Ethical Evaluation in Health Technology Assessment: A Challenge for Applied Philosophy

Abstract

The integration of ethical analysis in Health Technology Assessment (HTA) has proven difficult to implement even though it is explicitly recognized as an important component of such assessments in HTA literature. When compared to the standardized scientific method for systematic reviews in HTA, the diversity of ethical analysis has been characterized as a fundamental barrier to the integration of ethics. The present paper aims to identify the theoretical and practical differences between the approaches underpinning ethical analysis in HTA and clarify the reasons for such diversity. Our systematic review of HTA literature pertaining to the barriers to the integration of ethics in HTA identified nine ethical approaches: Principlism, Casuistry, Coherence Analysis, Wide Reflective Equilibrium, Axiology, the Socratic approach, the Triangular model, Constructive Technology Assessment and Social Shaping of Technology. Citations pertaining to each approach were extracted and categorized according to three constitutive components of ethical argumentation established in a previous research evaluating nanotechnologies: i) the disciplinary foundation that grounds the validity of the ethical evaluation, ii) the characteristics of such evaluation, iii) the operational process involved in applying it to a particular case (i.e., its practical reasoning). This comparison shows that, 1) the difference between these approaches rests primarily on their disciplinary foundation

Advanced therapy medicinal products: value judgement and ethical evaluation in health technology assessment

“…Legault and colleagues identified on HTA literature relating to the barriers to the incorporation of ethics in HTA nine ethical approaches: principlism, casuistry, coherence analysis, wide reflective equilibrium, axiology, the socratic approach, the triangular model, constructive technology assessment and social shaping of technology [10].…”

“…For the purpose of ethical evaluation based on the concept of a human person four principles have been identified: "a. the defense of human physical life; b. the contextual exercise of freedom and responsibility within the decision-making process; c. the safeguard of the therapeutic principle, according to which the human person has to be treated as a whole; d. the principles of sociality and subsidiarity, for which public and private authorities are called to help all persons in need" [10].…”

“…The EUnetHTA (European Network for Health Technology Assessment) HTA definition states that: "Health technology assessment 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" [10].…”

“…It is commonly accepted that decision making in medicine, research, and health policy often explicitly or implicitly considers normative ethical aspects [16]. Considering a sociological perspective, ethics can be described as the product of society and social norms and values that will act as the basis of ethical evaluation and ethical reasoning [10].…”

“…Several articles published by Hofmann and colleagues since 2005 have defended a better integration of ethical analysis in HTA [10]. HTA can be considered a process of value judgments.…”