1. Ethical issues

1.4. 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 will describe (analytically/theoretically) ethical attitudes, however, they will 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 as such 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 the 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 why a clear framework, agreed principles and processes will help making the analysis and decision transparent and acceptable.

Over the past few years there have been major developments in guidance supporting ethical analysis in HTA. Checklists have been developed by academics involved in HTA in order to help structured consideration of ethical issues. These checklists are used by many HTA bodies and are helpful for patient groups as well. The HTA Core Model Version 3.0[1]  deserves particular attention; it contains a specific section on Ethical Analysis (pp. 254 – 300), which provides a detailed and structured guide on ethical analysis in HTA, including in ’Appendix Intro-ETH: Ethical considerations within HTA process’ (pp. 406 – 407) a list of questions suggested to be addressed concerning ethical analysis  (see also course 5. Ethical, legal and societal issues (ELSI) checklist).