The biopharmaceutical industry has been at the forefront of the response to the current pandemic and, as a result, is uniquely positioned to contribute to future pandemic preparedness discussions. We welcome the opportunity to comment on this white paper and stand ready to contribute with the private sector’s expertise as the INB’s work progresses.
Given the limited time, we will focus our comments on three points:
Access to pathogens
Our ability to prepare for and respond to pandemics swiftly rests on improved global pathogen surveillance, immediate samples and data sharing, and the scientific community’s ability to collaborate efficiently to detect and understand new threats. Any delay in this process also impacts the development and delivery of vaccines, therapeutics, and diagnostics. Any system should effectively address the potentially negative impact on response timing from access and benefit-sharing (ABS) legislation, while ensuring the equity and access to medical countermeasures discussion is decoupled from the sharing of either samples or sequences. We believe this issue should be addressed under “capacities and systems strengthening” under 3.12[i] rather than under equity as proposed in 1.14.[ii]
Intellectual property and transfer of technology
The instrument should rely on the private sector’s strengths for R&D, manufacturing, and distribution, which can only be achieved through a robust intellectual property system. We encourage the instrument to focus on lessons learned and what works well, such as to “Facilitate technology diffusion and encouraging voluntary participation in technology sharing platforms” (point 22). We firmly believe that waiving of IP under 1.3[iii] is harmful and would undermine both innovation and efforts towards equitable access.
Governance and subsidiarity
While global coordination is fundamental, tasks and decision-making processes that are more efficiently performed nationally or regionally should remain at these levels. A future PPR system should build on already-existing infrastructures and, in respect of the principle of subsidiarity, be the reference instrument to coordinate at the global level only what cannot be more efficiently achieved regionally or nationally. We believe that while the World Health Organization would have a key role to play here, it should not be set within a command-and-control type structure. Therefore, we urge careful consideration of the role of different players when defining the governance arrangements to be discussed in 2.3.[iv]
IFPMA has recently released a report on Applying Lessons Learned from COVID-19 to Create a Healthier, Safer, More Equitable World. As the INB work advances, we encourage delegates to reflect on some of the lessons identified.
[i] 3.12 Enhancing national capacity for pathogen and genomic sequencing and its sharing for rapid pandemic risk assessment and global alert.
[ii] 1.14Rapid, regular and timely pathogen and genomic sequence sharing and related benefit sharing, including for the development and use of diagnostics, vaccines and therapeutics.
[iii] 1.3 Access to technology and know-how, in connection with epidemic and pandemic countermeasures without imposing legal or financial obligations, including time-bound waivers of intellectual property.
[iv] 2.3 Establishing appropriate governance arrangements to address and support pandemic prevention, preparedness and response, rooted in the WHO Constitution