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Making good policy decisions: a discipline we cannot afford to ignore

T here is a growing discussion on blood safety decision making and on policy approaches designed to optimize value in health care generally. In this issue, Kramer and colleagues provide some degree of evidence regarding the broad set of qualitative factors that affect policy making in the domain of blood safety, with an emphasis on ethical considerations. They propose and apply a social science approach (based on Grounded Theory) that provides a mechanism for identifying a taxonomy of concerns that have not to date been systematically and explicitly acknowledged in the domain of blood safety. The authors effectively catalog and classify advantages and disadvantages of possible safety policies, uncertainties and risk assessment difficulties, principles, and practical obstacles to translating assessments into actual decisions. They illustrate that there are a wide variety of competing concerns, but found no universally applicable decision-making algorithms to process those concerns. The authors suggest that for realistic and productive policy making, we should have explicit awareness of the multiplicity of concerns which decision makers must confront. These findings are strikingly consistent with the conclusions of the International Consensus Conference on Risk-Based Decision Making for Blood Safety (Toronto, 2010) and the subsequent efforts by the Alliance of Blood Operators to produce a framework to integrate these concerns into an overall risk profile to inform the decision-making process. The notion of “framework” conveys a structured approach: a systematic methodology for setting the best course of action under uncertainty by identifying, assessing, communicating, and mitigating risk. The first purpose of the riskbased decision-making framework for blood safety (RBDM framework) is to optimize the safety of the blood supply by enabling the proportional allocation of finite resources to mitigate the most serious risks, recognizing that the elimination of all risk is not possible. The second purpose of the framework is to analyze and account for a series of contextual factors that affect decision making in the management of blood risks, such as social, economic, and significantly, ethical perspectives. The central argument of the article by Kramer and coworkers is that a philosophical-ethical perspective can advance the quality of analysis; this contention has merit, especially for mesolevel and systemwide policy making. The study yielded several ethics-based decision factors: concern with safety, allocation of limited resources, opportunity cost that arises from forgoing some other morally valuable goal, considerations of justice, and potentially unique ethical duties owed to transfusion recipients. The study concludes that any systematic decision-making approach or framework should explicitly account for ethical reflection on 1) the reasonableness of the cost of a safety measure and 2) the value of transparency in public policy and that fundamental principles serve an important function in policy making. Whether viewed from a risk-based lens or an ethics-based lens, these considerations and the implications for our blood safety decision-making paradigm are remarkably similar. Kramer and colleagues suggest that it was at least in part our incapacity to address a variety of competing concerns, including political and economic ones, and weak policy-making practices that led to decision-making failures in the face of human immunodeficiency virus and hepatitis C virus. They cite various critiques of current policymaking practices and note controversy surrounding the precautionary principle and its application to blood safety issues. Such critiques also served as the genesis of the RBDM framework. Turning first to the reasonableness of the cost of a safety measure, we have observed the evolution of decision making since the crises of the 1980s and 1990s as a movement to precautionary risk minimization through safety measures with high incremental costeffectiveness ratios. The study yielded competing principles that assigned different (qualitative) priorities to safety and costs, but did not reveal risk or cost thresholds that were broadly recognized across or within countries. Similarly, it has been observed by Custer and Janssen that economic analyses of blood safety interventions in most countries have demonstrated that these interventions do not conform to broadly accepted cost-effectiveness thresholds. They show that threshold considerations need to be further developed specifically in the context of blood safety and transfusion medicine to appropriately inform the decision-making process. As noted by Custer and Janssen, there is an important link between blood safety decision making and the doi:10.1111/trf.13382