presented in the final chapter, address the need for reporting disaggregated analytic results in regulatory analyses.

Summary

This section briefly reviewed the ethical assumptions embedded in QALY-based CEA. Using QALYs in regulatory analysis widens the application of this analytic tool and introduces a complex normative construct to a new audience. Understanding what the QALY does and does not reflect in the measurement of health effects should help regulatory analysts and policy makers interpret and communicate their analytic results. In particular, analysts should keep in mind the need to present information on the nature of the individual health effects and the characteristics of affected population groups because QALYs subsume these distinctions. The societal perspective of regulatory analysis is best reflected by valuation of health states and conditions by people affected by the regulation. At the same time, it is important to keep in mind the potential biases in the valuation of some health states due to unfamiliarity, lack of experience, or because the states carry stigma. The rationale for using health state values elicited from community-based sample surveys in regulatory analysis is to reflect the preferences and values of the population likely to receive the benefits and/or bear the costs of the intervention.

ETHICAL AND OTHER IMPLICATIONS OF RISKS AND OF INTERVENTIONS TO ADDRESS RISKS

In this section we consider the ethical, distributional, and other factors relevant to decisions about regulating health and safety risks that are not captured in CEA.

Dimensions of Value Affecting the Acceptability of Risks

Not all kinds of risks are the same. Risks may differ in ways that can affect their acceptability for individuals and for society as a whole, as well as their assessment from an ethical point of view. How government agencies should address risks that differ in kind and in acceptability (both to individuals and the larger community) is a question that can be addressed only as part of broad, public, and deliberative discussions.

Regardless of whether the value of risk reductions is measured by cases averted, willingness to pay for health improvements, or QALY gains, the measure is likely to exclude some aspects of the risk reductions that are valued by society. For example, a 1-in-100,000 reduction in the risk of death may be valued differently depending on the source of the risk; society



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