Source: https://www.lawnet.gov.lk/1959/12/31/biotechnology-and-international-law/
Timestamp: 2019-04-19 07:28:47+00:00

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*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.
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.
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.
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.
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 of relevant non-state actors. Such a forum ultimately may be instrumental in achieving consensus on a coherent and effective legal regime to address concerns with transnational biotechnology, one that balances the tremendous opportunities of biotechnology against its potentially severe and adverse transnational effects.
recognize the indispensability of cooperation among non-governmental actors in advance of the formation of new international legal regimes and in advance of major reforms of existing regimes. Otherwise, the development of international law in such areas will prove increasingly ineffective and unsatisfactory in responding to the demands of international society.
plant-moves well beyond anything previously seen. Traditional cross-breeding involves selectively breeding for desired genetic traits, usually within a single species or species complex, while the genetic engineering that began in the 1970’s allows genes to be transferred between distant species that would never interbreed in nature, raising new issues, questions, and problems in both the national and transnational sphere.
Using such techniques, scientists are capable of joining DNA fragments from different sources to create novel DNA (known as recombinant DNA or rDNA) so as to take a valued quality of one organism and join it with the valued quality of a second organism. Although today’s science is not advanced enough to know what fragments of DNA to combine in order to cross complex organisms without seriously disrupting the normal development of the embryo,9 there already exist many less complex applications of this new biotechnology.
10 See Andrew Pollack, New Ventures Aim to Put Farms In Vanguard of Drug Production, N.Y. TIMES, May 14, 2000, at 1.
THE RETOOLING OF HUMAN LIFE (1995). Scientists currently mapping the multi-billion-unit human DNA sequence hope that it will lead to an ability to identify and manipulate human genes responsible for aging and disorders, leading to treatments for cancer, heart disease, and other maladies. See Karl Lenhard Rudolph et al., Longevity, Stress Response, and Cancer in Aging Telomerase-Deficient Mice, 96 CELL 701 (1999). As of July 2000, two entities-a private company named Celera Genomics Corporation and a multi-national consortium of educational centers named the Human Genome Project-are on the verge of completing a total sequencing of genes of a human cell. See Rick Weiss & Justin Gillis, DNA-Mapping Heralded, WASH. POST, June 27, 2000, at A1. As each gene sequence is uncovered by the Human Genome Project, there is complete and continuous public disclosure, which has the effect of blocking private patents on the uncovered gene sequence. For the consortium’s Internet site, maintained by the U.S. National Center for Biotechnology, see <http://www.ncbi.nlm.nih.gov/genome/seq>. Although public and private ventures are already seeking patents for various segments of the human genome, in all but a handful of these instances, the applicant does not yet understand the function, usefulness or commercial value of the genetic material.
12 Scientists have already manipulated the DNA sequence of mouse genes so as to make a smarter mouse. See Ya-Ping Tang et al., Genetic Enhancement of Learning and Memory in Mice, 401 NATURE 63 (Sept. 2, 1999).
14 For instance, antibodies (proteins created by certain white blood cells to fight infection) have been very difficult to create in the laboratory using traditional methods, since white blood cells do not survive easily outside the body. Using techniques of biotechnology, however, the antibody-producing qualities of white blood cells have been fused with cancer cells, which have the property of unstoppable growth, so as to turn out a continuous supply of antibodies. Other therapeutic proteins replicated using genetic manipulation include insulin, alpha interferon, and human growth hormones, some of which have purely animal applications. One advantage of using human genes to produce the drugs for humans is that they are less likely to generate adverse side-effects.
17 In 1996, Scottish scientists successfully cloned a lamb from an adult sheep, by taking the nucleus of an adult sheep’s cell and transferring it into another sheep’s unfertilized egg. The “reconstructed” embryo was placed in the womb of a foster mother and brought to term. Thus, was born Dolly. See I. Wilmut et al., Viable Ofspring Derived from Fetal and Adult Mammalian Cells, 385 NATURE 810 (1997).
university, every industry that supports work in this area to heed the Federal Government’s example” and to undertake a voluntary moratorium on the cloning of human beings “until our Bioethics Advisory Commission and our entire Nation have had a real chance to understand and debate the profound ethical implications of the latest advances”). The National Bioethics Advisory Commission was established by Exec. Order No. 12,975, 3 C.F.R. 409 (1995), reprinted in 42 U.S.C. §6601 (Supp. II 1996).
In January 1998, the FDA asserted that it had January 1998 that it had statutory authority to regulate human cloning. See Gregory J. Rokosz, Human Cloning: Is the Reach of FDA Authority Too Far a Stretch? 30 SETON HALL L. REV. 464 (2000). Meanwhile, some U.S. states have banned human cloning. See, e.g., CAL. HEALTH & SAFETY CODE §24185 (West Supp. 2000).
CODE OF CODES:SCIENTIFIC AND SOCIAL ISSUES IN THE HUMAN GENOME PROJECT (1992).
19 See Anne Simon Moffat, Toting Up the Early Harvest of Transgenic Plants, 282 SCI. 2176 (1998).
20 See David A. O’Brochta & Peter W. Atkinson, Building the Better Bug, SCI. AM., Dec. 1998, at 90.
AGRICULTURAL BIOTECHNOLOGY AND THE ENVIRONMENT 1 54-65 (1996).
23 The first genetically modified product for food use to receive U.S. Government approval was the Flavr-Savr tomato, developed by Calgene. Approved in May 1994, the tomato had been genetically engineered so that it could stay on the vine until fully ripe, picked, but then delay ripening (and hence rotting) further. See Calgene, Inc., Availability of Letter Concluding Consultation, 59 Fed. Reg. 26,647 (Dep’t Health & Human Services 1994). The Flavr-Savr tomato proved less successful than hoped, as it cost more and did not taste as good as competing tomatoes.
broken down into harmless chemicals when ingested by humans due to the highly acidic conditions of human stomachs. Ironically, Bt is the principle insect-controlling spray used by organic farmers, since it is an organic insecticide. Many genetically modified, insect-resistant crops currently used contain the Bt gene. See Michael Pollan, Playing God in the Garden, N.Y. TIMES, Oct. 25, 1998, §6 (Magazine), at 44.
28 See Seeds of Change, CONSUMER REP., Sept. 1999, at 41.
30 See Anne Kathrine Hvoslef-Eide & Odd Arne Rognli, Environmental Issues for Plant Biotechnology Transfer: A Norwegian Perspective, in PLANT BIOTECHNOLOGY TRANSFER TO DEVELOPING COUNTRIES 37, 38-39 (David W. Altman & Kazuo N. Watanabe eds., 1995) (arguing that biotechnology “will probably provide the key for producing more food and other agricultural commodities from less land and water in the twenty-first century, without the adverse ecological implications associated with the expression of the full yield potential of high-yielding crop varieties through high-input agriculture”).
<http://bob.nap.edu/html/transgenic> (collaborative report of eight national academies of science, including the U.S. National Academy of Sciences).
32 See Janet Raloff, An Alaskan Feast for Oil-Eating Microbes, 143 SCI. NEWS 253 (1993).
dangerous and should not be developed further absent extensive long-term testing, if at all. In particular, critics note that unlike hazardous chemicals or wastes, genetically modified organisms are potential hazards “with legs,” capable not just of spreading but of proliferating.34 Reviewing the scientific literature shows that scientists can be found to support both positions, with molecular biologists tending to see little risk in genetically modified organisms, and ecologists tending to see more. The widespread introduction in the United States of bioengineered products, from food to fabric, initially provoked little reaction from the public at large, but that now may be changing, and may result in greater attention by politicians to the means by which biotechnology is regulated.
source material. See ORGANIZATION FOR ECON. COOPERATION AND DEV., INTELLECTUAL PROPERTY, TECHNOLOGY TRANSFER AND GENETIC RESOURCES 28-29 (1996) [hereinafter OECD REPORT].
39 Other federal entities, such as the National Institutes of Health, the National Science Foundation, and the Department of Energy also play a role in federal regulation of the biotechnology industry. In fact, the earliest U.S. regulations concerning biotechnology arose with NIH’s effort to address contained testing in laboratories and greenhouses that developed during the 1970s. See Guidelines for Research Involving Recombinant DNA Molecules, 45 Fed. Reg. 77,384 (1980). For the White House’s interagency coordinating guidelines, see Coordinated Framework for Regulation of Biotechnology, 51 Fed. Reg. 23,302 (1986). Those guidelines make clear that existing laws will regulate biotechnology, that the products of biotechnology (rather than the process) will be regulated, and that the safety of a biotechnology product will be decided on a case-by-case basis.
extensive studies should be conducted by independent scientists regarding the risks to human and animal health from consumption of genetically modified food.
45 For a recent example, see Carol Kaesuk Yoon, Squash With Altered Genes Raises Fears of “Superweeds,” N.Y. TIMES, Nov. 3, 1999, at A1.
46 See, e.g., Allison A. Snow & Pedro Morán Palma, Commercialization of Transgenic Plants: Potential Ecological Risks, 47 BIOSCIENCE 86, 93 (1997).
47 See Rick Weiss, Corn Seed Producers Move to Avert Pesticide Resistance, WASH. POST, Jan. 9, 1999, at A4. Even though the soil bacterium Bt is already used to spray crops, see supra note 24, critics charge that crops genetically modified to contain Bt add much more of the toxin to the environment and are less apt to degrade, thus threatening insects far more with extinction, and in turn prompting greater mutation.
48 For Internet sites dealing with biotechnology in the transnational sphere, see listings that appear at the Internet site operated jointly by the Organization for Economic Cooperation and Development (OECD) and the U.N. Industrial Development Organization (UNIDO),<http://www.oecd.org/ehs/biobin>. The U.S. Information Agency also maintains an Internet site on global biotechnology issues at <http://usinfo.state.gov/topical/global/biotech>.
tissue transplantation. See also Additional Protocol to the Convention for the Protection of Human Rights and Dignity of the Human Being With Regard to the Application of Biology and Medicine, on the Prohibition of Cloning Human Beings, Jan. 12, 1998, Eur. T.S. No. 168, reprinted in 36 I.L.M. 1415 (1997).
The U.N. Educational, Scientific, and Cultural Organization (UNESCO) has adopted a nonlegally binding declaration stating that human cloning is “contrary to human dignity” and “shall not be permitted”. UNESCO, Universal Declaration on the Human Genome and Human Rights (1997), <http://www.unesco.org/ibc/uk/genome/projet/index.html>. Similarly, the World Health Organization (WHO) has adopted a resolution affirming “that the use of cloning for replication of human individuals is ethically unacceptable and contrary to human integrity and morality.” WHO Doc. WHA50.37 (May 14, 1997). No doubt further steps will need to be considered on a global level.
50 One can imagine a host of other potential problems of the future. In the field of immigration and refugee law, if the use of biotechnology for medical treatments in one group of states vastly outpaces in development in other states, there may emerge a new category of persons known as “medical refugees.” Or, if scientists can some day screen individuals genetically for their disposition to engage in criminal behavior, legislators may be tempted to use the information to deny the admission of refugees on grounds of national security or safety. U. S. law currently calls for refusal of asylum or for removal when an alien is shown to have engaged in a “serious nonpolitical crime” prior to the alien’s arrival in the United States, see, e.g., INS v. Aguirre-Aguirre, 526 U.S. 415 (1999), regardless of whether the alien has completed his or her sentence, presumably on grounds that the prior act is predictive of future behavior.
51 See Michael J. Malinowski, Globalization of Biotechnology and the Public Health Challenges Accompanying It, 60 ALB. L. REV. 119 (1996).
developing states, and in any event is inappropriate for life forms. Second, developed states desire relatively unrestricted access to the rich genetic diversity found in developing states as source material for genetic engineering, while developing states argue that the fruits of genetic resources uncovered in developing states should be equitably shared with them.52 Each theme is addressed in turn.
With respect to the first theme-concerning whether to grant and protect intellectual property rights in genetically modified products-U. S. intellectual property law generally does not acknowledge ownership or use of naturally occurring or socially maintained materials or information in the public domain, such as genetic resources. Consequently, access to such genetic resources is generally unrestricted. However, once novel products or processes are developed from genetic resources, then U.S. law may provide intellectual property protection. Thus, a naturally occurring substance, whether living or inanimate, in principle can be patented if it is isolated from its surroundings, identified and made available for the first time, and has a useful purpose. Further, patents may be issued for chemical compounds corresponding to genes or nucleotide sequences when isolated and made available for a useful purpose.
ANATOLE F. KRATTIGER, GLOBAL REVIEW OF THE FIELD TESTING AND COMMERCIALIZATION OF TRANSGENIC PLANTS, 1986 TO 1995: THE FIRST DECADE OF CROP BIOTECHNOLOGY 4-5 (Int’l Serv.
for the Acquisition of Agri-biotech Applications Briefs No. 1, 1996).
53 35 U.S.C. §101 (1994).
54 Diamond v. Chakrabarty, 447 U.S. 303 (1980) (finding that a genetically engineered bacterium capable of breaking down crude oil could be patented). See generally John M. Czarnetzky, Note, Altering Nature ‘s Blueprints for Profit: Patenting Multicellular Animals, 74 VA. L. REV. 1327 (1988). Interestingly, the oil eating bacterium at stake in Chakrabarty was never commercialized. See KRIMSKY & WRUBEL, supra note 22, at 158. On the generally favorable disposition of U.S. courts and of the policy decisions of the U.S. Patent and Trademark Office toward genetic innovation, see Timothy Caulfield et al., Patent Law and Human DNA: Current Practice, in LEGAL RIGHTS AND HUMAN GENETIC MATERIAL 117 (Bartha Maria Knoppers et al. eds., 1996).

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