Pietro Refolo

In the field of health technology assessment, there are several approaches that can be used for ethical analysis. However, there is a scarcity of literature that critically evaluates and compares the strength and weaknesses of these approaches when they are applied in practice. In this paper, we analyse the applicability of some selected approaches for addressing ethical issues in HTA in the field of complex health interventions. Complex health interventions have been the focus of methodological attention in HTA. However, the potential methodological challenges for ethical analysis are as yet unknown.Six of the most frequently described and applied ethical approaches in HTA were critically assessed against a set of five characteristics of complex health interventions: multiple and changing perspectives, indeterminate phenomena, uncertain causality, unpredictable outcomes, and ethical complexity. The assessments are based on literature and the authors’ experiences of developing, applying and assessing the approaches.The Interactive, participatory HTA approach is by its nature and flexibility, applicable across most complexity characteristics. Wide Reflective Equilibrium is also flexible and its openness to different perspectives makes it better suited for complex health interventions than more rigid conventional approaches, such as Principlism and Casuistry. Approaches developed for HTA purposes are fairly applicable for complex health interventions, which one could expect because they include various ethical perspectives, such as the HTA Core Model® and the Socratic approach.This study shows how the applicability for addressing ethical issues in HTA of complex health interventions differs between the selected ethical approaches. Knowledge about these differences may be helpful when choosing and applying an approach for ethical analyses in HTA. We believe that the study contributes to increasing awareness and interest of the ethical aspects of complex health interventions in general

“HTA is a multidisciplinary process that summarizes information about the medical, social, economic and ethical issues related to the use of a health technology in a systematic, transparent, unbiased, robust manner. Its aim is to inform the formulation of safe, effective, health policies that are patient focused, and seek to achieve best value” (EUnetHTA 2007). Even though the assessment of ethical aspects of a health technology is listed as one of the objectives of a HTA process, in practice, the integration of these dimensions into reports remains limited. The article is focused on four points: 1. the HTA concept; 2. the difficult HTA-ethics relationship; 3. the ethical issues in HTA; 4. the methods for integrating ethical analysis into HTA

La contribución recorre el debate sobre el tema de la ética y la colocación de los recursos en ámbito sanitario en los últimos sesenta años de publicaciones de la Revista Medicina e Morale. Apelando a algunas fuentes documentales que certifican la inserción de esta temática entre los objetos de indagación de la disciplina bioética, sigue una breve reseña de los contenidos de todos los escritos de la Revista en la materia, una discusión de los elementos que la contra distinguen y la indicación de las perspectivas de publicación deseables.The article deals with the debate on ethics and resource allocation in health care over the past sixty years of the Journal Medicina e Morale publications. The reference to some documental sources certifying the inclusion of this issue among the objects of investigation of bioethics discipline is followed by a brief overview of the contents of all text of the Journal on the subject, a discussion of the elements that mark them and the indication of the prospects of publication that are desirable