Assuring the Quality of Essential Medicines Procured with Donor Funds
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World Bank, Washington, DC
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The donor community spends millions of
dollars annually on procuring essential medicines as part of
development assistance for health. Defining and enforcing
quality standards for these medicines continues to prove
challenging as this involves complex regulatory processes.
While developed countries with stringent regulatory
authorities in place have the capacity to comply with strict
regulatory requirements, the essential medicines procured
for developing countries are either not available in
developed country markets, or are not the most competitively
priced medicines internationally. Donors have therefore been
forced to independently develop systems to purchase at
lowest feasible cost, essential medicines for the developing
world without compromising quality. Through a desk review
and consultation with key stakeholders, this paper compiles
data on various approaches used by international agencies
and donor bodies to improve the quality of essential
medicines they procure, beyond the World Health Organization
(WHO) prequalification of medicines program and the global
fund expert review panel, which focus only on medicines for
treating HIV/AIDS, tuberculosis, and malaria. This paper
additionally explores pragmatic options for a harmonized
approach to ensuring the quality of medicines procured with
donor funds. Based on the observed limitations of existing
approaches, this paper considers a risk-based approach
initiated by WHO, through which medicines in the WHO model
list of essential medicines are classified according to risk
categories (high, medium, and low). In the long run, the
goal of international donor aid is to build the capacity of
developing countries to take the lead in assuring the health
of their citizens. Effective harmonization, coordination,
and optimal leveraging of existing approaches may help
national regulatory authorities to strengthen their own
capacity to better control their markets, including
registering products according to stringent standards,
improving domestic manufacturing where applicable, and
enhancing post-marketing surveillance.
Palabras clave
ACCOUNTING, ACTIVE INGREDIENTS, AID, AIDS PREVENTION, AIDS RELIEF, ANALGESICS, ANTIBIOTICS, ANTIMALARIALS, AUDITS, BIOEQUIVALENCE, BIOLOGICAL ORIGIN, CANCER, CAPACITY BUILDING, CAPSULES, CENTRAL MEDICAL STORES, CERTIFICATION, CHILD HEALTH, CITIZENS, COMMODITIES, CONDOMS, CONTRACEPTIVES, COUNTERFEIT DRUGS, DEATHS, DEATHS OF CHILDREN, DEVELOPING COUNTRIES, DEVELOPMENT ASSISTANCE, DEVELOPMENT NETWORK, DISASTER, DISASTER ASSISTANCE, DISASTER SITUATIONS, DISEASE, DISEASES, DISTRIBUTION OF PHARMACEUTICALS, DOCTORS, EMERGENCY PLAN, EPIDEMIC, ESSENTIAL MEDICINES, FACT SHEET, FAMILY HEALTH, FAMILY HEALTH INTERNATIONAL, FAMILY PLANNING, FOOD SECURITY, GENERIC PRODUCTS, GLOBAL ADVOCACY, GMP, GOOD MANUFACTURING PRACTICES, HEALTH CARE, HEALTH IMPACT, HEALTH OUTCOMES, HEALTH RISK, HEALTH SECTOR, HIV, HIV/AIDS, HOME COUNTRIES, HOST COUNTRY, HUMAN DEVELOPMENT, INFLUENZA, INTERNATIONAL AGENCIES, INTERNATIONAL COMMITTEE, INTERNATIONAL COMMUNITY, INTERNATIONAL COOPERATION, INTERNATIONAL ORGANIZATIONS, INTRAUTERINE DEVICES, IUDS, LABORATORIES, LIMITED RESOURCES, MALARIA, MARKETING, MEDICAL SERVICES, MEDICAL SUPPLIES, MEDICINE, MEDICINES, MENINGITIS, MOSQUITO NETS, NATIONAL AUTHORITIES, NONGOVERNMENTAL ORGANIZATION, NONGOVERNMENTAL ORGANIZATIONS, NUTRITION, ORAL CONTRACEPTIVES, PACKAGING, PANDEMIC, PATIENTS, PHARMACEUTICAL, PHARMACEUTICAL EVALUATION, PHARMACEUTICAL INDUSTRY, PHARMACEUTICAL INSPECTION, PHARMACEUTICAL MANAGEMENT, PHARMACEUTICAL MANUFACTURERS, PHARMACEUTICAL MANUFACTURING, PHARMACEUTICAL PROCUREMENT, PHARMACEUTICAL PRODUCTS, PHARMACEUTICAL QUALITY, PHARMACEUTICAL QUALITY ASSURANCE, PHARMACEUTICAL SOURCES, PHARMACEUTICAL SYSTEMS, PHARMACEUTICALS, POOLED PROCUREMENT, POSTEXPOSURE PROPHYLAXIS, PRESS RELEASE, PROCUREMENT, PROGRESS, PROJECT IMPLEMENTATION, PROPHYLAXIS KITS, PUBLIC HEALTH, PURCHASING, PURITY, QUALITY ASSURANCE, QUALITY ASSURANCE CAPACITY, QUALITY CONTROL, QUALITY ASSURANCE, RECIPIENT COUNTRIES, REGIONAL INITIATIVES, REGIONAL NETWORKS, REGULATORY AGENCIES, REGULATORY AUTHORITIES, RELIEF SUPPLIES, REPRODUCTIVE HEALTH, REPRODUCTIVE HEALTH SUPPLY, RESEARCH ORGANIZATIONS, RESOURCE REQUIREMENTS, RESPECT, RISK ASSESSMENT, SAFETY, SCREENING, SECURE SUPPLY, SERVICE CAPACITY, SEXUALLY TRANSMITTED INFECTIONS, SOVEREIGN STATES, SPECIALIST, STANDARD TREATMENT GUIDELINES, SUPPLY CHAINS, TABLETS, TECHNICAL ASSISTANCE, TECHNICAL CAPACITY, TECHNICAL COOPERATION, TECHNICAL RESOURCES, TENDERING, THERAPIES, TROPICAL DISEASES, TROPICAL MEDICINE, TUBERCULOSIS, UNFPA, UNITED NATIONS ORGANIZATIONS, UNITED NATIONS POPULATION FUND, UNITED STATES AGENCY FOR INTERNATIONAL DEVELOPMENT, VACCINATION, VACCINES, VITAMINS, WORK EXPERIENCE, WORLD HEALTH ORGANIZATION