Neutral Citation Number: [2001] EWHC Admin 918
IN THE HIGH COURT OF JUSTICE                                                CO/4095/2000
QUEEN'S BENCH DIVISION
ADMINISTRATIVE COURT

Royal Courts of Justice
Strand, 
London WC2A 2LL

Thursday 15th November 2001
Before:

MR. JUSTICE CRANE

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BETWEEN:

THE QUEEN
on the application of BRUNO QUINTAVALLE
on behalf of PRO-LIFE ALLIANCE
Claimant

and

SECRETARY OF STATE FOR HEALTH
Defendant
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(Transcript of the Handed Down Judgment of
Smith Bernal Reporting Limited, 190 Fleet Street
London EC4A 2AG
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Mr.Gerald Barling QC and Mr.Martin Chamberlain appeared for the Claimant.

Mr.James Eadie appeared for the Defendant.

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Judgment
As Approved by the Court

Crown Copyright ©

1.	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 
2.	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".
3.	  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.
4.	  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.
5.	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.
6.	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".    
7.	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.  
8.	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.
9.	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. 
10.	During the course of the hearing, having heard sufficient of the arguments, I gave permission to apply for judicial review. 
11.	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
12.	The expert evidence describes the processes in detail, but for present purposes they can be shortly described.
13.	 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".  
14.	 Fertilisation may of course take place in the normal way or in vitro.
15.	 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.
16.	 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.
17.	 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.
18.	 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
19.	 I am invited by both parties to consider the history before and after the passing of the Act.
20.	 The story begins with the publication in 1984 of the Report of the Committee of Inquiry into Human Fertilisation and Embryology, chaired by Dame Mary Warnock ("the Warnock Report").   The Report recommended the setting up of a licensing authority to regulate both research and certain infertility services.  It recommended that human embryos should be afforded some protection in law and that certain procedures should be prohibited by the criminal law.
21.	In its discussion of cloning, the Report referred to nucleus substitution:
"12.14.  Another technique, which has sometimes been referred to as cloning, but which may more accurately be described as nucleus substitution would raise more fundamental questions.  These would occur if it became possible to remove the nucleus from a fertilised human egg and, without detriment to its subsequent development, replace it with the nucleus taken from an adult human.  This process would open the way for the creation of "carbon copy clones".  It has been suggested that one day it might be possible to produce immunologically identical organs for transplantation purposes to replace a diseased organ, for example a kidney.  The cloned replacement organ would be grown in an embryo in which the nucleus has been replaced by one taken from the person for whom the replacement organ was intended".
22.	 It is to be noted that the Report was referring to the removal of the nucleus from a fertilised human egg.
23.	 The Report also recommended that since the appearance of the primitive streak marks the beginning of individual development of the embryo, no live human embryo may be kept alive, if not transferred to a woman, nor used as a research subject beyond 14 days after fertilisation (ignoring any time when the embryo may have been frozen).
24.	Following a Consultation Paper, the Government published a White Paper, "Human Fertilisation and Embryology:  A Framework for Legislation" in November 1987.  The Government decided to set up a licensing authority.  
25.	 The White Paper said:
"7.  Before setting out the detail of the proposed legislation, it is important to define what is meant by the term "embryo".  One common definition of an embryo is the product of conception from fertilisation to the end of the eighth week of development.  The Warnock Committee regarded the embryonic stage as the six weeks following fertilisation. …  
"8.  The Government proposes that legislation should apply to embryos created in vitro (i.e. by mixing sperm and eggs together in a dish), from the point at which fertilisation is completed.  The start of cell division would be taken to be proof that the process of fertilisation has ended.  The legislation would apply to these embryos up to the time at which they are transferred to a woman's uterus.  This would mean that, if research were permitted, the use of embryos that were not transferred to a woman would be controlled throughout the time they were held outside the body. …"
26.	The Government proposed that if research was permitted, the Authority would not be able to give a licence for the use of embryos beyond fourteen days or after the appearance of the primitive streak, whichever was the earlier.
27.	  About nuclear substitution, the White Paper said:
"38.  Similar concerns [to those about modifying an embryo's genetic structure] arise from fears that it will one day be possible to produce artificially two or more genetically identical individuals (sometimes known as cloning).  The Warnock Report (paragraph 12.11 [on Cloning] and 12.14) described techniques by which such results might theoretically be achieved, although there is no knowledge of such work being carried out artificially with human embryos.  The Bill will make such practices a criminal offence."
28.	  The Act followed.  No evidence about the progress of the legislation through Parliament has been introduced.  The Human Fertilisation and Embryology Authority ("the Authority") was set up by the Act.
29.	On 27 February 1997 a paper entitled "Viable offspring derived from foetal and adult mammalian cells" by Professor Wilmut (one of the experts in this case) and others, was published in Nature.  The paper revealed the birth of lamb number 6LL3, now famous as Dolly the sheep.  Not only did she achieve popular fame; her birth following CNR using an adult sheep cell represented a very significant scientific development.  There had in fact been earlier births of sheep in 1996, following cell nuclear replacement, but using a sheep embryo as a donor source.
30.	  Much discussion of cloning followed, including, importantly for present purposes, the possible use of CNR on human organisms for research purposes, not intended to lead to the birth of a human being.  The House of Commons Science and Technology Committee published a report in March 1997 entitled "The Cloning of Animals from Adult Cells".  The Government published its response to that report in December 1997.  In December 1998 a report entitled "Cloning Issues in Reproduction, Science and Medicine" was published jointly by the Human Genetics Advisory Commission and the Authority.  There followed the Donaldson Report.

Delay
31.	 By CPR 54.5
"(1)  The claim form must be filed -
promptly; and
in any event not later than 3 months after the grounds to make the claim first arose".

32.	  In my judgement the grounds to make the claim first arose when the Response was published.  I shall give my reasons later for concluding that the Response provides grounds for judicial review.  The report of March 1997 could not be the subject of judicial review, for reasons of Parliamentary privilege.  In any event, neither that report, nor the response of December 1997, nor the report of December 1998 contained any firm indication of action of a kind that could be the subject of judicial review.  In my judgement the Claimant has acted with reasonable promptness.
33.	  In any event, it is open to the court to deal with applications made late if the applicant has behaved sensibly and reasonably or the matters raised are of general importance:  see R. v. Commissioner for Local Administration, ex parte Croydon LBC [1989] 1 All ER 1033 at 1046, per Woolf J.; R. v. Secretary of State for the Home Department, ex parte Ruddock [1987] 1 WLR 1482 at 1486, per Taylor LJ; and R. v. Foreign Secretary, ex parte World Development Movement [1995] 1 WLR 386 at 402, per Rose LJ.  On those principles, if I am wrong in my views about the absence of delay, I am satisfied that I should deal with the application on its merits.

Jurisdiction and discretion
34.	  It is submitted on behalf of the Defendant that the jurisdiction to grant a declaration does not arise in relation to the contents of the Response or alternatively that such a jurisdiction should not be exercised.
35.	  The Claimant relies on Gillick v. West Norfolk and Wisbech AHA [1986] AC 112.  Lord Bridge of Harwich (at 193) referred to the decision in Royal College of Nursing v. Department of Health and Social Security [1980] AC 800, where both the R.C.N. and the Department sought declarations as to the lawfulness of a circular issued by the Department which was said by the R.C.N. to give advice that was unlawful.  No technical question of jurisdiction was taken.  Lord Bridge continued (at 193G):
"Against that background it would have been surprising indeed if the courts had declined jurisdiction.  But I think it must be recognised that the decision (whether or not it was so intended) does effect a significant extension of the court's power of judicial review.  We must now say that if a government department, in a field of administration in which it exercises responsibility, promulgates in a public document, albeit non-statutory in form, advice which is erroneous in law, then the court, in proceedings in appropriate form commenced by an applicant or plaintiff who possesses the necessary locus standi, has jurisdiction to correct the error of law by an appropriate declaration.  Such an extended jurisdiction is no doubt a salutary and indeed a necessary one in certain circumstances, as the Royal College of Nursing case [1981] A.C. 800 itself well illustrates.  But the occasions of a departmental non-statutory publication raising, as in that case, a clearly defined issue of law, unclouded by political, social or moral overtones, will be rare.  In cases where any proposition of law implicit in a departmental advisory document is interwoven with questions of social and ethical controversy, the court should, in my opinion, exercise its jurisdiction with the utmost restraint, confine itself to deciding whether the proposition of law is erroneous and avoid either expressing ex cathedra opinions in areas of social; and ethical controversy in which it has no claim to speak with authority or proffering answers to hypothetical questions of law which do not strictly arise for decision".
36.	  I was also referred to the remarks of Lord Goff in Airedale N.H.S. Trust v. Bland [1993] 789 at 862 about the desirability of matters relating to the medical profession being determined by declaratory relief rather than being left for decision ex post facto in criminal proceedings.  Those were not judicial review proceedings, but proceedings in the Family Division for a declaration relating to withdrawal of treatment from a patient.
37.	  The Claimant seeks to rely on Parliamentary statements that the Government had received advice to the effect that the 1990 Act and in particular the definition in section 1 applied to organisms produced by CNR.  Leaving aside questions of Parliamentary privilege, I do not consider it appropriate to take those into account.  Opinions expressed by Government ministers about the meaning of an Act of Parliament, wherever expressed, appear to me to be well outside the jurisdiction contemplated by Lord Bridge.
38.	However, the Response was a definitive Government response to a proposal that new purposes of research be permitted not only on embryos undoubtedly within that definition but also on organisms produced by CNR, on the assumption that those are within the definition in the Act.  The Response proposed regulations based on that assumption.  Sullivan J. was told, as I have been, that the Authority has stated that it will not issue licences under the regulations until these proceedings are resolved.  It has set out that in a published bulletin.  The question of law is not merely hypothetical.  There is no indication that researchers are proposing to carry out CNR without waiting for a licence and hence there is no suggestion that criminal offences are likely.  Indeed, if the Claimant is correct, researchers may create organisms by CNR without reference to the Act, although they might face criminal proceedings on the basis of a contention that such creation is prohibited by section 3(3)(d) of the Act.  I shall consider that subsection later and I take the view that it does not prohibit CNR as presently under consideration.  Nevertheless the point might be tested in criminal proceedings.  As in some medical cases, it is undesirable that responsible researchers, and indeed the Authority, are left in doubt or that the matter be tested in ex post facto criminal proceedings.
39.	  The Defendant argues that the Claimant's stance is illogical, in that the Claimant opposes cloning and the creation and use of embryos for research on principle and the effect of a declaration would be that the CNR is not subject to any statutory or regulatory control.  The Defendant argues that the Claimant's motive is to force these issues back on to the Parliamentary agenda, when the Government have in fact announced that they propose to introduce primary legislation to put the coverage of the Act beyond doubt as far as reproductive cloning is concerned.
40.	  It may well be that the Claimant's motives include those suggested.  It is not for the court to influence the Parliamentary agenda.  However, no objection has been taken to the standing of the Claimant.  If they have raised a legitimate concern about the meaning of section 1 - and I consider that they have - the court has and should exercise jurisdiction.  Although, in Lord Bridge's words, the issue has "political, social and moral overtones", I shall confine myself to the proposition of law said to be erroneous.  I shall avoid expressing opinions in areas of social and ethical controversy, except to echo the submissions of both parties that these are matters of profound social and ethical importance.

The central issue
41.	  The Claimant now accepts that the organism produced by CNR is "live" and "human" for the purposes of the definition.  
42.	  During the hearing there has been discussion about whether the organism produced by CNR is properly described as an "embryo" as a matter of scientific language.  The Defendant submits that it is morphologically and functionally indistinguishable from an embryo produced by fertilisation.  The Claimant has pointed to certain differences of structure.  They point to the fact that on currently available data from animal experiments only a tiny percentage of such organisms will result in live births.  The Defendant replies that this difference is largely the result of the present state of scientific expertise.   The Claimant also points out that some scientific opinion refers to the organisms as "reconstructed embryos".
43.	Ultimately, however, it is conceded, in my view correctly, that the organism produced by CNR is naturally described as an "embryo", at least when the two-cell stage is reached.  That is consistent with the expert evidence before the court.  If the definition in section 1(1) had ended at the word "embryo", without the following words and without section 1(1)(b), I should have held that the organism fell within the definition.
44.	  The Claimant relies on the following words and submits simply that an embryo that has not been produced by fertilisation cannot be an "embryo where fertilisation is complete".  
45.	  The Defendant argues for a purposive construction of section 1(1).  It argues that the essential concept is "a live human embryo".   The subsection should be read as if the words were, in effect, "a live human embryo where [if it is produced by fertilisation] fertilisation is complete".
46.	  Assistance in construing section 1(1)(a) is to be obtained from other parts of the Act.
47.	  The effect of section 1(1)(b) is to extend the protection given to an embryo back in time before fertilisation is complete.  Fertilisation is for this purpose not complete until the appearance of the two-cell zygote.  But for the purposes of the Act an egg "in the process of fertilisation" is an embryo.  In other words, once the process of fertilisation, which is a process over a period of time, begins, the egg is an "embryo" for the purposes of the Act.
48.	  It is argued on behalf of the Claimant that the organism produced by CNR is not properly referred to as a "zygote".  They correctly point to the Greek origin of the word in the root zyg- (ζευγ), carrying the meaning of two things being yoked together, but the derivation of a word often does not govern its present meaning.  However, they also correctly point to definitions of "zygote" in scientific dictionaries published in 2000, which assume fertilisation.  I accept that although the organism developing from CNR has similarities to a zygote, it is not, at least so far, settled scientific practice to refer to it as a zygote.  Professor Templeton goes no further than saying that "In my opinion, the one cell structure can appropriately be described as a zygote".
49.	  In my view, even if the Defendant's central submission were correct, section 1(1)(b) would not apply to the organism produced by CNR.  Nothing is "in the process of fertilisation".  It follows that there could be doubt whether that organism was an "embryo" prior to the two-cell stage.  Professor Wilmut, for example, refers to the organism as a "reconstructed embryo", "a term used by biologists to describe embryos created using CNR usually at the one or two-cell stage".  It may well be that responsible researchers would treat the organism as subject to control from an earlier stage, by analogy with section 1(1)(b).  However, they would not be obliged to do so unless it became settled scientific practice to refer to the organism as an "embryo" before the two-cell stage.  The very fact that an area of doubt would result is in itself an argument against the Defendant's construction of section 1.
50.	 The remainder of section 1 reads:
"(2)  This Act, so far as it governs bringing about the creation of an embryo, applies only to bringing about the creation of an embryo outside the human body; and in this Act -
	(a)  references to embryos the creation of which was brought about in vitro (in their application to those where fertilisation is complete) are to those where fertilisation began outside the human body whether or not completed there, and
	(b)  references to embryos taken from a woman do not include embryos whose creation was brought about in vitro.
"(3)  This Act, so far as it governs the keeping or use of an embryo, applies only to keeping or using an embryo outside the human body.
"(4)  References in this Act to gametes, eggs or sperm, except where otherwise stated, are to live human gametes, eggs or sperm but references below in this Act to gametes or eggs do not include eggs in the process of fertilisation".
51.	  Subsections (2)(a) and (4) clearly assume a process of fertilisation.  The other parts of these subsections would generally have less relevance to an organism produced by CNR, but that is not necessarily decisive in deciding the central issue.
52.	  I turn to the important section 3:
"(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.

"(2)  No person shall place in a woman -
	(a)  a live embryo other than a human embryo, or
	(b)  any live gametes other than human gametes.

(3)  A licence cannot authorise -
	(a)  keeping or using an embryo after the appearance of the primitive streak,
	(b)  placing an embryo in any animal,
	(c)  keeping or using an embryo in any circumstances in which regulations prohibit its keeping or use,
	(d)  replacing a nucleus of a cell of an embryo with a nucleus taken from a cell of any person, embryo or subsequent development of an embryo.

"(4)  For the purposes of subsection (3)(a) above, the primitive streak is to be taken to have appeared in an embryo not later than the end of the period of 14 days beginning with the day when the gametes are mixed, not counting any time during which the embryo is stored".
53.	  Subsections (1), (2) and (3)(b) and (c) cause no difficulty of application if an organism produced by CNR is an embryo, although subsection (2)(b) would have no relevance.
54.	  Subsection (3)(a) must be read with subsection (4).  These provisions were inserted in the light of the Warnock Committee's recommendations.  The Claimant submits that subsection (4), a deeming provision, is definitive on the question when the primitive streak appears.  It is submitted that since subsection (4) cannot apply to an organism produced by CNR, the organism would be denied (as far as the Act is concerned) the protection intended for an embryo not only after the 14-day period, but after the appearance of the primitive streak.  I accept that subsection (4) cannot be read in a way that would apply to an organism produced by CNR.  However, the Defendant submits that although subsection (4) prohibits licences permitting keeping or use after 14 days, subsection (3)(a) prohibits licences permitting keeping or use after the appearance of the primitive streak even if that should occur earlier.  The latter construction is consistent with the proposal in the White Paper.  Partly for that reason, I prefer this construction.  It follows that a licence issued in relation to an organism produced by CNR would have to comply with subsection (3)(a).  Whether the licence included reference to any 14-day period would be a matter for the Authority.
55.	  Subsection (3)(d) raises important issues.  It was clearly inserted in the light of the concern expressed by the Warnock Committee and adopted by the White Paper.  Its effect is to prevent the licensing of nuclear substitution where the egg has been fertilised.  That is because such an egg is an "embryo" by reason of section 1(1)(b) and this conclusion is not affected by section 2(4) because there is no reference in section 3(3)(d) to an "egg".   However, section 3(3)(d) does not in terms prevent the licensing of CNR in the sense with which I am concerned, because the egg has not been fertilised.
56.	  The Claimant relies strongly on section 3(3)(d).  It is argued that if CNR in the present sense had been known to the Warnock Committee, the concern of the Committee about cloning would have applied equally to CNR in both senses.  It is further argued that if Parliament had been aware of this kind of CNR, the prohibition in the section would have extended to both kinds.
57.	Mr.Eadie on behalf of the Defendant argues that the court should not speculate about what the Warnock Committee, or Parliament, would have said about CNR of the present kind.  However, he concedes that somewhat similar ethical considerations arise in relation to nuclear substitution in fertilised and unfertilised eggs, although it might be argued that there is an ethical distinction.  I cannot accept his argument that I should take note of the fact that the Regulations have been the subject of affirmative resolutions.  I am construing the 1990 Act.  I cannot take into account the views expressed by Parliament in 2001.  Scientific knowledge has moved on.  Not only has nuclear substitution proved to be possible in animals, but it has become clear that CNR has potential for research purposes that was not known in 1990.  I do not think that I should speculate about whether, if Parliament had known about both types of CNR, it would have prohibited both.  Nor do I think that I should speculate about whether either or both might have been permitted for research purposes only, but not reproductive purposes, which is what is now proposed.    I remind myself that I am interpreting what Parliament in fact enacted in the 1990 Act, not what it would or might have enacted if the scientific advances of 1997 had been known then.
58.	  Section 12 of the Act requires certain conditions in every licence granted by the Authority.  Among those are the provisions of Schedule 3, requiring consents to the use of gametes (eggs or sperm) or embryos.  The provisions are tightly drawn to require effective consent to such use and to permit the withdrawal of such consent.  If the Defendant's construction of section 1 is correct, consent would be required from the woman whose egg was used for CNR, but not from the person whose cell was used for transplanting into the denucleated egg.  Such a person would be the person "cloned" by the process, that is, the organism produced would be genetically identical to that person.  The Claimant submits that this result cannot have been intended.  The Defendant points out that the Authority could require such consent.

Conclusions
59.	  The Defendant argues for a purposive interpretation of section 1.  The argument is a powerful one.  The Warnock Committee was appointed to examine the social, ethical and legal implications of recent, and potential developments in the field of human assisted reproduction.  Its report was, in the light of knowledge at the time, comprehensive.  Had the discoveries of 1997 been known, they would have been considered.  Similarly the White Paper and the Act itself was clearly intended to provide comprehensive control, either by prohibition or licensing, of human reproduction.  The parties differ about whether CNR would have fallen under the licensing provisions or under the prohibition in section 3(3)(d), but it is inconceivable that Parliament would have ignored CNR.  
60.	  The Claimant nevertheless argues that the words of section 1(1) cannot be stretched to cover organisms produced by CNR, involving no fertilisation.  Its argument is in my view supported by the way in which the provisions of section 3(3)(d) and Schedule 3 are worded.  I place less weight on the fact that sections 1(1(b) and 3(4) would not apply and that the Authority would be left to make decisions in areas not explicitly covered by the Act.
61.	  I decline any invitation to attempt to rewrite any of the sections of the 1990 Act to make them apply by analogy to organisms produced by CNR.
62.	  I accept the Defendant's argument that the reason for inserting in section 1(1)(a) the words "where fertilisation is complete" and the following words in section 1(1)(b) was to define the moment at which the Act's protection applied to the organism.  Nevertheless the words are there.  The question is whether to insert the additional words is permissible:  "a live human embryo where [if it is produced by fertilisation] fertilisation is complete".  With some reluctance, since it would leave organisms produced by CNR outside the statutory and licensing framework, I have come to the conclusion that to insert these words would involve an impermissible rewriting and extension of the definition.
63.	  The Claimant's alternative argument about section 3(3)(d) of the Act does not arise.  However, even if I had accepted the Defendant's interpretation of section 1(1), I should not have interpreted section 3(3)(d) in the way claimed.
64.	  I shall grant a declaration broadly in the terms sought in paragraph 45(1) of the Grounds.  However, I think it may be appropriate to refer to the appropriate paragraphs of the Response itself rather than of the Donaldson Report.  I invite submissions on the point and the preparation of an appropriate draft.