QUEEN'S BENCH DIVISION
THE ADMINISTRATIVE COURT
Strand London WC2A 2LL |
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B e f o r e :
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THE QUEEN ON THE APPLICATION OF (1) QUINTAVALLE | ||
(2) CLC | Claimant | |
v | ||
HUMAN FERTILISATION AND EMBRYOLOGY AUTHORITY (HFEA) | Defendant | |
UNIVERSITY OF NEWCASTLE | ||
KINGS COLLEGE LONDON | Interested Parties |
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Miss D Rose QC and Miss C Weir (instructed by Herbert Smith) appeared on behalf of the Defendant
Miss E Grey (instructed by Clifford Chance) appeared on behalf of the Interested Parties
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The Background
The Grounds
Ground One
(1) The Act was passed following the Warnock Committee report, White Paper and consideration of the issues in Parliament. The report, the White Paper and the observations of the Home Secretary made it clear, that there was to be a prohibition on the creation of human-animal hybrid embryos, with the exception of the hamster test. Any other trans-species fertilisation would be a criminal offence.(2) Looking at the provisions of the Act, in particular sections 1 and 4 and Schedule 2 to the Act, it is clear that "human embryo" means a fully human embryo, and that there should be no hybrids. The process in this case involves the transplantation of the nucleus of a human cell containing a full set of 46 human chromosomes into an unfertilised egg of an animal from which the nucleus has been removed. However, the mitochondrial DNA of the cell would be animal, and other animal egg factors would be present, such as proteins and RNA, which activate the animal embryo genome that is completed upon fertilisation of an animal egg with an animal sperm. It is submitted therefore, that an enucleated egg is an animal gamete and that the implanted human nucleus takes the part of the human gamete. That being the case, the HFEA has no power to issue such licences.
(3) If human had meant half human, then the Act would have failed to outlaw inter-species hybrid embryos. Save for the exception of the hamster test, which had a perceived utility and thus was subject to regulation, the creation of hybrids would have been subject to a complete ban. In this case it is submitted that an animal hybrid embryo, whether created by fertilisation or CNR, is not a fully human embryo.
(4) Applying the principles to be gleaned from the case of Quintavalle [2003] 2 AC 687, the task of the court is to give effect, within permissible bounds of interpretation, to Parliament's purpose -- thus, statutes should be generally construed as "always speaking statutes". When considering the application, the HFEA erred in failing to consider what Parliament rationally intended, namely that only fully human embryos could be licensed. It is also noted that the defendant failed to adopt the definition of "human embryo" as set out in the advice it received from the lawyers. In any event, it is submitted that the real test is: what did Parliament intend in the 1990 Act?
(5) The new legislation expressly deals with the creation and regulation of animal human embryos. The technique involved in this case is called human admixed embryos. This is to be subject to regulation under section 4. The fact, that section 1 of the Act is amended to expressly provide that a human embryo does not include a human admixed embryo, supports the contention that the reference in the Act referred only to fully human embryos.
(6) The cautious tone employed by the defendant in its consultation document of April 2007 (page 557) where it indicated that as a result of a legal decision, it probably has the power to regulate the creation of CHEs, shows that the claimants' case is arguable.
(1) The defendant had a full and public consultation between April and July 2007, before deciding on 5th September 2007 that the CHE constitutes a live human embryo within the meaning of the Act. The question raised in the consultation process was whether, as a matter of principle, the defendant should issue research licences permitting the creation or use of CHEs. The consultation explored both scientific questions as to the nature of CHEs and whether they were properly to be considered as human. It also explored the ethical questions arising from their creation. The defendant applied Quintavalle, namely that Parliament has opted for a strict regime of control in this area under the 1990 Act and did not intend any activity to be unregulated. Further, scientific expertise indicated that CHEs fall within the same genus of fact as other embryos covered by the 1990 Act, because the embryo has a complete human genome and is live.(2) The Act did not seek to define the term "human embryo" and the assessment of whether a particular embryo is human involves an exercise of scientific judgment. This the defendant did, following extensive consultation and expert consideration. The answer came back, that the embryos had a complete human genome and that the presence of a small amount of animal mitochondrial does not alter the position. This is a decision with which the courts would not lightly interfere. If the defendant is correct, then proper regulation is appropriate and the necessary conditions have to be considered as to whether a licence should be granted.
(3) If the embryos were not categorised as human, their creation would be unregulated. Neither section 4 nor any other section, assists the claimants, as there is no provision in the Act which is capable of being construed as prohibiting the creation of CHEs for research purposes. "Gametes" under section 4 are reproductive cells, having half the number of chromosomes as a normal adult cell, especially sperm or eggs. Section 4 refers solely to the mixing of human and animal gametes. Thus, if the claimants were right about the definition of "human embryo", it would mean that the interested parties could carry on the research without any regulation.
(4) The claimants need to show that it is arguable that there is a specific prohibition on the creation of such embryos. This is the only basis upon which they should succeed.
(5) Should there be any doubt as to whether this process should be regulated, it is cured by the 2008 Act, which expressly provides for regulation. The Act is due to come into force in October 2009.
(6) Quintavalle involved a bold construction of section 1. It was a much bolder decision than the scientific judgment that these embryos are human. The case laid great stress on the regulation and the strong presumption against this type of process falling outside the Act.
(7) The prohibition under section 3 of the Act, refers to a process whereby the nucleus of a cell of an embryo is replaced with the nucleus of another cell. It has no relevance in this case.
(8) Lord Millett in Quintavalle (at paragraph 43) was not seeking to construe the term, but was identifying the characteristics of the embryo.
(9) The court has to decide which approach best gives effect to the statute as enacted, regulated or unregulated, because it is impossible to read in any prohibitions.
Ground Two
(a) that the preconditions to be satisfied in the Act had not been satisfied, and(b) as the new Bill was going through Parliament, it was irrational to grant the licence before waiting to see what the will of Parliament was; that to do so, was usurping legitimate debate and the decision of Parliament, given that the Bill was controversial.
(a) Failure to satisfy the preconditions for granting the licence.
(i) there is little or no evidence that human cloning has been successful;(ii) embryonic stem cells have never been obtained from cloned human embryos;
(iii) the animal hybrid embryos will contain a form of DNA from the animal;
(iv) existing cloning techniques suffer from debilitating DNA reprogramming defects known to occur in all cloned embryos;
(v) the mitochondrial DNA (ie, from the animal) would be foreign to the immune system of the recipient patient, thus the technology does not work;
(vi) by introducing animal elements, the research cannot yield any scientifically valid information which could improve homologous human cloning.
(b) Making a decision during the passage of the Bill
(1) This is an area of cutting edge science which is developing quickly. The decision was taken following full public consultation, detailed submissions from the interested parties, the issues raised by the claimants and careful consideration of the views of expert peer reviewers. Relying on the Court of Appeal case of R (Assisted Reproduction and Gynaecology Centre) v HFEA, 31st January 2002, it is submitted, that it is not the function of the court to enter the scientific debate, nor to adjudicate on the merits of the Board's decisions or any advice it gives. The only challenge lies on the issue of whether the Board exceeds or abuses its powers or responsibilities. This challenge by the claimants is a thinly disguised attempt to canvass the merits of a decision based on expert scientific judgment.(2) It was appropriate for the HFEA, the statutory regulatory body, to take the decision on the basis of the current law, particularly having regard to the interests of the interested parties and the uncertain timetable of the future legislation.
Delay
(1) No attempt was made to challenge the decision in September, even though the claimants had indicated that they were in possession of legal advice to the effect that there was no power to grant the licence since at least May 2007.(2) It was clearly foreseeable that the interested parties would act on the granting of the licences. It was incumbent on the claimants to issue proceedings with particular urgency (Greenpeace case) because of the third party interests involved. The claimants had all the information they needed to institute proceedings.
(3) The proceedings were not issued promptly. They were issued without advance warning by way of letter before claim, to the prejudice of the interested parties. Had the claimants thought that there was a prima facie claim, but needed more information, they should have sent a letter before claim and asked for pre-action disclosure under the protocol.
(4) The claimants have acted in breach of the pre-action protocol.
(5) The claimants have provided no adequate explanation for the delay save to say, without specificity, that it took time to obtain legal advice, information under the Freedom of Information Act and expert evidence.
(6) Section 31 of the SCA provides the statutory framework for the rules in CPR 54. The relationship between the statute and the CPR was explained in R v Dairy Produce Quota Tribunal for England and Wales ex parte Caswell [1990] 2 AC 738 at pages 746 to 7. The court is entitled to refuse on the sole ground of delay without any requirement of a causal link between delay and prejudice (see also R v Secretary of State for health ex parte Furneaux [1994] 2 AER 652). Even if the claimants were able to establish good reason for the delay, leave may be refused if the court is of the opinion that the granting of the relief sought would be likely to cause hardship or prejudice or would be detrimental to good administration.
(7) Delay raises the bar. A strong prima facie case needs to be established by the claimants in order to obtain permission.
(1) Relying on the case of R v Hammersmith and Fulham LBC ex parte Burkett [2002] 1 WLR 1593 that an applicant is entitled to wait and see if the policy decision ripens into something more than theoretical, and that in this case, time ran from the decisions of January 2008.(2) The defendant itself took legal advice following 5th September on (inter alia) the power to grant the licence.
(3) With regard to the decisions made on 9th January 2008, the claim was brought promptly bearing in mind that:
(i) the claimants' past conduct indicates that they are not interested in delaying matters. They suggested an early construction summons which was declined;(ii) the HFEA, having said that a decision on the licences would be made in November, took much longer. The claimants did not know when the decision would be forthcoming and thus have their pro bono lawyers and scientists on stand-by;
(iii) the experts are very busy and their reports were not completed until 3rd and 4th April. Counsel was acting pro bono and was also busy;
(iv) following the decisions, the responsible thing to do, was to review the information upon which the decisions were made, by making a request under the Freedom of Information Act. It took time to decide what was needed and to assess what was received;
(v) the claimants have limited resources for what is a complex application;
(vi) the court should consider the extent of the alleged prejudice to the third parties caused by the alleged lack of promptness in commencing the proceedings. The case of Furneaux can be distinguished, because it was dealing with section 31(6) of the Supreme Court Act 1981 which refers to the prejudice arising from the granting of relief sought. Neither the defendant nor the interested parties have sought to rely on section 31(6).
Judgment
The Legislation
"1. 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.
(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. Prohibitions in connection with embryos
(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. Prohibitions in connection with gametes
(1) No person shall --
(a) store any gametes, or
(b) in the course of providing treatment services for any woman, use the sperm of any man unless the services are being provided for the woman and the man together or use the eggs of any other woman, or
(c) mix gametes with the live gametes of any animal
except in pursuance of a licence . . .
11. Licences for treatment, storage and research
(1) The Authority may grant the following and no other licences --
(a) licences under paragraph 1 of Schedule 2 to this Act authorising activities in the course of providing treatment services,
(b) licences under that Schedule authorising the storage of gametes and embryos, and
(c) licences under paragraph 3 of that Schedule authorising activities for the purposes of a project of research . . .
41. Offences
(1) A person who --
(a) contravenes section 3(2) or 4(1)(c) of this Act, or
(b) does anything which, by virtue of section 3(3) of this Act, cannot be authorised by a licence
is guilty of an offence and liable on conviction on indictment to imprisonment for a term not exceeding ten years or a fine or both . . .
SCHEDULE 2 . . .
(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."
"Further purposes for which research licences may be authorised
2.(1) The Authority may issue a licence for research under paragraph 3 of Schedule 2 to the Act for any of the purposes specified in the following paragraph.
(2) A licence may be issued for the purposes of --
(a) increasing knowledge about the development of embryos;
(b) increasing knowledge about serious disease, or
(c) enabling any such knowledge to be applied in developing treatments for serious disease."
The Merits
(1) I have considered the 1990 Act against the background material, the case of Quintavalle and the development in science, to ascertain what best gives effect to the policy of the statute as enacted. In my judgment, the clear purpose of Parliament can be detected, namely that these activities should be regulated. One only needs to quote Lord Bingham at paragraph 13 of Quintavalle to that effect:"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."(2) Dealing with the first limb of the claimants' argument, namely that human means "fully" human, the effect of this argument would mean that the process involving the insertion of a human nucleus containing the full 46 human chromosomes into an enucleated animal egg (in other words, an egg with the animal chromosomes removed) would fall outside the Act.
(3) Reliance was placed on Lord Millett's speech at paragraph 43 as being the definition of the human embryo:
"Now whatever may be the status of an organism created by CRN before its single cell has split into two, once it has reached the two-cell stage it is an embryo in every accepted sense of that term. In the case of a human embryo, it is a live human organism containing within its cell or cells a full set of 46 chromosomes with the normal potential to develop and, if planted in a woman, to become a foetus and eventually a human being. While there may or may not be good reasons for distinguishing between the different processes by which embryos may be created when it comes to regulating their creation, no one has been able to suggest a reason why Parliament should differentiate between the different processes when it comes to regulating their subsequent use. The placing of a human embryo in an animal is not the less abhorrent because the embryo was created by CNR."But that test, as it has been dubbed, has to be seen in the context of what Lord Millett was saying. I do not see it as seeking to lay down an immutable definition, especially in the light of what is said at paragraph 45:
"With this introduction I can turn to the wording of section 1(1). The definition in para (a) is in part circular, since it contains the very term to be defined. It assumes that the reader knows what an embryo is. The purpose of the opening words of the paragraph is not to define the word 'embryo' but to rather to limit it to an embryo which is (i) live and (ii) human. These are the essential characteristics which an embryo must possess if it is to be given statutory protection. The important point is that these characteristics are concerned with what an embryo is, not how it is produced. They are clearly necessary; the question is whether they are sufficient."(4) The Act did not seek to define "human embryo". What is "human" will be dependent on the particular facts of any case and informed by scientific knowledge at the time. I do not accept the claimants' submission, that the fact that this technique is in a separate category under the new Act, means that Parliament did not intend it to fall within the definition of "human embryo" under section 1 of the 1990 Act. The technique was unknown and not envisaged at the time. What is clear, as I have already found, is that regulation of these activities was important. The approach advocated by the defendant's lawyers in the advice of November 2007 -- namely to take a cautious approach by treating the technique as coming within regulation -- is, in my judgment, in accordance with the spirit and purpose of the 1990 Act. The fact that it is unknown, whether the embryo can develop into a human, is not fatal in the context of this case. It is to be noted that those who applied for the licences thought that the technique fell to be regulated by the Act. Both institutions took legal advice on the matter and, as a result, submitted their application to the defendant.
(5) Reliance on section 4 of paragraph 3 of Schedule 2 does not assist the claimants. The prohibition in the section is clear and the exception in the Schedule very limited. The meaning of the word "gamete" can be seen from the Oxford concise medical dictionary, namely a mature cell, the ovum of a female or the spermatozoon of a male. Gamete is a haploid containing half the number of chromosomes. This technique is a far cry from what was envisaged in section 4, namely the mixing of animal and human gametes. There may be cases which, as has been noted, might fall within the spirit of the prohibition but, in my judgment, this is not one of them. The claimants' contention that an enucleated egg is an animal gamete is, when the definition is clear, straining interpretation to unacceptable limits. One only has to look at the new Act, to see that Parliament clearly distinguished between gamete and human embryos. Moreover, the prohibition and exception in Schedule 2, paragraph 3 still apply, namely that the exception to the mixing of human and animal gametes is the hamster test. This can be seen on examination of the amendments to section 1, 4, 11 and Schedule 2, paragraph 3.
(6) As for what Parliament intends, we now know this. It is to be found in the new Act; an Act which recognises the need to move on with the development of science and which allows for amending regulations to be made to reflect developments when they occur within the intention of the Act. The technique in this case called human-animal embryos is to be regulated. This is in keeping with the approach taken by the defendant when it granted the licences in January 2008.
Delay
(1) The public consultation set out the defendant's provisional views in relation to the definition and its powers. The claimants were on notice.(2) The claimants had advice from leading counsel by at least May 2007, to the effect that the defendant did not have power to issue licences for this research.
(3) The claimants did contact the defendant and suggest a construction summons. However, when the defendant declined in July on the ground that it was premature as no policy had been formulated, the claimants did not pursue this suggested route once the 5th September press release had been issued and the defendant's position, however cautiously, set out.
(4) The claimants knew the basis of the research proposal. If it is correct that the IPFC science had been around for two years, one would have expected the claimants to have obtained information from the experts relied on to that effect already, thus making the preparation of statements for this hearing akin to an administrative matter.
(5) Given that leading counsel had advised that the defendant had no power to issue the licences, one assumes that this was based on some scientific information. The submission, that considerable work under the Freedom of Information Act was needed, does not hold water in my view. The advice was there and the scientific basis for the giving of the advice must have existed. Even if that were not the case, the claimants could (as noted by the defendant) have obtained pre-action disclosure following the protocol, which they did not.
(6) The claimants were aware of the decisions from at least 13th January. They did know that the licences would be due to start imminently. There was no justification for not following the pre-action protocol, so that the parties would be on early notice before the research started, thereby allowing them to make an informed judgment about whether or not to start. The argument that the interested parties have not stopped the research since the issuing of proceedings does not assist the claimants, so far as initiating the pre-action protocol before the licence started is concerned.
(7) As noted earlier, the essence of what the experts from the USA had to say must have been known to the claimants some time ago. The claim could have been filed earlier with a note, that supporting evidence was to follow.
(8) Dealing with the observation of leading counsel for the claimants that the case was being done on a pro bono basis and that counsel's lack of availability due to being busy on other cases was a factor to take into consideration, is not one which finds favour with the court. While it is admirable that counsel are prepared to do the case pro bono, this should not mean that the case is in a different category in relation to it being dealt with expeditiously by counsel.
"The court also said where a claimant does not follow the pre-action protocol procedure, he must expect to put his opponent to greater expense in preparing the summary grounds. This may be reflected in any order for costs against him if permission is refused."
That was Brooke LJ in that case. That is the costs of the acknowledgment of service.
"He drew particular attention to the indication in paragraph 24 of the Report that, in recommending the introduction of acknowledgements of service, it was not expected that defendants or other interested parties should incur substantial expense at the permission stage."
It was not intended that the acknowledgment of service would lead to a claim for tens of thousands of pounds. That is the first point.
"We would not normally expect a defendant to be able to demonstrate proportionate costs exceeding £1,000."