Doctors acted unlawfully in deciding on eligibility for drug – Court of Appeal

4 March 2021 by

Nusinersen, marketed as Spinraza

Basma (suing by her mother and litigation friend Sara Basma) v Manchester University Hospitals NHS Foundation Trust & Anr [2021] EWCA Civ 278

Sophie Basma (“Sophie”) is 10. She suffers from Type 3 Spinal Muscular Atrophy (“SMA”). SMA is a rare, genetic, neuromuscular disease which progressively leads to sufferers being unable to walk or sit unaided with devastating consequences on their quality of life. Sophie can no longer walk. There is medication for SMA sufferers which would have had the potential of helping Sophie regain her ability to work. But the NHS Trust had concluded that Sophie did not meet the eligibility criteria for this new medication, “Nusinersen”.

By her mother she challenged the decision by way of judicial review. The judge below found that the NHS Trust had lawfully reached the decision that they did. This was her appeal against that finding.

Background facts and law

One of the eligibility criteria for the drug was that the patient should have been able to walk five steps unaided in the 12-month period preceding the treatment decision. Sophie became entitled to be considered for treatment on 24 October 2019. It was not in dispute that Sophie had satisfied the other six of the seven criteria. She could walk more than five steps until at least January 2018. In February, at a physiotherapy assessment, she walked four steps unaided. By September 2019, she could no longer take any steps unaided. The respondent’s physician, Dr Hughes, decided that she was not eligible for the drug. A second opinion was sought from a consultant (Dr Scoto) who assessed the appellant in December 2019. Dr Scoto referred the case to the NHS England Clinical Panel for advice, expressing the view that it was possible she had walked five steps during the relevant period, during which time she had had no contact with health care professionals. The panel concluded that “family recollection” was unreliable and gave its opinion that the appellant was not eligible.

The appellant’s family and friends gathered extensive evidence that she had been able to walk five steps unaided during the period which was critical to the decision-making. That evidence was submitted to the NHS England Clinical Panel, which concluded that there was insufficient objective and clinical evidence on which to change its earlier view. Dr Scoto reached the decision that the appellant did not meet the five step criterion. At first instance, the judge hearing the application for judicial review held that the matter was one of clinical judgement rather than straightforward fact-finding and required a “light touch” review, as in R (Campaign to End All Animal Experiments) v Secretary of State for the Home Department) [2008] EWCA Civ 417.

The Court of Appeal allowed her appeal against this finding.

Reasoning behind the Court’s decision

The Court held, unanimously, that the judge below had erred in categorising the five step decision as one of “expert clinical judgment”. The decisions under appeal were largely factual, but with a clinical element. The judge had placed undue weight on the fact that the decision-maker was a clinician. A substantial part of the task was to ascertain the facts, which required the decision-maker to take into account all relevant evidence.

The judge’s consideration of the appropriate level of review was sharply influenced by his view that the five step criterion was wholly one of clinical judgement. He had erred in equating the level of intensity of review with that in the Campaign to End All Animal Experiments case which depended on “a composite scientific judgment based more upon an expert analysis of scientific material than upon the application of hard-edged terms of a document amenable to lawyer’s construction”.

The proper approach was whether the decision met the high threshold of irrationality or perversity. The correct analogy was the case of The Queen (on the application of Cotter) v NICE [2020] EWHC 435 (Admin). A conventional judicial review approach was to be applied, albeit according some deference to the fact that the matter under consideration involved an element of clinical judgment.

On the facts of this case, the court should be conscious when determining the appropriate intensity of review, not only that there is a substantial factual element in the decision-making process but, importantly, of the considerable impact on this little girl of the decision. Not only is it common ground that Sophie would benefit from Nusinersen now, but also it is accepted that it has the potential significantly to delay the inevitable day when she will be rendered immobile. There is no other treatment available for her. [para 83]

The informal evidence offered by the family regarding Sophie’s ability to walk was relevant because there was no clinical evidence during the relevant period. Dr Huges had failed to take account of the evidence of the appellant’s mother that she was able to walk during that period. And the consultant Dr Scoto, when assessing the extensive evidence from the family and friends in December 2019, was unclear as to whether to use this evidence in order to determine the appellant’s eligibility. She clearly did not have doubts as to the cogency of that evidence.

Because Dr Scoto had treated the panel’s response as determinative, not advisory, she had unlawfully delegated her decision making power to the panel, notwithstanding that it could not stand up against the earlier opinion she had expressed as a treating consultant.

The test as to whether the appellant had walked five steps unaided was not complicated and had a very substantial factual element to it. There was no clinical or video evidence to assist in the decision-making process during the relevant period. The credibility of the informal evidence had not been impugned. The test criteria made it clear that children could have “off days”; therefore, the February 2018 assessment, when the appellant walked four steps, should have been regarded with considerable caution. The impact of the decision on Sophie’s quality of life could not be overstated. The failure to take account of the evidence of the appellant’s mother in respect of her ability to walk during the period when there was no clinical evidence available was irrational. Dr Scoto’s failure to reconsider her decision in the light of the further informal evidence, instead of relying on the panel’s advice, was also irrational.

Comment

Humane and detailed though it is, there is something about this judgment that grates: the repeated emphasis on the impact on the patient’s life of the decision whether or not to grant her treatment. If impact were a criterion for eligibility that overrides all other criteria, there would be no point in having eligibility rules at all.

Possibly a better way for the Court to have reached the decision that it did would have been to base it on the Tameside criteria for unlawfulness or irrationality, per Lord Diplock in 1977:

the question for the court is did the Secretary of State ask himself the right question and take reasonable steps to acquaint himself with the relevant information to enable him to answer it correctly?

The Tameside duty is “a requirement of general application to all relevant decision makers and a necessary condition for a decision to be characterised as lawful” Stadlen J in R(RP) v Brent LBC [2011] EWHC 1738 (Admin) at para 239, and the duty to make sufficient inquiries; specifically, having decided to resolve certain factual issues, duty to carry out investigations in that regard in a thorough and balanced way (R v Camden LBC ex parte H [1996] ELR 360. The Tameside duty is not just an aspect of lawfulness, but of rationality as well: R(Campaign Against Arms Trade) v Secretary of State for International Trade [2019] EWCA Civ 1020.

There is a great deal said in the Basma appeal about the lack of consultations, physiotherapy appointments and general surveillance by the doctors of Sophie’s condition over the critical time period. The hurdles of credibility to be accorded to friends’ and family’s evidence could have been easily overcome had she been assessed by members of the clinical team more often.

1 comment;


  1. Sarah says:

    Very interesting article. Are there any statistics on these sorts of cases? How common are these incidents?

Comments are closed.

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