Bristol-Myers Squibb Pharmaceuticals Ltd, R (on the application of) v National Institute for Health and Clinical Excellence

Procedural fairness applies to a public health authority conducting a technology appraisal where the process has serious practical consequences and provides consultation and an appeal on fairness grounds. A manufacturer must receive information reasonably necessary to make informed and effective representations on an expert review. That does not invariably require disclosure of an executable economic model. The question is fact-sensitive. Disclosure may be unnecessary where the manufacturer knows the altered inputs, can reproduce their effect, and has addressed the substantive assumptions in consultation. The Transparency Directive requires communication of the criteria for inclusion on a positive list, but not every detailed method by which cost-effectiveness criteria are assessed and applied.

The claimant manufactured abatacept, a treatment for rheumatoid arthritis. NICE refused to recommend it for NHS use after a single technology appraisal produced an incremental cost-effectiveness ratio substantially above the range normally regarded as cost-effective.

The claimant challenged the appeal decision and resulting guidance. It alleged that the United Kingdom had failed to comply with Council Directive 89/105 EEC and that NICE had acted unfairly by relying on an Evidence Review Group’s revised economic analysis without disclosing the executable model as modified. The central issues were whether the Directive applied to NICE guidance and whether fairness required disclosure in the circumstances.

1. The application was dismissed. Permission to appeal was refused. The claimant was ordered to pay 80% of NICE’s costs and £65,000 on account within 14 days.
2. The Transparency Directive did not require the challenge to NICE’s guidance to succeed. The court considered it difficult to determine whether an unfavourable NICE recommendation was an exclusion from a negative list. It therefore did not resolve that issue or decide whether R v Secretary of State for Health ex parte Pfizer Ltd (Pfizer No. 1) should be distinguished or followed. The court held instead that Article 6 was engaged by positive NICE recommendations, because such a recommendation required NHS authorities to make the product available and was indistinguishable in effect from inclusion on a positive list.
3. The Directive required the United Kingdom to communicate the criteria for positive inclusion. It did not require communication of the detailed means by which a criterion was assessed and applied. Cost-effectiveness was treated as a sub-head of affordability, and the criterion already notified by the Secretary of State was sufficiently clear and transparent. The United Kingdom was therefore not in breach.
4. NICE was under a general duty to act fairly. The statutory and regulatory context, the manufacturer’s submission and consultation process, and the express appeal ground of unfairness all supported that conclusion. Once a public authority undertakes consultation, it must conduct it properly. The duty applied even though NICE’s final decision involved judgment and broad evaluation.
5. Fairness required disclosure of information necessary to enable the manufacturer to challenge the Evidence Review Group’s revised cost-effectiveness figures where those figures formed part of the basis for the decision. It did not necessarily require disclosure of the executable model itself. The manufacturer knew the material altered inputs, had the ability to rerun its own model, and made informed representations on the substantive assumptions. Those material factual differences distinguished the case from R (on the application of Eisai Ltd) v National Institute for Health and Clinical Excellence [2008] EWCA Civ 438.
6. The fact that the Evidence Review Group, rather than NICE’s committee, held relevant information did not prevent fairness requiring disclosure in an appropriate case. Equal treatment did not necessarily require identical disclosure to every consultee, since the manufacturer was uniquely placed to understand its own model and commercial confidentiality was relevant.