Biodiversity and Traditional Knowledge

Regulatory Framework at National, Regional and International Level

Biodiversity encompasses all species of plants, animals and micro-organisms and the variation between them, and the eco-systems of which they form a part. It occurs at three levels, namely: (i) species level - refers to number and kinds of living organisms; (ii) genetic level - refers to genetic variation within a population of species and (iii) eco-system level - refers to the variety of habitats, biological communities and ecological processes that occur in such habitats.

Traditional knowledge (TK) associated with biological resources is an intangible component of the resource itself. TK has the potential of being translated into commercial benefits by providing leads for development of useful products and processes. The valuable leads provided by TK save time, money and investment of modern biotech industry into any research and product development. Hence, a share of benefits must accrue to creators and holders of TK. Only new knowledge can be patented. Patents only apply to inventions, not to existing knowledge. But if knowledge is held only in oral form, then many IPR regimes, do not consider oral knowledge as proof of previous documentation and therefore such knowledge is in danger of being patented.

Biopiracy is obtaining IPRs without consent of / any benefits going to, the original holders of the biological resources/ knowledge on which the innovation is based and/or commercially exploiting biological resources/ knowledge without consent of / any benefits going to, the original holders (without obtaining IPRs). Biopiracy is a form of theft. Some examples of biopiracy are the patents, which were granted over Neem, Turmeric and Nap Hal Wheat Variety.

The implications of biopiracy are economic as well as ethical:

# Original holders get no share in profits / no recognition for nurturing resources/ knowledge
# Once IPR acquired, original holders cannot make commercial use of IPR-protected resources.
# Violation of rights of original holders over resources/ knowledge.

For the purposes of obtaining consent, or channeling of benefits, a major problem is to identify the 'original holders' of the biological resources or related knowledge.

India is one of the twelve mega-biodiversity countries of the world. With only 2.4 per cent of the land area, India already accounts for 7 per cent to 8 per cent of the recorded species of the world. This number is based on the survey of 65 to 70 per cent of the total geographical area of the country. The Botanical Survey of India and the Zoological Survey of India have recorded over 47,000 species of plants and 81,000 species of animals respectively. It is anticipated that some of the remaining areas (e.g., Himalayan region, A & N Islands) may be far richer in biological diversity than most of the areas already surveyed.
The Convention on Biological Diversity (CBD) is a landmark in the environment and development field, as it takes for the first time a comprehensive rather than a sectoral approach to the conservation of Earth's biodiversity and sustainable use of biological resources. It is a framework of agreement in two senses. In the first sense, it leaves it up to the individual Parties to determine how most of its provisions are to be implemented. This is because its provisions are mostly expressed as overall goals and policies, rather than as hard and precise obligations as in, for example, the Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES).

On May 22, 1992 the nations of the world adopted the CBD in Nairobi and on June 5, 1992 the CBD was tabled at the UN Conference on Environment and Development in Rio de Janeiro where a record 150 countries signed the Convention.

The main objectives of the Convention are:
# Conservation of biological diversity; # Sustainable use of the components of biodiversity; # Fair and equitable sharing of benefits arising out of the utilisation of genetic resources.

The CBD stipulates that the parties, even though having sovereign rights over their biological resources, would facilitate access to the genetic resources by other parties subject to national legislation and on mutually agreed terms. This has made it necessary for a legislation to be put in place, which lays down the framework for providing access, for determining the terms of such access and for ensuring the equitable sharing of benefits.

We have a number of Acts and Bills relating to forestry, wildlife etc.
# Indian Forest Act, 1927 # Wildlife (Protection) Act, 1972 # Forest (Conservation) Act, 1980 # Patent (Second Amendment) Act, 2002 # The Protection of Plant Varieties and Farmers' Rights Act, 2001 # Draft Biological Diversity Bill, 2000 # Draft Kerala Tribal Intellectual Property Rights Bill, 1996 # Draft Karnataka Community Intellectual Rights Bill, 1994.

These Acts cover protection of flora and fauna in notified sanctuaries and national parks, six specified plant species and regulates hunting of animals specified in Schedules appended to the Acts. The Acts thus leave out from its scope the following:
# wild flora outside the notified sanctuaries and National parks (many of which located outside forest areas including deserts, coastal and marine systems, grasslands, riverine systems, wetlands) # although the act provides for protection of a number wild animals which are included in Schedules, it leaves out a large number of invertebrates (out of the 81,000 animal species so far described from the country about 68,000 are invertebrates) and micro organisms

The Acts also do not deal with the following:
# Issue of access to biological resources and benefit sharing # Protection of traditional knowledge and equitable sharing of benefits arising out of the use of such knowledge.

The purpose of the Biodiversity Bill is to realize equitable sharing of benefits arising out of the use of biological resources and associated knowledge. The proposed legislation primarily addresses the issue concerning access to biological resources by foreign individuals, institutions or companies.

Traditional Knowledge on Biodiversity Conservation

In order to be effective, efforts on biodiversity conservation can learn from the context-specific local knowledge and institutional mechanisms such as cooperation and collective action; intergenerational transmission of knowledge, skills and strategies; concern for well-being of future generations; reliance on local resources; restraint in resource exploitation; an attitude of gratitude and respect for nature; management, conservation and sustainable use of biodiversity outside formal protected areas; and, transfer of useful species among the households, villages and larger landscape. Traditional knowledge on biodiversity conservation in India is as diverse as 2753 communities and their geographical distribution, farming strategies, food habits, subsistence strategies, and cultural traditions.

Over thousands of years local people have developed a variety of vegetation management practices that continue to exist in tropical Asia, South America, Africa and other parts of the world. People also follow ethics that often help them regulate interactions with their natural environment. Such systems are often integrated with traditional rainwater harvesting that promotes landscape heterogeneity through augmented growth of trees and other vegetation, which in turn support a variety of fauna.

In India these systems can be classified in several ways:
# Religious traditions: temple forests, monastery forests, sanctified and deified trees # Traditional tribal traditions: sacred forests, sacred groves and sacred trees # Royal traditions: royal hunting preserves, elephant forests, royal gardens etc. # Livelihood traditions: forests and groves serving as cultural and social space and source of livelihood products and services.

The traditions are also reflected in a variety of practices regarding the use and management of trees, forests and water. These include:
# Collection and management of wood and non-wood forest products. # Traditional ethics, norms and practices for restraint use of forests, water and other resources. # Traditional practices on protection, production and regeneration of forests. # Cultivation of useful trees in cultural landscapes and agro-forestry systems # Creation and maintenance of traditional water harvesting systems such as tanks along with plantation of the tree groves in the proximity.
These systems support biodiversity, which is although less than natural ecosystems but it helps reduce the harvest pressure. For instance, there are 15 types of resource management practices that result in biodiversity conservation and contribute to landscape heterogeneity in arid ecosystems of Rajasthan. Environmental ethics of Bisnoi community suggest compassion to wildlife, and forbid felling of Prosopis cineraria trees found in the region. Bisnoi teachings proclaim: "If one has to lose head (life) for saving a tree, know that the bargain is inexpensive".

Regulatory Framework at National Level

At the national level, India has enacted the Biological Diversity Act (2002), which provides that prior approval of National Biodiversity Authority is necessary before applying for any kind of intellectual property rights (IPRs) based on any research or information on a biological resource obtained from India. Further, the Patents (Second Amendment) Act provides for disclosure of the source and geographical origin of the biological material / associated knowledge, used in an invention. It also provides for opposition to the grant of patent or revocation of the patent in case of non-disclosure or wrongful disclosure of source of biological material and associated knowledge.

The Biodiversity Act – 2002 primarily addresses access to genetic resources and associated knowledge by foreign individuals, institutions or companies, to ensure equitable sharing of benefits arising out of the use of these resources and knowledge to the country and the people.

A three-tiered structure at the national, state and local level is to be established.

# National Biodiversity Authority (NBA): All matters relating to requests for access by foreign individuals, institutions or companies, and all matters relating to transfer of results of research to any foreigner will be dealt with by the National Biodiversity Authority.

# State Biodiversity Boards (SBB): All matters relating to access by Indians for commercial purposes will be under the purview of the State Biodiversity Boards (SBB). The Indian industry will be required to provide prior intimation to the concerned SBB about the use of biological resource. The State Board will have the power to restrict any such activity, which violates the objectives of conservation, sustainable use and equitable sharing of benefits which are derived from the biological resources.

# Biodiversity Management Committees (BMCs): Institutions of local self government will be required to set up Biodiversity Management Committees in their respective areas for conservation, sustainable use, documentation of biodiversity and chronicling of knowledge relating to biodiversity and traditional knowledge.
NBA and SBBs are required to consult the concerned BMCs on matters related to use of biological resources and associated knowledge within their jurisdiction.
While CBD envisages that access to genetic resources and realization of benefits is subject to national legislation through formalization of prior informed consent (PIC) and mutually agreed terms (MAT), India has been emphasizing that such national action alone is not sufficient to ensure realization of benefits to the country of origin or provider country. This is particularly so in cases where genetic material sourced from one country is utilized in another country for developing products and processes on which patent protection is obtained. The onus of benefit sharing must also be shared by the user country to create an enabling environment and confidence through legislative measures so as to ensure compliance of PIC stipulations and equitable sharing of benefits as visualized in the Convention.

Regulatory Framework at Regional Level

There is a need to set up an Indian Biodiversity Information System (IBIS), based on the wealth of existing information on biodiversity, as well as the information generated from preparation of PBRs. The IBIS would promote conservation and sustainable use of bio-resources, and value addition to biodiversity and associated knowledge along with equitable sharing of benefits arising from their use. NBA could take up preparation of IBIS during the Eleventh Plan. A number of issues relating to IBIS would however need to be addressed, such as: maintaining confidentiality while promoting value addition, IRP issues in the context of value addition and benefit sharing. These could possibly be done through the National Innovation Foundation. Legal framework for IPRs should be strengthened through augmentation of facilities in Law/Economics/Commerce Departments of selected Universities where IPR Centers are already functioning and also the National Law Schools.

The documentation of traditional knowledge available in our ancient texts is being undertaken by NISCAIR (a CSIR lab), in the form of a computerized database, Traditional Knowledge Digital Library (TKDL). Preparation of PBRs is expected to document the un-coded, oral traditional knowledge of local people. Considering that this would be a stupendous and time-consuming exercise, it is proposed that an All India Coordinated Project on Traditional Knowledge may be launched in the Eleventh Plan for documenting the un-coded, oral traditional knowledge of local people, especially of little-known bio-resources of potential economic value.
Conservation of biodiversity at the level of genes, populations, species, communities and ecosystems is achieved through two major approaches- (i) in situ and (ii) ex situ conservation. The Protected Areas (PA), which includes forests, wetlands, coastal, marine and mangrove ecosystems represent on-site conservation of biodiversity; these PAs constitute heritage sites and major repositories of gene pools.

There is an urgent need to strengthen the conservation research and monitoring in all protected areas. This can be achieved by establishing Conservation Research and Monitoring Units in each of the protected areas and each unit should at least have one plant taxonomist, one animal taxonomist/wildlife biologist, one ecologist, and one resource economist/social scientist.

The domesticated biodiversity includes a wide range of land races of plants and breeds of animals, which constitute valuable gene pools useful for improvement of modern varieties/cultivars. One method of in situ conservation of these gene pools is on-farm conservation through appropriate incentives to the farmers. This programme requires to be taken up as inter-sectoral linkages. Similarly, establishment of field gene banks and breeding safaris for the domesticated biodiversity and wild relatives of domesticated species should be done through inter-sectoral linkages involving Managers of Protected Area Network and the ICAR.

Under ex situ conservation approach, seed banks, sperm and ovum banks of threatened biota (excluding domesticated biodiversity) should be established at Forest Research Institutes, BSI, ZSI, selected Universities, National Institutes and even leading Botanical Gardens and Zoological Parks.

India has a network of 96 National Parks and 509 Wildlife Sanctuaries in the different States harbouring major flagship and endemic flora and fauna. However, the Protected Areas (PAs) can still be termed as discreet isolated patches of forests managed exclusively for wildlife/ biodiversity preservation and many important habitats still exist in the rest of the forests, which require special attention for conservation for ensuring sustainability of the populations. The habitat in these areas is being depleted due to various reasons, as will be discussed later. The problem is compounded by the fact that though a dedicated protection machinery is in place within the PAs and the wild life therein is adequately protected, wild life found outside such protected areas is still vulnerable. Here, protective vigilance is far too inadequately organized and managed and very poorly equipped. In fact, it can easily be said to be non-existent in most parts.

Regulatory Framework at International Level
The global push for privatisation of biodiversity continues to encourage ownership over these genetic resources. Many countries, and the large businesses they support, increasingly want to control these resources and the knowledge associated with them for commercial purposes. The means for such control is the use of intellectual property rights – particularly patents.

The obligations under TRIPS can have adverse impact on the use of biological and genetic resources and the distribution of benefits arising there from. IP protection in the current TRIPS regime may well deprive the countries providing the biological and genetic resources and the providers of traditional knowledge on the use of such resources, of their fair share of the benefits.

The fair and equitable sharing of benefits is one of the objectives of the Convention on Biological Diversity (CBD), and the implementation of intellectual property right (IPR) obligations has to be consistent with the objectives of the CBD. This is contained in Article 16(5) of the CBD.

On the issue of traditional knowledge that is associated with biological resources (in agriculture and medicinal uses), there have been growing concerns over the past few years regarding 'biopiracy' by developed-country institutions and corporations.

WTO - Under the World Trade Organisation's TRIPs Agreement, countries are obliged to provide intellectual property protection for plant varieties at the national level either through patents or an effective sui generis systemor both. In asking for not only a review of Article 27.3(b) but a complete review of the TRIPs Agreement, countries from Asia have adopted an important position at the WTO. India on behalf of other Asian countries in its submissions to the TRIPs Council asked that TRIPs be harmonised with the Convention on Biological Diversity (CBD). At the Fourth WTO Ministerial Conference at Doha, China & the G77 issued a statement, which said the TRIPs agreement should be supportive of, and not run counter to, the objectives and principles of the CBD. The statement also provided practical advice by saying that during the course of this review…members should agree not to invoke dispute settlement procedures against developing countries. China, India, Pakistan and Thailand with a few other African and Latin American countries have together also made a submission to the TRIPS Council asking that the TRIPS Agreement be amended so as to require an applicant for a patent relating to biological materials or traditional knowledge to provide information on the country of origin of the biological resources, evidence of prior informed consent and that of a fair and equitable benefit-sharing arrangement as a condition to acquiring patent rights.

UPOV - The UPOV Convention is an international agreement that sets rules, similar to patents, for monopoly rights over crop varieties. Several Asian countries already have, or are in the process of making, UPOV-styled laws for plant protection. Members of ASSINSEL, the international association of the seed industry, have continued to pressurize governments to adopt UPOV. In a position paper ASSINSEL wrote that any national legislation authorising farm saved seed…without safeguarding the legitimate interest of the breeders is not in conformity with the 1991 Act of the UPOV convention. ASSINSEL also adds that such national legislation would also not be an effective sui generis system in the meaning of the article 27.3(b) of the TRIPs agreement.

WIPO - Traditional knowledge and IPRs are being brought together at the World Intellectual Property Organisation (WIPO) under the Intergovernmental Committee on Genetic Resources, Traditional Knowledge and Folklore. Another WIPO-sponsored activity is the creation of a Task Force under the Committee of Experts of the International Patent Classification (IPC) Union, to study the relation and possible integration into the IPC of a Traditional Knowledge Resource Classification. In Asia, a joint statement adopted by the WIPO Asian Regional Forum on Intellectual Property Policy Development emphasized the urgent need for developing countries to modernize their intellectual property systems and to bring their national legislative and administrative structures into conformity with international treaties and agreements, including the TRIPS Agreement.

CBD: It is under the Convention of Biological Diversity (CBD) and its Article 8(j) that the need to protect traditional knowledge has gained an international foothold. With indigenous groups and peoples' organizations stressing the need for more focused attention on traditional knowledge, at the Madrid Workshop organized under the auspices of CBD, the requirement for a working group on Article 8(j) was endorsed. The Working Group is studying existing systems for handling and managing innovations at the local level and their relation to existing national and international systems of intellectual property rights, with a view to ensure their complementarily. Under the CBD, a working group on Access to Genetic Resources and Benefit Sharing has developed the Bonn Guidelines on Access and Benefit Sharing that were adopted at COP6. The relationship between IPR and benefit sharing is also being examined in the process.

FAO: Under the auspices of the Food and Agriculture Organisation, the International Treaty on Plant Genetic Resources provides a space for national recognition of farmers' rights. Several Asian country negotiators, including India, fought hard at the table for the inclusion of farmers' rights in the text. However, the Treaty fails to make international provisions for farmers' rights, putting the onus instead on national governments to do so. The Treaty also has controversial provisions on intellectual property rights.

APEC: Within the Asia-Pacific Economic Cooperation, there is an Intellectual Property Rights Experts Group (IPEG). The IPEG is developing Collective Action Plans (CAPs) in the area of IPRs for promoting the establishment of an internationally harmonised intellectual property system. The IPEG's CAP-based activities include work on issues associated with genetic resources, traditional knowledge, and folklore.

Conclusion
It is clear that industry, with increased support from governments, is quickly establishing control over plant genetic resources and associated knowledge through the use of IPRs. Yet resistance to this incursion on community rights has been disparate and experimental. Overall, communities are increasingly losing control over their own plants and are being increasingly exploited for their knowledge. As awareness amongst groups, communities and even governments increases, and as those affected become more organized, the tide has begun to turn. There is however a lot of strategic work to be done among NGOs and people's movements in order to build a stronger social force against the growing influence of trade and IPR over genetic resources and traditional knowledge.

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