The Pandemic Influenza Preparedness Framework as a ‘specialized international access and benefit-sharing instrument’ under the Nagoya Protocol

The World Health Organization (WHO) is starting to come to terms with the public health implications of the United Nations’ Convention on Biological Diversity (CBD) and its supplementary Nagoya Protocol about genetic resource access and benefit-sharing (ABS). Since 2017 there have been calls to recognize the WHO’s Pandemic Influenza Preparedness (PIP) Framework as a specialized international ABS instrument under the Nagoya Protocol. This article will examine whether the PIP Framework meets the criteria of a specialized international ABS instrument as laid out in a 2018 study commissioned by the Subsidiary Body on Implementation to the CBD (CBD/SBI/2/INF/17). Our analysis concludes that while the PIP Framework meets the specialization criteria, it fails to meet the supportiveness criteria and does not provide legal certainty for pandemic influenza virus ABS. Furthermore, we demonstrate that recognition of the PIP Framework as a specialized instrument would not mean that the CBD and Nagoya Protocol no longer apply to influenza viruses with human pandemic potential as has been asserted, rendering the relationship between the three international agreements unclear. As the WHO grapples with how to regulate access to other (non-influenza) human pathogens and the fair and equitable sharing of benefits associated with their use, a full appreciation of what ABS means when applied to pathogens is essential.