Pathogen Access and Benefit-Sharing System (PABS)

The Pathogen Access and Benefit-Sharing System (PABS) is a global framework adopted by the World Health Organization (WHO) in 2024 to ensure equitable access to and use of pathogen materials and associated information, while fairly distributing the benefits arising from their use. The system seeks to balance the need for rapid sharing of pathogen data for public health security with the principles of fairness, equity, and sovereignty of nations over their biological resources. It is particularly aimed at improving preparedness and response to pandemics and epidemics through structured and transparent sharing mechanisms.

Background and Rationale

The creation of the PABS system stems from the global experience during the COVID-19 pandemic, when the sharing of virus samples, genetic sequences, and related data became a crucial factor in the rapid development of vaccines and diagnostics. However, unequal access to these medical countermeasures revealed deep disparities between high-income and low- and middle-income countries.
The issue of pathogen sharing has long been linked with the Convention on Biological Diversity (CBD) and its Nagoya Protocol (2010), which assert that countries have sovereign rights over their biological resources, including pathogens found within their borders. However, the application of the Nagoya Protocol to pathogens created challenges for rapid outbreak response, as the bureaucratic procedures could delay access to critical samples needed for global health research.
To address these issues, the WHO initiated negotiations to establish a Pathogen Access and Benefit-Sharing System under its framework for pandemic prevention, preparedness, and response. The new system was formally endorsed in May 2024 during the World Health Assembly (WHA), as part of ongoing efforts to strengthen the WHO Pandemic Agreement.

Objectives of the PABS System

The PABS system is designed with the following core objectives:

• To facilitate timely, transparent, and equitable sharing of pathogen materials and genetic sequence data relevant to public health emergencies.
• To ensure fair and equitable benefit-sharing, including access to vaccines, therapeutics, diagnostics, and other countermeasures derived from shared materials.
• To safeguard national sovereignty over pathogen resources while promoting global solidarity and cooperation.
• To strengthen global preparedness by enabling rapid scientific collaboration and innovation.

Through these objectives, the system seeks to bridge the divide between pathogen sharing for global security and benefit distribution for national and regional equity.

Structural Framework

The PABS system is administered under the authority of the World Health Organization, with participation from Member States, research institutions, industry partners, and international health organisations. Its framework consists of two main pillars:

1. Access Component:
   • Facilitates rapid and secure sharing of pathogen samples and related genetic sequence data.
   • Utilises a network of WHO-recognised laboratories and biorepositories known as WHO Pathogen Access Nodes (PANs).
   • Establishes standardised data-sharing agreements and material transfer arrangements to ensure traceability and responsible use.
2. Benefit-Sharing Component:
   • Ensures that countries providing pathogen samples receive equitable benefits derived from their use.
   • Benefits may be monetary (e.g., financial contributions to global health funds) or non-monetary (e.g., access to vaccines, technology transfer, training, or diagnostic tools).
   • Includes mechanisms for advanced purchase commitments and reserved supplies of medical countermeasures for participating countries during health emergencies.

Legal and Ethical Foundations

The PABS system aligns with international legal instruments while adapting them to the realities of modern public health. It builds upon:

• The International Health Regulations (IHR, 2005), which obligate countries to notify and share information on disease outbreaks.
• The Nagoya Protocol on Access and Benefit-Sharing, ensuring respect for national sovereignty and fair benefit distribution.
• The WHO’s Pandemic Influenza Preparedness (PIP) Framework (2011), which served as a prototype for the PABS model.

Unlike the PIP Framework, which focused specifically on influenza viruses with pandemic potential, the PABS system applies to all pathogens with pandemic or epidemic potential, including viruses, bacteria, fungi, and other emerging infectious agents.

Implementation and Operation

Under the PABS mechanism:

• Member States designate national focal points to manage pathogen submission and benefit negotiation processes.
• Research institutions and laboratories contribute pathogen samples and sequence data to the system through approved channels.
• Private sector partners, particularly pharmaceutical companies, are required to commit to fair-sharing principles in exchange for access to PABS data and materials.
• A Global Benefit Fund is established to manage monetary contributions and to finance preparedness initiatives in low-income countries.

Operational transparency is ensured through a digital tracking platform, enabling all stakeholders to monitor pathogen movements, research usage, and benefit allocation.

Types of Benefits under PABS

The benefits shared under the PABS framework can be classified into the following categories:

• Access to Countermeasures: Priority allocation of vaccines, antivirals, and diagnostics developed using shared pathogen materials.
• Technology Transfer: Sharing of manufacturing know-how, laboratory technologies, and production capacities with developing nations.
• Capacity Building: Training of scientists, strengthening of laboratory infrastructure, and support for bioinformatics and genomic research.
• Financial Mechanisms: Contributions to global or regional health funds dedicated to pandemic preparedness, surveillance, and response.
• Data and Knowledge Sharing: Open access to non-proprietary research findings and pathogen genomic databases.

Global Implications and Significance

The establishment of the PABS system represents a major step toward creating a more equitable global health architecture. It ensures that while the world benefits from rapid scientific collaboration, countries that provide pathogen materials also receive tangible and fair returns.
The system enhances trust and cooperation among nations by institutionalising fairness and transparency in pathogen sharing. It also strengthens early warning systems by enabling faster detection and analysis of novel pathogens through global data networks.
From a public health perspective, the PABS framework aims to:

• Accelerate the development of diagnostics and vaccines during outbreaks.
• Reduce inequity in the distribution of medical products.
• Encourage participation by all countries, including those with limited scientific capacity.

Challenges and Criticisms

Despite its potential, the PABS system faces several practical and political challenges:

• Complex negotiation processes between countries and private sector entities over benefit-sharing terms.
• Intellectual property (IP) rights disputes related to the use of shared pathogen materials in vaccine and drug development.
• Data sovereignty concerns, particularly regarding digital sequence information (DSI), which may be used without physical sample transfer.
• Implementation capacity gaps in low-income countries that may struggle with regulatory or technical compliance.
• Enforcement mechanisms, as compliance with benefit-sharing commitments by private industry remains largely dependent on transparency and goodwill.

Addressing these issues requires continuous dialogue and global cooperation to ensure the system remains both effective and fair.

Relationship with Other Global Frameworks

The PABS system complements existing global health frameworks and contributes directly to:

• The WHO Pandemic Accord, which aims to establish a comprehensive agreement on pandemic prevention and response.
• The Global Health Security Agenda (GHSA), enhancing preparedness through international collaboration.
• The One Health approach, linking human, animal, and environmental health in managing pathogen risks.

It also aligns with the Sustainable Development Goals (SDGs), particularly Goal 3 (Good Health and Well-being) and Goal 17 (Partnerships for the Goals).

Future Outlook

As the world faces growing risks of emerging infectious diseases, the PABS system is expected to play a pivotal role in strengthening global pandemic governance. Future development of the system will focus on improving digital infrastructure for sequence data sharing, increasing transparency in benefit allocation, and ensuring that every country has the capacity to both contribute to and benefit from global pathogen-sharing efforts.