regulation. The most feasible and desirable way to account for ethical and normative considerations in regulatory policy is to include them explicitly in the deliberative policy-making process.


The choice of QALYs as the basis for measuring the production of health through regulatory interventions entails certain value commitments and ignores others, and these limitations should be made explicit in regulatory analysis. While some societal values regarding the distribution of health benefits could be incorporated through quantitative modifications of health state values, such adjustments are of questionable validity and make the quantification of health improvements more difficult to interpret. However, presenting the quantitative results of such alternative measures as sensitivity analyses may help to highlight those distributive implications in a way that promotes consideration of them in the deliberative process.


Presenting the components of summary economic analyses individually is an important contribution to the transparency and accountability of regulatory decisions because such disaggregated information may be easier to understand and it conveys the relative contributions of various health impacts to the summary results.


Public participation in the development of regulatory priorities and specific regulations is vital to well-informed policy making. Existing administrative procedures that govern the issuance of regulations provide a framework for publicity, transparency, public involvement, and accountability. They do not guarantee adequate citizen participation in setting regulatory agendas and rulemaking, however. Greater public understanding of the environmental, health, and safety risks and the benefits and costs of strategies to mitigate such risks can be promoted by well-conducted and clearly presented regulatory impact analyses.


The next and final chapter presents the Committee’s recommendations for regulatory analysis and policy development. Our recommendations reflect the conclusions above, as well as discussions and evidence that appeared earlier in this report.



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