Evidence-Based Medicine (EBM) is defined as the conscious, and judicious use of current best evidence in making decisions about the care of individual patients. The greater the level of evidence the greater the grade of recommendation. This pioneering explicit concept of EBM is embedded in a particular view of medical practice namely the singular nature of the patient-physician relation and the commitment of the latter towards a specific goal: the treatment and the well being of his or her client. Nevertheless, (...) in many European countries as well as the United States, this integration of the best evidence from systematic research with clinical expertise and patient values appears to be re-interpreted in light of the scarcity of healthcare resources. The purpose of this paper is double. First, to claim that from an ethical perspective EBM should be a guideline to clinical practice; and second, that in specific circumstances EBM might be a useful tool in macro-allocation of healthcare resources. Methodologically the author follows Norman Daniels' theory of democratic accountability to justify this assumption. That is, choices in healthcare must be accountable by democratic procedures. This perspective of distributive justice is responsible for the scope and limits of healthcare services. It follows that particular entitlements to healthcare — namely expensive innovative treatments and medicines —may be fairly restricted as long as this decision is socially and democratically accountable and imposed by financial restrictions of the system. In conclusion, the implementation of EBM, as long as it limits the access to drugs and treatments of unproven scientific results is in accordance with this perspective. The use of EBM is regarded as an instrument to facilitate the access of all citizens to a reasonable level of healthcare and to promote the efficiency of the system. (shrink)

Norman Daniels’ theory of justice and health faces a serious practical problem: his theory can ground the special moral importance of health and allows distinguishing just from unjust health inequalities, but it provides little practical guidance for allocating resources when they are especially scarce. Daniels’ solution to this problem is a fair process that he specifies as "accountability for reasonableness". Daniels claims that accountability for reasonableness makes limit-setting decisions in healthcare not only legitimate, but also fair. This paper assesses the (...) latter claim. Does accountability for reasonableness result in fair limit-setting decisions? It is argued that the answer to this question is not a clear yes. Daniels is remarkably unclear about the criterion of fairness that accountability for reasonableness satisfies. The paper discusses different options for resolving this lack of clarity and examines how they apply to Daniels’ accountability for reasonableness framework. It is concluded, first, that accountability for reasonableness is not a paradigm case of any of the classic notions of procedural justice; second, that what might be called "constrained pure procedural justice" best reflects how accountability for reasonableness results in fair limit-setting decisions; and third, that the procedural conditions of accountability for reasonableness must be further specified and amended to better achieve a fair process, and hence fair limit-setting decisions. (shrink)

The lack of economic sustainability of most healthcare systems and a higher demand for quality and safety has contributed to the development of regulation as a decisive factor for modernisation, innovation and competitiveness in the health sector. The aim of this paper is to determine the importance of the principle of public accountability in healthcare regulation, stressing the fact that sunshine regulation—as a direct and transparent control over health activities—is vital for an effective regulatory activity, for an appropriate supervision of (...) the different agents, to avoid quality shading problems and for healthy competition in this sector. Methodologically, the authors depart from Kieran Walshe’s regulatory theory that foresees healthcare regulation as an instrument of performance improvement and they articulate this theory with the different regulatory strategies. The authors conclude that sunshine regulation takes on a special relevance as, by promoting publicity of the performance indicators, it contributes directly and indirectly to an overall improvement of the healthcare services, namely in countries were citizens are more critical with regard to the overall performance of the system. Indeed, sunshine regulation contributes to the achievement of high levels of transparency, which are fundamental to overcoming some of the market failures that are inevitable in the transformation of a vertical and integrated public system into a decentralised network where entrepreneurialism appears to be the predominant culture. (shrink)

Norman Daniels' and James Sabin's theory of “accountability for reasonableness” (A4R) is a much discussed account of due process for decision-making on health care priority setting. Central to the theory is the acceptance that people may justifiably disagree on what reasons it is relevant to consider when priorities are made, but that there is a core set of reasons, that all centre on fairness, on which there will be no disagreement. A4R is designed as an institutional decision process which will (...) ensure that only those reasons which everybody will agree are relevant and appropriate form part of decision-making. The argument which we will put forward in this paper questions whether it is a simple matter to delineate the core set of reasons and claims that it is a potential problem in A4R that it does not provide an indication of the exact content of this process. The paper first briefly outlines the content of A4R. It is argued that disagreement on what services should be high priorities cannot be resolved solely with a reference to “due process.” In order to retain consistency over time, decision-makers are required to agree and articulate what reasons qualify as relevant and how conflicting reasons are to be balanced in the course of the process. The second and main part of the paper then considers how the reason of “solidarity” can be handled within the A4R framework, and it is shown that deciding whether solidarity should be admitted to the core set of allowable reasons is not a simple matter. (shrink)

This paper is a critique of Norman Daniels' and James Sabin's ‘Accountability for Reasonableness’ framework for making priority-setting decisions in health care in the face of widespread disagreement about values. Accountability for Reasonableness has been rapidly gaining worldwide acceptance, arguably to the point of becoming the dominant paradigm in the field of health policy. The framework attempts to set ground rules for a procedure that ensures that whatever decisions result will be fair, reasonable, and legitimate to the extent that even (...) those who would be adversely affected will have reason to abide by them. I argue that the framework's four conditions are inadequate to this task. While we certainly require a fair and legitimate procedure for making priority setting decisions in health care despite a lack of consensus on relevant ethical and political issues, we must significantly revise the four conditions, and we cannot avoid facing our substantive disagreements head on if we hope to arrive at decisions that would (and should) be acceptable to everyone. I offer two suggestions. First, there is need for greater public involvement in all stages of deliberation. Second, we should give up on the idea that we can simplify the task of democratic deliberation by disallowing particular kinds or reasons and types of reasoning. Reasons of all kinds should be on the table, but then should be judged on their merits, such as consistency, plausibility and explanatory power, without any regard for their alleged sources of authority. (shrink)