R (Quintavalle) v Secretary of State for Health
| Jurisdiction | England & Wales |
| Judgment Date | 15 November 2001 |
| Neutral Citation | [2001] EWHC 918 (Admin) |
| Docket Number | CO/4095/2000 |
| Court | Queen's Bench Division (Administrative Court) |
| Date | 15 November 2001 |
[2001] EWHC 918 (Admin)
IN THE HIGH COURT OF JUSTICE
ADMINISTRATIVE COURT
Royal Courts of Justice
Strand,
London WC2A 2LL
Mr. Justice Crane
CO/4095/2000
Mr.Gerald Barling QC and Mr.Martin Chamberlain appeared for the Claimant.
Mr.James Eadie appeared for the Defendant.
The central issue in this application for judicial review is whether the organism created by cell nuclear replacement (“CNR”), an organism often referred to as an “embryo”, falls within the definition of “embryo” in section 1(1) of the Human Fertilisation and Embryology Act 1990. Section 1(1) reads:
“Meaning of “embryo”, “gamete” and associated expressions
“(1) In this Act, except where otherwise stated —
(a) embryo means a live human embryo where fertilisation is complete, And
(b) references to an embryo include an egg in the process of fertilisation, and, for this purpose, fertilisation is not complete until the appearance of a two cell zygote”.
It is common ground that the CNR process does not involve fertilisation. It involves a procedure commonly known as cloning. To avoid begging the question, I shall not refer to the organism created by CNR as an “embryo” in this judgement.
The history of these proceedings
In June 2000 a report was published (“the Donaldson Report”) by the Chief Medical Officer's Expert Group “reviewing the potential of developments in stem cell research and cell nuclear replacement to benefit human health”. Its principal recommendation was (at paragraph 5.10):
“Research using embryos (whether created by in vitro fertilisation or cell nuclear replacement) to increase understanding about human disease and disorders and their cell-based treatments should be permitted, subject to the controls of the Human Fertilisation and Embryology Act 1990”.
Although the Donaldson Committee did not discuss whether as a matter of law the definition in section 1(1) covered organisms produced by CNR, it is clear that this was assumed, as the recommendation implies. The assumption is further made clear by the following passage (at paragraph 4.17):
“However, although these embryos [ sc. organisms produced by CNR] differ in the method of their creation, they are undoubtedly human embryonic life, which, given the right conditions, could develop into a human being”.
The assumption is confirmed by paragraph 2.26 and Box 9 at paragraph 2.29.
In August 2000 the Government published its Response (“the Response”), accepting the recommendations. In the foreword to the Response it indicated an intention of bringing forward legislation to implement them and noted that regulations necessary to extend the purposes for which embryos may be used for research were “affirmative”. It referred to organisms produced by CNR as “embryos created by cell nuclear replacement”. The Response proceeded on the basis that these were embryos and subject to the Act.
Pro-Life describes itself as an association committed to campaigning for absolute respect for innocent human life and is opposed inter alia to human cloning. It has been permitted to make submissions in at least one previous case and there has been no objection to its standing to make the present application. In referring to the Claimant I mean Pro-Life rather than its director, whose name appears on the application.
On 7 November 2000 the Claimant applied for permission to apply for judicial review. It sought a declaration that human embryos created by CNR are not within the definition in the Act. It also sought a declaration that the Secretary of State had no power to make regulations in this connection. In fact the Human Fertilisation and Embryology (Research Purposes) Regulations 2001 were made on 24 January 2001. The Claimant does not now contend that they are ultra vires, because they merely extended the purposes for which a licence for research may be issued, without purporting to alter the definition of an “embryo”.
On 26 January 2001 the application for permission was listed for oral hearing. At the suggestion of Sullivan J. it was ordered that the application for permission and any related issues, together with the substantive hearing of the matter, be listed together. They were eventually listed before me on 31 October 2001.
Pursuant to directions the Claimant produced a set of scientific propositions, on which the Defendant commented. Expert evidence was filed on both sides: For the Claimant, Dr.Gulam Bahadur, Head of Fertility and Reproductive Medicine Laboratories at University College, London, and University College London Hospital Trust; and Professor David Prentice, Professor of Life Sciences at Indiana State University and Adjunct Professor of Medical and Molecular Genetics at Indiana University School of Medicine, USA. For the Defendants, there are statements from Professor Allan Templeton, Professor of Obstetrics and Gynaecology at the University of Aberdeen, and from Professor Ian Wilmut, Head of Gene Expression and Development at the Roslin Institute in Midlothian and an honorary Professor at Edinburgh University.
Very shortly before the hearing the Defendant indicated an intention of applying to cross-examine the Claimant's expert witnesses and to file further evidence and for the inevitable consequential adjournment. I heard those applications on the afternoon of 30 October. I refused an adjournment and did not grant the other applications, although without finally refusing them. In the event my initial view that cross-examination and further evidence were inappropriate and unnecessary was confirmed during the hearing. I have read the experts' illuminating statements with interest and noted that there are differences of opinion on some matters, but I have not identified any differences that would make it difficult for me to resolve this application. Cross-examination in judicial review cases is rare. Both these applications by the Defendant are refused.
During the course of the hearing, having heard sufficient of the arguments, I gave permission to apply for judicial review.
The matters requiring consideration are these:
(1) Should permission be refused on the ground of delay? I have already indicated that I was not refusing permission on that ground, but would give my reasons in my judgement.
(2) Has the court jurisdiction in the circumstances to grant judicial review and, if it does, should the court in its discretion exercise that jurisdiction?
(3) The central issue as already described.
(4) The Claimant has argued in the alternative that if the Defendant's contentions on the central issue are correct and hence CNR is subject to the Act, section 3(3)(d) of the Act would render CNR unlawful. The Claimant has indicated an intention to amend to seek a declaration accordingly.
Fertilisation and cell nuclear replacement
The expert evidence describes the processes in detail, but for present purposes they can be shortly described.
In the ovary the egg is a diploid germ (or reproductive) cell. It is described as “diploid” because its nucleus contains a full set of 46 chromosomes. By the process of meiotic division the nucleus divides into two parts. Only one of these, a pronucleus containing only 23 chromosomes (described as “haploid”), plays any further part in the process. Fertilisation begins when the male germ cell, the sperm, whose pronucleus contains 23 chromosomes, meets the haploid female germ cell and is a continuous process taking up to 24 hours. As part of the process the male and female pronuclei fuse to form one nucleus with a full complement of 46 chromosomes, a process known as syngamy. The one-cell structure that exists following syngamy is the zygote. After several hours the cell divides to create a two-cell zygote. At this stage it is generally referred to as an embryo. At about 15 days after fertilisation a heaping-up of cells occurs which is described as the “primitive streak”.
Fertilisation may of course take place in the normal way or in vitro.
CNR is a process by which the nucleus, which is diploid, from one cell is transplanted into an unfertilised egg, from which (in the process I am considering) the nucleus has been removed. The nucleus is derived from either an embryonic or a foetal or an adult cell. The cell is then treated to encourage it to grow and divide, forming first a two-cell structure and then developing in a similar way to an ordinary embryo.
CNR is a form of cloning. Clones are organisms that are genetically identical to each other. When CNR is used, if the embryo develops into a live individual, that individual is genetically identical to the nucleus transplanted into the egg. There are other methods of cloning, for example, embryo splitting, which may occur naturally or be encouraged. Identical twins are the result of embryo splitting.
The famous Dolly the sheep was produced by CNR. Live young have since been produced by CNR in some other mammals. It has not yet been attempted in humans.
As I have indicated, CNR of the kind under consideration does not normally involve fertilisation. There are techniques that involve both cell nuclear replacement and fertilisation, but I am not considering those. In most circumstances at least, such techniques will fall within section 1(1) of the Act, because fertilisation is involved.
The history of the legislation
I am invited by both parties to consider the history before and after the passing of the Act.
The story begins with the publication in 1984 of the Report of the Committee of Inquiry into Human Fertilisation and Embryology, chaired by Dame...
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