2022-05-11-世界卫生组织-Report_from_the_C-TAP_Technical_Advisory_Group_to_the_WHO_C-TAP_Secretariat_on_NIH_licenses_6页_237kb

WHO C-TAP TAG Assessment of NIH Licenses

Key Recommendations & Findings

1. Agreement with Principles

• NIH licenses broadly align with C-TAP objectives and Solidarity Call principles.
• Suggested improvements needed for equitable pricing and LMIC access in follow-on amendments.

2. Notable Changes Integrated

• Public sector entities included in licensing terms alongside private entities.
• License transfer hub referenced C-TAP concept paper instead of prior commercial plan.
• Clarified NIH’s non-filing intention for low-middle and low-income countries only during PCT national phase.

3. License Assessment Details

NIAID & IC Agreement:

❌ Criticisms:

• Preferential royalty tiers not extending to low and middle-income countries.
• US local production requirements limiting market competition.
• High benchmark payments ($425k-$475k) before regulatory approval creating barriers for LMIC manufacturers.

✅ Positive Aspects:

• Global non-exclusive and royalty-free access to least developed countries.
• No patent filing in low-middle and low-income countries.

3. Further Recommendations:

• Engage NIH/US institutions to explore further technologies through C-TAP.
• Consider adopting dual royalty systems for public vs private entities in LMICs.
• Reduce benchmark fees to enable wider participation by LMIC firms.
• Leverage BARDA, NIH centers (e.g., NCATS) to strengthen COVID-19 R&D pathways through transfer.