艾昆纬-低分子量药物的关键准入途径和瓶颈（英）-2025.6_32页_2mb

SBIOVIA Institute for Human Data Science - Key Access Pathways and Bottlenecks for Medicines in LMICs

Report Summary

• Objective: To analyze bottlenecks and access pathways for medicines in low- and middle-income countries (LMICs), crucial for global health equity and outcomes.
• Countries Analyzed: 18 LMICs.
• Medicines Studied:
  • Recently Launched: 593 medicines (novel active substances).
  • Established: 477 drugs from the 2023 WHO Essential Medicines List (excluding recent launches).
• Key Findings:
  1. Global Burden: LMICs house 82% of the world's population, bearing a significant disease load (both communicable and non-communicable).
  2. Medicine Focus: Most recently launched medicines target NCDs (70%), aligning with the high mortality rate (55% in LMICs) in this category.
  3. Access Challenges: Despite data limitations, significant barriers exist, including regulatory hurdles, reimbursement difficulties, supply chain inefficiencies, and poor national infrastructure.
  4. Registration: Recently launched medicines are poorly registered in LMICs (average <20%). Brazil and Mexico show relative success. Established medicines registration is much higher (~100 registrations per country).
• WHO EML & Procurement Lists: A small percentage of recently launched (5%) and fewer established medicines appear on these key global and regional lists.
• National Levels (NEMLs, Reimbursement, Registration, Sales):
  • NEMLs: Contain very few recently launched medicines (max. ~10). They are infrequently updated.
  • Reimbursement: Recently launched medicines are rarely or insufficiently covered by reimbursement lists. Established medicines fare better.
  • Registration: Data quality and access vary by country, with scarce information overall for new drugs.
  • Sales: Recent launches reach countries but very limited numbers, sales share, and access compared to established medicines.
• Therapeutic Areas: Oncology, NCDs, and infectious diseases (especially for recently launched HIV treatments) show leadership across access metrics.
• Recommendations: Address healthcare infrastructure, update national lists, overcome reimbursement barriers, improve data availability, and foster cross-country collaboration within the framework of Sustainable Development Goals (SDGs). Urgent action is needed to improve the disparity between ambition and reality in medicine access globally.