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Vaccine Supply and Innovation Division of Health Promotion and Disease Prevention Institute of Medicine NATIONAL ACADEMY PRESS Washington,D.C. 1985

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NATIONAL ACADEMY PRESS 2101 CONSTITUTION AVENUE, N.W. WASHINGTON, DC 20418 NOTICE: The project that is the subject of this report 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. The members of the committee responsible for the report were chosen for their special competencies and with regard for appropriate balance. This report has been reviewed by a group other than the authors according to procedures approved by a Report Review Committee consisting of members of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine. The Institute of Medicine was chartered in 1970 by the National Academy of Sciences to enlist distinguished members of the appropriate professions in the examination of policy matters pertaining to the health of the public. In this, the Institute acts under both the Academy's 1863 congressional charter responsibility to be an adviser to the federal government and its own initiative in identifying issues of medical care, research, and education. The study was supported under contracts with the Food and Drug Administration (223-83-1109), the Department of the Army (DAMD17-83-G-9558), and the Centers for Disease Control (200-83-0609) and grants from Lederle Laboratories, the Merieux Institute, Inc., and Merck Sharp & Dohme. Addition- al support was provided by the National Research Council (NRC) Fund, a pool of private, discretionary nonfederal funds that is used to support a program of Academy-initiated studies of national issues in which science and technology figure significantly. The NRC Fund consists of contributions from a consortium of private foundations including the Carnegie Corporation of New York, the Charles E. Culpeper Foundation, the William and Flora Hewlett Foundation, the John D. and Catherine T. MacArthur Foundation, the Andrew W. Mellon Foundation, the Rockefeller Foundation, and the Alfred P. Sloan Foundation; the Academy Industry Program, which seeks annual contributions from companies that are concerned with the health of U.S. science and technology and with public policy issues with technological content; and the National Academy of Sciences and the National Academy of Engineering endowments. Library of Congress Catalog Card Number 85-60772 International Standard Book Number 0-309-03544-9 Publication No. IOM 85-02 Printed in the United States of America

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Committee on Public-Pr~vate Sector Relations in Vaccine Innovation JAY P. SANFORD (ch~atr), School of Medicine, Uniformed Services University of the Health Sciences MARSHALL H. BECKER, Department of Health Behavior and Health Education, University of Michigan, Ann Arbor ROGER B. DWORKIN, School of Law, Indiana University, Bloomington BERNARD N. FIELDS, Department of Microbiology and Molecular Genetics, Harvard Medical School JERK E. GOYAN, School of Pharmacy, University of California, San Francisco HENRY G. GRAB OWSKI, Department of Economics, Duke University SAMUEL L. KATZ, Department of Pediatrics, Duke University Medical Center EDMUND KITCH, University of Virginia School of Law, Charlottesville LOUIS LASAGNA, Sackler School of Graduate Biomedical Sciences, Tufts University Medical School MARTHA L. LEPOW, Department of Pediatrics, Albany Medical College DAVID W. MARTIN, JR., Genentech, Incorporated, South San Francisco DONALD N. MEDEARIS, JR., Department of Pediatrics, Harvard Medical School THOMAS C. MERIGAN, JR., Division of Infectious Diseases, Stanford University School of Medicine EDWARD A. MORTIMER, JR., School of Medicine, Case Western Reserve University JANE SISK, Office of Technology Assessment, United States Congress GENE H. STOLLERMAN, School of Medicine, Boston University THOMAS H. WELLER, Department of Tropical Public Health, Harvard School of Public Health See Appendix I for further information on committee members and consultants. Consultant LAWRENCE M. DeBROCK, Department of Economics, University of Illinois, Champaign . . .

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Government-Tndustry Liaison Pane! ROBERT F. ACKER, National Foundation for Infectious Diseases DAVID W. BARRY, Burroughs Wellcome Company A. JOHN BEALE, Wellcome Research Laboratories, United Kingdom JOHN H. BRYANT, National Institutes of Health FRANCIS R. CANO, Lederle Laboratories JAMES P. CARLOS, National Institutes of Health PINYA COHEN, Merieux Institute CIRO C.A. de QUADROS, Pan American Health Organization DAVID A. ESPESETH, United States Department of Agriculture LEONARD D. FENNINGER, American Medical Association JEROME GOLD, Wyeth Laboratories GEORGE F. GRADY, Massachusetts Public Health Biologics Laboratories MAURICE R. HILLEMAN, Merck Sharp & Dohme Research Laboratories ALAN HINMAN, Centers for Disease Control NEIL HOLLANDER, Blue Cross/Blue Shield Association DAVID L. HUXSOLL, United States Army Medical Research Institute of Infectious Diseases DONALD R. JAtEk;E, Parke-Davis WILLIAM S. JORDAN, National Institutes of Health JOEL KAVET, Department of Health and Human Services JEFFREY P. KOPLAN, Centers for Disease Control ROBERT E. LOUIE, Cutter Laboratories SUSAN H. MATHER, Veterans Administration DONALD P. METZGAR, Connaught Laboratories, Limited, Canada JOHN R. MITCHELL, Michigan Department of Public Health GARY NOBLE, Centers for Disease Control PAUL D. PARKMAN, Food and Drug Administration CORNELIUS W. PETTINGA, Eli Lilly and Company M. SUSAN UEBER RAYMOND, Center for Public Resources MICHAEL A. RIDDIOUGH, Springfield, Virginia DAVID ROBINSON, United States Army Medical Research and Development Command JOHN ROBBINS, National Institutes of Health PHILIP K. RUSSELL, Fitzsimons Army Medical Center MARTIN H. SMITH, American Academy of Pediatncs GASTON S. TAWIL, Pan American Health Organization KENNETH S. WARREN, The Rockefeller Foundation DONALD A. YOUNG, Health Care Financing Administration Institute of Me~dicine ,StaJ77 ROY WIDDUS, Study Director ENRIQUETA C. BOND, Director, Division of Health Promotion and Disease Prevention CYNTHIA HOWE, Research Assistant EVE K. NICHOLS, Editor JUDE C. PAYNE, Research Assistant GAIL E. SPEARS, Administrative Secretary 1V

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Preface Vaccines are an elegant solution to one of the perennial problems of the human race infectious disease. The body's own protective mechanisms are primed by specific interventions to thwart the invasion or multiplication of pathogens. Lewis Thomas has described this immunization process as one of the genuinely decisive technologies of modern medicine it is effective, relatively in- expensive, relatively simple, and relatively easy to deliver. In the United States, the contribution of vaccines to improved public health has been recognized by all 50 states in laws requiring preschool immunization. In addition, many studies have affirmed the benefits and cost-effectiveness of immunization programs for adults (Office of Technology Assessment 1979, 1980, Pneumococcal and Influenza Evaluations). Today's vaccines protect millions of people from the ravages of disease, and new developments offer the possibility of widening their scope even further. It is unlikely, however, that any existing vaccine will soon repeat the feat of the smallpox vaccine total worldwide eradication of a disease although this ultimately may be possible for diseases such as measles, polio, and rubella. For many other diseases, continuing immunization programs will be required because the pathogens occur in reservoirs from which they are difficult to eliminate, e.g., the environment or other animals. Also, no existing vaccine is universally effective or risk free; hence, research efforts must continue to further minimize undesirable side effects. Finally, vaccines are not available for some major diseases; extending the benefits of immunization will require efforts to encourage the development of new vaccines. The process of vaccine innovation in this country, including basic research' development, testing, production, and marketing, involves numerous organizations in both the public and private sectors. In general, however, the availability of vaccines for public use depends entirely on the willingness of commercial manufacturers to undertake production. Numerous studies over the past two decades have raised the concern that our reliance on market incentives to ensure vaccine availability may lead to a failure to meet public health needs. Also, these incentives may not result in optimal levels of vaccine innovation (National Immunization Work Groups, 19771. These concerns and others involving the application of advances in biotechnology to vaccine production led the Institute of Medicine to establish the Committee on Public-Pr~vate Sector Relations in Vaccine Innovation.* The committee, convened in May 1983, was charged with *The activities of this committee complemented the work of the Institute of Medicine's Committee on Issues and Priorities for New Vaccine Development. The latter's charge was to design a comprehensive approach to setting priorities for accelerated vaccine development. Its first report, New Vaccine Development: Establishing Priorities, Volume 1 (1985), describes application of the committee's model to diseases of importance in the United States; Volume 2 will evaluate the usefulness of the model in setting priorities for vaccines needed by technologically less developed nations. v

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analyzing and making recommendations about current institutional arrangements supporting the research, development, supply, and promotion of vaccines. Specifically, the committee was asked to suggest ways of improving interactions among federal agencies involved in vaccine research, regulation, and utilization; the pharmaceutical industry; and other interested parties, such as medical specialty organizations and the Advisory Committee on Immunization Practices define measures for fostering a more active exchange between the public and nriv~. ~.~.tr~r~ in development of vaccines for the United States and foreign markets ~; 1 ~ ~ ~ ~ _ ~.4 ~ _ _ 1 _ _ ~ ~. - . ~ . ~ ~^ v ^~^ `;ons~aer means for reversing tne Become in the domestic capability for vaccine production, including evaluation of the practicability and desirability of federally supported production facilities explore ways of encouraging the development of vaccines of low commercial potential and of . . . . . Improving existing vaccines address the legal issues involved in the testing, manufacture, and marketing of vaccines for domestic and foreign markets including antitrust matters, Dronosed changes in the. Art hews and liability for vaccine-related injuries ~r ---- ~AN Add_ t~~~ examine the process used in developing recommendations for vaccine use and for national deployment strategies Careful selection of members produced a committee with collective expertise in infectious disease, internal medicine, pediatrics, epidemiology, public health, vaccine development, sociolo- gy, ethics, economics, law, and public policy. A government-industry liaison pane! was established to assist the committee, and additional comments were invited from other individuals on specific topics. The committee also reviewed the extensive testimony given before congressional hearings on proposals for the establishment of a vaccine injury compensation system. In November 1983, the committee sponsored a conference on garners to Vaccine Innovation, attended by more than 80 participants from the United States and abroad. A range of vaccine development case histories and position papers were prepared for the conference. During the meeting, working groups identified and discussed means of reducing barriers and disincentives to vaccine research and development, production and supply, and utilization. As a result of the conference, our study committee defined two goals that became the framework for its recommenda- tions: (1) to facilitate the control of infectious diseases by ensuring the continued innovation, production, and use of vaccines and (2) to ensure that this goal is achieved in a socially responsible and just manner. All of the commiKee's discussions were based on the premise that a domestic vaccine industry is essential to ensure vaccine innovation and availability in the United States. This assumption derived from an understanding of the unique features of vaccine production: the difficulty of quality control for biological products, the length of the production cycle, and specific problems that would be created by sole reliance on foreign manufacturers. The committee believes that the information and approaches suggested in this report may contribute to the solution of problems that it could not address because of time and resource constraints. The economic analysis presented in Chapter 4, for example, should provide useful background information for a conference planned in 1986 on Preventive Biomedical Technologies (a symposium to be convened by the National Academy of Engineering). In addition, the national vaccine commission proposed in this report would be an appropriate body to deal with some of the issues presented in Chapter 7, including the special problems surrounding the development of vaccines for use in less developed countries, and the possible need for government facilities for vaccine production. Many of the issues on which the committee sought information or data to use as a basis for policy vat

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recommendations touched areas of commercial sensitivity. The committee is grateful to manufacturers for providing information that is not usually made public. This is presented in an aggregate form in the report. Not all of the information sought by the committee could be obtained, however. The conclusions presented in this document represent a synthesis of data, subjective information, and interpretation. The committee has tried to characterize the current environment surrounding vaccine innovation and production as objectively and honestly as possible. The Committee on Public-Private Sector Relations in Vaccine Innovation would like to take particular note of support provided by the Institute of Medicine staff and study director Roy Widdus. The support of the study's sponsors also is gratefully acknowledged. JAY P. SANFORD Chairman . . V11

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Contents 1 Summary ....................................................... 2 Vaccines: Past, Present, and Future .................................. 3 Vaccine Availability: Concerns, Barriers, and Impediments 4 Economic Aspects of Vaccine Innovation and Manufacturing Vaccine Tniurv ................................................... s 6 Liability for the Production and Sale of Vaccines ...................... 7 An Approach to Problems of Communication, Coordination, and Collaboration in Vaccine Policy ............................... 8 Vaccine Injury Compensation and Liability Remedies APPENDIXES A Product License Holders B ~~ C D Injury Compensation Systems in the United States E Vaccine-Injury Compensation in Other Countries F Proposed Vaccine-Injury Compensation Systems ....................... G Mechanisms Used in Other Countries to Ensure Vaccine Supply .......... H Background Papers Biographical Notes on Committee Members and Consultants Recommendations for the Proposed Vaccine Commission A Vaccine Supply Public insurance Option No-Fault Vaccine Injury Insurance .................................. Index 14 27 45 65 85 123 136 1X 161 164 166 171 176 183 192 194 196 201 205

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Vaccine Supply and Innovabon

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