R (on the application of Rogers) v. Swindon NHS Primary Care Trust and Anr.

The appellant Ann Rogers, suffered from type HER2 breast cancer, which was in its early stages. She had a poor prognosis of only a 25% chance of remaining free of breast cancer and a 43% chance of being alive at ten years.

Herceptin was licensed by the European Medicines Agency (EMEA) for treatment of only late stage cancer but held promise to significantly benefit people with early stage HER2 breast cancer. Without public subsidies, a complete treatment of Herceptin was prohibitively expensive at over £26,000.

The appellant’s clinician commenced treatment with the drug on a private basis but the appellant was unable to bear the costs of the entire course of treatment. Subsequently, the appellant’s clinician applied to the respondent Swindon NHS Primary Care Trust to fund her treatment. The respondent’s general policy was not to fund drugs for an off-license use. With respect to funding of Herceptin for early stage HER2 breast cancer, the respondent allowed clinicians to propose patients to an exceptional funding panel that would decide whether to provide funding on a case-by-case basis without regard to the  costs. The respondent did not view her case as an exceptional one since she was only one of several women who would stand to benefit from the treatment. She appealed the decision but the internal appeal panel only noted that her poor prognosis put her in “a gray area between unexceptional and exceptional.”

The appellant applied for judicial review of the decision but her application was dismissed. The present appeal alleged that the respondent’s refusal to fund her treatment with Herceptin was unlawful on the ground that it was arbitrary or irrational and unreasonable and it failed to give proper consideration to the relevant facts. She also alleged a violation of her rights under Article 2 (right to life) and Article 14 (Prohibition of discrimination) of the European Convention for the Protection of Human Rights and Fundamental Freedoms.

The Court found that the policy adopted by the respondent in relation to funding was irrational and unlawful. Consequently, the decision of the respondent to refuse to fund the treatment of Herceptin for the appellant in accordance with her clinician’s recommendation was also found to be unlawful and thus quashed. The Court did not order the respondent to fund the appellant’s treatment, allowing the respondent to formulate a new policy upon which to decide particular cases, including that of the appellant.

The Court held that a policy of funding exceptional circumstances will be legally rational only if it is possible to envisage and the decision-maker does envisage what such exceptional circumstances might be. The Court found no rational basis for distinguishing between the appellant who belonged to the eligible group of persons who qualified for Herceptin treatment and other patients within this eligible group on the basis of exceptional clinical circumstances. Once the Respondent had decided that it would fund Herceptin for some patients and that cost was irrelevant, the only reasonable approach was to focus on the patient's clinical needs and fund patients within the eligible group who were properly prescribed Herceptin by their physician.

The Court stressed on the respondent’s policy to not consider costs when making funding decisions and to a large extent based its decision on this factor of disregarding financial considerations. Accordingly, the Court held that once financial considerations were out of the picture, the only relevant considerations of the Respondent must relate to the legitimate clinical needs of the patient. Thus, the Court failed to see how the respondent could justify funding for one patient but not another when both fell within the eligible group for treatment. In testing the rationality of the Respondent’s policy in relation to Herceptin, the Court also drew a comparison between the Respondent’s general funding policy and its policy specifically in relation to Herceptin funding. The Court found the former policy to meet the rationality test since it factored in cost considerations, unlicensed status of drugs and the special health-care problems of the patient.

The Court did not consider it necessary to address the other bases on which the appellant challenged the respondent’s refusal to fund her treatment.

[56] “There is little if any dispute between the parties as to the correct approach at common law in a case of this kind. In R v Ministry of Defense, Sir Thomas Bingham accepted a submission as to the correct approach to irrationality: ‘The Court may not interfere with the exercise of an administrative discretion on substantive grounds save where the court is satisfied that the decision is unreasonable in the sense it is beyond the range of responses open to a reasonable decision-maker. But in judging whether the decision-maker has exceeded this margin of appreciation the human rights context is important. The more substantial the interference with human rights, the more the court will require by way of justification before it is satisfied that the decision is reasonable in the sense outline above.’ … [This] case is concerned with a decision which may be a life or death decision for the appellant. In these circumstances, as we think Mr Havers accepted, it is appropriate for the court to subject the decision to refuse funding for the treatment to rigorous scrutiny.”

[62] “[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 be in practice 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.”

[79] “The non-medical personal situation of a particular patient cannot in these circumstances be relevant to the question whether Herceptin prescribed by the patient's clinician should be funded for the benefit of the patient. Where the clinical needs are equal, and resources are not an issue, discrimination between patients in the same eligible group cannot be justified on the basis of personal characteristics not based on healthcare.”

[81] “… [O]nce the PCT decided that it would fund Herceptin for some patients and that cost was irrelevant, the only reasonable approach was to focus on the patient’s clinical needs and fund patients within the eligible group who were properly prescribed Herceptin by their physician. This would not open the floodgates to those suffering from breast cancer because only comparatively few satisfy criteria so as to qualify for the eligible group.”