Beyond the Black Box Approach to Ethics! Comment on "Expanded HTA: Enhancing Fairness and Legitimacy"

Abstract

In the editorial published in this journal, Daniels and colleagues argue that his and Sabin's accountability for reasonableness (A4R) framework should be used to handle ethical issues in the health technology assessment (HTA)-process, especially concerning fairness. In contrast to this suggestion, it is argued that such an approach risks suffering from the irrrelevance or insufficiency they warn against. This is for a number of reasons: lack of comprehensiveness, lack of guidance for how to assess ethical issues within the "black box" of A4R as to issues covered, competence and legitimate arguments and finally seemingly accepting consensus as the final verdict on ethical issues. We argue that the HTA community is already in a position to move beyond this black box approach.

Transparency in practice: Evidence from ‘verification analyses’ issued by the Polish Agency for Health Technology Assessment in 2012–2015

“…Because the data for analysis is presented by stakeholders with a clear business interest in its outcome, it is essential to ensure that the HTA assessment is rigorous, avoiding the risk of becoming a "black box" (Sandman and Gustavsson 2016). There are several reasons.…”

Moving Towards Accountability for Reasonableness – A Systematic Exploration of the Features of Legitimate Healthcare Coverage Decision-Making Processes Using Rare Diseases and Regenerative Therapies as a Case Study

“…Deliberation is a form of learning that cannot be replaced through quantitative methods or the majority vote. 8,39,41 It involves understanding the health intervention and one’s own values as well as sharing personal definitions, judgments and values (ie, ‘interpretive frames’) with others to question assumptions and engage in shared ethical reasoning. 8,14 Reflective multicriteria approaches can support this learning by providing a framework to structure the available evidence relevant to each decision criterion and to allow the explicit expression of values as separate from scientific judgments.…”

“…Identification of these features was supported by a review of the literature on the requirements for legitimate and accountable decision-making processes, 4-10,38 including the A4R framework and its implementation in HTA processes. 8,13,14,26-28,30,39-42 (Please refer to Supplementary file 1 for search strategies). A total of 34 features for operationalizing the A4R conditions were thus defined: 26 features for the A4R Relevance condition (including 19 features related to decision criteria, 3 to evidence and 4 to deliberation), 3 for the Publicity condition, 2 for the Appeal condition, and 3 for the Enforcement ( or Implementation) condition.…”

Ethics in HTA: Examining the "Need for Expansion"

“…We reject a by-exclusion framing of HTA arisen from such an expansion/no-expansion argument, be it per domain or discipline, by calculation or deliberation, academic or non-academic, or otherwise. In our opinion, ‘meaningfulness and relevance’ to the needs of the population must be the prime criteria for determining the extent of HTA and for ‘sufficiency’ 5 of analyses. As a tool to inform decision-making regarding health interventions, HTA must remain user-centred in the same fashion that airlines services must be tailored to the needs of passengers or health services to those of patients.…”