Assessment vs. appraisal of ethical aspects of health technology assessment: can the distinction be upheld?

Abstract

An essential component of health technology assessment (HTA) is the assessment of ethical aspects. In some healthcare contexts, tasks are strictly relegated to different expert groups: the HTA-agencies are limited to assessment of the technology and other actors within the health care sector are responsible for appraisal and recommendations. Ethical aspects of health technologies are considered with reference to values or norms in such a way that may be prescriptive, or offer guidance as to how to act or relate to the issue in question. Given this internal prescriptivity, the distinction between assessment and appraisal seems difficult to uphold, unless the scrutiny stops short of a full ethical analysis of the technology. In the present article we analyse the distinction between assessment and appraisal, using as an example ethical aspects of implementation of GPS-bracelets for people with dementia. It is concluded that for HTA-agencies with a strictly delineated assessment role, the question of how to deal with the internal prescriptivity of ethics may be confusing. A full ethical analysis might result in a definite conclusion as to whether the technology in question is ethically acceptable or not, thereby limiting choices for decision-makers, who are required to uphold certain ethical values and norms. At the same time, depending on the exact nature of such a conclusion, different action strategies can be supported. A positive appraisal within HTA could result in a decision on mandatory implementation, or funding of the technology, thereby making it available to patients, or decisions to allow and even encourage the use of the technology (even if someone else will have to fund it). A neutral appraisal, giving no definite answer as to whether implementation is recommended or not, could result in a laissez-faire attitude towards the technology. A negative appraisal could result in a decision to discourage or even prohibit implementation. This paper presents an overview of the implications of different outcomes of the ethical analysis on appraisal of the technology. It is considered important to uphold the distinction between assessment and appraisal, primarily to avoid the influence of preconceived values and political interests on the assessment. Hence, as long as it is not based on the subjective value judgments of the HTA-agency (or its representative), such an appraising conclusion would not seem to conflict with the rationale for the separation of these tasks. Moreover, it should be noted that if HTA agencies abstain from including full ethical analyses because of the risk of issuing an appraisal, they may fail to provide the best possible basis for decision-makers. Hence, we argue that as long as the ethical analysis and its conclusions are presented transparently, disclosing how well-founded the conclusions are and/or whether there are alternative conclusions, the HTA-agencies should not avoid taking the ethical analysis as close as possible to a definite conclusion.