PLoS Medicine
http://www.plosmedicine.org/
(Accessed 5 December 2015)

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The Ebola Vaccine, Iatrogenic Injuries, and Legal Liability
Amir Attaran, Kumanan Wilson
Policy Forum | published 01 Dec 2015 | PLOS Medicine
10.1371/journal.pmed.1001911
Summary Points
:: The development and eventual deployment of an Ebola vaccine was delayed for various technical and financial reasons, but with the apparent success of a vaccine candidate in a recently reported clinical trial, an urgent problem is the lack of any system to protect vaccine firms from the risks of legal liability caused by vaccine-related injuries.
:: Without indemnity or security against the legal risks, vaccine firms are less likely to engage in research and development of vaccines, particularly for rare diseases of poor countries such as Ebola.
:: WHO’s traditional method of mitigating the legal risks through indemnification agreements with countries appears too slow to implement in urgent pandemic situations. Also, the enforceability of any WHO-backed legal agreement is placed in doubt because the United Nations has the option to claim immunity from lawsuits.
:: Creating a compensation system for vaccine injuries, based on no-fault principles and, most likely, overseen by the World Bank, could address the liability concerns and facilitate getting novel vaccines into clinical trials and to the market. This system would also ensure that recipients of these vaccines are fairly compensated in the rare instances that they are harmed.