By Michelle Rourke
Griffith Law School
Return readers of the LFC blog will already be aware that the international legal regimes for accessing genetic resources for scientific research and development are constantly evolving and extremely complex. This is certainly the case for a uniquely dangerous subset of genetic resources: influenza viruses with human pandemic potential.
The World Health Organization (WHO) has overseen a global network of influenza surveillance laboratories for nearly 70 years. These labs use viruses isolated from the sputum samples of influenza patients from around the world to track the severity and evolution of influenza viruses, recommend which strains should be included in influenza vaccines and generate risk assessments about the next influenza pandemic.
Since 2011, the international transfer of influenza virus samples through this network of laboratories has occurred under the provisions of the WHO’s Pandemic Influenza Preparedness Framework (PIP Framework). This non-binding resolution applies to the sharing of influenza viruses with pandemic potential and was designed to provide a transparent legal mechanism for the fair and equitable sharing of benefits associated with the use of those viruses, like vaccines and antivirals. It’s essentially a highly specialised access and benefit-sharing instrument!
Like other international access and benefit-sharing instruments (the Convention on Biological Diversity, its Nagoya Protocol and the Food and Agriculture Organization’s Plant Treaty) the PIP Framework recognises the sovereign rights of nation states over their genetic resources. For viruses, this means that the countries from which a virus sample was isolated has the sovereign authority to determine how and by whom that sample is utilised. Countries are exercising their sovereignty by choosing to share viruses through the WHO’s network of influenza laboratories under the provisions of the PIP Framework.
My analysis of the contracts that give legal effect to the virus access and benefit-sharing provisions of the PIP Framework was published in The Milbank Quarterly earlier this year. It shows that during an influenza pandemic, the PIP Framework is likely to secure access to necessary virus samples, but highly unlikely to secure the promised benefits for countries in need. That is, in practice the PIP Framework only upholds one side of the access and benefit-sharing bargain!
The concern is that if countries feel that the PIP Framework is unable to secure promised benefits like vaccines and antivirals, then they may feel they are better able to protect their populations from an influenza pandemic by conducting the access and benefit-sharing transaction outside of the remit of the multilateral PIP Framework. This means that countries may opt to cut out the middleman — the WHO — to transfer influenza samples directly to third parties (like vaccine manufacturers) that are willing to pay for them. This would undermine the entire global surveillance system that has been vital to monitoring and responding to the threat posed by influenza!
The bigger problem may well be that the WHO and some of its member states are starting to consider applying this flawed access and benefit-sharing mechanism to the sharing of other human pathogens. The WHO has repeatedly stated that the PIP Framework has been a resounding success, but closer inspection reveals that it will likely fall apart under the pressure of an influenza pandemic: the very event it was supposed to help the world prepare for! More research is necessary to examine the possible avenues for a working system of access and benefit-sharing that can deliver for future pandemics. This is a focus of ongoing research through the CSIRO Future Science Fellowship in Synthetic Biology collaboration at Griffith University and the CSIRO.