2. Ethical issues
| Site: | EUPATI Open Classroom |
| Course: | Health Technology Assessment and Evaluation Methods |
| Book: | 2. Ethical issues |
| Printed by: | Guest user |
| Date: | Thursday, 4 June 2026, 11:37 AM |
1. Ethical issues
Ethical issues arising from health technologies have become more prominent over the last several decades. This is due to a combination of factors including:
- The rise of increasingly complex systems for delivering equally complex care
- A shift away from the assumption that all new health technologies are inherently beneficial
- Greater awareness of the difficult trade-offs required in allocating limited health-care resources
In the field of HTA, ethical issues arise in particular in relation to the following areas:
Use of technology
HTA evaluates both existing and emerging health technologies. However, how a technology is used—and in what context—shapes the ethical considerations associated with it. A technology applied in a different setting, population, or for a different purpose may raise new or altered ethical concerns.
đź“Ś Example: Genetic testing used to assess disease risk in healthy individuals may pose different ethical implications than when used in the diagnosis of symptomatic patients.
According to the 2020 INAHTA definition, HTA aims “to inform decision-making in order to promote an equitable, efficient, and high-quality health system.” In doing so, HTA helps illuminate the ethical balance between:
- Beneficence (promoting good)
- Non-maleficence (avoiding harm)
While HTA can guide policies and recommendations, it is ultimately patients and healthcare professionals who decide whether a technology is used in individual cases.
Short recap of Beneficence and Non-maleficence
Research should be worthwhile and designed to provide value that outweighs any potential risk or harm. Investigators are expected to:
- Maximise the potential benefits of research
- Minimise potential risk of harm to participants and researchers
- Implement robust safeguards to mitigate potential risk and harm
A favourable risk–benefit assessment requires evaluating the probability and magnitude of both potential harms and potential benefits. While "risk" typically refers to harm, the likelihood of benefits must also be weighed carefully.
Possible types of harm include:
- Psychological
- Physical
- Legal
- Societal
- Economic
Though physical (pain or injury) and psychological harms are most common, broader societal risks may also arise and must be considered.
Discovering true benefit often involves some degree of risk. Research entirely free of risk would limit progress and restrict meaningful advances in human welfare.
Where participants may experience direct benefit, accepting certain risks may be justified. In studies where participants do not directly benefit, potential societal gains—such as reducing disease burden or improving future care—may warrant proceeding, but only after careful ethical evaluation.
Conduct of research
HTA involves gathering information and in some cases conducting original research, not just about the science that underlies and supports a health technology, but also about the preferences or values of patients who may use it.
Some HTA organisations may explore patient preferences or values directly through qualitative methods. This is particularly relevant for technologies with both, significant desirable and adverse health effects, that must be weighed in decisions about using the technology.
From an ethics perspective, research on patient preferences is no different from research on health effects. Therefore, it must conform to the standards for doing research, and be consistent with the principles as laid out in the Declaration of Helsinki of respect for persons, beneficence, and justice.
Allocating resources
HTA assessments often inform decisions about how healthcare resources are allocated. When doing so, it is important to distinguish between equal access and equitable access:
- Equal access means everyone receives the same resources.
- Equitable access means resources are distributed based on need—so that outcomes are fair across different individuals or groups.
While the two terms may sound similar, equal allocation can unintentionally lead to inequitable outcomes, particularly when resources are limited. For example, distributing the same amount of healthcare support to everyone may fail to meet the needs of those who are most disadvantaged or at risk.
- Vertical equity: those with greater need receive more services.
- Horizontal equity: those with similar needs receive similar services.
“The fair allocation of resources or treatments among individuals or groups, such that each gets what they are owed or entitled to.”
Visualising the Difference: Equality ≠Equity
The diagram below illustrates the difference between equality and equity (source: Allies for Reaching Community Health Equity (ARCHE)[2]).
- Equality: Everyone is given the same number of crates—but not everyone can reach the apples.
- Equity: People receive a different number of crates depending on their height—so that everyone can reach the apples.
This analogy shows how equal treatment does not guarantee equal opportunity. Only by accounting for individual circumstances can fair access to healthcare be achieved.
Considerations for Ethical Analysis (ETH)
The ethical analysis differs from the other parts of an HTA, i.e., the parts relating to health science, economy, and other social science. The ethical understanding may be subjected to empirical studies, e.g., surveys, or qualitative, e.g., anthropological studies. Such studies describe (analytically/theoretically) ethical attitudes, but do not determine whether or not they are well-founded or broadly accepted.
It can be discussed if the ethical assessment should result in a concluding attitude to whether the technology in question is ethically justified. An argument against it could be that the HTA should form the basis of a decision of adoption but not make the decision. On the other hand, it seems natural that an analysis of ethical problems is followed by a conclusion, which can never be absolute or final because of the dynamic nature of principles.
It may be useful to draw the decision-makers’ attention to the problem of justice, which is always connected to the use of economic resources in the health care system. The chosen decision is always also a choice of rejecting other possibilities. A clear framework, agreed principles, and processes will help make the analysis and decision transparent and acceptable.
Recent Developments in Ethical Analysis Guidance
In recent years, several tools have been introduced to support the integration of ethics into HTA. These include:
- Checklists developed by HTA scholars to encourage a structured, transparent approach to identifying and evaluating ethical issues. Widely used by HTA bodies and useful for patient advocacy groups.
- The HTA Core Model® Version 3.0 developed by EUnetHTA, which contains a full section on Ethical Analysis (pp. 254–300). It also includes:
- Appendix Intro-ETH: Ethical considerations within the HTA process (pp. 406–407)
- A list of guiding questions to support ethical reflection during assessment
[1] Other, more detailed definition: The use of resource allocation rules based on the distributive justice principle. However, the latter involves various concepts that define these rules more precisely (merit, societal value, the greater good, equal opportunity, equal treatment, priority to the most disadvantaged, standard gamble, etc.). Available at: equity | HtaGlossary.net
[2] ARCHE. Available at: https://healthequity.globalpolicysolutions.org/about-health-equity/