Geneva, 13 Feb 2004
A joint study commissioned by the World Intellectual Property Organization (WIPO) and the United Nations Environment Programme (UNEP), and presented at an international meeting on the world's wildlife, highlights the complexities of how best to recompense countries, communities and indigenous peoples for the knowledge and genetic resources they nurture and hold, and the practicalities of ensuring that benefits from access and use of these resources are shared equitably.
The study features two examples relating to a 'wonder' medicine, derived from an Indian plant with apparent fatigue-busting properties, and a gene from a wild, West African rice which is being used in the multi-billion dollar biotech industry, which demonstrate the potential benefits and pitfalls of current benefit sharing agreements.
The study highlights the shortcomings of a number of existing voluntary agreements and suggests ways that these may be improved to ensure that the real custodians of genetic resources and traditional knowledge on which promising, agricultural discoveries are based have a share in the derived benefits.
WIPO and UNEP commissioned the independent study by Professor Anil K. Gupta, an internationally renowned expert on benefit sharing in relation to genetic resources and traditional knowledge. Profesor Gupta holds the Kasturbhai Lalbhai Chair of Entrepreneurship at the Indian Institute of Management in Vastrapur, Ahmedabad. Professor Gupta is the founder of the Honeybee Network of community-based grassroots innovators – which has documented more than 10,000 traditional practices using genetic and biological resources and other know-how (Honey Bee Database of Grassroots Innovations at http://www.sristi.org/honeybee.html).
Many top selling drugs, such as penicillin, cyclosporine and the anti-cancer drug Taxol, have been derived from nature; and traditional medical knowledge can point the way to new drug development. Future drugs, industrial products and genes for improved crops are being sought from plants and animals, particularly in the genetically rich developing world.
A so-called 'access and benefit sharing' system aims to promote scientific and technological breakthroughs from plant and animal sources, while at the same time recognizing the contributions and rights of those who cultivate and preserve these resources, or have come to understand their uses. Developing an equitable international system for access and benefit-sharing is is one of the key issues to be addressed at the Conference of the Parties to the Convention on Biological Diversity taking place in Kuala Lumpur, Malaysia.
In Germany, annual retail sales of over-the-counter herbal drugs was estimated to be around US $ 3.5 billion. Total annual sales in Germany, Italy, the United Kingdom, the Netherlands and Spain are estimated to be about US $ 7 billion, according to some industry estimates from the 1990s.
Establishing effective and fair rules, in which companies and local communities share in these profits and other non-monetary benefits that arise from the use of the biological resources, will not only help fight poverty in developing countries but will also create sustainable development on a broader base. It should also generate incentives for local people to conserve their biodiversity and reduce the threat of over-exploitation.
Intellectual property has been a much debated but vital element in the mix of legal tools that create effective benefit-sharing (patents and similar intellectual property rights can support the development of new products and processes that create benefits from genetic resources) but have been criticized as a form of misappropriating benefits, in the absence of appropriate benefit-sharing arrangements. The use of indigenous and other traditional knowledge to guide research and to create new products has also fuelled concerns that traditional knowledge should itself be protected through appropriate intellectual property rights that respect the collective interests and cultural values of traditional communities. The study suggests that there is scope for intellectual property rights to be used more effectively to generate and share more equitably both monetary and non-monetary benefits.
Klaus Toepfer, UNEP's Executive Director, said: "The natural world has been and will increasingly be a veritable treasure trove of new and novel compounds and products. However, the rate at which species are disappearing means that many promising cures, as well as health and industrial products, are also probably being lost at an alarming rate".
"Overcoming poverty is one of the central goals of the United Nations family as a whole, and is enshrined in the Millennium Development Goals. Ensuring that those with valuable genetic resources and knowledge are fairly and adequately recompensed is a double win. The incomes will help not only fight poverty but will give local communities economic incentives to conserve their important wildlife and habitats," he added.
Kamil Idris, WIPO Director General, said "The judicious and effective use of the intellectual property system has a vital role in achieving the goals of equitable access and benefit-sharing. The patent system, for example, recognizes innovations based on genetic resources and provides a framework for investment in the development of valuable new products and processes. It therefore offers potential to yield the desired benefits from access to genetic resources. Making sure these benefits are shared equitably with the custodians of genetic resources and traditional knowledge is a key challenge."
"These studies highlight the need, when genetic resources are first accessed, for a clear understanding of intellectual property issues. Agreement on how intellectual property derived from access is used and how the benefits are shared is an important part of the exercise of prior informed consent, and an important practical way of ensuring that access and benefit-sharing is fruitful, equitable and mutually agreeable, and becomes a true partnership between custodian and user of the genetic resource," he added.
Recently nations adopted the Bonn Guidelines on access and benefit sharing. These voluntary rules outline the roles and responsibilities of companies and scientists carrying out 'bio-prospecting', alongside those for countries and communities who hold the knowledge and genetic resources of interest.
The key issue in Kuala Lumpur is whether voluntary agreements between corporations, countries and communities are the way forward or whether they need strengthening by an international, legally-binding treaty.
The WIPO/UNEP Case Studies
The case study relating to a wild rice gene from Mali which was found to be resistant to bacterial rice blight, one of the most damaging rice diseases, shows how voluntary benefit-sharing agreements need to be improved to ensure that the custodians of traditional knowledge are better rewarded.
The genetic code from the wild rice was sequenced, cloned and patented in 1995. Between the original access to the Malian genetic resource and the patent application a chain of innovation and value-addition took place which literally spans the globe: A rice specimen was originally accessed in Mali and transferred to a rice research program in India, where its resistance to bacterial rice blight was identified. The blight resistant specimen was transferred to the International Rice Research Institute (IRRI) in the Philippines, which determined that the resistance was coded by a single locus called Xa21.
The Filipino experts bred the resistance into cultivated rice varieties by conventional plant breeding methods. One such variety was then acquired by the University of California at Davis, where gene Xa21 was mapped, sequenced and cloned. After a patent application was filed and granted for the cloned gene, a Genetic Resource Recognition Fund (GRRF) was established at UC Davis to share with the stakeholders in Mali and other developing countries the benefits arising from the commercial utilization of the patented gene.
The plant, from which the disease-resistance gene was found is called Oryza longistaminata. Many Malian farmers consider it a weed, but for the displaced peoples of the Bela community it is one of their staple foods and its stalks are used for many purposes, including in ritual dancing to the accompaniment of a drum beat.
The benefit-sharing arrangements established in this case have been debated extensively, and this study highlights the need for these arrangements to go beyond simple financial returns, and to take account of community needs and capacities, and developmental priorities.
The GRRF was designed primarily to fund agricultural fellowships to the University from Mali and other developing countries where the wild rice is found to boost the research capacities of the countries concerned. So far, however, the Trust has received no funds. The study questions the appropriateness of these benefit-sharing arrangements suggesting that offering PhD fellowships, the central benefit on offer, may be of little or no value to the Bela community because there may not be people "qualified to avail themselves of PhD fellowships at the University of California Davis." The report notes that even if there were suitable candidates from the Bela people for such fellowships, there are no requirements in the existing voluntary arrangements for them to return with their new-found expertise to Mali or their local community. Under such arrangements, fellowships may even contribute to 'brain drain' of talented Africans to developed countries.
The study also questions why the blight resistant gene and the associated "know-how"is not being made available to the Institute of Economic Research in Mali, given the university's current work with Chinese scientists to transfer the gene into Chinese rice varieties. It further raises concerns that the Bela people have no formal recognition as primary conservators and holders of detailed knowledge of this disease resistant variety of wild rice.
The report urges developed-world universities and institutions to re-double their efforts to devise improved voluntary agreements between themselves and developing countries so that the benefits of genetic resources are more appropriately and fairly shared.
The case study relating to a herbal medicine called Jeevani and touted as a wonder food and drink supplement in international exercise and fitness circles, demonstrates the need to strengthen international benefit-sharing and licensing arrangements.
Jeevani, a herbal medicine derived from the leaves of the Arogypaacha plant, is now on commercial sale in countries like India and the United States. It is claimed to have anti-fatigue, anti-stress and numerous other benefits. The medicine was stumbled upon in 1987 by a team of researchers from the All India Coordinated Research Project and subsequently developed, tested and licensed to companies by the Tropical Botanic Garden Research Institute in Kerala.
The All India team, on an expedition to the Western Ghats to look for promising new plant species, found that their guides from the local Kani tribe appeared alert and energetic long after the scientists were feeling weak and tired. The guides had been munching on the berries of an unknown plant.
Eventually the guides, who stressed that the plant concerned was part of a time-honored tribal secret, disclosed the source of the berries. Studies eventually led to the isolation of promising, medicinal compounds, one of which was patented in 1996 from the leaves.
Benefit Sharing Arrangements
The benefit-sharing arrangements in this case highlighted the potential value of an active role by local authorities in partnership with community leaders.
In order to share the benefits of their work with the tribal people who knew of the plant's benefits and who have helped maintain wild populations, the Kerala Kani Samudaya Kshema Trust was set up in the late 1980s. The trust is funded by some of the profits from licensing the herbal medicine to companies. It has numerous objectives, including community welfare and development projects for the Kani in Kerala, such as the setting up of a telephone booth in a remote area, insurance schemes for pregnant women and another covering accidental death.
There is also the development of a register documenting the tribe's knowledge of plants and animals and developing ways to help the local communities conserve their biological resources.
The case of Jeevani underscores the complexities of attempting to establish a voluntary access and benefit sharing agreement and highlights some of the pitfalls associated with such schemes.
While the establishment of the special Kani trust fund, which to date has had several thousand dollars of funding, has been widely applauded, further efforts could have been made to make the process more inclusive. A great deal of tribal medicinal knowledge is held by people called Plathis, an informal association of healers, who did not directly participate in the development of the agreements, but whose involvement from the outset could have ensured wider involvement from all sectors of the Kani communities.
The patents filed on the medicines covered just India. The study notes that Jeevani products are being sold outside that country with a least one company in the United States falling outside the licensing and benefit-sharing agreement.
"The scope of benefits to be shared would have been wider if international patent applications have been filed under the Patent Cooperation Treaty (PCT) administered by WIPO to protect the formulation in countries other than India,"" notes the report. The PCT mechanism offers a rapid and cost-effective route to obtain patent protection in more than 120 countries around the world.
One of the biggest problems has been the shortage of leaves from which to process the Jeevani products. Tests indicate that varieties found wild in forests yield the best compounds.
One company making and selling Jeevani, the Arya Vaidya Pharmacy of India, has proposed to pay the Kani cash for cultivating the plants alongside a buy-back agreement to purchase the leaves in order to boost supplies. However, officials from the local state Forest Department concerned that harvesting the plant for commercial uses could damage forest areas have banned cultivation and harvesting for commercial purposes.
The report says: " If the Forest Department had been involved from the beginning, perhaps their attitude might have been different".
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