Not unlawful to refuse egg freezing therapy for Crohn’s sufferer

18 April 2014 by Rosalind English

Rose, R (on the application of) v Thanet Clinical Commissioning Group [2014] EWHC 1182 (Admin) 15 April 2014 – read judgment

Jeremy Hyam of 1 Crown Office Row represented the claimant in this case. He had nothing to do with the writing of this post.

There are times when individual need comes up against the inflexible principles of the law and the outcome seems unjustifiably harsh. This is just such a case – where a relatively modest claim based on individual clinical need was refused with no breach of public law principles.  As it happens, since the Court rejected her case, the the young woman concerned has been offered private support for the therapy she was seeking. The case is nevertheless an interesting illustration of the sometimes difficult “fit” between principles of public law and the policy decisions behind the allocation of NHS resources.

Background

The claimant, a woman in her twenties, had suffered from a severe form of Crohn’s disease since she was 14.  At the time of this hearing she was aged 25 and her condition had deteriorated. Her doctors recommended that she underwent bone marrow transplantation and chemotherapy with the expectation of bringing the disease into remission.  It was a probable outcome of this therapy that she would be rendered infertile and suffer early onset of the menopause. Understandably, she wished to secure the best chance of having her own genetic children, and she therefore sought NHS funding for oocyte cryopreservation before the chemotherapy began. Thanet Clinical Commissioning Group (the “CCG”)  refused the Claimant’s application for funding on more than one occasion, giving rise to this application for judicial review. Ms Rose, who is in receipt of Disability Living Allowance and Income Support, was in no position to afford the sum of £4,050 which was the anticipated cost of this Assistive Reproduction Technique (“ART”).

As Jay J observed, at the outset,

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.

CCG’s Triage Group treated her application for funding as an “exceptionality request” for which it had to be established that the patient was 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.

Although the Triage Group recognised that the claimant’s symptoms were “regrettable” they could envisage other patients with other conditions (e.g. cancer) who could also benefit from oocyte preservation. They therefore did not find that clinical exceptionality had been demonstrated. There are three aspects to the exceptionality test:

1.  exceptionality is not demonstrated merely because a patient’s condition is refractory to existing treatments
2. 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
3. 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.

The CCG, like other NHS bodies, is pulled between two conflicting obligations: the 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, and the duty pursuant to section 223H to break even each year.

NICE Clinical Guideline 156, which was out at the time the CCG made its decision, was that oocyte cryopreservation should be offered to women about to undergo gonadotoxic treatment. This recommendation was described as “new 2013”, because NICE had changed its approach and was  no longer recommending that patients be advised that this treatment had very limited success.  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.

The claimant’s case was that, given that NICE had made this “strong” recommendation that oocyte cryopreservation should be offered to those in like case to her, this was 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. NICE recommendations have the status of public law relevant considerations. But she was ultimately not able to clear the hurdle of illegality by convincing court that the publication of NICE Clinical Guideline 156 demanded, in law, an immediate change of policy within the CCG.

The issues before the Court

(i) 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?

(ii) 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?

(iii) was the defendant’s latest policy in any event unlawful, because it failed to permit of any exceptional circumstances that were other than illusory?

(iv) was the refusal of funding directly discriminatory, either because males are treated differently from females on the basis of gender alone or because the defendant operates a policy of blanket refusal?

(v) was the defendant in breach of its duties under section 149 of the Equalities Act 2010 ?

(vi) had the defendant breached the claimant’s rights under Article 8 and Article 12 together with Article 14 of the Convention?

The arguments 

It was argued on behalf of the claimant that CCG’s policy was unlawful because it failed properly to reflect the change in the NICE Guidelines, which had changed in response to better success rates in “clinical pregnancies” (as opposed to live births)  with a new technique for freezing eggs; furthermore, their approach, it was argued, was unlawful because it failed to provide for an exceptionality criterion which was other than chimerical. The bar was effectively being placed beyond possible attainment by the Claimant or anyone else. The claimant relied on decisions by the Court of Appeal in in R(oao Rogers) v Swindon NHS PCT [2006] 1 WLR 2649 (the “Herceptin” case) and in North West Lancashire HA v A, D and G [2000] 1 WLR 977  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. 

For its part, the defendant CCG stressed that it was not seeking to justify its policy as a rational exception to NICE Guideline CG 156. It contended that it had given reasons for disagreeing with NICE that the evidence base for sufficiently successful cryopreservation was sufficiently strong.  The CCG’s obligation under the NHS Constitution was to make rational funding decisions grounded on a proper appraisal of the evidence base. It was implicit in the regulatory scheme that NICE recommendations made under the relevant Regulation  do not have to be followed. The extent of the public law obligation was to have regard to the relevant NICE guideline and to provide clear reasons for any general policy that did not follow it.

The judge found the claimant’s submissions arguable but rejected them on substantive grounds.

Reasoning behind the judgment

The main plank of the Ms Rose’s argument – that the Triage Group should have followed a policy which in turn followed the NICE change in approach to oocyte cryopreservation – did not hold.

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.

Furthermore, Jay J found that it was s 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:

This does serve to underscore the point that the [Primary Care Trust] was entitled in 2009 to reach a different conclusion in the exercise of its clinical judgment.

In the present case the wording of the exceptionality policy could not be regarded as potentially discriminatory, as it was in the Herceptin case; the issue was the more limited one of whether it could ever be fulfilled by someone in the claimant’s position, and if not whether that mattered.  The judge was not prepared to conclude that the policy under attack was a blanket policy which logically permitted of no exceptions. Indeed, he went 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.

…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 [counsel for the defendant] 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.

The gender discrimination argument under the Equality Act was 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, the judge did not 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.

As for the Convention argument, it failed because the state was under no positive duty to fund medical treatment pursuant to that article. The Article 8/14 ground raised the same issues as the section 149 Equality Act point, and failed accordingly.

Sign up to free human rights updates by email, Facebook, Twitter or RSS

• Public purse remains closed for morbidly obese man
• Human rights, anti-obesity surgery and the NHS purse
• Transsexual denied NHS breast surgery loses appeal