BIOTECHNOLOGY INTERNATIONAL TRENDS AND PERSPECTIVES BY ALAN T. BULL GEOFFREY HOLT MALCOLM D. LILLY ORGANISATION FOR ECONOMIC CO–OPERATION AND DEVELOPMENT 1 The Organisation for Economic Co–operation and Development (OECD) was set up under a Convention signed in Paris on 14th December 1960, which provides that the OECD shall promote policies designed: − to achieve the highest sustainable growth and employment and a rising standard of living in Member countries, while maintaining financial stability, and thus to contribute to the development of the world economy; − to contribute to sound economic expansion in Member as well as non–member countries in the process of economic development; and − to contribute to the expansion of world trade on a multilateral, non–discriminatory basis in accordance with international obligations. The Member countries of the OECD are Australia, Austria, Belgium, Canada, Denmark, Finland, France, the Federal Republic of Germany, Greece, Iceland, Ireland, Italy, Japan, Luxembourg, the Netherlands, New Zealand, Norway, Portugal, Spain, Sweden, Switzerland, Turkey, the United Kingdom and the United States. The opinions expressed and arguments employed in this publication are the responsibility of the authors and do not necessarily represent those of the OECD. Publié en français sous le titre: BIOTECHNOLOGIE TENDANCES ET PERSPECTIVES INTERNATIONALES © OECD 1982 2 One of the important tasks of the OECD Committee for Scientific and Technological Policy is to follow the emergence of major fields of technology, to debate the various policy issues arising from it, and to help solve those which fall within its Mandate. Thus, I am pleased that this report to OECD on Biotechnology is being made available to the public at large. This work is but the beginning of a more continuous interest of the Committee in a technology that is likely to modify the lives of most people in the OECD Member countries and beyond, through impacts on health, nutrition, energy and the environment. Three factors come together — in my view — to explain the interest which this report has generated in the Committee. First, it is an up–to–date, comprehensive review of prospects in an area of science and technology of major interest to Member countries. A second factor is the conviction of the authors of the report that the successful development of biotechnology depends upon conditions and directions which the Committee has attempted to foster in other sectors of the research system and in other areas of science policy. They are: the need for increased emphasis on inter– and multi–disciplinary research, the close interaction between fundamental research, applied research and engineering and the corresponding need for balanced support of all components of the R&D spectrum, the importance of assessing future opportunities in science and technology and their societal impacts, and the need for integration of science, economic and other policies (such as education and regulation policies). A third feature of this report is its timeliness. Several OECD countries have launched biotechnology plans or policies during the last few years, and they have now to concern themselves increasingly with the international implications of their projects. Other countries are in the process of drafting their first plans. Accordingly, the Committee has agreed to undertake further work on biotechnology. This work will focus on four issues: − Patent Protection in Biotechnology, which among others, will enable individual OECD countries to compare their legal situation to that of others. − Safety and Regulations, which will investigate among other aspects, the problems that might arise in industrial mass production. − Government Policies and Priorities in Biotechnology R&D, which will compare past and present R&D priorities related to biotechnology, and review the national debates and mechanisms that have helped to set these priorities. − Economic Impacts of Biotechnology, an important project that might begin when the other projects are nearing completion. I can only express my hope that the next steps in the Committee’s work on biotechnology will meet with as much interest and success as this first step. Prof. Dr. A.A.Th.M. Van Trier Chairman of the Committee for Scientific and Technological Policy 3 TABLE OF CONTENTS FORWARD by Prof. Daniel Thomas, Technological University of Cambridge.........................7 CONCLUSIONS AND RECOMMENDATIONS OF THE EXPERTS................................... 10 LIST OF EXPERTS ............................................................................................................... 14 AUTHORS’ PREFACE.......................................................................................................... 17 INTRODUCTION .................................................................................................................. 18 1. Definition of Biotechnology....................................................................................... 18 2. The Importance of Biotechnology and the Need for Comparative Statistics in OECD Member Countries.......................................................................................... 19 3. Present Activities and Future Impacts of Biotechnology............................................. 19 4. International Organizations involved in Biotechnology and the Needs of Developing Countries ................................................................................................................... 20 Chapter I POTENTIAL OF CONTRIBUTING SCIENCES AND TECHNOLOGIES TO BIOTECHNOLOGY .............................................................................................................. 22 A. Microbiology and Biochemistry................................................................................. 22 1. Organisms for Biotechnology............................................................................. 22 2. Physiology......................................................................................................... 24 3. Biochemistry...................................................................................................... 25 B. Genetic Manipulations............................................................................................... 25 1. Cell Fusion ........................................................................................................ 26 a) Animals .................................................................................................... 26 b) Plants and Microorganisms ....................................................................... 26 2. In vitro Recombinant DNA Methods.................................................................. 27 C. Engineering ............................................................................................................... 29 1. Aseptic Operation .............................................................................................. 30 2. Reactor Design................................................................................................... 31 a) Fermenters ................................................................................................ 31 b) Immobilized Biocatalyst Reactors ............................................................. 31 3. Product Recovery............................................................................................... 32 4. Instrumentation and Process Control.................................................................. 33 4 Chapter II SCIENTIFIC, TECHNOLOGICAL AND RESOURCE CONSTRAINTS ON BIOTECHNOLOGY .............................................................................................................. 34 A. Energy and Chemical Feedstocks............................................................................... 34 1. Future Sources ................................................................................................... 35 a) Renewable Raw Materials......................................................................... 35 b) Constraints on the Use of Conventional Biomass ...................................... 37 c) Energy Balance and Photosynthetic Efficiency.......................................... 38 2. Biotechnology and the Location of Industry....................................................... 39 3. Research, Development and Demonstration ....................................................... 39 4. Problems Peculiar to Developing Countries ....................................................... 40 B. The Trouble with Water............................................................................................. 41 1. Reactor Operation .............................................................................................. 41 2. Reactor Outputs ................................................................................................. 42 3. The Supply of Water.......................................................................................... 42 C. Product Recovery....................................................................................................... 42 D. Genetic Manipulation................................................................................................. 43 1. Host Vector Systems.......................................................................................... 43 2. Gene Expression ................................................................................................ 45 3.