Ethics in health technology assessment

Health technology assessment raises ethical questions about benefits and harms, individual autonomy, equitable access and the allocation of limited resources. These questions concern both the technology and the assessment process, including the consequences of decisions made under uncertainty.

Ethical principles and tensions

The EUnetHTA HTA Core Model version 3.0 recognises ethical aspects of technologies and recommends that assessments themselves respect key ethical principles and consider the consequences of conducting an assessment. ¹ INAHTA's ethical-issues working group identified methodological approaches used by assessment agencies. ¹

Six principles should be evaluated: ¹

1. Benefit–harm balance.
2. Autonomy.
3. Respect for persons.
4. Justice and equity.
5. Legislation.
6. Ethical consequences of the assessment.

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Four distinctions can involve conflicts or tensions: ¹

1. Product ethics and process ethics.
2. Individual patients' interests and society's interests.
3. Practice and research.
4. Economic and therapeutic value.

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Questions for an assessment include: ¹

• What trade-offs exist between benefits to patients and society?
• Should cost alone determine funding for new therapies?
• Are end-of-life years more or less valuable than earlier years?
• Should negative or inconclusive data be considered when they might represent an exception?
• Could prior assumptions about interventions or assessment goals bias decision makers?

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Contextual evaluation raises a further question: whether situational ethics is appropriate or some standards should remain absolute. ² Combining objective algorithms with subjective assessment informed by education, experience, expertise, values and instinct may help address it. ² Awareness of these questions may help writers recognise or prevent unintended harm from assessment-based decisions. ²

Individual needs and collective resources

Limited financial, therapeutic and personnel resources create tension between patients and society because all needs can seldom be met. ³ Decisions therefore often apply the greatest-good-for-the-greatest-number principle, while justice also requires avoiding socioeconomic or racial discrimination in access. ³ An ethical question is whether individuals owe an obligation to the wider group, alongside the liberties that protect them from unwarranted collective action. ³

Governments funding healthcare act as stewards for individuals and groups, allocating resources for affordable coverage. ³ Limited capacity to consider individual cases leads to generalisable, often algorithm-based solutions that can conflict with situational ethics. ³ Such tools remain imprecise, imperfect and uncertain. ⁴

Even rigorous decision tools allow subjective weighting and grading of factors. ⁵ Research on the neurocognitive basis of decisions may be useful in assessment because it incorporates economics, alongside the therapeutic considerations and reimbursement impact. ⁵

Reimbursement under uncertainty

Accelerated authorisation raises the question of whether reimbursement should change as evidence emerges, including evidence of limited long-term efficacy or safety. ⁶ Further questions concern whether regulators and assessors share goals or have conflicting interests, whether profit-driven companies have incentives to contain costs, and whether urgency should move approval and reimbursement decisions from sequential to parallel processes. ⁶ When an expensive treatment appears effective only anecdotally, the ethical questions include whether it should be offered widely and who should pay. ⁶

Healthcare approval and reimbursement decisions depend heavily on human factors and cannot avoid external influences. ⁴ Protective ethical standards, attention to unintended consequences and recognition that knowledge evolves remain necessary. ⁴