By David Lock QC

One of the fundamental problems for the NHS is that demand for healthcare by patients vastly exceeds the ability of the NHS to be able to fund that care. These types of decisions have been the subject of frequent challenges in the courts but, in two leading cases which went to the Court of Appeal, patients have failed to show that decisions to deny them treatment they wanted (and which was supported by the treating consultants) were unlawful.

It is entirely understandable that patients who believe that an operation, a course of drugs or a course of alternative therapy would be clinically beneficial to them are frustrated when NHS managers refuse to agree to fund the treatment. However in R v Cambridge Health Authority ex parte B [1995] 1 WLR 898 the Court of Appeal recognised the limits of the NHS to fund all clinically appropriate treatment and accept the right of the NHS to make difficult rationing decisions.

Despite the decision in R v Cambridge Health Authority ex parte B, in the last 10 years there have been a series of challenges to treatment allocation decisions and, up to about 2008, it appeared that the courts strained to find reasons to quash decisions to refuse clinically appropriate treatment for patients. Examples of such cases are: R (Ota Rogers) v Swindon Primary Care Trust [2006] 1 WLR 2649, R (Ota Otley) v Barking and Dagenham NHS Primary Care Trust [2007] EWHC 1927 (Admin) and R (Ota Ross) v West Sussex Primary Care Trust [2008] EWHC 2252 (Admin).

However there have been several recent challenges where patients have been unsuccessful in attempting to show that decisions by Primary Care Trusts to refuse to fund medical treatment were unlawful. Although each case turns on its particular facts, the trend of recent decisions has been to support the right of NHS managers to take difficult rationing decisions even though this results in patients being denied treatment that could be taken beneficial to them. This is perhaps indicative of a changed mood where annually expanding budgets for NHS bodies are a thing of the past and the courts are more sympathetic to NHS managers who say that they are only able to spend the budget once and therefore have to make difficult decisions which will inevitably lead to some patients been disappointed.

In R (ota Condliff) v. North Staffordshire Primary Care Trust [2011] EWHC 872 (Admin) and [2011] EWCA Civ 910 the PCT was challenged for its refusal to fund bariatric surgery to assist Mr Condliff to lose weight. Mr Condliff was a 62-year-old ex-policeman who weighed 140kg (22 stone). He had developed diabetes and a range of other co-morbidities. His weight gave him a Body Mass Index (“BMI”) of about 43. The National Institute for Health and Clinical Excellence (“NICE”) recommended bariatric surgery should be funded for patients with a BMI of more than 40, and for those with a BMI of more than 35 who had co-morbidities. This was not mandatory NICE guidance. The PCT policy provided that bariatric surgery would be funded for patients with a BMI of 50 or more. The PCT also had an “Individual Funding Request” policy (“an IFR policy”), which provided that funding could be agreed outside its standard policy where patients had exceptional clinical circumstances.

The PCT considered an IFR request from Mr Condliff but determined that sadly he was largely in the same position as other individuals who had a BMI of between 40 and 50 and co-morbidities and that he had not demonstrated any exceptional clinical circumstances. Funding for this operation, which was accepted to be clinically appropriate, was therefore refused.

This decision was challenged on large number of grounds, including the rationality of the policy to limit routine funding for bariatric surgery to patients with a BMI of more than 50. Shortly before the trial the claimant sought to serve expert evidence to show that the policy was irrational because the health benefits from having the surgery would, across a cohort of patients, have saved the NHS money rather than resulting in any extra expenditure. The judge, HHJ Waksman QC, refused to admit the evidence on the grounds that, save in exceptional circumstances, expert evidence is inadmissible in Judicial Review proceedings. A decision of a public body cannot be declared irrational based on expert evidence which was not before the public body at the time when it took its decision. The audit trail produced by the PCT clearly showed that the PCT had carefully considered the guidance from NICE but had made the decision on resource grounds only to fund the operation on a routine basis the patient with a BMI of over 50.

At the trial the claimant reluctantly accepted that he could not challenge the rationality of the main policy on the allocation of funding for bariatric surgery but sought to challenge the IFR policy, which provided that IFR decisions could only be made on clinical circumstances and not on factual matters relating to the lives of individuals which were unrelated to their clinical circumstances. This challenge was mounted on pure human rights grounds and not on rationality grounds. It failed before the Judge and was comprehensively dismissed by the Court Of Appeal in July 2011. The claimant was refused permission to appeal to the Supreme Court and is presently seeking permission to renew this challenge before the European Court of Human Rights in Strasbourg.

The Court of Appeal decided that the PCT IFR policy could not be challenged based on article 8 of the ECHR. The court accepted the right for the PCT, as a healthcare body which sought to make funding available for patients for clinical interventions, to make decisions about the allocation of NHS resources solely on clinical grounds. The Court accepted the PCT submission that this was a decision which did not engage the positive elements of article 8 and therefore was outside an ECHR challenge. However the court also decided that if article 8 had been engaged, the policy was justifiable under article 8(2).

The Court of Appeal also considered rationing of health care in February 2011 in R (ota AC) v Berkshire West Primary Care Trust. In that case the patient was a male to female transsexual who had had hormone treatment to stimulate breast growth but was dissatisfied with her outward appearance after an extended period of such treatment. She said that she suffered psychological distress from her body shape and sought NHS funding from her local PCT for a breast augmentation.

The PCT had a specific policy concerning the NHS funded medical treatment that would be supported for transsexuals. Breast augmentation for male to female transsexuals was specifically excluded but breast reduction for female to male transsexuals could be funded. Part of the reason for this was that the PCT considered that there was insufficient evidence to show that a breast augmentation operation would be clinically effective to improve the psychological condition of transsexual patients. In contrast, there was considerable evidence that female to male transsexuals required breast reduction surgery in order to be able to live in their new gender. One of the differences was that generally men do not display significant breasts and therefore the displaying of significant breast tissue causes psychological difficulties for female to male transsexuals. In contrast the evidence was that there is a very wide range of body shapes for natural women. 

Although there was a considerable amount of international evidence that transsexuals underwent breast augmentation surgery as part of the gender transformation process (usually funding the cost of the surgery themselves) there was a marked absence of reliable clinical evidence to show that breast augmentation surgery was clinically effective to improve well-being or the psychological state of the patient over anything other than a very short period. Thus the PCT substantially ruled out providing this treatment to both transsexuals and natural women a routine basis in part because it took the view that breast augmentation surgery was not clinically effective.

The PCT also had an IFR policy which was similar to the policy considered in Condliff. The IFR panel considered AC’s case number of occasions but on each occasion came to the view that there was insufficient evidence that a breast augmentation would be clinically effective in her case. The IFR panel also considered that AC had demonstrated no exceptional circumstances to justify funding AC when other patients with a similar condition would not have this treatment funded for them.

AC challenged both the IFR decision and the PCT policy and funding medical treatment for transsexuals. The claimant’s case failed both in the High Court and in the Court of Appeal. The case is interesting for two reasons. First, the Court of Appeal took the firm view that the PCT was entitled to reach a decision as to whether a proposed treatment was likely to be clinically effective or not. It was required to consider the views of the treating consultants who recommended the treatment for this particular patient or patients in general but was entitled to reach its own view as to what treatments would be funded as part of NHS funded care.

There was conflicting evidence in the AC case on the issue of clinical effectiveness of breast augmentation surgery. The court took the view that the PCT, as a decision maker, was entitled to reach the decision that the clinical evidence did not demonstrate that breast augmentation operations generally delivered the clinical benefits which they were intended to provide. The Court accepted the PCT’s case that it was entitled, in exercising a rationing approach to medical treatments, to rule out funding in cases where clinical effectiveness was not proved. The failure of the claimant to displace this basis for the decision effectively prevented the claimant from being ever to succeed in the Judicial Review case.

The second interesting point that the case was a question of comparison for the purposes of sex discrimination legislation. The PCT said that it was appropriate to compare the position of the claimant to the position a natural woman who suffered psychological distress at her lack of breast tissue who was also seeking funding for NHS treatment because she suffered psychological distress because of lack of breast tissue. The PCT said that it did not fund breast augmentations for natural women who suffered psychological distress in such circumstances and it would therefore be sex discrimination for it to fund the same operation for a transsexual woman. The claimant, supported by the Equality and Human Rights Commission, argued that transsexualism was sui generis and that no comparison was proper, and therefore there would be no sex discrimination if the funding was provided to a transsexual patient but refused to a natural woman who suffered the same level of distress. The Court accepted the PCT argument that the comparison was proper and therefore, in making the decision as to whether to fund a breast augmentation for a transsexual, it was right to bear in mind the need to be fair as between natural women and transsexual women.

In each of these cases the PCT was able successfully to defend the Judicial Review because the decisions were taken against a very clear framework of policies which themselves were supported by working papers which explained the rationale for the decisions. The IFR applications had a full audit trail and detailed decisions were taken by decision-makers who had explained themselves in the minutes of the meeting or subsequently in which statement. In Condliff the original IFR decision was fully documented but the patient had asked for it to reconsidered a few months later when “new evidence” was provided. The response to this new evidence failed to give sufficiently full reasons to allow the claimant to understand why his application and been refused. However the judge permitted the PCT doctor who had taken the decision to put in a witness statement to explain his thinking and thereby expand on the matters set out in the refusal letter. Thus, although the PCT had failed to give reasons for the original decision, this did not result in a quashing of the decision. 

The PCT recovered its costs against the Legal Services Commission in both cases in the Court of Appeal because the cost protection under the Access to Justice Act 1999 against legally aided litigants only effectively operates at first instance. The Condliff case was originally run on a Conditional Fee Agreement and the PCT recovered its costs for the trial from the insurance policy which supported the CFA.

David Lock QC acted for the primary care trusts in R (ota AC) v Berkshire West Primary Care Trust and in R (ota Condliff) v. North Staffordshire Primary Care Trust.