Fraser & Anor, R (on the application of) v National Institute for Health and Clinical Excellence & Ors

Judicial review of an expert body’s evidence-based clinical guideline requires proof of irrationality, not merely disagreement with the evidence, the weight assigned to it, or the resulting recommendation. A court must avoid substituting its assessment for that of the body entrusted with the decision.

For apparent bias, the court assesses all relevant circumstances and asks whether a fair-minded and informed observer would conclude that there was a real possibility of bias. In an expert advisory body, prior views or specialist experience do not establish predetermination. The claimant must show a closed mind at the time of decision.

The claimants challenged a clinical guideline issued by National Institute for Health and Clinical Excellence concerning chronic fatigue syndrome/myalgic encephalomyelitis. They argued that recommendations for cognitive behavioural therapy and graded exercise therapy were irrational because the evidence base was inadequate and risks had been overlooked.

They also alleged apparent bias and predetermination arising from the composition, expertise, prior publications and declared interests of members of the guideline development group. The interested party separately argued that NICE had failed to assess the cost-effectiveness of the recommended interventions.

The court considered the proper approach to expert public decision-making, apparent bias, conflicts of interest, and NICE’s statutory directions.

1. The claimants’ claim and the interested party’s claim were dismissed.
2. Where a public body acts in good faith, follows a proper procedure and conscientiously considers the material, a claimant must show that the decision could not reasonably have been reached or was otherwise irrational. The court must distinguish between whether a matter was material and the weight assigned to it. Weight is for the decision-maker, subject to irrationality review. The court should not engage in fine textual analysis or substitute its own assessment for that of the expert body.
3. The guideline development group was entitled to assess the York Review alongside patient and clinician evidence, the experience of its members and co-opted experts, and economic material. The evidence-weighting table in the guideline manual was advisory rather than prescriptive. The recommendation of cognitive behavioural therapy and graded exercise therapy was not irrational, and the alleged risks had not been overlooked.
4. The apparent-bias inquiry required two stages: identifying all circumstances bearing on the allegation, then asking whether a fair-minded and informed observer would conclude that there was a real possibility of bias. In the context of an independent expert body, prior views, published research and relevant expertise did not establish predetermination. The necessary showing was a closed mind at an early stage.
5. The individual interests relied upon did not require exclusion from the group or withdrawal from deliberations. NICE had an effective declaration system, and the chair was entitled to determine whether a declared interest required recusal from a particular matter. There was no evidence that the members approached the guideline with closed minds or acted other than in good faith.
6. The Secretary of State’s directions required NICE to develop a guideline under paragraph 2(1)(b), not to conduct a clinical-benefit and cost appraisal under paragraph 2(1)(a). NICE therefore had to consider the broad balance of clinical benefit and cost and the degree of clinical need, but was not required to perform a formal cost-benefit analysis. In any event, the evidence showed that cost-effectiveness had been considered.

First-instance judicial review decision. No earlier appellate decision is stated in the judgment.