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Shifting priorities at the Health Protection Branch: Challenges to the regulatory process

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Abstract

The Health Protection Branch (hpb) of Health Canada has recently undergone considerable policy and organizational renewal, with numerous and broad-ranging implications for the evaluation of drug product safety and efficacy. From a public-health perspective, however, the criteria used to develop organizational and policy change at the hpb have provided a sub-optimal basis for reform, due primarily to the many forms of market failure to which the regulation of pharmaceuticals is subject. For example, thepartnership andefficiency criteria that guided policy renewal have led to the transfer of important responsibilities to partners, with the potential for either a conflict of interest or inadequate information, for which the legal basis is not always clear. The resulting realignment of the hpb's roles and responsibilities may be characterized as leading to a shift from a comprehensive approach to public-health protection to one based on strategic risk management, with responsibilities dispersed among government, industry, academia and consumers. The rebalancing of goals in the redesign of the regulatory process suggests a change in the role of the state in the context of public-health protection and highlights issues of concern to the public interest that may not be fully recognized as deregulation occurs in other sectors of the economy.

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Nature is the international weekly journal of science: a magazine style journal that publishes full-length research papers in all disciplines of science, as well as News and Views, reviews, news, features, commentaries, web focuses and more, covering all branches of science and how science impacts upon all aspects of society and life.
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An ethical perspective applied to the use of cost/benefit analyses for environmental, safety, and health regulations reaches the following conclusions: (1) in areas of environmental, safety, and health regulation, there may be many instances where a certain decision might be right even though its benefits do not outweigh its costs; (2) there are good reasons to oppose efforts to put dollar values on non-marketed benefits and costs; (3) given the relative frequency of occasions in the areas of environmental, safety, and health regulation where one would not wish to use a benefits-outweigh-costs test as a decision rule, and given the reasons to oppose the monetizing of non-marketed benefits or costs that is a prerequisite for cost/benefit analysis, it is not justifiable to devote major resources to the generation of data for cost/benefit calculations or to undertake efforts to spread the gospel of cost/benefit analysis further. 5 references, 2 tables.
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