Informal evidence can be considered for clinical decision-making on access to critical medicines


In overturning the High Court’s decision, the Court of Appeal in R (Basma) v Manchester University Hospitals and NHS Foundation Trust & Anor [2021] EWCA Civ 278 ruled that clinicians must consider all evidence, including informal evidence provided by a patient’s family and friends, when making decisions on access to life-changing treatments, and that the clinicians in this case had failed to do so. In Basma, a ten-year old girl suffering from a rare, genetic, neuromuscular disease which progressively leads to sufferers being unable to walk or sit unaided, was denied access to a newly approved drug, Nusinersen. In the absence of any other treatment for her condition and without access to Nusinersen, the girl would have permanently and irreversibly lost the ability to walk.

The National Institute for Health and Care Excellence (“NICE”) prescribed a number of criteria for access to Nusinersen in 2019, including that the patient must still be able to walk or (for a child) have been able to so within the last 12-months. The decision to deny access to the drug was taken by the clinicians on the basis that there was no formal documentation that the claimant met this criterion. Such evidence was not sought formally given that the drug had recently been approved; thus, the requirement to assess the patient against the access criteria was not previously known. However, given the ‘powerful factual aspect’ to the patient’s case, the Court ruled that although the informal evidence is not decisive, as decision-makers the clinicians were bound to consider all evidence and give appropriate weightage in the decision-making process.

Basma further emphasised that each decision has both clinical and factual aspects and the balance between the two will vary from case to case. In Basma, the decision was substantially factual, but with clinical aspects; essentially, that in light of the informal evidence, it could be adduced from the formal evidence that the patient met the criterion to access life-changing treatment. In these circumstances, the court should adopt a conventional approach to judicial review, according due weight to the truly clinical judgment of clinicians but balancing that with the substantial factual element as well as the considerable importance of the decision to the patient.

The Court also emphasised that the clinicians were the primary decision-makers and the role of the expert clinical panel was advisory, not determinative. In denying access to the treatment in Basma, the clinicians had effectively delegated decision-making to the advisory panel by adopting their view where the clinicians could have reconsidered their decision in light of the evidence provided by the patient’s family and friends.

Tim Buley QC appeared for the appellant patient (via her mother and litigation friend) in the Court of Appeal and David Lock QC acted for the appellant at an early stage of the litigation in the High Court.

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