Publicly, biotechnology industries demand intellectual property protection on grounds that their products and processes are "novel" or even "revolutionary." However, they insist in public just as strongly that the same are no more than "extensions of traditional methods" when confronted with the possibility of health and environmental regulation. The problem is to determine whether and how modern biotechnology is novel, and to tease out the actual, sometimes hidden, links between biotechnology, intellectual property rights and regulation. Therefore, this paper has a number of related purposes:

1. to analyze some of the conflicting concepts of biotechnology;
2. to dissect the rhetoric that veils the purpose of intellectual property rights and importance of regulation;
3. to argue that the expansion of the scope of intellectual property rights, in particular its extension to living organisms, as well as its function in industrial and international trade, have a detrimental effect on local, decentralized and sustainable economies;
4. to show that--contrary to the protestations of industries--modern biotechnology poses unique ecological and socio-economic threats and requires legally binding international regulation;
5. to suggest that our system of economic and social values must change accordingly, making a few preliminary recommendations for appropriate institutions to solve problems of intellectual property rights and international regulation of biotechnology.

The history of biotechnology's institutional approbation and stricture is complex.

• It was researchers working with newly discovered techniques of biotechnology who first made public the potential dangers of the products that might result from their experiments (Asilomar, 1975).
• Nevertheless, by the end of the decade the US Supreme Court had decided that life forms could be subject to patents. It thereby set a precedent that gave industries protective sanction and powerful inducement in promulgating biological engineering.
• The peak in investment and market activity in biotechnology in 1991 coincided with the preparations for the United Nations Conference on Environment and Development, the purview of which included the opening for signature of the legally binding Convention on Biological Diversity, which provides for access to genetic resources, technology transfer, and the handling of biotechnology and the distribution of its presumed benefits. US President Clinton signed the CBD in 1993 after he had assured biotechnological companies and industry associations that his administration would protect intellectual properties according to the standards of the agreement on trade-related aspects of intellectual property of the Uruguay Round of the General Agreement on Trade and Tariffs, and that it would not consent to a legally binding protocol to the Convention regulating the handling, transfer and use of biotechnological products.

How biotechnology industries present themselves:

• Biotechnology industries and much of the mass media tout modern biotechnology as little less than miraculous. Genetic engineering is said to be responsible for two revolutions in contemporary society: a technological revolution, which promises solutions to the chronic problems of hunger and disease, and a productive revolution, which will increase the efficiency of research, development and manufacture of new products.
• Like most industries, those involving biotechnology present their aims as altruistic, taking the form of improvements in agriculture, medicine and environmental protection.
• Biotechnology industries are also promoting their message preemptively, describing modern biotechnology as the "new biology" and promoting its study in schools.

The reality of the past few years:

• By the early 1990s several reasons for the decrease in venture financing of biotechnology were widely recognized, including basic gene-splicing technology becoming readily available to an increasing number of companies in the industrialized world, slower product development than expected and unrealized returns on investment.
• Product failures in the pharmaceutical sector have been a especially notable in the last few years. Bio-engineered drugs have in many cases failed to provide a cure, have proven too costly to develop further, have not done well on the market or, in at least one case, had lethal side effects.
• Poor management and ill-advised investment have also plagued the biotechnology industries. During the height of investment between 1991 and 1992, the industries raised only about three years' worth of money.
• If biotechnology industries are to survive, it will be in part through consolidation, with fewer "dedicated" companies and more involvement of transnational corporations with broader industrial bases and bigger markets. For those who wish to challenge the aims and power of biotechnology companies the prospects grow more daunting.

The public face of IPRs:

• IPRs come in five varieties--patents, plant breeders' rights, copyrights, trademarks and trade secrets. (This paper focuses on the first two, since they are the most powerful and contentious.)
• A common notion of IPRs, one promulgated to a large extent by industries, is that they exist to reward discoverers and inventors for the benefits they confer on society.
• In theory, patents are more advantageous for both the patent holder and society, since intellectual property protection is considered society's payment for the full disclosure of information about the patented object.
• In practice this has not resulted in the complete information about products or processes that patents are supposed to entail; secrecy tends to surround research, and many recent patents in biotechnology have been exceedingly general.

The private face of IPRs:

• Closer examination reveals that intellectual property rights have no necessary relation to invention, innovation or ingenuity. IPRs exist to gain advantage over economic competitors, create monopolies and recoup the costs of research and development.
• Patents coupled with new technologies appear to be a means of increasing the productivity--the yield and the profit--of these technologies for those who control the patents and the patent system. In this sense, at least, biotechnology is revolutionary: it is one of a series of circumventions of the recurring diminishing returns that characterize any intensive, centralized system. Governments use patents in exactly this manner--as industrial policies.

IPRs in the United States:

• There are three forms of IPRs pertinent to biotechnology in the US: utility patents, patents on plants, and plant variety protection.
• The passage of the Plant Patent Act of 1930 (for asexually propagated varieties) marked the gradual separation of the farmer from control of seed and the making of seed a commodity.
• The passage of the Plant Variety Protection Act (PVPA) of 1970 (for sexually propagated varieties) was facilitated by the growth of agribusiness and the disappearance of the small, seed-saving farmer. A 1994 amendment to the PVPA no longer permits farmers to save seed for future harvests or to trade seed varieties among themselves.

There are several international agreements related to IPRs.

• The Uruguay Round of the General Agreement on Trade and Tariffs (GATT, 1994) is a legally binding trade convention of unprecedented broad scope, which contains provisions for Trade-Related Aspects of Intellectual Property (TRIPs). The TRIPs agreements requires signatory governments to provide patent protection for microorganisms, and either patent protection or some "effective sui generis" system of IPRs for plants. "Effective sui generis" is widely understood to refer to the UPOV Convention, the terms of which are not acceptable to many countries. (See below.) The GATT TRIPs link the "inventive step" required for patent protection to "industrial application," as well as for the first time explicitly linking IPRs to international trade.
• The UPOV Convention (1961) is a binding international agreement developed to harmonize rules governing plant breeders' rights. The Convention was substantially revised in 1991 to extend protection to derivatives of protected varieties and to make the farmers' privilege to save seed optional. Because of the Convention's implications for farmers' rights, Third World governments have stayed away from becoming parties to it.
• Articles 15, 16 and 19 of the Convention on Biological Diversity (CBD, 1992) are especially relevant to IPRs. They call upon parties to "take legislative, administrative and [or] policy measures" to ensure equitable access to genetic resources, access to and transfer of technology, and the handling of biotechnology and distribution of its benefits. The CBD also calls for the consideration of a legally binding "bio-safety" protocol.
• The International Undertaking on Plant Genetic Resources (IUPGR, 1983) is a non-binding agreement, aimed at promoting the proper conservation and use of all plant genetic resources, ensuring access to them without undue restriction. In 1989 it was amended to make it consistent with existing plant breeders' rights and to recognize the non-ownership rights of farmers' to their plant resources. After the establishment of the CBD members agreed to harmonize the IUPGR with the Convention. There is a movement to make the renegotiated IUPGR a legally binding protocol to the CBD, in order to protect small farmers and local and indigenous communities.

Biotechnology poses unique and considerable risks.

• These include the potential for genetically engineered organisms (GEOs) to invade ecosystems as destructive weeds, the possibility of gene flow ("introgression") to related species, the encouragement of the pollutive use of chemical herbicides and pesticides, excessive consumption of water, creation of tolerances to "bio-pesticides" in target populations, and unpredictable and deleterious effects on soil and soil ecosystems.
• The "principle of familiarity" with closely related natural species cannot be applied to GEOs. It cannot account for previously unknown--or previously nonexistent--trait-organism combinations and their expression in different circumstances.

The US regulatory framework:

• US (and international) health and environmental regulation of biotechnology reflects narrow economic priorities and not the actual and potential risks of GEOs. Yet it prides itself on being adequate and judicious.
• At least five separate agencies regulate biotechnology in the US, coordinated through the White House Office on Environmental Policy. This "Coordinated Framework" is neither up to date nor specific to biotechnology. Most of its forms of regulation were designed for the last generation of industrial technologies (for example industrial chemicals).
• The recent relaxation of the US rules on classifying genetically engineered plants as potential pests, on the basis of their relation to non-controlled varieties, is a dangerous misapplication of the principle of familiarity. (See above.)
• The most serious gap in the US framework is the lack of regulation of genetically engineered animals.

International regulation poses a great challenge and great hope.

• The call for a legally binding bio-safety protocol to the CBD opens the opportunity for the development of comprehensive and forward-looking supervision and regulation of biotechnology, as well as the international monitoring of the transboundary effects of transporting and releasing GEOs.
• In terms of substance a bio-safety protocol would mean the assertion of the precautionary principle concerning new technologies, instead of the principle of familiarity. In terms of process it would mean the public's notification about and participation in matters directly affecting its health and livelihood.
• Despite these advantages and precautions, biotechnology industries often try to suggest that concerns about the real and potential risks of biotechnology are not scientifically based. They are often unwilling to accept that advocacy groups are drawing properly on a complex understanding of ethical, social, economic and ecological factors.

Third World countries--and the indigenous and local communities within them--have a rational concern.

• The impact of previous biotechnologies on the Third World has been particularly devastating. The unregulated new biotechnology bodes more of the same: gene introgression, invasion of weeds, proliferation of new viral elements and "genetic erosion" in the globe's rich centers of biological diversity.
• Because Third World governments in general currently lack frameworks for regulating biotechnology, they have been the sites of unsupervised and sometimes illegal field tests of biotechnological inventions.

The rhetoric of stewardship often disguises the contribution of indigenous and local communities.

• References to local and indigenous communities' "maintenance" of genetic resources and "informal" system of husbandry imply that only First World industries, protected by "formal property systems," are ingenious and innovative. Industries do not seem eager to "reward" indigenous and local communities with any sort of property rights.
• If IPRs can be divorced from "innovation" and "invention" (as above), their relationship with investment is no more certain. Indeed, indigenous and local peoples have invested much in cultivating ecosystems and passing on the relevant, highly specialized knowledge.
• Very often the concept of "right" in such communities is based on the immemorial settlement of the land and the special relationship that has evolved between a community and its human and nonhuman environment.

The secret of the "inventive step":

• IPRs are one result of a process of economic rationalization dating to at least the European colonial era. This rationalization was borne out in the Green Revolution, which was designed to be an agricultural "analogue to the production paradigm in industry."
• Following this tradition, modern biotechnology is reductionistic and measured against a single scale of productivity and economic profit. It creates uniform commodities of certain commercial value for the mass market.
• In the final analysis unregulated biotechnology coupled with IPRs, especially patents, is a contrivance to dominate the international markets and maximize profit. It has nothing to do with invention or reward, or sustainable economic development and solutions to environmental problems. Quite the opposite, it invites ecological and socio-economic disaster.

• Substantive public participation at all levels: local, national, regional and global
• Immediate adoption of a bio-safety protocol to the CBD
• Inclusion of the prior informed consent - no intent to consent ("PIC-NIC") principle

  This means that countries have both the right to full disclosure of the aims, methods and products of biotechnology companies, and the right to prohibit their activities if they have not been given explicit permission.

• Countries should have the right not to patent life forms.

  They should not have to fear punitive economic sanctions for exercising this right.

• Support for the renegotiated IUPGR
• An international panel on environment and trade

  All interested parties should be involved: non-governmental organizations, governments, intergovernmental organizations, industries and--crucially--indigenous and local communities.

• The development of "traditional resource rights" or "community intellectual property rights" for local and indigenous communities.

  These could be based on existing agreements on human rights and the rights of indigenous peoples. They should include support for land tenure rights.

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