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Session 2002 - 03
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Judgments - Regina v. Secretary of State for Health (Respondent) ex parte Quintavalle (on behalf of Prof-Life Alliance) (Appellant)


SESSION 2002-03
[2003] UKHL 13
on appeal from: [2002] EWCA Civ 29




Regina v. Secretary of State for Health (Respondent) ex parte Quintavalle (on behalf of Pro-Life Alliance) (Appellant)



The Appellate Committee comprised:

  Lord Bingham of Cornhill

  Lord Steyn

  Lord Hoffmann

  Lord Millett

Lord Scott of Foscote




Regina v. Secretary of State for Health (Respondent) ex parte Quintavalle (on behalf of Pro-Life Alliance) (Appellant)

[2003] UKHL 13


My Lords,

    1. The issues in this appeal are whether live human embryos created by cell nuclear replacement (CNR) fall outside the regulatory scope of the Human Fertilisation and Embryology Act 1990 and whether licensing the creation of such embryos is prohibited by section 3(3)(d) of that Act. Crane J at first instance held that such creation fell outside the scope of the Act and was not prohibited by section 3(3)(d): [2001] 4 All ER 1013; [2001] EWHC Admin 918. The Court of Appeal (Lord Phillips of Worth Matravers MR, Thorpe and Buxton LJJ) agreed with the judge on the second point but reversed his ruling on the first: [2002] QB 628; [2002] EWCA Civ 29. Both points were re-argued before the House.

    2. This case is not concerned with embryos created in the ordinary way as a result of sexual intercourse. Nor is it directly concerned with the creation of live human embryos in vitro where the female egg is fertilised by the introduction of male sperm outside the body. CNR, a very recent scientific technique, involves neither of those things. In the Court of Appeal and in the House the parties were content to adopt the clear and succinct explanation given by the judge of what CNR means and involves ([2001] 4 All ER 1013, 1016):

    "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 . . . the nucleus has been removed. The [replacement] 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…. CNR of the kind under consideration does not . . . involve fertilisation."

The Act

    3. 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 sections at the heart of this appeal are sections 1 and 3, which I should quote in full:

    "Principal terms used

    1.(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.

    (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 it was 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.

    . . .

    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, or

      (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."

    4. The Act imposes three levels of control. The highest is that contained in the Act itself. As is apparent, for example from section 3(2) and (3), the Act prohibits certain activities absolutely, a prohibition fortified by a potential penalty of up to ten years' imprisonment (section 41(1)). The next level of control is provided by the Secretary of State, who is empowered to make regulations for certain purposes subject (so far as relevant here) to an affirmative resolution of both Houses of Parliament (section 45(1), (4)). Pursuant to section 3(3)(c) the Secretary of State may make regulations prohibiting the keeping or use of an embryo in specified circumstances. The third level of control is that exercised by the Authority. Section 3(1) prohibits the creation, keeping or use of an embryo except in pursuance of a licence, and the Act contains very detailed provisions governing the grant, revocation and suspension of licences and the conditions to which they may be subject: see, among other references, sections 11-22 of and Schedule 2 to the Act. A power is also conferred on the Authority to give binding directions: sections 23-24.

    5. The first argument of the Alliance is squarely based on the wording of section 1(1)(a) of the Act, fortified by that of subsection (1)(b). It hinges on the words "where fertilisation is complete". That makes clear, it is argued, that the live human embryos to which the Act applies are such embryos as are the product of fertilisation, for the obvious reason that if there is no fertilisation there can be no time when fertilisation is complete (and there is never an egg in the process of fertilisation). Therefore the Act does not apply to embryos created by CNR, unsurprisingly since in 1990 the creation of live human embryos was unknown to Parliament. The second argument of the Alliance is put as an alternative: if embryos created by CNR are, contrary to the first argument, embryos within the scope of the Act, then the CNR process is specifically prohibited by section 3(3)(d) and cannot be licensed.

The approach to interpretation

    6. By the end of the hearing it appeared that the parties were divided less on the principles governing interpretation than on their application to the present case. Since, however, the Court of Appeal were said to have erred in their approach to construction, it is necessary to address this aspect, if relatively briefly.

    7. Such is the skill of parliamentary draftsmen that most statutory enactments are expressed in language which is clear and unambiguous and gives rise to no serious controversy. But these are not the provisions which reach the courts, or at any rate the appellate courts. Where parties expend substantial resources arguing about the effect of a statutory provision it is usually because the provision is, or is said to be, capable of bearing two or more different meanings, or to be of doubtful application to the particular case which has now arisen, perhaps because the statutory language is said to be inapt to apply to it, sometimes because the situation which has arisen is one which the draftsman could not have foreseen and for which he has accordingly made no express provision.

    8. The basic task of the court is to ascertain and give effect to the true meaning of what Parliament has said in the enactment to be construed. But that is not to say that attention should be confined and a literal interpretation given to the particular provisions which give rise to difficulty. Such an approach not only encourages immense prolixity in drafting, since the draftsman will feel obliged to provide expressly for every contingency which may possibly arise. It may also (under the banner of loyalty to the will of Parliament) lead to the frustration of that will, because undue concentration on the minutiae of the enactment may lead the court to neglect the purpose which Parliament intended to achieve when it enacted the statute. Every statute other than a pure consolidating statute is, after all, enacted to make some change, or address some problem, or remove some blemish, or effect some improvement in the national life. The court's task, within the permissible bounds of interpretation, is to give effect to Parliament's purpose. So the controversial provisions should be read in the context of the statute as a whole, and the statute as a whole should be read in the historical context of the situation which led to its enactment.

    9. There is, I think, no inconsistency between the rule that statutory language retains the meaning it had when Parliament used it and the rule that a statute is always speaking. If Parliament, however long ago, passed an Act applicable to dogs, it could not properly be interpreted to apply to cats; but it could properly be held to apply to animals which were not regarded as dogs when the Act was passed but are so regarded now. The meaning of "cruel and unusual punishments" has not changed over the years since 1689, but many punishments which were not then thought to fall within that category would now be held to do so. The courts have frequently had to grapple with the question whether a modern invention or activity falls within old statutory language: see Bennion, Statutory Interpretation, 4th ed (2002) Part XVIII, Section 288. A revealing example is found in Grant v Southwestern and County Properties Ltd [1975] Ch 185, where Walton J had to decide whether a tape recording fell within the expression "document" in the Rules of the Supreme Court. Pointing out (page 190) that the furnishing of information had been treated as one of the main functions of a document, the judge concluded that the tape recording was a document.

    10. Limited help is in my opinion to be derived from statements made in cases where there is said to be an omission in a statute attributable to the oversight or inadvertence of the draftsman: see Jones v Wrotham Park Settled Estates [1980] AC 74 at 105; Inco Europe Ltd v First Choice Distribution [2000] 1 WLR 586. This is not such a case. More pertinent is the guidance given by the late Lord Wilberforce in his dissenting opinion in Royal College of Nursing of the United Kingdom v Department of Health and Social Security [1981] AC 800. The case concerned the Abortion Act 1967 and the issue which divided the House was whether nurses could lawfully take part in a termination procedure not known when the Act was passed. At page 822 Lord Wilberforce said:

    "In interpreting an Act of Parliament it is proper, and indeed necessary, to have regard to the state of affairs existing, and known by Parliament to be existing, at the time. It is a fair presumption that Parliament's policy or intention is directed to that state of affairs. Leaving aside cases of omission by inadvertence, this being not such a case, when a new state of affairs, or a fresh set of facts bearing on policy, comes into existence, the courts have to consider whether they fall within the Parliamentary intention. They may be held to do so, if they fall within the same genus of facts as those to which the expressed policy has been formulated. They may also be held to do so if there can be detected a clear purpose in the legislation which can only be fulfilled if the extension is made. How liberally these principles may be applied must depend upon the nature of the enactment, and the strictness or otherwise of the words in which it has been expressed. The courts should be less willing to extend expressed meanings if it is clear that the Act in question was designed to be restrictive or circumscribed in its operation rather than liberal or permissive. They will be much less willing to do so where the subject matter is different in kind or dimension from that for which the legislation was passed. In any event there is one course which the courts cannot take, under the law of this country; they cannot fill gaps; they cannot by asking the question 'What would Parliament have done in this current case - not being one in contemplation - if the facts had been before it?' attempt themselves to supply the answer, if the answer is not to be found in the terms of the Act itself."

Both parties relied on this passage, which may now be treated as authoritative. Mr Gordon QC for the Alliance submitted that the Court of Appeal had fallen into error by asking the question which Lord Wilberforce said should not be asked, and by themselves supplying the answer.

The background to the Act

    11. The birth of the first child resulting from in vitro fertilisation in July 1978 prompted much ethical and scientific debate which in turn led to the appointment in July 1982 of a Committee of Inquiry under the chairmanship of Dame Mary Warnock DBE to

    "consider recent and potential developments in medicine and science related to human fertilisation and embryology; to consider what policies and safeguards should be applied, including consideration of the social, ethical and legal implications of these developments; and to make recommendations."

The Committee reported in July 1984 (Cmnd 9314). A White Paper was published in November 1987 (Cm 259) when the Department of Health and Social Security recognised (paragraph 6) "the particular difficulties of framing legislation on these sensitive issues against a background of fast-moving medical and scientific development".

    12. There is no doubting the sensitivity of the issues. There were those who considered the creation of embryos, and thus of life, in vitro to be either sacrilegious or ethically repugnant and wished to ban such activities altogether. There were others who considered that these new techniques, by offering means of enabling the infertile to have children and increasing knowledge of congenital disease, had the potential to improve the human condition, and this view also did not lack religious and moral arguments to support it. Nor can one doubt the difficulty of legislating against a background of fast-moving medical and scientific development. It is not often that Parliament has to frame legislation apt to apply to developments at the advanced cutting edge of science.

    13. The solution recommended and embodied in the 1990 Act was not to ban all creation and subsequent use of live human embryos produced in vitro but instead, and subject to certain express prohibitions of which some have been noted above, to permit such creation and use subject to specified conditions, restrictions and time limits and subject to the regimes of control briefly described in paragraph 4 above. The merits of this solution are not a matter for the House in its judicial capacity. It is, however, plain that while Parliament outlawed certain grotesque possibilities (such as placing a live animal embryo in a woman or a live human embryo in an animal), it otherwise opted for a strict regime of control. No activity within this field was left unregulated. There was to be no free for all.

Section 1(1)(a)

    14. It is against this background that one comes to interpret section 1(1)(a). At first reading Mr Gordon's construction has an obvious attraction: the Act is dealing with live human embryos "where fertilisation is complete", and the definition is a composite one including the last four words. But the Act is only directed to the creation of embryos in vitro, outside the human body (section 1(2)). Can Parliament have been intending to distinguish between live human embryos produced by fertilisation of a female egg and live human embryos produced without such fertilisation? The answer must certainly be negative, since Parliament was unaware that the latter alternative was physically possible. This suggests that the four words were not intended to form an integral part of the definition of embryo but were directed to the time at which it should be treated as such. This was the view taken by the judge (in paragraph 62 of his judgment) and by the Court of Appeal (paragraphs 29, 53, 58) and I agree with it. The somewhat marginal importance of the four words is in my opinion indicated by the fact that section 1(1)(b) appears to contradict them. The crucial point, strongly relied on by Mr Parker QC in his compelling argument, is that this was an Act passed for the protection of live human embryos created outside the human body. The essential thrust of section 1(1)(a) was directed to such embryos, not to the manner of their creation, which Parliament (entirely understandably on the then current state of scientific knowledge) took for granted.

    15. Bearing in mind the constitutional imperative that the courts stick to their interpretative role and do not assume the mantle of legislators, however, I would not leave the matter there but would seek to apply the guidance of Lord Wilberforce quoted above in paragraph 10:

(1)  Does the creation of live human embryos by CNR fall within the same genus of facts as those to which the expressed policy of Parliament has been formulated? In my opinion, it plainly does. An embryo created by in vitro fertilisation and one created by CNR are very similar organisms. The difference between them as organisms is that the CNR embryo, if allowed to develop, will grow into a clone of the donor of the replacement nucleus which the embryo produced by fertilisation will not. But this is a difference which plainly points towards the need for regulation, not against it.

(2)  Is the operation of the 1990 Act to be regarded as liberal and permissive in its operation or restrictive and circumscribed? This is not an entirely simple question. The Act intended to permit certain activities but to circumscribe the freedom to pursue them which had previously been enjoyed. Loyalty to the evident purpose of the Act would require regulation of activities not distinguishable in any significant respect from those regulated by the Act, unless the wording or policy of the Act shows that they should be prohibited.

(3)  Is the embryo created by CNR different in kind or dimension from that for which the Act was passed? Plainly not: as already pointed out, the organisms in question are, as organisms, very similar.

While it is impermissible to ask what Parliament would have done if the facts had been before it, there is one important question which may permissibly be asked: it is whether Parliament, faced with the taxing task of enacting a legislative solution to the difficult religious, moral and scientific issues mentioned above, could rationally have intended to leave live human embryos created by CNR outside the scope of regulation had it known of them as a scientific possibility. There is only one possible answer to this question and it is negative.

    16. In support of his argument on construction Mr Gordon drew attention to three provisions of the Act which, he submitted, could not be applied to embryos created by CNR. The first of these was the starting point for the protection provided by the Act, specified in section 1(1) in relation to an embryo created by fertilisation but otherwise unprovided for. The second was the 14 day time limit provided in section 3(4), "beginning with the day when the gametes are mixed", inapplicable in a case where gametes are not mixed. Third was the absence of any requirement of consent by the donor of the replacement nucleus, in contrast with the stringent requirement of consent in other cases as provided by section 12(c) and Schedule 3. These are relevant points, and account must be taken of them when forming an overall judgment on the interpretation of section 1(1)(a). But once it is accepted that Parliament did not have embryos created by CNR specifically in mind when passing the Act, it almost inevitably follows that discrepancies will arise if the Act is applied to another member of the same genus. The real question is whether these discrepant features are of structural significance such that effect cannot be given to the intention of Parliament without observing them. Neither singly nor cumulatively do these three features have that effect. The appearance of a two cell zygote (section 1(1)), which occurs however the embryo is created, provides a satisfactory starting point, there is a period before that occurs, but like the Master of the Rolls (paragraph 45) I do not think this is of practical significance. The 14 day time limit (section 3(4)) is alternative to appearance of the primitive streak (section 3(3)(a)), and it is open to the Secretary of State to prescribe a period shorter than 14 days (section 3(3)(c)). The Authority may impose a requirement of consent as a condition of any licence to create an embryo by CNR, and could be expected to do so. Given the clarity of Parliament's purpose, I do not regard these discrepancies as significant.

    17. The criticisms made of the Court of Appeal's judgments are not, save in very minor respects, soundly based. I agree with the decision which that court reached on this interpretation question and substantially with the reasons given for it.

Section 3(3)(d)

    18. It seems to me quite clear that CNR does not involve "replacing a nucleus of a cell of an embryo" because there is no embryo until the nucleus of the recipient cell is replaced by the nucleus of the donor cell. I accordingly conclude that section 3(3)(d), which cannot have been drafted to prohibit CNR, does not, almost fortuitously, have that result. The target of section 3(3)(d) is in my opinion made plain by paragraph 12.14 of the Warnock Report, which need not be quoted but which was directed to a particular form of genetic manipulation, replacement of the nucleus of a fertilised human egg. The White Paper (paragraph 36) referred to "techniques aimed at modifying the genetic constitution of an embryo", and proposed that legislation "should clearly prohibit all such activities, but with a power for Parliament itself, by affirmative resolution, to make exceptions to these prohibitions if new developments made that appropriate". Section 3(3)(d) was, I infer, enacted to give effect to this recommendation. If, as Mr Gordon contended, Parliament intended to ban all cloning by section 3(3)(d), it would have been possible so to provide; but it seems clear that Parliament did not intend to prohibit embryo-splitting, which creates clones, and to which the Warnock Report referred in paragraph 12.11. In my opinion, the subsection cannot be interpreted to prohibit CNR.

    19. For these reasons I would dismiss the appeal with costs.


My Lords,

    20. Section 1 (1) of the Human Fertilisation and Embryology Act 1990 defines the scope of the regulatory system created by the Act. It provides:

    "……….except where otherwise stated -

      (a) embryo means a live human embryo where fertilisation is complete, and


      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."

In so legislating Parliament acted on the scientific insight of a decade ago, viz that an embryo could only be created by fertilisation. The ordinary and obvious meaning of section 1(1) reflects that understanding. Since 1990 the development of cell nuclear replacement has made possible the creation of an embryo without the means of fertilisation. The question arose whether embryos created by cell nuclear replacement were covered by the 1990 Act. Overruling a first instance decision ([2001] 4 All ER 1013), the Court of Appeal held that such embryos are subject to the Act: R (Quintavalle) v Secretary of State for Health [2002] QB 628. It is of some importance to consider how as a matter of interpretative method the House should approach the central question. I turn in the first place to three aspects of this matter.

Purposive Interpretation