Abstract and Keywords
This chapter focuses on the issues raised by experimental and innovative life-saving therapies, including equity and distributive justice, patient autonomy, and the role of various government institutions in regulating access to such therapies. It first considers the definitional vagueness of key terms pertaining to experimental and life-saving therapies, together with their often politicized nature. These include the terms “experimental” and “medical necessity.” It then charts the history of the regulatory regime for medical therapies before discussing three principal frameworks deployed within legal discourse to address the problems posed by new, experimental, and life-saving therapies: the constitutional framework (specifically, the constitutional right to access experimental or life-saving treatments), the public health framework, and the ethics and human rights framework. It concludes with the observation that the ethics and human rights framework is the most promising for resolving these challenges but is also the most politically infeasible, given the current state of constitutional doctrine and politics in the United States.
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