The work of the National Institute for Clinical Excellence, an agency which has recently been created by Tony Blair's Labour government to provide guidance on best clinical practice to the National Health Service, has generated considerable controversy in the United Kingdom. It has been argued that the role which the institute plays in appraising cost effectiveness, especially of expensive new health technologies, constitutes explicit, national rationing. Although the employment of scientific and evidence-based criteria as the basis of decisions might have been expected to secure legitimacy for the institute--even when its recommendations have the effect of denying access to a particular treatment--the reaction to much of its work so far indicates that this goal has not been fully achieved. While alterations to structure and procedure may be considered as possible means of addressing the agency's difficulties, such proposals are not without problems. Consequently, in the final analysis, the British example may serve as a demonstration that the inherently political nature of priority-setting in health care precludes any easy technocratic solution.
Recommendations issued by agencies undertaking appraisals of health technologies at the national level may impact upon the availability of certain treatments and services in some publicly funded health systems, and, as such, have regularly been subject to challenge, including by way of litigation. In addition to expertise in the evaluation of evidence, fairness of procedures has been identified as a necessary component of a claim to legitimacy in such circumstances. This article analyses the assessment of courts in three jurisdictions of the fairness of decision-making by such agencies and evaluates the judicial reading of procedural justice developed in this particular context against the conditions of 'accountability for reasonableness'.
Growing concerns over the related problems of more speedily bringing innovative pharmaceuticals (especially so-called 'precision medicines') to market, and addressing areas of unmet medical need, have engendered critical scrutiny of the existing process for the licensing of pharmaceutical products. The objective is to enable these products to receive approval sooner, but on the basis of the provision of less complete evidence, than was previously the case. This article examines the attempts made to tackle this issue at European Union level, through a pilot programme exploring 'adaptive' approaches to licensing operated by the European Medicines Agency.Responses to this initiative indicate significant difficulty in securing regulatory legitimacy in this context. This suggests that innovative pharmaceutical technologies are disruptive of existing regulatory frameworks, such that future attempts to accommodate them within these may be susceptible to failure.
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