Developing and Strengthening
the Global Supply Chain
for Second-Line Drugs for
Multidrug-Resistant Tuberculosis
WORKSHOP SUMMARY
Anna Nicholson, Rebecca A. English, Rita S. Guenther, and
Anne B. Claiborne, Rapporteurs
Forum on Drug Discovery, Development, and Translation
Board on Health Sciences Policy
INSTITUTE OF MEDICINE
OF THE NATIONAL ACADEMIES
THE NATIONAL ACADEMIES PRESS
Washington, D.C.
THE NATIONAL ACADEMIES PRESS | 500 Fifth Street, NW | Washington, DC 20001 |
NOTICE: The workshop that is the subject of this workshop summary was approved by the Governing Board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine.
This activity was supported by contracts between the National Academy of Sciences and Department of Health and Human Services (Contract Nos. N01-OD-4-2139 and HHSF223001003T), Abbott Pharmaceuticals, American Diabetes Association, American Society for Microbiology, Amgen Inc., Association of American Medical Colleges, Bristol-Myers Squibb, Burroughs Wellcome Fund, Celtic Therapeutics, LLLP, Critical Path Institute, Doris Duke Charitable Foundation, Eli Lilly and Company, Eli Lilly & Co. Foundation, FasterCures, Foundation for the NIH, Friends of Cancer Research, GlaxoSmithKline, Janssen Research & Development, LLC, March of Dimes Foundation, Merck & Co., Inc., Novartis Pharmaceuticals Corporation, and Pfizer Inc. The views presented in this publication do not necessarily reflect the views of the organizations or agencies that provided support for the activity.
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Suggested citation: IOM (Institute of Medicine). 2013. Developing and Strengthening the Global Supply Chain for Second-Line Drugs for Multidrug-Resistant Tuberculosis: Workshop Summary. Washington, DC: The National Academies Press.
THE NATIONAL ACADEMIES
Advisers to the Nation on Science, Engineering, and Medicine
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 Academy has a mandate that requires it to advise the federal government on scientific 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 engineers. 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 engineering programs aimed at meeting national needs, encourages education and research, and recognizes the superior achievements of engineers. Dr. Charles M. Vest is president 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 Institute acts under the responsibility given to the National Academy of Sciences by its congressional charter to be an adviser to the federal government and, upon its own initiative, to identify issues of medical care, research, and education. Dr. Harvey V. Fineberg is president of the Institute of Medicine.
The National Research Council was organized by the National Academy of Sciences in 1916 to associate the broad community of science and technology with the Academy’s purposes of furthering knowledge and advising the federal government. Functioning in accordance with general policies determined by the Academy, the Council has become the principal operating agency of both the National Academy of Sciences and the National Academy of Engineering in providing services to the government, the public, and the scientific and engineering communities. The Council is administered jointly by both Academies and the Institute of Medicine. Dr. Ralph J. Cicerone and Dr. Charles M. Vest are chair and vice chair, respectively, of the National Research Council.
PLANNING COMMITTEE FOR THE WORKSHOP ON GLOBAL DRUG SUPPLY CHAIN FOR SECOND-LINE ANTI-TUBERCULOSIS DRUGS1
BARRY R. BLOOM (Co-Chair), Harvard School of Public Health, Boston, MA
GAIL H. CASSELL (Co-Chair), Harvard Medical School (Visiting), Carmel, IN
RIFAT ATUN, Imperial College Business School, Imperial College London, England
PETER CEGIELSKI, U.S. Centers for Disease Control and Prevention, Atlanta, GA
LUCICA DITIU, Stop TB Partnership, World Health Organization, Geneva, Switzerland
GARY L. FILERMAN, Atlas Health Foundation, McLean, VA
HELLEN GELBAND, Center for Disease Dynamics, Economics & Policy, Inc., Washington, DC
MARK J. GOLDBERGER, Abbott Pharmaceuticals, Rockville, MD
DOUGLAS L. KEENE, Management Sciences for Health, Arlington, VA
SALMAAN KESHAVJEE, Harvard Medical School, Boston, MA
MONTSERRAT MEIRO-LORENZO, World Bank, Washington, DC
ELIZABETH (BETSY) MYERS, Doris Duke Charitable Foundation, New York, NY
PAUL P. NUNN,2 World Health Organization, Geneva, Switzerland
ARIEL PABLOS-MéNDEZ, United States Agency for International Development, Washington, DC
TRACY J. SIMS, Eli Lilly & Co. Foundation, Indianapolis, IN
BRENDA WANING, UNITAID, World Health Organization, Geneva, Switzerland
PRASHANT YADAV, University of Michigan, Ann Arbor
IOM Staff
ANNE B. CLAIBORNE, Forum Director
RITA S. GUENTHER, Program Officer
REBECCA A. ENGLISH, Associate Program Officer
ELIZABETH F. C. TYSON, Research Associate
ANDREW M. POPE, Director, Board on Health Sciences Policy
ROBIN GUYSE, Senior Program Assistant
___________________
1 Institute of Medicine planning committees are solely responsible for organizing the workshop, identifying topics, and choosing speakers. The responsibility for the published workshop summary rests with the workshop rapporteurs and the institution.
2 Paul Nunn was with the World Health Organization during the planning of the workshop.
FORUM ON DRUG DISCOVERY, DEVELOPMENT, AND TRANSLATION1
JEFFREY M. DRAZEN (Co-Chair), New England Journal of Medicine, Boston, MA
STEVEN K. GALSON (Co-Chair), Amgen Inc., Thousand Oaks, CA
MARGARET ANDERSON, FasterCures, Washington, DC
HUGH AUCHINCLOSS, National Institute of Allergy and Infectious Diseases, Bethesda, MD
CHRISTOPHER AUSTIN, National Center for Advancing Translational Sciences, Bethesda, MD
LESLIE Z. BENET, University of California, San Francisco
ANN BONHAM, Association of American Medical Colleges, Washington, DC
LINDA BRADY, National Institute of Mental Health, Bethesda, MD
ROBERT CALIFF, Duke University Medical Center, Durham, NC
C. THOMAS CASKEY, Baylor College of Medicine, Houston, TX
GAIL H. CASSELL, Harvard Medical School (Visiting), Carmel, IN
PETER B. CORR, Celtic Therapeutics, LLLP, New York, NY
ANDREW M. DAHLEM, Eli Lilly and Company, Indianapolis, IN
TAMARA DARSOW, American Diabetes Association, Alexandria, VA
JAMES H. DOROSHOW, National Cancer Institute, Bethesda, MD
GARY L. FILERMAN, Atlas Health Foundation, McLean, VA
GARRET A. FITZGERALD, University of Pennsylvania School of Medicine, Philadelphia
MARK J. GOLDBERGER, Abbott Pharmaceuticals, Rockville, MD
HARRY B. GREENBERG, Stanford University School of Medicine, CA
STEPHEN GROFT, National Center for Advancing Translational Sciences, Bethesda, MD
LYNN HUDSON, Critical Path Institute, Tucson, AZ
MICHAEL KATZ, March of Dimes Foundation, White Plains, NY
PETRA KAUFMANN, National Institute of Neurological Disorders and Stroke, Bethesda, MD
JACK D. KEENE, Duke University Medical Center, Durham, NC
RONALD L. KRALL, University of Pennsylvania Center for Bioethics, Steamboat Springs, CO
FREDA LEWIS-HALL, Pfizer Inc., New York, NY
MARK B. MCCLELLAN, The Brookings Institution, Washington, DC
CAROL MIMURA, University of California, Berkeley
___________________
1 Institute of Medicine forums and roundtables do not issue, review, or approve individual documents. The responsibility for the published workshop summary rests with the workshop rapporteurs and the institution.
ELIZABETH (BETSY) MYERS, Doris Duke Charitable Foundation, New York, NY
JOHN ORLOFF, Novartis Pharmaceuticals Corporation, East Hanover, NJ
AMY PATTERSON, National Institutes of Health, Bethesda, MD
MICHAEL ROSENBLATT, Merck & Co., Inc., Whitehouse Station, NJ
JANET SHOEMAKER, American Society for Microbiology, Washington, DC
ELLEN SIGAL, Friends of Cancer Research, Washington, DC
ELLIOTT SIGAL, Bristol-Myers Squibb, Princeton, NJ
ELLEN R. STRAHLMAN, GlaxoSmithKline, Research Triangle Park, NC
NANCY SUNG, Burroughs Wellcome Fund, Research Triangle Park, NC
JANET TOBIAS, Ikana Media and Mount Sinai School of Medicine, New York, NY
JOANNE WALDSTREICHER, Janssen Research & Development, LLC, Raritan, NJ
JANET WOODCOCK, Food and Drug Administration, White Oak, MD
IOM Staff
ANNE B. CLAIBORNE, Forum Director
RITA S. GUENTHER, Program Officer
REBECCA A. ENGLISH, Associate Program Officer
ELIZABETH F. C. TYSON, Research Associate
ANDREW M. POPE, Director, Board on Health Sciences Policy
ROBIN GUYSE, Senior Program Assistant
This workshop summary 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 workshop summary as sound as possible and to ensure that the workshop summary 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 process. We wish to thank the following individuals for their review of this workshop summary:
Colin Boyle, University of California, San Francisco, Global Health Sciences
Jennifer Furin, Case Western Reserve University School of Medicine
Robert Matiru, UNITAID
Owen Robinson, Partners In Health
Although the reviewers listed above have provided many constructive comments and suggestions, they did not see the final draft of the workshop summary before its release. The review of this workshop summary was overseen by Enriqueta C. Bond, QE Philanthropic Advisors. Appointed by the Institute of Medicine, she was responsible for making certain that an independent examination of this workshop summary was carried out in accordance with institutional procedures and that all review comments were carefully considered. Responsibility for the final content of this workshop summary rests entirely with the rapporteurs and the institution.
Background and History of the Current GLC Mechanism
Principles of Drug Supply Chains
Barriers, Challenges, and Needs
2 LOGISTICS, SUPLY, AND DEMAND
Forecasting and Information Management
Funding of the MDR TB Supply Chain
Models for Financing and Supply
4 INNOVATIVE SUGGESTIONS AND POTENTIAL SOLUTIONS
TABLE
1-1 SLD Supply Chain Stakeholders: Responsibilities, Interests, and Barriers
FIGURES
1-1 Number of GLC pilot projects implemented around the world between 2000 and 2009
1-2 Creation of a centralized node of control for the GLC-approved SLD supply chain
1-3 Existing supply chain for SLDs
1-4 A “buffer” supply of SLDs smoothens the lumpiness of demand
1-5 Shifting the push-pull boundary in the SLD supply chain
1-7 Key barriers to improving SLD access: high prices and limited availability of QA MDR TB drugs
1-8 The GLC initiative flow through cycle
1-10 Push and pull mechanisms for adopting innovations for MDR TB
1-11 Regulatory steps from drug development to delivery
2-1 WHO PQ second-line medicines as of the July 2012, IOM workshop
3-1 Global TB drug pipeline, as of June 18, 2012
3-2 Global Fund product classification framework proposed by Results for Development Institute (R4D)
3-3 Price benefits of splitting tenders
3-5 Owner/participant teams for the top five MDR TB Innovation Summit ideas
BOXES
1-1 Key Drug Supply Chain Themes from Previous IOM Forum Publications
1-2 Statement of Task for the Workshop
1-4 Country Approaches to the MDR TB SLD Supply Chain
2-1 Considering Two Key Priorities in the Donor-Funded MDR TB Market: QA and Treatment Access
ACT | artemisinin-combination therapy |
AIDS | acquired immune deficiency syndrome |
AMC | advance market commitment |
AMFm | Affordable Medicines Facility-malaria |
AMRH | African Medicines Regulatory Harmonization |
APC | advance purchase commitment |
API | active pharmaceutical ingredient |
ARV | antiretroviral |
BMGF | Bill & Melinda Gates Foundation |
BRICS | Brazil, Russia, India, China, and South Africa |
CDC | U.S. Centers for Disease Control and Prevention |
CHAI | Clinton Health Access Initiative |
DOT | directly observed treatment |
DOTS | Directly Observed Treatment-Short course |
DR TB | drug-resistant tuberculosis |
DST | drug susceptibility testing |
EMA | European Medicines Agency |
EMR | electronic medical record |
FDA | U.S. Food and Drug Administration |
FLD | first-line anti-TB drug |