Why is it difficult to integrate ethics in HTA? The epistemological viewpoint

Refolo P1, Sacchini D1, Brereton L2, Gerhardus A3, Hofmann B4, Lysdahl KB4, Mozygemba K3, Oortwijn W5, Tummers M6,van der Wilt GJ7, Wahlster P3, Spagnolo AG1, on behalf of the INTEGRATE-HTA Project Team

1 Institute of Bioethics and Medical Humanities, “A. Gemelli” School of Medicine, Università Cattolica del Sacro Cuore, Rome, Italy2 University of Sheffield, ScHARR, Sheffield, United Kingdom3 Department of Health Services Research, Institute of Public Health and Nursing Research, and Health Sciences Bremen, University of Bremen, Bremen, Germany4 Centre for Medical Ethics, University of Oslo, Oslo, Norway5 ECORYS Netherlands BV, Rotterdam, the Netherlands6 Radboud Institute for Health Sciences, Radboud university medical center, Nijmegen, the Netherlands7 Donders Institute for Brain, Cognition and Behavior, Radboud university medical center, Nijmegen, the Netherlands; Athena Institute for Innovation in the Health and

Life Sciences, VU University Amsterdam, Amsterdam, the Netherlands

For more information: pietro.refolo@rm.unicatt.it

Introduction: Ethical issues are still not frequently addressed explicitly in HTA for several valuable reasons. These are mainlypractical and discussed from an HTA perspective. A further hypothesis that was investigated in the FP7 research projectINTEGRATE-HTA (http://www.integrate-hta.eu/) is that ethics is not a part of HTA by using the fact/value dichotomy.

The Fact-Value dichotomy: The relationship between natural sciences and ethics has been one of the most debated topicsin modern philosophy. • At the centre of this debate is “Hume’s law”: stating that you cannot derive “norms” from “facts” – there is no logical

bridge between fact and value. • A similar argument has been defended by George Edward Moore (1873-1958), Max Weber (1864-1920) as well as bythose supporting Neo-positivism, an important philosophical movement of the early 1900s. The assumption of Neo-positivism was based on the “theory of verification,” according to which a proposition is “cognitively meaningful” only ifsome finite procedure conclusively determines its truth. Metaphysics, ontology and ethics fail this criterion, and therefore,they were considered to be cognitively meaningless. In this way, Neo-Positivism initiated a sort of “divorce” of sciencefrom ethics.• From the 1960s onwards, “Philosophical hermeneutics” initiated by Martin Heidegger and developed by Hans-GeorgGadamer came to play a fundamental role. In essence, Gadamer claimed that understanding is not fixed but ratherchanging and indicating new perspectives, because some “prejudice” is always present. This assumption had an impacton the methodological presuppositions on which modern science was based. According to the new viewpoint, there canbe no universal standpoint from which “objective knowledge” can be achieved, and all understanding – also scientificunderstanding – has to be considered as “contextual” and “historical”. • Another important role has been played by Karl-Otto Apel (1922-). He pointed out that moral language analysis alwaysrequires a criterion to distinguish moral language from any other form of language. This helped to support the thesis thatexistence of merely descriptive propositions is an illusion and that it is impossible to separate normative dimension fromdescriptive analysis. • Importantly, Hilary Putnam (1926-) has recently unveiled the “collapse of the fact/value dichotomy”.

These and others reflections have reduced the significance of the fact/value dichotomy, opening new research perspectives.More generally, we could say that ethics has started to be considered as a “more integrative part” of the scientific discourse.

Conclusion: From an epistemological point of view, theintegration itself of ethics in HTA can be considered asan attempt to overcome the neopositivisticepistemology, which was only interested in technicaland empirically testable issues. However, current HTA practice is still dominantly basedon the comparison among objective and empiricallytestable “facts”, whilst ethics is not empirically testable.Therefore, there is a sort of “epistemological gap”, whichcan explain why it is so difficult to integrate ethics in HTA.

Recommendation: Greater emphasis should be givento the notion that ethical analysis “works” on a differentlevel and that its findings have a different “meaning”. Itis therefore recommended that the epistemologicaldifferences among the various domains of HTA areaddressed more explicitly.

This project has been co-funded by the European Union under the Seventh Framework Programme(Grant Agreement No. 306141)

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