Dr. SHAKUNTALA MISRA NATIONAL REHABILITATION UNIVERSITY Lucknow Faculty of Law
PROJECT ON
PROTECTION OF PLANT VARIETIES & BIODIVERSITY
For
COURSE ON ‘LAW OF INTELLECTUAL PROPERTY RIGHTS – II’
Submitted by ABHISHEK GAURAV 154140002 Academic Session: 2017-18
Under the Guidance of Mr. Shail Shakya Asst. Prof. in Law & Faculty for IPR-II Faculty of Law Dr. Shakuntala Misra National Rehabilitation University
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ACKNOWLEDGEMENT I, ABHISHEK GAURAV, I feel myself highly elated, as it gives me tremendous pleasure to come out with work on the topic “ PROTECTION OF PLANT VARIETIES & BIODIVERSITY ”,.
First of all I express my sincere gratitude to my Professor MR. SHAIL SHAKYA SIR who who enlightened me with such a wonderful topic. Without Him, I think I would have accomplished only a fraction of what I eventually did. I thank her her for putting her trust in me and giving me a project topic such as this and for having the faith in me to deliver. Her sincere and honest approach have always inspired me and pulled me back on track whenever I went off-track. Sir, thank you for an opportunity opportunity to help me grow. I also express my heartfelt gratitude gratitude to staff and help for the completion of this project. project. Next I express my humble gratitude to my parents for their constant motivation and selfless support. I would thank my brother for guiding me.
THANKS YOU.
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ACKNOWLEDGEMENT I, ABHISHEK GAURAV, I feel myself highly elated, as it gives me tremendous pleasure to come out with work on the topic “ PROTECTION OF PLANT VARIETIES & BIODIVERSITY ”,.
First of all I express my sincere gratitude to my Professor MR. SHAIL SHAKYA SIR who who enlightened me with such a wonderful topic. Without Him, I think I would have accomplished only a fraction of what I eventually did. I thank her her for putting her trust in me and giving me a project topic such as this and for having the faith in me to deliver. Her sincere and honest approach have always inspired me and pulled me back on track whenever I went off-track. Sir, thank you for an opportunity opportunity to help me grow. I also express my heartfelt gratitude gratitude to staff and help for the completion of this project. project. Next I express my humble gratitude to my parents for their constant motivation and selfless support. I would thank my brother for guiding me.
THANKS YOU.
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TABLE OF CONTENTS
INTRODUCTION
TRIPS AND BIODIVERSITY
CONFLICTING
AGREEMENTS
UNDERMINING
BIODIVERSITY BIODIVERSITY AND BIOSAFETY
CASE STUDY
CONCLUSION
BIBLIOGRAPHY
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1. INTRODUCTION
1.1 BIODIVERSITY Biodiversity – or biological diversity - is the term given to the variety of life on earth. It includes the habitats and ecosystems which support this life and how life-forms interact with each other and the rest of the environment. Biodiversity covers plants, animals and micro-organisms both on land and in water. It relates to both wildlife and domesticated crops and animals. The biological diversity we see today is the result of millions of years of evolution Biodiversity provides humans with food, fresh water, fuel, building materials and even the resources used to develop most modern prescription drugs. For this reason, biodiversity can be considered as the very raw material that sustains life on earth. Many industries, including forestry, fisheries, and agriculture are sustained by Ireland’s biodiversity and the balanced development of these
industries is dependent on the sustainable use of these biological resources.
1.2 CONVENTION ON BIOLOGICAL DIVERSITY The UN Convention on Biological Diversity (CBD) resulted from the Earth Summit held in 1992 in Rio de Janeiro. Ireland ratified the Convention in 1996. The CBD is pre-eminent amongst nature/biodiversity related Conventions, both in terms of its widespread support (188 countries plus the EU are Parties) and its comprehensive scope. The Convention has three objectives, the conservation of biological diversity, the sustainable use of its components and the equitable sharing of the benefits arising out of the utilisation of genetic resources. By becoming a Party to the Convention, Ireland has committed itself to working at national level and to international measures to achieve these objectives. The Convention is aiming to secure a significant reduction in the current rate of loss of biodiversity, across the globe, by 2010. The CBD has developed seven thematic programmes of work aimed at meeting the 2010 target. These thematic programmes are: • Agricultural Biodiversity; • Dry and Sub-humid Lands Biodiversity; • Forest Biodiversity; 4
• Inland Waters Biodiversity; • Island Biodiversity; • Marine and Coastal Biodiversity; and • Mountain Biodiversity.
All parties to the Convention are required to develop national actions to achieve the implementation of these work programmes and must report periodically on progress in this regard.
1.3 TRADE AND BIODIVERSITY, AND RELATED ISSUES • International trade has conventionally been destructive of biodiversity and people’s livelihoods,
by encouraging over-exploitation of natural resources, creating pollution through increasing transportation as well as habitat loss by infrastructure development. • The World Trade Organization needs to focus on trade matters without linking trade with social
issues. India is opposed to multilateral rules on investment and competition in the WTO, as well as in linking trade with social issues. • There should be international recognition of effective and credible suigeneris systems of
protection of biodiversity and the associated traditional knowledge, including by way of prior informed consent and benefit sharing for traditional knowledge used by patent applicants and others. • International Property Right (IPR) protection should not displace the developing countries as
competitors, and transform them into mere suppliers of raw materials. Patenting of biological resources must not deny or restrict developing countries’ access to their own biological resources. • International cooperation and initiatives are required to strengthen the monitoring of bio-piracy
and to establish international mechanisms to ensure equitable sharing of benefits from the use of biological and genetic resources.
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1.4 ECONOMICS, TRADE AND INCENTIVE MEASURES Biodiversity generates and helps to maintain the supply of a myriad of goods and services that are essential for human well-being and economic development. Agriculture, for example, would simply not be possible without biological diversity and its contribution to the development of seed varieties and the breeding of domesticated livestock, as well as through the numerous species interacting with agriculture, such as pollinators or symbionts.
Biodiversity is under attack by a number of powerful external forces. From an economic viewpoint, perhaps the most dangerous force is simple neglect: an under-estimation of the value of biodiversity, an ignorance of its essential role in maintaining the foundations for human well being and economic growth alike.
It is well known among economists that markets alone do not assign appropriate monetary value to biodiversity. Hence, without policy intervention, market prices do not properly reflect the losses to society as a whole arising from biodiversity degradation. This ma rket failure leads individuals, companies and governments to use biodiversity in an unsustainable manner.
The Convention’s economic work focuses on two areas. First, it aims to elicit the value of
biodiversity through appropriate valuation tools and to "internalize" this value into market prices through the use of appropriate incentive measures. Such measures can include, for instance, payments for private conservation efforts, fees on biodiversity-degrading activities or transferable quotas for biological resources. As an important milestone, a set of proposals was adopted under the Convention to provide guidance to governments on how to design and implement such incentive measures.
A related objective is addressing policies or practices that generate "perverse" incentives, that is, incentives that accelerate the loss of biodiversity. Examples include those public subsidies that support unsustainable farming, forestry or fishery activities. The Conference of the Parties to the
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Convention encouraged Parties and other governments to identify such perverse incentives and consider the removal or mitigation of the negative effects on biological diversity.
Many of the goods generated through biodiversity are the subject of international trade, either as commodities or in manufactured goods. In addition, biodiversity plays an important role in poverty alleviation and, hence, wealth creation. It is therefore evident that the maintenance of biodiversity and the promotion of trade are interdependent. To address this interdependence forms the second area of economic work under the Convention.
While the Convention does not require measures that are directly related to international trade, there is a close relationship between many of its provisions – as well as those of its Biosafety Protocol – and the provisions of the multilateral trade agreements of the World Trade Organization (WTO). For instance, the Parties to the Conven tion have emphasized the interrelationship between the Convention and the provisions of the WTO’s Agreement on Trade-
related Aspects of Intellectual Property Rights (TRIPs), and the need to further ex plore this interrelationship. Similarly, Parties have underlined the relationship between the Biosafety Protocol and the provisions of the WTO Agreements on Technical Barriers to Trade (TBT) and Application of Sanitary and Phytosanitary Measures (SPS).
The trade-related work of the Convention is part of a broader effort of the international community to ensure harmony and mutual supportiveness between trade rules and international environmental law, in order to both maintain biodiversity and promote international trade.
1.5 PROGRAMME OF WORK ON INCENTIVE MEASURES
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In Article 11 of the Convention, the international community acknowledged the importance of incentive measures in achieving the conservation and sustainable use of biological diversity. In 2000, at its fifth meeting, the Conference of the Parties to the Convention adopted a programme of work on incentive measures which spells out a number of targets as well as the activities required from Parties, other governments, international organizations and the Secretariat to achieve these targets. The expected results of the work programme are: a.
The assessment of representative existing incentive measures, review of case studies, identification of new opportunities for incentive measures, and dissemination of information, through the clearing-house mechanism and other means, as appropriate;
b.
The development of methods to promote information on biodiversity in consumer decisions, for example through eco-labeling, if appropriate;
c.
The assessment, as appropriate and applicable to the circumstances of Parties, of the values of biodiversity, in order to better internalize these values in public policy initiatives and private-sector decisions;
d.
A consideration of biodiversity concern in liability schemes;
e.
The creation of incentives for integration of biodiversity concerns in all sectors.
Importantly, the Conference of the Parties decided to integrate actions on incentive measures in thematic work programmes and to ensure synergy with activities on sustainable use, noting that incentive measures are essential elements in developing effective approaches to conservation and sustainable use of biological diversity especially at the level of local communities. In order to achieve these and other results of the work programme, the Conference of the Parties requested the Executive Secretary to collaborate with relevant organizations, such as the Food and Agricultural Organization of the United Nations, the Organization of Economic Cooperation and Development, the United Nations Conference on Trade and Development, the United Nations Development Programme, and IUCN-The World Conservation Union, in order to engage in a coordinated effort. The programme of work is scheduled for in-depth review by the Conference of the Parties at its ninth meeting, in 2008.
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1.5 BIODIVERSITY AND INTERNATIONAL TRADE The trade-related work under the Convention captures the different aspects of the complex relationship between international trade and the objectives and provisions of the Convention. The production of value-added goods and services derived from biodiversity, both for domestic and for international markets (“Biotrade”) may generate incentives for the
conservation and sustainable use of biodiversity. Accordingly, a number of thematic programmes of work under the Convention call for the increased marketing of products derived from sustainable use (see pages on market creation for further information). The Conference of the Parties adopted a provisional framework of goals and targets to enhance the evaluation of achievements and progress in the implementation of the Strategic Plan of the Convention. Target 4.3 of this framework calls for no species of wild flora and fauna to be endangered by international trade. The Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES) is the key partner in implementing this target, and both Conventions are cooperating closely to implement this target, including through the liaison group of biodiversity-related Conventions. While the Convention on Biological Diversity does not require measures that are directly related to international trade, there is a close relationship between many of its provisions – as well as those of its Biosafety Protocol – and the multilateral rules and provisions of the World Trade Organization (WTO). For instance, the Parties to the Convention have emphasized the interrelationship between the Convention and the provisions of the WTO’s Agreement on
Trade-related Aspects of Intellectual Property Rights (TRIPs), and the need to further explore this interrelationship. Similarly, Parties have underlined the relationship between the Biosafety Protocol and the provisions of the WTO Agreements on Technical Barriers to Trade (TBT) and Application of Sanitary and Phytosanitary Measures (SPS). Accordingly, the Conference of the Parties requested the Executive Secretary to closely interact and cooperate with the relevant Committees of the WTO as well as with its Secretariat on these issues of mutual interest, and to also examine the impact of trade liberalization on biodiversity.
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1.6 BIODIVERSITY AND THE EMERGING WTO REGIMES Global biodiversity is a vast and often undervalued resource. Encompassing every form of life from the finest microbes to the mightiest beast, biodiversity is the variety and variability by all plants, animals and microorganisms along with the ecological processes/complexes of which they are a part. The whole system is referred as biosphere. Biodiversity is autosustainable, self-generating if there is no natural and/or man made perturbations. The only external input to the biosphere is solar energy which fuels the system as a whole. Biological diversity cannot exist without the support of ecological process (such as photosynthesis, water, and number of other biogeochemical cycles and soil formation) and organic evolution (mutation, recombination and natural selection). The latter lead to speciation, competition, predation/parasitism, mutualism, coadaptation and coevolution and finally the survival of the fittest. There are two main functions of biodiversity. Firstly, on it depends the stability of the biosphere, which in turn leads to stability of climate, water, soil, chemistry of air and overall health of the biosphere. Secondly biodiversity is the source from which human race depends for food, fodder, fuel, fibre, shelter, medicine and raw materials for industrial goods to meet his ever changing and ever increasing demand. The warm and humid tropics which are incidentally where the developing countries are located are richer in biodiversity. But it is the biodiversity poor nations of temperate region with their superior technological capability and managerial ability who are using the biodiversity for their best advantage and making the biodiversity rich nations poor. It is certainly a strange paradox. The extent and nature of biodiversity on earth has not remained static. In the geological history of the earth there have been both evolution and diversification, and at least five major episodes of mass extinction of species due to natural perturbations occurred in the geological past. However, today's extinction of biodiversity can be traced to perturbations emanating from the action of human race. Human interference leading to large scale biodepletion began with industrialization, threatening the very survival of human race. The realization of this impending danger led to the world community to meet at Stockholm in 1972 and discuss about human environment. This ultimately led to the Earth Summit at Rio in 1992 wherein the countries of the world resolved to sign the global treaty "Convention on Biological Diversity" (CBD). Side by 10
side there was another treaty piloted by the World Trade Organization (WTO). Trade Related. Intellectual Property Rights (TRIPs) evolved under the GATT agreement of WTO for regulating international trade and monopolistic rights called Intellectual Property Rights (IPR). CBD marks an historic commitment by nations of the world to conserve biological diversity, to use biological resources sustainable and share equitably the benefits arising from the use of genetic resources. It is the first global agreement to address comprehensively all aspects of biological diversity-genetic resources, species and ecosystems. Genetic resources have been traded across the world for centuries, though rarely to the advantage of biodiversity rich nations. CBD has now created a new international legal framework which regulates access to genetic resources and promote fair and equitable sharing of benefits arising from their use. CBD reaffirms the nation's sovereignty over genetic resources and stipulates a framework by which parties can assert their sovereign rights and demand a fair and equitable share of benefits. Article 8 (j) of CBD further stipulates an equitable sharing of the benefits arising from the utilization of traditional knowledge, innovations and practice. Intellectual Property Rights (IPRs) are essentially a concept and practice quite alien toihe third world. A number of legal rights have developed in various jurisdictions in the west during the past 100 yearsto allow ownership of or control over intangible products. These rights known collectively as IPR, have defined "Property Rights" "covering all things which emanate from the exercise of human brain". Historically it is a practice developed in the industrialized societies of the west to protect the product of human creativity, so as to provide economic incentive to those engaged in such creation. The products of such creations are recognized as property. 'IPR' include patents, Plant Breeders Rights (PBRs), copy rights and trade secrets. A patent is a legal certificate that gives an inventor exclusive rights and prevent others from producing, using, selling or importing the invention for a fixed period (usually 17-20 years). Legal action can be taken against those who infringe the patent by copying the invention or selling it without permission from patent owner. Patents can be bought, sold, hired or licensed. Originally biological products and processes were not eligible for intellectual property protection, but the multinational seed and drug companies in the developed countries have lobbied and are now successful in extending the IPR rights over life forms. This commercialization and the accompanying assignment of monetary value over life forms, 11
undermines the CBD's ethical approach towards conservation, which is based on the intrinsic value of all components of biological diversity. Article 27(3) (6) of the TRIPs text of the draft GATT agreement appears to exclude plants and animals from being patented. However, the same phrase in the US patent legislation has not prevented the US Patent and Trade mark office and courts of law from allowing patenting of more and more life forms. The first patent on life was recognized by US Supreme Court in the Chakrabarty Case in 1980 when genetically modified Pseudomonas bacteria was accepted by the court as an invention of the Scientist and, therefore,
patentable. The slippery slope towards ownership of all life forms was thus created by this US Supreme Court decision. In 1988 the first patent of a living animal (a genetically engineered mouse for cancer research) was approved for patent. There are over 190 genetically engineered animals including cows, pigs, mice and fish awaiting patenting in US. Patenting human gene is also in the horizon unless the international community, both citizens and governments, start rejecting it. Attempts by developing countries to revise the international regime for IPRs have been completely displaced by the successful efforts of the developed countries to include IPRs in the agenda for the Uruguay Round GATT. This has profound implications. A universal set of norms based on the current levels of protection granted in the most technologically advanced countries will replace the present system which allows freedom of each country to adopt, within certain limits, the regime of protection that it deems best suited to its own development needs and to the value of each society. To compound this problem new trade related patentable rights have been created, including property rights_ in biodiversity. This threatens the use and conservation of biological diversity and particularly affect the poor, biodiversity rich, nations. Implementation of CBD in its letter and spirit is the only solace for the world to pave the way for an equitable North-South relation and guard against the adverse ecological, social and ethical impacts of technology, especially biotechnology. It will all rest upon the outcome of the negotiations among the parties to be held sometime later in this year.
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2. TRIPS AND BIODIVERSITY In the last decades there has been a distinct shift in the way biological resources are viewed. What was a ‘natural’ resource, accessible to all, has now become an ‘economic’ resource, to be
privatised. In this process, public property jointly held and nurtured by communities, is converted to a private property owned by a few and withheld increasingly from the local communities. This shift can be seen in recent international and national developments. Two major international agreements, the Agreement on ‘Trade-Related Intellectual Property Rights’ (TRIPS) of the WTO and the United Nations ‘Convention on Biological Diversity’(CBD), with mutually conflicting
approaches, are now shaping the domestic regimes of member states with respect to biological resources and associated indigenous knowledge. The Agreement on TRIPS engenders privatisation of biological resources by allowing patents to be granted on biological materials and associated indigenous knowledge, and the CBD acknowledges that local communities have rights over bio resources and indigenous knowledge. Article 27.3(b) of TRIPS has brought biological resources under the purview of intellectual property rights, hence providing for private ownership over bio resources with exclusive commercial rights. Biological diversity has become the sought after raw material of the life sciences industry. Whilst corporations in the developed world have mastered the techniques of recombinant DNA technology, the raw matter is located principally in the tropical and semi-tropical countries of the developing South. Not only the resources, but the associated knowledge of their properties are located within indigenous communities. In order to gain access to biological resources, the life science corporations, through their governments, have extended the scope of intellectual property rights to biological materials at the global level. This development took place in the ‘Uruguay GATT Round’ that began in 1986 and
concluded in Marrakech in 1994. During this round, life forms and genetic resources were brought into the ambit of one system for intellectual property rights. TRIPS covers, amongst other things, copyright and related rights, trademarks such as the protection allowed to Champagne wine and Scotch whisky, industrial designs, patents and plant variety protection, layout-designs of integrated circuits used in electronics, protection of undisclosed information and trade secret and unfair competition. 13
2.1
INTELLECTUAL
PROPERTY
RIGHTS
OVER
BIOLOGICAL
MATERIALS The key element of the TRIPS Agreements related to agriculture and food security is the requirement for WTO Members to make patents available for any inventions, whether products or processes, in all fields of technology without discrimination. One reason for greater interest in patents is the rapid development of biotechnology in agriculture. There are four options within Article 27.3 (b). Firstly, o allows patents on everything. This would include all materials and all forms of technology. Secondly, to exclude plants, animals and biological processes, but not plant varieties. This means that whereas naturally found plants, animals and the natural biological process by which they are created, could be excluded from patents, crop varieties could not. The third option is to exclude plants, animals and biological processes from patenting and to introduce a special sui generis for the protection of plant varieties. A sui generis system allows the country to create a system of their choice that would enable the minimum protection agreed to in the WTO. The final option is to exclude plants, animals and essentially biological processes from patenting but not plant varieties, and to provide a sui generis right. This last would mean that plant varieties could be patented or protected by an independently created sui generis system. Most developing countries have chosen option 3. A sui generis system of protection is one adapted to particular subject matter, and allows countries to make their own rules for protection of new plant varieties. One possible sui generis system likely to be recognised is the International Union for the Protection of New Varieties of Plants (UPOV) system. This was initially developed in Europe and has now been adopted by the industrialised countries. The UPOV system has undergone several changes after its formulation in 1961, but these have resulted in almost no concessions for farmers and breeders. Article 27.3(b) of TRIPs is perhaps the most controversial clause of the entire WTO agreement. It requires members to provide for the patenting of micro organisms and genetically engineered organisms ("non-biological and microbiological processes") and WTO members are now in the process of defining their positions regarding the future of the provisions. There are indications that a few members like the US, would like the sui generis option to be eliminated altogether, while most developing countries are preparing national legislation to implement it. There are proposals to treat UPOV as the only sui generis option for plant varieties. UPOV is not in the 14
interest of developing countries since it does not have any rights for farmers. There is only one right, that granted to the breeder, which in today’s context is increasingly ‘the company’. Patents on seeds would severely restrict the farmers’ access to them, since they would have to buy fresh
seed for every sowing. Women would be particularly disadvantaged under UPOV since their access to their own seeds ensures that they can contribute to food and nutrition for the household. There are potential conflicts between TRIPs patenting regime and the Convention on Biological Diversity (CBD), as well as the International Treaty on Plant Genetic Resources (ITPGR) of the FAO. These conflicts are widely seen as more political than legal in nature, and the US government has made early implementation of TRIPs a top priority of its foreign policy. These matters are likely to emerge as matters of dispute under the WTO's dispute settlement system in the coming years. UPOV 1991 conditions will significantly diminish the farming community's capacity to be self sufficient in seed and self-reliant as agricultural producers. It promotes the interests of commercial plant breeders in the North rather than the farming communities. UPOV requires plant varieties to be "distinct" from other varieties, produce genetically "uniform" progeny, and remain genetically "stable" over generations. After the 1991 UPOV amendment, a new quality3 "novelty"- has been added to the minimal characteristics required The uniformity requirement Has potential to contribute to genetic erosion. In addition, the cost of maintaining UPOV certification is beyond the means of most farmer-breeders. Although peasant farmers have also cultivated plant varieties expressing desirable traits over time, their varieties rarely meet the UPOV requirements list. These conditions for a ‘Plant Breeders’ Right certificate’ under UPOV go contrary to the goal of
enhancing genetic diversity. Furthermore, the kind of protection it grants is an exclusive monopoly right. This contrasts sharply with the broader goals of collective remuneration and benefit-sharing expressed in a number of other global agreements.
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2.2 UPOV IS AGAINST DEVELOPING COUNTRY INTERESTS A number of influential bodies, including the WTO itself, are pushing for a narrowing of the sui generis option to one legislative model provided by the UPOV. UPOV is not mentioned in the
TRIPS Agreement. Independent legal and economic experts have reiterated that UPOV should not be accepted as an effective sui generis system for TRIPS and that there is ample scope for manoeuvre, flexibility and national discretion in interpreting the sui generis option. The UPOV system promotes commercially bred plant varieties for industrial agricultural systems. Under this system farmers have to pay royalties on seed and the seed sector becomes an investment opportunity for chemical and biotech concerns. Plants are bred to grow successfully with their chemical inputs or with their patented genes at the expense of more sustainable biodiverse systems. Since ‘Plant Breeders’ Rights’ (PBRs) are only given for a variety that is genetically uniform they limit both what kind of seeds can be marketed and who can market them. UPOV automatically discourages genetically diverse and locally adapted seeds from the market and from the field. The impact of UPOV type regimes will be highly detrimental to developing country situations. Firstly, farmers who have contributed the varieties on which plant breeders base their own varieties would have no rights, only the breeders would. Secondly, the UPOV conditions are for industrial economies where only 2 to 5% of the population practices agriculture and there are no small and marginal farmers. UPOV laws advantage countries where agriculture is largely a commercial activity. For the majority of farmers in Asia, A frica and Latin America however, it is a livelihood. Applying the TRIPS framework to bio resources is against the interests of indigenous and farming women and men. Women are the most skilled in the use of bio resources for food, medicine and other uses, and use these resources to improve the health and nutrition status of their families, as well as to earn some income. The TRIPS Agreement does not recognise that local communities have any rights over bio resources and associated knowledge. It fails to acknowledge or protect farmers’ rights, explicitly recognised in the CBD and ITPGR. In
addition, the TRIPS Agreement, unlike CBD or ITPGR, does not acknowledge the essential role of women in rural communities in conserving bio diversity. It does not make any provision to ensure benefit sharing from technology and innovation, or require any prior informed consent of the people (primarily women) whose knowledge is tapped for technological innovation. 16
2.3 IMPACT ON BIODIVERSITY AND COMMUNITIES Biodiversity is the basis of food and livelihood as well as human & animal health security for poor and marginalised communities. To alter the dynamics of control and usage of biodiversity through IPR rules will further impoverish and marginalise local communities, and women will be disadvantaged both in terms of their economic and decision making roles. IPR regimes on bioresources and the commercialisation of these for markets will result in resource depletion. The case of the Canadian farmer Percy Schmeiser and his run in with Monsanto, over an alleged violation of IPR shows the way IPR regimes are being implemented by corporations to establish monopolies. Monsanto sued Schmeiser for huge damages for violating its patent on ‘Roundup Ready’ canola after specimens of the proprietary canola were found on Schmeiser’s property.
Canola, is a cross pollinating crop so the likely source of the offending canola was pollen from a nearby Roundup ready field but the case demonstrates the extent to which MNCs will go to establish monopolies on bioresources. Such actions would have grave consequences in developing country situations since denying rights over vital resources would ultimately affect the community’s ability to survive.
Commercial interests that target bio resources on a large scale for the market will threaten the resource base, and with it, the knowledge base developed around the bio resources. The impact on women and through them, families, will be immediate. There is a steady depletion of rare medicinal flora from the hill regions because of collections being conducted by pharmaceutical companies. A sub-species of Taxus baccata, the Himalayan Yew tree in the Himalayan region is facing near extinction thanks to over exploitation for its the cancer curing properties. Large areas of the Kumaon and Garhwal Himalayas in India have been stripped of medicinal plants by head loaders collecting for foreign and Indian companies. This devastation of flora means that women lose the resources they need for use in home remedies to treat their families and their livestock. Patents on seeds would take away the women’s ability to breed new, locally adapted varieties for
food, healing and rituals. This would strike at food and nutritional security of families and also at the socio-cultural identity of communities. Women have bred varieties for special uses integral to local food habits and cultural and religious practices. Some varieties are offered to the Gods at certain festivals. Still others play a role in rituals during marriage and death ceremonies.
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When patents are permitted, there is currently no requirement for disclosing the source of the plant material, nor the key information lead for the claimed ‘invention’, that is the indigenous
knowledge of the characteristics, say of the particular medicinal plant. Biopiracy is a misappropriation of the intellectual property of local communities. In the case of the patent on turmeric, or neem, the knowledge of the wound healing property or the bactericidal property of the respective plants was the basis of the ‘invention’ that was granted a patent by the US Patent
and Trademark Office. The consequences could be twofold. Exercise of the patent in India could lead to corporate control over wound healing or antiseptic products derived from turmeric and neem. On the other hand if such products had export potential to the US, such an opportunity
could be denied because the existing US patent could be used to block any imports. Whether in the field of medicinal plants or in agriculture, it seems clear that women will be excluded from the decision making process. They will have less say in what will be planted in the field because seed availability will increasingly shift to crops with a single dominant trait. Women are likely to have fewer options and less flexibility to use bioresources for multiple uses. Since participation in the cash economy to make up the loss in these sectors will either not be possible for women or place additional burdens on them, it is more likely that the ensuing deprivations will become permanent.
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2.4 RESPONSE OF THE SOUTH India, Brazil, China, Cuba, Dominican Republic, Ecuador, Pakistan, Thailand, Venezuela, Zambia, and Zimbabwe have urged the TRIPS Council to include additional clauses in the TRIPS Agreement. These are to ensure that an applicant for a patent relating to biological materials or indigenous knowledge shall provide disclosure of the source and country of origin of the biological resources and of the indigenous knowledge used in the invention. The applicant would also have to provide evidence of prior informed consent and of fair and equitable benefit sharing under the relevant national regimes, These countries are also pushing for an international regime that grants protection to indigenous knowledge. Due to opposition from developed countries, particularly the US, no action has been taken on these proposals. On the contrary, developed countries are advocating a ‘TRIPS-plu s’ approach. The EU and the US have been pressurising countries through bilateral negotiations, to accept IPR regimes in excess of what the WTO demands. There are a number of bilateral or regional treaties between developed and developing countries that have more stringent rules than that provided under TRIPS.
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2.5 THE WAY AHEAD The only way to fully ensure a fair deal for communities in developing countries is to remove biodiversity from TRIPS altogether. Since achieving this ambitious goal may take more time than the mandated review period allows, one way might be to secure a five-year suspension of the implementation of Article 27.3(b) so that developing countries may sort out their strategies. In any case, developing countries must at least ensure that there is no strengthening of the TRIPS Agreement, as some developed countries are trying to do through bilateral treaties. The other approach could be to negotiate at the international level for establishing the primacy of CBD over TRIPS. Article 22 of the CBD says: The provisions of this Convention shall not affect the rights and obligations of any Contracting Party deriving from any existing international agreement, except where the exercise of those rights and obligations would cause a serious dama ge or threat to biological diversity.
It is clear that the implementation of TRIPs is detrimental to the health of biological diversity and therefore its implementation must be made subservient to the conditions of the CBD.
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3.
CONFLICTING
AGREEMENTS
UNDERMINING
BIODIVERSITY AND BIOSAFETY THE international Convention on Biological Diversity (CBD) and its Biosafety Protocol (BP) were achieved through hard bargaining on principles and national interests. Are these now being undermined by the World Trade Organisation (WTO) while pushing its objectives of providing a regulatory and institutional framework for the world trading system and of bringing national policies in line with international trade? The power invested under TRIPS in the `Dispute Settlement Body' and the `TRIPS Council' over-ride the jurisdiction and mandates of CBD and BP, as also the Convention on International Trade in Endangered Species (CITES), ILO Conventions (1957/107; 1989/169) dealing with the protection of the rights of indigenous people and local communities, the Declaration of the UN's Economic and Social Council (ECOSOC) on the rights of indigenous peoples (especially resolutions 1990/27 and 1991/31) and FAO's international undertaking on plant genetic resources. This power can nullify concepts and principles which are essential for sustainable development and environmental quality, and which were achieved after several rounds of international deliberations: The concept of sovereignty, the `precautionary', `internalising' and `polluter-pays' principles, and equitable benefit-sharing of genetic resources. Several agreements within WTO, particularly TRIPS (Article 27(3)b), directly or indirectly, affect biodiversity conservation. With respect to intellectual property, TRIPs (Articles 3 and 4) requires member-states to observe the principles of `national treatment' and `most-favoured nation'. Of seven forms of intellectual property protection (copyright, patenting, plant variety protection, industrial design, geographical indications, lay-out design of integrated circuits, and trade secrets) the three most important for biodiversity and biosafety are patents, Plant Variety Protection (PVP) and geographical indications. Article 27 of TRIPs sets the framework of the patent regime while Article 31 provides for compulsory licensing.
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India has already notified the Protection of Plant Varieties and Farmers' Rights Act 2001, following the provisions of UPOV, but the Geographic Indications Bill (2000) is still pending. Since the emergence of the WTO regime, three Articles of CBD have assumed greater relevance: Article 8(J) which relates to the preservation and maintenance of traditional knowledge systems of local communities, through equitable sharing of benefits; Article 16 covering the whole issue of access to and transfer of technology including biotechnology; and Article15.1 pertaining to the rights over genetic resources.
3.1 INDIGENOUS AND LOCAL COMMUNITY RIGHTS Article 8 (J) imposes a major responsibility on nations to establish a critical balance between biodiversity conservation and the protection of the rights of the indigenous and local communities. The debate on Intellectual Property Rights (IPRs) and on Article 8(J) took an interesting turn at the fifth meeting of the Conference of Parties (nations), at Nairobi in May 2000, with the Working Group II recommending the continuous involvement of indigenous people while the intellectual regime was being implemented. It also called for, inter alia, the full and direct participation of indigenous and local communities including women; recognition of the collective dimension of indigenous knowledge and the issues related to Mutually Agreed Terms (MAT)/Prior Informed Consent (PIC); and direct involvement of indigenous technical experts. The report recommended that parties support the development of traditional knowledge registers, recognised that the maintenance of such knowledge requires maintenance of cultural identities and the material base, and emphasised the need for indigenous and local communities to control and determine MAT/PIC arrangements so as to make informed decisions. The Working Group set out a two-phase approach for implementation. The first phase includes tasks that address participatory mechanisms, strategies and trends, benefit-sharing, exchange and dissemination of information, and other legal elements. The second phase would include participatory processes for conservation and systematic use, and other monitoring elements.
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3.2 ACCESS TO AND TRANSFER OF BIOTECHNOLOGY Article 16 covering "Access to and transfer of technology" particularly emphasises that transfer of technology should be provided and/or facilitated under fair and most favourable terms. In the case of patents and other property rights, such access and transfer are to be provided only after honouring IPRs. It further stipulates that measures be taken at the policy level to ensure that the private sector facilitates access to joint development and transfer of technology, subject to national and international laws.
3.3 ACCESS TO GENETIC RESOURCES Article 15 on access to genetic resources provides a framework for establishing that States have sovereign right over their natural resources. It says that access to genetic resources shall be subject to the PIC of the Contracting Parties providing such resources. PIC is an important mechanism as it ensures community participation in decision-making. The royalty-sharing experiment between the Kani tribe and the Tropical Botanical Garden, Kerala, is an example of this.
3.4 POINTS OF CONFLICT The points of conflict are: a) Recognition of national sovereignty under the CBD implies that countries have the right to prohibit IPRs on life forms (biological resources). TRIPS overlooks this right by requiring the provision of IPRs on micro-organisms, non-biological and microbiological process, as well patents and/or sui generis protection on plant varieties. b) The CBD gives nations a legal basis to demand equitable benefit sharing arising from the use of biological resources and associated traditional knowledge, practices and innovations. TRIPS negates the broad historical contributions made by the communities in the IPRs regime and establishes the monopolistic control of the patent holder. Thus, there will be no legal synergies between these two sets of rights. c) The CBD gives Parties legal authority to provide access based on PIC and MAT to biological resources. TRIPS ignores this authority. d) The CBD places public interest and common good over private property and vested interest. TRIPS does the oppsosite. To deal with this conflicting 23
situation, CBD must be fully developed as an effective international instrument if it is to promote the sustainable use and conservation of biodiversity, based on community control of resources. For example, since the WTO has an effective dispute redressal system, there is an urgent need for the establishment of a similar system under the CBD in the light of Article 22 (1) that states that the provisions of CBD "shall not affect the rights and obligations of any party deriving from any existing international agreement except where the exercise of those rights and obligations would cause a serious damage or threat to biological diversity." This would bring the CBD on a par with the WTO Agreements vis-à-vis biodiversity conservation and the sustainable use of biological resources. Taking into account the precautionary approach, the objective of the Biosafety Protocol, under the CBD, is "to contribute to ensuring an adequate level of protection in the field of the safe transfer, handling and use of Living Modified Organisms (LMOs) resulting from modern biotechnology that may have adverse effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health, and specifically focusing on transboundary movements" (Article 1). Surprisingly, the definition of LMO (Article 3) does not include `product thereof' and as such these would be internationally unregulated. However, "the protocol shall apply to the transboundary movement, transit, handling and use of all LMOs that may have adverse effects... " in accordance with its objectives (Article 4), and exclude LMOs which are pharmaceuticals (LMO-P) for human uses and are covered by other international agreements or organisations (Article 5). LMOs intended for direct use as food, feed or for processing have also been excluded from the regular Advanced Informed Agreement and risk assessment (Article 7.2), but alternative procedures have been set.
3.5 GATT Three major provisions of the WTO, if narrowly interpreted, may have serious implications for the implementation of BP. 24
GATT provides justification for trade barriers that are necessary to protect animal and plant life and health, and relate to the conservation of exhaustible natural resources" (Article XX ). Using these provisions, Trade Related Environmental Measures (under GATT) may be invoked as per the requirement of BP. However, the existing GATT panel has not taken measures comparable with the biosafety measures involving questions of scientific uncertainty, ethical and socioeconomic considerations, and the diverse levels of risk-awareness in different WTO Parties.
3.6 SANITARY AND PHYTOSANITARY MEASURES The Agreement on Sanitary and Phytosanitary Measures (SPS) under WTO has refined the rights and obligations of the Parties while adopting measures to protect human, animal and plant life, and health risks arising from the introduction of food, disease-carrying or disease-causing organisms, including the entry and establishment of pests. It is to be noted that Article 2 (2) of the SPS requires parties to base their SPS measures on scientific principles and not to maintain these without sufficient scientific evidence. This means that the importing countries might not accept the safety measures which are adopted by exporting countries in the absence of scientific certainty. Besides, the LMO labelling scheme could still be defended by the importing countries as it would not create `arbitrary or unjustifiable discrimination', or represent a `misguided restriction' on international trade.
3.7 TECHNICAL BARRIERS TO TRADE The Agreement on Technical Barriers to Trade (TBT) aims to ensure that parties do not use domestic regulations, standards, testing and certification procedures to create unnecessary obstacles to trade. It has been designed to prevent arbitrary standards from being used to protect industries from foreign competitors. It encourages international standards that producers must comply with to gain access to different markets.
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The TBT agreement includes obligations relating to the preparation, adoption and application of technical regulations and standards, and the procedures for assessing whether the products conform to these regulations and standards. The agreement also imposes requirements for labelling of products. It is to be seen how countries not party to the CBD and the BP use these WTO agreements from the perspective of biosafety concerns. The preamble of the Biosafety Protocol reflects the compromise reached at Cartegana in May 2000. As the preamble is weaker than the text agreed upon earlier in Miami, the substantive articles are also rendered vulnerable to misuse due to the specific provisions in the protocol that refer to other international obligations Apart from the specific points of conflict between the CBD and the WTO, there are broader issues of lack of compatibility between the various WTO agreements and the CBD, including the Biosafety Protocol. These include: a) The enhancement of global trade through implementing the WTO Agreements may aggravate the unsustainable use of biodiversity, which is contrary to the objectives of CBD. b) The increased transportation activity and infrastructure development to promote global trade may have an adverse impact on the functioning of ecosystems, which could result in biodiversity losses. c) The trans-boundary movement of biological products, including LMOs in trade may result in the accidental introduction of alien species which may lead to destabilization of native species. d) The liberalisation of trade and investment may intensify the direct and indirect adverse impacts on biodiversity and the supporting habitats. e) The WTO agreements may interfere with the international/ national subsidies as incentives to the industry, or with conservation laws and policies which seek control of traded goods. (For instance, GATT conflicts with the CITES provisions on Tuna-Dolphin harvesting from the Sea).
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f) Moreover, built into the WTO agreements are various policy interventions for trade enhancement which may completely ignore the cost required for maintaining the environmental functions of the major habitats, thus, resulting in unsustainable production or trade in certain sectors.
3.8 RESOLVING THE CONFLICTS If the WTO Agreements and the CBD (inclusive of the Biosafety Protocol) are to be implemented in the interest of human survival and well-being, urgent measures are required to be taken to ensure that the objectives of CBD are not undermined by the narrow agenda of WTO Agreements, particularly of TRIPS. These measures would include: First, that nations recognise and affirm in law the primacy of the CBD over the TRIPs in the areas of biological resources and traditional knowledge systems. Second, the collective rights of indigenous and local communities to freely use, exchange and develop biodiversity should be recognized as a priori rights and be placed over and above private intellectual property rights. This has to be reflected in legislation and p ublic policy at the national level. Third, the implementation of TRIPs in developing countries should be challenged so as to make these compatible with the provisions of the CBD. Fourthly, during the review of TRIPs, it should be ensured that there is an option to exclude all life forms and related knowledge from the IPR system. If such measures are taken by the parties concerned, the Convention on Biological Diversity and the Biosafety Protocol could provide an innovative approach to the interface of trade and environmental concerns, and set a precedent for `sustainable trade agreements' so that the potential value of biological resources can be optimised on a equitable basis for the welfare of human beings.
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4. CASE STUDY CASE
I KARNATAKA HIGH COURT ISSUES NOTICE IN PIL HIGHLIGHTING
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EGREGIOUS BIOPIRACY AND GOVERNMENTAL APATHY Meanwhile, Karnataka scandalously transfers prosecuting officers in biopiracy case
The Principal Bench of the High Court of Karnataka (comprising Chief Justice Mr. Vikramjit Sen and Justice Mrs. B. V. Nagarathna) ordered issue of notice on 21 Nov 2012 in the Public Interest Litigation (Writ Petition No. 41532/2012) filed by Environment Support Group, Bangalore (ESG) and listed the matter for further consideration for the fourth week of January 2013. ESG’s petition highlights the shocking state of biodiversity conservation in India, and urges
the Court to direct attention to the widespread practice of biopiracy by national and international corporate bodies. Further, the petition highlights a number of specific defects, lacunae and failures in the current legal and institutional regimes that are directly resulting in the rampant irreversible loss of India's biological diversity and associated traditional knowledge, and are thereby threatening not only sovereign control over biological resources but also the livelihoods of indigenous and natural resources dependent peoples. Specifically, the Petitioners have drawn the attention of the Court to the continuing failure on the part of regulatory authorities to initiate action against M/s Mahyco, M/s Monsanto, and various public agricultural universities involved in promoting B.t. Brinjal despite categorical evidence indicating that egregious criminal biopiracy of local varieties of brinjal (egg plant) was involved. This failure of the regulatory authorities has also been strongly criticised by the Parliamentary Committee on Agriculture in its August 2012 report on “Cultivation of
Genetically Modified Food Crops – Prospects and Effects” which has called for “....a thorough inquiry in the matter of continued paralysis in decision making on a case of this dimension.” The Petitioners have also highlighted that the Ministry of Environment and Forest's 26 October 2009 Notification listing 190 plants as Normally Traded Commodities (NTC) includes, shockingly, at least 18 critically endangered plants. The Petition contends that while 28
hundreds of community and regional initiatives are desperately trying to protect such endangered plants, the Ministry's Notification callously promotes their unfettered international trade thus driving them potentially into extinction. The Petition also argues that Section 40 of the Biodiversity Act, 2002, which arbitrarily allows such unfettered trade in India's biological wealth through an uncanalised power to label something as a Normally Traded Commodity, paves the way for rampant biopiracy. The writ petition therefore urges that this section be struck down as being ultra vires of the Biological Diversity Act, 2002 and the Constitution of India. Finally, the Petition draws the attention of the Court to the reports of the Comptroller and Auditor General of India and the Indian Parliament's Committees on Agriculture and Public Accounts, all of which have independently come to the conclusion that there has been colossal failure on the part of the Ministry of Environment and Forests and the National Biodiversity Authority in protecting the country's biodiversity. On such and other grounds, the petition prays that environment, social and bio-diversity impact assessments based on meaningful compliance with the Principle of Prior and Informed Consent must be made mandatory for all decisions impacting biodiversity, associated traditional knowledge and livelihoods. The prayer seeks the quashing of the Ministry's 26 October 2009 Notification on NTC and urges the Court to direct the Ministry and the National Biodiversity Authority to institute appropriate structures, procedures and norms to protect India's biodiversity in strict conformance with relevant constitutional norms, the Biological Diversity Act, 2002, the Scheduled Tribes and Other Traditional Forest Dwellers (Recognition of Forest Rights) Act, 2006, Environment (Protection) Act, 1986, amongst others. It may be recalled that the High Court had taken note of the PIL on 16 October 2012 when Chief Justice Mr. Vikramjit Sen pointedly observed that dharnas must be organised against the United States of America for its continued intransigence in complying with global biodiversity norms, highlighting that such action might perhaps be necessary in tackling challenges to global biodiversity conservation. This remark was made even as the 11th Conference of Parties on the Convention on Biological Diversity was held at Hyderabad, a gala UN event
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that was colossal failure in safeguardig biodiversity and traditional knowledge and livelihoods associated with it. Karnataka transfers officials prosecuting Monsanto/Mahyco and others in biopiracy case:
The extraordinary seriousness with which the Court had taken note of the Petition's concerns should have propelled regulatory agencies in initiating prosecution of those guilty of biopiracy. Quite in contrast, when Petition is under the active consideration of the Court, it is reported that the Karnataka Government has scandalously transferred the two key officers who were empowered by the Karnataka Biodiversity Board to file criminal complaints against Monsanto/Mahyco and others involved in biopiracy while advancing B.t. Brinjal . This is clearly demonstrative of the high levels of collusion that exists within the Government to scuttle the possibility of prosecution in India's first biopiracy case proceeding per law. ESG holds that this is clearly to benefit powerful agri-business corporations such as Monsanto, and will take up this matter at the very highest level to have the officers restored to their current positions forthwith.
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CONCLUSION Trade is a critically important issue for all of us. We are utterly dependent for our very survival, or at least welfare, on harvested natural resources from some of the most volatile parts of the world, causing our governments to make substantial military expenditures to keep the whole system functioning. Some people may have their doubts, but the consensus in most parts of the world is that global trade is, on balance, a good thing and a key component of sustainable development, even if it often seems that the benefits flow disproportionately in favour of those who are already well off. But what are the impacts of trade on biodiversity?
First, the institutional context of the resource management regime is essential. All depends on whether the harvested resource is being managed with a view toward optimal use, or whether it is simply open access to earn quick income. Renewable natural resources - forests, fisheries, crops- are inherently dynamic, often affected by unpredictable variables such as climate or rates of replenishment; and complex environmental issues surround resource extraction, including non-use values, ecosystem services, invasion of non-native species, and conversion of productive habitats to less productive alternative uses. Further, many of these resource systems have people who may have been living within them for several generations or more, but are not always fully involved in the decisions about how these resources are to be exploited today. Because the impacts of resource extraction on biodiversity are felt locally, those involved in global trade disclaim any responsibility for the mode of production or transport. They simply accept as a matter of faith that the responsible governments will ensure that any environmental costs are incorporated into the prices that are charged for the commodities traded. Small wonder that the international community is willing to leave such issues up to the national governments.
Instead of a general policy solution, each specific management problem affecting biodiversity will need to be analysed case by case in order to determine the linkages between the key economic, ecological, and institutional factors that are driving the problem. By identifying the impacts of trade on resource management, biodiversity and economic welfare, the possible policy remedies can be recommended to governments and possibly to the WTO, CBD, and CITES as well.
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Whether trade is good or bad for biodiversity and welfare depends on the interplay of complex economic, ecological, and institutional factors. Policy options and recommendations can also be expected to reflect the complexity of the issues involved, arguing against any simple answer supporting or opposing free trade. Instead, full consideration needs to be given to the wider ecological and economic links that provide the foundation for trade, natural resource management, and assessing the impacts of these on biodiversity.
Another externality of trade
is the impact on biodiversity of non-native species transported by trade. If these are beneficial, or at least harmless, no problem arises. But if they proliferate in their new home and spread in ways that are contrary to human health, economics or the environment, then a serious problem arises. If the species is being introduced intentionally, then existing mechanisms such as environmental impact assessment can readily be used. But far more insidious are the thousands of species that are unknowingly in motion at any one time, in the ballast water of freighters or navy vessels, as egg masses of insects in log shipments, in the form of mosquito larvae trapped in shipments of used tires, or even viruses carried by unsuspecting travellers. Invasive species cost countries around the world several hundred billion dollars per year biodiversity-related damages, calling for a far more effective policy response.
One final impact of trade on biodiversity that passes generally unnoticed is that it promotes specialisation in production, leading in turn to specialisation in ecosystems and their associated biodiversity. The conversion of large areas of highly diverse tropical rain forest into monospecific stands of oil palm, rubber, or coffee, makes the point dramatically in various parts of the tropics. Biodiversity certainly suffers in such a case, and when the systems being simplified are ones that are of recognised global importance because so many of their species are found nowhere else, then a vigorous public policy response is appropriate. This is again an example of a hidden externality; a tony Parisian sipping her demi-tasse of espresso is hardly aware that a unique patch of rainforest in Madagascar, containing species that are found nowhere else in the world, has been destroyed so that she can have her caffeine jump-starter each morning. Ultimately, it is all a question of feedback: how can markets better internalise the costs of biodiversity impacts of trade. This issue is of great, and growing, importance as biodiversity continues to be lost at an alarming rate, driven in part by growing resource consumption driven by trade. 32
