The Institute for Domestic and International Affairs
United Nations Conference on Trade and Development Biotechnology Rutgers Model United Nations 16-19 November 2006
Director: Ravi Patel
Š 2006 Institute for Domestic & International Affairs, Inc. (IDIA) This document is solely for use in preparation for Rutgers Model United Nations 2006. Use for other purposes is not permitted without the express written consent of IDIA. For more information, please write us at idiainfo@idia.net
Introduction _________________________________________________________________ 1 Background _________________________________________________________________ 3 Intellectual Property Rights ________________________________________________________ 7 Technology Transfer and Intellectual Property ________________________________________ 8 Agriculture _____________________________________________________________________ 10 Concerns Over GM Agriculture ____________________________________________________ 13 Biosafety _______________________________________________________________________ 14 Human Genome Project___________________________________________________________ 17
Current Status ______________________________________________________________ 17 Key Positions _______________________________________________________________ 20 Regional Blocs ___________________________________________________________________ 20 Africa ________________________________________________________________________________20 Asia __________________________________________________________________________________21 Europe ________________________________________________________________________________22 North America__________________________________________________________________________22
Business Interests ________________________________________________________________ 23
Summary___________________________________________________________________ 25 Discussion Questions _________________________________________________________ 26 Works Cited ________________________________________________________________ 27 Works Referenced ___________________________________________________________ 30
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Introduction In September 2000, the United Nations established the Millennium Development Goals (MDG), a list of eight priorities to be completed by the target year of 2015. The purpose of this declaration was to form “a blueprint agreed to by all the world’s countries and all the world’s leading development institutions.
They have galvanized
unprecedented efforts to meet the needs of the world’s poorest.”1 The eight goals encompassed
by
the
Millennium
Development Goals seek to develop and improve the economy, public health care, education,
and
developing states.
infrastructure
of
Of these aims,
Millennium Development Goals All 191 United Nations Members States made a commitment to the MDGs in 2000, with an aim to achieve them by 2015. They are: • • • • • • • •
Eradicate extreme poverty and hunger Achieve universal primary education Promote gender equality and empower women Reduce child mortality Improve maternal health Combat HIV and AIDS, malaria and other diseases Ensure environmental sustainability Develop a global partnership for development
Source: www.eu2005.gov.uk/servlet/Front
biotechnology directly affects six, including: eradicate extreme hunger and poverty; reduce child mortality; improve maternal health; combat HIV/AIDS, malaria, and other diseases; ensure environmental sustainability; and develop a global partnership for development.2
Using biotechnology, the problem of world hunger and other social
challenges can be solved while simultaneously building prosperous economies and environments. Biotechnology is one of the most remarkable advances carrying into the new millennium.
The biotechnology revolution has changed the path of science and
Biotechnology: collective term for a group of technologies that use biological matter or processes to generate new and useful products and processes Source: http://www.unctad.org/en/docs/poitetebd10.en.pdf
1 2
technology, from medicine, food, chemicals, alternative fuel sources, and countless other areas. A widely accepted definition for biotechnology
“UN Millenium Development Goals.” Accessed 9 August 2006. http://www.un.org/millenniumgoals/ Ibid.
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is a “collective term for a group of technologies that use biological matter or processes to generate new and useful products and processes.”3 Despite the immense promise of this new expertise, the international community has showed great resistance to agricultural biotechnology due to a perceived risk in the health of humans and animals, as well as alleged negative environmental consequences. These claims of adverse effects have not, however, been successfully proven. Aside from agricultural use, plants have a tremendous range of application in the modern world.
From developing new fuel sources, chemicals, rubbers, and
pharmaceutics, plants have shown the ability to reduce the demand for fossil fuel to develop these products and processes.
Unfortunately, the ongoing debate over
genetically modified organisms has caused research into this field to decrease rapidly, resulting in a considerable slowing of progress in these areas. Along with the problems caused by efforts to globalize genetically modified food, disputes over intellectual property rights and issues regarding biosafety add to the delays in commercialization. The United Nations Conference on Trade and Development (UNCTAD) can facilitate the research and development of these technologies in developing states by undertaking research and policy analysis, and by providing technical assistance so that they can be integrated into the mainstream economy. In the realm of intellectual property rights, UNCTAD has the authority to assist the transfer of technology to developing states. The issue of biosafety has prevented the
general
public
acceptance
and
commercialization of genetically modified foods (GMF), as many consumers are under the impression that these goods can have
Biosafety: The assessment of the impact and safety of genetically improved/modified organisms and the development of protective policies and procedures for adoption to ensure this. Source: www.pub.ac.za/resources/glossary.html
potentially harmful effects on the health of humans, animals, and the environment. Seeing the need to implement biosafety regulations, the Cartagena Protocol on Biosafety 3
“Key Issues in Biotechnology.” United Nations Conference on Trade and Development. www.unctad.org/en/docs/poitetebd10.en.pdf, accessed 15 August 2006.
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was adopted in 2000 by the United Nations Environmental Programme to establish minimum safety levels. Despite these measures, investors and consumers have not yet embraced the pursuit of biotechnology for the benefit of economic growth. Plagued by food security issues, Africa is projected to benefit the most from the advances in biotechnology, in areas ranging exports to public health.
Despite the
potential for growth, African states uniformly believe that without regulation and proper expertise, true implementation of biotechnology may not be attainable.
Europeans,
however, have different opinions on biotechnology. The European Union had banned the trade, production, and consumption of genetically modified organisms, including food, however these restrictions were overturned by the World Trade Organization (WTO). With many advances in science, research seems to be moving along well. Unfortunately, most biotechnological research is centered in highly developed areas such as the United States and Europe, as developing states do not have the resources to conduct high caliber research. With the hopes of the Millennium Development Goals and the efforts of UNCTAD for building capacity in poor states, developing nations will be able to compete with the developed market if they embrace biotechnology practices. In all areas of research and development and commercial production of the products of biotechnology, the needs of the changing world can be met through improvements in science.
Background Coupling biology and technology may seem like a recent development in the scheme of scientific development. Contrary to this view, applications of biotechnology have been in use for more than four thousand years in agriculture as farmers have mastered cross-breeding in crops. Broad-scale public interest in the field, however, did not emerge until the 1980s.
The scope of biotechnology ranges from developing
genetically modified crops in agriculture to synthesizing drugs in pharmaceuticals to the engineering of prosthetic limbs and organs in medicine. This large range of applications
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shows an immense promise for the future of science, technology, and the economy. This multi-billion dollar international industry has the potential to change the world in numerous different ways. Genetic modification (GM) is a part of
replicated and transferred to other cells or
Genetic Material: Genetic material is the material used to store genetic information for a living organism. For all currently known living organisms, with the exception of prions, the genetic material is almost exclusively DNA. This is supplemented with cytoplasmic inheritance factors, often proteins. For some forms of artificial life, the genetic material is computer memory or other digital data storage media.
organisms.
Source: en.wikipedia.org/wiki/Genetic material
biotechnology that occurs when an organism’s genetic material is altered using recombinant technology.
This process does not happen
naturally, but the modification can be The
technology
used
for
modification entails manipulating DNA after removing it from a cell. This new genetic information is inserted into the same organism or another specimen, allowing for new characteristics to be associated with the organism.4 In 1973, Stanley N. Cohen and Herbert Boyer created the first genetically modified organism combining and genetic information from different species.5 Shortly after this momentous development scientists instituted a moratorium on recombinant DNA experiments to allow time for a conference to be held to examine the new technology and any potential hazards relating to its development. Such a conference was held and the consensus determined that research regarding recombinant DNA was permissible, however, only under regulations, and national health institutes within each country were responsible for overseeing the implementation of these rules. Just a year following the creation of the first genetically modified organism, the first transgenic
4
“Genetically Modified Organisms (Contained Use).” Health and Safety Executive. Crown Copyright. 5 July 2006. Accessed 19 August 2006. http://www.hse.gov.uk/biosafety/gmo/index.htm 5 “Genetics and Genomics Timeline: 1973.” Genome News Network. J. Craig Venter Institute. 2004. Accessed 20 August 2006. http://www.genomenewsnetwork.org/resources/timeline/1973_Boyer.php
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animals were created in 1974 by Rudolf Janeisch. The experiment entailed mice embryos modified during prenatal stages of development.6 Since its inception, genetic modification has caused immense controversy in that many feel that the technology disrupts the natural order of life. Genetic modification technology offers immense benefits in multiple areas, however, that make it appealing. Indeed, many argue that genetic mutations and crossbreeding occurs naturally so conducting the same process through science does not interfere with any natural order. Beyond this scope of debate, there is question as to whether or not genetically modified commodities should be labeled as such.
Additionally, patents and property rights
regarding products created through genetic engineering also creates controversy.7 Genetic engineering is a fundamental practice in biotechnology. This technique has the capability to modify existing organisms by transferring existing genes from different organisms.
Examples of
genetic modification include the “incorporation insecticidal
of
proteins
genes of
for
Bacillus
thuringiensis (Bt) into the genomes
Genetic Engineering: The technique of removing, modifying, or adding genes to a DNA molecule in order to change the information it contains. By changing this information, genetic engineering changes the type or amount of proteins an organism is capable of producing, thus enabling it to make new substances or perform new functions. Source: usinfo.state.gov/journals/ites/0903/ijee/glossary.htm
of several crop species such as tobacco, maize, potato, rice and cotton, among others.”8 Genetic modification of these organisms allows scientists to create a variety of products.
Although the field of
biotechnology is blossoming, there may be difficult problems that the international community will have to face in the future if this area of scientific development is left unattended.
6
The biotech boom, attributed to the rapid advances in science and
Berg, Paul. “Asilomar and Recombinant DNA.” Nobel Prize in Chemistry. Nobelprize.Org. 26 August 2004. Accessed 19 August 2006. http://nobelprize.org/nobel_prizes/chemistry/articles/berg/ 7 Ibid. 8 Agenda 21: Chapter 16. http://www.un.org/esa/sustdev/documents/agenda21/english/agenda21chapter16.htm “The Biotechnology Promise” Capacity Building for Participation of Developing Countries in the Bioeconomy” 2004.
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engineering, has left some private firms in a financially secure situation with little governance. This key technology has the set the pace for the new millennium. In 1992, the United Nations Conference on Environment and Development regarded biotechnology is a field that “promises to make a significant contribution in enabling the development of, for example, better health care, enhanced food security through sustainable agricultural practices, improved supplies of potable water.”9 Other applications of biotechnology include “more efficient industrial development processes for transforming raw materials, support for sustainable methods of a forestation and reforestation, and detoxification of hazardous wastes.”10 The debate over governance of biotechnology is a very broad subject, but UNCTAD’s scope is limited to bioethics and safety, intellectual property rights, and food development. During the course of the conference, a program called Agenda 21 emerged. Agenda 21, is a five part program with an outline of actions to be taken to conserve and strengthen the environment, while combating poverty and promoting health and sustainable development. The five sections of Agenda 21 deal with social and economic dimensions, conservation and management of resources for development and strengthening the role of major groups. The primary goals for biotechnology established by Agenda 21 are as follows: to increase to the optimum possible extent the yield of major crops, livestock, and aquaculture species [and forests], … to reduce the need for volume increases of food, feed and raw materials … to reduce post-harvest losses of plant and animal products…to increase the use of integrated pest, disease and crop management techniques … to evaluate the agricultural potential of marginal lands allowing for sustainable productivity increases … to expand the applications of biotechnology in forestry ... to increase the efficiency of nitrogen fixation and mineral absorption…to improve capabilities in basic and applied sciences and in the management of complex interdisciplinary research projects.11
The United Nations Commission on Science and Technology for Development (CSTD), a subsidiary body of UNCTAD, is primarily used as a “gateway to information on science
9
Ibid. Ibid, 13. 11 Ibid. 10
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and technology within the United Nations system.”12 This body compiles relevant data from other United Nations bodies, such as the Food and Agriculture Organization (FAO) and the United Nations Environment Programme (UNEP), along with various other organizations.
Intellectual Property Rights According to the United Nations (UN), most of the technology developed in biotechnology is knowledge-intensive, rather than capacity-intensive.
This sets
biotechnology apart from most other types of business interests, as most of the methods Trade-Related Aspects of Intellectual Property Rights: Trade Related aspects of Intellectual Property. Term used in the context of the General Agreement on Tariffs and Trade (GATT) and the World Trade Organization (WTO) usually for attempts to harmonize the patents laws of different nations and enforce patent rights internationally. The Uruguay Round of the GATT, an agreement finalized in December of 1993, includes an agreement on TRIPs. Source: www.jmcgowan.com/avigloss.html Patent: the granting by a government of monopoly rights to the owner of an invention to manufacture and sell it for a certain number of years, conditional on the owner being willing to immediately reveal the ideas incorporated in the invention, so that they can be published for the advancement of knowledge of the general public. Source: www.smallbiz.nsw.gov.au/smallbusiness/Resources/ Business+Tools/Glossary+of+Business+Terms/
that have been developed are predominantly in the private sector of developed nations. Essentially, the problem lies in how to integrate technology into the mainstream and used in the rest of the world. The World
Trade
Organization’s
agreement on the Trade-Related Aspects of Intellectual Property Rights (TRIPS) protects scientific discoveries
in
biotechnology.
According to TRIPS, patents can be earned “for any inventions, whether products or processes, in all fields of technology, provided that they are new, involve an inventive step and are capable of industrial application.”13
Patents grant the inventor of the
technology a monopoly over its use for a certain amount of time.
As a form of
intellectual property, these patents can hinder the social, political, and economic growth of a country, while giving the firm very prosperous returns.
12 13
About StDev. http://stdev.unctad.org/about/index.html. The Biotechnology Promise.
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Technology Transfer and Intellectual Property Technology transfer defined “as the transfer of systematic knowledge for the manufacture of a product, for the application of a process or for the rendering of a service,” may be a solution to the problem.14 Essentially, technology transfer is the spread of knowledge and information from an original source to outside sources. For example, government funded research can be spread to the private sector, universities, and other institutions for the purpose of furthering knowledge and introduction to the mainstream market.
Since technology transfer is a type of trade, potentially costly
international tariffs and taxes may be applicable. When discussing technology transfer, disputes regarding intellectual property (IP) often arise, hindering scientific progress. IP challenges occur when one scientist of firm asserts ownership over technology being used without permission by another. Intellectual Property: In law, particularly in common law jurisdictions, intellectual property or IP refers to a legal entitlement which sometimes attaches to the expressed form of an idea, or to some other intangible subject matter. In general terms this legal entitlement sometimes enables its holder to exercise exclusive control over the use of the IP. Source: en.wikipedia.org/wiki/Intellectual_property_rights
UNCTAD’s work with technology transfer tries to “identify ways and means to use TOT-IP (transfer of technology and intellectual property) to promote the technological capabilities of developing countries, and provide
policy options for the operationalization of technology transfer clauses in international, regional and bilateral arrangements.”15 This measure will help the current rift between nations that have technological prowess in the field of biotechnology and nations that are still developing those abilities. The issues surrounding biotechnology are “particularly in the life sciences [and] have arisen around the definitions of what can and cannot be described as a human
14
Taxation and Technology transfer: Key Issues. United Nations Conference on Trade and Development: Transfer of Technology for Successful Integration into the Global Economy. 2005. 15 About Transfer of Technology and Intellectual Property Rights. http://www.unctad.org/Templates/Page.asp?intItemID=3424&lang=1 9/13/2006.
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invention, and is therefore considered eligible for patent protection.”16 Before stringent regulation of intellectual property rules, developing nations such as India and Brazil have benefited from the loose regulation. These nations developed industries in low cost generic pharmaceutical drugs. These drugs were duplicates of brand name designer drugs.
Since the implementation of TRIPS, the unregulated copying of these
pharmaceuticals is no longer be allowed. Many corporations and firms argue that intellectual property rights extend to manufactured genes and bacteria used in processes for pharmaceutical and agricultural products. For example, in 1995 the Bayer Corporation patented a drug to treat Type II Diabetes. The drug, known as Acarbose was produced and marketed within Europe, however just a year before it was introduced in North America, the corporation filed to obtain a patent on a new method for manufacturing the product. “The patent application, which was subsequently issued in Europe, the U.S., and Australia, reveals [in 2001] that an Actinoplanes sp. bacteria strain called SE 50 had unique genes that enable the biosynthesis of acarbose in fermentors. The strain comes from Kenya’s Lake Ruiru.”17 Patenting Acarbose essentially copyrights the genes in the Actinoplanes sp. bacteria strain which produces the drug. This regulation creates a monopoly for Bayer on all the producible Acarbose. In this way, Bayer has essentially received a patent over a naturally occurring process. Subject to dispute, the Lake Ruiru area may be under protection of its indigenous or traditional knowledge. This knowledge, according to many individual nations is “is under threat of exploitation by commercial interests and that which is being lost due modernization of local societies.”18 Although these areas of intellectual property rights are out of the scope of UNCTAD, it is important to consider the implications of these exploitations for future actions.
16
http://www.scidev.net/dossiers/index.cfm?fuseaction=dossierfulltext&Dossier=8 Out of Africa. 18 Promise of Biotechnology. 17
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Agriculture The United Nations has estimated the demand for food worldwide will double by the year 2050. The UN has also acknowledged that “conventional food production technology alone cannot meet this demand.
In designing their strategies for food
production, countries will need to examine the role of new technologies, especially biotechnology.”19 Genetically modified food (GMF) is one of the most notable potential benefits for development that can be derived from genetic modification technology as it could provide a sustainable supply of nutrient rich food. Genetically modified food is any food product that is either totally or partially derived from genetically modified organisms, meaning that food derived from a genetically modified crop, animal, or microbe is classified as GMF. These foods first became available for public consumption during the 1990s.20 The first GM food grown for commercial purposes was a tomato called FlavrSavr developed by the company Calgene Inc. The corporation obtained approval from the United States Food and Drug Administration (FDA) to market the product, and the tomato entered markets in 1994.21 Since that time, genetically modified cotton, canola, soybeans, maize, rice, and others commodities have been introduced into the market. Transgenic crops, those that have genes from more than one species, are grown throughout the world. The benefit to these plants is that they can be bred as herbicide, insecticide, and virus-resistant in addition to having enhanced flavor and increased nutritional value. These crops can also be bred to grow in extreme conditions such as those with water and nitrogen limitations, with high salinity or acidic soils, or with harsh weather conditions.22 About 109.2 million acres were planted with transgenic crops in
19
“Biotechnology and its impact on development.” “The ABIC 2004 Manifesto: Science Helps To Improve Agricultural Systems.” The International Society for Agricultural Meteorology. 2004. Accessed 20 August 2006. http://www.agrometeorology.org/index.php?id=386. 21 Crystal, Ellie. “Genetically Modified Foods.” Crystalinks. Accessed 19 August 2006. http://www.crystalinks.com/gmproducts.html. 22 “Scientific Facts on Genetically Modified Crops.” Greenfacts: Facts on Health and the Environment. Accessed 20 August 2006. http://www.greenfacts.org/gmo/index.htm. 20
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2000. The United States, Argentina, Canada, and China comprise 99 per cent of the total genetically modified surface area as of 2001. U.S. grocery stores are stocked with products of which an estimated 70 per cent contain GM ingredients.23 GM food has the potential to make crop production far more efficient. These changes in agricultural science show that “biotechnology could enable food-deficient countries to meet the objectives of food sufficiency, sustainable agricultural production and improved environmental management.”24 The earth has only a limited capacity for agricultural production, but by using GM crops to ensure quality and yield, the use of the area is maximized, and can in turn help alleviate the problem of global hunger by providing more stable, nutrient-rich crops. Both these features can be achieved through genetic modification.25 Engineering can also develop fish that mature earlier and fruit and nut trees that provide yield more quickly. Another potential benefit of genetic modification being developed is food commodities that produce vaccines against human diseases. This technology would provide an accessible way for people worldwide to be inoculated for harmful diseases. Also, a 2005 study by PG Economics showed that GM crops significantly reduced the emission of greenhouse gases that have been linked to global warming because of different farming practices that require the use of less fossil fuel.26 Scientists have developed rice strains that may prevent blindness in children, attributable to a vitamin A deficiency, be enriching rice with more of this important nutrient. Similarly, scientists have developed a rice strain that combats iron deficiency, which afflicts roughly thirty per cent of the world’s population. Iron enriched diets prevent malnourishment and promote rapid body growth in the first two years of development.27
23
Crystal. Ibid. 25 Trewavas, Anthony J. “The Population/Biodiversity Paradox. Agricultural Efficiency to Save Wilderness.” Plant Physiology. January 2001, Vol. 125, pp. 174-179. Accessed 20 August 2006. http://www.plantphysiol.org/cgi/content/full/125/1/174 26 Crystal. 27 Ten Reasons. 24
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Along with genetically modified foods, biotechnology affects agriculture by improving the quality and effectiveness of fertilizers and pesticides. An example of a biofertilizer is the biological nitrogen fixation process. Nitrogen fixation is a key role in biological processes in plants, it enables plants to convert nitrogen from the air into ammonium and nitrates. Biopesticides are biological pesticides, which are favored over chemical pesticides. According to UNCTAD, the most common biopesticide is the bacteria Bacillus thuringiensis (Bt).
These bacteria
accounts for 90 per cent of the 160 million United States Dollar biopesticides market.28 These developments can aid nations in the
Nitrogen Fixation: Nitrogen fixation is the process by which nitrogen is taken from its relatively inert molecular form (N2) in the atmosphere and converted into nitrogen compounds useful for other chemical processes (such as, notably, ammonia, nitrate and nitrogen dioxide). Source: en.wikipedia.org/wiki/Nitrogen_fixation
development of agriculture. For example, modified agricultural products can meet the demands of the population and develop stronger crops that have less dependence on water, fertilizers, and pesticides.
Additionally, modified crops can increase the
“productivity and competitiveness at national, regional and international levels … protect environment and biological diversity … improve soil fertility and conservation …and increase nitrogen and phosphorus absorption by crops.”29 In a study conducted for the Chinese State Council, researchers found that “genetically modified organisms do not pose a higher risk than varieties bred through ordinary breeding. The greater risk lies in a state that neglects to use these powerful techniques in order to solve the daily increase in food demand.”30 Derived from genetic engineering, biopharming is a revolutionary approach in the booming pharmaceutical industry that uses genetically modified plants to produce pharmacological products. Examples of on going biopharming research project are the production of genetically modified tobacco that produces vaccines against Hepatitis B, 28
Biotechnology promise. Ibid. 30 Ho, Peter and Eduard B. Vermeer. “Food Safety Concerns and Biotechnology: Consumers' Attitudes to Genetically Modified Products in Urban China” The Joural of AgroBiotechnology Managemetn and Economics. http://www.agbioforum.org/v7n4/v7n4a02-ho.htm. 29
Rutgers Model United Nations 2006 Biopharming: The production of biopharmaceuticals in plants or domestic animals. Srouce: www.csrees.usda.gov/nea/ biotech/res/biotechnology_res_glossary.html
13
tubers that produce human insulin, and potatoes that produce antibodies for reducing the risk of rejection in kidney transplants.31 Biopharming has
a
tremendous
cost
advantage
over
conventional chemical synthesis; these drugs can be produced in plants for as little as ten per cent of the cost compared to the conventional method. By the same token, these developments allow scientists to alter not only the physical characteristics of a crop, such as size, color, and shelf-life, but also allow them to alter the taste.
Genetic taste modification has been employed by various food
manufacturers such as Coca-Cola Company and Kraft Foods.
Concerns Over GM Agriculture Detractors call into question the safety of genetically modified foods as several studies have found evidence that the consumption of such food has negative effects on human health, although such claims have not yet been adequately substantiated.32 Others suggest that there is no way to control the GM technology and that without regulation, companies could create new foods and organism without the necessary oversight to ensure public safety.
The largest international issues pertaining to
genetically modified food involves a disagreement over labeling requirements and documentation.33 Genetically modified organisms (GMOs) in agriculture should be regulated, according to the Food and Agriculture Organization (FAO), which suggests that the “two main motivations are that GMO regulation allows developing countries to protect consumer health and the environment and/or to harness the benefits of these new technologies.”34 If genetically modified organisms were regulated, developing nations 31
Climbing the helical staircase: A survey of biotechnology. The Economist, 29 March, pp. 3-18. Ibid. 33 “WTO to probe Europe's GMO policy.” BBC News. 29 August 2003. Accessed 29 August 2006. http://news.bbc.co.uk/1/hi/business/3191395.stm. 34 “Regulation of GMO’s” http://www.fao.org/biotech/logs/C9/summary.htm. 32
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would be able to see potential benefits. Along with the FAO, many states feel that a regulatory framework should be implemented. In developing countries, strict regulation would require “substantial financial and human resources inputs, [that] would penalize public sector GMO research initiatives directed toward developing country needs and would allow multi-national corporations (MNCs) to continue dominating the area with their focus on major crops and traits”35
Stricter regulations would discourage the
unmanaged spread of GMO, and could increase the cost of the products.
Biosafety Biosafety is concerned with the potentially adverse impacts of biotechnology on human, animal, and plant health in addition to the environment.36 Moral and ethical objections also come into play when discussing this matter.
In January 2000, the
Cartagena Protocol on Biosafety was adopted. Drafted under the supervision on the United Nations Environmental Programme, this international agreement on biosafety ensured a sufficient level of protection “in the field of the safe transfer, handling and use of living modified organisms resulting from modern biotechnology that may have adverse effects on the conservation and sustainable use of biological diversity.”37 The Protocol addresses biosafety and asserts that new developments achieved through biotechnology should be pursued only so far as safety can be guaranteed. Therefore, if a state is uncertain regarding the safety of a specific product, they are entitled to prevent their population to being exposed to the potential danger by making the item inaccessible. The aim of the Protocol is to guarantee sufficient procedures are implemented to foster a safe environment for the transfer, handling, and use of living modified organisms in order to safeguard against potential negative effects on biological diversity. Sustainable use of biological diversity is seen as the foundation for lasting development, therefore the conservation of such resources is vital. The objective of the protocol is to protect 35
Ibid. Key Issues in Biotechnology 37 Caratgena Conference on Biosafety 36
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biological diversity and human health alike, while also allowing for the growth and promotion of innovative and effective new technology.38 Cartegena addresses modern biotechnology which it views as the application of in vitro nucleic acid techniques, which breach the barriers that exist in natural reproduction and breeding to create new combinations. The Protocol largely deals with cross-border movement, handling, and use of Living Modified Organisms (LMOs) because these matters have potentially dangerous effects on the conservation of biological diversity and might also prove harmful to human health.
The agreement developed a series of
provisions regarding the movement of LMOs. The Advance Informed Agreement (AIA) is a policy that pertains to the initial cross-border movement of LMOs wherein they are intentionally introduced into the environment of the party that is importing the organism. The agreement is comprised of four features.
First, the party that is exporting the product must notify the party
importing the item. The party importing the item must then acknowledge that they received notification through the correct channels. This is followed by the decision procedure and the opportunity to review the decision, which allows for the state or party importing the products to determine potential dangers related to the introduction of a certain LMO into their society before agreeing to grant it entry. The option to review decisions is meant to allow states or parties to reconsider their position if new information becomes available that might cause them to alter their stance.39 The AIA does not apply to LMOs in transit, LMOs meant for contained use, or LMOs to be used for food, feed, or processing. Although these categories are exempt from the AIA, states have the right to enact domestic legislation that regulates the import of such good. It is further important to note that the Cartegena Protocol does not attend to living modified organisms that are pharmaceuticals for humans because they are regulated through other international agreements. Although the jurisdiction of the AIA 38
“Cartagena Protocol on Biosafety.� Convention on Biological Diversity. http://www.biodiv.org/biosafety/default.aspx. 39 Ibid.
Accessed 20 August 2006.
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does not encompass LMOs to be used as food, feed, or for processing (LMOs-FFP), the Cartegena Protocol does address the movement of these agricultural commodities. The Protocol stipulates that a state must inform other involved parties of its decision concerning the domestic use of LMOs through the use of the Biosaftey Clearing House (BCH) within a fifteen day period. The Biosafety Clearing House is a means
to
share
environmental,
legal, and technological information pertaining to LMOs. Beyond the movement
of
LMOs,
Future Technologies and Their Benefits Technology Biofuels Biosensors
Bionics
Produce devices for neural transmission and stimulation, and functional artificial body parts
Cognitronics
Develop communication platforms between intelligent being and machine (e.g. robots and computers) Develop platforms for quick evaluation of drug/vaccine target and possible allergens
parties
involved in their transfer are also bound to adhere to guidelines regarding how they are handled, packaged, and labeled. LMOs are required
to
have
Combinatory Chemistry
certain
documentation for shipments in
Molecular Farming
Provide smart and precise tools for molecular design, production and manipulation
Stem Cell (Cloning)
To clone animals and organs/tissue from the person/patient’s own cells
Genomic
Profiling individuals based on their genetic materials; its analysis for the development of vaccines, drugs and diagnostic systems; and prediction of developing known conditions; silence or activate genetic information
addition to designating a specific person responsible for the items.40 Biosafety may be one of the most
significant
obstacles
to
research and development at this time. Commission
According on
to
the
Science
and
Purpose To provide alternative fuels and energy from biomass To locate and monitor the molecular and human/animal activities/position
Firms Involved Cargill-Dow, Iogen (Canada) Biocore, Digital Angel, Oxford Biosensors, Sensatex Advanced Bionics, Bionic Technologies, Optobionics Corp. Bionic Technologies, Iguana Robotics, Neural Signals Aurora Biosciences, Bioaalytical, Genetech, Stymyx Molecular Nanosystem, Nanowave, Zyvex Advanced Cell Technology, Biotransplant, Geron Celera Genomics, Incyte Genomics, Decode Genomics
Technology for Development, developing states have not fully exploited the benefits of biotechnology because of “declining investments in public agricultural research and development. Furthermore, the dominant role of developed countries’ private sector in
40
Ibid.
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biotechnology makes it difficulty for developing countries' public sector research to benefit from the new innovations.”41
Human Genome Project In 1990, the United States Department of Energy and United States National Institutes of Health launched an international program called the Human Genome Program. This program, expected to take 15 years to complete, seeks to understand identify all of the genetic material in humans.
The United States, France, China,
Germany, the United Kingdom, and Japan all contributed to the advancement of the program. The goals of the Human Genome Project were to identify all of the genes and sequences of human DNA, and to develop searchable databases that would be readily accessible to research scientists. Moreover, the program was to address the considerable ethical, legal, and social issues (ELSI) related to the identification and isolation of human genes.42 In 2003, two years ahead of schedule, the Human Genome Project was completed, and the human genome was fully decoded. Although the decoding of the human genome was complete, the data and information collected still needed to be analyzed and interpreted. In 1998, the U.S. government contracted a private firm, Celera Genomics, to aid with the completion of the Human Genome Project, and resulted in considerable cost savings to the government. Once the human genome is fully decoded, scientists will be able to understand many congenital diseases, which one day may lead to treatments for rare afflictions.
Current Status According to the Science and Technology Development Network, developing states can use research and development to improve social and economic progress by “developing procedures for originating, acquiring, assimilating, adapting and diffusing 41 42
Biotechnology Promise “Human Genome Project Information” http://www.ornl.gov/sci/techresources/Human_Genome/home.shtml
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new knowledge — in other words, in establishing a research and development (R&D) policy.”43 Although there are established methods to implement research and development systems, developing states lack the necessary resource to implement such efforts, as financial backing and scientific and technological expertise are scarce. An important characteristic of biotechnology is that it is a amalgam of different biological and technological sciences. Many states do not have specific laws or policies regarding biosafety, meaning that the people of these nations are not fully informed of the risks and benefits of these new technologies.
In March 2006, as part of the United Nations Convention on
Biodiversity and the Cartagena Protocol, 132 nations “agreed [to] rules on the international trade in products containing genetically modified (GM) organisms.”44 The rule deals with mandatory labeling of goods that contain genetically modified organisms. Only two major exporters of genetically modified organisms, Argentina and the United States, are not members of the Cartagena Protocol, and do not follow this convention. If these two states were to join the protocol, there would be a unified, worldwide system concerning the trade of genetically modified food and genetically modified organisms. This uniformity would reduce the costs of trade between states that trade and produce GM products. In April 2006, the European Union’s European Food Safety Authority approved “five genetically modified crops and foods that are banned in five European Union countries, saying they posed no risk to human or animal health.”45 The five nations, Austria, France, Germany, Greece and Luxembourg, imposed a moratorium on the trade, production, and processing of genetically modified food (GMF) in Europe, which was
43
“Research and Development” Science and Development Network. http://www.scidev.net/dossiers/index.cfm?fuseaction=dossierItem&Dossier=13 13 June 2006. 44 Shannahan, Mark. “'Landmark' decision reached on trade in GM products” Science and Development Network. 24 March 2006. http://www.scidev.net/dossiers/index.cfm?fuseaction=dossierReadItem&type=1&itemid=2747&language=1&dossie r=6 Accessed 13 June 2006. 45 “EU tries to break deadlock on biotech crops” International Herald Tribue. 13 April 2006.
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later ruled illegal by the WTO. Although the moratorium is now defunct, there are still barriers for production of GMF in Europe. Many Europeans are still hesitant about the safety of the products, and marketing organizations have not been able to allay these fears. In June 2006, representatives from more than 100 countries met at the first meeting of the International Treaty on Plant Genetic Resources for Food and Agriculture. With some states pursuing aggressive research in biotechnology, there was a “predicament that arose from the climate of distrust, engendered largely by patenting, that surrounded the negotiation of the Convention on Biological Diversity (CBD). The CBD established the idea that countries could exercise sovereign rights over their genetic resources.”46 The treaty sorts through many problems facing sharing and using resources in biological research. In the international scientific community, agriculture is compared to an ‘arms race’ since the competition has the potential to become quite significant. Although there is a working draft of the treaty, a final text has not yet been reached due to disagreements over the uses of plant resources and payments. Once the treaty enters into force, the future of sustainable development and food security will be greatly enhanced. Later that month, the Brazilian Development Bank established a USD $68.4 million fund for “projects that relate to economic and social development in specific subject areas, including agricultural biotechnology, drugs for neglected diseases, software and semiconductors.”47 This move will also help the research for alternative fuel sources, and to boost Brazil’s position in international markets.
For other developing states to
make a similar commitment, governments need to establish policies which can freely allow and foster scientific growth. These policies must be effective and rational such that 46
“Seed treaty is new hope for food security.” Science and Development Network. http://www.scidev.net/dossiers/index.cfm?fuseaction=dossierreaditem&dossier=6&type=3&itemid=506&language= 1 12 June 2006. 47 Almeida, Carla. “Brazil Creates Fund to fuel Technology innovation.” Science and Development Network. http://www.scidev.net/dossiers/index.cfm?fuseaction=dossierReadItem&type=1&itemid=2939&language=1&dossie r=13. 27 June 2006.
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the government “can formulate and implement them effectively. The basics for this capacity are a stable macroeconomic framework, open markets and secure private property rights.
Also important is a secure politico-institutional foundation for
formulating and implementing policy and enforcing regulations.”48 With these measures, a government can ensure a growing research sector.
Key Positions Regional Blocs Africa Africa represents the region with the largest unmet demand for food. According to most experts at the Africa Fertilizer Summit, fertilizers can be the key to the ongoing food crisis of this region. Fertilizers can add important nutrients necessary to rehabilitate the degraded soil found throughout much of the continent.
If genetically modified
organisms for modified food purposes were to be strictly regulated, experts feel developing states may suffer disastrous consequences. Poor financial resources coupled with high regulation costs would hinder the production of genetically modified crops. African nations acknowledge that they lack the expertise necessary to make prudent decisions regard biosafety. Only three African states, South Africa, Malawi, and Zimbabwe, have a definitive policy on biosafety, while the rest have draft resolutions and frameworks. Meme Baba Cisse, a delegate from Senegal to the Cartagena Protocol, thinks African nations and even some Eastern European nations “lack the scientific capacity both at the human and technological level to implement the Protocol and there have to be serious developing-developed country efforts to help build human and equipment capacities on very good terms.”49 This cooperation would enhance the level of education on these issues, which would allow African states to make educated 48
Arhens, Joachim. “Building Science, technology and innovation policies.” Science and Development Network. poliieshttp://www.scidev.net/dossiers/index.cfm?fuseaction=policybrief&policy=62&section=367&dossier=13. May 2005. 49 “Cartagena Protocol- What does Africa do now?” Africa News. 22 March 2006.
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decisions regarding the implementation and importation of biotech-related goods and processes. While the Cartagena Protocol can aid African nations in development of food and agriculture systems, he argues “countries must have national strategies on what technologies they need. If they need support then you must go for support, but human capital is a must.”50
Asia Many biotechnology companies are either starting up in Asia or are locating researchers in the region. Countries such as India and China already have multinational companies researching ways to increase biotechnology awareness and process integration. In 2003, Singapore announced its intention to compete with the rest of international community. Unveiling a plan to rival stronger Asian states, Singapore has built a “Biopolis, which is an integrated research and development complex that houses five public research institutes as well as biopharmaceutical industry laboratories.”51 This state-of-the-art design allows scientists to network and reduce costs while increasing efficiency. More than 100 companies and institutions occupy Biopolis, among them are “Novartis Institute for Tropical Diseases, Johns Hopkins, Vanda Pharmaceuticals, Paradigm Therapeutics, GlaxoSmithKline, Waseda-Olympus Bioscience Research Institute, ES Cell International, … Bioinformatics Institute, Bioprocessing Technology Institute, Genome Institute of Singapore, Institute of Molecular & Cell Biology, and the Institute of Bioengineering & Nanotechnology.”52 With time, these research facilities will be able to foster cooperative research projects, producing technological breakthroughs that can be economically beneficial. Japan maintains that labeling standards need to be implemented for GM food products. Their position has lead to “a small effort to set up separate processing facility
50
Ibid. Southeast Asia drives for biotech supremacy. 52 Ibid. 51
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for non-GM soybeans in the U.S.”53 China produces GM cotton which is noted as using less pesticides and reducing costs.
The Chinese government has also provided
certificates authorizing the cultivation of several other GM crops. Since 2002 China has been implementing vast biosafety measures such as strict labeling, documentation, and shipment standards.54
Europe A few nations in the European Union, such as Austria, France, Germany, Greece, Luxembourg, and Poland, have banned producing, selling, or consuming genetically modified food.
These nations are an important obstacle to the European Union’s
common market system. These nations, as a collective unit, must decide on the future of genetically modified foods. In May 2006, the World Trade Organization found the ban on GMO by the European Union illegal. Since the ruling, there has been a sluggish effort by the countries to initiate trade of GM goods into their markets.
North America The United States widely utilizes biotechnology in the area of medicine and pharmaceuticals, agriculture, and scientific innovation. The American Food and Drug Administration has approved GM foods as being safe for public consumption and aids companies in determining appropriate safety protocols. Surveys conducted by the Pew Initiative on Food and Biotechnology demonstrated that as of 2005, the American public had relatively little knowledge about genetically modified agricultural products – including both food and animals. Americans are concerned about GM foods, but are not in favor of prohibiting the development of new technology. They would generally prefer to have regulations implemented to guarantee safety. Although the United States is a close ally of the European Union, it has divergent positions regarding GM foods. According to the United States, “the EU is imposing undue delays on biotech approvals, resulting in delays and preventing the marketing of 53 54
Crystal. Ibid.
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many crops grown in the U.S.”55 The United States is the world leader in growing GM crops, having cultivated approximately 220 million acres, but virtually none of it is for sale in the EU. The ruling by the World Trade organization in May 2006 will bring relief and economic gains to farmers who produce GM crops in the United States, Canada, and Argentina, the world’s largest producers of GM crops. The United States also uses biotechnology for environmental purposes such as water treatment and pollution prevention, an effective strategy because biotechnology allows for an effective way to clean up waste. Biotechnology is also used in American industry as it allows for improved efficiency and can also reduce the negative impacts that many manufacturing factories have on the environment.56
Business Interests For most nations and consumers, biosafety is of the utmost concern. Seeing as genetically modified food is an attractive commercial product for many investors, a biosafety framework would be very beneficial to ensure that an investment would support a safe and orderly marketplace. Experts feel that an established framework regulation biotechnology would “remove fear and suspicion of the new technology and encourage its use in agriculture.”57 According to Professor Walter Alhassan, from the Program for Biosafety Systems, consumers should “learn the benefits and potential risks of biotechnology and genetically modified organisms and to liaise with their stakeholders so that they can make informed decisions.”58 He also stressed the fact that “proven and potential benefits of modern biotechnology are accepted as means of increasing food production efficiency, of ensuring sustainable agriculture and of developing new products from and uses for different plant varieties.”59 55
Rosenthal, Elisabeth, “Biotech Food Tears Rifts in Europe” The New York Times. 6 June 2006. Keener, Kevin, Thomas Hoban, and Rekha Balasubramanian. “Biotechnology and its Applications.” NC University: College of Agricultural and Life Sciences. Modified 20 August 2006. Accessed 20 August 2006. http://www.ces.ncsu.edu/depts/foodsci/ext/pubs/bioapp.html. 57 “U.S.AID calls for Biosafety Legislative Framework” Ghanian Chronicle 6 June 2006. 58 Ibid. 59 Ibid. 56
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Using genetically modified crops is a cost efficient practice due to the high yields produced, compared to conventional crops. Attributing to the cost efficiency, “Bt-type [Bacillus thuringiensis, a gene that produces its own pesticide] technologies are expected to increase yields while herbicide-resistant technologies are expected to reduce costs and input use.�60 Firms should focus on removing the fears and reservations about the dangers of biotechnology to increase support.
60
Ten Reasons.
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Summary The Millennium Development Goals as passed by the United Nations General Assembly serve as a reminder that people all around the world, especially those in developing countries, are at a severe disadvantage. By the year 2015, the UN hopes these areas can prosper, but progress cannot come with out help from the international community. Combined with the recent advances in science and technology and capacity building initiatives, developing states will be able to see dramatic changes in their economy and public health. For the UN, the biggest contribution from the advances in biotechnology is genetically modified food. Recently, disputes about the uses of biotechnology primarily focused around the uses of living modified organisms (LMOs) and genetically modified organisms (GMOs). From safety and intellectual property rights, the debates that surround the issue are very intricate. Much of the world is slowly beginning to accept the future of biotechnology. The World Trade Organization’s decision to repeal the European ban of GM foods has the effect of opening a potentially lucrative market for agricultural biotechnology and pharmaceuticals. Without the aid of governments, research and development expand and flourish properly. Together with state and national government, UNCTAD can facilitate the transfer of technology to developing states to foster economic growth. International agreements for the usage of genetic and biological resources have been recently introduced and provide a step toward global cooperation. A few developing states have also established programs to fund and manage research in biotechnology. Efforts such as these enable capacity building and international cooperation, in addition to strengthening the economy.
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Discussion Questions • Are all applications of biotechnology potentially threatening? technologies are considered “safe”?
If not, which
• In what ways do the perceived risks from biotechnology need handling differently from those relating to other technologies used in food production and health care? • Should scientists take a stronger view on the ethics of biotechnology and the government? If so, how? • How can the transfer of technology be implemented in a way that is beneficial to both the trading and the receiving parties? • How can the ratification of the Cartagena Protocol by the United States and Argentina affect the world’s view on biotechnology? How can it affect trade? • How can private firms alleviate the fears of consumers and investors on GMF? • Is using genetically modified food a good method to alleviate the food crisis? Why or why not? • How can developed states help developing states in the implementation of new technologies? How can UNCTAD help? • Is your state a signatory to the Cartagena Protocol? • What are the implications of banning more GM crops in certain areas of the world?
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Works Cited “Agenda 21: Chapter 16.” United Nations Department of Economic and Social Affairs. http://www.un.org/esa/sustdev/documents/agenda21/english/agenda21chapter16.ht m “About StDev.” Science and Technology for Development. Accessed 9 August 2006. http://stdev.unctad.org/about/index.html. “About Transfer of Technology and Intellectual Property rights (TOT-IP)” UNCTAD. Accessed 9 August 2006. http://www.unctad.org/Templates/Page.asp?intItemID=3424&lang=1 Almeida, Carla. “Brazil Creates Fund to fuel Technology innovation.” Science and Development Network. Accessed 27 June 2006. http://www.scidev.net/dossiers/index.cfm?fuseaction=dossierReadItem&type=1&i temid=2939&language=1&dossier=13. Arhens, Joachim. “Building Science, technology and innovation policies.” Science and Development Network. May 2005. http://www.scidev.net/dossiers/index.cfm?fuseaction=policybrief&policy=62&sec tion=367&dossier=13. “The Biotechnology Promise” Capacity Building for Participation of Developing Countries in the Bioeconomy” 2004 “Cartagena Protocol on Biosafety.” Convention on Biological Diversity. December 2005. http://www.biodiv.org/biosafety/default.aspx “Cartagena Protocol- What does Africa do now?” Africa News. 22 March 2006. “Climbing the helical staircase: A survey of biotechnology.” The Economist, 29 March, pp. 3-18 “EU tries to break deadlock on biotech crops” International Herald Tribune. 13 April 2006. Ho, Peter and Eduard B. Vermeer. “Food Safety Concerns and Biotechnology: Consumers' Attitudes to Genetically Modified Products in Urban China” The Joural of AgroBiotechnology Managemetn and Economics. Accessed 9 August 2006. http://www.agbioforum.org/v7n4/v7n4a02-ho.htm
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“Human Genome Project Information.” Human Genome Program. Accessed 9 August 2006. http://www.ornl.gov/sci/techresources/Human_Genome/home.shtml. “Intellectual Property Rights.” Science and Development Network. October 2001. Accessed 10 July 2006. http://www.scidev.net/dossiers/index.cfm?fuseaction=dossierfulltext&Dossier=8 “Key Issues in Biotechnology.” United Nations Conference on Trade and Development. 2002. McGloughlin, M. (1999). “Ten Reasons Why Biotechnology Will Be Important To The Developing World,” Accessed 9 August 2006. http://www.agbioforum.org/ McGown, Jay. “Out of Africa: Mysteries and Access to Benefit Sharing.” The Edmonds Institute and The African Center for Biosafety. 2006. “Regulation of GMO’s.” Food and Agriculture Association. Accessed 9 August 2006. http://www.fao.org/biotech/logs/C9/summary.htm “Research and Development” Science and Development Network. Accessed 13 June 2006. http://www.scidev.net/dossiers/index.cfm?fuseaction=dossierItem&Dossier=13 Rosenthal, Elisabeth, “Biotech Food Tears Rifts in Europe” The New York Times. 6 June 2006. Shannahan, Mark. “'Landmark' decision reached on trade in GM products” Science and Development Network. 24 March 2006. Accessed 13 June 2006. http://www.scidev.net/dossiers/index.cfm?fuseaction=dossierReadItem&type=1&i temid=2747&language=1&dossier=6 “Secretariat of the Convention on Biological Diversity.” Global Biosafety - From concepts to action: Decisions adopted by the first meeting of the Conference of the Parties to the Convention on Biological Diversity serving as the meeting of the Parties to the Cartagena Protocol on Biosafety. Montreal, Canada. 2004. “Secretariat of the Convention on Biological Diversity.” Cartagena Protocol on Biosafety to the Convention on Biological Diversity: text and annexes. Montreal, Canada. 2000.
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“Seed treaty is new hope for food security.” Science and Development Network. http://www.scidev.net/dossiers/index.cfm?fuseaction=dossierreaditem&dossier=6 &type=3&itemid=506&language=1 12 June 2006. “Southeast Asia drives for biotech supremacy.” Business and Management Practices. Industrial Research Institute. January 2006. Taxation and Technology transfer: Key Issues. United Nations Conference on Trade and Development: Transfer of Technology for Successful Integration into the Global Economy. 2005. “UN Millennium Development Goals.” Accessed 9 August 2006. http://www.un.org/millenniumgoals/ “USAID calls for Biosafety Legislative Framework” Ghanaian Chronicle. 6 June 2006.
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Works Referenced Altieri, M.A. and Rosset, P. (1999). “Ten reasons why biotechnology will not ensure food security, protect the environment and reduce poverty in the developing world”, accessible via http://www.grain.org/docs/altieri10.pdf The Economist (2002). Chinese biotechnology: Biotech's yin and yang. The Economist, 14 December, pp. 75-77. India beckons as a test bed for western drug companies. Financial Times, 14 October, p.18. Piore, A. (2003) What green revolution? Famine-torn Africa stands to gain the most from the biotech revolution. Why then have scientists ignored its staple crops? Newsweek, 15 September 2003, pp. 42-45. Salter, B. (2002). “The Changing governance of biotechnology; politics of trust”. Accessible through www.uea.ac.uk/ UNCTAD (2002).The New Bioeconomy: Industrial and Environmental Biotechnology in Developing Countries, UNCTAD, DITC/TED/12.