How Should the WHO Guide Access and Benefit Sharing During Infectious Disease Outbreaks?

Abstract

In response to the 2013-2016 Ebola virus disease (EVD) outbreak primarily affecting Guinea, Sierra Leone, and Liberia, the World Health Organization (WHO) set out Guidance for Managing Ethical Issues in Infectious Disease Outbreaks, which covered social distancing, research in outbreak settings, and clinical care. This article assesses the Guidance's recommendations on research and long-term storage of biological specimens during infectious disease outbreaks and argues that the Guidance does not provide adequate direction for responders', researchers', and organizations' actions. It considers local persons' access to benefits of research in the aftermath of outbreaks and preparedness for outbreaks, drawing on lessons from both the 2013-2016 EVD outbreak and ongoing research in the Democratic Republic of the Congo.

Countering the Pandemic Threat Through Global Coordination on Vaccines: The Influenza Imperative

“…Nevertheless, cost is not simply a matter of the cost of producing a vaccine or therapeutic procedure. Benefit sharing may also require necessary infrastructure, such as cold chains to store and deploy products once shared, research facilities and laboratories, or basic utility systems and roadworks" (Evans et al, 2020).…”

“…Second, samples provide sequence data for surveillance technologies, diagnostics, and medical interventions. Third, experimental interventions offer both information and tangible products, such as vaccines and therapeutics (Evans et al, 2020). WHO's Guidance for Managing Ethical Issues in Infectious Disease Outbreaks (WHO, 2016a) suggests that all three benefits should be shared and places a "fundamental moral obligation" on researchers and other actors involved.…”

Ethics committee meeting by video-conferencing during Covid-19

“…Studies during infectious disease outbreaks can involve collection of data and/or clinical specimens which is useful in understanding the pathophysiology of disease and for diagnostics, management and surveillance. The drug/device interventions in outbreaks provide information about the effects of vaccines and therapeutics (5).…”

“…Although the primary ethical obligation of physicians is to their patients, they also have a long-recognised public health responsibility (5). In the context of infectious disease, this may include the use of quarantine and isolation to reduce the transmission of disease and protect the health of the public.…”

A framework for the promotion of ethical benefit sharing in health research

“…To date, individual research participants in the global South rarely experience benefits from the research in which they participate 10. Recent Ebola virus outbreaks in West Africa and the current global SARS-CoV2 pandemic have starkly highlighted this in Africa: Samples from Ebola patients appropriated by teams from the global North were used for commercial development without consent or benefit sharing agreements with countries, communities or patients of origin6 11; and COVID-19 vaccine scarcity and delays in access for adults in Africa persist in the face of booster shots for adults and child vaccination in the global North despite willing African participation in COVID-19 vaccine research and trials 12–14. Allegations of misuse of African DNA for unconsented commercial applications with unshared benefits persist 15.…”