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Biotechnology and International Law GW Law Faculty Publications & Other Works Faculty Scholarship 2001 Biotechnology and International Law Sean D. Murphy George Washington University Law School, [email protected] Follow this and additional works at: https://scholarship.law.gwu.edu/faculty_publications Part of the Law Commons Recommended Citation Sean D. Murphy, Biotechnology and International Law, 42 Harv. Int'l L.J. 47 (2001). This Article is brought to you for free and open access by the Faculty Scholarship at Scholarly Commons. It has been accepted for inclusion in GW Law Faculty Publications & Other Works by an authorized administrator of Scholarly Commons. For more information, please contact [email protected]. 2 Draft January 2001 Biotechnology and International Law Sean D. Murphy* I. INTRODUCTION .......................................................................................................... II. THE SCIENCE OF BIOTECHNOLOGY, ITS APPLICATIONS, AND ITS CRITICS ................. The Science The Applications General Criticisms III. PROBLEMS OF BIOTECHNOLOGY IN THE TRANSNATIONAL SPHERE ............................ Equitable Concerns Regarding the Patenting of Genetically Modified Organisms Transparency Regarding Exports of Genetically Modified Products Import Bans on Genetically Modified Products Liability for Damage by Genetically Modified Imports Liability for Extraterritorial Damage by Genetically Modified Products Long-term Decline in Global Biological Diversity IV. THE JURISGENERATIVE NATURE OF INTERNATIONAL LAW ......................................... International Law as Driven by the Self-Interest of Transnational Actors International Law as Driven by Social Interaction Among Transnational Actors International Law as Grounded in National Law and Society V. TOWARD AN EPISTEMIC COMMUNITY ......................................................................... Developing an Epistemic Community The Structure of a Transnational Forum The Goals of a Transnational Forum Potential Crystallization of a Coherent Legal Regime VI. CONCLUSION ................................................................................................................ *George Washington University Law School. My thanks to Patrick Abbot, John Knox, Michael Reisman, Sabrina Safrin, and the author’s colleagues at the law school for their thoughtful comments on an earlier draft of this article, and to Dean Michael K. Young for financial support and Matthew Haws (‘02) for outstanding research assistance. 3 I. INTRODUCTION If one were to forecast the areas involving the greatest technological breakthroughs for the new millennium, the genetic engineering made possible by biotechnology1 would be at or near the top of the list. It is entirely possible that over the next fifty years thousands of novel, genetically modified bacteria, viruses, plants and animals could be developed and released into the global environment for pharmaceutical, agricultural, medical, environmental remediation, alternative fuel, and other purposes. For some internationalists, this is extremely good news, especially for the developing world. For instance, recent estimates indicate that around 790 million people in developing states are chronically undernourished (meaning their food intake is insufficient to meet basic energy requirements on a continuing basis) and millions more experience under nutrition (meaning they lack essential vitamins and minerals in their diet) leaving them underweight and stunted.2 Absent biotechnology developments, one might doubt that current plant-breeding techniques could increase the world’s food supply enough to 1 “Biotechnology” encompasses a variety of techniques, such as selecting natural strains of organisms that carry desirable traits, making hybrids by fusing cells from different parental sources, using chemicals and radiation to create mutant strains, or genetically engineering plants, animals, and micro-organisms to contain specific phenotypic characteristics. At its most general level, biotechnology concerns techniques for using the properties of living things to make products or services. The principal focus of this article is on recent, controversial developments in biotechnology relating to genetic engineering. 2 U.N. FOOD AND AGRIC. ORG., THE STATE OF FOOD INSECURITY IN THE WORLD 1999 at 10- 11 (1999). 4 feed an estimated 9.4 billion people by the year 2050.3 Yet the dawn of the biotechnology world is generating serious transnational concerns that pose an enormous challenge for the international law and structures of our new century. Concerns arise over whether the genetic resources of the world, once manipulated, should be reducible to property rights, allowing a few companies of technologically-rich states to control access to food, medical, and other resources essential to the health and welfare of billions of people. Concerns arise over whether states should be notified first before any genetically modified products are exported to them, and once informed, on what grounds they may refuse to permit the export to occur. Already a trade impasse has developed between the United States and the European Union over genetically modified food, fueled by consumer demands for labeling schemes or even outright bans. To the extent that widespread bans on exports among developed states emerge, they may inhibit the ability of developing states to obtain the fruits of biotechnology for their own urgent needs, and close off markets for exports of genetically modified products from developing states to the developed world. Further concerns arise if genetic engineering causes transnational catastrophic harm. Although no such harm has occurred to date (such as by destabilizing a state’s biosphere through “genetic pollution”), such an outcome is feared, and raises questions as to responsibility if such an event occurs. Finally, there are long-term concerns about the decline in global biological diversity, which may be accelerated by the widespread use of genetically modified products. The purpose of this article, broadly stated, is to assess the strengths and limits of existing 3 U.N. POPULATION FUND, THE STATE OF WORLD POPULATION 1998 at 2-3, fig. 1 (1998). 5 international law and structures designed to address these concerns, and to suggest a means for augmenting current structures to make them more effective. Part II begins with a discussion of the science of biotechnology, which is useful background for understanding its promises and perils, and then proceeds to briefly relate recent applications of the science and some general concerns about those applications. Part III clarifies and analyzes six specific concerns about biotechnology in the transnational sphere and associated international law and structures. As will be seen, there is no single treaty regime addressing these concerns but, rather, a segmented and at times conflicting network of intellectual property, trade, and environment treaties, accompanied by ambiguous customary law or principles. The few legal studies to date in this area tend to focus on just one of these several concerns, which results in an inability to see connections among them that suggest cross-sectoral opportunities for bargaining and cooperation among relevant state and non-state actors. Prior scholarly studies in this area also tend to focus on state-to-state negotiations as the means for addressing transnational biotechnology. Yet, as discussed in Part IV, international law develops and regulates transnational behavior in a manner that goes well beyond the development treaty regimes. International law is driven in large part by the self-interest of states, but they also arise from the social interaction of states and non-state actors, and they ultimately must become grounded in national laws and society in order to become effective. While Part III emphasizes the need for coordination across different treaty regimes, Part IV emphasizes the need for coordination at different levels of state and non-state behavior as the law develops over time. While states should continue to grapple with concerns in the area of biotechnology through incremental tinkering of existing treaty regimes—seen most recently in the adoption of a Biosafety Protocol to the Convention on Biological Diversity—this 6 article argues that the principal emphasis of the global community on episodic and segmented intergovernmental negotiations as a means for addressing these concerns is misplaced, especially since the science in this area is changing rapidly, the behavior to be regulated is highly commercial and private in nature, and transnational regulation affects a wide variety of state and non-state actors who have complex motivations that change over time. Rather, as advanced in Part V, there is value in coordinating and augmenting traditional treaty regimes by the coalescence of an “epistemic community” of scientists, environmentalists, multinational businesses, trade organizations, development experts, academic groups, and others that transcend sectors. The many issues raised by biotechnology in the transnational sphere need to be addressed by international society as a whole, rather than left to the vagaries of the market, to governments alone, or to the initiatives of a few well-financed interest groups, such as biotechnology companies and environmentalists. One approach would be to establish a transnational forum on biotechnology, which could serve as a relatively informal and non-binding means for the transnational “bargaining” of views among a wide range
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