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. Some HTA- Utilitarianism, Casuistry, etc.), which are more agencies are restricted to assessments of the tech - useful to make morals judgements. nology only and do not make recommendations about implementation/not implementation in the The Fact/Value Dichotomy healthcare system, while others perform both as - The difference in interpreting ethical analysis sessment and appraisal . as well as the difficulty in integrating ethics in What does it mean to perform an ethical as - HTA can be due to epistemological reasons . sessment? What does it mean exactly to inte - HTA encompasses domains which are “epis - grate ethics in HTA? What does it mean “to temologically heterogeneous ”: some of them support ” the process of decision-making by pro - clearly belong to the natural sciences (e.g. , viding the “best information ” about the ethical safety, effectiveness), others humanistic (e.g. issues of implementing/not implementing a ethical , socio-cultural and legal domains )20 . health technology ? The former follow methods from the natural There are many answers to these questions 4. sciences and are empirically testable; the latter According to EUnet HTA, the ethical domain are dealing with meaning and are not empiri - involves “an understanding of the consequences cally testable . of implementing or not implementing a health For instance, the safety domain is based on care technology in two respects: with regard to “verifiable facts ” ( e.g., that ovarian hyperstimu - the prevailing societal values and with regard to lation treatment can cause bleeding is a verifiable the norms and values that the technology itself fact) – even though “new facts” could disprove constructs when it is put into use” 18 . In addition, previously tested facts. On the other hand moral the domain also covers “moral and ethical issues statements and ethical assessments are not empir - related to the consequences of performing the ically testable (the morality of IVF-ET cannot be health technology assessment (HTA)” 18 . The established through observations), although ethi - HTA process itself can, in fact, raise ethical is - cal arguments and assessments may include 21-24 sues 2. These are , for example , issues about the empirical premises . ethical consequences of the choice of endpoints The relationship between sciences and human - or of comparators , and whether there are any eth - ities or, more specifically, between the natural ical issues in the economic evaluation 2,19 . sciences and ethics has been one of the most de - The ethical analyses in HTA vary according to bated topics in modern philosophy and has been the distinction between assessment and appraisal, addressed in many ways. e.g., sometimes ethical analyses consist of : (1) a One debate consists of wondering whether it “simple” list of ethical issues , which have to be would be possible “to draw ” moral norms from identified, described , and addressed (the most the knowledge or norms of nature. Another dis - widely used modality); or , in a more complex cussion focuses on studying the relationship be - way , (2) moral judgements (e.g., the use of the tween descriptive propositions (e.g., the moon is technology X is morally good/bad or licit/illicit). spherical) and normative propositions (e.g., With reference to IVF-ET, it is one thing to killing is despicable ). A further debate funda - identify, describe, and address ethical issues con - mentally considers whether ethics is an authentic nected to its implementation (such as risk of ovari - form of knowledge 25 .

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At the centre of much of this debate there has tion between facts and values, and repudiated been a famous passage from the Scottish any attempt to derive moral values from facts . philosopher David Hume (171 1-1776): “In The same argument has been defended by the every system of morality, which I have hitherto Neo-positivism (also called Logical Positivism met with, I have always remarked, that the au - or Logical Empiricism), an important philosophi - thor proceeds for some time in the ordinary cal movement of the early 1900s, whose radical ways of reasoning, and establishes the being of fringes ended up arguing even that normative a God, or makes observations concerning hu - propositions are meaningless . man affairs; when all of a sudden I am surprised 20 th Century Neo-positivism can be considered to find, that instead of the usual copulations of a more up to date version of Positivism of the propositions, is, and is not, I meet with no 19 th Century. The new positivists maintained the proposition that is not connected with an ought, radical empiricism from the old movement, the or an ought not. This change is imperceptible; attention given to the development of the sci - but is however, of the last consequence. For as ences, and the clear aversion to metaphysics. this ought, or ought not, expresses some new re - Its representatives gave a fundamental role to lation or affirmation, ‘tis necessary that it the logical techniques (which explains the addi - should be observed and explained; and at the tion of the adjective logical to Positivism) elabo - same time that a reason should be given, for rated by Gottlob Frege, Bertrand Russell and Al - what seems altogether inconceivable, how this fred North Whitehead at the beginning of the 20 th new relation can be a deduction from others, Century. Such techniques had tried to create “ar - which are entirely different from it. But as au - tificial ” and “neutral” languages capable of elim - thors do not commonly use this precaution, I inating the unavoidable ambiguity present in shall presume to recommend it to the readers; everyday language. and am persuaded, that this small attention The aim of Neo-positivism was to establish a would subvert all the vulgar systems of morali - “scientific philosophy ” which as far as possible ty, and let us see, that the distinction of vice and would respect the criteria of rigor and exactitude. virtue is not founded merely on the relations of It can be interpreted as a program of radical “re- objects, nor is perceived by reason” 26 . foundation ” of the knowledge of empirical bases, The passage is also known as “Hume’s law ” which would have had to lead to the elaboration or “Hume’s guillotine ” and has been interpreted of a “unified language” for the whole science in many ways . In short, it states that you cannot based on the model of physics. logically derive an “ought” from an “is”, that is, The assumption on which the whole philo - you cannot derive “norms” from “facts” – there sophical conception of Neo-positivism was based is no logical bridge between fact and value . is the well-known “theory of verification,” ac - A similar argument has been defended by the cording to which a proposition is “cognitively English philosopher George Edward Moore meaningful” only if some finite procedure con - (1873-1958) . In his Principia ethica , he argued clusively determines its truth . Metaphysics, on - against any identification of moral properties with tology, as well as ethics fail this criterion, and natural properties. In particular, he argued against therefore , they were considered to be cognitively what he called the “naturalistic fallacy” in ethics, meaningless. In this way, Neo-positivism cele - by which he meant any attempt to define the word brated a sort of “divorce” of science from ethics. “good ” in terms of some natural quality. However, from the 60s both Hume’s law and The German sociologist Max Weber (1864- Neo-positivism lost appeal . 1920) arrived at similar conclusions too. He In this context , the “Philosophical hermeneu - made a strict distinction between “statements of tics ” initiated by Martin Heidegger and devel - facts” (describing reality) and “statements of val - oped by Hans-Georg Gadamer in his Truth and ue” (relating to an ideal) . The former were con - Method came to play a fundamental role. In sidered to be objective and the latter subjective. essence, Gadamer claimed that understanding is On this basis, he argued that science, as the not fixed but rather changing and indicating new realm of facts, has to be considered strictly sepa - perspectives, because a certain “prejudice” is al - rated from the realm of values, i.e. , ethics, aes - ways present . Hence, understanding is always thetics, and politics. personal , subjective and never “disinterested”. Despite some differences in terminology, all This assumption had an impact on the the afore mentioned authors made a clear distinc - methodological presuppositions on which mod -

4205 P. Refolo, D. Sacchini, L. Brereton, A. Gerhardus, B. Hofmann, et al. ern science was based. According to the new is much more based on the social sciences than viewpoint, there can be no universal standpoint HTA, where the value-ladenness of technology from which “objective knowledge” can be and “empirical facts” is explicitly addressed. achieved, and all understanding – also scientific understanding – has to be considered as “contex - tual ” and “historical”. Discussion Another important role has been played by the German philosopher Karl-Otto Apel (1922-) . He The integration of ethics in HTA can be con - pointed out that moral language analysis always sidered as part of this trend . From a cultural point requires a criterion to distinguish moral language of view, it can be interpreted as an attempt to from any other form of language . This helped to overcome the neopositivistic epistemology, support the thesis that existence of merely de - which was only interested in technical and em - scriptive propositions is an illusion and that it is pirically testable issues . impossible to separate normative dimension from Why it is so difficult to integrate ethics in descriptive analysis . HTA seems now be clearer and easier to explain : Importantly , the American philosopher Hilary ethics meets the same difficulties and “preju - Putnam (1926-2016) has recently traced the “col - dices ” that it meets whenever it attempts to ac - lapse of the fact/value dichotomy”. According to cess to the scientific discourse. him, there is a distinction to be made, useful in To complicate matters, probably HTA owes some contexts, between statements of fact and much of its success to empirical testing itself . statements of value, especially of ethical value. One of the main strengths of HTA is its great Nevertheless, a strict dichotomy between fact “ability ” to provide empirical evidence in order and value would be indefensible because on the to support the decision -making . It is well known one side normative (e.g., ethical and aesthetic) that HTA relies heavily on Evidence-based medi - judgments have always a factual basis, and on cine (EBM), which is a strictly empirical ap - the other side scientific judgments encompass proach . For instance, safety assessment is gener - normative elements . As a consequence, science ally performed by means of observation or ex - cannot be considered as “value-free” since “sci - perimentation , which allow the acquisition of ence itself presupposes values which are in the “objective information”. same boat as ethical values with respect to objec - On the contrary, ethics fails to provide this tivity” 27 . type of “evidence ”, that is, it cannot be empiri - These and others reflections have reduced the cally tested . In this sense, the morality of IVF-ET significance of the fact/value dichotomy . At the cannot be established through observations. same time, there has been an increased con - However, the fact is that such epistemological sciousness that technical-instrumental rationality difference is not well highlighted in the defini - cannot be considered as the only form of knowl - tion of HTA. All the domains appear to be on the edge. So, the monism of the neopositivistic epis - same level. Hence, some – above all people not temology has entered a crisis, and a sort of “epis - expert in ethics – might think that the ethical do - temological pluralism” has arisen, thus opening main is capable of providing “empirical evi - new research perspectives . dence ” and that it can be treated like , for exam - There are several “cultural signs” of this epis - ple , the safety domain. As the operation of pro - temological change . First of all, the rehabilitation viding this type of evidence fails, then ethical of the Aristotelian practical philosophy 28 ; sec - analyses end up being considered as ineffective, ondly, the studies on the “normative tasks” con - inconclusive or unnecessary. It’s almost as if all nected to rationality by Discourse Ethics (partic - the old neopositivistic prejudices against any ularly, by Jürgen Habermas and Karl-Otto form of knowledge which cannot be empirically Apel) 29 ; thirdly, the birth of some forms of ap - testable resurface . plied ethics (e.g., clinical ethics, business ethics, To sum up , current HTA configuration is pre - organizational ethics, etc.); finally, the incorpora - dominantly based on the comparison among ob - tion of Humanities into medical education. More jective and empirically testable “facts”, whilst generally, we could say that ethics has started to ethics is not empirically testable. Therefore, there be considered as a “more integrative part ” of the is a sort of “epistemological gap”, which can ex - scientific discourse . This can clearly be seen in plain why it is so difficult to integrate ethics in (Parliamentary) Technology Assessment, which HTA.

4206 Ethics and HTA

–––––––––––––––– –-– –– Frameworks identifying moral issues with im - Conflict of Interest plementing health technologies are directed at The Authors declare that there are no conflicts of interest. highlighting value issues in order for the legiti - mate decision makers to make the decisions about health technologies. Classic methods from References moral philosophy (such as consequentialism, de - ontology, casuistry , etc .) are more oriented at 1) SACCHINI D, V IRDIS A, R EFOLO P, P ENNACCHINI M, C AR - providing recommendations. The former , there - RASCO DE PAULA I. Health technology assessment fore , appears to support a fact-generating para - (HTA): ethical aspects. Med Health Care Philos 2009; 12: 453-457. digm, while the latter appears to support a mean - 2) HOFMANN B. Toward a procedure for integrating ing or decision -generating paradigm. However, moral issues in health technology assessment. although this appears to underscore the “two cul - Int J Technol Assess Health Care 2005; 21: 312- tures” described above, it is, more correctly, 318. based on the distinction between assessment and 3) SAARNI SI, H OFMANN B, L AMPE K, L ÜHMANN D, M ÄKELÄ appraisal, described at the outset of this article . M, V ELASCO -G ARRIDO M, A UTTI -R ÄMÖ I. Ethical analy - In assessment, decisions about moral issues are sis to improve decision-making on health tech - not made by “moral experts,” i.e., ethicists, but nologies. Bull World Health Organ 2008; 86: 617- 623. by persons with legitimate decision -making ca - 4) HOFMANN B, O ORTWIJN W, L YSDAHL BK, R EFOLO P, S AC - pacity in the same manner as decisions about the CHINI D, VAN DER WILT GJ, G ERHARDUS A. Integrating appropriate level of effectiveness and efficiency Ethics in Health Technology Assessment: many is not made by medical and economic experts. ways to Rome. Int J Technol Assess Health Care 2015; 31: 131-137. Conclusions 5) INSTITUTE OF MEDICINE (IOM ). Assessing Medical Technologies. Washington D.C.: National Acade - From an epistemological point of view, the re - my Press, 1985. gard for the ethical consequences of implement - 6) http://www.eunethta.eu/about-us/faq#t287n73. ing/not implementing a health technology can be 7) LEHOUX P, B LUME S. Technology assessment and the sociopolitics of health technologies. J Health considered as part of a more general cultural Polit Policy Law 2000; 25: 1083-1120. process of rehabilitation of ethics into the scien - 8) DEJEAN D, G IACOMINI M, S CHWARTZ L, M ILLER FA . tific discourse. Ethics in Canadian health technology assess - However, although HTA encompasses branch - ment: A descriptive review. Int J Technol Assess es of knowledge which are heterogeneous from Health Care 2009; 25: 463-469. an epistemological standpoint , it owes much of 9) DROSTE S, G ERHARDUS A, K OLLEK R. Methods for inte - its success to those forms of knowledge, which grating ethical aspects and social values in short can be empirically testable. HTA-reports. An international inventory. German Agency of Health Technology Assessment at In our opinion, greater emphasis should be German Institute for Medical Documentation and given to the notion both that ethical analysis Information (DAHTA) (DIMDI), 2003; p. 9. “works” on a different level and that its findings 10) LAVIS J, W ILSON M, G RIMSHAW J. Towards optimally have a different “meaning” . As a result we , packaged and relevance assessed health tech - therefore , recommend that the epistemological nology assessments, Report Submitted to the differences among the various domains of HTA Canadian Agency for Drugs and Technologies in Healthcare. Hamilton, Ontario: McMaster Univer - are addressed more explicitly. sity Program in Policy Decision-Making, 2007. In this way, perhaps, this sort of “method dis - 11) ASSASI N, S CHWARTZ L, T ARRIDE JE . Methodological pute” ( Methodenstreit ) for integrating ethics in guidance documents for evaluation of ethical con - HTA will be mitigated and applications – which siderations in health technology assessment: a represent the “true heart” of the integration – systematic review. Expert Rev Pharmacoecon could be finally enhanced. Outcomes Res 2014; 14: 203-220. 12) DROSTE S, D INTSIOS CM, G ERBER A. Integrating ethi - ––––––––––––––––– –– cal issues in HTAs: More methods than applica - Acknowledgements tions?. HTAi 7th Annual Meeting: 2010 Jun 6-9; This paper is written within the research project INTE - Dublin, Ireland. Maximizing the Value of HTA. GRATE-HTA, co-funded by the European Union Seventh Book of Abstracts, 2010; p. 169. Framework Programme (Grant agreement no 306141). The 13) HOFMANN B. Why ethics should be part of health authors would like to thank members of the INTEGRATE technology assessment. Int J Technol Assess HTA project team for collaboration and support. Health Care 2008; 24: 423-429.

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