Biomedical Innovation Law and Policy

Why don't we have an HIV vaccine, or a cure for Alzheimer's disease? Why weren't we better prepared for the COVID-19 pandemic? Why do vast inequalities persist in who has access to biomedical innovations, and in what kinds of innovations are brought to market? In this seminar we will examine the economics of biomedical R&D and the legal institutions that are designed to incentivize and allocate access to new advances, with an emphasis on drugs and vaccines. We will consider legal tools including patents and other intellectual property, FDA-administered regulatory exclusivity, prizes, grants, tax incentives, and subsidized health insurance. The current U.S. policy mix of innovation incentives and access allocation mechanisms is far from perfect, and students will have the opportunity to discuss reform proposals with experts involved in real-world biomedical innovation in different sectors. There are no prerequisites, and no scientific or economic background is required. Elements used in grading: class participation, attendance, and short writing assignments.