Rose, R (on the application of) v Thanet Clinical Commissioning Group

Neutral Citation Number: [2014] EWHC 1182 (Admin) IN THE HIGH COURT OF JUSTICE QUEEN'S BENCH DIVISION ADMINISTRATIVE COURT Case No: CO/1272/2014 Royal Courts of Justice Strand, London, WC2A 2LL Date: 15/04/2014 Before: MR JUSTICE JAY - - - - - - - - - - - - - - - - - - - - - Between: R(on the application of ELIZABETH ROSE) - and - THANET CLINICAL COMMISSIONING GROUP Claimant Defendant - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - Jeremy Hyam (instructed by Leigh Day) for the Claimant Jenni Richards QC (instructed by Bevan Brittan LLP) for the Defendant Hearing date: 8th April 2014 - - - - - - - - - - - - - - - - - - - - - Judgment MR JUSTICE JAY: Introduction 1. 2. 3. 4. Ms Elizabeth Rose (“the Claimant”) has suffered from a severe form of Crohn’s disease since she was 14. She is now aged 25 and her condition has deteriorated. Her doctors at King’s College Hospital are recommending that she undergo bone marrow transplantation and chemotherapy with the expectation of bringing the disease into remission. Unfortunately, it is a probable outcome of this gonadotoxic therapy that the Claimant will be rendered infertile and suffer early onset of the menopause. Understandably, the Claimant wishes to secure the best chance of having her own genetic children, and she therefore seeks NHS funding for oocyte cryopreservation before the chemotherapy begins. Thanet Clinical Commissioning Group (hereinafter referred to as “the Defendant” or “the CCG”, depending on context) has refused the Claimant’s application for funding on more than one occasion, giving rise to this application for judicial review. The Claimant is in receipt of Disability Living Allowance and Income Support (she previously worked in an art gallery before her condition deteriorated), and is in no position to afford the sum of £4,050 which is the anticipated cost of this Assistive Reproduction Technique (“ART”). The application comes before me as a matter of extreme urgency. I am told that the chemotherapy can only be delayed for 4-6 weeks, and that oocyte preservation “takes a few weeks to complete”. On 21st March 2014 HHJ Anthony Thornton QC sitting as a Deputy High Court Judge adjourned the application for permission to apply for judicial review to be listed as a “rolled-up” application as soon as possible on or after 7th April. The parties are to be commended for preparing their respective cases within this compressed time-frame and for completing their able arguments within one day. Although the legal principles governing this application are not especially complex, the evidence is voluminous and careful navigation through the mass of detail is required. In opening her case to me Ms Jenni Richards QC emphasised the importance of this case. Its importance to the Claimant must be evident, but it is also important to the Defendant for a very different reason. The sum of money at stake is not intrinsically large, but what is in issue is the CCG’s approach to all similar cases and the legal integrity of its policies. Ms Richards also remarked that the Claimant’s case has evolved since its inception on 21st March 2014. Defendants are entitled to draw the Court’s attention to forensic points of this nature, but ultimately I must decide this application on the basis of Mr Jeremy Hyam’s considered view of his client’s best case. It often happens in rushed and urgent cases that it takes time for the lawyers to pinpoint and then formulate their most cogent arguments in answer to the Defendant’s pleaded position. No injustice has resulted because Ms Richards was able to adapt her oral argument to reflect what appeared to her, and to me, to be a slightly moving target. Essential Factual Background 5. 6. On 24th May 2013 the Claimant’s clinician, Dr Mittal, submitted an “Individual Funding Request” on her behalf for funding for oocyte cryopreservation treatment. Under the rubric, “for exception to existing policy, please describe as clearly as possible why the patient’s clinical circumstances are exceptional”, Dr Mittal stated: “this patient is undergoing invasive treatment for the severity of her condition which will render her infertile secondary to the high dosage and type of drugs needed for chemotherapy to help improve the quality of her life”. Elsewhere on the form, the treatment was described in more technical detail than I have attempted, and was characterised as “likely to be life-changing for her”. On 4th June 2013 the Defendant’s Individual Funding Request Applications Triage Team (referred to by the Defendant in various documents as “the Triage Group”) considered the application. The decision-making process is disclosed by the typed notes of the team meeting which I take to be contemporaneous, or nearly so. The Triage Group noted that the Defendant’s policy relating to ARTs for patients receiving gonadotoxic treatments precluded the funding of oocyte preservation, and concluded that clinical exceptionality was not established in the present case. The notes also observed that local policy was under review “in the light of new NICE Clinical Guidelines and other recently issued legislation”. Paragraph 4 of Ms Amelia Stecher’s witness statement makes clear that members of the Triage Group were well aware of NICE Guidance GC156 which had been published in February 2013 and had reaffirmed the recommendation that occyte cryopreservation be funded. She also asserts that the Triage Group “did have regard to the NICE Guidance”. 7. This decision was formally communicated to Dr Mittal on 17th June. It was made clear that the Triage Group was treating her application for funding as an “exceptionality request”, for which it had to be established – in order to be successful – that: “… [t]he patient is significantly different to other patients with the condition in question and significantly more likely to benefit. The fact that a treatment is likely to be efficacious for a patient is not in itself a basis for exceptionality.” 8. The reason the application was not treated as exceptional was as follows: “Although the Triage Group recognise that the patient’s symptoms are regrettable they can envisage other patients with other conditions (e.g. cancer) who could also benefit from oocyte preservation. They did not find that clinical exceptionality had been demonstrated, as your patient’s circumstances were found to be broadly in line with the cohort of similar patients addressed by this policy. There was insufficient evidence to show that the proposed treatment is likely to be clinically more effective for this patient than the cohort.” 9. On 24th June 2013 Mr Haitham Hamoda invited the Triage Group to consider the Claimant’s appeal. The treatment was said to be highly gonadotoxic and there was a very high chance that the Claimant would go into an early menopause. Furthermore, the Claimant was finding the whole situation very traumatic and painful, and the progression of her Crohn’s disease had not followed a typical pattern. 10. The Claimant as it happens did not have a right of appeal, but this further information was nonetheless considered. The Triage Group met on 9th July and its adverse decision was communicated to Mr Hamoda on 19th July in terms broadly duplicative of those I have already noted. Paragraph 13 of Ms Stecher’s first witness statement makes clear that the Triage Group did not consider that any of the matters advanced by Mr Hamoda could be regarded as demonstrating clinical exceptionality: either they were inherent in the need for cryopreservation, because the treatment in question would likely induce infertility, or they were not clinical factors at all. Mr Hyam did not press the point that the Defendant should have considered possible psychological benefit. 11. In the summer of 2013 there was some correspondence involving the Claimant’s Member of Parliament which I need not address in any detail. 12. Matters then fell entirely silent until 17th March 2014 when Leigh Day burst onto the scene and a pre-action protocol letter was sent to the Defendant. It sought a response within 48 hours. Leigh Day’s primary case was based on the applicability of NICE Clinical Guideline 156 to the Claimant, and: “… We note the current NICE Guidelines quoted above were published in 2013, yet the policy relied upon by the proposed Defendant to refuse funding was published in 2009 and due for review in 2011. Accordingly we submit the 2009 policy is itself unlawful as it fails to adhere to NICE guidelines with no reasonable explanation provided and appears to be based on information 5+ years old despite this being a rapidly evolving area of medicine …” In the alternative, Leigh Day advanced the following additional point in relation to exceptionality: “We understand that the treatment the proposed Claimant is due to receive for Crohn’s disease is exceptionally new and only to be used in extremely severe cases. We therefore consider the nature, progression and status of the proposed Claimant’s Crohn’s disease is significantly different to the general population of patients suffering Crohn’s disease and that, due to her planned chemotherapy, she is likely to gain significantly more benefit from oocyte cryopreservation than other patients suffering Crohn’s disease.” 13. Commendably, the Defendant was able to meet that deadline because the Triage Group reconvened on 18th March, noted that no new clinical information had been submitted, and “as such could not re-triage the case”. As for the Claimant’s wider contentions based on the absence of congruence between the CCG’s policy and NICE Guidelines (which I will be explaining in more detail later), the Defendant set out its store on 19th March in the following terms: “We reject that the refusal was unreasonable, irrational and unlawful. NICE guidelines are guidelines: they are not mandatory. We argue that it is for the CCGs to decide our commissioning priorities for our population and, for non- prescribed services, decide how health care resources in the local area are to be allocated. It is also up to the CCG, on the basis of clinical advice from its clinicians, as to the extent to which we implement NICE guidelines. We also reject the argument that the 2009 policy on which the decision was based was unlawful, given that NICE guidelines are not mandatory. A new policy will come into operation with effect from 1st April 2014.” 14. Proceedings were launched on 21st March 2014. The Legal Framework 15. 16. CCGs were established by determinations made by the NHS Commissioning Board pursuant to section 14C of the National Health Service Act 2006 as amended by the Health and Social Care Act 2012 (“the NHS Act 2006”). The Defendant has a duty under section 3 of the NHS Act 2006 to commission medical services to such extent as it considers necessary to meet the reasonable requirements of the persons for whom it has responsibility. It also has a duty pursuant to section 223H to break even each year. Lord Woolf MR characterised the duty under the 1977 Act as a “target duty”, and the same applies here. The Courts have opined on a number of occasions that the predecessor bodies to CCGs have had to take difficult decisions about the allocation of finite resources, and it is not the Claimant’s ambition in these proceedings to seek to re-write this axiomatic principle. 17. Further duties of the CCG are set out in sections 14P to 14Z of the NHS Act 2006. The Claimant draws particular attention to sections 14P and 14T, which provide respectively: “14P (1) Each CCG must, in the exercise of its functions- (a) act with a view to securing that health services are provided in a way which promotes the NHS Constitution, and (b) promote awareness of the NHS Constitution among patients, staff and members of the public. … 14T Each CCG must, in the exercise of its functions, have regard to the need to- (a) reduce inequalities between patients with respect to their ability to access health services, and (b) reduce inequalities between patients with respect to the outcomes achieved for them by the provision of health services.” 18. The Claimant places reliance on the following section of the NHS Constitution: “Nationally approved treatments, drugs and programmes: You have the right to drugs and treatments that have been recommended by the National Institute for Health and Care Excellence (“NICE”) for use in the NHS, if your doctor says they are clinically appropriate for you. You have the right to expect local decisions on funding of other drugs and treatments to be made rationally following a proper consideration of the evidence. If the local NHS decides not to fund a drug or treatment you and your doctor feel would be right for you, they will explain that decision to you.” 19. 20. 21. Initially, the Claimant contended that she had a right to oocyte cryopreservation because NICE had recommended it. It is now accepted that she does not: I will be explaining the basis of this concession very shortly. The Claimant’s revised case is that, given that NICE has made a “strong” recommendation that oocyte cryopreservation should be offered to those in like case to her, this is a relevant consideration bearing on the CCG’s public law obligation, reflected in the NHS Constitution, to make rational decisions following a proper evaluation of the evidence. The Defendant accepts the legal accuracy of this revised formulation of its duty, although seeks to underscore the need to focus on the clinical and research evidence base. NICE was established under section 232 of the 2012 Act. Previously, it existed under another name, albeit using the same acronym. It has the responsibility for providing national guidance on promoting good health and social care services. Under section 237(1) of the 2012 Act, the Secretary of State has power to make regulations conferring functions on NICE in relation to the giving of advice or guidance, the provision of information or the making of regulations about any matter concerning or connected with the provision of NHS services. Pursuant to this section the Secretary of State has made the National Institute for Health and Care Excellence (Constitution and Functions) and the Health and Social Care Information Centre (Functions) Regulations 2013 [2013 SI No 259] (“the NICE Regulations”). 22. It is common ground that the NICE Regulations confer on NICE the power to make three categories of recommendation, and that the present case is concerned with the category identified by Regulation 5. Under this Regulation, NICE has a general power to give advice or guidance, provide information or make recommendations about any matter concerning its core activity. This is in contrast to separate regulatory provisions relating to “technology appraisal recommendations” and “highly specialised technology appraisal recommendations”, with which relevant health bodies such as CCGs must comply. Regulation 5 is silent as to the CCGs’ adherence obligations in this domain, but it is clear from the overall structure of the scheme, and Ms Richards accepts, that NICE recommendations have the status of public law relevant considerations. If the position were otherwise Regulation 5 would have no practical utility. 23. This last point is reinforced by the NHS Constitution (see paragraph 18 above and the second part of the citation from it) and by Regulation 34 of the NHS Commissioning Board and Clinical Commissioning Groups (Responsibilities and Standing Rules) Regulations 2012 [2012 SI No 2996] which sets out a mandatory framework for decision-making in relation to particular health care interventions. Specifically: “(1) a relevant body must have in place arrangements for making decisions and adopting policies on whether a particular health care intervention is to be made available for persons for whom the relevant body has responsibility. (2) Arrangements under paragraph (1) must- (a) ensure that the relevant body complies with relevant NICE recommendations; and (b) include arrangements for the determination of any request for the funding of a health care intervention for a person, where there is no relevant NICE recommendation and the relevant body’s general policy is not to fund that intervention.” 24. It is clear from Regulation 33 that the term “relevant NICE recommendations” within Regulation 34(2) does not embrace all NICE recommendations but only those with which a CCG, as a relevant body specified under Regulation 7(7) with compliance obligations, is obliged to comply. In other words, Regulation 5 general recommendations are outside the scope of Regulation 34(2)(a), and are not relevant NICE recommendations for the purpose of Regulation 34(2)(b). 25. Regulation 35 is also relevant, and provides: “(1) A relevant body must- (a) publish on its website a written statement of its reasons for any general policy it has on whether a particular healthcare intervention is to be made available for persons for whom it has responsibility; or (b) where it has not published such a statement, provide a written statement of the reasons for any such policy when any person makes a written request for such a statement. (2) Where a relevant body- (a) makes a decision to refuse a request for the funding of a health care intervention for a person; and (b) its general policy is not to fund that intervention, the relevant body must provide that person with the reasons for that decision in writing.” 26. 27. 28. 29. In my view, it is clear that sub-regulation (1) is dealing with general policies and sub- regulation (2) with exceptional decisions. In my judgment, and insofar as is relevant to this case, there are three express regulatory obligations on the CCG and two implied ones. The express obligations are (i) to have in place arrangements and general policies for deciding whether to make available for persons particular health care interventions, (ii) to provide or make available its reasons for any general policy not to fund a particular intervention, and (iii) to include within its decision-making framework arrangements for dealing with specific requests by a person for funding in circumstances where there is no NICE- driven duty to make available the intervention at issue and the CCG’s general policy is not to fund. Put in these terms it may be seen that express obligation (iii) is addressed to the determination of exceptional cases. It is to be noted that Regulation 34(1) refers to “persons” and Regulation 34(2) to “a person”, underlining the distinction between general policies and special cases. As for the CCG’s implied obligations imposed by force of public law and/or the true construction of the regulatory scheme, the first is that the duty to have regard to NICE recommendations made under Regulation 5 must bear on the formulation of its general policies (see (i) above) rather than its exceptional policies (see (ii)). This flows from the structure of the regulatory scheme but I will be amplifying this point subsequently. The second implied obligation, and it flows from the first, is that the duty to give reasons for any general policy not to fund a particular intervention must encompass the giving of a reasoned explanation of why a NICE recommendation made under Regulation 5 is not being followed. As I shall be explaining shortly, this CCG has both a general policy and an exceptional policy relevant to the circumstances of the Claimant’s case. These separate policies reflect the conceptual and practical distinction inherent in the regulatory scheme, as correctly analysed. In my view, an undercurrent of the Claimant’s case has been to seek impermissibly to elide this distinction. At this stage I should record that the general policies of the Defendant and its predecessor body relating to ARTs were formulated by the South East Coast Health Policy Support Unit on behalf of a number of CCGs (and, previously, PCTs). The exceptional policy of the Defendant relating to all funding requests now comprehended within Regulation 34(2)(b) is comprised in the “Kent and Medway Commissioning Support Unit Policy and Operating Procedures for dealing with Individual Funding Requests” (“the IFR Policy”). By way of summary, there are two stages in the decision-making process. First, it is the function of the Triage Group to determine whether an application demonstrates sufficient evidence of exceptional clinical circumstances fit for consideration by the IFR Panel. Secondly, if and when a case is forwarded to that panel, it is the function of the IFR Panel to determine whether certain criteria are met. As has previously been explained, the Claimant’s case failed at stage one. 30. Thus, the role of the Triage Group is to determine the existence or otherwise of sufficient evidence of exceptional clinical circumstances. This is defined within the IFR policy as follows: “The patient is significantly different to the general population of patients with the condition in question at that stage of the condition’s development; and the patient is likely to gain significantly more benefit from the intervention than might be normally expected for patients with that condition at that stage of the condition’s development. The fact that a treatment is likely to be efficacious for a patient is not, in itself, a basis for exceptionality.” 31. 32. 33. I have already mentioned that there is no right of appeal from refusal decisions by the Triage Group, although it undertakes to consider new or additional information. If and when a case is forwarded to the IFR Panel, that body may take into account cost- benefit considerations. Finally, in a separate policy document (“Kent and Medway CCG’s Principles and Guidance for Dealing with Individual Funding Requests”), three salient matters are raised. First, exceptionality is not demonstrated merely because a patient’s condition is refractory to existing treatments. Secondly, the clinical circumstances of a case are defined with reference to the clinical features of the named patient’s medical condition rather than her or his social or personal circumstances. Thirdly, consistency of approach is mandated: if funding is approved in a particular case, then it must also be approved in all cases of equal clinical need. This last consideration, which is fundamental to the fair running of the whole NHS in this country, has already been foreshadowed by the reference to section 14T of the 2006 Act. It is also reflected in section 29(6) of the Equality Act 2010 and the definition of “direct discrimination” in section 13(1). The Claimant observes that the perceived vice which has to be tackled is the so-called “postcode lottery”, but in my view it goes further than that. Any system which has the duty of distributing finite resources must do so not merely on a basis which is not arbitrary (c.f. the happenstance of the postcode) but also on a basis which recognises the patient’s fundamental human right to be treated in exactly the same way as anyone else with the same clinical need. 34. Having set out the relevant legal framework, I shall now embark on a consideration of the making and development of the general policies applicable to the Claimant’s case. NICE Guidance and the CCG’s ART Policies for Patients undergoing Gonadotoxic Treatments 35. In February 2004 NICE (in its previous incarnation) published Clinical Guideline 11 entitled: “Fertility – Assessment and Treatment for People with Fertility Problems”. It is apparent from the Contents page that this covered the entire gamut of fertility related issues. Chapter 16 dealt with applications of cryopreservation in cancer treatment. Semen cryopreservation was described as “a realistic option to preserve fertility, regardless of diagnosis and treatment.” As for cryopreservation of oocytes: “[this] has had very limited success. [Evidence level 3-4] Live births following ICSI for fertilisation of in vitro cryopreserved oocytes has been reported in women with and without cancer. [Evidence level 3]” Evidence levels 3 and 4 are hardly robust (typically, case studies and clinical opinion), hence the tentative nature of these statements. 36. The NICE recommendations were couched in the following terms: “Women preparing for medical treatment that is likely to make them infertile should be offered oocyte or embryo cryostorage as appropriate if they are well enough to undergo ovarian stimulation and egg collection, provided that this will not worsen their condition and that sufficient time is available. Women preparing for medical treatment that is likely to make them infertile should be informed that oocyte cryostorage has very limited success ….” These were both characterised as “Grade C” recommendations, namely those supported by level 3 evidence. I was not taken to any previous version of Regulation 5, but the highest that the Claimant’s case could possibly be put is that the Defendant owed a public law duty to pay regard to the NICE Grade C recommendation. I would interpret such a recommendation as being at the weaker end of the spectrum. 37. In July 2009 the South East Coast’s Health Policy Report Unit published its Final Report entitled: “ARTs for Fertility Preservation for Patients undergoing Gonadotoxic Treatments”. This was part of the South East Coast’s Policy Review and Recommendation Process. Expert advice was given by the Fertility Preservation Topic Working Group (“FPWG”). In the opinion of the authors of this report, oocyte cryopreservation was an experimental technique. More precisely: “Although this technique is suitable for adults and for older teenagers who do not have a current partner, this is a new technique and success rates of only 5% are achievable per cycle. Fewer than 100 pregnancies have been documented worldwide using this technique. Oocytes are much more sensitive to damage from cryopreservation techniques than embryos.” And, as for the evidence base: “Mature oocyte preservation has potential for females that do not have a partner at the time of diagnosis, or when treatment can not be delayed for the IVF process or there are concerns with ovarian stimulation in oestrogen sensitive tumours. In the last five years there has been an increasing success in the number of live births using this technique (Tulandi et al 2008). Porcu et al (2008) reports a birth rate of 5-6% with a total of 500 live births. This has been a considerable increase in the last two years and is attributed to rapid freezing techniques and the use of ISCI. Previous fertilisation rates of 48.5% and pregnancy rates of 1-2% were commonly reported (Sonmezer and Oktay 2004)” The discrepancy between the 100 pregnancies worldwide figure and the 500 live births figure has not been explained, but was not the source of any submissions to me. 38. 39. The report also recognised the existence of NICE Clinical Guideline 11, which was described as “clear guidance”, as well as the need to ensure equity of access to fertility services. Furthermore, it was also fairly accepted that PCT policy for fertility preservation varied across England. Mr Hyam made something of this last point, and produced a file of documents evidencing CCGs which currently offer NHS-funded oocyte cryopreservation, but in my view this cannot be other than a forensic point; it does not convert into a judicial review issue. The Findings and Proposals of the FPWG were that oocyte cryopreservation should continue not to be funded, but that further work should be done by 1 st April 2011 to determine which groups of patients in this category should receive ART for fertility preservation. The express reason for not following the NICE recommendation was as follows: “Both NICE and the Royal Colleges support access to ART for FP for patients receiving gonadotoxic treatments. However, the FPWG noted that the Royal College’s guidance (2007) stresses that the literature in the field of gonadal toxicity is limited, with few or no randomised trials. The Royal Colleges therefore strongly advocate the development of the research and evidence base and have asked clinicians and researchers to support this.” 40. In July 2009 the South East Coast Recommendation Committee published Policy Recommendation PR 2009-08, “ARTs for Fertility Preservation for Patients receiving Gonadotoxic Treatments”. This had a review date of July 2011. PR 2009-08 precisely reflected the terms of the report. It also stated: “PCTs in NHS South Coast will always consider appropriate funding requests through their IFR process.” 41. Whereas Mr Hyam did not challenge the lawfulness of the 2009 policy, an issue does arise as to its susceptibility to any exceptions. 42. 43. 44. 45. 46. PR 2009-08 (or the formal policy statement of which it was the precursor: the bundle does not contain a copy) was not in fact reviewed in 2011 because, so Ms Richards informed me without objection from Mr Hyam, it became known within the then PCT that NICE was reviewing Clinical Guideline 11. NICE’s report was expected in 2012 but it did not in fact emerge until February 2013 in the form of NICE Clinical Guideline 156. In order fully to understand this guideline, it is necessary carefully to examine chapter 19 of NICE’s full report, both in the context of cryopreservation of semen and oocytes. As for cryopreservation of semen, NICE recognised that this has been a well established practice for “many decades”. However, on closer examination of the evidence base it is clear that this was not particularly robust. Table 19.1 summarises the results of 14 observational, non-comparative studies, some of which were available when NICE last reported in 2004, but others were more recent. In the view of the authors of the report: “Only non-comparative evidence from single centres was available for cryopreservation of semen, and studies provided very limited information on any of the main outcomes. This made the evidence liable to bias.” As for oocyte cryopreservation, NICE opined that the benefits were “well- established”, although there was debate as to the preferred technique. There were two RCTs tabulated in Table 19.3 (Cao et al, 2009; Fasano et al, 2010) which suggested very promising rates of post-thaw survival (89% and 65% respectively), but the quality of these two studies was said to be “moderate”. NICE did not refer to the other studies mentioned in the 2009 report (see paragraph 37 above), but its authors must have been aware of them. A further RCT which has acquired particular importance in these proceedings was written up in Prospective Randomised Comparison of Human Oocyte Cryopreservation with Slow-Rate Freezing or Vitrification, Smith et al, Fertility and Sterility Vol 94, No 6, November 2010 issue. It should be noted that the purpose of the paper was to compare the effectiveness of the traditional method of cryopreservation (namely, the slow-freezing technique) with a newer method (namely vitrification, which entails a rapid-freezing technique, and then “warming” the cell, rather than “thawing” it); it was not to evaluate the overall effectiveness of oocyte cryopreservation. The Smith et al paper did not identify the duration or cause of infertility. Its findings were summarised by NICE as showing that, out of a group of 48 women, 18 achieved clinical pregnancy via the vitrification method (i.e. 38%), whereas the numbers were 4 and 30 respectively for the slow-freezing method (i.e. 13%). The NICE view was that this was “high” quality evidence, no doubt because it was a prospective RCT. On the other hand, this study was similar to the others in that it did not report the number of live, full-term singleton births. 47. The NICE authors drew the conclusion that the vitrification method of cryopreservation was preferable to the slow-freezing method but the former should only be offered if it was available already. 48. NICE did not undertake a formal health economic investigation, although it did expressly consider health benefits and resource matters. As for the absence of evidence regarding live full-term singleton births: “… Clinical pregnancy rate is the outcome reported more often in the studies and the guideline development group felt that this can be used as a reasonable surrogate outcome for live birth. However, not all clinical pregnancies result in live birth at term. Furthermore, depending on the ART used to achieve conception (using the stored material) after the cancer treatment is successfully completed, multiple pregnancy could be a significant risk.” 49. NICE Clinical Guideline 156 repeated the recommendation made in Clinical Guideline 11 to the effect that oocyte cryopreservation should be offered to women about to undergo gonadotoxic treatment. This recommendation was described as “new 2013”, not because the core wording had changed as regards the clinical characteristics of the women within scope, but because the evidence had been reviewed and NICE was no longer recommending that patients be advised that this treatment had very limited success. This point cannot in my view be lightly dismissed. Further, Mr Hyam drew attention to the fact that NICE subsequently explained that this was a “strong” recommendation in the sense that it was confident that the intervention would do more good than harm for the vast majority of patients, and would also be cost-effective. This was in contrast to recommendations which used the verb “consider”, which recognised that there were other options which might be similarly cost-effective. This was also to be contrasted with the “must” recommendations which carried with them a legal duty to comply. 50. NICE Clinical Guideline CG 156 also had this to say about the importance of the equalities issue: “Equalities The GDG was strongly in favour of separating the policy on access to cryopreservation and storage found in the general fertility pathway from that within the treatment of cancer patients. The potential loss of natural fertility is the consequence of the cancer treatment regime and so it did not seem appropriate to put in place a policy that would inhibit their access to cryopreservation and storage. The GDG concluded that, where there were no specific biological or safety considerations, there should not be any barriers to referral for cryopreservation for men and women with cancer. Specifically, the GDG stressed that there should be no referral criteria to be fulfilled for cryopreservation in contrast to the detailed referral criteria laid down for access to fertility services.” 51. Finally, the NICE report observed that there were many PCTs in the UK which were funding oocyte cryopreservation in line with the 2004 NICE guidelines. 52. I agree with Ms Richards that the publication of NICE Clinical Guideline 156 could not legally demand an immediate change of policy within the CCG. No doubt if it delayed unreasonably separate public law issues would arise, and I will need to consider these issues in the light of Mr Hyam’s submissions. At all events, on 2nd May 2013 Kent and Medway Commissioning Support Unit published a Briefing Note in response to NICE Clinical Guideline 156. This set out what was described as a “holding position” in these terms: “CCGs in Kent and Medway have commissioned KMCS, the Commissioning Support Unit for Kent and Medway, to work with clinicians and patients to review local policy in the light of the new NICE Clinical Guidelines and other recently issued legislation. This is a complex task and will take some time to work through. During 2013/4 we do not anticipate any changes in access criteria or the assisted conception services available to individuals served by Kent and Medway CCGs; for 2013/4 services will be provided in line with current policy. We anticipate any new policy will be implemented for 2014/5.” 53. In October 2013 Kent and Medway Commissioning Support Unit published its Final report. It was commissioned by eight CCGs including this Defendant. It, like its predecessor counterpart, was prepared by an expert panel – on this occasion called the ART Working Group. As section 1.3 explained: “The remit of the review is to advise CCGs on how best to meet the requirements of NICE CG156 and the Equality Act 2010 within the available resources. There will be no additional funding available as CCGs have not prioritised ART for additional investment. The needs of the ART population and the wider Sussex CCGs’, Kent and Medway CCGs’ populations will be taken into account.” 54. 55. The October 2013 report clearly understood, as must in any event have been obvious, that as regards oocyte cryopreservation (but not sperm and embryo cryopreservation) PR 2009-08 was not consistent with the new NICE guidelines, as indeed it had not been with the previous NICE guidelines. The report also clearly understood, in the context of an equality scoping exercise, that an issue of gender inequality arose because local funding was provided for the freezing of sperm but not oocytes. None of this was remarkable or surprising; it was close to being self-evident. But, these points having been identified, they did of course have to be addressed. Section 5 of the October 2013 report reviewed the available evidence. As for the cryopreservation of semen, this was characterised as “a well-established practice for many decades”. The supporting evidence was not particularly strong (14 non- comparative retrospective cohort studies) but the sample sizes were high and cancer patients were included. As for oocyte cryopreservation: “As no RCT data on oocyte cryopreservation in cancer patients was identified, the review was expanded to include non-cancer patients. One RCT was identified (Smith et al, 2010), which compared slow to vitrification/warming (n=48). Neither the duration nor the cause of infertility was reported in the study. Clinical pregnancies per cycle were 13% and 38% respectively. The quality of the study was rated as high.” freezing/thawing (n=30) rate 56. 57. This was an accurate summary of the Smith et al paper, and appears to have been lifted out of the NICE report. However, I cannot agree that there was only one relevant RCT. As I have already pointed out, NICE identified two more, and these were relevant to the issue of post-thaw survival. In interpreting the available evidence the authors of the October 2013 report clearly had in mind that the most important outcome measure for present purposes (in its view) was “live full-term singleton births”. Accordingly, in their view, if a study, such as Smith et al’s, did not report that outcome then its data “should be downgraded for indirectness in the GRADE profiles”. This is an understandable approach which Mr Hyam did not seek to challenge. On the other hand, this point cannot be permitted to bear an excessive burden: the NICE report had made the sound point that clinical pregnancies could be regarded as a reasonable surrogate for live births. Additionally, one cannot place too much emphasis for these purposes on the difference between singleton and multiple births. 58. Mr Hyam placed reliance on the fact that, as reported in section 7 of the report, the majority of local clinicians were in agreement with the new NICE guidelines. Even so, I fail to see how far, if at all, this point could advance the Claimant’s case: the report was prepared by an expert panel which, subject to the nature and extent of the regard due to the NICE guidelines, was entitled to reach its own conclusion on the issue. 59. Having weighed up the evidence base and taken on board health/cost impact issues, the report recommended that the cryopreservation of oocytes should not be funded for patients due to undergo gonadotoxic treatments. The rationale was as follows: “The evidence base for the use of cryopreserved oocytes in patients who have undergone gonadotoxic treatments is lacking. The ARTWG considered that success rates from studies which have recruited other populations are likely to be inflated as these patients are likely to be healthy in comparison to those due to undergo gonadotoxic treatments. Furthermore, interventions would be undertaken at clinics with considerable experience undertaking these techniques.” 60. It is notable that in this rationale, and in contrast to the narrative section of the report, reference is made to “studies” in the plural. Mr Hyam launched a full-scale assault on this passage, and I will be returning to it. I indicated to Counsel that I had obtained the Smith et al paper online, and at this stage I content myself with four observations. First, and wholly unsurprisingly, both NICE and the authors of the October 2013 report have correctly summarised its essential findings. Secondly, the article does expressly state that patients were excluded from the study if they had a clinically significant condition/disease. Thirdly, the study was performed at two clinics in Sao Paulo and Rio de Janeiro, with the lead author based at the University of Michigan, Ann Arbor. Fourthly, although the study does not refer to numbers of live births, it does mention spontaneous abortion rates. Before leaving the October 2013 report, I should record Ms Richards’ submission with reference to page 116 that the ART Working Group accepted NICE recommendations in four other areas. This was relied on to demonstrate an appropriate degree of flexibility in a domain where two reasonable decision-makers could rationally come to different conclusions on the same issue. In October 2013 Kent and Medway Policy Recommendation and Guidance Committee published PR 2013-18, “ARTs for Fertility Preservation for Patients Receiving Gonadotoxic Treatments”. This formalised the recommendation in the report that cryopreservation of occytes “is not funded within the local NHS for any patient group”. The series of recommendations concluded with this: “CCGs in Kent and Medway will always consider appropriate individual funding requests through their IFR process.” As for the rationale, the wording is not quite the same as in the report: “The evidence base for the use of cryopreserved oocytes in patients who have undergone gonadotoxic treatments is absent. Only one study was identified that assessed pregnancy rates following two methods of oocyte cryopreservation. Neither the duration nor cause of infertility was reported in the study. Clinical pregnancy rates per cycle were 13% and 38% depending on the method of cryopreservation. Success rates are likely to be inflated as these patients are likely to be healthy in comparison to those due to undergo gonadotoxic treatments and interventions would be undertaken at clinics with considerable experience undertaking these techniques. The PRGC therefore did not feel that there was sufficient evidence to prioritise this intervention for funding.” Two points should be made at this stage. First, here there is reference to one study (not “studies”), which from the statistics given must be the Smith et al paper. Secondly, the first sentence of the rationale in PR 2013-18 contains wording which differs slightly from the report (“absent” as opposed to “lacking”). The former is somewhat more emphatic than the latter, but ultimately I have been persuaded by Ms Richards that nothing turns on this. PR 2013-18, as its acronym indicates, is only a policy recommendation. The recommendation was accepted by Kent and Medway CCGs, including this Defendant, and the Schedule of Policy Statements for ARTs was issued by the KMCS Health Policy Support Unit with effect from 1st April 2014. The policy for not funding the cryopreservation of oocytes, and its rationale, exactly duplicates the wording of the recommendation. 61. 62. 63. 64. The Issues 65. Shortly before lunch on the day of the hearing, Mr Hyam gave me a summary of what he accepted was his reformulated case. I took a careful note of his oral reformulation and have compared it with his Grounds of Claim as set out in his Skeleton Argument. This document does differ somewhat from the Detailed Grounds of Claim lodged with the Claim Form on 21st March, but I am not troubled by that, and have already explained why. On my understanding of the position, Mr Hyam was not in oral argument seeking to abandon any of the Grounds of Claim advanced in his Skeleton Argument; his reformulation should be envisaged as a slight expansion of them. I propose accordingly to marry the Skeleton Argument with Mr Hyam’s oral submissions with a view to seeking to identify, and then to address, the Claimant’s very best case. The urgency and overall justice of the matter call for this benevolent approach. 66. In line with this thinking, the issues which arise in these judicial review proceedings appear to me to be as follows: (i) (ii) (iii) (iv) (v) (vi) (vii) were the decisions adverse to the Claimant taken with reference to a policy which was irrational because it failed to take into account a relevant consideration, namely relevant NICE guidance (reformulated Ground 1)? given that NICE Guideline 156 was published in February 2013, was the Defendant’s decision-making legally flawed because it failed to take into account up-to-date national policy (reformulated Ground 3)? was the Defendant’s latest policy, which ought to have been considered notwithstanding that it was not formally brought into effect until 1st April 2014, (a) irrational, because it failed to take into account NICE guidance, or (b) irrational, because it failed to explain why it disagreed with NICE guidance (on the alternative assumption that NICE guidance was taken into account), and/or (c) in any event unlawful, because it failed to permit of any exceptional circumstances that were other than illusory (Ground 3, and a further reformulation of Ground 1)? was the refusal of funding directly discriminatory, either because males are treated differently from females on the basis of gender alone (Ground 4), and/or because the Defendant operates a policy of blanket refusal (reformulated Ground 4)? was the Defendant in breach of its duties under section 149 of the Equalities Act 2010 (sub-set of Ground 4)? has the Defendant breached the Claimant’s rights under Articles 8/12 and 14 of the Convention (further sub-set of Ground 4)? should the Claimant be refused permission or relief in these proceedings owing to her delay, as the Defendant contends? Amplification of the Claimant’s Case 67. 68. On my understanding of his written and oral argument, Mr Hyam raises no challenge to the Defendant’s 2009 policy (more precisely, the policy of the Defendant’s predecessor PCT), as evidenced by PR 2009-08, but relies on the change in circumstances which had arisen in February 2013 in the form of the new NICE guidelines. NICE Guideline CG 156 differed from earlier guidance in that the evidence base had significantly strengthened, the recommendation was now “strong”, and the recommendation to the effect that patients should be advised that the success rate was low was removed. It is also my understanding of Mr Hyam’s case that the Defendant should have revised PR 2009-08 much sooner than it did, and that a revised policy (c.f. the policy in fact promulgated, applicable from 1 st April 2014) should have reflected the NICE guideline rather than fail properly to have regard to it. It is in the context of this last submission that Mr Hyam seeks to assail the rationale set out at page 119 of the October 2013 report for – in shorthand terms - rejecting the NICE view. Specifically, he submits that, as NICE itself carefully considered, the findings of a high quality study were worthy of high respect, and that it is pure speculation to assert that they could not be replicated across the local population for the reasons given. Next, Mr Hyam submitted that the IFR policy was unlawful because it too failed properly to reflect the change in the NICE Guidelines; indeed, paragraph 4 of Ms Stecher’s second witness statement substantiates that error by suggesting that there was no change. It was also unlawful because it failed to provide for an exceptionality criterion which was other than chimerical. Thus, in examining the practical application of the criterion (see paragraph 30 above), it is patent that no one in the Claimant’s position could meet its terms. The bar was effectively being placed beyond possible attainment. 69. Mr Hyam submitted in the alternative that if, contrary to the foregoing, the exceptionality criterion did permit of the possibility of being satisfied, then the Triage Group failed properly to address the particular circumstances of the Claimant’s case. Aside from the issue of the relevance of the new NICE Guidelines to the work of the Triage Group, it was a highly salient feature of the Claimant’s case that she was suffering from very severe Crohn’s disease, not cancer, and that this was new, life- changing treatment. Further, no regard was had to the fact that the hormone treatments routinely deployed to stimulate a patient’s oocyte production are contra- indicated for certain cancer patients, but could not logically be for the Claimant. Ms Richards pointed out that this last matter had never been raised before, and could not be now. I agree, and therefore say nothing more about it. 70. In support of these foregoing submissions, Mr Hyam relied on three authorities. The decision of Dyson J in R v North Derbyshire Health Authority, ex parte Fisher [1997- 8] 1 CCLR 150 was recruited to support the submission that the public law duty to have regard to national policy required the identification of some exceptional basis for not following it, not the mere evincing of opposition to it. The decisions of the Court of Appeal in R(oao Rogers) v Swindon NHS PCT [2006] 1 WLR 2649 and in North West Lancashire HA v A, D and G [2000] 1 WLR 977 were relied on in support of the proposition that an exceptionality policy defined by reference to clinical need had genuinely to permit of the possibility of being met. 71. Further, Mr Hyam advanced a separate body of submissions based on direct discrimination (section 13 of the Equality Act 2010), breach of the section 149 duty to have regard to the need to reduce inequalities, and breach of the similar duty under section 14T of the 2006 Act. As for the first of these, Mr Hyam submitted that this was a classic instance of discrimination on the ground of gender (see paragraphs 13 and 14 of the judgment of Lord Phillips in R(E) v Governing Body of JFS [2010] 2 AC 728)) because, in objective terms, the Defendant was implementing a blanket policy precluding oocyte cryopreservation (c.f. sperm), and no issue of justification arises. As for the broader equality duties (as to which, see in particular paragraph 16 of the judgment of Wilkie J in R(oao Williams) v Surrey County Council [2012] EWHC 867 (QB)), NICE Guideline CG 156 clearly explained the need to avoid barriers to referral for cryopreservation for men and women with cancer. Finally, Mr Hyam submitted that the Defendant was in breach of Articles 8/12 and 14 of the Convention. He did not expand on his skeleton argument in this respect, and it is therefore unnecessary for me to summarise this aspect of his case. I do not intend to set out the Defendant’s point-by-point rebuttal of the Claimant’s case, but I will be referring to a number of Ms Richards’ submissions during the course of my analysis. 72. 73. My Approach to the Issues 74. 75. 76. 77. 78. 79. It is necessary at the outset to identify the nature of this challenge. The decision formally under challenge is the CCG’s decision given on 19 th March 2014 not to fund oocyte cryopreservation in the Claimant’s case: see section 3 of the Claim Form. This appears to be targeting the Defendant’s response to the pre-action protocol letter. Mr Hyam’s judicial review Grounds attack what is described as a continuing refusal to fund this treatment, most recently contained in the reconsideration by the Triage Group on 18th March. Paragraph 33 of the Grounds seeks a quashing of the Triage Group’s decision given on 18th March, not the decision contained in the letter written the following day. Further, paragraph 33 of the Grounds seeks declaratory relief in relation to the earlier decisions. Frankly, the Claimant’s pleadings are somewhat unsatisfactory. Earlier I made mention of a moving target, but on one view the target is oscillating so much it can hardly be identified at all. Ms Richards, however, did not complain – beyond submitting that the Claimant’s case had evolved – and I am grateful for that. However, I am not prepared entirely to ignore these pleading points because they bear on the substantive issues. If the relevant decision under challenge is the decision of the Triage Group made on 18th March 2014 not to re-open the Claimant’s case, I have to say that it is legally unobjectionable. The Claimant had advanced no further clinical reasons for establishing exceptionality. Additionally, if the focus is solely on the decision of the Triage Group, the claim faces a further difficulty. What the Claimant seeks to do is to bring into play a whole raft of considerations which bear on the legality of the Defendant’s ART policies. 80. 81. 82. 83. But, in order to do this the Claimant must forge a link between the exceptionality policy on the one hand and the general policy on the other. In my view there is no such link. In essence, the Claimant’s case is that the Triage Group should have had regard to the NICE recommendations when making its decisions. In my judgment, this contention is wrong. The Triage Group’s role is solely to determine the issue of clinical exceptionality; its function is not to question or second-guess the CCG’s general policy. Furthermore, in formulating its exceptionality policy, as opposed to its general policy, there can be no public law requirement to have regard to NICE guidelines. It is the very nature of these guidelines that they are of general application rather than exceptional. I do not read the final sentence of paragraph 4 of Ms Stecher’s witness statement as indicating that the Triage Group had regard to NICE guidelines in the same way as those advising the CCG on its general policies would and should have done. Paragraph 4 could have been better worded, but I understand it to mean that Ms Stecher and her colleagues were aware of NICE Guideline CG 156 at the time the relevant decisions were made. If an issue arose in connection with any particular triage decision, it could be drawn to the attention of those developing the new policy. The bottom line is that the Triage Group did not have power to determine the exceptionality question with reference to NICE guidelines. An additional difficulty for the Claimant is that on 18th or 19th March 2014 the new ART policy was not yet in force and the 2009 ART policy is not sought to be impugned; and, in any event, it could not be successfully. In order to circumvent that problem the Claimant says that the Defendant unreasonably delayed in implementing the new NICE recommendations. I cannot accept that. The Defendant needed time to formulate its considered response to NICE Guideline CG 156 published in February 2013. The hurdle is a high one – irrational delay – and the Claimant is a long way from establishing it having regard to the milestone dates I have previously given and the complexity of the issues. Oocyte cryopreservation was just one of many issues which fell to be addressed. The available evidence indicates that the CCG wished to give a considered response in time for the 2014/5 financial year. That deadline was met. The claim for declaratory relief in relation to the exceptionality decisions made in 2013 must fail on the same basis; indeed, these are a fortiori. The issue arises of whether in these circumstances I need go any further. I have found decisive reasons for finding against the Claimant on her main point. However, I believe that I should, for four reasons. First, Ms Richards did not seek to defend this challenge solely on these narrow points, or contend that this should be my approach. Secondly, the Defendant’s letter dated 19th March 2014 does seek to engage with the broader issue of compatibility of local policy with NICE recommendations (admittedly, the letter addresses the argument that the 2009 policy is unlawful, a point which the Claimant no longer pursues). Thirdly, I have heard detailed submissions on the broader issue, and it is right that I rule on them. Fourthly, my ruling on the broader issue has the propensity to reduce, rather than increase, the possibility of further litigation. 84. My point of departure is to reiterate that the Claimant does not contend that the general ART policy evidenced by PR 2009-08 was unlawful, and relies instead on the change in the NICE guidelines which were promulgated in February 2013. It is, therefore, the Defendant’s approach to that new guidance which falls under present scrutiny. 85. 86. The strongest support for the Claimant’s case is undoubtedly to be located in the decision of Dyson J in ex parte Fisher. During the course of oral argument I remarked that if Dyson J’s reasoning applied directly to the present case, then the Claimant should win. Admittedly, that was at a stage before I has grasped the full ramifications of the Claimant’s case as pleaded, but my observations hold true in relation to the issue I am now examining. The issue in ex parte Fisher was whether the health authority properly took into account national guidance issued by the Secretary of State concerning the managing into entry of Beta-Interferon (at that stage, a new drug for patients suffering from the relapsing/remitting form of MS, but now a standard treatment) into the NHS, and in particular initiating the continued prescribing of the drug through hospitals. Dyson J held that this guidance did not confer on health authorities an absolute duty to comply, but in public law terms there was a duty to take it into account in the discharge of their functions. Specifically: “They would be susceptible to challenge only on Wednesbury principles if they failed to consider the Circular, or they misconstrued or misapplied it whether deliberately or negligently: see Grandsden v Secretary of State [1985] 54 P&CR 86, 93-94).” 87. The Respondents accepted in ex parte Fisher that they were under a duty to give serious consideration to the Circular and, if they decided to depart from it, clear reasons had to be provided. I do not understand Ms Richards to dissent from any of that. The ratio of Dyson J’s decision was as follows: “I do not consider that the respondents’ policy could at any time have been fairly described as a reasonable way of giving effect to the Circular. The respondents, like others, no doubt honestly and conscientiously believed that the efficacy of Beta- Interferon had not been sufficiently tested. The assumption that underpinned the Circular was that it had been sufficiently tested. A possible outcome of a further trial would be to demonstrate that Beta-Interferon should cease to be a drug prescribed on the NHS. This merely serves to underline how far away the respondents’ policy was from an implementation of the Circular. This is not the case in which a health authority departed from national policy because there were special factor which it considered exceptionally justified departure. The respondents failed to implement any aspect of national policy, principally because they disagreed with it altogether. They now seek to argue that at least they acted consistently with the policy, although for the reasons I have given that is plainly not the case. Accordingly, they do not seek to justify their policy as a rationale exception to the national policy. That is hardly surprising, since I expect that the situation in which the respondent found themselves when the Circular was issued was not materially different from that faced by most other health authorities. The respondents did not take the Circular into account and decide exceptionally not to follow it. They decided to disregard it altogether throughout 1996, because they were opposed to it. That is something which in my judgment they were not entitled to do.” 88. The value of ex parte Fisher for My Hyam’s purposes is evident. The CCG is not seeking to justify its policy as a rational exception to NICE Guideline CG 156. Instead, Ms Richards’ submission was that the CCG has given reasons for disagreeing with NICE that the evidence base is sufficiently strong. Accordingly, if Dyson J’s reasoning applies to the present circumstances the Defendant would be in difficulty. 89. Ms Richards sought to escape from the snare of ex parte Fisher by submitting that in the instant case the evidence base is not sufficiently strong and NICE guidelines are not national policy. I cannot accept that these are, without more, valid grounds of distinction. NICE is a national body and its guidelines are intended to have nationwide application. NICE recommendations are based on an evaluation of the evidence, health benefit and cost, and nothing else. The assertion that the evidence base is not sufficiently strong emanates from the CCG, not from NICE. If NICE’s view has the same status as that of the Secretary of State in ex parte Fisher, it would surely follow that the CCG could not disagree with NICE; it would need to find an exceptional basis for not following the NICE recommendation. Ms Richards ended up submitting that I should not follow ex parte Fisher. 90. 91. 92. For obvious reasons I am not particularly attracted by the submission that I should not follow ex parte Fisher, although I have applied my mind to that possibility, if only soon to reject it. The question does arise, however, of whether the present case is distinguishable from ex parte Fisher on the basis that the regulatory scheme is different. I confess that I have not found that an easy question to answer. In the present case the CCG’s obligation under the NHS Constitution is to make rational funding decisions grounded on a proper appraisal of the evidence base. As previously discussed, it is implicit in the regulatory scheme that NICE recommendations made under Regulation 5 do not have to be followed. The extent of the public law obligation is to have regard to the relevant NICE guideline and to provide clear reasons for any general policy that does not follow it. In such circumstances, I consider that it is arguable that the possibility of rational opposition (c.f. ex parte Fisher) is an implied characteristic of the regulatory scheme. On balance, however, I have concluded that the better view is that there is no material distinction between the present case and ex parte Fisher, at least to this following extent. The Defendant has no compliance obligation as such, but the issue in the instant case is whether CCGs may legitimately disagree with NICE on matters concerning the current state of medical science. NICE’s view is that the evidence base supports the effectiveness of oocyte cryopreservation, and the CCG’s sole basis for not following the NICE recommendation is that it disagrees. No basis or reasoning on grounds of exceptionality has been put forward. In my judgment the Defendant could have found other reasons for not following the NICE recommendation, but not this one. It follows that the new ART policy is unlawful. 93. Given that my mind has wavered in reaching this conclusion, it is appropriate that I approach this question on the alternative basis that ex parte Fisher is distinguishable from the present case, or that some higher Court decides that it does not represent the law. On that premise, the ambit of inquiry necessarily broadens to consider whether in the circumstances of this case the CCG has in fact provided a rational basis for not following the NICE recommendation in relation to cryopreservation of oocytes for female patients about to undergo gonadotoxic treatment. The focus of this issue is not on the 2009 policy, as to which no complaint has been made, but on the new policy. 94. This broader question merits a much lengthier answer. 95. Ms Richards reminds me that the role of this Court is limited to a review of the rationality of the CCG’s decision, and that I cannot substitute for that my own view. I naturally agree. However, I consider that the issue is capable of being subjected to a greater degree of subtlety. Irrationality simpliciter is a very high hurdle to surmount, and in its most straightforward sense entails the Court coming to the conclusion that the decision under scrutiny was so unreasonable as to be perverse. That assessment does not necessarily entail any evaluation of the reasons given by the decision-maker or the reasoning process displayed thereby. In my view, it is certainly possible to advance what may be seen as a somewhat narrower irrationality challenge which focuses on the quality and logicality of the reasons actually given by the decision- maker in the particular case. For example, in R(Interbrew SA) v Competition Commission [2001] EWHC Admin 367, Moses J commented that the Court can intervene “if the reasons make no sense and are without foundation”, or fail to “stack up”. 96. 97. In my view, this might well be a better way of approaching Mr Hyam’s irrationality challenge in the context of issue (iii) (see paragraph 66 above) and the second implied obligation on the CCG which I outlined under paragraph 27 above. This may well be closely allied to the pure irrationality challenge, or to the related failing to take account of relevant considerations challenge, but it is a convenient and appropriate way of categorising what lies at the heart of the present complaint. In my judgment, it is a relevant feature of this case that the 2004 NICE recommendation that oocyte cryopreservation be funded, if certain clinical matters were satisfied, was made at a time when the evidence base was lacking in substance. I was not referred to the regulatory regime which governed the status of NICE recommendations made ten years ago. However, it is clear from the 2004 report that the level of the supporting evidence (level C) was indicated, and there was nothing in NICE Guideline CG 11 which calibrated the strength of any particular recommendation, beyond reference to the level of evidential support. This does serve to underscore the point that the PCT was entitled in 2009 to reach a different conclusion in the exercise of its clinical judgment. 98. I cannot accept that the only new piece of evidence in February 2013 was the Smith et al paper. NICE was bound to have in mind all the evidence which had emerged since 2004 and that included the studies referred to under paragraph 37 above as well as the three RCTs specifically mentioned in NICE’s full report. 99. I accept some of what Ms Richards had to say about the Smith et al paper. By its very nature it could only be classed as level 1a evidence (it was a singleton study), the patient group was quite small (and the distribution of findings across the statistical mean correspondingly wide), and the weight it could bear was therefore limited. However, I have already said that there was other available evidence, and I have previously pointed out that the Smith et al study was not designed to evaluate the overall effectiveness of oocyte cryopreservation. 100. Mr Hyam strongly criticised the CCG’s advisors for attaching any weight to the probable good health of the patient group in the Smith et al study, as well as to the suggestion that the clinics in question were likely to have considerable experience in performing these techniques. I cannot agree with his criticisms in the form in which they were advanced. It is unclear whether the CCG’s advisors ever read the Smith et al paper (I suspect that they did not) but they would have known from their experience of medical trials of this sort that researchers tend to use healthy patients in the first instance. As it happens, the paper states in terms that the patient group was healthy. It is also well understood in the medical community that cutting edge research tends to be carried out at elite centres. The CCG’s advisors were also entitled to make something of the fact that the Smith et al paper did not expressly state the number of live births. 101. However, the reasons/reasoning challenge is capable of being advanced in a slightly different way. The issue is not the rationality of the CCG’s evaluation of the Smith et al study viewed in isolation but whether the CCG has advanced a clear and proper reason for disagreeing with NICE. The CCG’s advisors may have been entitled to draw attention to the obvious point that high-quality research tends to over-state effectiveness, but it is unthinkable that this point was not also well understood by NICE. To suggest otherwise would be to contend that NICE, who are after all the pre- eminent body, ignored an elementary consideration. I simply cannot accept that NICE did. It follows that, in coming to the conclusion that the evidence base justified a “strong” recommendation, NICE plainly gave the appropriate discount for the very matters the CCG has alighted upon. One may quibble about the quantum of the discount, but in my judgment it was irrational for the CCG’s advisors to base their core reasoning on factors which NICE must already have taken into consideration. 102. There is also a wider dimension. I return to the wording of the NICE recommendations in Clinical Guideline CG 156. The relevant section reads as follows: “Some recommendations can be made with more certainty than others. The Guideline Development Group makes a recommendation based on the trade-off between the benefits and harms of an intervention, taking into account the quality of the underpinning evidence. For some interventions, the Guideline Development Group is confident that, given the information it has looked at, most patients would choose the intervention ... … Interventions that should (or should not) be used – a ‘strong’ recommendation We use ‘offer’ (and similar words such as ‘refer’ and ‘advise’) when we are confident that, for the majority of patients, an intervention will do more good than harm, and be cost effective. …” 103. Given this terminology, I would have expected the October 2013 report to have contained a clear explanation of exactly why its expert advisors were coming to a different view on these key matters of the intervention doing more good than harm and of cost effectiveness. Although the October 2013 report does clearly refer to NICE Guideline CG 156, it fails to engage with any of its reasoning process beyond analysing the Smith et al paper and stating that its findings may not be replicated in unhealthy cohorts and other than elite clinics. 104. The authors of NICE Guideline CG 156 did not venture to suggest that the Smith et al report alone altered the landscape. To say that it did would be to misunderstand the NICE reasoning. To my mind, NICE has considered all the available evidence, including the two other RCTs to which I have drawn attention and, possibly, other research material and clinical judgments which it has not expressly set out, and come to the clear conclusion that oocyte cryopreservation is of clinical benefit to patients. NICE has come to the entirely sensible conclusion that clinical pregnancy may be regarded as a reasonable surrogate for live births, and as it happens the spontaneous abortion rate in Smith et al was stated to be 20%. Accordingly, for the October 2013 report to assert, without more, that the evidence base is lacking/absent is, in my judgment, an irrational conclusion and, in particular, one whose reasoning is without foundation. 105. Overall, no attempt has been made to grapple with the NICE recommendation, the strength of it, and all the evidence and reasons NICE has advanced for making it. Additionally, I do regard it as material that NICE’s new guideline removed the recommendation that patients should be warned that the chances of a successful outcome are very poor. The clear inference is that NICE no longer believes that to be the case. 106. 107. It is also right to point out the way in which the October 2013 report addressed the NICE recommendations in various places. The remit of the review was “to advise CCGs on how best to meet the requirements of NICE CG 156”. As previously observed, there are instances where the NICE recommendation was accepted. There are other instances where the NICE recommendation was rejected and an explanation given: see, for example, recommendation 9 on page 119 of the report. However, in relation to oocyte cryopreservation (recommendation 10) and the ARTWG’s proposal, no reference was made to the NICE recommendation at all. I have already set out the full text of the rationale on page 119 of the report. It follows that on this broader, alternative basis I conclude that in the circumstances of this case the CCG has failed to advance clear, lawful reasons for departing from the relevant NICE recommendation. The effect of my ruling is that in reality the CCG could not lawfully disagree with the medical or scientific rationale for NICE’s recommendation in relation to oocyte cryopreservation, but I am not ruling out the possibility that other reasons of a different nature could not lawfully be relied on. I should also make clear that my conclusion (on this alternative basis) applies only to this particular NICE recommendation. 108. 109. It is to be emphasised that the conclusion I have just reached does not directly benefit the Claimant in these current proceedings, but for obvious reasons the Defendant will need to consider the ramifications of it. I now move on to consider Mr Hyam’s separate series of submissions based on the contention that there are no true exceptions to the non-funding of oocyte cryopreservation. In my view this is an issue which arises directly out of the Claimant’s pleaded case, and does not face the difficulties I have identified under paragraphs 75-82 above. 110. Mr Hyam placed considerable emphasis on the decision of the Court of Appeal in the North West Lancashire Health Authority case. In my judgment, that case turned on its particular facts. The first issue in that case was whether the health authority’s policy in relation to gender reassignment treatment properly recognised that those suffering from gender identity dysphoria had a genuine illness. The Court of Appeal concluded that it did not. The second issue was whether the health authority operated a blanket policy which did not permit of exceptions, and the Court of Appeal concluded that it did. However, part and parcel of the reason for this latter conclusion was that the health authority’s policy was really grounded on the impermissible notion that trans- sexualism was not a genuine illness or condition. The issue in that case, unlike that in the present case, had little or nothing to do with clinical need. 111. A more promising authority from the Claimant’s perspective is the decision of the Court of Appeal in the Rogers case. The issue there was whether the PCT could justify its exceptional circumstances policy in relation to the administration of the cancer drug, Herceptin, in situations where certain women within the eligible group would be granted funding but others would not. The Court of Appeal held that such a policy could not be justified with reference to considerations of clinical need. In the later case of R(oao Condliff) v North Staffordshire PCT [2011] EWCA Civ 910 the Court of Appeal held that exceptionality policies should be confined to the examination of clinical grounds and medical need, not subjective and potentially discriminatory non-medical factors. 112. The passage in Rogers which most assists Mr Hyam appears in paragraphs 62 and 63 of the judgment of Sir Anthony Clarke MR: “We would accept that conclusion subject to this important qualification, which can in our view be seen from the passage just quoted. In it Auld LJ stresses that a policy which allows for exceptions in undefined personal circumstances is not unlawful “provided that the policy genuinely recognises the possibility of there being an overriding clinical need and requires each request for treatment to be considered on its individual merits”. As we see it, that means that a policy of withholding assistance save in unstated exceptional circumstances (in the case addressed by Auld LJ, and no doubt in this case also, overriding clinical need) will be rational in the legal sense provided that it is possible to envisage, and the decision-maker does envisage, what such exceptional circumstances might be. If it is not possible to envisage any such circumstances, then the policy will in practice be a complete refusal of assistance: and irrational as such because it is sought to be justified not as a complete refusal but as a policy of exceptionality. Thus we would not hold that the policy was arbitrary because it refers to unidentified exceptional circumstances. The essential question is whether the policy was rational; and, in deciding whether it is rational or not, the court must consider whether there are relevant exceptional circumstances which could justify the PCT refusing treatment to one woman within the eligible group but granting it to another. And to anticipate, the difficulty that the PCT encounters in the present case is that while the policy is stated to be one of exceptionality, no persuasive grounds can be identified, at least in clinical terms, for treating one patient who fulfils the clinical requirements for Herceptin treatment differently from others in the cohort.” 113. The final sentence of paragraph 63 was a clear signpost to the Court of Appeal’s decision in that case. In the present case the wording of the exceptionality policy (see paragraph 30 above) cannot be regarded as potentially discriminatory; the issue is the more limited one of whether it could ever be fulfilled by someone in the Claimant’s position, and if not whether that matters. 114. In Condliff, Toulson LJ remarked that the exceptionality wording in the Defendant’s IFR Policy was “the approach gaining most popularity amongst PCTs” (see paragraph 22), but its legality was not directly addressed by the Court of Appeal. 115. Ms Richards could not come up with any examples of patients, in situations broadly comparable to this Claimant, who might benefit from the exceptionality policy, and submitted that it was not incumbent on her to do so. The reference in paragraph 62 of Rogers to the decision-maker envisaging what the exceptional circumstances might be did not mandate other than the CCG define the relevant characteristics of the successful patient, and the Defendant has done precisely that. Furthermore, the clearer the evidence of lack of effectiveness, the harder it would be to think of exceptions, and on the Claimant’s approach the more unlawful the policy would be. This is a logical paradox which could not sensibly be generated. 116. I do have some difficulty with an exceptionality policy which contains two hurdles rather than one. If the general policy is justified on the basis that the evidence for clinical effectiveness is lacking, why should someone asserting exceptionality have to do more than demonstrate that in her or his case there is – contrary to the general run of the mill of cases – evidence of clinical effectiveness? On the other hand, the exceptionality policy is no doubt designed to cater for a range of different types of case and situations, and the final sentence (“the fact that a treatment is likely to be efficacious for a patient is not, in itself, a basis for exceptionality ”) needs to be read and understood in its proper context. Thus, if the general policy happens to be to refuse funding because there is little or no evidence of clinical effectiveness, the patient would need to establish that there is something different about her or him which might take the case away from the norm, and that there is evidence of significant clinical benefit. The two limbs of the test are to some extent linked, and in this context proof of the second limb is likely to be established in cases which fall within the first limb. However, proof of the first limb, without more, is not sufficient. 117. It follows that I am not prepared to conclude that the IFR Policy is a blanket policy which logically permits of no exceptions. Indeed, I would go further. If, in a hypothetical case there is no evidence of clinical benefit for the cohort as a whole, and medical science agrees that the position is exactly the same for every conceivable patient falling within that cohort, I would not be troubled by the practical impossibility of any applicant for exceptional funding failing to surmount the relevant hurdle. 118. Mr Hyam also advanced some fact-specific points addressed to the Triage Group’s decision on exceptionality. The parties are agreed that the correct comparator is other patients about to undergo gonadotoxic treatment. This is because it is that treatment, regardless of the underlying disease, which creates the need for the ART. The Claimant says that she is an exceptional sufferer of Crohn’s disease; that she is likely to gain significantly more benefit from oocyte cryopreservation than other patients suffering from her disease; that she is young, has no children and is highly traumatised; and that she cannot afford to fund the treatment privately. However, I entirely agree with Ms Richards that these are unsustainable grounds for establishing exceptionality. The first two focus on the Claimant’s Crohn’s disease rather than the gonadotoxic treatment on which she is about to embark; the remaining matters are non-clinical. 119. Overall, I reject the various manifestations of the Claimant’s case based on the existence and application of the Defendant’s exceptionality policy. 120. I turn to address the Claimant’s fourth ground and her various discrimination and human rights points. Because the fate of this ground is in my view so closely connected with the Claimant’s main ground, I believe that I may be fairly brief. The connection arises because if there are sound clinical grounds for differentiating between oocyte and semen cryopreservation then, subject to Mr Hyam’s direct discrimination argument, it would tend to follow that the discrimination has been justified. But, if on the other hand there are no such grounds, then proof of discrimination naturally flows. 121. Mr Hyam invites me to hold that the CCG has been guilty of direct discrimination on the ground of gender, contrary to section 13 of the Equality Act 2010. It is clear law that direct discrimination cannot be justified. He relies by analogy on R(E) v Governing Body of JFS [2010] 2 AC 728. In that case direct discrimination was established because the school was applying a factual criterion or ground which was based on ethnic rather than any religious status. The motive for the discrimination was irrelevant. Here, Mr Hyam submits, the CCG is applying a criterion which is inherently gender-based, and the motive for the discrimination, being actual or perceived clinical grounds, is irrelevant. 122. I am not attracted by Mr Hyam’s submission. It is based on the fallacy that because only women produce oocytes they must be treated in the same way as men who only produce semen. Although gender is the sole determinant of the production of gametes, I cannot accept that differentiating between gametes in this context means the same as differentiating between men and women. There are obvious, relevant biological differences between gametes. Moreover if, for example, there were rock-solid medical evidence that the cryopreservation (and subsequent thawing) of sperm was highly effective whereas oocytes could not be successfully cryopreserved, the logic of Mr Hyam’s argument would be that men and women would still have to be treated in exactly the same way. 123. Mr Hyam’s more attractive Equality Act submission was addressed to the section 149 duty. Ms Richards emphasised that this is a process, not an outcome duty, and I of course agree. However, it also to be recognised that the “due regard” duty requires more than simply giving consideration to the issue, but awareness of the special duties the decision-maker owes in this context (see paragraph 16 of Williams). On the other hand, the duty is only to have due regard to the need to take the relevant steps. The Court will only interfere if the decision-maker has acted outwith the scope of any reasonable public authority in the circumstances. 124. As Ms Stecher has explained, the CCG did carry out an equality scoping exercise. However, exhibit 4 to her second witness statement is jejune, as is the relevant section in the October 2013 report. All that they say is that a gender issue arises because sperm is frozen in fertility preservation and not eggs. This comes very close to paying lip-service to the section 149 obligation. 125. The issue is much more complex than exhibit 4 accepts, and the NICE report recognised many of the nuances and sensitive assessments which fall to be made (see paragraph 50 above). One may not necessarily agree with the NICE viewpoint, but to my mind it requires proper consideration. I have already pointed out that the studies vouching the effectiveness of semen cryopreservation are of very mediocre quality. In my view, the CCG has failed to grapple with any of these issues. Instead of clear reasons and an appropriately in-depth approach, we see the most gentle of genuflections towards the statutory obligation. 126. A proper discharge of the section 149 duty would embark on the following pathway. Consideration would certainly need to be given to the quality of the evidence base relating to semen and oocyte cryopreservation. In my judgment, it would be an exaggeration to say that the evidence base is much stronger in the one case than in the other. Consideration would also need to be given to the factors mentioned by NICE. Issues of cost and resource may well be relevant too, but one cannot help feeling that some decision-makers have a more favourable mindset towards semen cryopreservation because, put bluntly, semen is cheaper to obtain and to freeze. 127. However, in this respect too it is necessary to be precise as to where this finding might lead. I am not holding that the CCG owed any section 149 duty in relation to its exceptionality policy. It clearly did not. The duty arose in relation to the formulation of general policy, and I reiterate the various pleading and related points I raised in this regard under paragraphs 75-82 above. 128. I do not propose to lengthen this judgment by addressing the Claimant’s Convention grounds in any detail. The pure Article 8 ground fails because the State is under no positive duty to fund medical treatment pursuant to that article. The Article 8/14 ground raises the same issues as the section 149 Equality Act point, which I have already addressed. I do not find it necessary to consider whether this claim engages Article 8. Delay/Relief 129. Given that this is a “rolled-up” hearing, it is right that I record my decisions on the separate questions of permission, substance and relief. 130. In my judgment, all of the Claimant’s grounds are arguable, save for the pure Article 8 ground, and permission is therefore granted to that extent. 131. As regards the decision directly under challenge, whether it is the decision dated 18 th March or 19th March 2014, I have found that the Claimant has failed to demonstrate any public law unlawfulness. The same applies to the earlier decisions in respect of which the Claimant seeks declarations. It follows that relief must be refused. 132. 133. To the extent that I have found favour with aspects of the Claimant’s extended case (viz. in formulating its new ART policy, the CCG failed properly to address the relevant NICE recommendation and to discharge its section 149 duty), my provisional view is that no question of any relief arises, but I invite further short written submissions on the issue. I indicated to Ms Richards at the outset of the hearing that I was not minded to shut out the Claimant from the Court by refusing permission on the sole ground of delay. The nature of his litigation did not lend itself to such a peremptory approach, and Ms Richards did not force the issue. She reverted to the matter at the end of her oral argument, and I am therefore required to deal with it. 134. On analysis, the issue of delay does not really add anything. If the scope of inquiry is confined to whether the Triage Group was entitled to refuse to re-open the Claimant’s case because no new clinical information had been submitted, the Claimant has to go back in time to the earlier decisions, in relation to which (a) she makes no direct challenge (save to seek declaratory relief) and (b) she has unduly delayed. Accordingly, if necessary and to this extent I would hold that the Claimant’s undue delay is an additional ground for refusing relief. If the scope of inquiry is slightly broadened to take on board the point that the Triage Group does not determine matters of general policy, I doubt whether a separate delay point arises. No such point does arise in relation to the much wider inquiry I have undertaken in relation to the new ART policy. Disposal 135. Save to the extent that, in the light of written submissions from the parties, any declaratory relief is appropriate in respect of the Claimant’s extended case, this application for judicial review must be dismissed.