WHO Pandemic Agreement offers opportunities and risks for American innovators

The World Health Organization (WHO) recently released negotiating text for the WHO Pandemic Agreement, which seeks to establish a global consensus on how to strengthen pandemic prevention, preparedness and response. The biopharmaceutical industry is committed to working with policymakers, at the WHO and elsewhere, to apply our lessons learned during COVID-19 and ensure that global agreements support the research, development and delivery of lifesaving treatments and vaccines. 

Significant portions of the WHO text would advance global health and pandemic readiness, while other sections would centralize WHO’s role in the research and development (R&D) and manufacturing of vaccines and therapeutics in which it has no expertise or mandate. Here’s what the current draft gets right and wrong: 
 
Efforts that Support Global Health and Innovation

• The draft promotes a multifaceted “One Health” approach for preventing and protecting global health in the face of emerging crises including through enhancing disease surveillance at the human-animal-environment interface for the detection and reporting of infectious disease threats across nations, regions and the world.
• The draft calls on countries to strengthen their health care workforce and health systems in order to increase countries’ routine and emergency response capabilities.
• Additionally, the text aims to empower national and regional regulatory authorities to expedite authorization for pandemic-related products through harmonization.
• The text also highlights the critical need to enhance science and public health literacy to help combat misleading or false health information. 

Measures that Undermine Biopharmaceutical Innovation and Collaboration

• Provisions call for linking pathogen sharing with access to medical countermeasures and monetary benefits, centered through the WHO, which could slow access for researchers and dissuade new scientists from entering infectious disease research.
• The current text outlines worrisome proposals that will stifle scientific innovation, including automatic “time bound waivers of intellectual property rights” and mandating the use of TRIPS flexibilities that strip innovators of intellectual property rights.
• The text centralizes the WHO in highly complex supply chains for vaccines and therapeutics manufacturing — a role in which it has no expertise or access to the data around which to make critical, timely and costly decisions that can impact non-pandemic medicines, products and lives.
• The draft also calls for blanket transparency of government-funded R&D agreements and forced technology transfer and know how, which pose significant risks to trade secrets, especially for small and medium sized companies that are more likely to seek public funding for R&D. 

Several countries from across different income levels have continuously advocated to engage the key private sector stakeholders in discussions around the Pandemic Agreement in order to learn what worked in COVID-19, what didn’t work and how a more equitable access to vaccines and therapeutics can be managed for the next health emergency. To date, those calls for private sector inclusion have gone unanswered. 

America’s biopharmaceutical companies met a once in a generation challenge by delivering safe and effective COVID-19 vaccines and treatments to patients in record time. The biopharmaceutical industry is committed to improving global health during interpandemic and pandemic periods and has much knowledge to contribute. Leaders should use the lessons learned from the COVID-19 pandemic and lean on policies that allow for innovation to deliver on our shared goal of collaborating to protect public health.