Eisai Ltd, R (on the application of) v National Institute for Health and Clinical Excellence (NICE)

Factual and Procedural Background

The appeal concerns a challenge by Plaintiff, a pharmaceutical company holding the UK marketing authorisation for a drug used in treating Alzheimer's Disease (AD), against guidance issued by Defendant, a national health authority responsible for appraising healthcare interventions and issuing recommendations for their use in the National Health Service (NHS). The guidance limited the use of acetylcholinesterase inhibitors (AChEIs) to patients with moderately severe AD, reversing earlier recommendations for use in mild to moderately severe cases. Plaintiff initiated judicial review proceedings contesting the guidance on multiple grounds, succeeding partially on anti-discrimination but failing on procedural fairness and irrationality at first instance. On appeal, Plaintiff pursued only the procedural fairness ground, specifically challenging Defendant's refusal to provide a fully executable version of an economic model used in the appraisal process, which Plaintiff argued rendered the consultation unfair and the guidance unlawful.

The procedural history includes detailed consultations involving multiple stakeholders, including Plaintiff and other pharmaceutical companies, patient groups, and professional bodies. The final guidance followed a series of appraisal committee meetings, consultation documents, and an appeal panel decision rejecting Plaintiff's procedural fairness complaint. Plaintiff then sought judicial review of the refusal to disclose the fully executable economic model, with Defendant resisting and cross-appealing a costs order. The appeal focuses on whether procedural fairness required disclosure of the fully executable model.

Legal Issues Presented

1. Whether Defendant's refusal to provide Plaintiff with the fully executable economic model during the consultation process constituted a breach of procedural fairness.
2. Whether the consultation process was rendered unlawful due to the non-disclosure of the fully executable model.
3. Whether Plaintiff's delay in applying for judicial review should preclude relief.
4. The appropriateness of the costs order made by the court below in light of the appeal outcome.

Arguments of the Parties

Appellant's Arguments

• Non-disclosure of the fully executable economic model prevented Plaintiff from conducting sensitivity analyses and verifying the model's accuracy, thereby limiting its ability to make informed representations on a central element of the appraisal.
• Consultation fairness requires that consultees be given sufficient information and opportunity to challenge the evidence relied upon by the decision-maker, including the ability to test the model's reliability.
• Defendant's confidentiality and delay arguments do not justify withholding the model, especially as similar models submitted by manufacturers are disclosed in fully executable form.
• Any additional burden or delay caused by disclosure could be managed by imposing reasonable conditions and time limits on the use of the model.
• Plaintiff sought only to comment on the model with a view to a fresh determination, not to quash the existing guidance outright.

Respondent's Arguments

• Provision of a read-only version of the model was sufficient to meet procedural fairness requirements, allowing consultees to understand and comment on the model.
• Defendant has a duty to quality assure the model; consultees are not required to perform this function.
• Disclosure of the fully executable model is restricted by confidentiality obligations owed to the academic institution that developed it, which holds intellectual property rights.
• Disclosure would impose a significant practical burden, causing delay of 2 to 3 months and additional resource demands, potentially disrupting the appraisal timetable.
• There was no undue delay by Plaintiff in raising the challenge, but even if there were, it would not be a bar to relief.
• Only Plaintiff requested the fully executable model during the consultation, and other consultees did not raise similar concerns, suggesting the complaint lacks substance.

Table of Precedents Cited

Court's Reasoning and Analysis

The court acknowledged the vital public function performed by Defendant and the significant role of its guidance in determining treatment availability within the NHS. It recognized the appraisal process as highly detailed and transparent, with extensive consultation and disclosure. The economic model at the center of the dispute was crucial to assessing cost-effectiveness and determining whether treatments met acceptable thresholds.

The court accepted that while the read-only version of the model allowed consultees to view formulae and data, it prevented them from running sensitivity analyses or altering assumptions, which was important for testing the model's robustness. Expert evidence presented sharply contrasting views on the practical disadvantages of the read-only format, but the inability to perform sensitivity analyses was undisputed and significant.

The court rejected Defendant's argument that consultees have no right to quality assure the model, emphasizing that fairness requires consultees to be able to test reliability themselves to make informed representations. The court found that withholding the fully executable model placed consultees, particularly pharmaceutical companies, at a significant disadvantage in challenging the model's reliability and limited their ability to respond intelligently on a central aspect of the appraisal.

Confidentiality concerns were examined in detail. The court found that contractual and intellectual property arguments did not justify non-disclosure, as the model was commissioned and paid for by the Secretary of State, and the read-only version was already disclosed under confidentiality undertakings. Past instances of disclosure with consent further undermined confidentiality objections. Even if confidentiality were prima facie engaged, public interest in fairness would justify disclosure.

Regarding practical concerns, the court accepted that disclosure might cause additional workload and delay but found these factors insufficient to outweigh the fairness requirement. The possibility of imposing reasonable conditions to manage workload and timing was noted. The court also considered Plaintiff's delay in bringing judicial review and found it not to be a bar to relief, given the context and availability of an appeal mechanism.

Ultimately, the court concluded that procedural fairness required the release of the fully executable model to Plaintiff, allowing it to make representations and prompting a fresh determination by Defendant with a right of appeal.

Holding and Implications

The court's final decision was to allow Plaintiff's appeal on the ground of procedural unfairness related to non-disclosure of the fully executable economic model.

Holding: The refusal by Defendant to provide the fully executable version of the economic model during consultation was procedurally unfair and unlawful in the circumstances of this case.

Implications: The decision requires Defendant to disclose the fully executable model to Plaintiff and permit representations to be made, followed by a fresh appraisal determination with an appeal right. The ruling does not quash the existing guidance but mandates further procedural steps to ensure fairness. No new binding precedent was established beyond the application of existing procedural fairness principles to this context. The court also deferred the question of relief and costs for further consideration, indicating that the cross-appeal on costs would be reconsidered in light of this outcome.