2016-05-14-世界卫生组织-An_R_D_Blueprint_for_Action_to_Prevent_Epidemics_48页_5mb

WHO R&D Blueprint for Action to Prevent Epidemics

The World Health Organization (WHO) developed the R&D Blueprint in 2016 to accelerate research and development (R&D) responses to infectious disease epidemics. The blueprint aims to ensure faster and more effective availability of vaccines, diagnostics, and therapeutics during outbreaks, coordinating efforts globally with a focus on low and middle-income countries (LMICs). It builds on lessons from the 2014-2015 Ebola outbreak and incorporates input from various stakeholders and organizations.

Key Strategies and Components

Three Main Approaches

1. Improving Coordination and Enabling Environment

   • Establishing a global coordination framework to streamline collaboration among stakeholders.
   • Developing innovative funding mechanisms (e.g., pooled financing, joint programming) to address market failures.
   • Promoting transparency and equitable access through open knowledge innovation and delinkage of R&D costs from product prices.

2. Accelerating R&D Processes

   • Prioritizing pathogens and mapping knowledge gaps through the WHO list of top emerging diseases.
   • Creating R&D roadmaps for priority threats (e.g., diagnostics, therapeutics, vaccines) and identifying versatile technology platforms.
   • Streamlining regulatory pathways (e.g., Emergency Use Assessment and Listing) and ethical approvals.

3. Developing Norms and Standards

   • Supporting LMICs through capacity building, fair data and sample sharing, and guidance on collaborative agreements.
   • Anticipating evidence needs to inform policy decisions and regulatory reviews during emergencies.

Additional Initiatives

• Monitoring and Evaluation Framework: To track the Blueprint's impact and outcomes.
• Connections to Other Global Efforts: Complements initiatives like CEPI and GloPID-R to enhance global R&D readiness.

Real-Time Tests and Case Study: Zika Virus

• The Zika outbreak served as a live test for the Blueprint. WHO expedited R&D processes, coordinated studies, and utilized mechanisms like the Emergency Use Assessment and Listing to support diagnostic availability.

Overall Impact

The Blueprint seeks to minimize life loss and economic disruption by fostering global collaboration, sustainable funding, and ethical, efficient R&D. Success depends on coordinated action from stakeholders, ensuring timely and equitable access to medical technologies during health emergencies.