Health technology assessment (HTA) is a multidisciplinary field of policy analysis. It studies the implications of the development, diffusion and use of health technology. Its power lies in providing a joint basis for policy discussions about health care, instead of each party bringing its own calculations and then disagreeing on who is right. However, it is also a fundamentally value-laden enterprise.
HTA started in the 1970s with the primary interest of ensuring the effectiveness and safety of new health technologies. (1) The cost and comparative cost-effectiveness became increasingly important as methods of assessment developed parallel to methods in health economics. More recently, the effects of health technologies on organizations, as well as legal, societal and ethical aspects of technologies, have come under the scope of HTA. (2) This reflects the aim to increase the relevance and applicability of the assessments and the realization that health technologies are always applied in a social context. (3-5) However, a shortage of accepted and practical methods for incorporating these considerations within HTA has been recognized. (6,7)
This paper describes a flexible, easy-to-use model for incorporating ethics into HTA. The aim is to make HTAs more internationally transferable and relevant to policy-makers in different health-care settings and cultures.
Ethics and HTA
The importance of considering technology's impact on "social, ethical, legal and other systems" was recognized early (1) and has subsequently been generally accepted. (4,6,7) The importance of ethics in HTA is based on three insights. (5,8) First, implementing health technologies may have moral consequences, which justifies adding an ethical analysis to a "traditional" assessment of cost and effectiveness. Second, technology also carries values and may challenge prevalent moral principles or rules of society (3,9-11) that should be addressed by HTA.
Third, a more fundamental insight, is that the whole HTA enterprise is value laden. The goal of HTA is to improve health care, and as health care is value laden (in trying to improve the well-being of people), then HTA is value laden too. The conviction that health care and health policy should be evidence-based and decisions should be transparent is a generally accepted value-base within HTA. Important value-decisions are often made implicitly in HTA methodology: when choosing which technology to assess; interpreting research results; deciding on what counts as evidence; and whose view decides the rationality of implementing a technology. (8,11-14) Considering a particular HTA, the formulation of the problem, the choice of outcome measures and comparative technologies also reflect values and determine the possible outcomes of the assessment. In summary, this approach to ethics aims to uncover and justify the underlying normative structure of HTA, to assure the usefulness of the assessment. (13,15)
Decisions to implement technologies imply resource allocation. Choosing a technology may imply devaluing or abandoning other technologies, but may also lead to reallocation of resources within health care, or between wider sectors of society. (16,17) Ideally, political decision-makers are expected to balance individual and wider societal interests, taking into consideration ail values at stake. Ethical analysis within HTA can provide insight into these issues, and assist decision-makers in interpreting information in a policy-relevant way. (18)
Despite the general agreement on the importance of integrating ethics in HTA, (5,8,14,15) ethical issues are still rarely addressed in HTA reports. (19-21)
The objective of the EUnetHTA project, launched in 2006, is to connect public HTA agencies, research institutions and health ministries and to enhance the exchange of information and support policy decisions. …