SB, R (on the application of) v NHS England

An NHS funding decision must apply the relevant policy according to its proper meaning and on a correct understanding of the evidence. “Clinical effectiveness” concerns whether the treatment achieves the intended clinical outcome; it is distinct from the duration of that effect or proof of a long-term clinical benefit. An individual funding request must first address both limbs of the exceptional-clinical-circumstances threshold, before considering the evidence of likely benefit, cost-effectiveness and other discretionary factors. A decision materially based on misunderstanding the evidence or the policy is unlawful and should ordinarily be quashed and remitted. The statutory duty to have regard to children’s welfare does not alter the nature of NHS resource-allocation functions, and refusal to fund treatment does not generally engage article 8 ECHR.

The claimant was a severely autistic child with phenylketonuria whose clinicians sought NHS funding for Kuvan. Dietary treatment had not consistently kept his blood phenylalanine within the accepted safe range. NHS England’s Individual Funding Request Panel accepted that the claimant’s circumstances were exceptional but refused funding, principally because it considered that clinical effectiveness had not been demonstrated. An IFR Screening Group later declined to refer the matter back to the Panel. The claim challenged those decisions on irrationality and on alleged failures concerning children’s welfare, best interests and article 8 ECHR.

1. Claim allowed in part. The decision of 14 December 2016 was quashed and remitted to the IFR Panel for reconsideration. The challenge to the Screening Group’s later refusal to remit had become academic.
2. The statutory scheme gave NHS England substantial judgment in arranging specialist services and allocating finite resources. There was no individual entitlement to a particular treatment. The court’s function was to ensure that the policy was correctly interpreted and that its application was based on a proper understanding of the evidence and relevant considerations: see R (Dyer) v The Welsh Ministers [2015] EWHC 3712 (Admin) and R v Cambridge Health Authority, ex parte B [1995] 1 WLR 898.
3. The IFR Policy required the Panel at the threshold stage to consider both whether the patient was significantly clinically different from the relevant cohort and whether he was likely to gain significantly more clinical benefit. The Panel had accepted that the claimant’s severe autism made him exceptional. The later questions concerning robust evidence, likely benefit and cost-effectiveness were discretionary merits questions after the threshold had been crossed.
4. “Clinical effectiveness” had to be interpreted uniformly and in its ordinary clinical sense. It meant whether the treatment achieved the intended clinical outcome, not whether a long-term clinical benefit such as improved cognition or growth had been proved. The relevant outcome here was reduction of blood phenylalanine and improved dietary tolerance. NHS England’s own policy accepted strong evidence of those effects. The Panel therefore either misinterpreted the policy or materially mischaracterised the evidence.
5. The Panel also misunderstood the clinical evidence by treating the claimant’s levels as acceptable because they were generally below 600 μmol/L. The target range identified the point at which the risk of neurological impairment justified intervention; it was not merely a distinction between normal and abnormal levels. The Panel was entitled to form its own judgment, but it had to address the actual evidence and the risk arising from repeated levels above the accepted range.
6. The challenge based on Children Act 2004, section 11(2), failed. Following Kensington and Chelsea Royal London Borough Council v Mohamoud [2015] EWCA Civ 780, with the analysis in Castle v Commissioner of Police of the Metropolis [2012] 1 All ER 953, the duty was not free-standing and did not change the scope of NHS England’s statutory functions.
7. The article 8 and best-interests ground also failed. Nzolomeso v Westminster City Council [2015] UKSC 22 concerned a different statutory context. Refusal to fund a particular medical treatment did not engage article 8, and there was no additional obligation to treat the claimant’s welfare as paramount.