As one part of a comprehensive plan to promote vaccine development for diseases of poverty, such as Ebola, there needs to be a plan to lessen the risks of litigation and liability and ensure recipients of vaccines are fairly compensated in the rare instances that they are harmed. A compensation system for vaccine injuries, based on no-fault principles and, most likely, overseen by the World Bank, could represent a solution to this problem argue Amir Attaran and Kumanan Wilson of the University of Ottawa, Ontario, Canada in a Policy Forum article published this week in PLOS Medicine.
The recent devastating Ebola outbreak has revealed myriad systemic deficiencies in health systems, international institutions, drug development and global readiness for public health emergencies. While there are substantial technical challenges in developing vaccines the lack of arrangements for vaccines to be deployed rapidly without hesitation because of liability due to iatrogenic harm also represents a potential barrier for vaccine deployment for future outbreaks.
Solutions to the liability issue include the country experiencing the public health emergency indemnifying the vaccine supplier, or using the United Nations' immunity from lawsuit to shield the vaccine supplier as was done during the H1N1 pandemic. However, the authors argue that a superior option is for the international community to establish a no-fault compensation fund for novel vaccines released on an emergency basis to low-income countries.
The authors conclude, "[w]e think it is not too ambitious in the available time before an Ebola vaccine is available for routine use to create an international no-fault vaccine injury compensation program, disbursed upon the advice of an expert panel agreeing as to causality, and funded through the World Bank's residual influenza trust funds, plus possibly other Ebola-specific contributions. In the intermediate term, such an arrangement should be institutionalized through the World Bank, its access to insurance markets, and its proposed Global Pandemic Emergency Facility. In the long term, countries should be given assistance to devise no-fault compensation systems within their domestic law, so as to obviate the need to manage liability at the international level."
This work was funded by Canada's Social Sciences and Humanities Research Council and the Canadian Institutes of Health Research. KW has received funding from the World Health Organization. KW has received funding from Sanofi-Pasteur for mobile bar code scanning. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
AA holds a Canada Research Chair in Population Health and Global Development Policy. KW is supported by The Ottawa Hospital, Department of Medicine, Ottawa Hospital Research Institute Chair in Public Health Policy.
Attaran A, Wilson K (2015) The Ebola Vaccine, Iatrogenic Injuries, and Legal Liability. PLoS Med 12(12): e1001911. doi:10.1371/journal.pmed.1001911
Institute of Population Health, Faculty of Law, Faculty of Medicine, University of Ottawa, Ottawa, Ontario, Canada
Department of Medicine, University of Ottawa, Ottawa, Ontario, Canada
Ottawa Hospital Research Institute, Ottawa, Ontario, Canada
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Professor Amir Attaran
Faculties of Law and Medicine; University of Ottawa
Dr. Kumanan Wilson
Senior Scientist Ottawa Hospital Research Institute
Department of Medicine, University of Ottawa
Ottawa Hospital Civic Campus