R (Quintavalle) v Human Fertilisation and Embryology Authority
| Jurisdiction | England & Wales |
| Judge | Mr Justice Maurice Kay |
| Judgment Date | 20 December 2002 |
| Neutral Citation | [2002] EWHC 3000 (Admin),[2002] EWHC 2785 (Admin) |
| Date | 20 December 2002 |
| Docket Number | Case No: CO/1162/02 |
| Court | Queen's Bench Division (Administrative Court) |
[2002] EWHC 2785 (Admin)
IN THE HIGH COURT OF JUSTICE
QUEENS BENCH DIVISION
ADMINISTRATIVE COURT
Royal Courts of Justice
Strand,
London, WC2A 2LL
THE HONOURABLE MR JUSTICE MAURICE KAY
Case No: CO/1162/02
Richard Gordon QC and Martin Chamberlain (instructed by Coningsbys) for the Claimant
Miss Dinah Rose (instructed by Morgan Cole) for the Defendant
1. This case is concerned with human leukocyte antigen typing, which is otherwise known as tissue typing. It is a technique which enables an embryologist to ascertain whether an embryo will produce a child whose tissue will match that of an existing person. Such a match would enable that child to act as a donor for an older sibling with a serious genetic disorder by the donation of stem cell material from the umbilical cord. The issue is whether the Human Fertilisation and Embryology (HFEA) has the power to permit tissue-typing in conjunction with pre-implantation genetic diagnosis or PGD. This technique involves three stages: (1) an in vitro embryo is permitted to develop to the 6–8 cell stage which occurs three days after fertilisation; (2) one or two cells are removed from it by the process of embryo biopsy; (3) genetic material from the extracted cells is then taken and analysed. In this way it is possible to see whether the original embryo will develop into a child with matching tissue. No one doubts that this technology is capable of producing benefits –for example, to the family whose circumstances are in evidence in this case, the child of whom suffers from beta thalassaemia major and whose best hope for a normal and longer life would be the transfer of blood stem cells from a matched sibling donor. On the other hand, nor does anyone doubt that such procedures raise serious ethical issues.
2. The HFEA was established by section 5 of the Human Fertilisation and Embryology Act 1990 (“the Act”). By section 11(1) it is empowered to grant
“the following and no other licences –
(a) licences under paragraph 1 of Schedule 2…authorising activities in the course of treatment services….”
“Treatment services” are defined in section 2(1) as
“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 –
(a) bringing about the creation of embryos in vitro,
(b) keeping embryos,
(c) using gametes,
(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.
(e) placing any embryo in a woman….
(2) Subject to the provisions of this Act, a licence under this paragraph may be granted subject to such conditions as may be specified in the licence and may authorise the performance of any of the activities referred to in sub-paragraph (1) above in such manner as may be so specified.
(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….”
I shall have to refer to other aspects of the licensing system later. The other side of the coin is what the Act prohibits. Section 3, which is headed “Prohibitions in connection with embryos”, provides:
“(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.”
3. On 13 December 2001 the HFEA issued a press release under the heading “HFEA to allow tissue typing in conjunction with pre-implantation genetic diagnosis”. It described PGD and referred to tissue typing as “an additional step whereby the embryo is simultaneously tested for its tissue compatibility with an affected sibling”. It added
“Before this technique can be used in treatment, approval will be required from an HFEA Licence Committee which will consider applications on a case-by-case basis. If licences are issued, these will be subject to strict conditions.”
4. At the time of the press release the HFEA had before it an application from a clinic for a licence to perform PGD screening for beta thalassaemia and tissue typing in relation to the family to whom I referred earlier. On 22 February 2002, the Licence Committee granted the clinic a licence in relation to (amongst other things) PGD pre-implantation genetic screening for aneuploidy, subject to many conditions, including one forbidding the use of information derived from tests on an embryo or any material removed from it to select embryos of a particular sex “for social reasons”.
5. The present application for judicial review is brought by Josephine Quintavalle on behalf of Comment on Reproductive Ethics (CORE), a group whose purpose is “to focus and facilitate debate on ethical issues arising from human reproduction and, in particular, assisted reproduction”. Its standing to bring the application was questioned by the HFEA in its Acknowledgment of Service but no point has been taken about it since Crane J granted permission to apply.
6. In a nutshell, the case for CORE is that (1) tissue typing is prohibited by section 3(1)(b) as it involves the use of an embryo but (2) it cannot be licensed under Schedule 2 because it cannot be said to arise in the course of providing “treatment services” or to be necessary or desirable for the purpose of providing “treatment services”. This is said to flow from the definition of “treatment services” as services “for the purpose of assisting women to carry children” and the fact that the purpose of tissue typing is not to assist a woman to carry a child but to relieve the suffering of another child. The case for the HFEA at the permission hearing was that tissue typing can be licensed on the basis that it is necessary or desirable for the purpose of assisting women to carry children. At the substantive hearing, that has now been relegated to an alternative submission. Now the primary submission on behalf of the HFEA is that tissue typing does not in itself require a licence because it is performed not on an embryo but on cells extracted from an embryo. However, it can be regulated by the imposition of conditions on a licence permitting PGD. In Supplementary Grounds of Opposition dated 31 July 2002 it was suggested that suitable conditions to be imposed on a licence might include (a) that no material recovered from an embryo may be subjected to a test which supplies genetic information about the embryo that is not listed in an annex to the licence or specifically approved by a licence committee in any particular case; and (b) that no embryo may be transferred to a woman where any material removed from it has been subject to a test which supplies genetic information about the embryo that is not listed in an annex or approved by a licence committee in any particular case. These conditions are among those imposed in the licence which was granted on 22 February 2002.
7. The task of the Court in this case is legal rather than ethical. That much is common ground. The task is one of statutory interpretation. As such, it is unaffected by the perceptions or changes in the perceptions of others as to what the law is or ought to be. The importance and sensitivity of the subject is illustrated by a passage in the report of the House of Commons Select Committee on Science and Technology which was published on 18 July 2002. The Committee had received evidence from Dame Ruth Deech, the then Chair of the HFEA. The report is critical of the HFEA's approach to tissue typing, saying that it “went beyond the scope of its own public consultation”. It seems, that Dame Ruth had expressed the view that it was desirable for the HFEA to take such decisions because “this protects Members of Parliament from direct involvement in that sort of thing”. The Committee replied (at para 26):
“Parliament does not need protecting and democracy is not served by unelected quangos taking decisions on behalf of Parliament.”
I include reference to this spat out of historical interest. I accept that it has no bearing on the task of statutory interpretation. Before I turn to that task, it is appropriate for me to recount a little more history.
8. In July 1982 the Committee of Inquiry into Human Fertilisation and Embryology was established to examine the social, ethical and legal implications of recent and potential developments in the field of human assisted reproduction. It was chaired by Dame Mary (now Baroness) Warnock. It reported in June 1984. Following a period of consultation, in November 1987 the Department of Health and Social Security published a White Paper, Human Fertilisation and Embryology: A Framework for Legislation. This led to the eventual enactment of the Act, the long title to which describes it as an Act
“to make provision in connection with human embryos and any subsequent development of such embryos; to prohibit certain practices in connection with embryos and genetics; to establish [the HFEA]”
Section 1(1)(a) provides that, except where otherwise stated, “embryo means a live human embryo where fertilisation is complete”.
9. In R (Quintavalle) v. Secretary of State for Health [2002] EWCA Civ 29 the primary issue was whether an organism created by cell nuclear replacement came within the definition of an embryo in section 1(1). The Court of Appeal, on the basis of a purposive construction, held that it...
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