Document(s) 5 of 16

Introduction

As we enter the new millennium, globalization and privatization are among the most obvious and fundamental trends that affect and influence policy debates on ownership, conservation and exchange of biological materials. The past two decades have witnessed increasing privatization of agricultural research and development, expansion of the scope of intellectual property rights to cover biological products and processes, and liberalization of global markets. These trends have stimulated the commercial development of biotechnology products for agriculture and human health, and the concentration of economic power among a handful of giant life sciences corporations. The process of globalization influences not just the economy, but also culture, technology and governance relating to biological materials.

Globalization and trade liberalization are fueling economic growth, increased prosperity and new opportunities. World exports of goods and services nearly tripled between the 1970s and 1997. Foreign direct investment exceeded (US)$400 billion in 1997, seven times the level in the 1970s.¹⁵  However, there is growing disparity between poverty and privilege, both within and between countries and regions. Thus far, the benefits of globalization are uneven. The United Nations Development Programme (UNDP) concludes that the top fifth of the world’s people in the richest countries accounts for 82% of the expanding export trade and 68% of foreign direct investment. The bottom fifth of humanity in the poorest countries account for only 1%.¹⁶  While millions of people are integrated and empowered by knowledge and communication technologies such as the World Wide Web, others remain isolated and marginalized.

New actors, new roles and new rules are redefining global governance. The World Trade Organization (WTO), for example, and the multilateral agreement on intellectual property it administers are reducing the scope for national policy in that arena. Multilateral rule-making in a global marketplace is changing the role of state sovereignty. There is concern that countries and local communities will be increasingly restricted in their ability to determine domestic standards for regulatory and environmental protection, for instance.

The combined pressures of poverty, population growth and environmental degradation pose daunting challenges for agriculture and human development, especially in the developing world. Over 800 million people in the world today are chronically undernourished.¹⁷  An estimated 1.3 billion people live on incomes of less than one dollar a day.¹⁸  Within ten years, more than half of the world’s population will be living in cities.¹⁹  By the year 2020 there will be an additional 2 billion people to feed. Members of the Crucible Group may not agree on the underlying causes of poverty and hunger, but it is clear that different visions of agricultural development are emerging to meet the challenge of global food security and sustainability.²⁰

Given limited possibilities for expanding cultivated land area, the Crucible Group agrees that our future food security depends upon a combination of carefully crafted production and distribution policies combined with scientific strategies that ally farmer-researchers with formal sector plant breeders and laboratory-researchers to maximize germplasm enhancement and farming systems. Beyond this, however, policy and program choices often differ. The conventional approach to closing the food gap emphasizes the role of high-input, industrial-scale farming, perhaps complimented by commercial biotechnologies to raise yield ceilings. A second perspective, sometimes described as the ‘Double-Green Revolution’ approach, proposes sustainable crop production with fewer chemicals and with plant varieties designed to increase resistance to insects and diseases, and with drought tolerance and improved nutritional qualities. Others consider the ‘Double-Green Revolution’ to be little more than ‘business as usual’ for the multinational chemicals industry and argue instead for biodiversity-based agricultural research emphasizing local and regional self-sufficiency in food production, focusing primarily on the needs of limited-resource farmers in marginal farming environments. This approach stresses the contribution of farmer-led initiatives, the use of crop varieties developed by farmer/breeders in partnership with formal sector plant breeders, and the use of technologies that will lessen farmers’ dependence on purchased inputs. Not without its critics, this approach is sometimes attacked for its perceived Malthusian naivety or absurd political correctness. Still others would see policy as by far the most important engine of change and argue that sound, ‘pro-poor’ choices in land tenure, credit and price subsidization are the key to food security.

No matter what combination of germplasm, technologies, farming systems and policies are employed to achieve food security in the 21st century, commercial biotechnology and subsistence farmers alike will need to make better use of a broader range of the world’s plant and animal genetic diversity. Farmers will require crop varieties and livestock breeds capable of producing under diverse and rapidly changing conditions. Under any scenario, genetic resources for food and agriculture, the role of farming communities who nurture and develop diversity, and the vital contributions of formal sector plant breeders, all assume critical importance.

This chapter introduces some of the major social, economic and environmental trends that influence or inform the larger debate on ownership, conservation and exchange of biological materials. What are these trends that influence the way society thinks about, values and uses biological diversity at the beginning of a new millennium?
 

The accelerating loss of biological diversity 

There is increasing awareness worldwide of the value, importance and fragility of biological diversity. In the final decade of the 20th century, greater numbers of people became aware of species extinction, erosion of genetic resources and the threat of ecosystem destruction. The concept of biodiversity has entered the mainstream of government thinking and, in some cases, traveled beyond national ministries of environment. Despite heightened appreciation and awareness of biodiversity and the crafting of international conventions designed to conserve it, the loss of biological diversity continues. Forests are falling, fisheries are collapsing, plant and animal genetic diversity is eroding all over the world.

• Loss of diversity in plant genetic resources for food and agriculture has been substantial, and these resources are disappearing at unprecedented rates. No one knows how much diversity once existed in domesticated species, so it is impossible to say exactly how much has been lost historically.²¹ 

• Domestic animal breeds are disappearing at an annual rate of 5%, or six breeds per month.²²  According to FAO, the status of almost one-third of all livestock breeds is endangered or critical.

• Tropical forests are falling at a rate of just under 1% per annum, or 29 hectares per minute.²³  From 1980 to 1990, the loss was equivalent to an area the size of Ecuador and Peru combined.

• All of the world’s main fishing grounds are being fished at or beyond their limits. About 70% of the world’s conventional marine species are fully exploited, overexploited, depleted or in the process of recovering from overfishing.²⁴  During the 20th century, about 980 fish species became threatened.²⁵ 

• Nearly 60% of the earth’s coral reefs are threatened by human activity.²⁶ 

• A new study conservatively estimates that 34 000 species of plants — 12.5% of the world’s flora — are facing extinction. At least one of every eight known plant species on earth is threatened.²⁷ 

• For every plant that becomes extinct, 30 other species go with it — many of them are microorganisms. Some biologists warn that plant pathogens (including fungi, viruses and bacteria) should be conserved with the same urgency as other species because they play a vital role in the functioning of ecosystems.²⁸ 

The loss of biodiversity threatens food security, especially for the poor, who rely on biological products for 85–90% of their livelihood needs (i.e. food, medicine, fuel, fibre, clothing, shelter, energy, transportation, etc.). New estimates from FAO indicate that there are 828 million chronically undernourished people in the world, a small increase since the early 1990s.²⁹
 

Erosion of cultural diversity

The 1993 Crucible Group concluded that we cannot conserve the world’s biological diversity unless we also nurture the human diversity that protects and develops it. Today, there is growing recognition that loss of cultural diversity — of traditional farm communities, languages and indigenous cultures — is intricately linked to the loss of biological diversity. Many members of the Crucible II Group are alarmed by the loss of the culturally-based knowledge represented by thousands of diverse cultures that are themselves endangered or disappearing.

Globally, language is one of the strongest indicators of cultural diversity. The highest levels of plant and animal diversity, as well as the world’s richest linguistic life, are found close to the equator. Ten out of 12 ‘megadiversity’ countries identified by the International Union for Conservation of Nature and Natural Resources (IUCN) rank among the top 25 countries for ‘endemic’ languages (i.e. languages spoken exclusively within a country’s borders — which usually means the majority of the smaller languages of the world).³⁰  Some cultures have many distinct names describing a single plant, its parts and its uses. The diversity of names associated with distinct properties of a species is multiplied by the number of languages and dialects spoken by distinct communities that use the same biological resource.³¹  With the loss of their language, the community loses its ability to describe and therefore to use the plant. While loss of knowledge does not imply the loss of the plant itself, this is commonly the case, since with the decline in the knowledge of the uses of the plant, the community may lose interest in its conservation.

As with biological diversity, the magnitude and pace of the current ‘extinction crisis’ in linguistic diversity is unprecedented. Linguists who monitor the status of surviving languages conclude that approximately 6–11% of the 6703 languages spoken in the world today are ‘nearly extinct’, and they predict that 50–90% will disappear during the 21st century.³²

Local and indigenous peoples who speak ancestral languages are severely threatened by loss of sovereignty over land, resources and cultural traditions, and the promotion of linguistic assimilation. As they become increasingly marginalized, local people lose local scientific knowledge, innovative capacity, and wisdom about species and ecosystem management.³³  As one scholar concludes: ‘Any reduction of language diversity diminishes the adaptational strength of our species because it lowers the pool of knowledge from which we can draw.’³⁴

The loss of traditional farm communities, languages and indigenous cultures all represent the erosion of human intellectual capital on a massive scale. It is tantamount to losing a road map for survival, the key to food security, environmental stability and improving the human condition. Thus, it is increasingly difficult to talk about the conservation and sustainable use of genes, species and ecosystems separate from human cultures. 
 

On-farm conservation and use of plant genetic resources

Although many in the scientific community are used to measuring progress through precisely defined achievements, one of the genuinely significant ‘breakthroughs’ of the past five years owes more to rediscovery (by some) than discovery. Since 1993, agricultural research, including plant breeding and germplasm conservation, has been revitalized by the creative association of farmer-innovators, and their communities, with formal sector scientists and research institutions. The management and enhancement of plant genetic resources has been in the hands of farmers from the beginning of agriculture. Fortunately, there is far greater recognition today than there was five years ago that the contributions of farmers and indigenous peoples are critical to the conservation, use and active enhancement of biological diversity, and that these groups and individuals should be recognized and rewarded for their contributions. This principle is a prominent feature of the Convention on Biological Diversity (CBD) and of Farmers’ Rights as discussed and supported in the FAO Commission on Genetic Resources for Food and Agriculture (CGRFA). The innovative activity of farmers with respect to the development of crop varieties and farming methods is described variously: research, plant breeding, ethno-science, informal innovation, and so on. Not everyone agrees on which is the best term. As a collective, the Crucible Group wants to avoid getting bogged-down in terminological wrangling. In the end, what is important is that the Group recognizes the value of farmers’ innovations.

In the field of agricultural genetic resources, there is greater appreciation for the fact that in situ (on farm) conservation is a crucial element in the conservation of agricultural biodiversity and that it must be complementary to gene bank collections. When ex situ germplasm is removed from its cultural and environmental context, it loses the ability to adapt to constantly evolving pests, diseases and the ever-changing needs of local communities. By placing greater emphasis on in situ and farmer/community level management of genetic resources, both the CBD and the Leipzig Global Plan of Action for Plant Genetic Resources for Food and Agriculture (PGRFA) emphasize that the future of world food security depends not just on stored crop genes, but on the people who use and maintain diversity on a daily basis. Leipzig’s Global Plan of Action provides the first intergovernmental recognition and support for on-farm management and improvement of plant genetic resources. It recommends new on-farm conservation and participatory breeding initiatives, including the need for stronger links between conservation and utilization of plant genetic resources.

‘Participatory plant breeding’ (PPB) is still in its youth, but spreading quickly.³⁵ PPB is a new approach to germplasm development and conservation involving scientists, farmers and other end-users (i.e. rural cooperatives, consumers, extension workers, etc). It is termed ‘participatory’ because users have a research role in all major stages of the breeding and selection process. PPB is a crop improvement strategy that especially seeks to involve disadvantaged user groups (i.e. women and other resource-poor farmers). Over 70 cases of participatory plant breeding are documented, involving a range of crops and geographic regions.³⁶  These include, for example, pearl millet in India, barley in Syria, common beans in Brazil, rice in Nepal and cassava in Colombia.

Support and recognition for on-farm conservation and farmer-driven breeding is growing. A range of strategies is being developed to enhance genetic materials on-farm, for and by farmers. Examples include: CGIAR’s Systemwide Program on Participatory Research and Gender Analysis (and its working group on participatory plant breeding),³⁷  the Community Biodiversity and Development Conservation Program (CBDC), the Seeds of Survival Program in Africa, the Academy of Development Sciences in India and Projecto en Tecnologia Alternativa (PTA) in Brazil. Efforts to conserve and enhance germplasm systems are found for both minor and major crops, and in ‘marginal’ farming areas (i.e. those with poor soil, little rainfall, steep hillsides) as well as irrigated lands.

The increase in participatory plant breeding and other collaborative programs involving farmers, their communities and formal sector scientists raises new questions and challenges for recognizing collaborative innovation in plant breeding. Some observers believe that neither Farmers’ Rights nor Breeders’ Rights adequately address these issues. The International Development Research Centre (Canada) has recently funded work to address the property rights, best practice, and ethical dimensions of community-based and formal collaborations.

Many members of the Crucible Group agree that there is a need to strengthen the role of indigenous and local communities in order to ensure their full participation in germplasm conservation and enhancement. 
 

Global climate change and biodiversity

Although there is no consensus among scientists, there is growing international opinion that global climate change will have profound impacts on biodiversity and will compromise the sustainability of human development on the planet. The Intergovernmental Panel on Climate Change (IPCC) predicts that the build-up of greenhouse gases in the atmosphere will cause global temperatures to rise by 1–3.5 degrees Centigrade during the next century; and that melting glaciers and thermal expansion of the ocean will bring an associated rise in sea level of between 15 and 95 centimeters.³⁸  Simulation models predict that each one-degree rise in temperature will displace the adaptation of terrestrial species some 125 km towards the poles, or 150 metres in altitude. Approximately 30% of the earth’s vegetation could experience a shift as a result of climate change. But since climate will change faster than the migration rate of many species, models predict a ‘drastic reduction’ in global species diversity.³⁹

New research on the impact of global warming on vegetation offers especially grim predictions for the tropics. According to the Institute of Terrestrial Ecology (Edinburgh, UK), by 2050 a warming of up to 8 degrees Centigrade in parts of the tropics will lead to higher evaporation rates, lower rainfall and eventually the collapse of tropical ecosystems. The World Bank estimates that a 2–3 degree rise in global mean temperature will reduce the mass of mountain glaciers by one-third to one-half, and endanger at least one-third of all species surviving in forests.⁴⁰  Changes in glacier mass and forest area will have a profound impact on agricultural productivity. Millet crop yields in Africa are expected to drop by between 6% and 8%; a Senegalese study predicts that millet yields in Senegal will decrease by between 11% and 38%.⁴¹  In South Asia, yields for rice and wheat are expected to fluctuate wildly. The maize crop in South Asia and Latin America may shrink by between 10% and 65%.⁴²

Not all scientists (and not all members of the Crucible Group) agree with grim predictions for global climate change, and some point out that substitute crops may be developed to offset shrinking yields and increase productivity in some regions. Some models have shown that global warming could be neutral or favorable in temperate latitudes and disadvantageous for the tropics and sub-tropics. The discrepancies and uncertainties in climate models do not permit more accurate predictions. Regional projections suggest that Africa might be the continent worst hit by climate change.⁴³

Ultimately, biological diversity is the key to adapting to global climate change. If we are to adapt food production systems to radically changing conditions in the coming decades, plant and animal diversity will be the single most critical resource for doing so. 
 

The changing roles of public and private sector agricultural research

Until recently, agricultural research has been largely publicly financed and its products made freely available. Today, agricultural research is increasingly privatized. A rapidly changing IP environment and declining research budgets have marginalized the role of public sector agricultural research in both industrialized and developing countries. We are living in an era when, increasingly, science is subject to property rights and knowledge is commodified.

Given the demonstrated success of agricultural research in bringing science and technology-based solutions to agricultural production constraints, it is paradoxical that public agricultural research is now facing a global crisis. Many national agricultural research institutions in developing countries suffer from lack of money, even to buy the basic essentials or to pay salaries. Institutions in industrialized countries and the international research centres of the Consultative Group on International Agricultural Research (CGIAR) face similar financial constraints.⁴⁴

The crisis is not only financial, it is also one of confidence. In spite of the demonstrated effectiveness of agricultural research in the past, policy-makers today are not convinced that further investments are necessary or that they can accomplish the seemingly overwhelming tasks of assuring food security to millions of the poorest of the poor. The end result is that financial allocations to agricultural research are reduced at a time when its importance to economic development remains critical. Reduced support leads to low productivity, low visibility and, ultimately, less political support for the agricultural research system — a vicious circle.⁴⁵

Public funds for agricultural research have stagnated or declined, while private investments have increased at an unprecedented rate: 

• In the OECD, for example, private agricultural R&D totaled $7 billion in 1993 compared with $4 billion in 1981, an annual rate of growth of 5.1%. By contrast, publicly performed agricultural R&D rose by 1.7% per annum, from $5.7 billion in 1981 to $6.9 billion in 1991.⁴⁶ 

• The relative importance of private R&D in total agricultural R&D varies across the OECD countries, but exceeds 50% in seven countries, including the US and Japan, which together account for over one-half of all private agricultural research throughout the OECD. The private share in the remaining OECD countries is smaller (about one-third in 1993), but has been growing rapidly. Private sector R&D in developing countries typically accounts for 10–15% of total agricultural R&D.⁴⁷ 

• Private and public agencies perform different types of R&D. About 12% of private agricultural research focuses on farm-level technologies, while 80% of public research has that orientation. Food processing and post-harvest research is the dominant focus of private agricultural research, accounting for 30–90% of all private agricultural R&D.⁴⁸ 

The increased role of the private sector is propelled, in part, by dramatic advances in biotechnology and the strengthening of intellectual property protection for biological materials in many countries. Until about a decade ago, market failure in agricultural R&D seems to have been widely taken for granted. The main reason was inappropriability of benefits.⁴⁹  Constraints to private investment in agricultural research have changed dramatically: with advances in biotechnology, the process of technology generation has accelerated, making it possible to reap the benefits of investments relatively soon. Since 1980, the evolution of intellectual property laws has allowed for the patenting of living organisms, enabling biotechnology companies to patent biological processes and products,⁵⁰  thereby increasing incentives for the private sector to invest in this type of research.

With globalization of trade and the disappearance of trade barriers, the market for biotechnology products has expanded, providing increased opportunities for large multinational corporations. The role of multinational corporations has both positive and negative implications for global science. From a positive point of view, these firms have strong research and development arms that are involved in both applied and basic research, frequently involving scientists from many countries and benefits that extend across borders. However, the products of private sector research are generally proprietary and may not be accessible to the poor or those who need them.⁵¹

The decline in public sector agricultural research budgets is prompting new partnerships between the public and private sectors, especially in the field of agricultural biotechnology. For example, Swiss agrochemical giant, Novartis, and the University of California at Berkeley signed a $25 million, five-year agreement in November 1998. Although the agreement specifies that Novartis cannot dictate what research will be performed with its money, the company will have first rights to negotiate an exclusive license on 30–40% of any inventions made in the Department of Plant and Microbial Biology.⁵²  Private–public interactions can create fertile ground for knowledge generation and transfer of technology to the marketplace. But private financing of the public sector is not without controversy. Critics charge that such alliances will give private companies the ability to influence the research agenda at publicly funded institutions, allowing public goods to be appropriated for private profit.

The CGIAR’s agricultural research centres are also discussing new models of collaboration with the private sector (joint research projects, strategic alliances, etc.) and policies relating to the use of proprietary materials and technologies. For example, a B.t. (Bacillus thuringiensis) gene for insect resistance provided by Plant Genetic Systems (Belgium) has been transferred to potato varieties, and the International Potato Centre has permission to distribute them in ten developing countries. Monsanto has entered into agreements with Kenyan and Mexican agricultural research institutes to develop virus-resistant crops. While these collaborations are successful, they are few in number, highly bilateral and often components of philanthropic programs.⁵³

The potential neglect of the public good is one of the primary issues raised by the dramatically changing roles of the public and private sector in agricultural research. There is concern that the formerly open exchange of materials and technologies to help the poor is being constrained and complicated by intellectual property. Over the past five years, the New York-based Rockefeller Foundation has invested $50 million in plant biotechnology for the developing world. In the words of Dr Gordon Conway, President of the Rockefeller Foundation:

"As plant research in the industrialized world has come to be dominated by private companies who closely guard their proprietary technologies, the process of innovation in the developing countries has slowed. Public sector plant breeders don’t know how to respond, and when they try, they are handicapped by the huge disparity in resources and negotiating power between themselves and the companies."⁵⁴

Crucible Recommendation 1 Broadening research participation The Crucible Group believes that it is both possible and necessary to increase participation and partnership in agricultural research and in genetic resource conservation. The Group recommends that: governments increase their contributions and strengthen their long-term commitments to national and international agricultural research and genetic resource conservation; governments and non-governmental organizations increase financial support and institutional commitment to all agricultural research that involves participatory plant breeding and to on-farm genetic resource conservation; all concerned parties give support to innovative initiatives to encourage effective and equitable forms of partnership collaboration in agricultural research.

Crucible Recommendation 2 Support for in situ or on-farm conservation We recognize the complimentarity of ex situ and in situ conservation strategies. The two have very different effects in terms of which germplasm endures and how that material evolves, yet both are essential to safeguard germplasm for future generations and both require increased support. In particular, in situ or on-farm conservation deserves increased support as few approaches have yet been identified that are financially, socially and technically efficient, effective and acceptable to those who primarily undertake in situ conservation, that is, farming communities themselves. Increased support for in situ or on-farm conservation activities need not displace or diminish funding for ex situ conservation.

Crucible Recommendation 3 Support to farmer-led science and participatory plant breeding Organizations and governments should formulate policies and actions to develop and promote more farmer-based and farmer-led science, including participatory plant breeding. Sustainable agriculture, including dynamic crop management, can better be achieved if farmers’ own creative capacities are stimulated and strengthened (financially and technically) to partner with the more formal research and development efforts.

How can the benefits of technology that is subject to intellectual property rights be harnessed for the needs of the poor and the environment? How can public systems, both nationally and internationally, insure that research priorities are not unduly influenced by private companies, and that international public goods remain in the public domain? Of course, there are no guarantees that the public sector is benign or always acts in the public interest. Conversely, it is unfair to assume that the private sector is acting against the public good.
 

Consolidation in the life sciences industry

Consolidation is taking place in all sectors of the global economy. In 1997, the value of all mergers and acquisitions hit a staggering $1.6 trillion in worldwide deals, up from $454 billion in global activity recorded in 1990.⁵⁵  In 1998, the total volume of mergers and acquisitions worldwide was a record $2.4 trillion — a 50% increase over 1997.⁵⁶  According to the UN Conference on Trade and Development, over four-fifths of all foreign direct investment worldwide is now in the form of global mergers and acquisitions.⁵⁷  The past decade recorded dramatic consolidation in the ‘life sciences’, with market shares of bioindustrial products related to agriculture, food and health tightly concentrated in the hands of giant transnational enterprises. For example:

• the world’s top ten agrochemical corporations account for 91% of the $31 billion agrochemical market worldwide;⁵⁸ 

• the top ten global seed companies control an estimated one-quarter to one-third of the $30 billion commercial seed trade;⁵⁹ 

• the top ten pharmaceutical companies account for 36% of the $251 billion global pharmaceutical market;⁶⁰ 

• the top ten firms hold 61% of the animal health industry market valued at $16 billion.⁶¹ 

Under the life sciences banner, many firms are using complementary technologies to become significant actors in all of these categories.⁶²  Traditional boundaries between pharmaceutical, biotechnology, agribusiness, food, chemicals cosmetics, and energy sectors are blurring and eroding. Major transnational companies are restructuring to take advantage of the molecular revolution and the complementary use of technologies such as high-throughput screening, combinatorial chemistry, transgenics, bioinformatics and genomics. Life sciences companies are securing and protecting information and technology via patents, and, in some cases, that quest is driving a restructuring of the industry. In today’s knowledge-based economy, intellectual property assets have surpassed physical assets such as land, machinery or labor as the basis of corporate value.⁶³  At the end of 1995, for example, the Hoechst group held 86 000 patents and patent applications.⁶⁴  According to Dr Richard Helmut Rupp, head of Hoechst R & D, ‘The most important publications for our researchers are not chemistry journals, but patent office journals around the world.’ Demonstrating the value of intellectual property assets, the cover of Novartis’ 1997 annual report announces that the company holds more than 40 000 patents.⁶⁵  Worldwide demand for patents shows a strong upward trend. At the end of 1995, approximately 3.84 million patents were in force worldwide. The patent offices of the US and Japan together with the European Patent Convention accounted for 81% of the total.

Seed industry concentration
The Crucible Group believes that it is especially important to monitor concentration in the global seed industry, a trend that has been accompanied by dramatic declines in public sector plant breeding. In some industry sectors, particularly in countries of the Organization for Economic Cooperation and Development (OECD), there is evidence of highly concentrated markets. For example:

• the top five vegetable seed companies control 75% of the global vegetable seed market;⁶⁶ 

• four companies control 69% of the North American maize seed market;⁶⁷ 

• at the end of 1998, a single company controlled 71% of the US cotton seed market.⁶⁸ 

Private sector plant breeding and seed sales have been a highly effective tool in many parts of the world to transfer innovation in agriculture, especially through the provision of reliable, clean planting material. Strategies such as market segmentation could play a role in increasing the availability of new crop technologies to poor farmers in the developing world.⁶⁹  In the future, however, if access to biotechnological and other plant breeding-related innovations are restricted to a handful of seed companies, the possibility exists for market dominance by a few suppliers, with potentially serious implications for technology choice and price fixing. Free and fair competition may not be possible in the absence of government oversight and regulation, including the use of anti-trust legislation. The option of government anti-trust laws is one mechanism that could be invoked to curb excessive consolidation in the seed industry. Substantial technical assistance would have to be provided to developing countries in order for them to sort meaningfully through the complexities of, and implement, anti-trust laws.

Crucible Recommendation 4 Anti-trust legislation for seed industry The Crucible Group recommends that anti-trust legislation at the international level be provided and enforced to ensure fair competition practices in the seed industry.

Transgenic crops commercialized

When the first Crucible Group concluded its negotiations in October 1993 genetically engineered crops were not yet sold commercially. Although opinions differ on the ethics and safety of transgenic crops, the commercial market for genetically engineered seeds has expanded dramatically in scale and geographic scope in recent years.

• From 1986–1997, approximately 25 000 transgenic crop field trials were conducted by 45 countries on more than 60 crops and ten traits. Of this total, 15 000 field trials were conducted during the first ten-year period, and 10 000 in the last two years.⁷⁰ 

• Soybean, maize, cotton, canola/rapeseed and potato were the five principal transgenic crops grown in 1998. Transgenic soybean and maize accounted for 52% and 30% of global transgenic area respectively. Herbicide tolerance was the dominant trait, accounting for 71% of all transgenic crops; insect resistance accounted for 28% of the global transgenic area.⁷¹ 

• According to the International Seed Trade Federation, the world market for genetically engineered seeds is expected to reach $2 billion by the year 2000 and will triple to $6 billion by 2005. The Federation predicts that the market for bioengineered seeds will reach $20 billion in the year 2010.⁷² 

Clive James of the International Service for the Acquisition of Agri-biotech Applications (ISAAA) produced figures showing a sharp rise between 1997 and 1998 in the size of area of planted with transgenic crops in eight countries (see Table 1) and forecast that by the end of 1999, an estimated 40 million hectares would be planted in genetically modified crops worldwide.⁷⁴  Proponents of genetic engineering point out that after thousands of field tests and commercial-scale plantings on numerous continents, no major ecological problems have been identified with genetically modified (GM) crops, nor hazards associated with GM foods currently found on the shelf. However, there is concern about possible ecological impacts of transgenic crops, including the possibilities of gene transfer to related species and resistance to biopesticides.

Table 1. Area of transgenic crops planted (million ha)⁷³
 

Country	1997	1998
USA	8.1	20.5
Argentina	1.4	4.3
Canada	1.3	2.8
Australia	0.1	0.1
Mexico	0.1	0.1
Spain	0.0	0.1
France	0.0	0.1
South Africa	0.0	0.1
TOTAL	11.0	27.8

Source: C. James, ISAAA

In recent years the ‘precautionary principle’ has gained prominence in environmental protection and regulatory debates, especially relating to the approval and commercialization of biotechnology products. In very general terms, the precautionary principle says that government regulators have a responsibility to take preventive action to avoid harm before scientific certainty has been established. However, the precautionary principle has no one internationally recognized definition and its status under international law is widely debated.⁷⁵  Many observers view it as a significant innovation in the arena of risk assessment and environmental protection, although its definition, application, and scope are still evolving.

In February 1999, delegates from 175 countries met in Cartagena to conclude four year’s worth of negotiations on a draft international protocol on biosafety, under the auspices of the Convention on Biological Diversity. Given the wide disparity in negotiating positions, it proved impossible to reach consensus on criteria to govern transboundary movement, handling and use of living modified organisms (LMOs), also referred to as genetically modified organisms (GMOs).

Failure to reach agreement in Cartagena, and at follow-up informal biosafety consultations in Vienna in September 1999, has done little to ease concerns of some governments, farmers and consumers over trade in genetically engineered crops and issues surrounding the potential impacts of genetically modified organisms on health, safety and the environment. 1998 and 1999 witnessed unprecedented public debate over the introduction and use of genetically modified products for food and agriculture — especially, but not only, in Europe. Consumer and farmer resistance to genetically engineered products for agriculture is influencing policy-makers, as well as major food retailers and processors; questions surrounding socioeconomic, health and environmental impacts are not resolved. Consumer demand for mandatory labeling of GMO products and more rigorous biosafety regulations are growing in many parts of the world.

• In April 1999, the seven largest grocery chains in six European countries made a public commitment to sell products that contain no genetically modified foods.

• European-based Unilever and Nestlé, two of the world’s largest food and beverage corporations, announced that they would reject genetically modified ingredients for their European products. 

• US-based Archer Daniels Midland and A.E. Staley Manufacturing Co., two of the world’s largest maize processors, announced that they would not purchase any genetically modified maize that is not accepted in Europe.

• In January 1999, Canada’s national health agency declined to approve the use of genetically engineered bovine growth hormone, citing concerns over the drug’s impact on animal health and welfare.

• A laboratory study by Cornell University scientists published in May 1999 shows that pollen from genetically engineered insect resistant B.t. (Bacillus thuringiensis) maize is toxic to caterpillars of monarch butterflies. Dr John Loose, one of the Cornell researchers who conducted the study, cautions: ‘Our study was conducted in the laboratory and, while it raises an important issue, it would be inappropriate to draw any conclusion about the risk to Monarch populations solely on these initial results.’⁷⁶ 

• Following the release of the Cornell study, the Japanese Ministry of Agriculture, Forestry and Fisheries (MAFF) announced that it would suspend approval of B.t. crops in Japan until revised safety protocols are developed for GM crops.⁷⁷ 

• The Brazilian State of Rio Grande do Sul has declared itself a GM-free state. Legislation is being drafted to ban commercialization and importation of genetically modified seeds. In June 1999 a Brazilian federal court barred the planting and distribution of genetically modified soybeans in Brazil until environmental impact assessments are prepared. Brazil is the world’s second largest exporter of soybeans.

• In June 1999, European Union environment ministers stressed the need to implement a more transparent and strict framework concerning risk assessment, monitoring and labeling of GMOs. Ministers from France, Italy, Greece, Denmark and Luxembourg declared that, pending the adoption of stricter regulations, they would take steps to suspend any new authorizations for the growing or marketing of GMOs.⁷⁸ 

There is a concern that the controversy and debate surrounding the introduction and use of genetically modified products for food and agriculture could jeoize the future development and release of bioengineered crops that aim to help the poor and malnourished.⁷⁹  For example, the Rockefeller Foundation and the European Union are funding the development of genetically engineered rice strains that they believe will combat widespread nutritional disorders (vitamin A and iron deficiencies) afflicting billions of people worldwide.⁸⁰  It is understood that, once perfected, the rice strains would be made freely available to agricultural research centres worldwide.
 

Restrictions on the right of farmers to save seed

National and international institutions, both public and private, are implementing, developing and promoting a variety of legal and technological tools that are designed to give the seed industry greater control and protection over plant genetics and restrict or eliminate the right of farmers to save and re-use seed from their harvest. For example, the 1991 Act of the Union for the Protection of New Varieties of Plants (UPOV) does not mandate an exemption allowing farmers to use farm-saved seed freely as further planting material. If successfully commercialized and widely adapted, genetic seed sterilization technologies may also restrict the ability of farmers to save seed. In some industrialized countries, the commercialization of patent-protected, genetically engineered seeds is altering the relationship of the seed industry to its customer — the farmer — and is changing traditional farming practices. In order to protect its investment and recoup research costs, the seed industry asserts that it is illegal for farmers to save patented seed for replanting. In the United States it is becoming increasingly common for seed companies to require their customers to sign a licensing agreement that prohibits farmers from saving, selling, or reusing patented seed for any purpose — even on their own land. Some companies are aggressively enforcing patent rights on transgenic (genetically engineered) seed technology.⁸¹  Virtually all transgenic seeds are protected by patents. In the United States, utility patents do not provide for the ‘farmers’ privilege’.

In the developing world, where the majority of farmers depend on farm-saved seed as their primary seed source, the notion of legal or biological prohibitions on seed saving is perceived by some as both alien and life-threatening. Others believe that restrictions on seed saving will act as an incentive for the private sector to invest in developing improved varieties, stimulate plant breeding in the developing world and thereby contribute to food security.

Viewpoint: Merits and myths of seed saving

Biopiracy: fact or fiction?

Some people are concerned that the expanded scope of IPRs and their extension to biological materials enables institutions or researchers effectively to appropriate the resources and knowledge of farmers and indigenous communities, especially in the developing world. In recent years, IP claims relating to plants and human genetic material have provoked charges of ‘biopiracy’ in many regions. Members of the Crucible Group disagree on whether or not, and to what degree, biopiracy is a significant problem. The following viewpoint boxes on biopiracy, and the specific case of basmati rice, illustrate widely divergent views on the subject.

Viewpoint: What is biopiracy?

Viewpoint: The basmati rice patent: biopiracy or invention?

Human biodiversity

The Crucible Group notes that many of the issues now being hotly debated over plant genetic resources may be reappearing in the emerging debate over the management of human genetic resources.

Many of the issues that have challenged the plant genetic resources community over the past two decades, including the need for intergovernmental involvement with respect to the collection, storage, exchange, benefit-sharing and IP aspects of plant germplasm, also arise with regard to human genetic diversity — albeit with more profound moral and ethical considerations.

Controversy over the collection and patenting of human genetic material is not new. In 1993 the Human Genome Diversity Project, an informal consortium of universities and scientists in North America and Europe, proposed to collect human DNA samples from hundreds of so-called ‘endangered’ indigenous communities around the world. Many indigenous peoples’ organizations protested vigorously, asking: Will profits be made from the genes of poor people whose physical survival is in question? Who will have access to stored DNA samples, and where will these collections be located? What benefits, if any, will accrue to the indigenous peoples from whom DNA samples will be taken?

In March 1995 the US patent office issued a patent on a cell line containing unmodified DNA from a Hagahai tribesman in Papua New Guinea. Indigenous peoples’ organizations vocally denounced the patent as a threat to human dignity and a violation of human rights. The controversy, generated by scores of indigenous peoples’ organizations, together with civil society organizations and governments, eventually caused the US government to ‘disclaim’ the Hagahai patent in October 1996.

Commercial trade in human tissue is accelerating. Scientists, in both the public and private sector, are collecting human DNA samples from rural and urban communities across the globe. Of particular interest to genetic researchers are populations that are genetically homogeneous, or those that exhibit a genetic predisposition to an inherited disease. After pinpointing the location of so-called ‘disease genes’ genomic companies and their pharmaceutical partners hope to develop commercial products such as diagnostic tests and therapies that are based on proprietary human genes. That quest has taken gene prospectors to remote locations such as Tristan da Cunha in search of asthma genes, to Kosrae in Micronesia in search of obesity genes, and to Tibet in pursuit of high-altitude genes, just to name a few.⁸²

In early 1998 the prospect of nationwide collection and commercialization of human DNA made headlines when Hoffman-La Roche (Switzerland) and DeCode Genetics Inc. (Iceland) signed a $200 million collaborative research contract to identify disease genes based on studies of Iceland’s relatively isolated and strikingly homogeneous population.⁸³  DeCode’s goal is to amass the world’s most comprehensive collection of genealogical family data for studying the genetic causes of common diseases. The company says that its studies could lead to new diagnostic tests and drugs for inherited diseases — which would be made available free to Icelanders if the research leads to a new therapy.⁸⁴  The Icelandic situation has become an international test case for many of the ethical and intellectual property issues surrounding collection and commercialization of human DNA.⁸⁵  Despite opposition by growing numbers of Iceland’s scientific and medical community, a bill was passed by the Icelandic parliament on 17 December 1998 that gives DeCode Genetics the right to collect current and retrospective medical information from Iceland’s 270 000 inhabitants into a centralized, comprehensive database.⁸⁶  The new law gives DeCode Genetics exclusive rights to the commercial exploitation of genetic information for 12 years.

A vocal minority of Iceland’s scientific and medical community, including the Icelandic Medical Association, the Association of Icelanders for Ethical Science and the Icelandic Mental Health Alliance oppose implementation of the law and are advising doctors and their patients to refuse participation in the collection of DNA samples.⁸⁷  Opponents believe that the bill violates principles of privacy and informed consent and they object to a single company gaining exclusive rights to a valuable scientific resource. For example, the law allows only for individuals to opt out of the database, but does not require any other form of consent. Although the database is supposed to be confidential and anonymous, critics charge that personal information can be deciphered and that computer security measures proposed by the company are not adequate to insure confidentiality.

Crucible Recommendation 5 Protecting human genetic diversity The Crucible Group notes that human genetic material is being collected worldwide in the absence of intergovernmental oversight, and without consistent regulations concerning the collection, exchange and use of human genetic diversity and the protection of human subjects. The Group recommends that all aspects of the conservation and utilization of human genetic diversity be governed, monitored and reviewed by governmental or intergovernmental agencies, as appropriate, with the full, informed consent and participation of all human subjects involved, especially indigenous peoples.

Bioethics and societal choices: who will decide?

By the close of the 20th century, humankind had acquired the power to transform the processes of all living species, including its own. The potential benefits of these powers can be exciting and the perils ominous. Consider, for example, the recent announcement that scientists have successfully produced cultures of embryonic stem cells.⁸⁸  This breakthrough offers the potential to grow any type of human tissue and may eventually be used to repair damaged hearts, blood vessels or brains. The very same week, the UK’s Sunday Times reported that scientists can theoretically engineer deadly biological organisms to produce ‘ethno-bombs’ that are capable of targeting human victims by ethnic origin.⁸⁹

Given the dizzying pace of technological advancements in genetics and biology, it is not surprising that society is grappling ever more urgently with the social, ethical and legal implications of humankind’s ability to decipher and control the genetic blueprint of life. Opinions differ sharply on the implications of new biotechnologies, but nearly everyone agrees that advances in technology are taking place at a rate far faster than social policies can be devised to guide them, or legal systems can evolve to address them.

There is growing recognition worldwide that the development of scientific knowledge must be accompanied by public debate on societal choices and the informed participation of citizens. ‘Bioethics’ attempts to identify the social and cultural implications of breakthroughs in life sciences, to anticipate its applications, and to ensure that progress in the life sciences benefits humanity as a whole.⁹⁰  Bioethics acknowledges that there is a distinction between what is scientifically possible and ethically acceptable. What is good for society, what is equitable, and what is safe? Who will decide? These are among the questions that are fueling debate on the applications of biotechnology to health, agriculture and human development.

At the intergovernmental level, the United Nations Educational, Scientific and Cultural Organization (UNESCO) created the International Bioethics Committee in 1993 as the world’s only international body to study the implications of human genome research and genetic engineering. In November 1997, UNESCO adopted a non-binding Universal Declaration on the Human Genome and Human Rights, the first international text on the ethics of genetics research. Since 1993, a growing number of countries have established national bioethics advisory committees to examine bioethics and to provide guidance to national governments. In 1998, the CGIAR adopted a set of ethical principles to guide its work on genetic resources.

The Crucible Group recognizes and appreciates the vital contribution of ethical debates. There is concern, however, that the appointment of expert panels and commissions devoted to bioethics should not become a substitute for broad public debate and participation in the review and assessment of new technologies.

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