In a world in which infectious diseases are spreading increasingly faster, the development of new human vaccines remains a priority in biopharmaceutical innovation. Legal scholars have addressed different aspects of vaccine regulation and administration, but less attention has been paid to the role of laws governing innovation during the stages of research and development (R&D) of vaccines.
This Article explores the race to develop new vaccines from its beginnings through the early 21st century, with a particular focus on the progressively pervasive role of intellectual property in governing vaccine innovation. It describes the insufficiencies of current innovation regimes in promoting socially desirable levels of vaccine R&D, particularly in the case of emerging pathogens, a phenomenon that is at odds with public health needs.
Moreover, the Article identifies transactional inefficiencies affecting the licensure of vaccine technology. In order to address this problem, the Article argues for adoption of a technology-specific solution, and proposes a narrowly construed “take-and-pay” regime based on liability rules, enabling access to vaccine technology by follow-on innovators.
Ana Santos Rutschman, (2019). The Vaccine Race in the 21st Century. Forthcoming Arizona Law Review 61:4.