PABS – Reshaping the vaccine and diagnostics industry

The COVID-19 pandemic has revealed a stark reality: the world’s ability to detect, respond to, and equitably distribute medical countermeasures was deeply inadequate. While a handful of nations secured early access to vaccines, therapeutics, and diagnostics (VTDs), most low and middle-income countries waited for months. This failure is now the central problem the WHO Pandemic Agreement, adopted in May 2025, seeks to correct. At its core is the Pathogen Access and Benefit-Sharing (PABS) framework, a mechanism designed to ensure that countries that share pathogen data also share in the benefits of the health products derived from that data.

For the vaccine and diagnostics industry, it is a structural shift that will reshape manufacturing obligations, market access, and investment priorities for years ahead.

What PABS means for manufacturers
The framework establishes legally binding obligations for participating manufacturers in exchange for timely access to pathogen materials and sequence data. The proposed commitments are significant:

• Allocating 20 percent of real-time production of vaccines, therapeutics, and diagnostics to WHO during a pandemic emergency.
• Donating no less than 10 percent of that allocation, with the remainder made available at affordable prices.
• Engaging in non-monetary benefit-sharing through technology transfer, licensing arrangements, and collaborative research with manufacturers in developing countries.

These obligations are still being finalized through an ongoing Intergovernmental Working Group (IGWG) process. Three areas remain contested: the scope of pathogens covered, the enforceability of manufacturing commitments, and the governance of compliance. Regardless of how these are resolved, the direction is unambiguous – manufacturers operating in the pandemic preparedness space will face greater accountability and allocation expectations than before.

Growth areas for the diagnostics sector
The diagnostics industry stands to gain significantly from the PABS framework. Future pandemic response will be anchored in early detection, which means sustained investment in the tools that enable detection. Demand is expected to accelerate for portable molecular testing platforms, next-generation sequencing technologies, multiplex diagnostics, and technology-driven outbreak analytics. The emphasis on real-time genomic surveillance also creates opportunities in bioinformatics and laboratory automation – areas where Indian companies are actively building capability.

India’s industrial opportunity
India enters this new landscape from a position of strength. Its vaccine manufacturing base, expanding diagnostics sector, skilled scientific workforce, and growing genomic surveillance infrastructure make it a natural anchor for the distributed manufacturing model that PABS encourages. As global health systems deliberately diversify supply chains away from concentrated manufacturing hubs, Indian CDMOs, diagnostics manufacturers, and biotechnology companies are well-placed to win long-term contracts and agreements. The key differentiator will be readiness: companies that have already invested in quality systems, regulatory compliance, and international certifications will have a decisive advantage.

Preparing for what’s coming
The precise text of the PABS Annex is still being negotiated, and final obligations may shift. But the strategic signals are clear. Companies should audit their manufacturing flexibility, assess technology transfer readiness, and engage with industry associations that track the IGWG process. Those who treat PABS as a compliance burden will be outpaced by those who recognise it as an opportunity. The rules are still being written. The time to position is now.

(Views expressed in this article are personal and based on information available in the public domain).