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 [2004] 3 Web JCLI 

‘Designer donors’?: Tissue-typing and the regulation of pre-implantation genetic diagnosis


Colin Gavaghan,

Lecturer in Medical Law, University of Glasgow
c.gavaghan@law.gla.ac.uk

Copyright © Colin Gavaghan 2004
First published in Web Journal of Current Legal Issues



Summary

The attempts by Shahana and Raj Hashmi to produce a child that would serve as a life-saving tissue donor for their existing child was almost guaranteed to provoke reference to ‘designer’ and ‘spare parts’ babies. The decision by the Court of Appeal to allow the Human Fertilisation & Embryology Authority to license this practice, and the conditions the Authority put in place, reassured some commentators that a sensible compromise had been found. This article argues, however, that the court’s decision was legally questionable, that the HFEA’s conditions were arbitrary and ethically muddled, and that overall, the regulation of tissue typing in the UK lacks coherence and consistency.



Contents

1. Introduction
2. Background to the Hashmi application
3. The HFEA’s approach to tissue typing
4. The Select Committee on Science and Technology
5. The legal challenge
6. Was the Court of Appeal correct?
7. The role of the HFEA
a. Condition 1: Last resorts and necessary evils
b. Condition 2: The parental exception
8. The Whitaker case: an arbitrary distinction?
9. Conclusion
Bibliography


1. Introduction

When Robert Nozick coined the term ‘Genetic Supermarket’ in 1974, he was writing in an era when even in vitro fertilisation (IVF) was undreamt of by most lay persons. (Nozick, 1986, 315n.) The question of parents actually being able to make choices about the genetic composition of their offspring was no more than an admittedly fascinating thought experiment, firmly rooted in the realm of the hypothetical. Indeed, for the next quarter of a century, the debate remained a largely theoretical one; although the increasingly widespread availability of IVF rendered the possibility more plausible, the actual ‘hard cases’ that so engaged ethicists intrigued by the notion of the Genetic Supermarket did not materialise.

In the first few years of the Twenty-first Century, however, several instances have arisen in the UK where couples have sought to use pre-implantation genetic diagnosis (PGD) technology to make precisely these kinds of choices. Inevitably, these attempts have proved controversial. Two areas in particular have provided intriguing insights into the manner in which the Human Fertilisation and Embryology Authority (HFEA) - the body entrusted with regulating such technology - will discharge that obligation. The first, sex pre-selection, has recently been the subject of a lengthy consultation process, the result of which seems to have confirmed public support for the HFEA’s earlier decision to prohibit such choices.

The second area of interest, the selection of tissue-compatible embryos to act as donors, has produced a considerably more equivocal response from the HFEA. It has also, as explained below, given rise to a confrontation between Parliament and the body it created, and, ultimately, to a challenge in the courts to the Authority’s position (R (on the application of Quintavalle) v Human Fertilisation and Embryology Authority [2003] EWCA Civ 667; [2003] 3 All ER 257). Unlike sex selection, then, tissue typing remains very much a subject of legal and ethical uncertainty.

In this article, I will outline the approach both the courts and the HFEA have adopted to tissue typing. I will argue that while the position adopted by the Court of Appeal is somewhat questionable, that adopted towards this technology by the HFEA is simply untenable, relying on an eclectic hotchpotch of ethical principles none of which is applied consistently, and resulting ultimately in an exercise in line-drawing that seems largely arbitrary and unfair.

2. Background to the Hashmi application

Zain Hashmi suffers from beta thalassaemia major, an autosomal recessive genetic disorder which causes an abnormally high rate of breakdown of red blood cells, leading in turn to severe anaemia. Sufferers require frequent blood transfusions, but such a regimen can cause iron overload and consequent organ deterioration. It is therefore considered that the only long-term solution, and certainly the only cure for the condition, lies in correcting the genetic defect by bone marrow transplantation. (Lucarelli, et al, 2001) Without such treatment, the sufferer’s life expectancy may well be reduced to as little as twenty-five years.

Developments in the field of stem cell technology, however, have obviated the need for actual bone marrow. It has been discovered that ‘[c]ord blood from neonates contains substantial numbers of haemopoietic stem cells, which can be harvested at delivery, frozen, and then transplanted to patients who would not otherwise have a donor’. (Lennard and Jackson, 2000) Rather than subjecting the donor to the painful process of bone marrow retrieval in the future, then, all that would be required would be a quantity of blood from his or her umbilical cord.

Those wishing to utilise this technology are still faced with the problem of finding a suitable donor, one who is Human Leukocyte Antigen (HLA) compatible. As with all transplant situations, the likelihood of finding a match among genetic relatives is higher than among the population at large, but since neither Zain’s parents, nor any of his three elder siblings, were compatible, the Hashmis undertook to have another child that could act as a donor for Zain.

Their first attempt ended in unfortunate circumstances; prenatal testing revealed that the child Shahana Hashmi was carrying would be afflicted with the same condition as Zain, and she elected to have an abortion. A second pregnancy was more successful, in that the child was unaffected, but it quickly became apparent that this child was not a suitable tissue match and could therefore not provide the required transplant. This outcome was not entirely surprising; even among siblings, the chances of a child being both HLA compatible and free from the disease were not especially favourable. Around this time, Mrs Hashmi discussed her problem with Dr Simon Fishel, the Director of CARE (Centres for Assisted Reproduction Limited), the ‘largest single provider of in vitro fertilisation ... services in the United Kingdom’ (R (on the application of Quintavalle) v Human Fertilisation and Embryology Authority [2003] 3 All ER 257, per Lord Phillips of Worth Matravers MR, at p259). Dr Fishel was aware of a groundbreaking procedure being piloted at the Reproductive Genetics Institute in Chicago, and he brought this to Mrs Hashmi’s attention. The procedure Dr Fishel described comprised five steps:

1. the creation by in vitro fertilisation of several embryos, using gametes from Mr and Mrs Hashmi;
2. the biopsy of a single cell from the embryos thus created;
3. the use of PGD to screen those embryos for the presence of beta thalassaemia (henceforth referred to as Phase 1 screening);
4. simultaneous screening of the embryos to ensure HLA compatibility with Zain (referred to by the court as ‘tissue typing’, but henceforth referred to as Phase 2 screening);
5. jettisoning of those embryos found either to be affected by the disease, or to be HLA-incompatible with Zain.

Although PGD had already been used for the screening out of embryos that carried genetic diseases, Phase 2 screening had not been carried out in the UK before. Fishel therefore enquired of the HFEA whether a licence would be granted for such a procedure.

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3. The HFEA’s approach to tissue typing

The HFEA appears to have found this question somewhat troubling. In 1999, a Joint Working Party (JWP) of the HFEA and the Human Genetics Commission had been established to consider the extent to which, and circumstances in which, PGD should be available. When it reported in 2001, the Working Party recommended that PGD ‘should only be available where there is a significant risk of a serious genetic condition being present in the embryo’. (Joint Working Group, 2001, Recommendation 11.)

The use of PGD to ensure the birth of a suitable tissue donor had not been specifically considered in the consultation process preceding the Report, but it is clear that it was tacitly precluded by the terms of this Recommendation. While the first phase of screening, to ensure the new child would itself be free from genetic illness, would appear to fall within the terms of Recommendation 11, the second phase, to ensure compatibility with the existing child, clearly would not. Indeed, the Report went on (at Paragraph 29) to make this rejection of HLA typing explicit, at least until further discussion of the perceived ethical difficulties took place.

This further discussion was carried out by the HFEA’s Ethics Committee, which in December 2001 published a document entitled ‘Ethical Issues in the Creation and Selection of Preimplantation Embryos to Produce Tissue Donors’. These new guidelines allowed for the possibility of the use of PGD for this purpose, but such use was tightly restricted by the conditions attached thereto. The precise nature of these conditions will be discussed in more detail later.

The Ethics Committee’s recommendation seems to have satisfied the HFEA that Dr Fishel’s clinic should be granted the licence, and that the Hashmis should therefore be permitted to make use of the two-phase screening technique (HFEA Press Release, 13 December 2001). As will be discussed in due course, however, not all of the Ethics Committee’s recommendations were taken on board by the Authority.

In contrast to many accounts of developments at the ‘cutting edge’ of reproductive and genetic technology, the decision in the case of Raj and Shahana Hashmi was widely welcomed, by the popular press as well as the medical profession.(1) The HFEA, it was thought, had adroitly picked a path through an ethical minefield, balancing the life of Zain Hashmi, and the reproductive freedom of his parents, against the possible ethical perils of ‘designer’ and ‘spare-part babies’. The latter concerns were, it is widely considered, reflected in the strict guidelines on tissue typing which the Authority had published a few months prior to the decision. (‘A Summary of the One Hundred and Thirteenth Meeting of the Human Fertilisation and Embryology Authority’ on 29th November 2001) As then-chairwoman Ruth Deech reassured the press, ‘[t]he authority will only approve the treatment in very rare circumstances and under strict controls’. (Dyer, 2002)

4. The Select Committee on Science and Technology

In July 2002, the HFEA’s decision in relation to tissue typing in circumstances like those of the Hashmis, together with Chairwoman Ruth Deech’s defence of that decision, were the subjects of criticism from the House of Commons Select Committee on Science and Technology. (Select Committee, 2002) Noting that the public consultation process had not addressed the scenario that arose in the Hashmi application, and that the only consideration of this particular practice had been before the HFEA’s Ethics Committee, the Select Committee took the view that

The HFEA’s decision to allow tissue typing in conjunction with preimplantation genetic diagnosis went beyond the scope of its own public consultation. It is vital that the public are taken along with decisions of such ethical importance. (Paragraph 17)

In response to Ruth Deech’s submission that the fact that the HFEA took the decision on PGD ‘protects Members of Parliament from direct involvement in that sort of thing’ (Paragraph 18), the Select Committee retorted that ‘Parliament does not need protecting and democracy is not served by unelected quangos taking decisions on behalf of Parliament.’ The Select Committee concluded on this issue by drawing attention to the fact that ‘[a] pressure group, Comment on Reproductive Ethics, is seeking judicial review in the High Court on PGD on the grounds that the 1990 Act only permits distinguishing between embryos on the basis of whether they are healthy or not or for providing treatment services to the mother’, warning that ‘[s]hould this ultimately be successful, Parliament's intervention may be inevitable.’

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5. The legal challenge

The licence in question was granted on 22 February 2002, but the HFEA’s policy decision to permit HLA tissue typing was by this time already the subject of a legal challenge. Josephine Quintavalle, backed by the pressure group Comment on Reproductive Ethics (CORE), sought judicial review of the HFEA’s decision, on the grounds that it had acted ultra vires of the powers vested in it by the Human Fertilisation and Embryology Act 1990.(2)

The basis of Mrs Quintavalle’s challenge lay in the wording of the 1990 Act, and comprised four elements.
1. Section 3 of the Act prohibits the creation or use of any embryo ‘except in pursuance of a licence’.
2. Section 11 of the Act limits the circumstances within which the Authority may issue a licence to those set out in Schedule 2.
3. Schedule 2 provides, inter alia, that a licence may only be issued if ‘it appears to the Authority to be necessary or desirable for the purpose of providing treatment services’.
4. The definition of ‘treatment services’ is in turn spelt out in Section 2(1), which provides the following definition: ‘“treatment services” means medical, surgical or obstetric services provided to the public or a section of the public for the purposes of assisting women to carry children.’
Quintavalle’s contention was that the Hashmis’ intention to use IVF/PGD for tissue typing did not fall within the definition of ‘providing treatment services’, and therefore fell outwith that range of purposes for which the Authority could legitimately issue a licence.

The Authority responded to this challenge with two contentions of its own. Firstly, it submitted that the testing for HLA compatibility of a cell biopsed from an embryo did not constitute ‘use’ or ‘creation’ of an embryo, and therefore did not require a licence within Section 3 of the Act. While it accepted that the removal of a cell from the embryo constituted ‘use of an embryo’, whatever was done to that cell once removed, it averred, could not be so defined.

In the event that this first submission was rejected, the Authority submitted that it was in any event within its power to grant a licence for this purpose, since tissue typing was ‘at least desirable for the overall purpose of providing fertility treatment’. Again, Quintavalle disputed this, maintaining that the purpose of tissue typing was not to ‘assist women to carry children’, but rather, ‘to ensure that a child born to a particular woman would have tissue that was compatible with the tissue of a sibling.’

On 20 December 2002, at the High Court, Maurice Kay J decided in favour of Mrs Quintavalle ([2003] 2 All ER 105). He rejected the Authority’s contention that tissue typing did not constitute ‘use of an embryo’, deeming it ‘inconceivable’ that Parliament could have intended to exclude such a practice from regulation by the Authority. (pp.263-264) Having stated that the procedure required a licence, he then went on hold that, contrary to the second of the Authority’s submissions, the procedure could not be licensed, since – as Mrs Quintavalle had contended – tissue typing could not be said to be ‘necessary or desirable for the purpose of assisting a woman to carry a child’.

The Authority appealed against this decision, and was supported in that appeal by the Secretary of State for Health, who was concerned that the decision, were it to stand, could impede the use of PGD more generally, and specifically for the purpose of eliminating genetic disease. The trial judge’s interpretation of the relevant section as being restricted to allowing a woman to become pregnant and carry a child to term was arguably not wide enough to permit screening for genetic disorders that would not manifest themselves phenotypically until after birth. Certainly, it is clear from CORE’s website that their objection was not solely to tissue typing, but to PGD more generally.(3)

On appeal, counsel for the Authority dropped the first strand of its original case. Carrying out the biopsy, it was conceded, clearly involved ‘using’ the embryo, and therefore must itself be ‘for the purpose of assisting a woman to carry a child’. Since the purpose of the biopsy was to allow tissue typing, then in order for the biopsy to fall within the terms of the Act, so too must the tissue typing. (p264) Both parties, therefore, now agreed that, if tissue typing were to be permitted, a licence from the Authority would required.

The Authority’s case, rather, relied on a contention more central to the matter, namely, that

the entire treatment, comprehending creation of the embryo, biopsy for PGD and tissue typing, the analysis of the cell removed by the biopsy and the implantation of the embryo, if it proved to be free of disease and a tissue match for Zain (p264)

amounted to treatment ‘for the purpose of assisting a woman to carry a child’. Counsel for the Authority disputed the trial judge’s narrow interpretation of that phrase, which seemed to see ‘treatment services’ as ‘hav[ing] as their sole object the assistance of the physical process of producing a child.’ Rather, a broader reading of the phrase – one which, it was contended, was closer to legislative intention – took account of the fact that, in some circumstances, allowing a woman to eliminate the possibility of genetic disease could be regarded as assisting her to carry a child, since ‘[w]ithout such knowledge some women who carried genetic diseases would not be prepared to have children.’

Were it to be accepted that PGD for the ‘screening out’ of genetic disease fell within the definition, counsel for the Authority went on, it followed that the purpose for which Mrs Hashmi wished to use PGD should also be so regarded, since

In the same way tissue typing would assist Mrs Hashmi to carry a child, for her wish to do so was conditional upon knowing that the birth of that child would be capable of saving the life and health of Zain.

When challenged as to whether such a wide reading of the Act could allow PGD for the selection of any traits to be regarded as ‘assisting’, and thence the subject of a possible licence, counsel for the Authority conceded this possibility, but regarded the policing of the use of this technology to be the proper responsibility of the Authority, and not a reason to read the governing legislation restrictively.

Counsel for Mrs Quintavalle responded by reiterating his insistence that ‘treatment services’ should be interpreted narrowly, as referring only to measures required to overcome problems in conceiving and maintaining a pregnancy. To this, however, he added the second claim that, even if the term could be extended to include measures to screen out genetic defects, what the Hashmis sought was a step further even than this, being designed ‘to reject healthy and viable embryos because they lacked some desired characteristic.’

In considering the respective merits of these submissions, the Court of Appeal placed considerable importance on the intent of the framers of the 1990 Act. The Master of the Rolls, Lord Phillips of Worth Matravers, was impressed by the argument from counsel for the Authority to the effect that Parliament tacitly permitted screening of embryos for genetic abnormalities. Counsel had pointed to Paragraph 3(2)(b) of Schedule 2, which permits the licensing of embryo research activities for the purpose of ‘developing methods for detecting the presence of gene or chromosome abnormalities in embryos before implantation’. If, he argued, Parliament specifically made allowance for research into such screening, it would be strange indeed if it intended to prohibit the screening itself. Lord Phillips found this argument persuasive.(4)

Parliamentary intent, then, had not been specifically to prohibit embryo screening; but did it follow that it had been specifically permitted? Did screening fall within the definition of ‘assisting women to carry children’? Though admitting that his initial reaction was to agree with the trial judge, i.e. that the phrase should be interpreted narrowly as applying only to ‘treatment designed to assist the physical processes from fertilisation to the birth of a child’ (p270), Lord Phillips eventually came to the view that screening could fall within this definition. An unwillingness to risk the birth of a child affected by a hereditary defect could, he reasoned, constitute an impediment just as surely as a physical obstacle, and treatment which circumvented that impediment could be regarded as ‘for the purpose of assisting women to carry children’.

Having accepted that screening for genetic disorder could fall within the terms of the Act, the next question for Lord Phillips was whether this could be extended to tissue typing. While conceding that this might be thought to amount to a step too far for the Authority, Lord Phillips was not prepared to draw a distinction between those cases of PGD that are intended to screen out genetic disease, and those designed to select other traits, such as HLA compatibility:

My conclusion is that whether the PGD has the purpose of producing a child free from genetic defects, or of producing a child with stem cells matching a sick or dying sibling, the IVF treatment that includes the PGD constitutes ‘treatment for the purpose of assisting women to bear children’. (p271)

In short, these were matters which Parliament had intended for the Authority to decide, and the Authority had acted perfectly properly in exercising this discretion in the case of the Hashmis.

Lord Justice Schiemann adopted a similar approach, drawing attention to the distinction in the Act between those activities that were prohibited altogether,(5) and those which may only be done in pursuit of a licence issued by the Authority. He further concurred with Lord Phillips that ‘it was lawfully open to the Authority to come to the conclusion that [PGD] would assist some women, who would otherwise refrain from conception or abort either spontaneously or deliberately, to carry a child.’ (pp.275-276) In a somewhat curious phrase, he stated his view that ‘paragraph 1(1)(d) is wide enough to embrace ensuring that the embryo does not suffer from a genetic defect and tissue incompatibility.’

Whether an embryo may meaningfully be said to ‘suffer’ from tissue incompatibility is a moot point – any suffering, it might be assumed, will be on the part of the sibling that will be denied a transplant – but again, the reasoning seems to be that, since the principal reason for the pregnancy is the creation of a donor, then the inability to ensure that the next child will be a tissue match will constitute an obstacle to the pregnancy. As such, providing such a guarantee may be regarded as ‘assisting women to carry children’.

To the concern that such a ruling could open the proverbial floodgates to any choices prospective parents might want to make about their children’s genetic constitution, provided such choices were stated as preconditions of their birth, Lord Schiemann was, like Lord Phillips, prepared to entrust the policing of this to the Authority:

I point out in conclusion that Parliament did not impose upon the Authority any express obligation to sanction the grant of licences even if what was proposed was indubitably necessary for the purpose of assisting a woman to carry a child. ... If the decision of the Authority is upheld in the present case it does not mean that parents have a right to in vitro fertilisation for social selection purposes. (p.276)

Finally, Lord Justice Mance also favoured an interpretation that took account of more than allowing a woman to overcome physical obstacles to initiating and maintaining a pregnancy. As well as considering the same background sources as his fellow judges – the Warnock Report, the White Paper that preceded the 1990 Act – he sought support for his position within the terms of the Act itself. Section 13(5) of the Act, he pointed out, specifically enjoined the Authority to have regard for the welfare of the child created thereby. That being so, he found himself

in these circumstances left in no real doubt that the concept of “medical, surgical or obstetric services .... for the purpose of assisting women to carry children” was intended to embrace not merely services to assist women physically to carry to term and give birth, but also services to assist them to give birth to children who would be normal and healthy during their lives and would in turn be able to have normal and healthy children. (p.284)


The requirement, then, ‘is better served if the legislation is read as permitting such screening.’

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6. Was the Court of Appeal correct?

The Court of Appeal’s decision to overturn the first instance ruling was predicated on two assumptions: firstly, that the definition of ‘treatment services’ was wide enough to encompass PGD aimed at eliminating the possibility of a child being born with a hereditary defect; and secondly, that this in turn could be extended to apply to screening for HLA compatibility. I would suggest, however, that the former assumption is built upon considerably firmer foundations than the latter.

Firstly, the recognition by Lord Phillips MR and Mance LJ that Paragraph 3(2)(b) of Schedule 2 clearly permitted the use of embryos for research into ‘developing methods for detecting the presence of gene or chromosome abnormalities in embryos before implantation’ lends some credence to the claim that Parliament envisaged screening for such abnormalities. It is, indeed, unlikely that the framers of the Act would allow research into a procedure, but outlaw the procedure itself.

Secondly, Mance LJ was surely correct to point out that the requirement in Section 13(5) that consideration be paid to the welfare of any child born as a result of treatment seems to sit uneasily with a prohibition on screening pre-implantation embryos for even serious disorders.

Thirdly, much of the background material referred to by the Court – in particular, from the Warnock Report, the White Paper that preceded the 1990 Act, and the then Secretary of State Kenneth Clarke’s contributions to the debate as the Bill made its way through Parliament - adds weight to the contention that the intention of the Act’s framers was to allow screening for hereditary abnormalities.

As Lord Phillips recognised, however, accepting that PGD for hereditary defects was permitted within the Act was only a ‘stepping stone’ to the destination the appellants wished to arrive at, i.e., judicial recognition that the Authority was empowered to issue a licence for tissue typing. And that second step is one that is taken on a decidedly slippier surface. Nothing in the background materials to which the Court looked, nor in the other provisions of the Act, make explicit or implicit reference to tissue typing.

An argument could perhaps be fashioned around the Section 13(5) requirement that concern be paid to the welfare of the child born or any other children affected by the treatment. Juliet Tizzard, of the Progress Educational Trust, has suggested that this might be used to draw attention to the extent to which allowing the Hashmis to use tissue typing might further the interests of Zain in being provided with a HLA compatible sibling. (Tizzard, 2002) This clause has caused a degree of confusion among academic commentators perplexed as to what sort of situation was being envisaged when it was inserted. However, it may be thought likely that this provision was intended as a further check on the provision of treatment – treatment providers should exercise caution if other children are likely to be harmed as a result – rather than a justification for treatment that would not otherwise fall within the terms of the Act.

Equally questionable was the Court’s decision that tissue typing could fall within the definition of ‘treatment for the purpose of assisting women to bear children’, on the basis that, were it not permitted, Mrs Hashmi may well not have had a further child. ‘Treatment’, it might be thought, carries some connotation of restoring normal functioning after, or ameliorating the effects of, some disability or disease. Walter Glannon, for example, speaks of ‘treatment’ as being aimed at ‘avoiding harm to people and benefiting them by allowing them to realize their interest in having healthy lives.’ (Glannon, 2001, 79) We may well speak of ‘assisting’ people to overcome other obstacles to achieving what they want, but we would on the whole speak of ‘treating’ them only if their health was impaired.

It could, of course, be argued that Mrs Hashmi’s status as a carrier of the thalassaemia with which Zain was afflicted compromised her interest in a healthy life, in that she was disabled from being able to bear a child with an average chance of being free from serious disability. If this view were taken, then PGD to screen out affected embryos could perhaps be seen as ‘treatment’ for that disorder. However, her inability to guarantee that any child she bore would be a suitable tissue match for Zain was not the result of any pathology or deficiency, but simply the nature of normal genetic inheritance. To categorise Phase 2 screening as ‘treatment’ seems to stretch the definition beyond reasonable usage.

7. The role of the HFEA

Whatever the legal merits of its decision, the Court of Appeal seems to have been considerably less troubled than the Select Committee by the prospect of entrusting policy decisions about PGD and tissue typing to the HFEA. How, then, has the HFEA discharged that obligation? Although, as we have seen, the Authority was prepared to permit tissue-typing in circumstances like those of the Hashmis, it appeared to be greatly concerned to demonstrate that they had in no way thrown open the floodgates to ‘designer babies’, attaching a series of strict conditions to that decision.

a. Condition 1: Last resorts and necessary evils

The first two of the conditions which the Ethics Committee recommended, and the HFEA subsequently accepted, require that ‘all other possibilities of treatment and sources of tissue for the affected child should have been explored’ and that the use of HLA typing should be limited to ‘severe or life-threatening’ cases. In short, the HFEA requires that this technology be utilised only in cases of direst need, and even then, only as a last resort. In so doing, it might be thought that the HFEA is making a statement about the pro tanto wrongness of the technology. If, after all, there were nothing inherently wrong in the practice, there would be no need to find such compelling justification for its use.

What, then, might the Ethics Committee – and ultimately the Authority, which accepted its recommendations on these points – regard as being ethically problematic about using PGD for tissue-typing? And is it reasonable to conclude that these concerns were more adequately addressed when the conditions listed are met? At the outset of its consideration, the Committee identified three questions which it hoped would guide it in framing its recommendations:

The last of these three questions might be thought to presuppose the answers to the first two, in that no such demarcation would be necessary unless there actually existed unacceptable reasons. It seems, therefore, that the question of the pro tanto wrongness of PGD/HLA rests in the first instance on its likely impact on this question of welfare, and in the second on the likely impact on the public good.

Welfare of the unborn child

In considering the welfare of the future child, the Ethics Committee considered both a fairly traditional formulation of the ‘welfare principle’, asking ‘whether the outcome of the technique adversely shifts the balance of benefit and harm’, (Para. 2.14) together with a more unusual formulation where the Committee considered the proposition that:

It could be suggested that positive consideration of the welfare of the child requires respect for beings as ends and that the putative child be treated not merely as a means to a further end but also as an “end in itself”. (at para. 2.9)

The first, and more straightforward, of these conceptions of welfare asks whether the donor child will experience a balance of benefit over harm as a result of the technique in question. Such concern may seem entirely valid in this context. Is it not reasonable to take account of the possible emotional and psychological burdens that may be experienced by a child who grows up knowing that it was created for such a purpose? That their relationship with the parents who conceived them for that reason, or with the sibling they saved, will be adversely affected?

Such possible objections begin to look less compelling, however, when we consider what the alternative was for the child in question. Because of course, for this particular child, the alternative to being born as a tissue donor is not to be born into a more conventional family setting, but rather, not to be born at all. This counter-intuitive but compelling conclusion was brought to prominence by Derek Parfit in his seminal philosophical work, Reasons and Persons, and it has been highly influential upon many writers in the field of bioethics (Heyd, 1994; Roberts, 1998; Gavaghan, 2000). Parfit’s conclusion rested on the understanding that our identity is dependent upon the precise combination of sperm and ovum from which we developed; had two different gametes been combined, my parents would have had a different child. Though it would have had the same parents, same environment, possibly the same name, it would not have been me.

Once this is accepted, then it becomes difficult to conclude that the child created as a tissue donor is harmed by those decisions upon which its very existence is dependent. Unless we foresee that its life is likely to be so unremittingly awful that existence itself will be a burden, we must conclude that it is better off (or at least no worse off) being born into these unusual circumstances than never being born at all.

Having identified a fairly traditional conception of the welfare of the resultant child as one of its primary concerns, the Committee went on to elaborate that ‘positive consideration of the welfare of the child requires respect for beings as ends and that the putative child be treated not simply as a means to a further end but also as an “end in itself.”’ (para 2.9) The Kantian imperative that all humans should be treated as ends in themselves is one that commands widespread adherence, and it is perhaps understandable that the Committee would wish to conduct its deliberations in that light.

What does it mean to treat someone as a means and not as an end? As Beauchamp and Childress point out (2001), this ethical rule is often misinterpreted as meaning simply that it is objectionable to use someone as a means to furthering one's own objectives – something we do every time we hire a plumber to unblock our sink or taxi driver to take us home. Kant's imperative, in fact, did not prohibit such acts of ‘using’, but rather, warned against treating people merely as a means and not also as an end in themselves. That is to say, there is nothing objectionable per se in using someone as a means, provided I do not lose sight of the fact that s/he is also an end in him/herself.

Alan Donagan is a leading contemporary adherent to and interpreter of Kantian ethics. For him

Kant’s formula of the fundamental principle may be restated in a form more like that of the spiritual commandment that is its original: Act always so that you respect every human being, yourself or another, as being a rational creature. (Donagan, 1977, at p65.)

What sort of duties, then, are owed to a being by virtue of its status as a rational creature? Much of Donagan’s book is given over to a discussion of this question, and he identifies various ‘precepts’ that derive from the core imperative. He maintains, for example, that ‘it is impermissible for anybody at will to use force upon another’, (p.82) a precept that itself gives rise to derivative precepts prohibiting killing, inflicting bodily injury or holding another in slavery (p.83); that ‘[i]t is impermissible not to promote the well-being of others by actions in themselves permissible’; that it is impermissible to lie (p.88); and that there exists a duty (subject, as are almost all of these ‘first-order precepts’, to certain exceptions) to obey the law (p.109).

One striking aspect of these precepts is that they seem to give rise to a more obvious case in favour of HLA-typing in cases like those of the Hashmis and Whitakers than they support the contrary position. For while Donagan has nothing to say about the sort of scenario about which the Committee were asked to deliberate, the precept that imposes a positive duty of beneficence - ‘[i]t is impermissible not to promote the well-being of others by actions in themselves permissible’ – gives arise to a pro tanto obligation to rescue Zain. Of course, the caveat ‘by actions in themselves permissible’ prevents us from leaping too readily to this conclusion. But nonetheless, a first reading of Donagan’s precepts seems to see the scales tilt in favour not only of allowing HLA-typing in life-or-death cases such as those under consideration, but perhaps in cases of less serious illness too; the precept, after all, does not stop at imposing a duty to save life, but rather speaks of ‘promot[ing] the well-being of others’.

The question that remains is whether the actions in question are ‘in themselves permissible’. It is impossible to advance a definitive answer to this without attempting a fuller study of deontological ethics, a task beyond the remit of this article. However, on an admittedly superficial reading, it is not obvious that HLA-typing would contravene the duty to respect the new child as an end in itself in any of the ways specifically identified by Donagan. The new child would certainly not be killed, exposed to bodily harm or enslaved. The positive duty to promote its interests is arguably meaningless in a context where the future child does not presently possess any interests, and there is certainly no obvious sense in which such a possibility exists but is being neglected. And duties in relation to truthfulness, honouring contracts, and obeying the law are irrelevent in this context.

What the Kantian imperative seems to require, then – at least as Donagan interprets it – is that the well-being of Zain Hashmi (and Charlie Whitaker, considered below) should be promoted unless it can be demonstrated that some other aspect of the duty – presumably as owed to the new child - is being violated. It is for scholars of Kant, of Donagan and of such duty-based ethics more generally to ascertain whether any such competing obligation exists and, if so, whether it can outweigh what Donagan clearly recognises as a duty to the existing, suffering children. For the purposes of this article, it is sufficient to note that it is by no means uncontroversial or obvious that this ethical obligation to which the Ethics Committee attached such weight, namely to respect all humans as ends in themselves and as rational beings, weighs against HLA-typing, either in life-or-death cases or in cases where it is only well-being rather than life itself that is at stake. Indeed, it may even be that this obligation – contrary to the Ethics Committee’s apparent assumption - pulls in the opposite direction.

A similar approach to the Kantian imperative has been advanced by Walter Glannon, this time in relation to the possibility of reproductive human cloning. Glannon invites us to imagine a (far from implausible) scenario wherein

the parents of a recently deceased or dying child want to clone an individual who is genetically identical to that child and thus “replace” it to compensate for their loss or else carry on the family line. (Glannon, 2001, p118.)

Glannon acknowledges that, if ‘the sole intent of the parents is replacement or compensation, then the cloned individual would be treated solely as a means,’ and that this ‘would deny the intrinsic dignity and worth one possesses in virtue of the fact that one is a human agent for the capacity for reason.’ However, for Glannon, the motives with which the clone was created would be less important than the manner in which it is treated throughout its life:

if the clone were loved and treated with the dignity and respect commanded by its intrinsic worth, then cloning might be morally justifiable on Kantian grounds. Although the intention to clone the child suggests that he or she would be treated instrumentally, the fact that the child is treated as a unique individual once she exists is enough to dispel any moral qualms about the parent’s behavior.

In short, ‘how one is treated by others over the course of one’s life is more morally significant than the reasons for causing one to exist.’ (at p.120)

Yet even if this is an erroneous interpretation of the duty, and that HLA-typing presents greater difficulties for the duty to respect the new child as an end in itself than has been recognised here, it is by no means clear that the recommendations at which the Committee arrived would follow from this. For if it is felt that ‘being born to be a donor’ is incompatible with being treated as an end in oneself, then it is difficult to see how this is only so when the anticipated donee is a parent, rather than a sibling. In neither case is the prospective child able to consent to the donation, nor of course to its creation. In both cases the decision involves consideration for a party other than the putative child itself. In both scenarios, in other words, the donor child is being created at least partly as a means to some other end. The next section will consider this most perplexing of conditions.

b. Condition 2: The parental exception

The fact that the Committee had wandered into areas of ethical confusion, and perhaps departed from its original remit, became clearest when it came to consider the possibility of utilising this technology to provide a tissue donation to a parent. Among its final recommendations, it proposed that ‘because it [the Committee] favours a principle of qualified parental decision-making with respect to the use of the technique the technique should not be available where the intended tissue recipient is a parent.’ (Para. 3.15, original emphasis) No further justification is offered for such a condition in this paragraph, and it is necessary to search the remainder of the document in some depth to locate some indication of the Committee’s reasoning.

Paragraph 2.21 concluded with the claim that ‘it appears prima facie to be morally less acceptable than selecting an embryo to provide tissue to treat a sibling, as it seems to replace concern with another with concern for oneself.’ There are several observations that could be made regarding this assertion. Firstly, it may be seen to conflate that which is morally acceptable with that which is morally commendable. Undertaking a physically, emotionally and perhaps financially demanding process such as IVF and pregnancy in order to save the life of another may perhaps scale heights of altruism and selflessness greater than undertaking these burdens to save one’s own life. But that is not to say that the latter course of action is morally unacceptable. To make out the case for moral unacceptability, the Committee would need to have demonstrated some aspect of the treatment that contravened some ethical principle.

Secondly, the Committee’s assessment perhaps overlooks the contribution and sacrifice of the other parent. If, for example, it had been the father who suffered from a debilitating and life-threatening condition requiring stem cell transfusion, and if the couple had undergone the same procedure in attempt to find a suitable donor, would the requisite element of sacrifice and altruism not have been displayed in the mother’s willingness to go through ova retrieval, embryo implantation, pregnancy and labour to save her husband?

Neither the 1990 Act nor the common law require parents to have wholly or primarily non-selfish motives when they act on behalf of their children. The parent whose selfish decision happens to coincide with his child’s interests will not have his motives scrutinised for any hint of self-interest. Why, we might ask, should such an unfeasibly high standard be set for prospective parents seeking to use PGD-HLA?

It might also be asked whether it is not invariably the case that, by the very fact of its conception and birth, a child is serving as a means to some other end? It is perhaps unlikely that any pregnancies are commenced wholly or predominantly out of beneficence towards the future child. Couples or individuals have children for a wide variety of reasons, ranging from the fulfilment of long-harboured life plans to unwelcome accidents, via myriad psychologically complicated motivations involving self-fulfilment, tradition, peer expectation, strengthening ailing relationships and a – perhaps subconscious – quest for some sort of genetic immortality. As Julian Savulescu has said:

Parents have many desires related to their children: perhaps to have a companion, to have a friend to the first child, or to hold a marriage together. It is unlikely that any parent ever desires a child solely as an end in itself. ... Provided that parents love their child as an end in itself, there is no problem with the child's life also fulfilling some of the parents’ desires for their own lives. (Savulescu, 1999, p373.)

It is also entirely common to hear parents citing a desire for companionship for an existing child as a reason.

Whatever the precise reasoning, however, the fact that a couple want to be genetic parents is a selfish, or at best a mixed, motive, just as surely as the fact that one of them needs a donation of stem cells. It may be that in other times and in other societies, couples greeted the news of pregnancy with a stoical acceptance that they were fulfilling an unhappy duty, but it would be difficult to see this as a preferable state of affairs to that wherein the forthcoming birth of a child is seen as a joyous event for all concerned. For the most part, we want parents to satisfy their own wants and ambitions when bringing a child into the world. Of course, if these wants and ambitions were likely to harm the child once it is existence – if the child was wanted as a slave or a sacrifice, for example - that might be problematic. But the mere fact that the creation of a life symbiotically benefits the parents is not only accepted, but is for the most part expected and welcomed.

Considered through the lens of the welfare of the future child, what the Hashmis sought to do was unproblematic, for precisely the reasons identified by Derek Parfit and discussed earlier in this article. But even for those concerned about such children ‘being treated as an end in oneself and not merely a means’, it is far from clear that the putative Hashmi child would be so treated; provided it is treated with respect, dignity and compassion once it is born, the categorical imperative is satisfied in its regard. Furthermore, I submit, this would be so whether the intended recipient of the transplant is a sibling, a parent, or any other third party.

Whether the parents are motivated by altruistic concern for other children, or selfish concern for their own health, they are nonetheless viewing the new child as a means to some other end. But provided they do not view it, and more importantly do not treat it, only as a means, they have not violated its interest in being treated with respect.

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8. The Whitaker case: an arbitrary distinction?

The Quintavalle challenge, then, demonstrated that the Court of Appeal was content to entrust to the HFEA the responsibility for ensuring that PGD is used only in ‘appropriate’ circumstances. The manner in which this task is being carried out has, I submit, been cast into doubt by the apparent ethical confusion underlying the conditions attached to the decision about HLA tissue typing. Even greater reason for dissatisfaction lies in the Authority’s handling of the next application for a licence to carry out tissue typing.

Charlie Whitaker suffered from Diamond Blackfan Anaemia (DBA), a rare blood disorder requiring day-long blood transfusions. In that the condition is painful, debilitating and impossible to cure without transfusion, it is analogous to Zain Hashmi’s thalassaemia. The distinction, upon which the HFEA placed so much reliance, is that DBA is rarely a hereditary condition; indeed, tests of Charlie’s parents, Michelle and Jayson Whitaker, revealed that they were not carriers, and that Charlie’s condition was attributable to a spontaneous mutation.

As already noted, the Joint Working Party’s Recommendation 11 restricted PGD to cases where the embryo being screened was itself at significant risk of developing a particular genetic condition. While the future Hashmi child satisfied this criterion – both Shahana and Raj Hashmi being asymptomatic carriers - any future child the Whitakers may have would be at no greater than average risk of developing DBA. The terms of the Recommendation, therefore, would not be satisfied in the latter case.

However, the HFEA Ethics Committee, charged specifically with the role of considering the ethics of HLA tissue-typing, reached an entirely different conclusion. Paragraph 3.14 of the Committee’s Report addressed precisely the scenario in which the Whitakers found themselves, and recommended that PGD should be available in those circumstances. In announcing in August 2002 that the Whitakers would be denied access to PGD for tissue-typing only, the HFEA acted against the recommendation of its own Ethics Committee in this matter. While it is of course free to do so, it is difficult to discern what ethical or legal basis the HFEA was relying on when it made this decision.

The ethical approach

The Minutes of the first HFEA meeting after the Ethics Committee’s Report contain only a fairly cursory discussion of the issue:

Members felt that to allow PGD for tissue typing alone would run contrary to the requirements of the welfare of the child assessment. Therefore, it was agreed that tissue typing using PGD should only be offered where PGD was already necessary to avoid the passing on of a serious genetic disorder. (HFEA, 2001b)

As discussed earlier, the Ethics Committee had in fact identified the ‘putative child’s actual moral, psychological, social and physical welfare’ as an issue of great significance. (Ethics Committee, 2001) Its Report considered both a fairly traditional formulation of the ‘welfare principle’, asking ‘whether the outcome of the technique adversely shifts the balance of benefit and harm’, (at Para. 2.14) together with a more unusual formulation where the Committee considered the proposition that:

It could be suggested that positive consideration of the welfare of the child requires respect for beings as ends and that the putative child be treated not merely as a means to a further end but also as an “end in itself”. (at Para. 2.9)

It is unclear which of these concepts of ‘welfare’ the HFEA felt to be compromised by the Whitakers’ application. The first version, concerned with the prospect of harm to the future child, seems to be answerable in terms of Parfit’s Non-Identity Principle in exactly the same manner as in the Hashmi scenario. Unless we can predict with confidence that either child will suffer a net balance of harms over benefits as a result of its existence, it is impossible to conclude that the very fact of its creation constitutes a harm to it.

Had the HFEA contended that the Whitakers would be likely to neglect or abuse the new child, regarding it literally as an instrument to save Charlie’s life, to be tossed aside when that end was attained, then there may have been a case to answer. As far as can be ascertained from the Minutes of the November meeting, however, the HFEA at no point seriously considered the possibility that the new child would be treated in a manner likely to give rise to such concerns.

The only indication of the thinking that led the HFEA to conclude that the future child’s welfare would be compromised lies in the Minutes’ brief reference to ‘the psychological burden that may be placed on a child who was an “engineered” match as opposed to a ‘natural’ match.’ (HFEA, 2001b) The terminology used here might be considered imprecise and unfortunate. The Whitakers did not seek to alter the genetic makeup of their future child, as the term ‘engineered’ is ordinarily thought to denote. If the distinction the HFEA sought to address was between a ‘selected’ match as opposed to a ‘randomly occurring’ match, then it is not apparent how the former child would be at a disadvantage. In both cases, there will be an expectation that the child will act as a donor.

Similarly, the second of the Ethics Committee’s conceptions of ‘welfare’ seems ill-suited to distinguish between the Hashmis case and that of the Whitakers. The concern that the putative child be considered ‘not merely as a means to a further end but also as an “end in itself”’ reflects the widely recognised Kantian principle that requires that we regard the new child as an end in itself, taking account of its interests and rights, and not merely as an instrument of someone else’s welfare.

As discussed earlier in this article, such a principle may – although by no means uncontroversially – be accommodated within a consideration of the welfare of the future child. However, as explained above, it is by no means clear that the creation of a child to serve as a donor violates this principle – provided that child is treated with the dignity and respect due to an individual, then it has not been treated solely as a means. Furthermore, it is far from clear how it serves to distinguish the two cases. Both families sought to have a new child, and to use PGD to select that child, at least partly for the good of an existing child. Even if we were to accept that ‘first phase’ PGD, for disease screening, was in the interests of that future child (a conclusion that is difficult, if not impossible, to reconcile with the Non-Identity Principle), it is surely the case that in both scenarios, the use of ‘second phase’ screening, for HLA tissue-typing, was sought exclusively for the benefit of another party. If the HFEA’s concern is with preventing embryos being screened wholly for the benefit of someone else, then it is difficult to see how it was any more justified for the Hashmis than for the Whitakers.

While medico-legal academics may have hoped that the Whitakers would contest the HFEA’s refusal through the courts, affording us the opportunity to ascertain judicial views on the validity of the distinction upon which the Authority relied, the Whitakers availed themselves of a different option. Instead of investing money and time in a potentially fruitless challenge to the obstacles facing them in the UK, they opted instead to travel to the USA, where no such regulatory difficulties presented themselves. In June 2003, after treatment in the Chicago Reproductive Genetics Institute, Michelle Whitaker gave birth to Jamie, a healthy son whose stem cells could be used to treat his brother Charlie. (Dobson, 2003) It is a somewhat ironic facet of the tale that the Hashmis, whose efforts to conceive a donor child were supported by the HFEA and the courts, have as yet been unable to do so.

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8. Conclusion

The Court of Appeal’s decision in the Quintavalle case, and in particular its recognition that non-pathological factors could be considered as suitable matters for ‘treatment’ in terms of the 1990 Act, could be seen to have lent a wide margin of discretion to the HFEA in terms of granting licences for PGD. The manner in which the Authority has exercised this discretion, however, has afforded little room for optimism in terms of ethical coherence or consistency. While the ethical principles identified by the Authority and its Ethics Committee – concerning the welfare of the child, and the Kantian requirement that it be treated as an end and not merely a means – are respectable and widely recognised, they have been applied in a manner that suggests only a superficial understanding of their implications. In particular, although the welfare of the child figures prominently in these discussions, at no point is the Non-Identity Principle explicitly considered, nor does it appear to influence the eventual decisions at which they arrived.

The categorical imperative (or more specifically that variation thereof that requires that all individuals be treated not merely as means but also as ends in themselves) was applied with apparent lack of rigour, and a marked lack of consistency can be discerned from the manner in which it was applied to the various permutations of circumstances that might arise. It is, I have argued, by no means certain that creating a child to serve as a tissue donor violates that imperative; certainly, the interpretation of the principle adopted by Alan Donagan, one of its most influential proponents, seems almost to suggest the very opposite.

However, even if the view is taken that creating a child with the principal motive of having it serve as a tissue donor does in fact amount to a contravention of the Kantian imperative, and even if it is accepted that this in turn amounts to harming the child, it is by no means obvious how this provides a valid ground to distinguish between the (a) Hashmi scenario, (b) the Whitaker scenario, and (c) scenario where the intended recipient is a parent. In all three cases, the child is being created to serve as a donor, and in all three cases Phase 2 screening is being carried out precisely for that end. Either the Kantian imperative is violated by none of these – as I suggest – or it is violated by all three. That being so, the decisions and rules arrived at by the HFEA certainly seem arbitrary, and it may not even be unduly cynical to suggest that they are motivated more by a desire to maintain an appearance of control - in the face of Select Committee criticism and media concern about ‘designer babies’ – than about legitimate concern for the ‘welfare’ of the resulting child. If, as the Court of Appeal’s decision in Hashmi seems to suggest, it is the HFEA rather than the courts that is to be entrusted with regulating PGD, then it is incumbent upon that body to arrive at more carefully reasoned, and consistent, rules and decisions.

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Bibliography

Ethics Committee of the Human Fertilisation and Embryology Authority, (2001), Ethical Issues in the Creation and Selection of Preimplantation Embryos to Produce Tissue Donors, 22 November 2001

Joint Working Group of the HFEA and Human Genetics Commission (2001), Outcome of the Public Consultation on Preimplantation Genetic Diagnosis, November 2001

Human Fertilisation and Embryology Authority (2001a), Press Release, 13 December 2001, ‘HFEA to allow tissue typing in conjunction with preimplantation genetic diagnosis’ (HFEA, 2001a)

Human Fertilisation and Embryology Authority,(2001b): A Summary of the One Hundred and Thirteenth Meeting of the Human Fertilisation and Embryology Authority on 29th November 2001, at http://www.hfea.gov.uk/AboutHFEA/AuthorityMinutes/2001/November2001

Berkowitz, Jonathan M., Snyder, Jack W. (1998): ‘Racism and Sexism in Medically Assisted Conception’, Bioethics; 12(1): 25-44

Dobson, R (2003): ‘“Saviour sibling” is born after embryo selection in the United States’, British Medical Journal, 326:1416 (28June).

Donagan, A (1977): The Theory of Morality, Chicago, University of Chicago Press

Dyer, C. (2002): ‘Watchdog approves embryo selection to treat 3 year old child.’ British Medical Journal; 324: 503

Glannon, W. (2001): Genes and Future People: Philosophical Issues in Human Genetics, Oxford, Westview Press, 2001

Lennard, A. L., Jackson, G. H. (2000) ‘Stem cell transplantation’. British Medical Journal; 321: 433-437

Lucarelli, G., Andreani, M., Angelucci, E. (2001) ‘The cure of thalassemia with bone marrow transplantation’ Bone Marrow Transplantation; 28: S11-3.

Savulescu, Julian (1999). ‘Sex selection: the case for’, Medical Journal of Australia; 171(7): 373-375



(1) See, for example, ‘Why Mr and Mrs Hashmi were right to choose life’, Independent on Sunday, 24 February 2002; ‘The virtue of IVF’, The Observer, 24 February 2002
(2) The Quintavalle family were by this point no strangers to the English civil courts, Mrs Quintavalle’s son, Bruno, having already attained prominence by challenging – initially successfully, although he ultimately lost on appeal to the House of Lords - the efficacy of the 1990 Act in prohibiting human cloning (R. (on the application of Quintavalle) v Secretary of State for Health (2002) 63 B.M.L.R. 167, (2003) 71 BMLR 209). It is interesting to speculate on the extent to which the courts are likely to replace the legislature as the primary forum within which bioethical disputes will be played out.
(3) ‘PGD is purely and simply another example of modern eugenics, practised ever earlier on developing human life. ... With PGD the purpose of diagnosis is simply to identify who should be killed.  Neither for the disabled baby in the womb, nor for the disabled embryo do you offer any choice but the final solution - death. ’ From CORE’s Response to Human Fertilisation and Embryology Authority/ Advisory Committee on Genetic Testing Consultation Document on Preimplantation Genetic Diagnosis, available at http://www.corethics.org/document.asp?id=fresponse.htm&se=3&st=5
(4) See also the judgment of Lord Justice Mance at p.283.
(5) Including, inter alia, placing a non-human embryo in a human, or vice versa; keeping an embryo after the appearance of the primitive streak, and cell nuclear replacement.


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