Who Owns Smallpox?: The Nagoya Protocol and Smallpox Virus Retention

Overview by: Morasa Shaker, GMU Biodefense graduate student

Who Owns Smallpox?: The Nagoya Protocol and Smallpox Virus Retention
By Center for the Study of WMD
Spotlight Speaker: Michelle Rourke

It is more than likely that most people would not be opposed to efforts conserving the critically endangered Borneo elephant found on the island of Borneo in Sabah, or the Radiated Tortoise near extinction on the island of Madagascar. However, it would take a lot more convincing to reach a unanimous consensus that we should conserve a fatal virus. While the case can be made that endangered species pose an intrinsic value to the world’s genetic diversity, it is has proven less feasible to make the same case for a virus, specifically the variola virus—the causative agent of smallpox. Nevertheless, Michelle Rourke, a Fulbright scholar at Georgetown University’s O’Neill Institute for Domestic and Global Health Law, led an in-depth educational seminar organized by the Center for the Study of Weapons of Mass Destruction to support that very case—the smallpox virus is worthy of our conservation efforts.

This discussion, based on her article “Never Mind the Science, Here’s the Convention on Biological Diversity: Viral Sovereignty in the Smallpox Destruction Debate,” published in the Journal of Law and Medicine, addressed the smallpox virus retention controversy that has ensued since the disease was declared eradicated in in 1980. Rourke, a PhD candidate at Griffith Law School in Nathan, Australia, found it increasingly more difficult to access virus samples for research purposes while studying both dengue viruses and Ross River virus. These major hindrances in her studies served as the context for her research on the international law around ‘who owns virus samples’ and then using those principles of international law and extending them to a specific case: Who owns the smallpox stocks maintained in the Centers for Disease Control (CDC) in the United States in Atlanta, GA and in Koltsovo, Russia?

Since the declaration of the eradication of smallpox, the World Health Organization (WHO) has debated the merit of destroying the variola virus isolate stocks for over thirty years, deferring the decision to destroy the last remaining stocks each time. In large, the implication of this reticence has been passive conservation of the smallpox virus. Rourke discussed how the legal aspects of the smallpox conservation controversy have been overlooked. She reasoned that the samples of the smallpox virus in the United States and Russian repositories are classified as genetic resources under the Convention on Biological Diversity (CBD). Entered into force in 1993, the CBD and has a universal acceptance of 196 parties with the notable exception of the United States. Its objectives are[1]:

1. “the conversation of biological diversity…”
2. “the sustainable use of its components…”
3. “the fair and equitable sharing of the benefits arising out of the utilization of genetic resources…”

The third objective has been consequential in unexpected ways since the implementation of this conservation framework treaty. This is because the CBD attempts to link the conservation of biological materials financially to the genetic resources, creating a market mechanism that is intended to encourage the sustainable use of biodiversity rather than the more incentivized short-term exploitation. Furthermore, it creates a financial mechanism through the principle of resource sovereignty and recognizes the sovereign rights of states over its natural resources. In effect, this essentially sets up a transaction, based on a platform known as Access and Benefit Sharing (ABS), in genetic resources between the country of origin who owns those genetic resources and states and/or individuals who want to use them. While ABS does not appear in the CBD, it has become shorthand for access to genetic resources and the benefits associated with their use. What exactly are genetic resources? Genetic resources are defined as “genetic material of actual or potential value”, and “genetic material means any material of plant, animal, microbial or other origin containing functional units of heredity.”[2]

The relation of the CBD, genetic resources, and ABS come into play with viruses when we acknowledge that viruses are starting to be seen as commodities. The leading narrative surrounding human relationships with viruses is that viruses do harm and humans attempt to ameliorate their effects, or eradicate them, and because of this and CBD, no one had previously thought of viruses in terms of conservation. Historically, there had been no desire to regulate them for any reasons other than for biosecurity or biosafety purposes at the international or national level. However, Rourke informed that in some ways, viruses could be distinguished as raw, naturally occurring resources—owned, collected, traded, stored, and used as marketable assets. Further, viruses can be de-materialized, meaning they can be extracted from their raw state and expressed in the form of genetic sequence data, and that genetic sequence data can be also be traded as a commodity.

Rourke noted that even though CBD has been around for over two decades, viruses had not been considered for conservation until the CBD was applied to viruses for the first time in 2007 when Indonesia claimed sovereignty over the H5N1 influenza viruses that were circulating their territory and borders. Using Indonesia’s example, Rourke urged that in recognizing viruses are being traded as commodities and being cognizant of the real world effects, we need to ask these contentious, yet critical questions about the countries providing emergency response, yet also transporting those virus samples back to their own home country: Do they have the right to take those viruses out of the country without agreement? Who do those viruses belong to—the emergency response countries or the country of origin? Who has the right to claim intellectual property of those viruses? Should countries be remediated for the use of those virus samples?

Citing the CBD as legal justification for withholding their H5N1 influenza virus samples from WHO, Indonesia’s argument was that developing countries were freely providing their sovereign viruses, or their genetic resources, and WHO was passing those viruses to commercial companies in developed countries who used the virus to market those vaccines back to Indonesia and other developing countries at unaffordable prices. Indonesia wanted benefits like vaccines and antivirals from the West in exchange for their genetic resources. Although Indonesia was widely condemned by the West for this issue, Rourke emphasized that in terms of international law, viruses are genetic resources within the scope of the CBD.

From a scientific standpoint, viruses have major implications for synthetic biology and the genetic revolution. Some viruses have been genetically sequenced, providing a surplus of genetic information that could ultimately be used to combat future infectious diseases. Rourke stated that virus samples have been essential to the development and testing of vaccines, medical countermeasures, and in our understanding of how the human immune system operates. Given that viruses are a library of genetic information, and there are still missing components of that library that scientists cannot understand, the conservation of smallpox as a pathogenic genetic resource is vital to our understanding and knowledge of the emergence and evolution of future diseases.

Rourke highlighted that although the application of the CBD does not provide conclusive answers to the controversy around the destruction of the remaining stocks of smallpox, it does provides a new lens from which to approach an ongoing debate. She noted that while the ownership rights of the variola virus stocks are ambiguous, in terms of international law and the CBD, the United States and Russian repositories still have a legal obligation to abide by the sovereignty of those countries that may posses a rightful claim to the remaining variola virus.

[1] Convention on Biological Diversity [1993] ATS 32, Art 1.

[2] (World Intellectual Property Organization 2018)