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After Ebola, Social Justice as a Base for a Biobanking Governance Framework
by Dr. Calvin WL Ho
Centre for Biomedical Ethics, Yong Loo Lin School of Medicine, National University of Singapore

About two years ago, the outbreak of Ebola in West Africa has generated a great number and variety of biological samples. Such samples constitute a valuable, non-renewable resource, and offer a unique opportunity to increase our knowledge of the Ebola virus and its pathogenesis. However, there is no generally agreed plan on how to manage these specimens equitably. This paper argues for the establishment of a global framework on Ebola biobanking that is premised on social justice.

Social Justice in Public Health

With the outbreak of Ebola, initially in Guinea, Liberia and Sierra Leone, biological specimens collected were primarily composed of blood, semen, urine and breast milk from patients confirmed or suspected to have contracted the virus, and swabs from the bodies of those who have died from the disease. However, the exact number of specimens that are held by health agencies and research organisations both in and outside of West Africa is unknown [1]. It is also unclear if the specimens taken out of West Africa was pursuant to a material transfer agreement, and how they are currently managed. What is clear though, is that research on Ebola will continue as there is no known therapeutic intervention that is recognised to be effective, although a study of Merck’s Ebola vaccine has produced promising results of effectiveness [2]. A deeper understanding of the disease will be necessary to control and prevent the disease in the future.

If an infectious diseases biobank is to be created, a range of possible arrangements has been proposed to include national, through regional, to international models; centralised or distributed among different physical sites; or even as a repository of distributed, shared, or ‘virtual’ knowledge resources. But there are formidable challenges. These include those that relate to infrastructure and cost, and a number of ethical concerns. From an ethical and regulatory standpoint, appropriate standards must be put in place to ensure the immediate needs for preservation and storage of thousands of biological samples taken from patients during the crisis are met, along with longer–term concerns with advancement of therapeutic interventions and capacity building in the West African sub-region, that has been most affected by the outbreak. Arguably, these are basic requirements if the prospect of a future Ebola outbreak is recognised to be a global public health concern.

Madison Powers and Ruth Faden (2006) persuasively present social justice to be the foundational moral justification for the social institution of public health [3]. By their account, social justice is concerned with human well-being, composed of six essential dimensions, namely health, personal security, reasoning, respect, attachment, and self-determination. It aspires to secure sufficiently high levels of well-being in each of these dimensions for everyone. For this reason, social justice requires public health institutions to identify patterns of systematic disadvantage that profoundly and perversely undermine prospects of well-being. Where the Ebola outbreak is concerned, it highlighted the need to build scientific, administrative, and technological capacities in the West African sub-region.

Significant Gaps in Social Justice and Global Governance

The Ebola outbreak has revealed serious gaps in national and international capacity in infectious diseases surveillance and pandemic responsiveness. Whether then or now, health systems of the affected West African countries would not have had the capability to detect, monitor and respond to the outbreak, despite the availability of technological means to augment disease surveillance, such as the acquisition of real-time pathogen genome data. In addition, they do not have the means to safely manage the currently untreatable virus.

There is currently no high-containment lab in West Africa that is required to safely store live Ebola viruses. While Ebola may have spurred the creation of Japan’s first BSL-4 laboratory in Musashi-Murayama, these facilities are extremely expensive to construct and operate. Even for a relatively high income country like Japan, its BSL-4 laboratory has in fact been operating as a BSL-3 laboratory since 1981. Cost-wise, this step-up development would have been less prohibitive than what it would take to establish a new BSL-4 laboratory, although additional investment is still required, as protocols will need to be established and staff will have to be trained for high-security work. It may not be sensible for such a laboratory to be established in West Africa, where investment may perhaps be better applied in other health or health-related areas. Conceivably, West African countries need not have their own high-security infrastructure if a transnational framework is in place to ensure that Ebola specimens are held on trust and for their benefit.

The lack of a transnational (or global) governance framework is a serious limitation. Given that poorer countries are unlikely to have the research capability or the governance mechanisms to effectively operate a high-security biobank, such a governance framework is needed to enable collaboration between high-income countries and lower-income countries in biobanking, and to ensure that there is equitable distribution of benefits among them. Haidan Chen and Tikki Pang [4] have proposed that such a global governance framework for biobanks should have a number of key features that include:

  • respecting donors of biological samples;
  • informing donors of potential risks through initial consultations;
  • sharing samples, data and benefits in a fair, transparent and equitable manner;
  • ensuring quality and interoperability of samples and their associated data;
  • improving public awareness, trust and participation in biobanks; and
  • defining the role of the private sector in the use of knowledge derived from biobank operations.

A perhaps limited example of such a global governance framework exists in the form of the Pandemic Influenza Preparedness (PIP) Framework, which was established following Indonesia’s refusal to share samples of the avian influenza A (H5N1) as it was concerned that high-income countries would ultimately have greater access to vaccines developed from these samples than lower-income countries. Under the PIP Framework, researchers and manufacturers are contractually obligated to provide a percentage of vaccines, diagnostics or pharmaceuticals to the stock-pile of the World Health Organization (WHO) or otherwise grant reasonable access to such products in exchange for access to the biological specimens. The current PIP Framework is strictly limited to influenza viruses with pandemic potential, and hence will not even apply to seasonal influenza viruses, let alone Ebola. However, as a framework that is composed of contractually binding obligations, it applies effectively to both state and non-state actors alike. Lawrence Gostin and others have proposed that a revised PIP or PIP-like framework based on social justice and shared global vulnerability is necessary to ensure the vaccines, pharmaceuticals and research findings are equitably distributed to lower-income countries that might have lower purchasing ability [5].

The Ebola crisis has also contributed to a critical re-evaluation of WHO’s role in global health emergencies. Following the publication of recommendations from a panel of independent experts [6], the WHO has indicated that it is actively developing an “R&D Blueprint” in relation to research and development in epidemics or health emergency situations. This is being done in consultation with its Member States and relevant stakeholders, to address the prospect of accelerating research and development in epidemics or health emergency situations where there are no, or insufficient, preventive, and curative solutions.

WHO has also indicated its commitment to support ongoing work to accelerate the development of appropriate diagnostics, vaccines, therapeutics, medical and information technology for the end-phase of the current Ebola epidemic. Initiatives to establish adequate international financing for pandemics and other health emergencies are being explored, including a pandemic emergency financing facility (PEFF), and a newly established WHO Contingency Fund for Emergencies. It further committed itself to work closely with actors across the international humanitarian system to improve the effectiveness, coordination, mobilisation and use of humanitarian financing, including strengthening of common evidence-based needs assessments and strategic response planning. It is less clear how WHO’s re-invigorated role and initiatives support public health as a social justice enterprise. More specifically, it should be considered how the global community (possibly through WHO) can better enable the health systems of these West African countries to detect and respond to future outbreaks, and thereby secure a higher level of well-being for their populations.

The Work Ahead

As essential tools for translating biomedical research into practice, biobanks (and databanks) have become a global phenomenon. Their importance as research infrastructure will grow with increasing emphasis on precision medicine as a means to improve therapeutics development and treatment pathways. Yet despite their prevalence and the different governance systems that have been established to address ethical, legal and social concerns, the recent Ebola outbreak highlights formidable operational and equity issues. It is expected that vaccines may be developed using only genetic sequencing data of a virus. If so, there will be no need for physical biological specimen. Should this come to pass, even a PIP-like framework may not alleviate the deepening inequities in global health, as there will be even less political and economic incentive to address capacity building concerns or ensure equitable distribution of the burdens and benefits of research.

On 11 August 2014, WHO convened a consultation to consider if unregistered interventions that have shown promising results in the laboratory and in animal models that have not yet been evaluated for safety and efficacy in humans may be used to try to save the lives of patients and to curb the epidemic [7]. The experts at the consultation unanimously agreed that it would be acceptable to use these unregistered interventions provided that certain conditions are met. In addition, it was also noted that more detailed analysis and discussion will be required for at least three areas, one of which being the ethical criteria for achieving fair distribution in communities and countries of the growing number of investigational interventions. This conversation should be a global priority.

References:

  1. Hayden, E.C. Biobank planned for Ebola samples. Nature (August 2015) 524: 146-147.
  2. Henao-Restrepo, A.M., et al. Efficacy and effectiveness of an rVSV-vectored vaccine expressing Ebola surface glycoprotein: interim results from the Guinea ring vaccination cluster-randomised trial. The Lancet (August 2015) 386: 857-866.
  3. Powers, M., Faden, R. Social Justice: The Moral Foundations of Public Health and Health Policy. Oxford and New York: Oxford University Press, 2006.
  4. Chen, H-d., Pang T. A call for global governance of biobanks. Bulletin of the World Health Organization (2015) 93: 113-117.
  5. Gostin, L.O., et al. Virus sharing, genetic sequencing, and global health security. Science (September 2014) 345, 6202: 1295-1296.
  6. World Health Organization. WHO Secretariat response to the Report of the Ebola Interim Assessment Panel. World Health Organization: August 2015.
  7. World Health Organization. Ethical considerations for use of unregistered interventions for Ebola viral disease. World Health Organization: 2014.
About the Author

Dr Calvin WL Ho, JSD MSc LLM, is Assistant Professor at CBmE, Co-Head of the World Health Organization Collaborator Centre on Bioethics in Singapore, and Co-Head of the Accountability Policy Task Team of the Global Alliance for Genomics & Health. He is also an Ethics Review Board member of Médecins Sans Frontières (Doctors Without Borders) and serves as an Assistant Director with the Legal Aid Bureau (Singapore), as well as a member on the advisory committees for transplantation and on genetic testing of the Ministry of Health (Singapore). He has published on research ethics and policy, health policy and services, and is the co-editor of Bioethics in Singapore: An Ethical Microcosm (2010, World Scientific) and Genetic Privacy (2013, Imperial College Press).

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