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Philosophers engaged in the field of applied ethics are often challenged to revisit certain philosophical debates in order to clarify the background concepts involved in a given undertaking at stake. This is particularly evident in the field of Health Technological Assessment (HTA) where the integration of ethics has been a debate for many years. Interdisciplinary technological assessment involves a head-on discussion between the frame of reference of natural sciences and those of philosophy, which often reproduce the fact/value dichotomy debated in the field of philosophy. The challenge for a philosopher is then to explain how the fact/value dichotomy has been criticized by philosophers in such a way that the distinction between “verifiable facts” and “unverifiable values” cannot be accounted for anymore. The critiques of H. Putnam and S. E. Toulmin were the first steps towards the understanding of the dichotomy. A speech act approach, based on J. L. Austin illocutionary acts, can shed a new light on this issue by clarifying the difference between assertions, evaluations and prescriptions. By using a speech-act approach we can define the respective role of scientific evaluation and ethical evaluation in the HTA process and offer a better guide for the decision-makers on all aspects of adopting a technological development in health.

How can technological development, economic development, and the claims from society be reconciled? How should responsible innovation be promoted? The “responsible social uses” approach proposed here was devised with these considerations in view. In this article, a support procedure for promoting responsible social uses (RSU) is set out and presented. First, the context in which this procedure emerged, which incorporates features of both the user-experience approach and that of ethical acceptability in technological development, is specified. Next, the characteristic features of the procedure are presented, that is, its purpose, fundamental orientation, and component parts as experimented by partners. Third, the RSU approach is compared with other support approaches and considered in term of how each approach assumes responsible innovation. Briefly, the RSU procedure is a way of addressing the issue of responsible innovation through an effective integration of social concerns.

INTRODUCTION:The main difficulties encountered in the integration of ethics in Health Technology Assessment (HTA) were identified in our systematic review. In the process of analyzing these difficulties we then addressed the question of the diversity of ethical approaches (1) and the difficulties in their operationalization (2,3).METHODS:Nine ethical approaches were identified: principlism, casuistry, coherence analysis, wide reflexive equilibrium, axiology, socratic approach, triangular method, constructive technology assessment and social shaping of technology. Three criteria were used to clarify the nature of each of these approaches: 1.The characteristics of the ethical evaluation2.The disciplinary foundation of the ethical evaluation3.The operational process of the ethical evaluation in HTA analysis.RESULTS:In HTA, both norm-based ethics and value-based ethics are mobilized. This duality is fundamental since it proposes two different ethical evaluations: the first is based on the conformity to a norm, whereas the second rests on the actualization of values. The disciplinary foundation generates diversity as philosophy, sociology and theology propose different justifications for ethical evaluation. At the operational level, ethical evaluation's characteristics are applied to the case at stake by specific practical reasoning. In a norm-based practical reasoning, one must substantiate the facts that will be correlated to a moral norm for clearly identifying conformity or non-conformity. In value-based practical reasoning, one must identify the impacts of the object of assessment that will be subject to ethical evaluation. Two difficulties arise: how to apply values to facts and prioritize amongst conflicting ethical evaluations of the impacts?CONCLUSIONS:Applying these three criteria to ethical approaches in HTA helps understanding their complexity and the difficulty of operationalizing them in HTA tools. The choice of any ethical evaluations is never neutral; it must be justified by a moral point of view. Developing tools for ethics in HTA is operationalizing a specific practical reasoning in ethics.

The emergence and development of convergent technologies for the purpose of improving human performance, including nanotechnology, biotechnology, information sciences, and cognitive science (NBICs), open up new horizons in the debates and moral arguments that must be engaged by philosophers who hope to take seriously the question of the ethical and social acceptability of these technologies. This article advances an analysis of the factors that contribute to confusion and discord on the topic, in order to help in understanding why arguments that form a part of the debate between transhumanism and humanism result in a philosophical and ethical impasse: 1. The lack of clarity that emerges from the fact that any given argument deployed (arguments based on nature and human nature, dignity, the good life) can serve as the basis for both the positive and the negative evaluation of NBICs. 2. The impossibility of providing these arguments with foundations that will enable others to deem them acceptable. 3. The difficulty of applying these same arguments to a specific situation. 4. The ineffectiveness of moral argument in a democratic society. The present effort at communication about the difficulties of the argumentation process is intended as a necessary first step towards developing an interdisciplinary response to those difficulties.

How are we to understand the fact that the philosophical debate over nanotechnologies has been reduced to a clash of seemingly preprogrammed arguments and counterarguments that paralyzes all rational discussion of the ultimate ethical question of social acceptability in matters of nanotechnological development? With this issue as its starting point, the study reported on here, intended to further comprehension of the issues rather than provide a cause-and-effect explanation, seeks to achieve a rational grasp of what is being said through the appeals made to this or that principle in the range of arguments put forward in publications on the subject. We present the results of the study’s analyses in two parts. In the first, we lay out the seven categories of argument that emerged from an analysis of the literature: the arguments based on nature, dignity, the good life, utility, equity, autonomy, and rights. In the second part, we present the background moral stances that support each category of argument. Identifying the different categories of argument and the moral stance that underlies each category will enable a better grasp of the reasons for the multiplicity of the arguments that figure in discussions of the acceptability of nanotechnologies and will ultimately contribute to overcoming the tendency towards talking past each other that all too often disfigures the exchange. Clarifying the implications of the moral arguments deployed in the debate over nanotechnologies may make it possible to reduce the confusion observable in these exchanges and contribute to a better grasp of the reasons for their current unproductiveness.

This paper aims to provide a better understanding of the law circumscribing the social role of Health Technology Assessment (HTA) and gain insight into the reasons challenging the inclusion of ethics into HTA. We focused on a debate at the core of the perceived role of regulatory law in health technology development, namely: Environment, Health and Safety Issues (EHSI) vs Ethical, Legal and Social Issues (ELSI) that arose in technology governance. Data collection was based on a literature review and a case study analysis. The former was founded on previous work. Three HTA agencies were selected for the latter using categories ranging from a greater to a lesser level of legal obligatory intensity. Our literature review revealed five different themes relating to the social role of HTA and a distinction between the role/use of “hard law” and “soft law” in regulatory law, thus providing an understanding of how agencies used law for handling ethics in HTA. Both approaches revealed that the debate, first observed in the EHSI/ELSI technology-governance and assessment, is reproduced in HTA. The main trend revealed by the literature review and the case study, is the presence of a pact between science and regulatory law. The social demand for integrating ELSI, and more precisely, ethical evaluation into HTA, is not the main preoccupation of the traditional legal frameworks governing HTA and remains to be considered primarily by alternative, soft law initiatives. The reported difficulties in integrating ethics into HTA demonstrate the need for rethinking legal governance in HTA., Nous voulons mieux comprendre les lois circonscrivant le rôle social de l’Évaluation des technologies en santé (ETS) et les raisons empêchant l’inclusion de l’éthique en ETS. Nous avons ciblé un débat qui est au coeur du rôle perçu du droit réglementaire dans le développement de technologies en santé : l’opposition entre les enjeux environnementaux, sécuritaires et sanitaires (EHSI) et les enjeux éthiques, légaux et sociaux (ELSI), issus de la gouvernance technologique. La collecte de données est basée sur une revue de la littérature issue de travaux antérieurs, et sur une analyse de cas où trois agences d’ETS ont été sélectionnées en utilisant différentes catégories d’obligation légale selon leur degré de force contraignante. La revue de littérature a révélé cinq thèmes relatifs au rôle social de l’ETS et une distinction entre le rôle/utilisation du droit dur et du droit souple dans le droit réglementaire, permettant ainsi de comprendre comment les agences ont utilisé le droit pour intégrer (ou non) l’éthique en ETS. Les deux approches ont démontré que le débat, EHSI/ELSI observé initialement dans la gouvernance et l’évaluation de technologies est reproduit en ETS. La principale tendance confirmée par ces analyses est la présence d’un pacte entre la science et le droit réglementaire. La demande sociale d’intégrer les ELSI, particulièrement l’évaluation éthique en ETS, n’est pas prise en compte par le droit réglementaire traditionnel régissant l’ETS et doit plutôt être considérée par le droit souple. Les difficultés d’intégration de l’éthique en ETS démontrent la nécessité de repenser la gouvernance juridique de l’ETS.