Assuring the Quality of Essential Medicines Procured with Donor Funds

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 comp...

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Main Authors: Moore, Thomas, Lee, David, Konduri, Niranjan, Kasonde, Lombe
Format: Working Paper
Language:English
en_US
Published: World Bank, Washington, DC 2013
Subjects:
AID
GMP
HIV
Online Access:http://documents.worldbank.org/curated/en/2012/04/16465396/assuring-quality-essential-medicines-procured-donor-funds
http://hdl.handle.net/10986/13577
id okr-10986-13577
recordtype oai_dc
repository_type Digital Repository
institution_category Foreign Institution
institution Digital Repositories
building World Bank Open Knowledge Repository
collection World Bank
language English
en_US
topic 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
spellingShingle 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
Moore, Thomas
Lee, David
Konduri, Niranjan
Kasonde, Lombe
Assuring the Quality of Essential Medicines Procured with Donor Funds
relation Health, Nutrition and Population (HNP) discussion paper;
description 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.
format Publications & Research :: Working Paper
author Moore, Thomas
Lee, David
Konduri, Niranjan
Kasonde, Lombe
author_facet Moore, Thomas
Lee, David
Konduri, Niranjan
Kasonde, Lombe
author_sort Moore, Thomas
title Assuring the Quality of Essential Medicines Procured with Donor Funds
title_short Assuring the Quality of Essential Medicines Procured with Donor Funds
title_full Assuring the Quality of Essential Medicines Procured with Donor Funds
title_fullStr Assuring the Quality of Essential Medicines Procured with Donor Funds
title_full_unstemmed Assuring the Quality of Essential Medicines Procured with Donor Funds
title_sort assuring the quality of essential medicines procured with donor funds
publisher World Bank, Washington, DC
publishDate 2013
url http://documents.worldbank.org/curated/en/2012/04/16465396/assuring-quality-essential-medicines-procured-donor-funds
http://hdl.handle.net/10986/13577
_version_ 1764423791869427712
spelling okr-10986-135772021-04-23T14:03:08Z Assuring the Quality of Essential Medicines Procured with Donor Funds Moore, Thomas Lee, David Konduri, Niranjan Kasonde, Lombe 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 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. 2013-05-28T19:39:06Z 2013-05-28T19:39:06Z 2012-04 http://documents.worldbank.org/curated/en/2012/04/16465396/assuring-quality-essential-medicines-procured-donor-funds http://hdl.handle.net/10986/13577 English en_US Health, Nutrition and Population (HNP) discussion paper; CC BY 3.0 IGO http://creativecommons.org/licenses/by/3.0/igo/ World Bank World Bank, Washington, DC Publications & Research :: Working Paper Publications & Research