Rogers, R (on the application of) v Swindon NHS Primary Care Trust & Anor

A primary care trust may adopt a policy that an unlicensed treatment will be funded only in undefined exceptional circumstances, provided each application is considered on its individual merits. Such a policy is not irrational merely because other trusts adopt a more generous approach. Guidance must be distinguished from a statutory direction: guidance requires proper consideration, whereas a direction requires compliance. A trust may await licensing and national appraisal, provided it does not operate a blanket refusal or reject treatment solely because of cost. The court reviews rationality and lawfulness, not which policy is preferable. The policy and decision were compatible with Articles 2, 3 and 8 of the Convention.

Ann Marie Rogers sought judicial review of Swindon NHS Primary Care Trust’s refusal to fund Herceptin for early-stage HER2-positive breast cancer. The Trust’s policy allowed funding of off-licence treatment only where the patient’s case was exceptional. Its Clinical Priorities Committee and appeal process considered Ms Rogers’s application, but concluded that no exceptional clinical or personal circumstances had been shown.

The challenge alleged breach of a Secretary of State communication, irrationality and arbitrariness in the policy and its application, and infringement of Convention rights under Articles 2, 3, 8 and 14. The central issues were whether the Chief Executive Bulletin was a direction or guidance, whether the exceptionality policy was lawful, and whether refusal of treatment engaged or breached the Convention.

1. Domestic law. The claim for judicial review was dismissed. The Chief Executive Bulletin was guidance, not a direction. The use of “should”, together with the absence of clear language requiring compliance, did not demonstrate an intention to issue a direction. Under the distinction recognised in R v North Derbyshire Health Authority, ex p Fisher (1998) 38 BMLR 76, guidance had to be taken into account, while a direction imposed an absolute duty to comply.
2. The Bulletin did not require funding for every woman in the eligible group. Its reference to considering individual circumstances was consistent with a policy allowing exceptions. The Trust was required to consider the evidence and circumstances of each case, not to maintain a blanket refusal based on cost or absence of regulatory approval.
3. A policy of funding an unlicensed treatment only in undefined exceptional circumstances was not, of itself, unlawful. The principle in R v North West Lancashire Health Authority ex p A, D & G [2000] 1 WLR 977 applied even though that case concerned resource prioritisation. It was lawful to leave “exceptional circumstances” undefined, provided the possibility of an overriding clinical need was genuinely recognised and each request was considered individually.
4. The Trust’s policy was not arbitrary or irrational. The eligible group was a permissible comparator pool, and the fact that other trusts funded all eligible patients did not determine the legality of Swindon’s different policy. There could be more than one lawful answer to a policy question. The policy had to remain under review as evidence, Secretary of State guidance, licensing and NICE appraisal developed.
5. The Convention claims failed. On the reasoning of Nitecki v Poland and Pentiacova v Moldova, Article 2 did not apply because the treatment had not been undertaken for general availability. Article 3 was not engaged: the threat was serious but less immediate, and the threshold for treatment arising from omission was high. Article 8 supplied no right to the treatment sought.
6. Permission to appeal was granted because the case raised issues of public interest and importance. Interim funding was continued until 31 March 2006 or judgment in the Court of Appeal, whichever was earlier. The Trust received an order for costs, not enforceable without leave; the claimant’s costs were directed to detailed assessment, and there was no order as to the interested party’s costs.

This was a first-instance judicial review. Permission to appeal to the Court of Appeal was granted, with an expedited transcript and interim funding continuing until 31 March 2006 or judgment in the Court of Appeal, whichever was earlier.