Access by Design, Benefits if Convenient: A Closer Look at the Pandemic Influenza Preparedness Framework's Standard Material Transfer Agreements.

Policy Points Securing access to pathogen samples for research purposes is crucial for pandemic preparedness and responding to infectious disease outbreaks. The Pandemic Influenza Preparedness Framework (PIP Framework) is the only pathogen-specific international access and benefit-sharing (ABS) instrument. This analysis reveals that during an influenza pandemic, the PIP Framework will safeguard access to virus samples but may not be as effective in delivering the associated benefits, like vaccines and antivirals, to countries in need. The PIP Framework's deficiencies must be addressed before an influenza pandemic and before this ABS model is extended to other human pathogens. CONTEXT: The World Health Organization (WHO) adopted the Pandemic Influenza Preparedness Framework (PIP Framework) after being forced to grapple with the demands of developing countries for the fairer distribution of vaccines and antivirals created using influenza viruses isolated from within their territories. Though adopted as a nonbinding resolution, the PIP Framework has been praised for its novel legal approach to access and benefit-sharing (ABS), using Standard Material Transfer Agreements (SMTAs) to create binding terms and conditions on both providers and users of PIP biological materials. The PIP Framework's SMTA1 regulates the movement of influenza viruses with human pandemic potential through the WHO's Global Influenza Surveillance and Response System (GISRS) as it operates to monitor the spread of seasonal influenza and detect the emergence of pandemic strains. Member States give consent to the WHO to transfer their materials to third parties under the terms of a negotiated SMTA2. The SMTA2 details benefits such as vaccines and antivirals to be made available to the WHO for distribution in the event of an influenza pandemic. METHODS: I analyzed the PIP Framework, its SMTAs, and secondary sources to determine whether the PIP Framework will effectively function as an ABS instrument during an influenza pandemic. FINDINGS: The SMTAs do not create any direct or binding agreements between Member States and third-party recipients of influenza viruses. In the lead-up to and during a pandemic, the SMTA1 secures access to influenza viruses for the WHO, and the SMTA2 secures access for commercial users of virus samples, but the SMTA2 may be ineffective in securing tangible benefits for the sovereign providers of those materials. CONCLUSIONS: As the international community starts to consider how to best regulate access to nonpandemic influenza pathogen samples, it is imperative that we first address the shortcomings of the only pathogen-specific international ABS instrument available, and we should do so before it is put to the ultimate test.

Never Mind the Science, Here's the Convention on Biological Diversity: Viral Sovereignty in the Smallpox Destruction Debate.

Since the eradication of smallpox was declared in 1980, debate has ensued over what to do with the remaining stocks of the causative agent, variola virus. For more than three decades the World Health Organization has resolved to destroy the virus isolates, now maintained in high-security laboratories in the Russian Federation and the United States, and each time the deadline has been deferred. The legal facets of this debate have been largely overlooked. As genetic resources, all viruses fall within the scope of the United Nations' Convention on Biological Diversity (CBD) that provides for the fair and equitable sharing of the benefits arising out of the utilisation of genetic resources. This article examines the possible ownership scenarios for variola viruses and concludes that the conservation principles of the CBD and the ambiguous sovereign status of individual isolates may preclude the destruction of the world's remaining variola stocks.

Who Are Indigenous and Local Communities and What Is Traditional Knowledge for Virus Access and Benefit-sharing? A Textual Analysis of the Convention on Biological Diversity and Its Nagoya Protocol.

The United Nations' Convention on Biological Diversity (1992) (CBD) has become the focal point for the regulation of traditional knowledge (TK) held by indigenous and local communities (ILCs). The legally binding CBD is bolstered by a supplementary, non-binding agreement, The Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization (2010) (Nagoya Protocol). Both instruments create the conditions for the access and benefit-sharing (ABS) of genetic resources, and for TK associated with those resources. There has been no consideration as to how TK might factor into virus ABS arrangements. Most of the literature on these issues relates to how the TK provisions of the CBD and Nagoya Protocol should be implemented; there is little guidance as to how to interpret the text itself. This article provides a textual analysis of all provisions of the CBD and Nagoya Protocol that relate to TK and the interests of ILCs. The analysis clarifies the differences in scope between the two instruments and will provide some insights as to how to interpret key terms, particularly indigenous and local communities, traditional knowledge and traditional knowledge associated with genetic resources. This is critical to understanding the obligations that apply to accessing virus samples that are regulated as genetic resources under the CBD.

Persistence of multiple genetic lineages within intrahost populations of Ross River virus.

We examined the structure and extent of genetic diversity in intrahost populations of Ross River virus (RRV) in samples from six human patients, focusing on the nonstructural (nsP3) and structural (E2) protein genes. Strikingly, although the samples were collected from contrasting ecological settings 3,000 kilometers apart in Australia, we observed multiple viral lineages in four of the six individuals, which is indicative of widespread mixed infections. In addition, a comparison with previously published RRV sequences revealed that these distinct lineages have been in circulation for at least 5 years, and we were able to document their long-term persistence over extensive geographical distances.