The Court of Appeal has overturned a decision made by two leading NHS bodies that had been advised by an NHS England expert panel that it was only entitled to consider evidence from clinicians when considering whether factual criteria were satisfied to meet access conditions for an NHS drug. The case contains an important message to clinicians that they have a duty to listen and take note of factual matters explained to them by patients and their families, and cannot discount that evidence simply because details are not recorded in clinical notes.
In R (Basma) v Manchester University Hospitals NHS Foundation Trust & Anor  EWCA Civ 278 a child, Sophie Basma, sought treatment with Nusinersen to treat her Type 3 Spinal Muscular Atrophy (“SMA”) which progressively leads to sufferers being unable to walk or sit unaided with devastating consequences on their quality of life. The child satisfied 7 out of the 8 clinical criteria but the issue was whether Sophie had taken “at least five steps independently in upright position with back straight” in the 12 month period prior to the start of the drug.
There was no clinical assessment in the 12 month period but the family provided considerable eye-witness evidence from family and non-clinical professionals such as teachers that Sophie had walked during this period. Whilst the clinicians did not dispute this evidence, NHS England advised it should be discounted because the evidence from others might be unreliable and only clinical observations could be used to satisfy the test. As a result, Sophie was denied the drug despite the fact that it could have been hugely beneficial for her.
The Court of Appeal held that the decision to deny Sophie the drug by excluding evidence from outside the NHS was unlawful and the conclusions of the doctors were irrational. The Court held that where a clinician is a decision maker as to whether criteria are fulfilled, the decision maker has a duty to take account of all relevant evidence, not just that contained within clinical records.