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Committee on Understanding the Global Public Health Implications of
Substandard, Falsified, and Counterfeit Medical Products
Board on Global Health
Gillian J. Buckley and Lawrence O. Gostin, Editors
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THE NATIONAL ACADEMIES PRESS 500 Fifth Street, NW Washington, DC 20001
NOTICE: The project that is the subject of this report was approved by the Govern-
ing Board of the National Research Council, whose members are drawn from the
councils of the National Academy of Sciences, the National Academy of Engineer-
ing, and the Institute of Medicine. The members of the committee responsible for
the report were chosen for their special competences and with regard for appropri-
ate balance.
This study was supported by Contract No. HHSF22301024T, TO #25 between the
National Academy of Sciences and the U.S. Food and Drug Administration. Any
opinions, findings, conclusions, or recommendations expressed in this publication
are those of the author(s) and do not necessarily reflect the view of the organizations
or agencies that provided support for this project.
International Standard Book Number-13: 978-0-309-26939-1
International Standard Book Number-10: 0-309-26939-3
Additional copies of this report are available from the National Academies Press,
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his/antikamnia/antikamnia.html).
Suggested citation: IOM (Institute of Medicine). 2013. Countering the problem of
falsified and substandard drugs. Washington, DC: The National Academies Press.
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“Knowing is not enough; we must apply.
Willing is not enough; we must do.”
—Goethe
Advising the Nation. Improving Health.
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The National Academy of Sciences is a private, nonprofit, self-perpetuating society
of distinguished scholars engaged in scientific and engineering research, dedicated to
the furtherance of science and technology and to their use for the general welfare.
Upon the authority of the charter granted to it by the Congress in 1863, the Acad-
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and technical matters. Dr. Ralph J. Cicerone is president of the National Academy
of Sciences.
The National Academy of Engineering was established in 1964, under the charter
of the National Academy of Sciences, as a parallel organization of outstanding engi
neers. It is autonomous in its administration and in the selection of its members,
sharing with the National Academy of Sciences the responsibility for advising the
federal government. The National Academy of Engineering also sponsors engineer-
ing programs aimed at meeting national needs, encourages education and research,
and recognizes the superior achievements of engineers. Dr. Charles M. Vest is presi-
dent of the National Academy of Engineering.
The Institute of Medicine was established in 1970 by the National Academy of
Sciences to secure the services of eminent members of appropriate professions in
the examination of policy matters pertaining to the health of the public. The Insti-
tute acts under the responsibility given to the National Academy of Sciences by its
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The National Research Council was organized by the National Academy of Sci-
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Dr. Ralph J. Cicerone and Dr. Charles M. Vest are chair and vice chair, respectively,
of the National Research Council.
www.national-academies.org
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COMMITTEE ON UNDERSTANDING THE GLOBAL
PUBLIC HEALTH IMPLICATIONS OF SUBSTANDARD,
FALSIFIED, AND COUNTERFEIT MEDICAL PRODUCTS
LAWRENCE O. GOSTIN (Chair), the Linda and Timothy O’Neill
Professor of Global Health Law; Director, WHO Collaborating
Center on Public Health Law and Human Rights, Georgetown
University Law Center, Washington, DC
DANIEL CARPENTER, Allie S. Freed Professor of Government, Harvard
University, Cambridge, MA
HANS HOGERZEIL, Professor of Global Health, Groningen University, The
Netherlands; Former Director, Essential Medicines and Pharmaceutical
Policies, World Health Organization, Geneva, Switzerland
THOMAS P. LAYLOFF, Senior Quality Assurance Director, Supply Chain
Management System, Arlington, VA
ANN MARIE KIMBALL, Senior Program Officer of Epidemiology and
Surveillance, Bill & Melinda Gates Foundation, Seattle, WA
PATRICK LUKULAY, Director, Promoting the Quality of Medicines
Program, U.S. Pharmacopeia, Rockville, MD
MARGARETH NDOMONDO-SIGONDA, Pharmaceutical Coordinator,
New Partnership for Africa’s Development, Pretoria, South Africa
ARTI K. RAI, Elvin R. Latty Professor, Duke University School of Law,
Durham, NC
MARCO ANTONIO STEPHANO, Professor, University of São Paulo,
School of Pharmaceutical Sciences, Brazil
JOHN THERIAULT, Former Vice President of Security, Apple Inc.,
Cupertino, CA; Former Vice President of Security, Pfizer, Inc.,
New York, NY
MARY E. WILSON, Adjunct Associate Professor of Global Health and
Population, Harvard University School of Public Health, Boston, MA
PRASHANT YADAV, Director, Healthcare Research, William Davidson
Institute, University of Michigan, Ann Arbor
IOM Staff
GILLIAN BUCKLEY, Program Officer, Study Director
KENISHA PETERS, Research Associate
MEGAN GINIVAN, Research Assistant
KATHLEEN BURNS, Intern
JULIE WILTSHIRE, Financial Associate
PATRICK W. KELLEY, Director, Boards on Global Health and African
Science Academy Development
v
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Reviewers
This report has been reviewed in draft form by individuals chosen
for their diverse perspectives and technical expertise, in accordance with
procedures approved by the National Research Council’s Report Review
Committee. The purpose of this independent review is to provide candid
and critical comments that will assist the institution in making its published
report as sound as possible and to ensure that the report meets institutional
standards for objectivity, evidence, and responsiveness to the study charge.
The review comments and draft manuscript remain confidential to protect
the integrity of the deliberative process. We wish to thank the following
individuals for their review of this report:
Georges Benjamin, American Public Health Association
Martha Brumfield, Martha A. Brumfield, LLC
Stephen Byrn, Purdue University
Philip Chen, formerly of Georgetown University Law Center
Charles Clift, Chatham House
Michael Greene, Centers for Disease Control and Prevention
William Greene, St. Jude Children’s Research Hospital
Noel Greis, University of North Carolina at Chapel Hill
Harparkash Kaur, London School of Hygiene and Tropical Medicine
Thomas Kubic, Pharmaceutical Security Institute
Joshua Sharfstein, Maryland Department of Health & Mental Hygiene
Marv Shepherd, University of Texas at Austin
Andy Stergachis, University of Washington
Chen Yang, Sidley Austin, LLP
vii
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viii REVIEWERS
Although the reviewers listed above have provided many constructive
comments and suggestions, they were not asked to endorse the conclusions
or recommendations, nor did they see the final draft of the report before its
release. The review of this report was overseen by Harold Fallon, Medical
University of South Carolina, and Elaine Larson, School of Nursing and
Mailman School of Public Health, Columbia University. Appointed by the
National Research Council and the Institute of Medicine, they were respon-
sible for making certain that an independent examination of this report was
carried out in accordance with institutional procedures and that all review
comments were carefully considered. Responsibility for the final content of
this report rests entirely with the authoring committee and the institution.
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Acknowledgments
This report is a product of the cooperation and contributions of
many people. The committee and staff are especially grateful to Danielle
Turnipseed and Livia Navon for their work on the manuscript, and to
Deepali Patel and Susan McCutchen for their fast and accurate refer-
ence review. The project ran smoothly because of the contributions of
Jim Banihashemi, Sarah Ziegenhorn, Laura Harbold DeStefano, Anne
Claiborne, and Vilija Teel of the Institute of Medicine. Janice Mehler of the
Report Review Committee oversaw a careful peer review of the manuscript.
Many experts outside of the Academies helped the committee and staff
with this project. Bryan Liang of the University of California, San Diego,
was not able to serve on the committee but contributed to the first meeting.
Michael Deats, Jitka Sabartova, and Sabine Kopp of the WHO shared their
technical expertise; Tom Kubic of PSI, Inc. shared and explained his orga-
nization’s unpublished data; Vincent Ahonkai of the Bill & Melinda Gates
Foundation, Kelly Catlin of CHAI, and James Droop and Saul Walker of
DFID shared information about medicine procurement and quality assur-
ance; Mark Paxton of the FDA explained RFID technology; Ashifi Gogo
of Sproxil explained mobile verification; Mariam Khan of BMI shared
pharmaceutical sales data; and Lynda Scammell of the MHRA shared her
technical expertise.
Members of the committee and staff traveled to Brasília, Delhi, Ge-
neva, Hyderabad, London, and São Paulo, during this project. Their
meetings abroad were made easier because of the help and hospitality of
Teija Katajainen of the WHO; Maria Alves of the EMA; Arthy Santhaku-
mar of Chatham House; A. Srinivasa Chakravarthy, K.V. Surendra Nath,
ix
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x ACKNOWLEDGMENTS
and Syed Mohammed Arifullah of the U.S. Pharmacopeia–India; Carlos
Morel of FIOCRUZ; and Laura Oliveira of the University of São Paulo.
Charles Nwasor of the Altarum Institute, Kelley Badiane of USAID, Monica
Eimunjeze of NAFDAC, Henrietta Williams of the Catholic Medical Asso-
ciation of Nigeria, and Isaac Umunna also helped the staff and committee
prepare for their meetings.
The committee is grateful to the following participants who spoke at
meetings and helped staff plan agendas:
Martin Harvey Allchurch Laurie Garrett
P.V. Appaji David R. Gaugh
Amir Attaran Debora Germano
Martin Auton Raj Shankar Ghosh
Sunil Bahl Ashifi Gogo
Roger Bate Antony Raj Gomes
Ilisa Bernstein Subhash Gouda
Katherine Bond L.C. Goyal
Regina Brown Wendy Greenall
Gian Luca Burci Jeffery Gren
Claudio Henrique Cabral Catherine Hill-Herndon
Nicholas Cappuccino Meghana Inamdar
Ranjan Chakrabarti Mariaou Tala Jallow
Ranjit Chaudhury Kees de Joncheere
Lim Chin Chin Connie Jung
John Clark Mohga Kamal-Yanni
Charles Clift Harparkash Kaur
David Cockburn Sabine Kopp
Emer Cooke Alan Leather
Ediná Alves Costa Jamie Love
Alan Coukell Rohit Malpani
Elize Massard da Fonseca Paola Manchisini
Filipe Soares Quirino da Silva Linda Marks
Ashok Dang Sylvia Meek
Joelle Daviaud Mayira Milano
Leandro Teixeira de Morais Bejon Misra
Jenifer Devine Archna Mudgal
Pritu Dhalaria Koduru Surendra Nath
Albinus D’Sa Paul Newton
Douglas Duarte Fernando Nogueira
Paul Ellis Doroteia Koparanova Ollivier
Frederico Benite Filho Arun Panda
Michele Forzley Sharon Peacock
Odile Frank Patrícia Oliveira Pereira
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ACKNOWLEDGMENTS xi
Rebeca Mancini Pereira Nirupa Sen
Greg Perry Dilip Shah
Terezinha de Jesus Andreoli Pinto Sangeeta Shashikant
Aline Plancon Janice Soreth
Flávia Poppe Sadu Srivinas
Tiago Lanius Rauber Fergus Sweeny
Subbi Reddy Nirmalya Syam
Christophe Rérat Paulo Teixeira
Judit Rius Mary Lou Valdez
Nicolina Romano-Lieber German Velasquez
Francis Roodt Tarun Vij
Luciano Gonçalves Rosado Simeon Wilson
Bruce Ross Mark Witkowski
Percy Alberto Ocampo Rujel Shunmay Yeung
Niall Sargent Regina Zamith
Philippa Saunders Anthony Zook
Lynda Scammell Howard Zucker
Aluísio Segurado
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xiv ACRONYMS AND ABBREVIATIONS
HIV human immunodeficiency virus
HPLC high-performance liquid chromatography
ICH International Conference on Harmonisation of Technical
Requirements for Registration of Pharmaceuticals for
Human Use
IFC International Finance Corporation
IMPACT International Medical Products Anti-Counterfeiting
Taskforce
Medicrime Council of Europe Convention on the counterfeiting of
Convention medical products and similar crimes involving threats to
public health
MSF Médecins Sans Frontières (Doctors Without Borders)
MSH Management Sciences for Health
NABP National Association of Boards of Pharmacy
NGO nongovernmental organization
NIST National Institute of Standards and Technology
NSF National Science Foundation
OECD Organisation for Economic Co-operation and
Development
OPIC Overseas Private Investment Corporation
PhRMA Pharmaceutical Research and Manufacturers of America
PQM Promoting the Quality of Medicines
PSI Pharmaceutical Security Institute
PSM Partnership for Safe Medicines
RFID radio frequency identification
SBIR Small Business Innovation Research
SSFFC substandard, spurious, falsely-labeled, falsified, counterfeit
TLC thin layer chromatography
TRIPS Trade-Related Aspects of Intellectual Property Rights
Unicef United Nations Children’s Fund
UNODC United Nations Office on Drugs and Crime
USAID United States Agency for International Development
USP U.S. Pharmacopeia
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ACRONYMS AND ABBREVIATIONS xv
VIPPS Verified Internet Pharmacy Practice Sites
WCO World Customs Organization
WHA World Health Assembly
WHO World Health Organization
WIPO World Intellectual Property Organization
WTO World Trade Organization
WWARN WorldWide Antimalarial Resistance Network
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Contents
ACKNOWLEDGMENTS ix
ACRONYMS AND ABBREVIATIONS xiii
SUMMARY 1
1 INTRODUCTION 15
Background and Terms, 17
Intellectual Property and Public Health, 18
TRIPS and the Doha Declaration, 18
Patent and Trademark Infringement, 20
Competing Meanings of the Term Counterfeit, 22
Substandard and Falsified Drugs, 24
The Problem of Unregistered Medicines, 26
A Proposed Vocabulary, 28
Drug Quality Standards, 30
Pharmacopeia, 30
Registration Agencies and National Pharmaceutical
Authorities, 31
References, 48
2 THE EFFECTS OF FALSIFIED AND SUBSTANDARD DRUGS 55
Public Health Consequences, 55
Poisoning, 55
Untreated Disease, Disease Progression, and Death, 57
xvii
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xviii CONTENTS
Medications for Chronic Diseases, 58
Medications for Infectious Diseases, 60
Treatment Failure, 62
Antimicrobial Resistance, 63
Antimalarial Resistance, 65
Other Antiparasitic Resistance, 67
Economic and Social Consequences, 67
Costs to the Health System, 68
Social and Developmental Costs, 72
References, 78
3 THE MAGNITUDE OF THE PROBLEM 85
Industry and Government Data, 85
The Pharmaceutical Security Institute Incident Reporting
System, 86
Government and Intergovernmental Investigations, 90
The FDA Office of Criminal Investigations, 90
International Police Investigations, 92
Case Reports and Convenience Samples, 94
Case Reports, 95
Convenience Samples, 96
Antimicrobial Drugs, 96
Systematic Random Samples of Drug Quality, 100
A Need for More Field Surveys, 102
Global Prevalence Estimates, 103
The WHO Global Capacity-Building Project, 107
References, 134
4 CAUSES OF FALSIFIED AND SUBSTANDARD DRUGS 137
Reasons for Substandard Drugs, 137
Uneven Manufacturing Quality, 137
The IFC and OPIC, 142
Tiered Production, 144
Procurement and Substandard Medicines, 146
Applying the Model Quality Assurance System to
Secondary Procurement, 152
Reasons for Falsified Drugs, 153
Corruption and Organized Crime, 154
Enforcement and Punishment, 157
Reasons for Both, 162
Expense and Scarcity, 162
Reducing the Costs of Market Authorization, 165
Weak Regulatory Systems, 166
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CONTENTS xix
Gaps in Regulatory Oversight, 171
Lack of Awareness and Action, 173
Uneven Awareness, 173
Public Action, 176
References, 187
5 WEAKNESSES IN THE DRUG DISTRIBUTION CHAIN 197
An Overview of Drug Distribution in Developed and
Developing Countries, 197
The Wholesale System, 203
The U.S. Wholesale Market, 208
The Wholesale Market in Low- and Middle-Income
Countries, 209
Drug Diversion, 210
Pilfering and Heists, 211
Drug Resale and Late Diversion, 213
Tracking and Tracing Products Through the Supply Chain, 214
Barcodes, 215
Electronic Product Codes and Radio Frequency
Identification, 217
Mobile Verification, 218
Medicines Retail, 222
Unregistered Pharmacies in Low- and Middle-Income
Countries, 223
Shortage of Quality-Assured Drug Shops, 224
Shortage of Trained Pharmacy Staff, 224
Improving Retail, 228
Pharmaceutical Task Shifting, 229
Giving Incentives to Pharmaceutical Personnel, 232
Internet Pharmacies in Middle- and High-Income Countries, 233
The Legality of Internet Drugs Retail, 233
The Attraction of Internet Pharmacies, 236
Distinguishing Rogue Pharmacies from Legitimate Ones, 238
References, 243
6 DETECTION TECHNOLOGY 255
Qualitative and Quantitative Methods, 255
Overview of Detection, Screening, and Analytical
Techniques, 257
Visual Inspection and Package Technologies, 257
Physical and Bulk Property Testing, 260
Colorimetry and Other Chemical Testing, 261
Chromatography, 261
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xx CONTENTS
Spectroscopy, 265
Mass Spectrometry, 271
Emerging Technologies, 273
Using Technology, 274
Combining Techniques, 277
Using Technology in Developing Countries, 279
Field Technologies, 279
Detection in Every Setting, 281
The Technological Landscape, 284
References, 290
7 AN INTERNATIONAL CODE OF PRACTICE FOR
FALSIFIED AND SUBSTANDARD MEDICINES 295
The Role of the WHO, 297
Engaging Stakeholders, 298
Content of the Code, 300
International Surveillance, 300
Medicines Regulation, 301
Law Enforcement, 303
Compliance by States and Stakeholders, 304
References, 305
APPENDIXES
A GLOSSARY 309
B COMMITTEE BIOGRAPHIES 331
C MEETING AGENDAS 339
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Boxes, Figures, and Tables
BOXES
1-1 Statement of Task, 18
1-2 Definitions of Terms, 29
2-1 Defective Glucose Test Strips, 59
2-2 Deaths from Substandard and Falsified Vaccines, 61
2-3 The WorldWide Antimalarial Resistance Network, 68
4-1 The Medicines Manufacturing Process, 140
4-2 Fatal Falsified Iron, 155
4-3 Adulterated Cancer Drugs, 156
4-4 Pharmaceutical Security Institute Crime and Arrest Data, 159
4-5 Manuel Calvelo, 161
4-6 Dissolution of the Pakistani Drug Regulatory Authority, 169
4-7 A National Awareness Campaign in Nigeria, 175
4-8 Health Worker Guidelines, 177
5-1 Drug Distribution in Humanitarian Emergencies, 202
5-2 Falsified Avastin’s Circuitous Path to the United States, 206
5-3 CareShop Franchisee Profiles, 230
5-4 The Australian Rural Pharmacy Workforce Program, 234
6-1 Classifying Falsified Medicines, 257
6-2 PharmaCheck, 273
xxi
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xxii BOXES, FIGURES, AND TABLES
6-3 Chinese Mobile Laboratories, 280
6-4 The Global Pharma Health Fund Minilab, 282
FIGURES
1-1 two-dimensional description of medicine quality and
A
registration, 27
2-1 Increasing incidence of multidrug-resistant tuberculosis
(MDR-TB), 64
2-2 Percentage of nosocomial Staphylococcus aureus isolates with
resistance to meticillin in studies in Latin American countries, 66
2-3 The increasing costs of drug development, 71
2-4 Comparative values of trafficking flows in West Africa, 73
3-1 Results of packaging and product analysis, 2011, 90
3-2 Geographic distribution of pharmaceutical sales in $U.S. billions,
2011 data, 91
3-3 Geographic distribution of Pharmaceutical Security Institute incident
reports, affected countries, 2011 data, 91
3-4 Registration status of antimalarial samples by distribution level, 98
3-5 Quality failures of registered and unregistered antimalarials in 267
samples, 99
3-6 Results of full quality-control analysis in 267 samples, 99
4-1 Schematic block diagram of a pharmaceutical manufacturing
process, 140
4-2 Arrests by activity, 2010-2011, 159
4-3 Average of country-level mean percentage availability of medicines
by World Bank income group, 164
4-4 Number of sub-Saharan African countries out of 26 surveyed
meeting the main functions of a regulatory authority, 168
4-5 FDA public service announcement that promotes the Verified
An
Internet Pharmacy Practice certification, 179
4-6 The English translation of a Cambodian poster encouraging
consumers to buy medicines only from licensed pharmacies and to
examine the drug’s color, shape, and taste for abnormalities, 180
5-1 The drug distribution system, 199
5-2 The private, public, and NGO drug distribution systems for
essential medicines in developing countries, 200
5-3 Risks in the medicine distribution system, 212
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BOXES, FIGURES, AND TABLES xxiii
5-4 Number of pharmacists per 10,000 people and number of
pharmacies per 10,000 people in 50 countries, 226
5-5 The world’s pharmacists, pharmacy technicians, and pharmacy
assistants, 2006 data, 227
5-6 Legislation of internet pharmacy operations by WHO region, 235
6-1 More sophisticated fakes require more sophisticated technologies to
detect them, 258
6-2 The printing on a fake Cialis blister pack is less crisp at 32×
magnification, 260
6-3a n HPLC chromatogram with distinct peaks for chloroquine,
A
quinine, and mefloquine can be used to identify cheap chloroquine
and quinine treatments labeled as the more expensive
mefloquine, 264
6-3b he similar chemical structures of chloroquine, quinine, and
T
mefloquine, 264
6-4 Infrared Spectra for artemisinin (top) and artemether, an
artemisinin-derivative (bottom) illustrate differences in their
chemical composition, 266
6-5 Use of FT-IR spectroscopy to distinguish between real (left) and
falsified (right) packaging in Singapore, 267
6-6 Image (a) is a pain relief tablet, image (b) its near-infrared
spectra, 268
6-7 Proton NMR spectrum of aspirin (o-acetoxybenzoic acid), 270
6-8 Nearly identical analogues of tadalafil (left, 389.40 g/mol),
aminotadalafil (right, 390.39 g/mol), 272
6-9 CODFIN analysis flowchart, 276
6-10 enuine (left) and falsified (right) holograms on artesunate blister
G
packs found in Southeast Asia, 284
TABLES
1-1 Definitions of Counterfeit Pharmaceuticals, 34
1-2 National Definitions of Counterfeit Pharmaceuticals, 37
1-3 Definitions of Substandard Pharmaceuticals, 42
1-4 National Definitions of Substandard Pharmaceuticals, 44
1-5 Other Terms of Interest, 45
2-1 Medicines Use to Treat the Most Common Causes of Child Death
Are Compromised in Developing Countries, 75
3-1 Ranking of Seizures or Detections by Country, 2011, 88
3-2 Ten Countries Most Named in PSI Incident Reports, 2011, 89
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xxiv BOXES, FIGURES, AND TABLES
3-3 Operation Pangea Against Online Pharmacies, 2008-2012, 93
3-4 Operations Storm, Mamba, and Cobra, 2008-2011, 94
3-5 The Pharmaceutical Security Institute’s 2011 Open-Source
Review, 111
3-6 Major Studies of Falsified and Substandard Antibiotics,
1996-2006, 118
3-7 Reports of Poor-Quality Antimalarial Drugs by Region in Southeast
Asia and Sub-Saharan Africa, 1999-2011, 126
3-8 Medicine Quality Assessment Reporting Guidelines, 105
3-9 Information Collected in the WHO Rapid Alert System, 109
4-1 Overview of Selected Donors’, Procurement Service Agencies’, and
Quality-Assurance Organizations’ Quality-Assurance Policies, 149
4-2 Pharmaceutical Procurement Best Practices, 153
4-3 Top Countries for Arrests, 2011, 158
4-4 Top 10 Countries Ranked by Number of Counterfeit Drug Seizures
and Discoveries in 2006, 160
4-5 Penalties for Falsifying Medicine, 182
4-6 Penalties for Patent Infringement, 184
4-7 Penalties for Trademark Infringement, 186
4-8 Response to the Question “Are You Aware of the Presence of Fake
Medicine in This Country?”, 174
5-1 Differences in Overall Structure of the Pharmaceutical Market in
Developed and Developing Countries, 201
5-2 Number of Pharmaceutical Thefts in the United States, 2006-
2011, 213
5-3 Advantages and Disadvantages of Internet Pharmacies, 237
6-1 Techniques for Detecting Poor-Quality Drugs, 286
6-2 Product Quality Attributes and Assessments, 275
