We are pleased to present this symposium featuring commentary from participants in the “Between Complacency and Panic: Legal, Ethical and Policy Responses to Emerging Infectious Diseases” conference held on April 14, 2017, at Northeastern University School of Law. The conference was sponsored by the Center for Health Policy and Law and the American Society for Law, Medicine, and Ethics (ASLME), with support from The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School.
By Ana S. Ayala
There is no doubt that viruses, emerging and re-emerging, have become an imminent global health threat. Starting in 2014, we saw the decimation of West African countries as a result of the Ebola epidemic. Soon after came the Zika outbreak that continues to pose a threat to countries in the Americas and around the world. Since December 2016, Brazil has been experiencing a rise in yellow fever cases , and deaths, among humans and monkeys alike. Colombia and Peru have already reported probable cases. As a response to rising human cases of the H7N9 bird flu, China just ordered the closure of all poultry markets in the eastern province of Zhejiang to stop the trade of live poultry.
Experts warn that the question is not whether but when a pandemic will hit. Unknown or little-known viruses currently looming in animal populations undetected pose a especially dangerous risk–we have little to no experience with them, we do not know whether or when they will spill over to humans, and we do not know where they will emerge next.
As recent outbreaks have demonstrated, we are ill- prepared to protect ourselves–we continue to react rather than adopt a more proactive and preventative approach. That said, experts working in this area are challenging the world to think outside the box, and the Global Virome Project (GVP) is exactly that. Envisioned as a global partnership, the GVP would seek to identify 99% to 100% of viruses with potential of becoming epidemics through the use of revolutionary technologies. This ten-year project promises to facilitate the development of various countermeasures, including vaccines and diagnostics.
From a legal perspective, the mere idea of the GVP calls into question the legal frameworks currently available to support efforts to prevent and control epidemics. The WHO International Health Regulations (IHR) (2005), for example, reflect our less effective way of approaching the issue–it is generally triggered once an outbreak occurs. The GVP can help identify dangerous viruses before they spill over to humans. While the IHR’s relevance and utility to addressing infectious disease outbreaks should not be dismissed or undermined, it is important to think beyond the IHR and embrace legal and policy instruments that would support the work of the GVP.
The WHO Pandemic Influenza Preparedness (PIP) Framework represents an approach that better aligns with what GVP hopes to achieve. Now, the PIP Framework is limited to pandemic influenza, meaning to “rare and unpredictable event” arising from “a new influenza virus … to which people have no pre-existing immunity”; however, it addresses the very issue that will determine the success of the GVP and its significance in the greater context of pandemic preparedness: virus sharing. By bringing a range of stakeholders together, including the private sector, the PIP Framework works to “improve and strengthen the sharing of influenza viruses with human pandemic potential” and “increase the access of developing countries to vaccines and other pandemic related supplies.” This instrument is a response to our realization that the effectiveness of vaccines largely depends on the sharing of viruses that more often than not emerge in countries that cannot afford or access vaccines.
Many of us may recall Indonesia’s refusal in 2007 to provide virus samples of H5N1, a strain feared to give rise to an influenza pandemic, to protest the use by pharmaceutical companies in developed countries of virus samples freely provided by disease-stricken countries (usually developing countries) in order to develop vaccines, diagnostics, and therapeutics, which would later be sold to the same countries at unaffordable prices. The Convention on Biological Diversity (CDB) was the legal foundation on which Indonesia claimed sovereign control over its H5N1 virus samples, interpreting them as “biological resources” found in its territory. Under Article 2 of the CBD, “biological resources” include “genetic resources, organisms or parts thereof, populations, or any other biotic component of ecosystems with actual or potential use or value for humanity.” The same article defines “genetic resources” as “genetic material of actual or potential value” and “genetic material” as “any material of plant, animal, microbial or other origin containing functional units of heredity.” What is more, Article 15 of the CBD provides not only that “the authority to determine access to genetic resources rests with the national governments and is subject to national legislation,” but that “access to genetic resources shall be subject to prior informed consent of the Contracting Party providing such resources,” which “shall be on mutually agreed terms.” Therefore, underlying it all was a call for greater equity and trust within the system.
Taking into account these concerns over virus sharing, through a global partnership built on equity and trust that includes all stakeholders from the get-go and a thorough understanding of the legal and political implications of virus sharing, the GVP can help avert serious obstacles to the development of countermeasures that are to emanate from this initiative.
Learn more about the GVP: