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. (shrink)

“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. (shrink)

Background In Italy, clinical ethics is not well institutionalized. On February 7, 2023, the Italian Ministry of Health published four long-awaited decrees regarding the reorganization of ethics committees. Aim: The aim of this article is twofold: firstly, we aim to briefly summarize the development of clinical ethics in Italy from a legislative point of view; secondly, we aim to examine how Italian regions are implementing the part of the new decrees on the organization of ethics committees that concerns clinical ethics. (...) Methods: As for the first aim, we conducted a critical interpretive review (CIR). The search was restricted to the opinions offered by the Italian National Bioethics Committee (CNB) and to the major Italian legislative decrees on the topic. Regarding the second aim, we conducted an online search through Regional Official Bulletins of each Italian region. Results: Our analysis showed that despite the recommendations from the CNB to differentiate Research Ethics Committees (RECs) and Clinical Ethics Committees (CECs), over the years legislative attention has mainly focused on RECs and pharmacological matters. The new decrees allow regions to be flexible in organizing their activities. However, it emerged that only four regions (Veneto, Friuli-Venezia Giulia, Puglia, Emilia-Romagna) have split the roles, while all the other regions have entrusted both roles to a single committee. Conclusion: The risk for Italy is to take a step backward in the development of clinical ethics. Possible solutions could be either making Local Ethics Committees (CELs) mandatory or institutionalizing Ethics Consultation services (ECSs). (shrink)