Basma v Manchester University Hospitals NHS Foundation Trust & Anor

Eligibility decisions under a managed access agreement may involve clinical expertise, but they are not thereby insulated from ordinary judicial review. Where the evidence is substantially factual, the decision-maker must consider all relevant material and decide what weight it deserves. Informal evidence may be relevant, particularly where no contemporaneous clinical assessment exists; formal records or video evidence cannot be treated as mandatory on the facts unless the governing scheme requires them. The reviewing court should give appropriate deference to clinical judgment while reflecting the decision’s impact on the patient. An advisory clinical panel may assist but cannot replace or determine the treating consultant’s decision. Failure to consider relevant informal evidence, or effective delegation to the panel, may render the decision unlawful and irrational.

A child with type 3 spinal muscular atrophy sought access to Nusinersen under a NICE technology appraisal and a Managed Access Agreement. The treating consultants decided that she had not been independently ambulant for at least five steps during the relevant 12-month period. They relied primarily on a formal assessment recording four steps and the absence of contemporaneous clinical documentation, while excluding or discounting evidence from her mother, family, teachers and friends.

The Administrative Court granted permission but dismissed the judicial review: [2020] EWHC 3189 (Admin). The appeal concerned whether the five-steps criterion involved clinical judgment or fact-finding, the appropriate intensity of review, the treatment of informal evidence, and the role of the NHS England Clinical Panel.

Appeal allowed. The Court of Appeal allowed the appeal on all four grounds, quashed the decisions of 11 September 2019 and 12 December 2019, and ordered the respondents to reconsider them in light of the judgment and any evidence submitted.

1. The statutory framework included the Health and Social Care Act 2012 and the Health and Social Care Information Centre (Functions) Regulations 2013. The NICE technology appraisal was binding on relevant health authorities. The treating consultant was the decision-maker. The Clinical Panel’s role was advisory and it was not an appeal or review body.
2. The five-steps criterion was not invariably a matter of expert clinical judgment. Its application could be substantially factual, with clinical elements whose importance depended on the evidence in the particular case.
3. The appropriate approach was conventional judicial review, with due deference to the clinical element. The court should not adopt the hands-off approach appropriate to a decision based on complex scientific judgment. The intensity of review also had to reflect the substantial factual element and the serious impact on the patient. This approach followed the guidance in R (on the application of Cotter) v NICE, [2020] EWHC 435 (Admin), and distinguished R (Campaign to End All Animal Experiments) v Secretary of State for the Home Department, [2008] EWCA Civ 417.
4. Evidence from family, friends and other lay witnesses was relevant in principle, particularly where no clinical evidence covered the relevant period. The decision-maker had to consider it and determine its weight. The MAA did not make formal clinical documentation or video evidence a prerequisite.
5. Both consultants failed to take relevant informal evidence into account. Dr Scoto also treated the Clinical Panel’s advice as determinative and effectively delegated the decision to it. In the circumstances, those failures were unlawful and irrational, notwithstanding the high threshold for an irrationality challenge.

1. Court of Appeal (Civil Division): Allowed the appeal, quashed the decisions of 11 September 2019 and 12 December 2019, and ordered reconsideration.
2. Administrative Court: HHJ Bird, sitting as Deputy High Court Judge, granted permission for judicial review but dismissed the claim. The decision is reported at [2020] EWHC 3189 (Admin).