of technological production. Many disabled people view the medical surveillance of reproduction, and, in particular, prenatal screening, as a continuation of the eugenic practices of the early 20th century. They believe that social pressures, such as the continuing negative images of disabled people, competition amongst parents to give their child the best possible start in life, inadequate financial and other support for families with disabled children, combined with increasing control over reproduction is leading to the pursuit of an ideal of perfection or even enhancement, which has little room for disabled people. This ‘free-market’ or consumer eugenics may allow the rich to purchase biological advantages for their children, thus creating a genetically-enhanced elite group and an underclass. There is not space here to properly assess whether these concerns are justified; however in HGA’s view; they are not without substance.
In stating these concerns, we do not seek to deny the benefits brought by these technologies, or to suggest doctors or scientists are dedicated to advancing eugenics and the objectification of human beings. Indeed, the difficulty that we face as a society is precisely that in seeking to help people and relieve suffering we create these profound problems. However, we wish to emphasise that these issues and the public expressions of concern about them cannot be dismissed as ‘misunderstandings of science’, ‘irrationality’ or ‘fear of change’. The forcing of human reproduction into the industrial production/consumerist free market model poses truly existential problems and challenges for humanity, which are, in our view, as important as those created by globalisation and climate change. They must be confronted and dealt with head on, through an adequate legal, social and political process and set of institutions.
In this context we wish to emphasise the crucial importance of banning social sex selection. There is a strong public consensus on this issue and it is vital that there is a clear signal that the government takes these issues very seriously and is prepared to tackle them. If the government is unable to act in such a clear cut case, there is little possibility for responsible social control of these technologies.
From this (by no means exhaustive) discussion of the issues at stake, we conclude that the existing Act does not satisfactorily deal with the range of concerns in this field. Nor can it be expected to do so on its own. The 1990 Act was practical piece of legislation to establish regulation of artificial fertilisation and embryological research. However, it is the key piece of legislation in this field, and it makes sense to adapt it in order to make it as adequate as possible: we need a ‘Genetic and Reproductive Technologies Act’, not just an HFE Act.
An important step would be for the UK Government to sign and implement the Council of Europe Convention on Biomedicine and Human Rights, which contains a range of widely accepted ethical rules. The UK failure to sign the Convention is difficult to explain and is making us increasingly isolated in Europe on these issues. It is time to take this simple and necessary step.
The balance between regulation and ‘reproductive freedom’
As should be clear from the above discussion, the current advocacy of ‘reproductive freedom’ is part of the problem, rather than part of the solution. The insistence by some commentators on ‘reproductive liberty’ has become the key ideological element in the construction of a free market consumerist model for reproduction, rather than any attempt to free women from patriarchal control over their bodies.
Although the claims of reproductive freedom have a superficial plausibility, they are in fact consumerist extensions of well-founded, but much more narrowly-drawn rights. The first legitimate right is a woman’s right to choose to terminate her pregnancy. This right is based on the fact that a foetus is part of a woman’s body and that women have the right to have control over their own bodies, as a protection of their vital personal interests. That is very different from saying that women have the right to choose the characteristics of their children. Many women argue that technologies that increasingly subject reproduction to medical control actually decrease their personal autonomy, rather than increase it.
The other basis for reproductive rights claims is the Universal Declaration of Human Rights, which includes ‘the right to marry and found a family’. This article arose in reponse to the Nazi atrocities and from eugenics laws restricting disabled people’s reproduction in other countries. Again, this right is narrowly drawn to protect vital personal interests and does not include a right to reproduce with whomever a person wishes, using whatever technological assistance. Jurisdictions legitimately restrict whom we can marry (for example, generally prohibiting marriage with close family members). Neither does the Declaration guarantee access to any form of technological assistance needed to reproduce, when this is not possible in the normal way.
The expansion of these narrowly-drawn rights into much broader claims for access to technology and non-interference by the state are due to a general climate of individualism and consumerism in some countries. Especially in the USA , claims of personal autonomy now dominate in bioethical discourse. It is often thought that strong individual rights protect against eugenic interference by the state. However, at present, as many commentators have noted, in Western countries, the greater threat is of a free-market eugenics, driven by commerce and by consumerist desires for the perfect baby. Rather than non-interference, what is needed now is more state regulation to restrain the eugenic trend.
A somewhat more plausible way of formulating the argument against regulation is to say that reproduction is a private matter, which should be outside the realm of state regulation. However, the issues raised by the proliferation of reprogenetics raise such profound challenges for humanity as a whole that they cannot be left up to individual couples and their doctors. Choice by individual couples to demand new reprogenetic technologies affect everyone, and it is not satisfactory that decisions of great importance to everyone are made on the basis of media campaigns of emotional blackmail. Such case by case decision making not only often crosses important ethical lines, but in doing so irreversibly legitimates further steps, even though these are not yet technically feasible, (for example, permitting social sex selection would irreversibly legitimate selection for other non-pathological characteristics in the future).
We therefore recommend that the HFE Act be amended so that the HFEA is obliged to consider the long-term ethical social implications of decisions in individual cases. Obviously, this requires a broader set of expertise and representation than the HFEA currently possesses. We describe below some necessary changes in the HFEA.
3. The role and constitution of the HFEA
We are concerned by the HFEA's tendency to support apparently promising new scientific techniques. Like other such regulatory committees, it is dominated by the technocratic worldview, even though it does not necessarily have a majority of scientists in its membership. Such bodies, which are set up to regulate science, find it difficult to fundamentally question its direction. In some cases, the HFEA's has clearly overstepped its remit, for example in the case of 'therapeutic cloning'. During the Parliamentary debates in 2000/1, the HFEA vocally supported the idea of 'therapeutic cloning', and abused its role as independent watchdog in which the public should be able to trust. This was repeated earlier this year with the HFEA's enthusiastic welcome for the Korean research on therapeutic cloning. In our view, it is the HFEA’s role to regulate, not to takes sides in public controversies about science.
As noted above, a further problem is that the HFEA, as regulator, is obliged to make decisions on a case-by-case basis. The need for it to make legally defensible decisions in each case leaves very little room for consideration of the long-term direction in which its decisions are taking it.
A more subtle effect of the HFEA's need to keep within the letter of the HFE Act is that it is restricted to a rather narrow range of ethical concerns. This was particularly apparent in the Whitaker case, concerning so-called saviour siblings. Surveying the HFEA's public statements on the Whitaker case, we find two arguments: the potential psychological effects on the child born as a tissue donor, and the risk of PGD to the embryo, which can only be justified if there is a benefit to that embryo i.e. being assured of not suffering from a genetic disorder. The latter argument is the basis of HFEA's distinction between the Whitakers and the Hashmis, yet this makes little sense to most people.
Nowhere in the HFEA's public pronouncements can we find any clear reference to the Kantian ethical principle of not using people merely as means to an end. The reason for this is that the HFEA is, by virtue of its role as regulator, not allowed to use the sort of ethical principles that ordinary people do. It can consider medical benefit and risk, and, because it is written into the Act, the welfare of the child. But for the HFEA, which has legal responsibilities, and exists in a controversial and indeed, highly litigious climate, it is impossible to publicly base its decision even on ethical principles as universally accepted as Kant's, because to do so makes it vulnerable. (The Whitaker/Hashmi distinction in reality is not based on any real moral difference between the cases, and in the Whitaker case the HFEA overruled its own ethics committee, which wanted to be consistent with its decision with regard to Hashmis. What dictated the HFEA's decision in these cases was the need to stay within the letter of the law, which would appear to forbid selection of embryos in order to benefit another individual. Their calculation was correct, and allowed them to defend their decision in the Appeal Court against a pro-life group's challenge.)
Thus, as a result of the HFEA's institutional status, we have a position in which the key ethical decision-making body in this area is forced to behave as an ethical illiterate, and to operate ethically on the basis of legal defensibility. This will never produce decisions which are either principled or in the public interest.
Overall, what is happening here is typical of what often happens with British government advisory and regulatory committees. It is strikingly reminiscent of the history of GMOs, and that experience should serve as a warning. Throughout the 1990s critics complained that the Advisory Committee on Release to the Environment (ACRE) based its judgements on the environmental risk of GMOs on a narrow, case by case analysis of the direct environmental impact of particular small scale experimental trials, without considering wider issues. It operated in this way because it was forced to do so by the narrow definition of environmental harm in the 1990 Environmental Protection Act, which was in turn dictated by the EU directive, 90/220. ACRE was not permitted to consider the impact of GMOs in farming (for example changes in patterns of pesticide use created by GMO use) which might have large environmental impacts, let alone the wider implications of GMOs. ACRE was constituted from a narrow range of scientific expertise, including no sociologists, economists or experts in farming and the environment. Thus it was incapable of addressing many of the concerns raised by the environmentalists and other critics of GMOs, yet it was the main venue for regulatory decision making, which, according to dogma, must be 'science-based'. The result was that these concerns eventually exploded into direct action and public furore in the late 1990s. ACRE was completely overhauled, the EU directive was rewritten to allow assessment of the indirect effects of GMOs, and the government was forced into a three-year delay while it mounted farm-scale trials of the impact of GMOs.
The HFEA is in essentially in the same position that ACRE was in the 1990s. It is hampered by its inbuilt tendencies as a regulatory committee, and it's legal responsibilities from addressing the public's real concerns, about the trends of objectification, consumerism and eugenics, and where these technologies, step by step, are taking us. The Human Genetics Commission also recently decided that the roles of case-by-case regulation and policy consideration could not properly be combined within a single body.
We conclude that something more adequate to the state of the technology and the public's concern in 2004 is needed. One solution would be to create a new commission, linked to the HFEA, with statutory powers to lay down policy directives for the Authority. The Commission would have a different, broader membership to the Authority, and would regularly consult the public and Parliament. It should be much more transparent in its operation than the HFEA is currently.
Such a body would need powers, written into the Act, to take decisions based not only on considerations of medical benefits, risk and welfare of the child, but also on other ethical considerations, such as the non-instrumentalisation of human life, and on the long term 'social' impacts of allowing or prohibiting certain technologies.
There are a number of changes needed to existing legislation, which fall into three main groups: (i) problems with the 1990 Act as drafted, (ii) loopholes in the wording of the Act and (iii) problems exposed by scientific advances.
4.1 Problems with the 1990 Act as drafted
1. Preimplantation genetic diagnosis
Recent cases involving the use of PGD to produce children as tissue donors, and the public concern over the eugenic implications of PGD suggest that the HFEA needs a firmer basis in the primary legislation upon which to base its decisions, if it is not to face charges of arbitrary and undemocratic decision-making.
We recommend that the primary legislation establish firm guidelines restricting the use of PGD to the most serious diseases. In HGA’s view PGD should be used only for genetic testing where there is a known risk of a particular genetic condition in the family, rather than for screening of embryos for multiple conditions, where there is no known elevation of risk. PGD should not be used for creating children as tissue donors, since this violates the rule that people should be treated as ends in themselves not primarily as means to an end. There should be a publicly available register of conditions for which PGD had been approved. The Commission which we proposed above would be responsible for ensuring that there is no gradual tendency to approve the use of PGD for less and less serious conditions.
2. Creation of embryos for research/treatment
In HGA’s view, the Act should be amended to prohibit the creation of embryos purely for research or as sources of material for treatment. The UK is one of only five countries which permit this, although many countries permit embryo research. Canada , for example, which has recently passed legislation similar to the HFE Act, has expressly outlawed the creation of embryos for research. The reason generally cited for this is that the creation of embryos for purposes other reproduction is an instrumentalisation of embryos, which is inconsistent with their ethical status and degrades them to the level of a mere tool, a source of biological raw material. This objectification of embryos underlies the attempts by several companies to claim patents on human embryos as a ‘manufacture’ or ‘composition of matter’ (in patent parlance). In our view, embryos should be created only for the purpose of reproduction: this does not necessarily mean that embryos from IVF cannot be used for research if it is clear that they will not be used for reproductive purposes.
3. Reproductive tourism
An ongoing major problem in the social control of reproductive and genetic technologies is the possibility for people to travel abroad to use techniques prohibited in the UK , such as sex selection using PGD. There is precedent in other legislation for people to be convicted in the UK for acts committed abroad which are legal there but illegal in Britain . It should also be made an offence for reproductive technology practitioners to refer people to clinics abroad for the use of technologies illegal in the UK . The Government should make the utmost efforts towards promotion of the international harmonisation of legislation and the discouragement of reproductive tourism.
4. Discrimination against disabled people
Section 37 of the 1990 Act allows abortion after 24 weeks of pregnancy in the case of ‘serious’ impairment of the foetus; where there is no impairment, abortion is not permitted after 24 weeks, because the foetus is potentially viable after this point. In the view of many disabled people this clause is a form of discrimination against them, and a continuation of eugenic practices designed to eliminate them from society. HGA supports this point of view. We urge the Committee to recommend the removal of this provision.
5. Human germ line genetic engineering
While the 1990 Act prohibits the licensing of one form of human germ line genetic engineering, (HGE) for treatment, it envisages that the Secretary of State may make regulations to allow research in this area. HGE is widely regarded as the most serious harmful outcome to be avoided in human genetics, and should be prohibited for a number of very strong reasons. Research to develop such techniques in humans would only increase the likelihood that this ethically and socially disastrous outcome would be realised, for example by the application of published research techniques developed in the UK , in countries which lack legislation. The EU in its Framework 6 research programme, has ruled out such research and we recommend that he UK should follow suit.
4.2 Loopholes in the wording of the Act and regulations
It was clearly Parliament’s intention in 1990 to prohibit all nuclear transfer cloning, irrespective of whether the nucleus is introduced into an egg or an embryo. However, according to the Government’s lawyers, the wording of the Act does not prohibit cloning by the Roslin technique, into an unfertilised egg. This meant that the 2000/01 Parliamentary debate on ‘therapeutic cloning’ was distorted, in that MPs voted only on regulations regarding the purposes of embryo research, and not on regulations to allow cloning. As noted above, it was also distorted in being polarised between scientists and pro-life groups. The permissibility of this technique should not rest on an arbitrary loophole in the Act: if the government wishes to permit research cloning, it should amend the HFE Act to make this clear, and allow Parliament to debate the issue properly.
Schedule 2 of the 1990 Act states that the HFEA may only licence research when it ‘appears’ to it that the research is ‘necessary or desirable’. It is widely thought that Parliament wished to allay public concerns about the use of embryos for trivial purposes, and to realise the principle of respect for embryos by making sure that any embryo research was really necessary for making important medical progress. However the term is not defined, and the words ‘or desirable’ appear to give wide room for discretion. In HGA’s view these words should be removed and necessity should be defined narrowly, e.g. ‘when there are no alternative approaches which may be used to obtain similar data’.
4.3 Changes needed to take account of scientific developments
The HFE Act is designed primarily to deal with conventional IVF using fresh or frozen sperm. ‘Gametes’ are defined as live human sperm or eggs and there is an implicit assumption, which was appropriate in 1990, that sperm and eggs are produced by natural processes in intact human reproductive organs. However, since 1990 there have been many developments in our ability to grow and manipulate germ line cells in culture, and some of these techniques have even entered into clinical practice. ICSI is particularly significant since it allows the creation of embryos from male germ line cells.
These techniques raise many safety and ethical issues, which we cannot deal with adequately here. Although the Act requires these activities to be licensed, since they constitute storage, it is silent about which manipulations of such cells are permitted. One issue that we wish to highlight is that the genetic engineering of immature gametes is not expressly prohibited in the Act, although Parliament felt strongly enough about genetic engineering to prohibit the engineering of embryos. In the absence of clarity in the legislation, HFEA decisions in this respect could be challenged. This is a major loophole, which we believe should be closed. Given the many issues involved, we believe that the Act should be amended to provide detailed rules regarding all human germ line cells.
Human Genetics Alert
June 7 th 2004