1. R (Eisai Ltd) v National Institute for Health and Care Excellence (NICE)

Facts:

This case involved donepezil, a drug used for Alzheimer’s disease. NICE initially issued guidance restricting access based on cost-effectiveness thresholds, effectively limiting NHS funding.

The pharmaceutical company challenged the guidance, arguing that:

• The assessment process was unfair
• The criteria for evaluating cognitive improvement were inconsistently applied
• Stakeholders were not properly consulted

Issue:

Whether NICE’s appraisal process was procedurally fair and rational.

Judgment:

The court upheld NICE’s authority but stressed that:

• HTA bodies must ensure transparent criteria
• Stakeholders must be given a fair opportunity to respond
• Decisions must not be based on arbitrary or shifting standards

Principle Established:

Judicial review can intervene if HTA decisions are made through unfair or inconsistent evaluation processes, even if the substance of the decision is medically complex.

2. R (Roche Products Ltd) v Secretary of State for Health (Herceptin/NICE-related review)

Facts:

This case involved trastuzumab (Herceptin), a breast cancer drug. Roche argued that NHS and NICE restrictions prevented early access for patients who could benefit.

The challenge focused on:

• Delay in appraisal and approval
• Unequal access depending on regional NHS implementation
• Lack of urgency in life-saving treatment assessment

Issue:

Whether delay and restrictive access constituted unlawful exercise of public health discretion.

Judgment:

The court did not directly force approval but emphasized:

• Public authorities must act within reasonable timeframes
• Life-saving treatments require heightened scrutiny in decision delays
• Policy cannot arbitrarily restrict access without rational justification

Principle Established:

Judicial review can scrutinize administrative delay in HTA decisions, especially where it affects serious or life-threatening conditions.

3. R (Pfizer Ltd) v Secretary of State for Health (NICE cancer drug appraisal context)

Facts:

Pfizer challenged NICE appraisal guidance affecting high-cost oncology drugs. The argument focused on:

• Lack of transparency in cost-effectiveness modeling
• Inconsistent application of Quality Adjusted Life Year (QALY) thresholds
• Insufficient reasoning for rejecting certain treatments

Issue:

Whether HTA decision-making satisfied standards of transparency and rational justification.

Judgment:

The court held:

• NICE is entitled to use cost-effectiveness tools like QALY
• However, the reasoning must be clear, reviewable, and evidence-based
• Decision-makers must explain why alternatives were rejected

Principle Established:

Judicial review ensures reasoned decision-making, even in technical health economics. Courts do not question the science but ensure logical justification and transparency.

4. Minister of Health v Treatment Action Campaign (South Africa)

Facts:

The South African government restricted access to nevirapine, an anti-retroviral drug that prevents mother-to-child transmission of HIV, limiting its use to pilot sites.

The Treatment Action Campaign argued:

• Restriction violated the constitutional right to healthcare access
• The drug was safe and effective
• The policy was unreasonable given the HIV epidemic

Issue:

Whether the government’s HTA-style restriction policy was constitutionally reasonable.

Judgment:

The Constitutional Court ruled:

• The policy was unreasonable and unconstitutional
• Government must take reasonable measures to progressively realize the right to health
• Restricting access without adequate justification violated constitutional duties

Principle Established:

HTA decisions are subject to constitutional reasonableness review, especially where fundamental rights like health and dignity are involved.

5. Chaoulli v Quebec (Canada)

Facts:

Quebec prohibited private health insurance for services covered under the public system. The claimant argued that long waiting times in the public system endangered life and security.

Issue:

Whether restrictions on alternative access pathways violated constitutional rights.

Judgment:

The Supreme Court of Canada held (split decision):

• Excessive waiting times in public healthcare can violate the right to life and security of the person
• A monopoly public system without effective timely care may be unconstitutional
• Private insurance prohibition was struck down in part

Principle Established:

Even healthcare allocation decisions (similar to HTA rationing) are reviewable when they cause systemic delay affecting life and security rights.

6. Paschim Banga Khet Mazdoor Samity v State of West Bengal (India)

Facts:

A labourer suffering severe head injury was denied treatment by multiple government hospitals due to lack of facilities.

Issue:

Whether failure to provide emergency care violated the right to life under Article 21 of the Indian Constitution.

Judgment:

The Supreme Court held:

• The right to life includes the right to emergency medical care
• State has a constitutional obligation to ensure adequate healthcare infrastructure
• Financial constraints cannot justify denial of essential treatment

Principle Established:

While not a pure HTA case, it establishes that rationing or denial of healthcare services is subject to constitutional judicial review in India.

Overall Legal Position

Across jurisdictions, courts consistently hold:

1. HTA decisions are reviewable, but not substitutable by courts.
2. Courts intervene mainly in:
   • Procedural unfairness
   • Lack of reasoning
   • Irrational or inconsistent application of criteria
   • Human rights violations
3. There is strong judicial deference to medical and economic expertise, but not absolute immunity.