Case No: C/2001/0997
 Neutral Citation [2002] EWCA Civ 20
IN THE SUPREME COURT OF JUDICATURE
COURT OF APPEAL (CIVIL DIVISION)
ON APPEAL FROM THE ADMINISTRATIVE COURT
Mr Justice Ouseley
Royal Courts of Justice
Strand, London, WC2A 2LL

Thursday 31 January 2002

Before :

LORD JUSTICE CLARKE
and
MR JUSTICE WALL

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Between :

	THE QUEEN ON THE APPLICATION OF
		
	(1) ASSISTED REPRODUCTION AND GYNAECOLOGY CENTRE	First Appellant/
Claimant	
	(2) “H”	Second Appellant/
Claimant	
	and		
	THE HUMAN FERTILISATION AND EMBRYOLOGY AUTHORITY	Respondent/
Defendant	

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(Transcript of the Handed Down Judgment of
Smith Bernal Reporting Limited, 190 Fleet Street
London EC4A 2AG
Tel No: 020 7421 4040,  Fax No:  020 7831 8838
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Mr Mohamed Taranissi, of the First Appellant, represented the First Appellant
Ms B Schwehr (Solicitor Advocate, of Rowe & Maw) for the Second Appellant
Miss D Rose (instructed by Morgan Cole) for the Respondent

Hearing date: 7 December 2001
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Judgment
As Approved by the Court

Crown Copyright ©

Mr Justice Wall: 
This is the judgment of the court.
Introduction
1.	The first appellant, the Assisted Reproduction and Gynaecology Centre (which we will call “the clinic”) is a limited company.  Its name accurately describes its function.  Its medical director is Mr Mohamed Taranissi FRCOG (Mr Taranissi), who represented the clinic before us.  The second appellant, Mrs H, is a patient of the clinic, who has been unable to conceive a child, and is being treated by Mr Taranissi.  Mrs H’s anonymity has been preserved throughout the proceedings, and nothing must be published which identifies her.  The respondent to the appeal is the Human Fertilisation and Embryology Authority (the Authority).
2.	The applications before this court are somewhat unusual.  They are: (1) a renewed application by the appellants for permission to appeal against an order for costs made against them on 25 April 2001 by Ouseley J when refusing their application for permission to apply for judicial review of advice given by the Authority on 23 November 2000 and communicated to the appellants by letter dated 4 December 2000 (the first decision); and (2) a renewed application for permission to apply for judicial review of further advice given by the Authority on 28 June 2001 and communicated to the appellants by letter dated 11 July 2001 (the second decision).
3.	The second decision superseded the first, and rendered academic the appellants’ application for permission to appeal against Ouseley J’s refusal of permission to apply for judicial review of the first decision.  Accordingly, when the matter was considered by the single Lord Justice, Sedley LJ, on the papers, he granted the appellants permission in principle to amend their application to challenge the second decision.  However, he refused permission to appeal and directed that any renewed application was to be on notice and was to include a proper draft amendment.  Whilst, accordingly, it might appear that we are taking on the function of a court of first instance in relation to the second of the two applications before us, it was sensibly agreed between the parties that, if we give permission to apply for judicial review of the second decision, that application will then be heard by a judge of the Queen’s Bench Division in the usual way, but that, if we refuse the application, our decision will be treated as final.
The Nature of the Issue
4.	The appellants challenge two particular decisions of the Authority whereby, at the appellants’ request, it gave advice about Mrs H’s treatment for infertility by the clinic.  At the material time, paragraph 7.9 of the Authority’s published Code of Practice stated that: “No more than three eggs or embryos should be placed in a woman in any one cycle, regardless of the procedure used.”
5.	Mr Taranissi wished to treat Mrs H by using more than three embryos.  As was made clear on a number of occasions, and indeed was repeated before us by Mr Taranissi, the clinic did not challenge the appropriateness of the general rule contained in paragraph 7.9.  The clinic’s argument was that it was appropriate to make an exception to the rule in Mrs H’s case, based on her particular treatment needs.  The Authority’s advice throughout was that to use more than three embryos in Mrs H’s case was not acceptable.
The Statutory Provisions
6.	The Authority is a body corporate created by section 5 of the Human Fertilisation and Embryology Act (the Act).  The Authority has a number of functions laid down by the Act.  In the introduction to its Code of Practice (5th edition, published in April 2001) the Authority gives this assessment of its role:
“The Authority’s principal task is to regulate, by means of a licensing system, any research or treatment which involves the creation, keeping and use of human embryos outside the body, or the storage or donation of human eggs and sperm.  It must also maintain a Code of Practice giving guidance about the proper conduct of the licensed activities.  The Act also allows the Authority to give guidance on any procedure involving the placing of eggs and sperm in a woman.”
7.	The relevant statutory provisions underpinning these powers are, firstly, section 3 of the Act, which provides as follows: 
“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 ………”
8.	By section 11 of the Act the Authority is given the power to grant licences authorising activities in the course of providing treatment.  The “licence” referred to in section 3(1) is defined in paragraph 1 of Schedule 2 to the Act as follows:
“Licences for treatment
(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,
(f)	….
(g)	such other practices as may be specified in, or determined in accordance with, regulations.
(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.
(4)	A licence under this paragraph cannot authorise altering the genetic structure of any cell while it forms part of an embryo.
(5)	A licence under this paragraph shall be granted for such period not exceeding five years as may be specified in the licence.”  
9.	The Act contains very detailed provisions relating to the grant and revocation of licences.  Section 13 sets out the conditions which must be attached to every licence.  These include, in section 13(2), an obligation on the holder of the licence to record such information as the Authority may specify about the following:
(a)	the persons for whom services are provided in pursuance of the licence,
(b)	the services provided for them.
10.	Two other sections of the Act are of relevance in this case.  The first is  section 8, by virtue of which the Authority has the following general functions:
“The Authority shall:
(a)	keep under review information about embryos and any subsequent development of embryos and about the provision of treatment services and activities governed by this Act, and advise the Secretary of State, if he asks it to do so, about those matters,
(b)	publicise the services provided to the public by the Authority or provided in pursuance of licences,
(c)	provide, to such extent as it considers appropriate, advice and information for persons to whom licences apply or who are receiving treatment services or providing gametes or embryos for use for the purposes of activities governed by this Act, or may wish to do so, and 
(d)	perform such other functions as may be specified in regulations.”
11.	The second relevant matter is that by virtue of section 25 of the Act, the Authority is required to maintain a code of practice giving guidance about the proper conduct of activities carried on in pursuance of a licence under the Act, and the proper discharge of the functions of the person responsible and other persons to whom the licence applies.  By section 25(3) the code of practice may also give guidance about the use of any technique involving the placing of sperm and eggs in a woman.  By section 25(4) the Authority is empowered from time to time to revise the whole or any part of the code, which must be published.  Section 25(6) provides that a failure on the part of any person to observe any provision of the code shall not of itself render the person liable to any proceedings, but;
(a)	a licence committee shall, in considering whether there has been any failure to comply with any conditions of a licence and, in particular, conditions requiring anything to be “proper” or “suitable”, take account of any relevant provision of the code, and
(b)	a licence committee may, in considering, where it has power to do so, whether or not to vary or revoke a licence, take into account any observance of or failure to observe the provisions of the code.
12.	As will be apparent, Mr Taranissi and the clinic operate under a licence granted by the Authority. 
The view we have formed
13.	We have come to the very clear conclusion that both applications before this court are devoid of merit and, inevitably, fall to be dismissed.  In these circumstances, it would, of course, be possible for us to deal with the appellants’ arguments succinctly, and to dispose of the applications in a few paragraphs. We have, however, decided, for two principal reasons, to set out the facts and the reasons for our conclusions in some detail. 
14.	Our first reason for taking this course is that, in common with the three judges before whom the case has come prior to it reaching this court, we do not regard either decision of the Authority as being capable of challenge by way of judicial review, and we think it important that any future litigant wishing to challenge a decision of, or advice given by, the Authority should be aware of the limits of  the court’s ability to intervene in the exercise by the Authority of its powers under the Act. 
15.	This is an area of rapidly developing scientific knowledge and debate, in which the Authority, as the licensing body established by Parliament, makes decisions and gives advice.  It is not the function of the court to enter the scientific debate, nor is it the function of the court to adjudicate on the merits of the Board’s decisions or any advice it gives. Like any public authority, the Board is open to challenge by way of judicial review, but only if it exceeds or abuses the powers and responsibilities given to it by parliament;
16.	Secondly, we owe it to Mrs. H to explain in detail why it is, in our judgment, that the attempt by the clinic and herself to use the courts to force the Authority to change its advice was a hopeless quest.  
The Facts
17.	Mrs H is 47.  She married when she was 41.  She and her husband were unable to conceive a child.  In May 1996, she consulted MrTaranissi.  Between June 1996 and July 2000, Mrs H underwent eight in vitro fertilisation treatment cycles, in each of which three of her embryos were replaced in the uterus.  Mrs H did not however become pregnant.
18.	On 3 July 2000, Ms Belinda Schwehr, of Rowe & Maw, wrote to the Authority on behalf of the clinic, inviting it to consider a relaxation of the ban on the insertion of more than three embryos in relation to several older patients.  Two paragraphs from the letter encapsulate Mr Taranissi’s view: 
“My client takes the view, as a medical professional, and as an expert in the field, with the statistics to prove his expertise, that the risk of any of these women having a multiple birth is non-existent, given the previous history.  He wants to transfer more than 3 embryos to each of these patients simply in order to give them a reasonable chance of conceiving or carrying a foetus beyond the first three months at all.  He takes the view that to do so is the minimum required by way of suitable fertility practice for these individuals, and is prepared to act on his professional judgment.
We are aware of the spirit of collaboration and co-operation now existing between the HFEA and my client’s Centre.  Would the HFEA be willing to acknowledge that transfer of more than 3 embryos in an individual case would be considered appropriate if it were credibly asserted that there was evidence which would convince a responsible body of fertility specialist opinion that such transfer was medically essential.”
19.	In a follow up letter dated 6 July, in what is plainly a reference to Mrs H, Ms Schwehr emphasised the urgency of treatment in relation to her case, and concluded that Mr Taranissi felt obliged to proceed on the basis set out in Ms Schwehr’s previous letter.  This produced a response from solicitors acting on behalf of the Authority which set out in detail the relevant provisions of the Act and the Code of Practice.  The letter concluded with a warning that if Mr Taranissi proceeded with the transfer of more than three embryos in one treatment cycle, the matter would be referred to a Licence Committee.  It pointed out that if the Licence Committee concluded that Mr Taranissi had failed to discharge his duty under section 17 of the Act, then his licence could be revoked.
20.	On 9 July 2000, Mr Taranissi wrote to the Authority inviting it to refer the “three embryos rule” to a Licence Committee for formal consideration as a matter of urgency.  Mr Taranissi made it clear that it was not the clinic’s intention to challenge the “three embryos rule” in its wider application to IVF treatment, but only in its application to this specific case, which he believed required special consideration.  Attached to his letter was a “summary of the history of the patient in question”, who was, of course, Mrs H.  This document read as follows:
“DOB: 17/6/1954 ....  
Para 0+1, 1st trimester miscarriage in 1984.
History of bilateral tubal block and unsuccessful tubal surgery in 1995.
Hysteroscopy in 1998 revealed an initially normal uterine cavity.
Starting in 1996, she has had seven unsuccessful IVF/ICSI treatments (of which three were unsuccessful frozen embryos replacement cycles) coupled with AH and prolonged embryo culture.  Her last frozen embryo replacement cycle was in January 2000.
She has always responded adequately to ovarian stimulation in the past and produced good quality embryos; hence the frozen embryos replacement cycles.
Her gonadotrophic assessment in the early follicular phase has always been in the normal range including the last assessment in June 2000.
She is currently undergoing controlled ovarian hyper-stimulation with 300 iu of HMG (to which she has responded adequately) and is scheduled for embryo transfer on Thursday/Friday 13/14 July 2000
Taking into account the above history the chance of a high order multiple pregnancy in this particular case is negligible.  (After all this patient has had a total of 21 embryos replaced during the course of her previous treatments without even getting pregnant once!).  It is also ironic that should her tubes been patent, GIFT procedure with the replacement of an unlimited number of eggs would have been an accepted medical practice in her case
It is my strong belief that the replacement of more than three embryos in this particular case is not just medically essential and professionally sound, but is the minimum required in the discharge of my professional responsibility towards this patient.”
21.	On 10 July 2000, Ms Schwehr wrote to the Authority’s solicitors pointing out that the current guidance from the American Society for Reproductive Medicine (ASRM) was a recommendation for the use of more than three embryos in older patients with poorer prognosis of pregnancy, although the decision was a matter for the individual doctor, based on the specific characteristics of each patient.
22.	A Licence Committee of the Authority duly met on 27 July 2000 to consider the case, and its conclusions were communicated to Ms Schwehr by letter dated 29 July 2000.  After making a number of points relating to the powers and duties of the Authority, the advice tendered by the Committee was in the following terms.
“4.	The Licence Committee has noted the guidelines issued by ASRM as well as guidelines issued by other countries.  The Committee has taken particular note of the recommendations on good practice of BFS (the British Fertility Society) and RCOG (the Royal College of Gynaecologists), recognising that these have specific relevance to practice in the UK.  (These guidelines have already been mentioned in correspondence).  The Licence Committee draws your client’s attention to the concerns expressed in both the BFS and RCOG guidelines about the consequences of multiple pregnancies following embryo transfer.
5.	The Committee has considered the summary of the specific characteristics and history of one of the patients mentioned in your correspondence.  The Committee has also considered data held by the Authority in relation to cycles between 1.8.91 and 31.3.98 involving fresh embryo transfers created from patient’s own eggs.  The data indicate that the multiple birth rate for women aged 40 and above is 11.7%.  Whilst numbers achieving pregnancy at age 46 and above are very small, the multiple birth rate was actually 60% (3/5).  The Licence Committee’s view is that this could not be considered negligible.
6.	The Committee has also considered statistics published by the US Department of Health entitled “1997 Assisted Reproductive Technology Success Rates: National Summary and Fertility Clinic Reports” published in December 1999, recognising that those statistics relate to a country where there are no restrictions on the number of embryos that can be transferred.  These data indicate that, for a woman aged 46, the live birth rate is approximately 2%.  This compares with a live birth rate in the UK where no more than 3 embryos can be implanted in any one cycle of 1.2%.  The Licence Committee’s advice is that this data does not support the view that the replacement of more than 3 embryos leads to any significant increase in the likelihood of a live birth or that this could be said to be medically essential.
In conclusion the Licence Committee’s advice is that your client should not proceed with the transfer of more than 3 embryos.  If he should do so, then he takes a risk that he will be found, by a Licence Committee, to have failed to follow a suitable practice for the reasons stated.”
23.	On 7 August 2000, following queries raised by Ms Schwehr, the Authority’s solicitors wrote to her on 7 August 2000 in the following terms:
“We confirm that the live birth rate of 1.2% (referred to in paragraph 6 of our letter) relates to cycles between 1 8.91 and 31.3.98 involving transfer of fresh embryos create from patients’ own eggs.  As our letter confirms, the multiple birth rate (referred to in paragraph 5) is based on the same data.  Whilst numbers achieving pregnancy at age 46 and above are very small, this was the largest data set available.  Of the numbers achieving pregnancy at age 46 and above, the triplet birth rate was 20% (1/5).  The Licence Committee did not consider the risk of multiple pregnancy (including the risk of higher order multiple pregnancy) to be negligible.”
24.	It is accepted by the Authority that the statistics relating to multiple births contained in paragraph 5 of its advice of 27 July 2000 and the letter of 7 August were inaccurate.  In fact, in the category of women aged over 46 in the United Kingdom, there had been no live births resulting from transfers of embryos created from the patient’s own eggs.  The Authority’s error, we were told, was the result of clinics providing it with inaccurate reports of their results.  As a consequence, the Licence Committee reconsidered the questions raised by the clinic, and on 14 August 2000 the Authority’s solicitors wrote to the appellants’ solicitors in these terms:
“We refer to our letters of 28 July and 7 August.
In those letters we mentioned certain UK data relating to cycles between 1.8.91 and 31.3.98.  The Licence Committee has reconsidered the questions raised by you in correspondence without reference to that data.
The Licence Committee considered other available evidence, including that derived from the four publications referred to in the attached annex and in addition to the guidelines of the RCOG and BFS.
The Licence Committee acknowledges that the numbers of cases are limited but what published evidence there is indicates there is still a risk of multiple pregnancy (including higher order births).  It would, therefore, be prudent, given the case that you have described, not to replace more than three embryos in any one treatment cycle.
On the evidence available, the Licence Committee remains of the view that it would be an unsuitable practice to transfer more than three embryos.”
25.	The publications sent with the letter included two which were to feature later, namely Live Birth Rates and Multiple Birth Risk Using In Vitro Fertilisation by Dr.  L.A.  Schieve ( the Schieve paper) and by Dr S Senoz entitled An IVF Fallacy: multiple pregnancy risk is lower for older women (the Senoz paper).  The letter of 18 August, which we have reproduced in full, was subsequently described by Ouseley J, on the appellants’ application for permission to apply for judicial review of the first decision as “not an explicit disavowal of those earlier errors”, and was the principal reason, it appears, why he awarded the Authority only one half of its costs of resisting the application.
26.	In a lengthy letter dated 18 August 2000 Ms Schwehr told the Authority’s solicitors that she had advised Mr Taranissi that he had grounds for challenging the Committee’s stance.  She contended, in particular, that the advice did not indicate what weight had been given to the individual treatment history of the patient.  She invited the Authority to reconsider its position “as a matter of urgency”.
27.	The Authority duly did so and on 21 September 2000 a letter was written to Ms Schwehr confirming that in reaching its decision the Authority had taken into account the specific circumstances and treatment history of the particular patient and that it had considered all relevant and available evidence, including the studies previously mentioned.  Having done so, the Committee remained of the same view. 
28.	On 2 October 2000, in another detailed letter, Ms Schwehr invited the Authority “as a whole” to reconsider its advice failing which she anticipated receiving instructions to apply for judicial review.
29.	The Authority again acceded to this request and set a date for its meeting of 26 October 2000.  It did not, however, reach a conclusion at that meeting; rather, by letter from Morgan Cole dated 27 October, it sought additional information from the appellants.  The information sought was:
(1)	In relation to the treatment history of the particular patient please provide a chronology of treatment and indicate, in respect of each date of treatment:
(i)	whether the cycle was stimulated;
(ii)	the number of embryos used;
(iii)	whether those used were fresh or frozen.
(2)	In relation to the proposal that the patient should undergo further treatment using 5 embryos, please confirm:
(i)	whether it is proposed to transfer fresh or frozen embryos;
(ii)	whether it is proposed that the replacement of 5 embryos be limited to one cycle or whether further cycles are envisaged;
(iii)	why it is considered to be medically essential to transfer 5 as distinct from 3 embryos in this patients case;
(iv)	what information has been given to the patient about
•	the limitations and possible outcomes of the treatment proposed in her case including the prospects of a live birth;
•	the possible side effects and risks of the treatment to her and any resulting child including the risks associated with multiple pregnancy.”
The letter concluded with the information that the Authority would give further consideration to the matter at its meeting on 23 November 2000.
30.	Ms Schwehr replied on 30 October 2000.  The Authority was sent a further copy of the treatment summary which we set out in full at paragraph 20.  It is also relevant to what happened later that, in the course of the letter, Ms Schwehr said this:
“The information states clearly that frozen embryos were used on three occasions and our client has confirmed that fresh embryos were used for the eighth treatment.  Consequently it is implicit that the cycles for the treatment during which fresh embryos were used were in fact stimulated, and this is further indicated by the statement that the patient “has always responded adequately to ovarian stimulation in the past and produced good quality embryos”.
The summary also explains why the transfer of more than 3 embryos is considered to be medically essential.  As we have explained previously, it remains our clients professional and medical view that the transfer of more than 3 embryos is essential simply in order to give the patient a reasonable chance of conceiving or carrying a foetus beyond the first few months at all and he regards this as the minimum required by way of suitable fertility practice at this stage.  Such practice would be in line with the current guidelines produced by the American Society for Reproductive Medicine (November 1999).  The Authority’s own statistics, supplied to us under cover of a letter dated 13 October, show that the chances of a patient at this stage becoming pregnant are negligible, to say the least.
31.	On 16 November 2000, Ms Schwehr wrote to Morgan Cole giving particulars of the dates of the cycles of treatment undergone by Mrs H.  There were, in total, 8 cycles between 12 June 1996 and 14 July 2000.  For present purposes, it is only relevant to note that cycle 5, which commenced on 22 October 1998, cycle 6, which commenced on 1 October 1999, and cycle 8, which commenced on 14 July 2000 all used fresh embryos, whereas the 7th cycle, which began on 25 January 2000, used frozen embryos.
32.	The Authority’s decision taken at its meeting on 23 November 2000 (the first decision) was conveyed to the appellant’s solicitors by letter from Morgan Cole dated 4 December 2000.  This is a letter of 4 pages containing some 18 paragraphs.  In her skeleton argument on behalf of the Authority, Ms Dinah Rose summarised it by submitting that the advice was based on the evidence before the Authority at the time, including the information that had been provided by the appellants to the effect that Mrs H had always produced “good quality embryos”.  Ms Rose pointed out that this assertion was corroborated by the fact that Mrs H had received treatment with frozen embryos on three occasions.  Embryos which appear to the clinician to be of a poor quality are not frozen.
33.	In the light of subsequent challenge to the first decision, it is necessary for us to set out 4 paragraphs of the advice in full.  Paragraphs 4, 5 and 6 were in these terms:
4.	At the meeting on 23 November, the Authority considered very carefully the information contained in your letter dated 16 November 2000.  The Members noted the history of treatment provided to the particular patient and the reasons for opinion that the transfer of five embryos in one treatment cycle is medically necessary in this case.
5.	The members noted that the patient concerned has always responded adequately to ovarian stimulation and produced good quality embryos.  This has enabled fresh embryos to be transferred and spare embryos to be cryopreserved for subsequent transfer.  The members considered that it was unusual for a 46 year old patient to be producing a large number of good quality embryos following relatively low doses of stimulatory drugs.  The members considered that the availability of good quality embryos for transfer meant that this particular patient would be at a higher risk of having a multiple birth than a 46 year old patient with poor quality embryos.  The Authority was also concerned that the possible complications arising from a multiple pregnancy were more severe than in the case of a younger patient.
6.	The members considered whether there might be any advantage to the patient in her having one transfer of 5 embryos rather than the same number (or possibly 6) being replaced over two transfers.  The members considered that pregnancy rates achieved following separate embryo transfers from a single egg collection were on the whole better than those following a single transfer of a large number of embryos.  The Members did not agree that the transfer of more than 3 embryos in a single cycle is “medically necessary” or “medically essential” in this patient’s case.
34.	After what was plainly a full and careful consideration of all the relevant and available material, the Authority concluded in paragraph 14 that:
“The Authority did not agree that in this patient’s case the transfer of more than 3 embryos in one treatment cycle would significantly increase the chances of a live birth without a more than negligible increase in the risk of a higher order multiple pregnancy.  Accordingly, the Members did not feel that this case could be regarded as an exception justifying departure from the guidance in the Code of Practice.  The Members recognise that one factor might affect future decisions in that the state of the clinical evidence (and therefore the evaluation of the risk) might change.”
The application for judicial review of the first decision
35.	We have set out the detail of the process from the initial letter of enquiry to the authority dated 3 July 2000 to the decision letter of 4 December 2000 to demonstrate what in our judgment is the careful, thorough and responsible way the Authority went about its task of responding to the requests for advice made by Mr Taranissi and Mrs H.
36.	The appellants issued proceedings for judicial review on 20 December 2000.  They contended that the Authority erred in law three respects:
“(1)	fettering its discretion in treating its own Code of Practice as “authoritative” and refusing to depart from that guidance despite the existence of exceptional circumstances;
(2)	taking into account irrelevant factors and not taking into account relevant considerations in making its decision; and
(3) 	failing to give any rational or proportionate reasons for its decision, and thereby inviting the inference that it has acted irrationally.”
37.	The statement of grounds in section 6 of the Application runs to some 22 pages, which we will not attempt to summarise.  It is, however, noteworthy that the Statement of Grounds does not suggest, contrary to a submission made to us, that paragraph 5 of the Authority’s decision letter (set out in paragraph 33 above) represented a fundamental misunderstanding of Mr Taranissi’s treatment summary set out in paragraph 20.
38.	The application was considered on the papers by Richards J.  He refused permission.  He did not consider there to be an arguable case for judicial review, and in particular he stated:
“There has plainly been no fettering of discretion: the advice does not accord a disguised mandatory status to the Code, but is based on consideration of the merits of the individual case.
I see no reason to reject the statement in paragraph 4 of the letter of 4 December 2000 that the Authority considered very carefully the information contained in the claimant’s letter of 16 November 2000.  Grounds do not show that the Authority took into account something that it was not legally entitled to take into account, all failed to take into account something that it was legally required to take into account.  The arguments advanced by reference to relevant/irrelevant considerations are in truth an attempt to canvass the merits of the case before the court.  That is not the role of the court on judicial review - a point of particular importance in relation to matters of judgment by an expert body in a specialist field.
The decision is not arguably irrational.
Article 6 ECHR is not engaged.
If and to the extent that the advice given by the Authority interferes with the rights of the second claimant under Articles 8 and 12 ECHR, the resulting issues were properly considered by the Authority which was entitled to conclude (paragraphs 16 - 18 of letter of 4 December) that any such interference was justified as being in accordance with law and no more than necessary to meet a legitimate aim.
39.	We entirely agree with that analysis. However, the appellants did not accept Richards J’s decision.  They renewed their application for permission before Ouseley J, who heard the matter on 24 April 2001 and gave judgment the following day.  In his judgment, the judge accepted entirely that the personal circumstances of Mrs H, and the possible impact of the court’s decision on her individual and matrimonial fulfilment, warranted anxious scrutiny.  He was, moreover, prepared to assume that articles 8 and 12 of the European Convention on Human Rights applied, and that what he described as “a more intrusive form of judicial intervention” was arguably required.  This we take to be a reference to the speech of Lord Steyn in R v Secretary of State for the Home Department ex parte Daly [2001] UKHL 26, [2001] 2 WLR 1622.  The judge continued:
“However, wherever the boundaries of judicial review are drawn for these purposes, it remains fundamental to the arguability of the claimant’s case that there be features demonstrated which arguably take the decision out of the range of available decisions.  Even with a more intrusive approach, the court would be bound to allow substantial room for the application of expert and scientific judgment by the bodies specifically entrusted to provide guidance in these sensitive medical and ethical areas.
Fundamental to leading counsel’s submissions is the contention that, whilst the balancing exercise carried out by the Authority reflected the correct approach to be adopted, the inputs to the analysis of harm and benefit which would flow from the use of 5 rather than 3 embryos in one cycle, arguably involved such a significant degree of misunderstanding of the relevant scientific considerations as to enable the decision to be described as one falling outside the range of available decisions, even on the basis of a more limited available range.”
As that was patently not the case, Ouseley J concluded that the application for judicial review was unarguable.
40.	Before Ouseley J, leading counsel for the appellants relied on the statistical errors to which we referred in paragraph 24.  He argued that the Authority’s own statistics contradicted its assessment of the prospects of pregnancy and multiple birth.  He referred to the fact that a document produced by the Authority showed that for cycles between 1991 and 1998 involving woman of 46 or over and the transfers of fresh embryos created from the patient’s own eggs, there were no pregnancies and hence no multiple births.  This, it was argued, stood in stark contrast to what was said in correspondence by the Authority’s solicitors.  Reference was made to paragraphs 5 and 6 the letter of 29 July 2000 (set out at paragraph 19 above), which referred to data indicating that there was a 60% multiple birth rate for women achieving pregnancy at 46, and that there was a live birth rate of 1.2% in the United Kingdom for women of 46.  Likewise, it was pointed out, the letter of 7 August 2000 from the Authority’s solicitors referred to data which said that a live birth rate of 1.2% was achieved for women aged 46 and above, and that the triplet birth rate was 20% of live births.
41.	The judge commented:
15.	Plainly, the [Authority’s] statistics and the letters cannot live together.  However, Miss Rose pointed out that the Authority as a whole had specifically considered the matter; that is to say the Authority, rather than the licence committee responsible for the two letters which I have referred to, was responsible for the reasoned decision letter upon specific consideration of the second claimant’s individual circumstances.  She also pointed out that in a letter dated 14th August 2000, the Authority had acknowledged that the earlier letters were referring to the wrong statistics, and in fact [these] statistics [relating to cycles between 1991 and 1998] were those which had been relied upon.
16.	It is true to observe that the renunciation of the earlier correspondence could have been more explicit, but the error to which that earlier correspondence was prey is not repeated in the decision letter under consideration.”
42.	The judge then considered a paper prepared by the American Society for Reproductive Medicine, which recommended in patients with the most favourable prognosis, that usually no more than two good quality embryos should be transferred.  The judge also considered the Senoz paper, published in 1997, and the Schieve paper, published in November 1999.  Each of these papers had, of course, been considered by the Authority as part of its decision making process.  The judge commented on the debate in these terms:
“25.	The debate, to my mind demonstrated three points.  First the Authority had a clear answer to the statistical point that had been raised by leading counsel, both as to the figures which it actually used and as to the fact that those statistics did not arguably contradict the fundamental approach it adopted, namely the risk of multiple births from pregnancy should it occur was greater with a patient who had good eggs if more than three were transplanted.  Secondly, the Authority considered the specific medical circumstances and age of the second claimant, rather than applying its policy guideline without considering what was appropriate for a woman with her characteristics of age and egg producing capabilities.  Thirdly, however intrusive a level of scrutiny by the court might be appropriate, the court could not be the adjudicator between two views of an academic paper or its relationship to the United States National Vital Statistics Reports referred to in paragraph 10 of the letter, or the Schieve paper.  Certainly [leading counsel] had not demonstrated that it was clearly arguable that there was a serious misunderstanding by the Authority of that academic paper falling outside the scope of appreciation available to a specialist and an expert body.”
43.	In brief, the judge’s view was that the medical evidence relied upon by the appellants did not show the Authority to be irrational: it merely showed that two differing views were possible.  Echoing the view expressed by Richards J, the judge commented that, if that was all it showed, the application constituted a clear and wholly impermissible invitation to the court to descend into a decision on the merits at a level of intervention far beyond that necessary for the anxious scrutiny of the lawfulness of a decision in which human rights are potentially engaged.  The judge continued:
“27.	As to whether two successive cyclical treatments with three eggs as opposed to five eggs in one cycle would achieve better prospects of pregnancy without a greater risk of multiple births, the Authority was entitled to reach the view it did in paragraphs 6 and 7 of its reasoned decision letter.  There may of course be two reasonable views possible but to suggest that the absence of success so far for (Mrs H) showed the Authority’s view to be outside the range available to an expert body, again simply impermissibly invites the court to have a range of medical views deployed before it and to decide between them for itself.”
The judge concluded:
“30.	I do not consider that any of the other points raised by [the clinic] in paragraph 13 of [its] skeleton argument raise an arguable point on rationality, within even the narrow limits applicable because of the potential engagement of Articles 8 and 12 of the Human Rights Convention.  They all come back to or depend upon the statistical issues discussed above.  I do not consider that the decision letter shows any fettering of the Authority’s view such that the appropriate or proportionate application of the guidelines to this particular patient was ignored.  On the contrary, the relevant personal medical information was sought, and a conclusion was reached in the light of the significance of the production, even at her age, of a large number of good quality embryos with little artificial stimulation.
31.	It may be that the circumstances in which the Authority give different advice as to appropriate practice are indeed very limited, but it may also be that in comparison with other opinions, for example the United States appears to favour no more than two embryos being transferred, United Kingdom guidance is already drawn more generously in the first place.
32.	I have taken some time to set out my reasons in some detail, notwithstanding that this is but an application for permission, because (Mrs H)’s circumstances do warrant anxious and indeed sympathetic scrutiny.  It is my judgment, however, that the submissions placed before this court on behalf of both parties, by which I mean the claimants and defendant, have shown this to be a case in which there is no arguable point, and that the asserted errors are not errors at all but at the best differences of expert view, the resolution of which is for the Authority and not for the court.”
44.	We entirely agree with Ouseley J’s analysis. The judge then went on to make an order that the appellants pay one half of the Authority’s costs.  As this is one of the orders which the appellants seek permission to appeal, we record that the judge accepted that it was a normal exercise of discretion to award a successful defendant costs albeit not an invariable practice.  He continued:
“My reason for a partial departure from it is that I accept the thrust of submissions made by Ms Schwehr that up until the moment when the assistance was received in this court from Miss Rose, the Authority had not clearly dealt with the point that arose in relation to statistics.  The letter (of 14 August 2000) is not an explicit disavowal of those earlier errors, and the relevance of the true statistics is not explicitly dealt with in the decision letter.
Secondly, whilst the decision letter undoubtedly identifies the importance of the availability of good quality embryos to transfer as being the basis for the conclusion that the patient would be at high risk of multiple birth, there is no explanation of why that might be so.  It might be a matter of statistics, it might be a matter of mechanics, but nothing was explained.
The second decision
45.	Following the hearing before Ouseley J, the appellants obtained a statement from Dr Senoz to the effect that the data in his paper could not be extrapolated to patients over the age of 40.  We have read Dr Senoz’s paper and we agree with Ms Rose, for the Authority, that such a conclusion is not apparent from the text of his paper.  The conclusion reached in the paper was that “the number of embryos transferred should be limited to a maximum of three regardless of the age of the patient” (our emphasis).  Moreover, the text of the paper concluded with this sentence:
“The false impression of low multiple pregnancies in older patients comes from the low pregnancy rate in general in this age group.  Therefore, we conclude that women over the age of 35 should not be treated differently than their younger counterparts with regard to the number of embryos transferred, unless there is an individual indication to transfer more
There is nothing in the text of the paper to suggest that 40 is a “cut off point”.  Miss Rose commented, and we agree with her, that the use of the phrase “regardless of the age of the patient” is surprising, if the paper was in fact intended to be relevant only to patients aged 40 or under.
46.	By a letter dated 3 May 2001, the appellants invited the Authority to reconsider its decision on the basis of the fresh evidence obtained from Dr Senoz, amongst other matters.  They also referred to “further evidence from Mr Taranissi” that the eighth attempt at IVF (carried out after the Authority was first asked to consider the case) suggested to him that the patient’s embryo quality was in fact deteriorating.
47.	On 18 May 2001 the Authority agreed to reconsider the matter, and on 30 May 2001 explained that the date for reconsideration would be 28 June 2001, in order “to enable members to give careful consideration to the further information submitted”.  In addition to the new material and evidence submitted by the appellants, the Authority had itself also obtained further material, which was provided to the appellants for comment.  In the meantime, on 26 June 2001, the appellant’s application for permission to appeal against Ouseley J’s refusal of permission to apply for judicial review and his order that the appellants pay one half of the Authority’s costs came before Sedley LJ on paper.  In the light of the Authority’s imminent reconsideration of its decision, Sedley LJ deferred consideration of the papers until the outcome of the Authority’s deliberations was known.  
48.	The correspondence leading up to the Authority’s decision letter of 11 July 2001 is marked by some intemperate letters from the appellants’ solicitors, upon which Sedley LJ commented adversely in his reasons for refusing permission on 23 July.  We note in passing that the unfortunate tone of the correspondence from the appellants’ solicitors was not reciprocated, and that the letters from the Authority’s solicitors remained moderate and professional throughout.  It is fair to say that Ms Schwehr did not attempt to justify the tone of the correspondence.  She sought to explain it by what she described as her clients’ increasing frustration at the attitude of the Authority.  However, we are bound to say that the tone of the correspondence emanating from her firm in this period is highly regrettable, and particularly inappropriate in a case dealing with such sensitive and emotive issues.
49.	The authority’s second decision was communicated by letter dated 11 July 2001.  Once again this was a long and careful document containing some 15 paragraphs.  The Authority made it clear that the reason for the policy contained in paragraph 7.9 of the 4th edition of the Code of Practice was to minimise as far as possible the health risks arising from multiple pregnancies and multiple births, including the risk to any child that is born and is damaged by obstetric or neonatal complications.  It pointed out that multiple pregnancies can lead to a much higher risk of complications during pregnancy, premature birth, and low birth rate, disability and neonatal death.  Low birth weight babies, it pointed out, are much more likely to suffer from serious life-long health problems such as cerebral palsy.  The cost of these problems also places a financial burden on the National Health Service and society.  In paragraph 4 of the letter, the Authority stated:
“The Authority has considered carefully, whether, in this case, the transfer of more than three embryos would be likely to significantly enhance the chance of this patient becoming pregnant, and whether any such benefit is outweighed by a greater risk of a multiple pregnancy.  The Authority has assessed both the general state of clinical knowledge and the available statistics and the facts of this case.”
50.	After considering Dr Senoz’s statement that his study could not be extrapolated to patients over the age of 40, the Authority recorded that certain cycles between August 1991 and 31 March 1998 involving transfer of fresh embryos created from patients’ own eggs had been inaccurately reported by the centres concerned.  The members noted the revised table of UK data.
51.	The letter continued:
“7.	The Authority also considered the US data for the years 1995 to 1998 and the additional data and information provided by Dr Schieve concerning cycles between 1996 and 1998, involving women aged 46 or over.
8.	The Authority recognises that the available data relating to patients over the age of 46 is very limited.  The revised UK data confirms that there have been no live births in the UK for any patient aged 46 or over.  Furthermore, apart from the data for 1995, (which indicates a success rate of patients aged 47 or over was zero), the US data for the years 1996 to 1998 confirms that very few women aged 47 or over have treatment using their own eggs.
9.	The data information from Dr Schieve confirms that between 1996 and 1998 there were 394 procedures involving women aged 46 or over using their own eggs.  Amongst these there were a total of 14 procedures (3.6%) that resulted in a live birth of which 6 (43%) were multiple births.  The Authority recognises that this data involves very small numbers and cannot be broken down into further categories.  The Members also took into account the points made in your letter dated 27 June 2001.  Nevertheless, the data indicate a multiple birth rate of 43% for procedures involving the use of patient’s own eggs.
10.	The Authority is anxious to avoid multiple pregnancies, not just births.  This is in line with the guidelines of the Royal College of Obstetricians and Gynaecologists and the British Fertility Societies.  The Authority noted that 1998 US data refers to there being “almost twice as many triplet pregnancies as triplet births”.  Information on medical multi-foetal pregnancy reduction is incomplete and not provided within the US data.
11.	The Members considered that the reduction in embryo quality would reduce the prospects of a live birth (including a multiple birth) in this patient’s case.  The Members noted the comments made about the likely viability of the embryos.  The Members noted the treatment history of this patient, in particular her age and the number of previous cycles that had failed.  They noted that, after 8 cycles in which 24 embryos have been transferred, no pregnancy has occurred.  The Members considered it almost certain that any future treatment will fail whatever number of embryos are transferred.  The Members considered that it is very doubtful that increasing the number of embryos transferred will have any significant effect on this patient’s chance of pregnancy.
12.	On the other hand the members considered that in the very unlikely event that the patient succeeds in becoming pregnant, the risk of a multiple pregnancy would be higher if five embryos are transferred rather than three.  In the context of the very low chance of pregnancy for this patient the Authority considered that a possible marginal improvement in that chance was outweighed by the attendant risks (albeit small) of a multiple pregnancy if five embryos are transferred.  The Authority did not agree that the transfer of more than three embryos in one cycle could be considered “medically necessary” or “medically essential” in this patient’s case.  The Authority also noted that health risks associated with multiple pregnancy are particularly severe for older women.”
52.	The Authority then advised that it had approached the case on the basis that Articles 8 and 12 of the European Convention on Human Rights and Fundamental Freedoms might apply, and expressed the opinion that any interference with those rights was in accordance with the law, given that the Act required it to determine what constitutes suitable practice and to give appropriate advice.  The Authority also specifically considered whether the interference pursued a legitimate aim, and decided that it did - namely the obviation of health risks and costs of multiple pregnancy and multiple births.  Finally, in considering proportionality, the Members were reported to have balanced the importance of the need for interference against any detriment to the rights of the individual patient.  The Members did not consider that the interference with the rights in this particular case was more than necessary to meet the legitimate aim.
53.	On receipt of the decision made on 28 June 2001, Sedley LJ reconsidered the papers.  In order to accommodate the appellants, he granted them permission in principle to amend the application for judicial review to challenge the second decision.  However, as stated above, he refused permission to appeal, and directed that any renewal of the application for permission to appeal should be on notice and should include a proper draft amendment.  This, accordingly, is how the matter came before us.
54.	We propose to set out Sedley LJ’s reasons for his decision in their entirety:
“I initially considered this application on 26 June, two days before the Authority was due to reconvene on the case.  It was evident that, whatever the legal character of the further decision, it was going to traverse all the ground, new or old, relied on by the applicants.  This seemed to me preferable, even from the applicants’ point of view, to a judicial review appeal in which at least one important element was going to have to be introduced (if at all) as fresh evidence and in which intractable problems of interventionism and deference were going to arise.  If there was ever a field in which the important thing was a properly considered decision by an expert body and not a court, it is this.
I was also concerned at the tone of some of the correspondence, which appeared designed to put pressure on the Authority to capitulate rather than to reconsider.  Rowe and Maw’s lengthy letter of 13 June 2001 to the Authority’s solicitors, with its hectoring prose and typographical extravagances, is entirely unacceptable in judicial review proceedings, and never more so than when the subject-matter is as difficult and as fraught as it is here.  One knows that costs are always a residual problem where an application is pre-empted by voluntary reconsideration, but this is not solved either by such correspondence.
I now have before me the further decision of 28 June, together with Rowe and Maw’s letter of 18 July and the associated documents.  I accept that the preferable course is to bring the new decision on board by amendment, and so have granted permission in principle to amend, but I do not consider that any of the proposed heads of challenge is tenable.
Clearly, any challenge now has to be to the 28 June decision.  The earlier decision, however, and the critiques of it are part of the evidence in support of the fresh challenge.  I do not accept, even so, that the inevitable imperfection or paucity of empirical date can possible serve to impugn the rationality of either decision.  So far as there was an initial misappreciation of the data (which can, I accept, go to rationality), this has been corrected.  For the rest, the Authority must make what it considers right of the materials at its disposal.  No court can be asked to re-evaluate the data.
The argument that the Authority has fettered its discretion is, I have to say, sophistry.  It is one thing for a decision-maker to decide in advance that no applications of a particular kind are going to succeed.  It is another to reach a reasoned decision which no doubt would - and arguably should - be reached again similar facts.  To call the latter a fettering of discretion is to damn the Authority if it attempts to achieve consistency from case to case and to damn it if it does not.
The initial allegation under head 3 (“the Authority is merely selectively choosing extracts from the data which support its own position...”) is not of fettered discretion but of bad faith.  The only support offered for it is the Authority’s re-evaluation of certain research data.  The allegation is unsustainable.
The ECHR claim has been based throughout on an unargued assumption that Article 8 and Article 12 Rights are engaged.  I see no reason to assume that they are.  But if they are, they have been contingently addressed with care by the Authority, and I see no realistic prospect that a court would reach a different conclusion if the Authority’s decision is otherwise sound.
Although the applicants do not raise it, I have also considered whether the shift in the intensity of review signalled by the recent decision in Daly is capable of affecting the prospects of this application.  In my view it cannot do so.
We entirely agree with Sedley LJ’s analysis.
55.	Notwithstanding the powerful views expressed by Sedley LJ, the applications before us proceeded, and were vigorously argued by Ms Schwehr on behalf of Mrs H and by Mr Taranissi on behalf of the clinic.  Ms Schwehr’s skeleton argument with its annexes, runs to some 33 pages.  As we understood it, in essence three points were advanced.  They were:
(1)	that the second decision was an attempt by the Authority to pre-empt the appeal from Ouseley J’s decision refusing permission to apply for judicial review of the first decision;

(2)	that the Authority acted irrationally in placing reliance on the statistics contained in the report of Dr. Schieve; 

(3)	that the Authority's conclusions in paragraph 11 and 12 of the second decision letter dated 11 July 2001 relating to the risk of the treatment of Mrs H with more than three embryos resulting in a multiple birth were irrational.

In our judgment, none of these propositions is arguable.  However, we consider them briefly in turn.
Pre-empting the appeal from the decision of Ouseley J.
56.	We are not, of course, strictly speaking, concerned with the rationality of the first decision, since it was superseded by the second. As we have already indicated, however, we find ourselves in entire agreement both with the views of Richards J when refusing permission on the papers, and with Ouseley J when refusing permission after argument.  We are quite satisfied that any application for permission to appeal the substantive decision of Ouseley J would have failed.
57.	We should also make it clear that in our judgment, the decision by the Authority to reconsider its advice following the failure of the appellants’ application before Ouseley J was in no sense a tactic by the Authority to avoid what the appellants’ solicitors described in correspondence, quite inappropriately, as “the embarrassment inherent in the disclosure of the true facts described in the Grounds of Appeal within the context of a permission hearing, at the same time as avoiding paying the costs for its unreasonable and mistaken approach in November 2000”.
58.	Ms Schwehr, albeit in somewhat more moderate language, nonetheless sought to persuade us that there was substance in the point.  The submission is demonstrably unsustainable by a simple recitation of the facts.  In the letter of 3 May 2001, to which we have already referred, the appellant’s solicitors accuse the Authority of acting both unreasonably and incompetently in relation to Dr Senoz, and announce that they have lodged grounds of appeal.  However, without prejudice to those grounds, they say they are prepared to offer the Authority a further opportunity to reconsider its position in relation to Mrs H’s case.  The appellants thereupon specifically invite the Authority to re-convene the members who participated in the original decision as a matter of urgency, so that a number of identified factors could be re-considered “with a view to avoiding further litigation”.  Six factors are then listed, including the Senoz point and the question of the quality of Mrs H’s embryos.  This, as we have already described in paragraph 47 is an invitation which the Authority accepted. 
59.	In the light of this correspondence we do not understand how the appellants can criticise the Authority for doing what they themselves invited the Authority to do.
Reliance on Dr Schieve
60.	As to the second point, the reliance on Dr Schieve, Ms Schwehr, in argument before us, described paragraph 9 of the Authority’s letter of advice of 11 July 2001 (quoted in paragraph 51 above) as both “astonishing” and “impossibly irrational”.  Even without the hyperbolic adverb, we do not understand the submission.  It is clear from the text that of the 394 procedures referred to, 14 resulted in live births and that of the 14, 6 were multiple births.  In percentage terms, 6 is 43% of 14 and 14 is 3.6% of 394.  Thus of the 394 procedures, 6 resulted in multiple births (1.52%), and the sentence: “Nevertheless, the data indicates a multiple birth rate of 43% for procedures involving the use of patients’ own eggs” can only mean, in the context, 43% of procedures resulting in live births. 
61.	Paragraph 9 of the letter must also, of course, be read in context, starting with paragraph 7.  The Authority recognised that the data were limited and that the numbers were small.  We recognise that the analysis is cautious, but, in our judgment, it can by no stretch of the imagination be described as irrational.
Irrationality in paragraphs 11 and 12 of the letter of 11 July 2001
62.	As to the third point, we likewise see nothing irrational in the Authority’s position.  The members thought that future treatment for Mrs H was likely to fail but that, if she did succeed in becoming pregnant, there would be a higher risk of multiple pregnancy if five embryos had been transplanted rather than three. The Authority therefore considered that the possible marginal improvement in the chances of pregnancy were outweighed by the albeit small risk of multiple pregnancy.  Two scientists may disagree over that proposition, but in our judgment it is impossible to describe it as irrational.
63.	Finally, we must deal, albeit briefly, with the suggestion, raised by Mr Taranissi before us, that paragraph 5 of the first decision letter, of 4 December 2000 (set out in paragraph 33), was irrational and represented a serious misunderstanding by the Authority of the condition of Mrs H’s embryos.  We think that argument unsustainable for two very simple reasons.  The first is that paragraph 5 is an accurate reflection of what Mr Taranissi wrote in the treatment summary, and was the subject of a specific inquiry from the Authority before it reached its decision.  The second is that, had it been thought to be a fundamental error, we have no doubt (given the overall tenor of the appellants’ solicitors’ letters in this case) that it would swiftly have been seized upon in correspondence.  As it is, it features in the grounds for the application for permission to apply for judicial review, but only on the basis that the fact that Mrs H’s embryo quality had been good in the past did not mean that it would remain good in the future, given her age.
64.	In our judgment, the appellant’s challenges to both the first and the second decisions of the Authority are hopeless.  As both Richards J and Ouseley J pointed out, the appellant’s attempts to impugn the Authority’s decisions are a thinly disguised attempt to canvass the merits of the decision before the court.  That is not the stuff of judicial review.  In our judgment, the result is the same whether one applies the traditional test or that enunciated by Lord Steyn in Daly.
65.	We entirely agree with Sedley LJ’s comments about the sensitive nature of the subject matter debated in this case.  As we have already stated, it is an area of rapidly developing science in which judicial review has a limited role to play.  Disagreements between doctors and scientific bodies in this pioneering field are inevitable.  The United Kingdom, through the Act, has opted for a system of licensing and regulation.  The Authority is the body which is empowered by parliament to regulate.  Like any public authority, it is open to challenge by way of judicial review, if it exceeds or abuses the powers and responsibilities given to it by parliament; but where, as is manifest here from an examination of the facts, it considers requests for advice carefully and thoroughly, and produces opinions which are plainly rational, the court, in our judgment, has no part to play in the debate, and certainly no power to intervene to strike down any such decision.  The fact that the appellants may disagree with the Authority’s advice is neither here nor there.
66.	In our judgment, it is most unfortunate that the appellants did not heed the wise words of Richards J, Ouseley J, and Sedley LJ.  For the reasons we have given, the application for permission to apply for judicial review of the second decision is refused.
67.	As to the order made by Ouseley J in relation to costs, Ms Schwehr faced, in our view, an impossible task in appealing an order which was substantially in her clients’ favour.  She recognised this.  She acknowledged that she would not only have to show that Ouseley J’s order as to both substance and costs was wrong when he made it (which she cannot); she would also have to show that the application for judicial review of the first decision would have succeeded (which it would not have done) and that Sedley LJ was wrong to refuse permission to appeal (which plainly he was not).  Finally, she would have to show that we should grant permission for her to mount an application for judicial review of the second decision (which we are not going to do).  The application for permission to appeal Mr Justice Ouseley’s order for costs is, accordingly, also refused.
Order: applications dismissed with the costs.
(Order not part of approved judgment)