Technological advances in diagnostics and therapeutics have the potential to revolutionize health care and improve the lives of millions of people. However, many of these technologies remain out of reach to those who need them, particularly the poor in low- and middle-income countries.
With increased investment and global attention over the last decade, there has been tremendous progress in building a pipeline of candidate medical technologies to meet the health needs of the world’s poorest people. This course will explore the legal, regulatory and policy issues that are shaping the research, development, and delivery of those drugs, vaccines, and diagnostics. Part I of the course will provide an overview of the burden of neglected diseases in low- and middle-income countries and the new institutions and initiatives that have arisen to address that burden. Part II will examine the incentives for global health innovation, including intellectual property management, regulatory and tax incentives, and prizes and advance market commitments. Part III will consider the role of national and international regulation, international clinical trials and the globalization of research, and World Health Organization’s policy processes for ensuring drug and vaccine safety and recommending their use. Part IV of the course will explore the legal, regulatory and policy issues that arise in the delivery and use of global health technologies, particularly supply chain contracting, drug resistance, and post-market surveillance in low- and middle-income countries.