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Facilitating Access To Cross-Border Supplies Of Patented Pharmaceuticals: The Case Of The Covid-19 Pandemic, Frederick M. Abbott
Facilitating Access To Cross-Border Supplies Of Patented Pharmaceuticals: The Case Of The Covid-19 Pandemic, Frederick M. Abbott
Scholarly Publications
The COVID-19 pandemic has brought into stark relief the gaps in global preparedness to address widespread outbreaks of deadly viral infections. This article proposes legal mechanisms for addressing critical issues facing the international community in terms of providing equitable access to vaccines, treatments, diagnostics, and medical equipment. On the supply side, the authors propose the establishment of mandatory patent pools ('Licensing Facilities') on a global or regional, or even national basis, depending upon the degree of cooperation that maybe achieved. The authors also discuss the importance of creating shared production facilities. On the demand side, the authors propose the establishment …
Conflicts Of Interest In International Human Drug Research And The Insufficiency Of International Protections, Robert Gatter
Conflicts Of Interest In International Human Drug Research And The Insufficiency Of International Protections, Robert Gatter
All Faculty Scholarship
The problem of financial conflicts of interest in human subjects research is international in scope as drug manufacturers conduct trials in countries outside of the U.S., Japan, and the European Union, thereby side-stepping domestic regulation of conflicts of interest. Because such out-sourcing of human drug trials results in exporting risks associated with financial conflicts of interest, this essay examines the primary international sources for regulating those conflicts. These sources include the World Health Organization’s Guidelines for Good Clinical Practice for Trials on Pharmaceutical Products, the Guidelines for Good Clinical Practice adopted by the International Conference on Harmonisation of Technical Requirements …