On pathogens and PIP: why lawyers should really care about mutating viruses
Michelle Rourke and Mark Eccleston-Turner
Thanks to the Delta and Omicron variants of SARS-CoV-2, the virus that causes Covid-19, most people now have some idea of what a virus variant is and why it is so important to keep tabs on how viruses mutate and evolve as they spread through their host population.
Scientists track these changes by taking specimens from infected hosts and sequencing the viral genetic material. They then compare the sequences of new virus samples to known virus sequences to see what changes have occurred. Virus variants of concern might arise due to changes in sections of the viral genome that control for host range, transmissibility, or disease severity.
But a lot of countries don’t have the technological capacity to conduct genetic sequencing, so virus samples from poorer nations are often sent to wealthier ones with genetic sequencing capability. When a variant of concern is discovered, many scientists around the world want to obtain isolates (copies of the sample) on which to conduct further research. This includes biotechnology and pharmaceutical companies that run experiments to ensure their existing diagnostic kits and vaccines work against the new variant. If not, they will need those samples to develop new diagnostics and vaccines to get out to market as quickly as possible. This makes virus samples valuable commodities that are vital inputs to public health surveillance, infectious disease research and emergency response.
In 2006, the World Health Organization (WHO) was keeping a close eye on the H5N1 avian influenza virus variants circulating in Indonesia that appeared to be evolving the ability to transmit between humans. The WHO had been receiving influenza virus samples from around the globe and then sharing those samples informally between various influenza laboratories and with pharmaceutical companies. That year the Indonesian government highlighted the fact that the rich nations of the Global North were expecting to receive virus samples free of charge from the Global South with which to make vaccines, but were not similarly making those vaccines available at a fair and reasonable price to those most in need. They stated that viruses were ‘genetic resources’ under the United Nations’ Convention on Biological Diversity (CBD 1992). One of the core objectives of this widely adopted environmental conservation treaty is the ‘the fair and equitable sharing of the benefits arising out of the utilization of genetic resources’, and vaccine development can be considered utilisation of genetic resources.
Indonesia refused to send its samples to the WHO until its sovereign rights over viruses were recognised. Under the CBD, the use of genetic resources in research and development requires the prior informed consent of the provider (e.g. Indonesia) and the provider and user parties must come to mutually agreed terms about how the genetic resources are to be used and how the benefits generated will be shared. This is a policy known as access and benefit-sharing (or ABS), which is short for ‘access to genetic resources and the fair and equitable sharing of the benefits associated with their use in research and development’.
This standoff between Indonesia (and other countries of the Global South) and countries (and industries) of the Global North ended in 2011 with the adoption of the Pandemic Influenza Preparedness Framework (PIP Framework) by the World Health Assembly. The PIP Framework ‘recognize[d] the sovereign right of States over their biological resources’ and outlined multilateral ABS terms for the exchange of influenza virus samples with human pandemic potential between provider nations and third-party users (like pharmaceutical companies), all mediated by contracts with the WHO.
While the PIP Framework has been praised as an innovative way to bind non-state actors to what is a non-binding resolution of the World Health Assembly, it was also criticised as a band-aid measure due to its extremely narrow scope. The PIP Framework only applies to ‘the sharing of H5N1 and other influenza viruses with human pandemic potential’. This means that all other types of viruses, including seasonal influenza viruses and SARS-CoV-2 viruses, are covered by the CBD and its supplementary Nagoya Protocol on Access and Benefit Sharing (Nagoya Protocol 2010), a binding agreement that was negotiated at the same time as the PIP Framework.
There is little clarity as to the relationship between the PIP Framework and the international ABS regime created by the CBD and Nagoya Protocol. For instance, even with the adoption of the PIP Framework, nations can still choose to share their pandemic influenza virus samples with pharmaceutical companies on a bilateral basis, in accordance with their domestic laws implemented under the CBD and Nagoya Protocol, cutting the WHO out of the ABS equation. This has led to suggestions for the PIP Framework to be recognised under the Nagoya Protocol as a specialised international ABS instrument. The thinking being that recognition as a specialised instrument would result in the disapplication of the Nagoya Protocol for all pandemic influenza viruses and will therefore increase legal clarity for provider and user parties.
Our recent article in the Northern Ireland Legal Quarterly, examines whether the PIP Framework would qualify as a specialised international ABS instrument based on criteria developed in 2018. In doing so, we found that the recognition of the PIP Framework as a specialised ABS instrument would not create the legal certainty that some think it will. This is because it could only ever result in the disapplication of the Nagoya Protocol for the specific pandemic influenza virus samples that countries choose to share with the WHO under the terms of the PIP Framework. The CBD and Nagoya Protocol will continue to operate in the background as the default ABS mechanism for pandemic influenza, and all other viruses. Recognition, then, becomes a symbolic rather than a legal gesture.
The WHO has now moved to start negotiating a Pandemic Treaty that is likely to include terms about access to pathogen samples and associated information (including genetic sequence data), as well as access to medical countermeasures (including diagnostics and vaccines). We hope that the provision of medical countermeasures will not be contingent upon the provision of pathogen samples and associated data in any way, and instead be grounded in public health need and justice. Access to pathogen samples and access to medicines are two activities that need not be linked using the ABS transaction, indeed, we think that linking them leads to inefficiencies in both. Either way, the Pandemic Treaty will need to grapple with the fact that nations have sovereign rights over their viruses and other pathogen samples. Our analysis shows that it is vital that the negotiators of the Pandemic Treaty take into account how that instrument will interact with the international ABS regime created by the CBD and Nagoya Protocol in order to be effective.