The Vaccine Race in the 21st Century
Panel
Panel 8: Innovation in Pharmaceutical R&D
Moderator
Brett Taylor, Assistant Professor, University of the Pacific, Gladys L. Benerd School of Education
Description
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 virtually no attention has been paid to the role of laws governing innovation during the stages of research and development (R&D) of vaccines.
This Article provides the first legal analysis of the race to develop new vaccines in the 21st century. Drawing on interviews with project directors, advisors and lawyers at partnerships focused on vaccine R&D, as well as an analysis of selected contractual provisions regulating the ownership and transfer of emerging vaccine technologies, the Article identifies a set of emerging trends: a move towards public private partnerships as the backbone of innovative vaccine R&D; a limited, albeit occasionally detrimental, role of patent-based incentives to R&D; a consequent shift towards R&D incentives complementary to, but not centered on, strong proprietary rights; and the adoption of flexible contractual frameworks regulating transfers of vaccine technology.
While the new dynamics of vaccine R&D have already yielded new vaccine candidates, the Article also shows that current innovation regimes are insufficient to promote socially desirable levels of vaccine R&D. The Article argues that additional legal interventions are required to promote sustained innovation in the field of vaccines, and offers one such proposal: the adoption of a “take-and-pay” regime based on liability rules, enabling access to vaccine technology by follow-on innovators.
Location
Pacific McGeorge School of Law, Lecture Hall, 3200 Fifth Ave., Sacramento, CA
The Vaccine Race in the 21st Century
Pacific McGeorge School of Law, Lecture Hall, 3200 Fifth Ave., Sacramento, CA
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 virtually no attention has been paid to the role of laws governing innovation during the stages of research and development (R&D) of vaccines.
This Article provides the first legal analysis of the race to develop new vaccines in the 21st century. Drawing on interviews with project directors, advisors and lawyers at partnerships focused on vaccine R&D, as well as an analysis of selected contractual provisions regulating the ownership and transfer of emerging vaccine technologies, the Article identifies a set of emerging trends: a move towards public private partnerships as the backbone of innovative vaccine R&D; a limited, albeit occasionally detrimental, role of patent-based incentives to R&D; a consequent shift towards R&D incentives complementary to, but not centered on, strong proprietary rights; and the adoption of flexible contractual frameworks regulating transfers of vaccine technology.
While the new dynamics of vaccine R&D have already yielded new vaccine candidates, the Article also shows that current innovation regimes are insufficient to promote socially desirable levels of vaccine R&D. The Article argues that additional legal interventions are required to promote sustained innovation in the field of vaccines, and offers one such proposal: the adoption of a “take-and-pay” regime based on liability rules, enabling access to vaccine technology by follow-on innovators.
Speaker Bio
Ana Santos Rutschman teaches law at Saint Louis University School of Law. Her primary research and teaching interests include intellectual property, health law, innovation policy and regulation in the life sciences. She has also worked and written on topics related to biotechnology, biobanking, blockchain in healthcare, artificial intelligence, health data and e-health. Professor Rutschman has spoken on these topics in conferences and panels around the world. She recently consulted for the World Health Organization on the development of the Ebola and Zika vaccines. Her academic writing has appeared in publications including the UCLA Law Review, the Yale Law Journal Forum and the Duke Law and Technology Review. Her opinion pieces have been printed or reprinted in newspapers and magazines across the United States, including Scientific American.