Lessons from Bioprospecting in India and Nigeria
The Goals of the Convention on Biological Diversity (CBD), introduced in Rio de Janeiro during the 1992 Earth Summit, are (1) the conservation of biological diversity, (2) the sustainable use of its components, and (3) the fair and equitable sharing of the benefits arising out of its commercial use. Ratification of the CBD by 177 nations has led most commercial users of bioresources to comply with convention provisions, which gains them access to the raw bioresources and traditional medicinal plant knowledge that can be developed into bioproducts. These arrangements are called bioprospecting, or exploring biocultural diversity for commercially valuable genetic, biochemical, and cultural resources.
It is useful to examine how these practices are working today among provider countries, user companies, and other stakeholders. Major stakeholders involve both the domestic and international research communities, including botanical gardens and universities, and the forest-dwelling (or native, tribal, indigenous) peoples who live in or near tropical forests and possess information on the use of plants for medicinal purposes.
Non-governmental organizations (NGOs) such as conservation, development, health and other nonprofit groups play growing roles as intermediaries in fostering and facilitating bioprospecting partnerships. To level the playing field in negotiating expertise, many countries and cultural groups have successfully sought outside expertise at different stages of bioprospecting negotiations from intermediaries with some vested interest in promoting equitable arrangements. Many intermediaries speak the local language, have worked many years and often lived in the community and earned its trust. They play multiple roles in access and benefit-sharing arrangements with source countries and other entities, often becoming partners in the relationship.
This article briefly reviews two case studies on bioprospecting for pharmaceuticals and botanical medicines in Asia and Africa, focusing on benefit-sharing, the third goal of the CBD.
Case Study: India
Rich in biological and cultural diversity, India houses over 45,000 species of plants and 400 unique ethnic groups. India's proposed Biodiversity Act strictly regulates international access to bioresources for both research and commercial use, with heavy fines for breach of the Act.
The Tropical Botanic Garden and Research Institute (TBGRI) was established by the government of Kerala, India, in 1979. The TBGRI held an ethnobotanical field study in the forests of southwest India in 1987. These forests are home to the Kani tribe, nomadic traditional collectors of non-timber forest products, who now lead a primarily settled life in tribal hamlets. The Kanis use a wild plant species for energy that they called arogyapacha, identified as Trichopus zeylanicus by the TBGRI. It provided a lead in the development of the drug "Jeevani" (giver of life) after the TBGRI transferred the manufacturing license to a major Ayurvedic drug company in India. The Aryavaidya Pharmacy Coimbatore, Ltd. licensed Jeevani as a tonic to bolster the immune system and provide energy for a fee of Rs 10 lakhs (approximately U.S. $25,000). The TGBRI agreed to share 50 percent of the license fee and the 2 percent royalty on profits with the Kani.
Kani traditional systems have eroded and been replaced by those of non-tribal local communities. Rather than governance by a tribal chief, today's system, referred to as the Panchayati Raj, is based on the principle of devolution of administrative powers to the local village level under the Constitution of India. The predominantly non-tribal Panchayat's decision-making body is elected by members.
With a population of under 17,000, Kanis live in different areas and have differing opinions on the arrangement with the TBGRI, which has interacted primarily with the Kanis from one area. This group of Kanis support and appreciate the role of the TBGRI, but others are offended that the TBGRI only works with one group. Some feel the benefit-sharing arrangement is superficial, since most Kanis are not involved in the process.
The TBGRI acknowledges that it did not reach out to all members of the Kani tribe, so, with the help of NGOs, a trust was established and registered. In March, 1999, the journal Science reported that $21,000, the first payment into the trust, would be made and shared by the tribal community.
The TBGRI cultivated arogyapacha, a perennial undergrowth, to ensure a regular supply of the raw drug for the company, but learned that the medicinal qualities of the plant are lost unless grown in natural forest settings. So TBGRI organized 50 forest Kani families to cultivate and pre-process the plant under the supervision of the TBGRI scientists. This plan generated employment for the Kani who manage the semi-wild crop. Each family has 1 or 2 acres of arogyapacha under cultivation in the first year of the project and earns about Rs. 30,000 per acre. This income is expected to increase in subsequent years, as it is anticipated that the production of leaves will increase and last for 20-30 years. Since the plant must be grown in a natural forest habitat to maintain its medicinal qualities, it seems the Kani are in an effective bargaining position to regulate and control its harvest. Arogyapacha is "forest friendly" because it is grown under the shade of the natural forest canopy, but no sustainability studies on its management were completed. Although it contributed no labor, material, or finances to the effort, the State Forest Department now demands a share of the license fee and royalties on the grounds that the plant material is collected within a forest area.
In all fairness, it must be remembered that the TBGRI process for benefit-sharing with the Kanis evolved in a policy vacuum, well before the CBD was introduced. The TBGRI did not have the luxury of precedent, or of guiding legislation by the national government, but gradually developed procedures in an ad hoc manner over a dozen years. This occurred despite the fact that all project participants were nationals.
Likewise, absence of an intact traditional system of governance by the Kani crippled decision-making processes. Even though the Kani are quite powerless in relation to a large Indian government research institution, their uncontested right to deny access to bioresources or traditional knowledge would have supplied strong leverage during access negotiations, had the bioprospecting arrangement been negotiated today. The right for communities to deny access is widely recognized and these processes are now undertaken well before any bioprospecting activities begin. No collecting permits are issued until such contractual agreements are negotiated after a process of prior informed consent. There must be a written understanding among all relevant stakeholders of rights, obligations, roles, and ownership of who shares how much in what kinds of benefits, and when. Such an understanding defines exactly who the state and/or national authority is, whether it be the Kani, the State Forest Department, the TBGRI, or some other entity that claims a stake.
The system of sourcing arogyapacha is questionable since there is no information on sustainability studies connected to methods of managing and harvesting the plant. Environmental impacts on the forest and social impact studies on the Kani are clearly required if the need for arogyapacha will increase and last for 20-30 years.
Case Study: Nigeria
Africa currently has one of the highest rates of deforestation in the world, calculated at about 1 percent annually. The Federal Republic of Nigeria suffers an annual deforestation rate of 5.0 percent, compared to a global rate of 0.6 percent. To contend with such statistics, Nigeria modified its national parks law to attract and encourage conservation funding by establishing biodiversity prospecting requirements.
The Nigerian population, estimated at over 100 million in 1995, includes over 250 distinct ethnic groups. Traditional leaders, such as chiefs, healers, clan and lineage heads, are a major social force in communities, where numerous community development associations provide fora for citizens to identify, discuss and prioritize problems and to seek means to solve them.
The oldest component of the Nigerian health sector consists of traditional healers and birth attendants, who are the de facto providers of primary health care in Nigeria (estimated to serve about 80 percent of the population). Healers provide client-centered, personalized health care that is culturally appropriate, holistic, and tailored to meet the needs and expectations of the patient. Since healers share the cognitive understandings and cultural values of those they treat, they serve a function broader and more complex than their medical counterparts in the modern sector.
The Bioresources Development and Conservation Programme (BDCP) is a multiethnic international NGO based in Nigeria that builds technical skills so that bioresources are a viable vehicle for improved health care and sustainable development. The BDCP views science and technology as useful tools to be adapted to the local cultural framework, rather than as a modern alternative to the contributions of community members. One of the objectives of the BDCP is to use local bioresources and knowledge to target therapeutic categories for tropical diseases suffered in Nigeria such as malaria, leishmaniasis, and trypanosomiasis.
In 1990, Shaman Pharmaceuticals, Inc. established a research relationship with Nigerian scientific institutions, and the BDCP became the focal point for collaborative research. Shaman is a small San Francisco company that uses ethnobotany as well as isolation and natural products chemistry to discover and develop novel pharmaceuticals. Nigerian scientists proposed initial discussions with healers and traditional leaders to talk about a collaborative relationship with Shaman for bioprospecting. Before bioprospecting began, the BDCP visited communities where members had worked for several years. Village discussions covered topics such as the intentions and goals of the project, how and where the plants would be analyzed, and their potential for commercialization and benefit-sharing. After lengthy discussions, the groups felt that Shaman shared with them a common purpose consistent with their cultural values concerning human health, and they agreed to collaborate.
Four ethnobotanical field expeditions were conducted. By choice of Nigerian collaborators, immediate and medium-term benefits from the expeditions took the form of workshops and training programs on public health, botany, conservation and ethnobotany; support for a medicinal plant reserve; supplies for village schools; botanical collection supplies for a herbarium; laboratory equipment for scientific research on plants that treat parasitic diseases prevalent in West Africa; and support for Nigerian scientists to apply modern analytical techniques. Fulfilling company policy, immediate and medium-term benefits -- such as those listed above -- totaling over U.S. $200,000 have been distributed through programs to the various stakeholders in the collaboration as the expeditions occur. The company regularly reports laboratory results to participating communities and general literature on the project is published with both Nigerian and U.S. authors.
On October 20, 1997, in Abuja, Nigeria, the BDCP launched the Fund for Integrated Rural Development and Traditional Medicine (FIRD-TM). The FIRD-TM is the vehicle for receiving and channeling benefits from many contributors in an equitable and consistent manner. Funds are directed to source communities from which commercially useful bioresources and ethnobotanical knowledge is derived. The BDCP facilitated the establishment of the Fund and is its sponsoring entity. The Fund, however, has an independent board composed of leaders of traditional healers' associations, senior government officials, multiethnic representatives of village councils, and technical experts from scientific institutions. Diverse culture groups in Nigeria will receive resources from the Fund through traditional healers' organizations and villages, consistent with their governing customs. Town associations, village heads, and professional guilds of healers are empowered to make decisions regarding use of the funds for projects in their localities.
After 10 years and $170 million, Shaman Pharmaceuticals in early 1999 abandoned attempts to take any of its discoveries through the Food and Drug Administration regulatory process, as future time and costs for additional clinical trials proved prohibitive. Shaman Botanicals.com was incorporated as a private, wholly-owned subsidiary of Shaman Pharmaceuticals to leverage the company's research and development.
This case study demonstrates the time, costs, and risks associated with drug discovery, a burden shouldered primarily by the company, but with critical implications for benefit-sharing to source countries and culture groups. Royalties may never materialize due to the tremendous costs, long time frame, unpredictability and volatility of the market, and the many other potential pitfalls of drug discovery. Some sort of up-front benefits -- monetary or non-monetary -- as well as "milestone" payments like those Shaman sent to Nigeria, are essential. Royalties come into play only if and when a drug is marketed; it is risky to rely only on benefits from a product that may never materialize.
The study also demonstrates how biodiversity-rich yet financially-poor tropical nations, such as Nigeria, can increase conservation and research funding and gain valuable training and technology. Countries can choose whether to supply natural products in the form of extracts, rather than raw unprocessed material, to foreign investors, or to establish their own medicinal plant, phytochemical or pharmaceutical industry.
The BDCP goals of discovering and marketing bioproducts for diseases important to Nigeria is itself a lesson in opportunities brought about through bioprospecting. Too often, when the importance of biodiversity conservation is discussed for its value to human health, it refers to the health of residents of industrialized nations. The attitude is that biodiversity must be preserved to enlarge the pharmacopoeia of Western medicine, which provides therapeutics primarily for Western societies. Less discussed is the vitality of biodiversity to the health of 80 percent of the world, populations that depend solely on medicinal plants for their primary health care. Preserving biodiversity for the benefit of human health means preserving it for those in the tropics already using it, as well as for distant populations that may know it only in some refined or synthetic form at some unspecified future date.
References & further reading
Anuradha, R.V. (1998). Sharing with the Kanis: a case study from Kerala, India. Secretariat to the Convention on Biological Diversity, Fourth Meeting of the COP, Bratislava, Slovakia, May 1998.
News of the Week. (1999, March 12). Science 283, pp 1614-1615.
Iwu, M.M. (1996). Biodiversity prospecting in Nigeria: seeking equity and reciprocity in intellectual property rights through partnership arrangements and capacity building. Journal of Ethnopharmacology 5:1, pp 209-219.
Carlson, T.J., Iwu, M.M., King, S., Obialor, C., & Ozioko, A. (1997). Medicinal plant research in Nigeria: an approach for compliance with the Convention on Biological Diversity. Diversity 13:1, pp 29-33.
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