Judgments - Quintavalle v Human Fertilisation and Embryology Authority

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    34.  Lord Brennan and Mr Pannick each relied upon different statements made by ministers in Parliament during the debates on the Bill which became the 1990 Act. As is almost invariably the case when such statements are tendered under the rule in Pepper v Hart [1993] AC 593, I found neither of any assistance.

    35.  I would therefore accept Mr Pannick's argument and hold that both PGD and HLA typing could lawfully be authorised by the authority as activities to determine the suitability of the embryo for implantation within the meaning of paragraph 1(1)(d).

    36.  Lord Brennan made some criticism of the way in which the authority had from time to time stated its policy and relaxed some of the conditions upon which licences were granted. For example, the authority originally gave a licence for HLA typing only if the cell biopsy was also required for PGD, because it considered that the risk to the embryo from removal of a cell did not warrant it being done for HLA typing alone. More recently, after further study of the effects of a cell biopsy, it has decided that the risk is low enough to justify a licence for HLA typing alone. That seems to me exactly in accordance with the duty of the authority to keep the state of the art under constant review.

    37.  Another point on which the authority has shifted its position is the use of bone marrow rather than umbilical cord blood as a source of stem cells. Bone marrow may in some cases be more suitable but involves a far more intrusive operation upon the donor child than taking cord blood. The policy formulated by the authority in 2001 (under which the licence which authorised the treatment of Mrs Hashmi was granted) required a condition that "the intention" should be only to take cord blood. After a review in 2004, the authority decided to delete this condition. It was in practice unenforceable because once the embryo had been implanted and the child conceived, the case passed out of the jurisdiction of the authority. On 21 July 2004 the authority endorsed with amendment the following recommendation of its Ethics and Legal Committee:

    "It was acknowledged that the HFEA did not have any power to impose a condition that would prohibit any future attempt to obtain bone marrow. However the committee noted that obtaining bone marrow for the treatment of siblings from children from the age of one year was a relatively routine treatment strategy where no other matched donor was available. The committee also noted that under common law the test for the type of medical procedures that may be performed on a child is very much higher when such treatment is non-therapeutic. Although parents usually give consent to a child's medical treatment, the courts always have the power to overrule their consent where the procedure would not be in the child's best interests."

    38.  These reasons appear to be valid. I have no doubt that medical practitioners take very seriously the law that any operation upon a child for which there is no clinical reason relating to the child itself must be justified as being for other reasons in the child's best interests. If the question appears to be doubtful, a ruling from the court may be obtained. The authority is in my opinion entitled to assume that a child conceived pursuant to its licence will, after birth, receive the full protection of the law.

    39.  In my opinion, however, it is unnecessary to express any view about Lord Brennan's criticisms of the way the authority has exercised its jurisdiction. There has never been any suggestion that the authority acted unreasonably in granting a licence. The case has always been that it had no power to do so. In my opinion it did, and I would therefore dismiss the appeal.

LORD SCOTT OF FOSCOTE

My Lords,

    40.  I have had the advantage of reading in draft the opinions of my noble and learned friends Lord Hoffmann and Lord Brown of Eaton-under-Heywood. For the reasons they have given I, too, would dismiss the appeal.

LORD WALKER OF GESTINGTHORPE

My Lords,

    41.  I have had the privilege of reading in draft the opinions of my noble and learned friends Lord Hoffmann and Lord Brown of Eaton-under-Heywood. I am in full agreement with them and for the reasons given by Lord Hoffmann and Lord Brown I too would dismiss this appeal.

LORD BROWN OF EATON-UNDER-HEYWOOD

My Lords,

    42.  This case is all about the scope of a power, not about its exercise. The important, but limited, question it raises is whether the Human Fertilisation and Embryology Authority ("the authority"), created by the Human Fertilisation and Embryology Act 1990 ("the 1990 Act"), is empowered by the 1990 Act to license tissue typing, a process by which embryonic cells are tested for their compatibility with the tissue of a sick sibling with a view to planting a compatible embryo into the mother's womb and the eventual treatment of the sibling with blood from the baby's umbilical cord (or, failing that, with bone marrow to be taken when the newborn child is older).

    43.  The ethical questions raised by such a process are, it need hardly be stated, profound. Should genetic testing be used to enable a choice to be made between a number of healthy embryos, a choice based on the selection of certain preferred genetic characteristics? Is it acceptable to follow a procedure resulting in the birth of a child designed to secure the health of a sibling and necessarily therefore intended to donate tissue (including perhaps bone marrow) to that sibling? Is this straying into the field of "designer babies" or, as the celebrated geneticist, Lord Winston, has put it, "treating the offspring to be born as a commodity?" These are just some of the questions prompted by this litigation. But troubling though such questions are, the arguments are certainly not all one way, as may be demonstrated by the facts of this very case.

    44.  Mr and Mrs Hashmi's fourth child, Zain, has a serious blood disorder, beta thalassaemia major. His condition is wretched, his prospects uncertain. His best chance of a cure is by a transplant of stem cells from someone with matching tissue. Since none of the three elder siblings have matching tissue, Mrs Hashmi decided to have a fifth child in the hope that its tissue would match Zain's. Having conceived, she discovered from pre-natal testing that that child too would have beta thalassaemia major and so she underwent an abortion. She conceived again and a healthy son was born, but unfortunately his tissue did not match Zain's. It was at this point that Mrs Hashmi, contemplating a sixth child, began investigating the possibilities of IVF treatment and eventually, with medical advice, sought to benefit from a licence under the 1990 Act.

    45.  The licence was granted by the authority on 22 February 2002. It was made subject to conditions which the authority had laid down on 13 December 2001 when announcing a policy decision to permit tissue typing in cases where pre-implantation genetic diagnosis ("PGD") was already necessary to avoid passing on a serious genetic disorder. Included amongst the conditions were that the sick sibling's condition should be severe or life threatening, of a sufficient seriousness to justify the use of PGD; that the embryos should themselves be at risk of that condition; that all other possibilities of treatment and sources of tissue for the sick sibling should have been explored; that the technique should not be available where the intended recipient is a parent; and that the intention should be to take only cord blood for the purposes of the treatment.

    46.  True it is that since that December 2001 policy decision the authority has contemplated licensing tissue typing on a less restricted basis: first, in cases where there is no need for PGD; secondly, where the intention is if necessary to use bone marrow and not just blood from the abdominal cord; and thirdly, where a parent rather than a sibling is to be benefited. All this, however, goes only to emphasise the comparative narrowness of the issue presently before the House. Your Lordships are simply not concerned with the conditions under which tissue testing should be licensed, assuming it is licensable at all—nor even, indeed, with whether it should be licensed. Your Lordships' sole concern is whether the Act allows the authority to license tissue typing were it in its discretion to think it right to do so.

    47.  IVF treatment is a fast moving medical science. It is clear that when the 1990 Act was passed PGD was expressly foreseen but tissue typing was not. It is your Lordships' task to decide whether by the 1990 Act, Parliament was conferring power upon the newly created authority to take whatever decisions arose from such unforeseen possibilities as tissue typing, or whether Parliament must rather have been contemplating the need for further primary legislation to deal with whatever ethical questions arose out of such future discoveries.

    48.  Whether or not the authority is empowered to license tissue typing ultimately depends on the true construction of two particular provisions in the 1990 Act, section 2(1) and paragraph 1(1)(d) of Schedule 2. It is convenient at once to set these out (italicising the most important words) and also section 11(1), their immediate statutory context:

    Section 11(1) provides:

    "The authority may grant the following and no other licences—(a) licences under paragraph 1 of Schedule 2 to this Act authorising activities in the course of providing treatment services . . .".

    Section 2(1) provides:

    "In this Act . . . 'treatment services' means medical, surgical or obstetric services provided to the public or a section of the public for the purpose of assisting women to carry children."

    Paragraph 1 of Schedule 2 provides:

    "(1) A licence under this paragraph may authorise any of the following in the course of providing treatment services— … (d) practices designed to secure that embryos are in a suitable condition to be placed in a woman or to determine whether embryos are suitable for that purpose

    . . .

    (3) A licence under this paragraph cannot authorise any activity unless it appears to the authority to be necessary or desirable for the purpose of providing treatment services."

    49.  The critical question, therefore, put compendiously, is whether tissue testing is a practice designed to determine whether an embryo is suitable for placing in a woman (para 1(1)(d)) and necessary or desirable for the purpose of providing a medical service which itself is to assist a woman to carry the child (section 2(1)). Putting the matter quite simply at this stage, there are essentially three possible answers to this question. First, 'no' because the only embryo testing permitted by these provisions is PGD insofar as that is necessary to ensure that the woman can carry the child successfully to full term—in other words embryonic screening to eliminate just such genetic defects as may affect the viability of the foetus and no other. Second, 'no' because, whilst the 1990 Act allows PGD screening to eliminate gene and chromosome defects such as may affect that child (or be carried by that child to future generations), it does not permit tissue typing. Third, 'yes' because tissue typing also can be licensed: like PGD screening, it provides information about the characteristics of the embryo which is relevant to the woman's decision whether or not to carry the child.

    50.  No one now is contending for the first of those three possible meanings (although it was the meaning adopted by Maurice Kay J at first instance). The appellants contend for the second; the respondent authority and the Secretary of State for Health as intervener contend for the third (the meaning preferred by the Court of Appeal).

    51.  Initially, I confess to having found some considerable force in the appellant's argument that PGD screening is one thing, and properly licensable under the 1990 Act, tissue typing a completely different concept and impermissible. It is one thing to enable a woman to conceive and bear a child which will itself be free of genetic abnormality; quite another to bear a child specifically selected for the purpose of treating someone else. One can read into the statutory purpose specified by section 2(1), that of "assisting women to carry children", the notion of healthy children—only a genetically healthy embryo being "suitable" for placing in the woman within the meaning of paragraph 1(1)(d). To read into section 2(1), however, the notion that the child will be a suitable future donor for the health of another would be to stretch the statutory language too far. And it may be said to raise ethical questions of a quite different order from those arising out of straightforward PGD screening.

    52.  By the end of the argument, however, I had come to the conclusion that Mr Pannick QC's contended for construction of the 1990 Act is to be preferred. My reasons for this conclusion can be grouped under three headings and, since I have now had the advantage of reading in draft the speech of my noble and learned friend, Lord Hoffmann, can be comparatively shortly stated.

The background to the 1990 Act

    53.  I pass over the Warnock Report, pausing only to note that in Chapter 9, headed "The wider use of these techniques" ("Techniques for the alleviation of infertility"), the committee, at paragraph 9.11, expressly envisaged the future possibility of sex selection "for purely social reasons" and concluded that "the whole question of the acceptability of sex selection should be kept under review"—review which inferentially was to be undertaken by a proposed new statutory licensing authority established "to regulate and monitor practice in relation to those sensitive areas which raise fundamental ethical questions." (paragraph 13.3). The White Paper which followed the Warnock Report, Human Fertilisation and Embryology: A Framework for Legislation (1987) (Cm 259), proposed at paragraph 14:

    "To ensure that the legislation is flexible enough to deal with as yet unforeseen treatment developments which may raise new ethical issues, the Bill will contain powers to make regulations (subject to the affirmative resolution procedure) to add to or subtract from the range of matters coming within the regulatory scope of [the authority]."

The scheme and structure of the 1990 Act

    54.  Certain activities in connection with embryos are expressly prohibited—see sections 3, 3A (a prohibition in connection with germ cells introduced by section 156 of the Criminal Justice and Public Order Act 1994), section 4, and paragraph 1(4) of Schedule 2.

    55.  Consistently with paragraph 14 of the White Paper, there is power to make regulations (subject to affirmative resolution) both to add to the range of matters coming within the authority's regulatory scope—see paragraph 1(1)(g) of Schedule 2 enabling regulations to be made for the licensing of other practices in the course of providing treatment services—and to subtract from the licensing powers already conferred on the authority—see section 3(3)(c) which enables regulations to be made prohibiting the keeping or use of an embryo in such circumstances as may be specified.

    56.  This legislative scheme necessarily contemplates that the only fresh practices arising out of unforeseen treatment developments capable of becoming licensable by regulation under paragraph 1(1)(g) will themselves have to be characterisable as being "in the course of," and "necessary or desirable for the purpose of," providing treatment services, which itself argues for a wide construction to be given to the definition of "treatment services" in section 2(1). The scheme also, of course, enables section 3(3)(c) regulations to be made restricting the authority's powers if ever it were thought to be dealing inappropriately with the "new ethical issues" arising out of the "as yet unforeseen treatment developments" contemplated by the White Paper.

    57.  Lord Brennan QC sought to rely on the interpretative guidance provided by Lord Wilberforce in Royal College of Nursing of the United Kingdom v Department of Health and Social Security [1981] AC 800, 822, particularly with regard to legislation "dealing with a controversial subject involving moral and social judgments on which opinions strongly differ", as applied by Lord Bingham of Cornhill in R (Quintavalle) v Secretary of State for Health [2003] 2 AC 687. There Lord Bingham observed (p 697) that the 1990 Act, besides

    "outlaw[ing] certain grotesque possibilities (such as placing a live animal embryo in a woman or a live human embryo in an animal), . . . otherwise opted for a strict regime of control. No activity within this field was left unregulated. There was to be no free for all."

    58.  There is no inconsistency however, between that approach and the authority's stance in the present case. There it led to a newly discovered method of creating embryos being held to fall within the scope of regulatory control under the 1990 Act. So too here, the respondent's case is that tissue testing is controlled by the 1990 Act. It is not "left unregulated." There will be "no free for all." Rather the licensing of this new technique is for the discretion of the authority.

The true construction of section 2(1) and paragraph 1(1)(d)

    59.  I have already described (in para 49) the three possible meanings to be ascribed to section 2(1) and paragraph 1(1)(d) and the rival positions now taken by the respective parties.

    60.  The strength of Lord Brennan's case lies in the lengths to which Mr Pannick's argument necessarily takes him. Mr Pannick argues that PGD screening assists a woman to carry a child   because it gives her the knowledge that the child will not be born handicapped. Without such knowledge some women who carry genetic diseases would not be prepared to have children. In the   same way, he argues, tissue typing would assist Mrs Hashmi to carry a child because her wish to do so is conditional upon knowing that the birth of that child would be capable of curing Zain. As, however, Mr Pannick was bound to accept, under this reasoning PGD to ensure that a child had certain characteristics for purely social reasons could also be said to be "for the purpose of assisting women to carry children." (It is of course his case, supported by Mr Eadie for the Secretary of State, that it is for the authority to control PGD so as to ensure that it is not used for such ethically objectionable purposes.)

    61.  That consequence of the respondent's argument, I repeat, may be seen as the strength of the appellant's case. Its weakness, however, lies in the difficulty Lord Brennan himself has in establishing a satisfactory and coherent dividing line between embryo selection which is permissible and that which is not—let alone finding support for any such dividing line in the 1990 Act. As already stated, I was at one time attracted to Lord Brennan's dividing line between selection aimed purely at eliminating serious genetic or chromosome defects (permissible) and other selective criteria (impermissible). As, however, Lord Hoffmann points out at para 27 of his speech, what amounts to a serious genetic defect will itself often be contentious. Still less can one find in the statutory language any basis for saying that the elimination of serious genetic or chromosome defects contributes to the process of "assisting women to carry children" whereas other embryo selection does not.

    62.  The fact is that once the concession is made (as necessarily it had to be) that PGD itself is licensable to produce not just a viable foetus but a genetically healthy child, there can be no logical basis for construing the authority's power to end at that point. PGD with a view to producing a healthy child assists a woman to carry a child only in the sense that it helps her decide whether the embryo is "suitable" and whether she will bear the child. Whereas, however, suitability is for the woman, the limits of permissible embryo selection are for the authority. In the unlikely event that the authority were to propose licensing genetic selection for purely social reasons, Parliament would surely act at once to remove that possibility, doubtless using for the purpose the regulation making power under section 3(3)(c). Failing that, in an extreme case the court's supervisory jurisdiction could be invoked.

    

 
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