Addressing Ethical and Moral Issues in Health Technology Assessment: Development of a Practical Framework

In response to the increasing demand for expansion of health technology assessment (HTA) methodology to include ethical issues more systematically, this document reports on a multi-stage study that aimed at construction of a new practical framework for integration of ethical issues in HTA. The document is divided into three major parts. The first part provides the results of a systematic review of literature that was performed to identify and compare the scope and details of previously proposed frameworks for ethical considerations in HTA. Of the 1390 potential citations that were identified during the systematic search, 21 frameworks met the inclusion criteria and were included in the review. The identified frameworks varied in their philosophical approach, structure, and comprehensiveness. The review showed that ethical frameworks for HTA had been designed for different purposes throughout the HTA process. These purposes ranged from helping HTA producers in identification, appraisal and analysis of ethical data to supporting decision-makers in making better informed value-sensitive decisions. They frequently promoted combining normative reflection with descriptive approaches to the analysis of values and preferences of potential stakeholders and other societal or technical actors. The reviewed frameworks proposed a wide range of analytical methods including: principlism, casuistry, coherence analysis, wide reflective equilibrium, value analysis, eclectic approach, triangular model, complexity theory, actor-network theory, and social shaping of technology. The second part of the report describes the results of an exploratory survey that was performed to learn about current practices, motivations and challenges in including ethical considerations in HTA. Directors or representatives of 26 HTA agencies around the world completed our online survey questionnaire. The results showed that close to 90% of the HTA agencies assigned some level of priority to inclusion of ethical considerations in HTA. However, a relatively small proportion of them incorporated relevant ethical analysis methods in their assessments. More than a quarter of the responding agencies were not aware of any guidance documents for addressing ethical issues or found the existing guidelines and frameworks not useful. The lack of practical guidelines and complexity of the existing frameworks were the most commonly stated barriers; and the availability of well-designed frameworks or guidelines was considered as a key motivator by the respondents. The third part outlines a new stepwise framework that has been developed to help facilitate a consistent and efficient ethical evaluation process for the assessment of healthcare technologies. The proposed framework guides HTA practitioners through seven main …