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Ownership of Human Tissues and Cells New Developments in Biotechnology: Ownership of Human Tissues and Cells March 1987 NTIS order #PB87-207536 Recommended Citation: U.S. Congress, Office of Technology Assessment, New Developments in Biotechnology: Ownership of Human Tissues and Cells—Special Report, OTA-BA-337 (Washington, DC: U.S. Government Printing Office, March 1987). Library of Congress Catalog Card Number 87-619804 For sale by the Superintendent of Documents U.S. Government Printing Office, Washington, DC 20402-9325 Foreword In the 1960s, the term “biotechnology” did not exist. In the 1970s, development of techniques for: 1) splicing genetic information of one organism into that of another, and 2) fusing cells to produce large quantities of valuable proteins led to recognition that a revolution in biological technology—that is, biotechnology—was at hand. In the 1980s, biotechnology is best viewed as a growing cohort of technologies, each with its own scientific benefits and risks, and allied social, economic, legal, and ethical issues. In this special report, OTA analyzes the economic, legal, and ethical rights of the human sources of tissues and cells and also those of the physicians or researchers who obtain and develop these biological materials. The study describes the potential of three rapidly moving technologies (tissue and cell culture, cell fusion to produce monoclinal antibodies, and recombinant DNA) for manipulating human tissues and cells to yield commercially valuable products. The report includes a range of options for congres- sional action related to commercialization of human biological materials, regulation of research with human subjects, and disclosure of physicians’ commercial interest in pa- tient treatment. This special report is the first in a series of OTA studies being carried out under an assessment of "New Developments in Biotechnology. ” Forthcoming reports wrill in- clude evaluations of: U.S. investment in biotechnology; public attitudes toward biotech- nology; genetic and ecological issues in the environmental release of genetically engi- neered organisms; and the impact of intellectual property law on biotechnology. The assessment was requested by the House Committee on Science and Technology and the House Committee on Energy and Commerce. OTA was assisted in preparing this study by an advisory panel, a workshop group, and reviewers selected for their expertise and diverse points of view on the issues cov- ered in the report. OTA gratefully acknowledges the contribution of each of these indi- viduals. As with all OTA reports, responsibility for the content of the special report is OTA alone. The special report does not necessarily constitute the consensus or en- dorsement of the advisory panel, the workshop group, or the Technology Assessment Board. Director . Ill New Developments in Biotechnology Advisory Panel Bernadine P. Healy, Panel Chair The Cleveland Clinic Foundation Cleveland, OH Timothy B. Atkeson Sheldon Krimsky Steptoe & Johnson Tufts University Washington, DC Medford, MA David Blumenthal Joshua Lederberg Brigham and Women’s Hospital Corp. The Rockefeller University Boston, MA New York, NY Hon. Edmund G. Brown, Jr. William E. Marshall Reavis & McGrath Pioneer Hi-Bred International, Inc. Los Angeles, CA Johnston, IA Nancy L. Buc Ronald L. Meeusen Weil, Gotshal & Manges Rohm and Haas Company Washington, DC Spring House, PA Mark F. Cantley Robert B. Nicholas Concertation Unit for Biotechnology in Europe Blum, Nash & Railsback Brussels, Belgium Washington, DC Alexander M. Capron Eric J. Stanbridge University of Southern California University of California, Irvine Los Angeles, CA Irvine, CA Jerry D. Caulder James M. Tiedje Mycogen Corporation Michigan State University San Diego, CA East Lansing, MI Lawrence I. Gilbert Kunio Toriyama The University of North Carolina ZEN-NOH Chapel Hill, NC Tokyo, Japan Conrad A. Istock Pablo D.T. Valenzuela The University of Arizona Chiron Corporation Tucson, AZ Emeryviile, CA Edward L. Korwek Thomas E. Wagner Keller and Heckman Ohio University Washington, DC Athens, OH Tsune Kosuge Luther S. Williams University of California, Davis Atlanta University Davis, CA Atlanta, GA Richard Krasnow Resources for the Future Washington, DC NOTE: OTA appreciates and is grateful for the valuable assistance and thoughtful critiques provided by the panel members. The panel members do not, however, necessarily approve, disapprove, or endorse this report. OTA assumes full respon- sibility for the report and the accuracy of its contents. iv Ownership of Human Tissues and Cells—OTA Project Staff Roger C. Herdman, OTA Assistant Director Health and Life Sciences Division Gretchen S. Kolsrud, Biological Applications Program Manager Gary B. Ellis, Project Director Gladys B. White, Study Director and Analyst Lisa J. Raines, Study Director and Legal Analyst Robyn Y. Nishimi, Analyst Kevin W. O’Connor, Legal Analyst Support Staff Sharon Kay Oatman, Administrative Assistant Linda S. Ray ford, Secretary/Word Processing Specialist Barbara V. Ketchum, Clerical Assistant Editor Chris Elfring, Takoma Park, MD Outside Contributors James F. Childress, University of Virginia Iver P. Cooper, Mackler, Cooper and Marx Jeffrey N. Gibbs, Mackler, Cooper and Marx Bruce G. Goodman, Damon Corporation Warren Greenberg, George Washington University Rosemary Gibson Kern, American Enterprise Institute Patricia A. King, Georgetown University Gilah Langner, ICF, Inc. Robert J. Levine, Yale University Mark J. Minasi, Moulton & Minasi Thomas H. Murray, University of Texas Medical Branch, Galveston Fay A. Rozovsky, Halifax, Nova Scotia Emanuel Thorne, Washington, DC Allen B. Wagner, Berkeley, CA Acknowledgment to Other OTA Staff Clyde J. Behney, Health Program, Manager R. Alta Charo, Legal Analyst Kathi E. Hanna, Analyst Jane E. Sisk, Senior Associate — New Developments in Biotechnology Working Group on Ownership of Human Tissues and Cells LeRoy Walters, Working Group Chair Georgetown University Washington, DC Thomas L. Beauchamp Barbara Mishkin Georgetown University Hogan & Hartson Washington, DC Washington, DC Bruce G. Goodman Thomas H. Murray Damon Corporation University of Texas Medical Branch Needham Heights, MA Galveston, TX Geoffrey M. Karny Joseph G. Perpich Finnegan, Henderson, Farabow, Garrett and Meloy Laboratories, Inc. Dunner Springfield, VA Washington, DC Patricia A. King Ivor Royston Georgetown University Law Center University of California, San Diego Washington, DC San Diego, CA Robert J. Levine Herbert F. Schwartz Yale University School of Medicine Fish & Neave New Haven, CT New York, NY Charles R. McCarthy Howard S. Schwartz National Institutes of Heal th Jewish General Hospital Bethesda, MD Montreal, Quebec OTA is grateful for the valuable assistance and thoughtful critiques provided by the Working Group members. The views expressed in this OTA report, however, are the sole responsibility of the Office of Technology Assessment. Contents Chapter 1. Summary, Policy Issues, and Options for Congressional Action . 3 2. Introduction . 23 3. The Technologies . 31 4. The Interested Parties . 49 5. Legal Considerations . 69 6. Informed Consent and Disclosure. 93 7. Economic Considerations . .115 8. Ethical Considerations . ., . .129 Appendix A. Code of Federal Regulations, Part 46, Subpart A . ........147 B. Acknowledgments . 155 C. Glossary.. 156 Index . ......161 vii chapter 1 Summary, Policy Issues, and Options for Congressional Action — CONTENTS Human Biological Materials: Questions for the Future . 3 Definitions . 3 The Problem of Uncertainty . 4 The Technologies . 5 Tissue and Cell Culture Technology . 5 Hybridoma Technology . 5 Recombinant DNA Technology . 5 The Interested Parties . 7 Commercial Interest in Human Biological Research and Inventions 7 Sources of Human Tissue. 7 The Research Community . 8 Industry . 8 Legal Considerations . 9 Can Human Biological Materials Be Sold Like Property? . 9 Informed Consent and Disclosure . 10 Consent and the Prospect of Commercial Gain . 10 Are Changes Needed in the Consent Process?. 11 Economic Considerations. 11 Equity of Production and Distribution . 12 Added C:osts. 12 Resolving the Payment Dilemma . 13 Ethical Considerations . 13 The Moral Status of Bodies and Their Parts . 13 Tomorrow’s Choices . 15 Policy Issues and Options for Congressional Action. 15 Tables Table No. l. Human Biological Materials: Many Questions, Few Definitive Answers . 3 2. Possible Sources of Rights Relating to Human Biological Materials . 9 Figure Figure No. Page l. The Genetic Engineering of Human Cells . 6 Boxes Box No. Page A. The Hagiwara Case: An Example of a Dispute Over Human Biological Materials . 4 B. A Hypothetical Case Study: How the Relationship Between Doctor and Patient Might Change . 14 Chapter 1 Summary, Policy Issues, and Options for Congressional Action HUMAN BIOLOGICAL MATERIALS: QUESTIONS FOR THE FUTURE New developments in biotechnology hold great Table 1 .—Human Biological Materials: promise for advancing knowledge about various Many Questions, Few Definitive Answers life forms and improving human health. But with ● Are bodily substances “property” to be disposed of by any this promise come greater responsibilities for sci- means one chooses, including donation or sale? entists and policymakers. Human biological ma- ● Do property rights to their genetic identity adhere to in- terials—tissues and cells—can be used to develop dividuals or to the species? commercial products (e.g., hybridomas and cul- ● Who should make the basic decisions affecting the acqui- tured cell lines]),
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