Viral Sovereignty, Intellectual Property, and the Changing Global System for Sharing Pathogens for Infectious Disease Research

This article analyzes the substantial changes under way in the global system for infectious disease research demonstrated by the changing practices in negotiating MTAs. Instead of the open system of sharing bacterial and viral human pathogens that characterized the research system for much of the 20th Century, notions of viral sovereignty, access contingent upon provisions like sharing research benefits, and acrimonious negotiations, are far more common. The increasing barriers to the flow of research material and related data like genetic sequencing information are posing threats to public health responses and the potential use of such resources in diagnostic, therapeutic, and vaccine innovations. This article assesses the extent of these barriers and proposes approaches that may address the global inequalities behind material transfer negotiation issues. This article proceeds as follows: Part II provides a brief history of the human pathogen sharing system that existed prior to the movement for sovereignty over biological resources that commenced in the 1970s. That system involved various means by which researchers, especially in Europe and North America, obtained pathogen samples from low- and middleincome countries as well as some sui generis systems like the WHO\u27s system for influenza sample sharing and research. Part III explains how the 1993 Convention on Biological Diversity, the 2010 Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization, and the 2011 WHO Pandemic Influenza Preparedness Framework shifted the system from one in which pathogens and other biological materials traveled essentially unregulated to one in which MTAs negotiated by governments and firms, but rarely researchers themselves, prevail. Part IV analyzes the disruptions the current regulatory system causes to the biomedical research system that leads to diagnostics, therapeutics, and vaccines. Part V provides a brief conclusion