Japanese Biotechnology: A Comprehensive Study of Government Policy, R & D and Industry

330 Pages·1990·26.299 MB·English

by  Robert T. Yuan, Mark D. Dibner (auth.)

~APANESE
BIOTECHNOLOGY
A Comprehensive Study
0/
Government Policy,
R & D and Industry
JAPANESE
BIOTECHNOLOGY
A Comprehensive Study
0/
Government Policy,
R & D and Industry
Robert T. Yuan
Mark D. Dibner
M
© Robert T. Yuan and Mark D. Dibner, 1990
Softcover reprint of the hardcover 1s t edition 1990 978-0-333-53148-8
All rights reserved. No reproduction, copy or transmission
of this publication may be made without written permission.
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(as amended).
Any person who does any unauthorised act in relation to
this publication may be liable to criminal prosecution and
civil claims for damage.
First published by
MACMILLAN PUBLISHERS LTD, 1990
Distributed by Globe Book Services Ltd
BruneI Road, Houndmills
Basingstoke, Hants RG21 2XS
British Library Cataloguing in Publication Data
Yuan, Robert T.
Japanese Biotechnology
1. Japan. Biotechnology
I. Title. II. Dibner, Mark D. (Mark Douglas) 1951-
660.60952
ISBN 978-1-349-11764-2 ISBN 978-1-349-11762-8 (eBook)
DOI 10.1007/978-1-349-11762-8
C 0 N T E N T S
Contents ......................................................... v
List of Tables and Figures ............................................ vii
F oreword . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
IX
Preface .......................................................... xiii
Exchange Rates .................................................... xv
Chapter 1. Executive Summary. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Chapter 2. Introduction ............................................. 15
Chapter 3. Government Policy ........................................ 18
Chapter 4. Universities and Research Institutes. . . . . . . . . . . . . . . . . . . . . . . . . . . . 70
Chapter 5. The Japanese Biotechnology Industry . . . . . . . . . . . . . . . . . . . . . . . . . . . 107
Chapter 6. Technology Transfer ....................................... 166
Chapter 7. Finance................................................. 175
Chapter 8. Doing Business in Japan .................................... 181
Chapter 9. COnclusions................................................ 189
List of Organizations and Individuals Visited . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 197
References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 202
Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 205
v
Japanese Biotechnology
Appendix A: Guidelines for Recombinant DNA Experiments in Universities and Other
Research Institutes ............................................ 207
Appendix B: MITl's Regulations for Large-Scale Industrial Processes . . . . . . . . . . . . 245
Appendix C: Full Text of Notification of Application Data for Recombinant DNA
Drugs ...................................................... 261
Appendix D: Guidelines for Manufacturing Drugs Etc. by Application of Recombinant
DNA Technology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 270
Appendix E: Guidelines for the Application of Recombinant DNA Organisms in
Agriculture, Forestry, Fisheries, the Food Industry and Other Related
Industries in Japan. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 286
Glossary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 305
Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 315
vi
L IST OFT A B L E S
F I GUR E S
A N 0
Table 1. 1989 Japanese Government Budgets for Biotechnology R&D . . . . . . . . . . .. 24
Table 2. Japan Health Sciences Foundation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 28
Table 3. Activities of Science and Technology Agency ........................ 31
Table 4. Budget for Life Sciences Programs of STA . . . . . . . . . . . . . . . . . . . . . . . . . .32-33
Table 5. 1989 Budget of Research Development Corporation of Japan ........... 36
Table 6. ERAT O Projects . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .39-40
Table 7. AIST Biotechnology-Related Projects . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 50
Table 8. Budget for MAFF Biotechnology Programs .........................5 7-58
Table 9. 1989 Budget of Government-Industry Research Programs . . . . . . . . . . . . . .. 67
Table 10. Key Researchers at Three Selected Japanese Universities . . . . . . . . . . . . . .. 72
Table 11. Laboratories with Biotechnology-Related Projects, Kyoto University . . . . . . . 73
Table 12. Research at the Institute for Molecular and Cell Biology, Osaka University .. 75-76
Table 13. Research Projects of Biosensor and Bioelectronics Laboratory ........... 79
Table 14. Principal Government Research laboratories Involved in Biotechnology .... 81
Table 15. RIKEN Biotechnology-Related Laboratories, Wako Facility .............8 3-84
Table 16. Research Groups at RIKEN's Tsukuba Life Science Center .. . . . . . . . . . . . 85
Table 17. RIKEN - Division of Life Science Promotion Program Areas ............ 87
Table 18. Frontier Research Program - Bio-Homeostasis Program . . . . . . . . . . . . . . .. 88
Table 19. Tsukuba Research Consortium ...................................9 0-91
Table 20. Member Companies of Protein Engineering Research Institute . . . . . . . . . .. 93
Table 21. Organization of Protein Engineering Research Institute ................ 94
Table 22. Organization of Osaka Bioscience Institute . . . . . . . . . . . . . . . . . . . . . . . . .. 96
Table 23. Primary Industry Focus of Japanese Biotechnology Companies - 1989 . . . . .. 111
Table 24. Primary Biotechnology Focus of Japanese Biotechnology Companies - 1989 . 120
vii
Japanese Biotechnology
Figure 1. Organization of Biotechnology within the Japanese Government . . . . . . . . .. 25
Figure 2. Structure of the Ministry of Health and Welfare . . . . . . . . . . . . . . . . . . . . .. 25
Figure 3. Structure of the Science and Technology Agency ..................... 34
Figure 4. Structure of the Ministry of International Trade and Industry . . . . . . . . . . .. 47
Figure 5. Map of Technopolis Areas . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 53
Figure 6. Structure of the Ministry of Agriculture, Forestry and Fisheries .......... 55
Vlll
FOREWORD
Japanese Biotechnology is part of a continuing series on international biotechnology. Earlier
volumes have examined biotechnology in Western Europe; Singapore, South Korea and Taiwan;
and the People's Republic of China and Hong Kong.
This study has been supported by:
Office of the Vice-Chancellor for Agricultural Affairs, University of Maryland
N orth Carolina Biotechnology Center
IC2 InstitutelRGK Foundation, Austin, TX
KPMG Peat Marwick, Oakland, CA
Office of Biotechnology, Iowa State University
State of Iowa, Department of Economic Development
State of Maryland, Office of International Trade
University of Iowa
Dr Robert Yuan is Professor of Microbiology at the University of Maryland at College Park,
MD. He is also director of BioTechnology International, a program of the International
Development Management Center. He has done extensive research in molecular biology, which
included appointments at the University of Edinburgh and at the Biozentrum of the University
of Basel, Switzerland. He has also served as First Secretary to the American Embassy in London,
and has carried out aseries of biotechnology assessments in Europe and Asia for the U .S.
International Trade Administration (Biotechnology in Western Europe; Biotechnology in Singapore,
South Korea and Taiwan; and Biotechnology in the People's Republic 01 China and Hong Kong).
He has also carried out a number of private studies for foreign governments and multinational
companies. He is multilingual and is familiar with the culture and customs of many European and
Asian countries.
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Japanese Biotechnology
Dr Mark D. Dibner is direetor of the Bioteehnology Information Division of the North
Carolina Bioteehnology Center. He is also Adjunet Associate Professor at Duke University's
Fuqua Sehool of Business, where he teaehes management of teehnology. In addition, he has
served as Chairman of the Couneil of Bioteehnology Centers, anational organization. He holds
a Ph.D. in neurobiology and behavior from Cornell University and an M.B.A. in strategie planning
from Widener University. He has written manyarticles on the bioteehnology industry and has
eonsulted and leetured in the United States and abroad on eommercial bioteehnology. Dr Dibner
is the author of Biotechnology Japan; Biotechnology Guide U.SA.: Companies, Data and Analysis;
and Basic Methods in Molecular Biology.
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