Democratic societies find it difficult to reach consensus concerning principles for healthcare distribution in the face of resource constraints. At the same time the need for legitimacy of allocation decisions has been recognised. Against this background, the National Institute for Health and Clinical Excellence (NICE) aspires to meet the principles of procedural justice, specifically the conditions of accountability for reasonableness as espoused by Daniels and Sabin, that is, publicity, relevance, revisions and appeal, and enforcement. Although NICE has adopted a highly (...) standardised approach and continuously publishes key documents on its website, its technology appraisal programme does not fulfil the publicity condition of accountability for reasonableness. Economic models are not made sufficiently transparent to enable public scrutiny, and decision criteria other than cost-effectiveness remain enigmatic. NICE’s reliance on cost-utility analysis and “plausible” cost-per-quality-adjusted life year (QALY) benchmarks further raises serious issues with regard to the relevance condition of accountability for reasonableness. This is illustrated by counterintuitive cost-per-QALY rankings that are difficult to justify using reflective equilibrium methods, and by the current debate surrounding expensive therapies for rare diseases (“orphan” treatments). In addition, an excessive focus on QALYs may stand in the way of exploiting the best available effectiveness evidence. The NICE mechanism for revision and appeals is also more restrictive than provided in accountability for reasonableness. As to the enforcement condition, no effective quality assurance processes are in place for technology assessments, and implementation of guidance remains imperfect. NICE, despite impressive efforts, appears to have a long way to go before meeting the conditions of accountability for reasonableness. (shrink)

A recent organ distribution scandal in Germany raises questions of general importance on which many thousands of lives may well depend. The scandal in Germany has produced reactions that are likely to occur whenever and wherever distribution irregularities occur and become public knowledge. After it had become known that physicians in three German hospitals were in the habit of manipulating records in order to fast-track their patients’ cases, the country experienced a decrease of available organs by a staggering 40% in (...) October 2012. Even though this loss of trust by donors and their families is understandable, and potentially a legitimate form of protest against wrongful distribution, the withdrawal of agreement to serve as a posthumous donor in response to irregularities also inevitably results in avoidable poor outcomes for highly vulnerable individuals. In this paper, we provide a moral analysis of such dilemmas and make recommendations as to the way forward. (shrink)