Introduction

Basma v. Manchester University Hospitals NHS Foundation Trust & Anor ([2021] EWCA Civ 278) is a landmark case adjudicated by the England and Wales Court of Appeal (Civil Division) on March 2, 2021. The case revolves around Sophie Basma, a 10-year-old girl diagnosed with Type 3 Spinal Muscular Atrophy (SMA), a debilitating genetic neuromuscular disease that progressively impairs motor functions. The central issue pertains to whether the Respondents, Dr. Imelda Hughes and Dr. Mariacristina Scoto, acted unlawfully and irrationally in deeming Sophie ineligible for treatment with Nusinersen (“Spinraza”), a newly approved and potentially life-altering drug.

Sophie’s eligibility for Nusinersen hinged on the "5 Steps Criterion" outlined in the National Institute for Health and Care Excellence ("NICE") guidance, which required her to demonstrate the ability to walk five steps unaided within twelve months prior to treatment initiation. Despite meeting all other criteria, the Respondents concluded that Sophie did not satisfy this pivotal condition, leading to judicial review proceedings initiated by her mother, Ms. Basma.

Summary of the Judgment

The High Court Judge, HHJ Bird, initially dismissed Ms. Basma's application for judicial review. However, upon appeal, the Court of Appeal scrutinized the decisions of Dr. Hughes and Dr. Scoto, finding them both unlawful and irrational. The court determined that the Respondents failed to adequately consider relevant informal evidence provided by Sophie’s family, which indicated instances of her independent ambulation within the critical period. Consequently, the decisions to deny Sophie access to Nusinersen were quashed, mandating the Respondents to reconsider their decisions in light of the appellate court's findings and any additional evidence presented by Ms. Basma.

Analysis

Precedents Cited

The judgment extensively referenced key precedents to frame the appropriate standard of judicial review in cases involving complex medical judgments:

• Campaign to End All Animal Experiments v. Secretary of State for the Home Department ([2008] EWCA Civ 417): This case established the boundaries of judicial review concerning decisions heavily reliant on scientific judgment, advocating for a "light touch" approach.
• The Queen (on the application of Cotter) v. NICE ([2020] EWHC 435 (Admin)): Highlighted the necessity of balancing expert judgment with judicial oversight, emphasizing that even specialized decisions are not beyond judicial scrutiny.

These cases underscored the principle that while courts should defer to expert judgments, especially in specialized fields like medicine, they retain the authority to review such decisions to prevent unlawful or irrational outcomes.

Legal Reasoning

The crux of the legal reasoning centered on whether the decision to deny Sophie Nusinersen was based on unlawful and irrational grounds. The court evaluated:

• Classification of the Decision: The original judge categorized the 5 Steps Criterion as a matter of clinical judgment, warranting a light-touch review. However, the appellate court contested this, positing that the decision was substantially factual with clinical elements, thereby necessitating a more traditional review approach.
• Consideration of Evidence: The Respondents were criticized for not adequately considering informal evidence from the family, which could have demonstrated Sophie’s ability to meet the 5 Steps Criterion. The court emphasized that in the absence of formal clinical assessments, such evidence should not be dismissed outright.
• Standard of Review: The appellate court departed from the light-touch approach applied in Campaign to End All Animal Experiments, advocating for a conventional judicial review that balances deference to expert opinion with the necessity to ensure fair and lawful decision-making.

The court concluded that the Respondents' failure to consider all relevant evidence rendered their decisions unlawful. Additionally, by relying excessively on the Clinical Panel's advisory role, Dr. Scoto neglected her duty to independently assess the evidence, culminating in irrational decision-making.

Impact

This judgment sets a significant precedent for judicial reviews involving medical treatment eligibility, particularly in cases where formal clinical evidence is scarce. Key impacts include:

• Enhanced Scrutiny of Medical Decisions: Courts may adopt a more active role in reviewing medical decisions, ensuring that all relevant evidence, including informal accounts, is duly considered.
• Balanced Review Standards: The decision delineates the boundary between purely clinical judgments and those involving substantial factual components, advocating for appropriate scrutiny based on the nature of the decision.
• Family and Lay Evidence: Establishes the importance of considering familial and observational evidence in medical eligibility decisions, especially when formal assessments are lacking.

Future cases involving eligibility for expensive or life-changing treatments may reference this judgment to argue for more inclusive evidence assessment and to challenge decisions deemed unlawful or irrational.

Complex Concepts Simplified

Judicial Review

Judicial review is a process by which courts examine the legality of decisions or actions made by public bodies. It ensures that such decisions comply with the law and adhere to principles of fairness and rationality.

5 Steps Criterion

In the context of this case, the "5 Steps Criterion" refers to a specific eligibility condition defined by NICE for administering Nusinersen. It requires that a patient with Type 3 SMA must be able to walk five steps independently within twelve months prior to treatment initiation. Independent walking implies taking steps without assistance, maintaining an upright posture, and not relying on contact with persons or objects.

Managed Access Agreement (MAA)

The MAA is a contractual framework negotiated between Biogen, NICE, and NHS England, governing the criteria and data collection for administering Nusinersen. It outlines clinical conditions for treatment eligibility and stipulates the process for assessing and reviewing patient suitability.

Irrationality in Judicial Review

A decision is deemed irrational if it is so unreasonable that no reasonable decision-maker could have arrived at it. This is a high threshold, meaning only egregiously flawed decisions are overturned on this ground.

Conclusion

The case of Basma v. Manchester University Hospitals NHS Foundation Trust & Anor underscores the judiciary’s role in ensuring that medical eligibility decisions are both lawful and rational. By mandating the consideration of informal evidence alongside formal clinical assessments, the court reinforced the necessity for comprehensive and fair evaluation processes in healthcare decision-making.

This judgment serves as a pivotal reference for future cases involving the eligibility for specialized treatments, particularly in scenarios where formal medical evidence may be limited or contested. It emphasizes the balance courts must maintain between respecting expert medical judgment and safeguarding the rights and well-being of patients.

Ultimately, the ruling highlights the imperative for healthcare providers to adopt transparent, evidence-based decision-making processes that account for all relevant information, thereby ensuring equitable access to life-enhancing treatments.