R Quintavalle v Human Fertilisation and Embryology Authority Appellant
| Jurisdiction | England & Wales |
| Judge | Lord Phillips, MR,Lord Justice Schiemann,Lord Justice Mance |
| Judgment Date | 16 May 2003 |
| Neutral Citation | [2003] EWCA Civ 667 |
| Docket Number | Case No: C1/2003/0101 |
| Court | Court of Appeal (Civil Division) |
| Date | 16 May 2003 |
IN THE SUPREME COURT OF JUDICATURE
COURT OF APPEAL (CIVIL DIVISION)
ADMINISTRATIVE COURT AND DIVISIONAL COURT
The Hon Mr Justice Maurice Kay
ON APPEAL FROM QUEEN'S BENCH DIVISION
Lord Phillips Of Worth Matravers, Mr
Lord Justice Schiemann and
Lord Justice Mance
Case No: C1/2003/0101
David Pannick QC and Dinah Rose (instructed by Messrs Morgan Cole) for the Appellant
James Dingemans QC and Martin Chamberlain (instructed by Messrs Coningsbys) for the Respondent
James Eadie (instructed by Department of Work and Pensions) for the Secretary of State for Health as Intervener
Mr and Mrs Hashmi have five children. The fourth, a son Zain was born with a blood disorder known as beta thalassaemia major. By the time that he was 2 1/2 years old this had reduced him to a parlous condition, requiring him to take a daily cocktail of drugs and to submit to regular blood transfusions in hospital in order to remain alive. His life expectancy is uncertain. Mrs Hashmi had been aware that she had a genetic predisposition to producing children with this disorder and, when pregnant with Zain had undergone prenatal testing to see whether, if she carried Zain to term, he would be born with the disorder. The test failed to disclose that this was indeed the position.
Zain's condition might be cured by a transplant of stem cells from someone with matching tissue. The stem cells could be supplied from blood taken from the umbilical cord of a new born child, or from bone marrow. The most likely source of matching tissue would be a sibling, for statistically Mrs Hashmi has one chance in four of producing a child with matching tissue, although the odds are somewhat longer of producing such a child who is not affected with beta thalassaemia major. None of Zain's three elder siblings have tissue that matches his.
Mrs Hashmi resolved to have another child, in the hope that it would have matching tissue. She conceived, but prenatal testing showed that the child would have beta thalassaemia major, so she underwent an abortion. She conceived again, and a healthy son was born, but unfortunately his tissue did not match that of Zain.
At this point Mrs Hashmi met Dr Simon Fishel, the Managing and Scientific Director of Centres for Assisted Reproduction Limited ('CARE'). CARE is the largest single provider of in vitro fertilisation ('IVF') services in the United Kingdom. It provides these services at various locations both to NHS and private patients. Dr Fishel told Mrs Hashmi of a procedure, at the cutting edge of technology, that had been developed at the Reproductive Genetics Institute ('RGI') in Chicago in the United States and which might provide the solution to her problem. In summary, that procedure would include the following stages:
i) The fertilisation 'in vitro' ('IVF') of a number of eggs taken from Mrs Hashmi with sperm taken from her husband to form embryos.
ii) The removal from the developing embryo of a single cell by a biopsy.
iii) The examination of that cell using molecular genetics to see whether the embryo carried the beta thalassaemia disease. This process is commonly described as 'Pre-implantation Genetic Diagnosis ['PGD'].
iv) Use simultaneously of the same process to identify whether the embryo had the same tissue type as Zain. Because this process involves examination of proteins known as human leukocyte antigens ('HLA'), this form of PGD is described as 'HLA typing'. I shall refer to it by the more popular phrase of 'tissue typing'.
v) Jettison of embryos found by this analysis to be either disease bearing or of a different HLA type to Zain and implantation in the womb of Mrs H of an embryo shown to be disease free and of the same HLA as Zain.
Mrs Hashmi asked Dr Fishel whether it would be possible for her to be impregnated in this country with an embryo created and selected in this way. IVF treatment can only be carried out in this country under licence issued by the appellant ('HFEA') pursuant to the Human Fertilisation and Embryology Act 1990 ('the Act'). For some years PGD screening against genetic disease had been carried out as part of IVF treatment licensed by the HFEA. Tissue typing had never, however, been carried out as part of such treatment and Dr Fishel considered that this procedure required express authorisation under licence from HFEA. After careful consideration of the implications, CARE applied to the HFEA for a ruling as to whether an IVF clinic could properly apply for a licence to administer treatment including tissue typing.
The HFEA announced their decision in a press release on 13 December 2001. They would be prepared in principle to grant a licence for treatment that included tissue typing, subject to a number of conditions. The HFEA decided that tissue typing should only be permitted where PGD was already necessary to avoid the passing on of a serious genetic disorder. They also decided that licences permitting PGD in conjunction with tissue typing should only be granted on a case by case basis. Such licences would only be granted subject to the following conditions:
a) The condition of the affected child should be severe or life threatening, of a sufficient seriousness to justify the use of PGD
b) The embryos should themselves be at risk of the condition affecting the child
c) All other possibilities of treatment and sources of tissue for the affected child should have been explored
d) The techniques should not be available where the intended recipient is a parent
e) The intention should be to take only cord blood for the purposes of the treatment
f) Appropriate counselling should be given to the parents
g) Families should be encouraged to take part in follow-up studies
h) Embryos should not be genetically modified to provide a tissue match
In accordance with this decision, on 22 February 2002, the HFEA granted a licence to Park Hospital operated by CARE in Nottingham to carry out IVF treatment that included PGD for 'beta thalassaemia in conjunction with HLA typing for patients known as Mr and Mrs H'.
Mr and Mrs Hashmi then made two attempts to produce a child by IVF treatment involving PGD and tissue typing. In the first IVF was effected at Park Hospital. 15 embryos were produced. The biopsied cells from those were then flown to RGI in Chicago for genetic analysis, while the embryos were frozen awaiting the results. Only one embryo proved to have an exact tissue match, but it carried the beta thalassaemia disease. Mr and Mrs Hashmi travelled to RGI for the second attempt. 10 embryos were produced. Two of these proved disease free and to have a tissue match with Zain. One was implanted in Mrs Hashmi, but no pregnancy resulted.
Mr and Mrs Hashmi were prevented from a further attempt by the judgment that is the subject of this appeal.
The science involved
Dr Fishel in his witness statement described how PGD in conjunction with tissue typing is carried out by the RGI. There is no need to attempt to describe the entire process; it suffices to identify the following two stages.
i) About 3 days after in vitro fertilisation, when the embryo has sub-divided into 8 cells, one of these cells is removed by a biopsy.
ii) The genetic material in the cell is then tested with a genetic probe, the DNA sequence of which has been so prepared as to identify whether there is a tissue match and whether the embryonic tissue contains any form of thalassaemia disease.
The Challenge
The Respondent, Josephine Quintavalle, acts on behalf of Comment on Reproductive Ethics ('CORE'). CORE is a group whose purpose is 'to focus and facilitate debate on ethical issues arising from human reproduction and, in particular, assisted reproduction'. Absolute respect for the human embryo is a principal tenet of CORE. The respondent sought and obtained permission to seek judicial review of the HFEA's decision announced on 13 December 2001. She challenged that decision on the ground that the HFEA had no power to issue a licence that permitted the use of HLA typing to select between healthy embryos. Her challenge succeeded. On 20 December 2002 Maurice Kay J. gave judgment in her favour, quashing the HFEA's decision.
Maurice Kay J. gave permission to appeal against his judgment to this Court because of the importance of the issue of whether tissue typing can lawfully be licensed by the HFEA. The Secretary of State for Health was concerned that the judgment has wider implications —in particular that it puts in doubt the legitimacy of the beneficial practice of PGD screening for genetic diseases. Accordingly the Secretary of State obtained permission to intervene to support the HFEA's appeal.
The Act
The 1990 Act was passed "to make provision in connection with human embryos and any subsequent development of such embryos; to prohibit certain practices in connection with embryos and gametes; to establish a Human Fertilisation and Embryology Authority", and for other purposes.
The following provisions of the Act are particularly material:
(1) 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.
Activities governed by the Act
Prohibitions in connection with embryos
(1) No person shall
(a) bring about the creation of an embryo, or
(b) keep or use an embryo,
except in pursuance of a licence.
The Human Fertilisation and Embryology Authority
(1) There shall be a body corporate called the...
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