Quintavalle v Human Fertilisation and Embryology Authority

JurisdictionUK Non-devolved
JudgeLORD BROWN OF EATON-UNDER-HEYWOOD,LORD HOFFMANN,LORD STEYN,LORD SCOTT OF FOSCOTE,LORD WALKER OF GESTINGTHORPE
Judgment Date28 April 2005
Neutral Citation[2005] UKHL 28
CourtHouse of Lords
Date28 April 2005
Quintavalle (on behalf of Comment on Reproductive Ethics)
(Appellant)
and
Human Fertilisation and Embryology Authority
(Respondents)

[2005] UKHL 28

The Appellate Committee comprised:

Lord Steyn

Lord Hoffmann

Lord Scott of Foscote

Lord Walker of Gestingthorpe

Lord Brown of Eaton-under-Heywood

HOUSE OF LORDS

LORD STEYN

My Lords,

1

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

LORD HOFFMANN

My Lords,

2

Zain Hashmi is a little boy, now aged 6, who suffers from a serious genetic disorder called beta thalassaemia major. His bone marrow does not produce enough red blood cells and in consequence he is often very poorly and needs daily drugs and regular blood transfusions to keep him alive. But he could be restored to normal life by a transplant of stem cells from a tissue compatible donor.

3

The problem is to find compatible tissue which Zain's immune system will not reject. The chances of finding a compatible donor who is not a sibling are extremely low. Even in the case of siblings, the chances are only one in four. None of Zain's three elder siblings is compatible. In addition, the donor must be free of the same disorder. That lengthens the odds even more. Zain's mother, Mrs Hashmi, has twice conceived in the hope of giving birth to a child whose umbilical blood could provide stem cells for Zain. Once the foetus was found to have beta thalassaemia major and she had an abortion. On the second occasion she gave birth to a child whose tissue turned out not to be compatible.

4

There is a way to save the Hashmi family from having to play dice with conception. For 30 years it has been possible to produce a human embryo by fertilisation of egg and sperm outside the body and then to implant that embryo in the womb. In vitro fertilisation (IVF) has enabled many couples who could not achieve natural fertilisation to have children. More recently, it has become possible to perform a biopsy upon the newly fertilised IVF embryo and remove a single cell to test it for genetic disorders. This is called pre-implantation genetic diagnosis (PGD). It provides a woman with information about the embryo proposed to be implanted in her body so that she may decide whether or not to proceed. Mrs Hashmi, for example, would have been spared having to have her foetus carrying beta thalassaemia major aborted if the embryo had been created by IVF and the disorder diagnosed by PGD.

5

Still more recently, and so far only in the United States, it has become possible to use the same single cell biopsy technique to test for tissue compatibility. This involves examination of the human leukocyte antigens (HLA) and is known as HLA typing. That means that if Mr and Mrs Hashmi's sperm and eggs are used to create IVF embryos which are then tested for beta thalassaemia major by PGD and for tissue compatibility with Zain by HLA typing, they can know that the child Mrs Hashmi conceives will have stem cells which could cure Zain. The question in this appeal is whether this can lawfully be done in the United Kingdom.

6

After the birth of the first IVF child or "test tube baby" in 1978, it became clear that the new technique, together with other potential developments in embryology and genetics, could raise serious medical and ethical issues. The government appointed a committee under the chairmanship of Dame Mary Warnock DBE to advise. It reported in 1984 (Report of the Committee of Inquiry into Human Fertilisation and Embryology (Cmnd 9314)). The centrepiece of the committee's recommendations was the creation of a statutory licensing authority to regulate all research and treatment which involved the use of IVF embryos.

7

This recommendation was given effect by the Human Fertilisation and Embryology Act 1990, which set up the Human Fertilisation and Embryology Authority ("the authority"). Members are appointed by the Secretary of State and it has to have a lay (ie not medically qualified or engaged in IVF treatment or research) chairman and deputy chairman and a majority of lay members: para 4 of Schedule 1. Members provide a broad range of experience: social, legal, managerial, religious and philosophical, as well as medical and scientific.

8

The source of the authority's power is section 3(1), which makes it a criminal offence to bring about the creation of an embryo or keep or use an embryo except pursuant to a licence from the authority. The proposed treatment of Mrs Hashmi to assist her in bearing a tissue-compatible child involves the creation and use of embryos and therefore requires a licence. In this case, the authority has granted a licence which permits both PGD and HLA typing. But Ms Quintavalle, the claimant in these proceedings, who is director and founder of a group which believes in absolute respect for the human embryo, says that the authority has no power to authorise HLA typing. She brought judicial review proceedings for a declaration to that effect. It was granted by Maurice Kay J but an appeal was allowed and the application dismissed by the Court of Appeal (Lord Phillips of Worth Matravers MR and Schiemann and Mance LJJ) [2004] QB 168.

9

Whether the authority can grant such a licence depends on the extent of its powers under the 1990 Act. Section 11 provides that the authority may grant three kinds of licences and no others. Licences must be (a) "authorising activities in the course of providing treatment services" or (b) "authorising the storage of gametes and embryos" or (c) "authorising activities for the purposes of a project of research". The specific activities which may be authorised in the course of providing treatment services or for the purposes of research are then set out in Schedule 2.

10

In this case we are particularly concerned with the activities which may be authorised to be done in the course of providing treatment services. "Treatment services" are defined by section 2(1) to mean, among other things, medical services provided to the public for the purpose of assisting women to carry children. IVF is of course such a service; the proposal is to assist Mrs Hashmi to carry a child conceived by the implantation of an IVF embryo. So the question is whether PGD and HLA typing are activities which the authority can authorise to be done "in the course" of providing her with IVF treatment.

11

To find the answer, one must look at the list of activities in para 1 of Schedule 2. Para 1(3) provides that the authority may licence an activity on the list only if it appears to the authority to be "necessary or desirable for the purpose of providing treatment services". The activities include:

"(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".

12

The authority's case is that both PGD and HLA typing are to determine whether an embryo would be suitable for the purpose of being placed in Mrs Hashmi. The definition of treatment services focuses upon the woman as the person to whom the services are provided. The authority says that Mrs Hashmi is entitled to regard an embryo as unsuitable unless it is both free of abnormality and tissue compatible with Zain. Without such testing, she cannot make an informed choice as to whether she wants the embryo placed in her body or not. The authority considers it desirable for the purpose of providing her with treatment services, ie IVF treatment, that she should be able to make such a choice. Mr Pannick QC, who appeared for the authority, pointed out that the Act does not require that PGD or HLA typing should constitute treatment services. They must be activities in the course of such services, ie in the course of providing IVF treatment.

13

The claimant, on the other hand, says that this gives far too wide a meaning to the notion of being suitable. It would enable the authority to authorise a single cell biopsy to test the embryo for whatever characteristics the mother might wish to know: whether the child would be male or female, dark or blonde, perhaps even, in time to come, intelligent or stupid. Suitable must therefore have a narrower meaning than suitable for that particular mother. Maurice Kay J thought that suitable meant only that the embryo would be viable. That would rule out a good deal of PGD, because many genetic abnormalities do not affect the viability of the foetus. The abnormality manifests itself after birth. Before your Lordships Lord Brennan QC, for the claimant, disavowed so narrow a construction. I think that he was right to do so. The narrower meaning is particularly difficult to support when paragraph 3(2)(e) lists, among the research projects which may be licensed, "developing methods for detecting the presence of gene or chromosome abnormalities in embryos before implantation." It would be very odd if Parliament contemplated research to develop techniques which could not lawfully be used. So Lord Brennan accepts that suitable means more than viable. Building on paragraph 3(2)(e), he says that an embryo is suitable if it is capable of becoming a healthy child, free of abnormalities. PGD to establish that the embryo is free from genetic abnormalities is therefore acceptable. But not HLA typing. A baby which is not tissue compatible with Zain would not be in any way abnormal. It just would not answer the particular needs of the Hashmi family.

14

"Suitable" is one of those adjectives which leaves its content to be determined entirely by context. As my noble and learned friend Lord Scott of Foscote put it in argument, a suitable hat for Royal Ascot is very different from a suitable hat for the Banbury cattle market. The context must be...

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