亚开行-斯里兰卡药品供应链评估（英）-2025.3_118页_1mb

报告摘要

Pharmaceutical Supply Chain Assessment for Sri Lanka (March 2025)

Core Content

This report presents an assessment of Sri Lanka's pharmaceutical supply chain, conducted from September 2023 to May 2024, with support from the Asian Development Bank (ADB) and other development partners. The assessment aimed to understand the current state of the supply chain, identify barriers, and propose improvements to enhance efficiency and effectiveness in the public health-led pharmaceutical system.

Main Objectives

To evaluate the pharmaceutical supply chain system in Sri Lanka.
To identify key vulnerabilities and areas for improvement.
To propose program and policy options to strengthen the system.
To support the Ministry of Health (MOH) and Ministry of Finance (MOF) in decision-making for future reforms.

Key Findings

1. Access and Affordability

Sri Lanka has achieved high accessibility and affordability of medical products due to government health facilities within 5 km of the population and free medicine provisions.
Patient satisfaction is high, and the system is resilient in terms of health outcomes, particularly post-COVID-19 recovery.

2. Funding and Economic Crisis

The pharmaceutical supply chain has been affected by the economic crisis, leading to a reliance on donor financing in 2023 and 2024.
Predictable funding and foreign currency availability are crucial for stability and improvement in the postcrisis period.

3. Key Gaps

Governance: Lack of clear segregation of roles, accountability mechanisms, and oversight.
Procurement: Long lead times, limited forecasting accuracy, and insufficient use of strategic procurement methods.
Rational Use: The Essential Medicine List (EML) and priority list need further reduction and consolidation.
Logistics: Inefficient storage and distribution systems, leading to delays and quality risks.
Data Analytics: Limited use of data for decision-making, with a need for better digitalization and monitoring.
Quality Assurance: Inadequate prequalification and quality checks at the manufacturer and importer levels.
Capacity Building: Lack of trained professionals and institutional training programs.
Market Shaping: Limited use of framework agreements and pooled procurement to influence market behavior.

Key Recommendations and Pathways

1. Pathway 1: Strengthen Pharmaceutical Supply Chain Governance

Review and revise the organizational structure for better streamlining.
Optimize product selection and rational use mechanisms.
Segregate roles such as technical standards setting, policy making, and oversight.
Establish units or enhance technical committees for clinical excellence.
Update and streamline the implementation of national guidelines and EML.
Implement generic prescription and prescription audits.
Develop an electronic tool for rational product selection.
Establish a National Institute of Clinical Excellence.
Conduct periodic drug resistance monitoring surveys.

2. Pathway 2: Employ Strategic Procurement

Use historical and epidemiological data for strategic procurement.
Develop standard operating procedures for forecasting and supply planning.
Integrate forecasting modules into the existing IT system (SWASTHA).
Create procurement strategies based on product characteristics.
Introduce framework agreements and e-catalog systems.
Utilize interoperable enterprise resource planning systems like epromise.lk.
Implement prequalification and price negotiation processes.

3. Pathway 3: Optimize Storage and Distribution Network

Conduct distribution network analysis and optimization.
Improve storage conditions with proper infrastructure and monitoring systems.
Establish efficient inventory control and distribution policies.
Fill vacant staff positions and provide training on storage and distribution practices.
Redesign the distribution network based on options analysis.

4. Pathway 4: Improve Data Visibility and Use Data Analytics

Optimize the use of SWASTHA for health records, logistics, and monitoring.
Train staff on interpreting and using supply chain data.
Deploy information systems for NMRA, SPC, and MSD to support product selection, registration, and quality assurance.
Develop a roadmap for implementing GS1 standards and barcode systems.
Strengthen oversight committees for monitoring and evaluation.

5. Pathway 5: Strengthen Quality Assurance and Medicine Regulatory System

Strengthen NMRA and NMQAL by hiring and training staff.
Develop a roadmap for ISO certification and WHO prequalification of NMQAL.
Implement a comprehensive national quality assurance strategy.
Establish a national network of quality assurance laboratories with NMQAL as the reference lab.
Strengthen SPC’s quality assurance laboratory.
Leverage WHO collaborative laboratory networks.
Optimize product registration processes and harmonize CTD formats.

6. Pathway 6: Build Pharmaceutical Supply Chain Workforce Capacity

Provide training and orientation for key leaders and managers.
Conduct a workforce assessment and develop a development plan.
Implement pre- and in-service training programs.
Establish an online training platform for continuous learning.
Integrate pharmaceutical supply chain management into academic curricula.

7. Pathway 7: Explore Opportunities for Regional Mechanism

Conduct feasibility studies for regional and international pooled procurement and market access mechanisms.
Set up a commission under MOH for price negotiation and market shaping.
Initiate participation in regional or international quality assurance and procurement frameworks.

Conclusion

The assessment highlights the need for systemic reforms to enhance the efficiency and effectiveness of Sri Lanka’s pharmaceutical supply chain. These include strengthening governance, optimizing procurement and logistics, improving data use, enhancing quality assurance, building workforce capacity, and exploring regional collaboration. By adopting these pathways, Sri Lanka can improve its pharmaceutical system to better serve its population, especially in the context of economic recovery and increasing health demands.

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