England and Wales High Court (Administrative Court) Decisions

IN THE HIGH COURT OF JUSTICE
QUEENS BENCH DIVISION
ADMINISTRATIVE COURT

		Royal Courts of Justice Strand, London, WC2A 2LL
		20 December 2002

Mr Justice Maurice Kay :

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 did. Lord Phillips of Worth Matravers MR described the policy of the Act as follows (paras. 36-38):

   "The Act brings the creation and use of embryos within a regulatory regime which very severely restricts the right to indulge in those activities. The reasons for legislating to impose these restrictions are not in doubt. They are essentially ethical…..

   Broadly speaking it can be said that the legislative policy was that it was essential to bring the creation and use of embryos under strict regulatory control for ethical reasons.

   To the question of whether it is necessary to bring embryos created by cell nuclear replacement within the regulatory regime created by the Act in order to give effect to the intention of Parliament, there can only be one answer. It is essential. There is no factor that takes embryos created by cell nuclear replacement outside the need, recognised by Parliament, to control the creation and use of human organisms."

   I am told that that case is the subject of an appeal to the House of Lords which is to be heard 'in about three months' time. However, it is presently binding on this Court and, in any event, I respectfully agree with it. I take the view that, in relation to an area such as this, the purpose of the legislation must play a very important part in its interpretation if that interpretation is open to doubt.

10. I now turn to the issues of interpretation which arise. I gratefully adopt the two headings used by Miss Rose in her Skeleton Argument.

    (1) Is tissue typing governed by the Act?

11. The first question is whether tissue typing involves the "use" of "an embryo" within the meaning of section 3(1)(b). If it does not, then it falls outside the prohibition and is lawful without the need for a licence. The case for the HFEA is a simple one. It accepts that embryonic biopsy, involving the extraction of one or two cells from an embryo, involves the use of an embryo. However, once such cells have been removed from an embryo pursuant to a licence for the purpose of PGD, the carrying out of further tests on them does not amount to the use of an embryo.

12. In my judgment this interpretation of section 3(1)(b) is incorrect. Tissue typing involves the use of an embryo for the following reasons. First, tissue typing involves the testing of an embryonic cell – a term used by Miss Rose and one consonant with the language of the HFEA press release which gave rise to these proceedings:

    "….an additional step whereby the embryo is simultaneously tested for its tissue compatibility with an affected sibling."

    Secondly, section 3 is headed "Prohibitions in connection with embryos". The words "in connection with" militate against a narrow construction. Thirdly, it is common ground that tissue typing has a potential for misuse. That is why the HFEA would only countenance it – in the words of its Chief Executive – "in very rare circumstances and under strict controls". Although the HFEA is entrusted by the Act with the making of many difficult decisions, it acts within ground rules set by the Act. I find it inconceivable that an Act which goes to great lengths to provide for the statutory control of the persons by whom and the places at which controversial activities are carried out and subject to inspection, was intended by Parliament to leave an activity such as tissue typing outside the direct control of the Act. It cannot have been the intention of Parliament to draw a line between the extraction of embryonic cells, which in itself gives rise to no real ethical problem, and the subsequent genetic testing of them, which has the potential for misuse. The distinction is artificial, unattractive and unnecessary, having regard to the policy of the Act as explained by the Master of the Rolls.

13. Fourthly, when one considers the structure of the Act as a whole, it is plain to see that, to the extent that it addressed the testing of embryonic material, it did so within the context of the licensing system. Schedule 2, paragraph 1(1) provides that a licence may authorise:

    "any of the following in the course of providing treatment services…..

    "(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.

    That is a licence in relation to the "use" of an embryo within the meaning of section 3(1)(b). The fact that the licences enabled by Schedule 2, paragraph 1(1), are limited to those there specified or "such other practices as may be specified in, or determined in accordance with, regulations" (paragraph 1(1)(g)) suggests that anything not specified in paragraph 1(1) is unlawful unless its licensing is permitted by some future regulation. Miss Rose submits that it is inappropriate to use Schedule 2 as an aid to construe section 3(1) but these two parts of the Act are the two sides of the prohibition/licence coin and, in my judgment, it is appropriate and necessary to consider one by reference to the other.

14. For all these reasons I am satisfied that tissue typing falls within the prohibition of section 3.

    (2) Can tissue typing be authorised under the Act?

15. Miss Rose's alternative submission is that, if tissue typing is an activity governed by the Act, it can lawfully be authorised by the HFEA by way of a licence. The case for the Claimant is that it cannot. Mr. Gordon QC submits that (1) the Act provides an exhaustive list of activities which may be authorised by a licence; (2) a licence under Schedule 2, paragraph 1, cannot authorise any activity "unless it appears to the Authority to be necessary or desirable for the purpose of providing treatment services (paragraph 1(3)); (3) "treatment services" are services provided "for the purpose of assisting women to carry children (section 2(1)); (4) the purpose of tissue typing is not to assist women to carry children but to ensure that a child born to the particular woman will have tissue – compatibility with an affected sibling.

16. There can be no doubt that the Act provides an exhaustive list of activities which may be licensed by the HFEA. This is made clear by the language of section 11(1) – "may grant the following and no other licences". The dispute in this case is whether the purpose of tissue typing is one of "assisting women to have children". It is submitted on behalf of the HFEA that, at least in the circumstances of the present case, it is. Miss Rose contends for a broad construction of the Act in the following stages: (1) the definition of "treatment services" in section 2(1) is intended to be a wide definition of the forms of treatment falling within the Act and should be construed as being broadly synonymous with "fertility treatment"; (2) paragraph 1(3) of Schedule 2 does no more than to make it clear that the HFEA cannot authorise an activity under a licence unless it considers such an activity to be at least desirable for the overall purpose of providing fertility treatment; and (3) to assist a woman to carry a child with a particular characteristic – whether it be freedom from genetic disorder or tissue compatability with an affected sibling – is an activity which is desirable for that permitted purpose. Miss Rose accepts with equanimity that such a construction might open the door to the use of PGD for what is sometimes called "social selection" – for example selection based on sex. Her answer is that it is the job of the HFEA to determine what is acceptable and what is not through the licensing system and the HEFA, as a mixed body of clinicians, religious leaders, ethicists and others, can be trusted to grapple with the difficult questions that will arise. She then seeks to turn Mr. Gordon's argument round by submitting that, if he is right, it is not only tissue typing but PGD generally which would be unlawful. That is something which this case does not require me to resolve.

17. In my judgment, the construction for which Miss Rose contends is not correct. When "treatment services" have been defined with a high degree of specificity by section 2(1), it is not appropriate to rewrite that definition as being "broadly synonymous with fertility treatment". Moreover, section 2(1) expressly defines "treatment services" by reference to a single purpose – that of "assisting women to carry children". To take the example of the unfortunate family whose problems have given rise to this case – it is not suggested that those problems arise from an impaired ability to conceive or to carry a child through pregnancy to full term and birth. The sole purpose of tissue typing is to ensure that any such child would have tissue compatibility with its older sibling. I do not consider that it can be said to be "necessary or desirable" for the purpose of assisting a woman to carry a child. The carrying of such a child after implantation would be wholly unaffected by the tissue typing. It seems to me that the language of the Act does not bear the strain which would be necessary to read "with particular characteristics" into the carrying of a child. Nor do I find it appropriate to resort to the Warnock Report as an aid to construction. The Report was indeed the catalyst for the Act and the HFEA but it did not anticipate the detailed statutory structure which is highly specific and restrictive, as the Master of the Rolls observed in the other Quintavalle case (above). There is no reason to give the language of the Act anything other than its ordinary meaning in the context of the purpose which was identified in that case.

18. Miss Rose's final submission is that, as section 3 of the Human Rights Act 1998 requires me to construe the 1990 Act compatibly with Convention rights so far as it is possible to do so, the right of the parents to respect for their private and family life (Article 8) and the right of life of their existing child (Article 2) compel the construction for which she contends. I reject this submission because I find no incompatibility between the proper construction (as I have held it to be) and Convention rights. This case is in the form of a challenge to the HFEA on the basis that it has exceeded the powers which Parliament conferred on it. Parliament plainly enjoyed a margin of appreciation in that respect. It seems that the activity which the HFEA seeks to licence is one which is unlawful in most, if not all, Convention countries. In these circumstances it is difficult to see how the present case exhibits breaches of Convention rights.

    Conclusion

19. If follows from what I have said that this application for judicial review succeeds. I shall hear counsel further on the form of relief, although if they are able to agree it and other ancillary matters there will be no need for them to attend when the judgment is handed down.

20. I wish to make it clear that I have great sympathy with the family whose tragic circumstances may be said to have given rise to this case and I respect the sincerity of the views of those who wish to help them. This is a difficult area of medical science and ethics. On any reading of it, the legislation has been tightly drawn so as to ensure that the ground rules within which the HFEA operates restrict the potential for misuse of science and technology. The pace of development in this area in the last decade shows the sense of that. It is pertinent to observe that when the HFEA and the Human Genetics Commission carried out a consultative process in 2001 it produced the recommendation that there were sufficient ethical difficulties with tissue typing to need further discussion before its use was considered.
    - - - - - - - - - - - - -

    MR JUSTICE MAURICE KAY: For reasons set out in the judgment handed down, this application for judicial review succeeds.

    That raises the question of the form of relief.

    MR CHAMBERLAIN: My Lord, yes. I have had an opportunity to discuss with my learned friend, Mr Jaffa, who appears for the Authority, the proper form for relief in the light of your Lordship's judgment. We have agreed that the relief should be that set out in paragraph 24(A)of the grounds for judicial review, namely a quashing order to quash the decision of the Authority announced on 13 December 2001 in principle to a allow a human (inaudible) tissue typing in order to test embryos for testing for siblings.

    MR JUSTICE MAURICE KAY: Are you content with the order in that form, Mr Jaffa?

    MR JAFFA: Yes.

    MR JUSTICE MAURICE KAY: Certainly. Could you draw up a minute reflecting that and lodge it?

    MR CHAMBERLAIN: Certainly. I do also have an application for costs. I do not think that it is opposed.

    MR JUSTICE MAURICE KAY: To be assessed.

    MR CHAMBERLAIN: Detailed assessment.

    MR JAFFA: My Lord, I cannot resist an application for costs. The application I do have is for permission to appeal. I submit where permission to appeal should clearly be granted is where it raises substantial matters of public importance in the interest of the community. It also raises the question which, in reality, has an impact on human life, and which are in any event urgent. Similar cases dealing with the same legislation have also been appealed. Indeed, the same claimants in this case are currently taking the case to the House of Lords. The matters raised are of the upmost importance.

    MR JUSTICE MAURICE KAY: Is that the same claimant?

    MR JAFFA: My understanding is it is the same organisation.

    MR CHAMBERLAIN: It is not the same organisation or the same claimant; the two are in fact related; they are mother and son.

    MR JAFFA: I do apologise.

    Nevertheless, it is my submission that this case is likely to effect substantial changes to the policy of the factors of the Human Fertilisation Embryology. In those circumstances, I would invite your Lordship to grant permission to appeal on the ground that there are compelling reasons that the Court of Appeal consider the claim. That would be regardless of your Lordship's conclusion on the merits. If I need to, I will invite your Lordship to grant permission to appeal on the grounds that we have a real prospect of success.

    MR JUSTICE MAURICE KAY: Yes, thank you.

    MR CHAMBERLAIN: My Lord, I do resist that application. The substantial issue in this claim at root, in my submission, at is a simple one; namely whether tissue typing is a service provided for the purpose of assisting women to carry children. Your Lordship's judgment deals with that straightforward issue in a straightforward manner. It is not on the evidence.

    The only other issue in this claim was what your Lordship's judgment I think characterises as an evasive construction in order to get around the substantial issue. That construction your Lordship has rejected with very little hesitation. For those reasons my Lord, I would resist the application my learned friend makes.

    MR JUSTICE MAURICE KAY: Mr Jaffa, you may have permission. I will express this on the basis of the compelling reason rather than the real prospect ground, but it does seem to me that there is, as you say, a matter of life.

    MR JAFFA: Could I ask, first of all, that your Lordship makes an order that the appellant's notice be served within 28 days rather than 14 days because of the impending Christmas vacation?

    MR JUSTICE MAURICE KAY: Yes.

    MR JAFFA: Finally, although it is a matter for the Court of Appeal, I would invite your Lordship to indicate that expedition might be a matter that is appropriate for the Court of Appeal to consider.

    MR JUSTICE MAURICE KAY: I would simply say that I hope it would be possible for the Court of Appeal to make directions to that effect.

    MR JAFFA: I am very grateful.

    MR JUSTICE MAURICE KAY: Mr Chamberlain, if that order is drawn up within the next few minutes, the Associate will see that it is done today.

    MR CHAMBERLAIN: I will undertake to get it within the next half an hour if I can.