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(HTA)? the Epistemological Viewpoint Eur opean Rev iew for Med ical and Pharmacol ogical Sci ences 2016; 20: 4202-4208 Why is it so difficult to integrate ethics in Health Technology Assessment (HTA)? The epistemological viewpoint P. REFOLO 1, D. SACCHINI 1, L. BRERETON 3, A. GERHARDUS 4, B. HOFMANN 2, K.B. LYSDAHL 2, K. MOZYGEMBA 4, W. OORTWIJN 5, M. TUMMERS 6, G.J. VAN DER WILT 7, P. WAHLSTER 4, A.G. SPAGNOLO 1 1Institute of Bioethics and Medical Humanities, “A. Gemelli” School of Medicine, Catholic University of the Sacred Heart, Rome, Italy 2Centre for Medical Ethics, University of Oslo, Oslo, Norway and NTNU, Gjøvik, Norway 3ScHARR, University of Sheffield, Sheffield, United Kingdom 4Department of Health Services Research, Institute of Public Health and Nursing Research, and Health Sciences Bremen, University of Bremen, Bremen, Germany 5ECORYS Netherlands BV, Rotterdam, The Netherlands 6Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, The Netherlands 7Donders 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 Abstract. – Ethics has been identified as a cal issues raised by the consequences of imple - key element in Health Technology Assessment menting/not implementing a health technology 1-4 . (HTA) since its conception. However, ethical is - Early , as well as more recent definitions of sues are still not frequently addressed explicitly in HTA. Several valuable reasons have been HTA include ethics. For instance, in 1985, the identified. U.S. Institute of Medicine defined HTA as “any The basis of the article is the claim that ethics process of examining and reporting properties of is often not part of HTA for “epistemological rea - a medical technology used in health care, such as sons”. Hence, the main aim of the contribution safety, efficacy, feasibility, and indications for is to explore in more details and emphasize use, cost, and cost-effectiveness, as well as so - them by using the fact/value dichotomy. cial, economic, and ethics consequences, whether Our conclusion is that current HTA configura - 5 tion is predominantly based on the comparison intended or unintended” . among objective and empirically testable The European network for Health Technology “facts”, whilst ethics is not empirically testable. Assessment (EUnet HTA) defines HTA as: “a In this sense, there is a sort of “epistemological multidisciplinary process that summarises infor - gap”, which can explain why it is so difficult to mation about the medical, social, economic and integrate ethics in HTA. We suggest that the ethical issues related to the use of a health tech - epistemological differences among the various domains of HTA are addressed more explicitly. nology in a systematic, transparent, unbiased, ro - bust manner. Its aim is to inform the formulation Key Words: of safe, effective, health policies that are patient Ethics, Health Technology Assessment, Epistemolo - focused and seek to achieve the best value” 6. gy, Integration. Indeed, over the last 40 years , ethics has rarely been part of HTA work and ethical issues are still not frequently addressed explicitly in HTA . Introduction Some studies can confirm this argument : a 2000 study by Lehoux and Blume of the 1999 Interna - From the conception of Health Technology tional Society of Technology Assessment in Assessment (HTA) in the 1970s, it has been ar - Health Care CD-ROM database of abstracts pre - gued that ethics is a constitutive part of HTA. sented at the Annual Meetings (1994-1998) and Ethics within an HTA aims at analyzing the ethi - all abstracts of papers published in the Interna - 4202 Corresponding Author: Dario Sacchini, MD; e-mail: [email protected] Ethics and HTA tional Journal of Technology Assessment in would be dominated by an “engineering” model Health Care (1985-19 99) found that from a total of moral reasoning 14 . of 2.906 records, only 19 records contained “eth - Hofmann has identified ten arguments for why ical” in their title (0,7% )7. An analysis of 680 ethics should be part of HTA 13 and has identified HTA reports produced by six Canadian agencies the following list of reasons why ethics may not between 1997 and 2006 showed that only 17% be integrated in HTA: “(A) Ethicists are profes - addressed ethical issues 8. In 2003, the Deutsches sional strangers in HTA, i.e., the “goals, meth - Institut für Medizinische Dokumentation und In - ods, models, and modes of rationality of HTA formation (DIMDI) arrived at similar conclu - and ethics are categorically dissimilar ”. (B) A sions analyzing “short assessments on medical common agreed methodology for integrating technologies” published worldwide (n = 282) : ethics is lacking. Ethics methodology appears to only 25 reports (9%) described ethical issues 9. be (C) deficient, (D) insufficient, or (E) unsuit - A 2007 survey showed that only 5% of 223 able. (F) Integrating ethics in HTA is neither ef - HTA reports published between 2003 and 2006 ficient nor needed for successful HTA. (G) Most from nine different agencies (five in Canada, two moral issues are general, and are not specific to a in the UK, one in Denmark and one in the USA) given technology. (H) All relevant ethical issues considered ethical, social and organizational is - can be handled within other frameworks, e.g., sues , in addition to clinical and economic evalua - within economics. (I) Ethics can undermine or tions 10 . burst the foundation of HTA ”15 . The above trend can be considered as unex - The reasons discussed by Hofmann are mainly pected for at least four reasons: (1) Ethics is part conceptual, methodological or practical and dis - of HTA definitions. ( 2) HTA has a moral aim (to cussed from within the HTA perspective. Al - improve health and care for people) ; (3) HTA is though epistemic reasons are mentioned, Hof - evaluative; ( 4) Technology is value laden and mann does not elaborate on this. confronts us with moral problems which need to Therefore, the hypothesis to be investigated in be addressed, supported by a large part of con - this article is that ethics is not a part of HTA for temporary philosophy (Horkheimer, Adorno, “epistemological reasons ”. Our aim is to explore Heidegger, Jonas, Gehlen, Hottois just to men - them by using the fact/value dichotomy . Before tion very few examples). Consequently, it is we do that, we would like to try to explain in quite strange that researchers have not embarked more detail what it means to integrate ethical in - on this activity, i.e. the ethical assessment of quiry in HTA. health technologies, especially as ethical and so - cial issues are at the core of HTA’s big brother, Hta & Ethics. What Does it Mean to Parliamentary Technology Assessment. It is par - Integrate Ethics in HTA? ticularly surprising that Bioethics, whose future HTA is a multidisciplinary process that sum - itself is currently debated, seems unable to take marises information about the short- and the on this task . long-term consequences of implementing/not im - Why does it happen so rarely that ethics is in - plementing a health technology . The purpose of tegrated into HTA? At first glance, the reason HTA is to support the process of decision-mak - seems not to be “methodological”, i.e. related to ing in health care by providing the “best ” infor - “how” this type of investigation is performed . mation. In this respect, HTA has been compared Over the years , a wide range of approaches have to a “bridge” between the world of research and been suggested to address ethical aspects of the world of decision-making 16 . health technologies. A recent systematic review 11 In order to achieve this, HTA is committed to has identified 43 conceptual frameworks or prac - the activity of collecting and analyzing “evi - tical guidelines for addressing ethical issues in dence” from research in a systematic and repro - HTA, so some authors 12,13 have asked whether ducible way and to make it accessible and usable there are more methods than applications. for decision-making purposes by means of “as - Several reasons why ethics is not a part of sessment ” reports. HTA have been identified. “Assessment” is generally defined as the ac - According to ten Have, an ethical analysis is tion of evaluating relevant aspects of the health rarely incorporated in HTA studies for two rea - technology to form a basis for decision -making. sons: technology would often be regarded as a It is almost always comparative: the health tech - “value-neutral” tool; at the same time, bioethics nology under review is evaluated against some 4203 P. Refolo, D. Sacchini, L. Brereton, A. Gerhardus, B. Hofmann, et al. specified standard of performance or other prod - an hyperstimulation syndrome in women , embryo ucts and treatments. For instance, assessment of freezing, pre -implantation diagnosis, etc .) and an - In Vitro Fertilization and Embryo Transfer (IVF- other thing to judge whether its implementation is ET) safety can be performed by comparing its morally good/bad or licit/illicit as a whole. safety profile with the safety profile of another In a certain sense, also the “configuration” of reproductive technology (e.g. , with Intra-Cyto - the approaches for the ethical analysis in HTA plasmic Sperm Injection, ICSI ). reflect this “dichotomy ”: some of them (e.g., the “Assessment” differs from “appraisal”, which HTA Core Model 18 or the Socratic approach 19 ) generally implies some form of recommendation consist of “conceptual frameworks ” (which are (prescriptive level) about the implementation/non often characterized by both a set of questions and implementation of the technology based on the wide literature search), whose aim is to identify assessment 17 . Such a recommendation can lead to the ethical issues in a clear and efficient manner . several concrete actions: encouraging, discourag - Others are represented by the well -known classic ing or even prohibiting implementation, reim - models of Moral Philosophy (e.g., Deontology, bursing, funding, disinvesting, etc.
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