2012年-世界发展银行全球_Assuring_the_Quality_of_Essential_Medicines_Procured_with_Donor_Funds_72页_1mb

Summary of "Assuring the Quality of Essential Medicines Procured with Donor Funds"

Core Content

This document, authored by Thomas Moore, David Lee, Niranjan Konduri, and Lombe Kasonde, presents an analysis of the challenges and opportunities in assuring the quality of essential medicines procured with donor funds. It outlines the current state of quality assurance (QA) systems and proposes a pragmatic, harmonized approach to improve the quality of medicines in low- and middle-income countries.

Main Objectives

• To analyze options for assuring the quality of essential medicines not covered by existing donor requirements.
• To propose a harmonized, interagency approach that resource-limited countries can use for procurement with donor funds.
• To describe a five-year roadmap for implementing the recommended approach.

Key Information

Problem to be Addressed

• Medicines procurement is a critical step in donor-funded health projects.
• Many low- and middle-income countries lack robust regulatory systems, leading to the circulation of substandard and counterfeit medicines.
• Substandard medicines are ineffective and potentially harmful; counterfeit medicines are deliberately mislabeled and may contain no active ingredients.
• Donors are increasingly involved in the procurement of non-ATM (AIDS, tuberculosis, malaria) essential medicines.

Current Quality Assurance Approaches

1. National Medicines Regulatory Authority (NMRA) Approvals

   • NMRAs are responsible for approving medicines, but often lack capacity to monitor quality effectively.

2. World Health Organization (WHO) Prequalification of Medicines Programme (PQP)

   • PQP provides a certification process for medicines, but covers only a limited range of products.

3. Global Fund's Expert Review Panel (ERP)

   • ERP is used to evaluate medicines for HIV/AIDS, TB, and malaria, but not for other essential medicines.

4. Stringent Regulatory Authority (SRA) Approvals

   • SRA refers to regulatory bodies in developed countries that approve medicines with high quality standards.

5. Procurement Service Agency (PSA) QA Systems

   • PSAs implement QA procedures aligned with international standards, but require significant resources.

Limitations of Existing Approaches

• Lack of standardized QA processes across donor agencies.
• Inadequate capacity of NMRAs in many developing countries.
• Proprietary nature of QA documents and results.
• No centralized, internationally accepted certification process for non-ATM medicines.

Proposed Harmonized and Coordinated Approach

• A risk-based categorization of essential medicines is recommended to prioritize QA efforts.
• Shared QA tools and harmonized policies across donor agencies are necessary to reduce duplication and inefficiency.
• Country ownership and capacity building are emphasized to ensure sustainable QA systems.
• WHO Model Quality Assurance System (MQAS) can serve as a foundation for an independent QA system.
• A five-year roadmap is suggested to implement the proposed approach, including:
  • Developing a risk-based categorization system for non-ATM medicines.
  • Harmonizing QA policies and tools.
  • Strengthening NMRAs' QA capacities.
  • Establishing a common technical document to facilitate registration and reduce costs.
  • Implementing a shared information platform for QA data.

Consensus from Stakeholders

• Stakeholders agree on the need for a more coordinated and risk-based approach.
• There is a strong interest in harmonizing donor QA policies and using improved tools to assess manufacturers and wholesalers.
• Donors should gradually reduce reliance on international prequalification and increase support for local regulatory capacity.

Key Recommendations

• Continue developing a risk-based categorization of essential medicines.
• Harmonize QA tools and policies across donor agencies.
• Establish a shared information platform for QA data.
• Strengthen national regulatory capacities.
• Implement a common technical document to streamline registration processes.
• Promote country ownership in QA systems.

Conclusion

• The goal is to build local capacity in developing countries to ensure the quality of essential medicines.
• A harmonized, risk-based, and coordinated approach can help improve access to quality medicines, reduce costs, and shorten procurement timelines.
• If the cost of implementing these initiatives is not fundable, quality improvements will depend on market dynamics.

Key Stakeholders and Organizations Involved

• WHO and Global Fund led the stakeholder consultation.
• USAID and SPS provided funding and technical support.
• UNICEF, UNFPA, MSF, JSI, and DG ECHO were involved in the discussions.
• The Interagency Pharmaceutical Coordination Group (IPC) was engaged in the harmonization process.

Supporting Materials

• The report includes annexes with:
  • A list of organizations that were interviewed.
  • A survey questionnaire used for stakeholder interviews.
  • ECHO criteria for humanitarian procurement centers.
  • A summary of findings from interviews and document reviews.
  • Manufacturer-related risks.
  • Recommendations from the WHO and Global Fund joint stakeholder meeting.

Keywords

• Quality assurance
• Essential medicines
• Regulatory authorities
• Prequalification
• Procurement
• Donors
• International organizations

Disclaimer

• The findings, interpretations, and conclusions are those of the authors and do not represent the views of the World Bank, its Executive Directors, or the countries they represent.