Access, Fairness and Affordability: Procedural Justice in NICE, Anvisa and Conitec

Abstract

Everywhere, health care systems are making hard choices about medicines. These choices are sensitive, controversial and often result in litigation. For example, the recent report in the UK about the drug Tamiflu casts doubt on the efficacy of the treatment and its value for money to the public health system. In Brazil too, the uncontrollable judicialization of public health decision-making illustrates the gravity of these issues and the challenges they present. They demonstrate that health systems have to operate within finite budgets and that, because we cannot afford everything, we must ensure that treatments are effective and good value for money. We suggest that the hard choices required should not be made by judges deciding individual cases. National public authorities should perform these functions where possible, taking full account of public interests.All public authorities are subject to judicial supervision. Public health care resource allocators should work within a clear and transparent procedural framework which assures everyone the system is operating fairly and consistently. We should be clear about the role of public authorities and judicial review in decision-making, and the principles governing the incorporation of new treatments.A comparative study of Brazil - UK is helpful for two reasons. First, the rules governing judicial review in Brazil and the UK are different. In Brazil, the courts are more willing to take substantive responsibility for administrative decision-making by ordering that specific treatments are provided to individual patients. In the UK, by contrast, the principle of procedural review is normally limited to the reasonableness of the decision only, so that when a decision is wrong, it is referred back to the public authority to be reconsidered. Second, it is useful to compare the structural and procedural similarities of NICE, Anvisa and Conitec to assess the extent to which they are capable of promoting equality of access to a proper range of affordable medicines. In particular, we recommend a need for strong and transparent administrative procedures to relieve the courts of the duty to intervene in these cases.We also consider the many medicines which cannot be considered by national public authorities. Which local authorities decide about these medicines and what procedures should they follow? We recommend a framework of procedural values which reassures the courts that the system (whether national or local) is working fairly and consistently and does not require extensive interference from judges.Thus, we will consider: (A) The process for evaluating new technologies in NICE, Anvisa and Conitec, (B) The role of the courts in supervising these administrative procedures and (C) the residual role of judicial review of payment decisions in the NHS and SUS. The study concludes that the proper balance between increasing demand for health care, finite public health budgets and the promotion of public interests is best achieved through public authorities structured in ways which are open and accountable. We recommend that such bodies be subject to proper procedural judicial review and that “public” access to medicines is most likely to be served by courts which respect the public dimension of decision-making.