Industry welcomes the progress made so far in influenza preparedness, although we wish to call out 3 key policy areas where much work still needs to be done: 1) improving seasonal influenza vaccine coverage, 2) addressing the increasing challenges and barriers being posed by national ABS legislation in accessing pathogen samples, and 3) in finally defining how to declare an influenza pandemic – still an open item at WHO more than 10 years after the last pandemic. It is also essential to ensure that the expansion of GISRS to include SARS-CoV-2 and RSV does not undermine the excellent work being done so far for influenza surveillance.
We are concerned to see that generic antiviral manufacturers are signing voluntary SMTA-2s under the PIP Framework, when for IFPMA, BIO and DCVMN members those are mandatory for access to pandemic influenza virus samples. We ask WHO to clarify why those are not mandatory agreements as well, as this could create a major gap in access to antivirals in the event of a pandemic as the majority of global supply of antivirals is now with generic manufacturers.
Finally, we reiterate our concerns about national ABS legislation continuing to hinder access to physical samples of influenza viruses. This is no longer just ‘a risk’, it is a reality: in 2021 one manufacturer lost 40% of their vaccine production capacity due to the inability to use the best strain for manufacturing, as there was no legal clarity regarding the use of that strain from a certain country. Measures such as potentially expanding the PIP Framework, a non-legally binding instrument, would simply not address such issues, and could weaken the Framework by forcing its reopening for negotiation.
