biotechnology & bioprospecting for sustainable development
biotechnology & bioprospecting for sustainable development
biotechnology & bioprospecting for sustainable development
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BIOTECHNOLOGY & BIOPROSPECTING<br />
FOR<br />
SUSTAINABLE DEVELOPMENT<br />
Ministry of Environment & Forests<br />
Government of India<br />
India’s presentation <strong>for</strong> the Ministerial Meeting of<br />
Megabiodiversity Countries<br />
Cancun, Mexico<br />
February 16-18, 2002
Biotechnology and Bioprospecting <strong>for</strong><br />
Sustainable Development<br />
1. Introduction<br />
2. Bioprospecting<br />
2.1 Bioprospecting Case Studies<br />
(a) The Kani experience- India<br />
(b) The International Cooperative Biodiversity Group<br />
(c) The Bioresource Development & Conservation<br />
Programme (BDCP) – Nigeria.<br />
2.2 Lessons learned<br />
2.3 Future outlook<br />
3. Biotechnology, Intellectual Property Rights, Biodiversity<br />
& Traditional Knowledge.<br />
4. India’s legislation on Biodiversity<br />
5. TRIPS, Biodiversity and Patent issues
Biotechnology and Bioprospecting <strong>for</strong> Sustainable<br />
Development<br />
1. Introduction<br />
Biotechnology, a modern science is revolutionizing production in both<br />
industry and agriculture in certain areas. One of the main features of<br />
<strong>biotechnology</strong> is its linkages with human welfare, environment and sustainability.<br />
Two sectors where <strong>biotechnology</strong> has already made significant contributions are<br />
pharmaceuticals and agriculture. The search <strong>for</strong> useful products derived from<br />
biological resources coupled with innovative ways to link benefits with<br />
conservation of biodiversity and economic <strong>development</strong> is attracting attention<br />
worldwide. Bioprospecting describes the systematic search <strong>for</strong> and <strong>development</strong><br />
of new sources of chemical compounds, genes, micro- and macro organisms,<br />
and other valuable products from nature. Bioprospecting incorporates two<br />
fundamental goals, (i) the <strong>sustainable</strong> use through <strong>biotechnology</strong> of biological<br />
resources and their conservation, and (2) the scientific and socioeconomic<br />
<strong>development</strong> of source countries and local communities (Sittenfeld 1996).<br />
For thousands of years, biodiversity has been source of useful compounds<br />
and materials <strong>for</strong> food, energy, shelter, medicines, and environmental services.<br />
The overall economic value from biodiversity is not known. However, a recent<br />
attempt estimated that biodiversity ecosystem services amounts about US $ 2.9<br />
trillion <strong>for</strong> the entire world. From those estimates, $ 500 million represents <strong>for</strong><br />
ecotourism, $ 200 million <strong>for</strong> pollination, $ 90 million <strong>for</strong> nitrogen fixation, and<br />
$135 million <strong>for</strong> Co2 sequestration, worldwide ( Gordon 1998).<br />
The pharmaceutical industry has benefited from biodiversity through drugs<br />
developed from natural compounds, while the agricultural industry improves<br />
crops by breeding them with wild relatives (Reid et al 1993). As per one study<br />
half of the current best selling pharmaceuticals are natural or related to natural<br />
products. (Demain 1998). The combined market worldwide <strong>for</strong> pharmaceuticals,<br />
agrochemicals, and seeds is over $400 billion annually, and genetic resources<br />
provide the starting material <strong>for</strong> a portion of this market (Putterman 1994: Ten<br />
Kate 1995: Thayer 1998a: James 1997).<br />
Agricultural biodiversity provides genetic resources <strong>for</strong> domestication<br />
through intra-specific genetic variability of cultivated species and agricultural<br />
practices. The introduction of molecular markers to characterize genetic<br />
variance, together with the possibility of introducing genetic material from other<br />
species and genera, to increase crop yields as well as resistance to disease or<br />
environmental conditions, are increasing the potential value of biodiversity <strong>for</strong><br />
agriculture. It is considered that from the manipulation of DNA in agricultural<br />
research, the world will obtain most of its food, fuel, fiber, chemicals, feedstock,<br />
and even some pharmaceuticals from genetically modified plants (Abelson<br />
1998).
The megadiversity countries with 60-70% of the world`s known biological<br />
diversity have significant stake <strong>for</strong> harnessing the potential of <strong>biotechnology</strong> and<br />
<strong>bioprospecting</strong> <strong>for</strong> achieving <strong>sustainable</strong> economic <strong>development</strong>. The Convention<br />
on Biological Diversity (CBD), the first international treaty provides opportunities<br />
to biodiversity rich countries to realize benefits arising out of the utilization of their<br />
bioresources. The CBD states that national governments have authority to<br />
determine access to their genetic resources, and calls on governments to provide<br />
<strong>for</strong> conservation, <strong>sustainable</strong> use and equitable sharing of benefits from<br />
commercial use of those resources. However, despite the clear articulation of<br />
equitable sharing of benefits by CBD, this has not been furthered and clouded by<br />
issues such as IPRs, conflicts between CBD and TRIPs, and lack of conducive<br />
international environment and commitment.<br />
This paper, based upon some case studies and experience gained in<br />
<strong>for</strong>mulation of biodiversity legislation in India presents a policy framework <strong>for</strong><br />
<strong>bioprospecting</strong> at national level and international action towards linking<br />
<strong>bioprospecting</strong> and <strong>sustainable</strong> <strong>development</strong>.<br />
2. Bioprospecting<br />
In recent years <strong>bioprospecting</strong> has acquired increased attention as<br />
countries seek to conserve their biodiversity and also share the benefits from<br />
<strong>bioprospecting</strong>. Agreements in this field are seen as “a means of improving<br />
national capacities to add value to natural resources, to share benefits with<br />
developed countries at the same time ensuring that these resources are<br />
protected and used sustainably” (Sittenfeld 1997)<br />
While <strong>bioprospecting</strong> offers, in theory, a potentially interesting approach<br />
<strong>for</strong> linking biodiversity conservation with the <strong>biotechnology</strong> sector, its success in<br />
practice will depend upon the ability of these ef<strong>for</strong>ts in isolating useful<br />
compounds at a cost comparable to other techniques <strong>for</strong> drug <strong>development</strong>.<br />
There continues to be great interest in <strong>bioprospecting</strong> from the academic,<br />
industrial and conservation communities, as well as the general public, and there<br />
have been some significant results in the <strong>bioprospecting</strong> programmes to date.<br />
However, it is still too early to say how much <strong>bioprospecting</strong> can contribute to<br />
conservation and economic <strong>development</strong> ( Sagar and Daemmrich 2000, Rojas<br />
1999).<br />
Bioprospecting is fundamentally tied to scientific interest and commercial<br />
success of natural product derivatives. In the rapidly changing and complex<br />
world of drug discovery, the perceived value of natural products seems to wax<br />
and wane every few years with the entrance of a new technology and the time<br />
since a major new natural product drug has hit the market. Combinatorial<br />
chemistry is the latest perceived replacement <strong>for</strong> natural products( Service 1999).<br />
However, the very limited number of important leads that combinatorial chemistry<br />
has provided has led some scientists and organizations to seek means of
integrating this technology and rational drug design with natural product leads in<br />
order to gain the best results ( Lahana 1999, Nicolaou et al., 1999)<br />
Success of <strong>bioprospecting</strong> ef<strong>for</strong>ts in megadiversity countries and other<br />
developing countries will depend on the ability of these countries to effectively<br />
monitor and en<strong>for</strong>ce <strong>bioprospecting</strong> agreements.<br />
2.1 Bioprospecting Case Studies<br />
( a ) The Kani experience- India<br />
In India, a well-known documented example of <strong>bioprospecting</strong> and benefit<br />
sharing is the Kani - TBGRI - model in Kerala. Kani is a tribal community<br />
inhabiting the Southern Western Ghat region of Kerala State in India. In 1987, a<br />
team of scientists from the Tropical Botanic Garden and Research Institute<br />
(TBGRI) undertook an ethnobotanical field study in the tribal inhabited Western<br />
Ghat region of Kerala. During this expedition, they came across an interesting<br />
ethnomedical in<strong>for</strong>mation on a wild plant Trichophus zeylanicus, locally called as<br />
“Arogyapacha” by the Kani tribe. The scientists noticed that the Kani tribals<br />
accompanying the team frequently ate some fruits which kept them energetic and<br />
agile. When asked about the source of the fruit, the Kani men were initially<br />
reluctant to reveal the in<strong>for</strong>mation. The team convinced the Kani men that<br />
in<strong>for</strong>mation would not be misused and that, they would conduct scientific<br />
investigation. If any marketable drugs/products got developed, the benefits<br />
accrued would be shared with the tribe. The Kani tribe then showed the plant,<br />
which was identified as Trichophus zeylanicus.<br />
Pharmacological investigations of the fruit confirmed its anti-fatigue<br />
properties. Detailed chemical and pharmacological investigations showed that<br />
the leaves contained various glycolipids and some other non-steroidal<br />
compounds with anti -stress and anti-hepatoxic properties. The team developed<br />
a polyherbal <strong>for</strong>mulation by Arogyapacha Ayurvedic pharmaceutical methods<br />
which was named “Jeevni”. After satisfactory clinical evaluation this herbal drug<br />
was released <strong>for</strong> commercial production.<br />
Many pharmaceutical firms approached TBGRI <strong>for</strong> getting the licence <strong>for</strong><br />
the production of “Jeevni”. After negotiations with various interested parties, the<br />
manufacturing licence of “Jeevni” was transferred to the Aryavaidya Pharmacy<br />
Coimbatore Ltd. <strong>for</strong> a licence fee of Rs. 10 lakhs <strong>for</strong> a period of 7 years . The<br />
TBGRI in consultation with the tribal community has worked out an arrangement<br />
<strong>for</strong> benefit sharing. According to this arrangement, the TBGRI has agreed to<br />
share 50% of the licence fee and royalty with the tribal community. In November<br />
1997, a number of Kanis got together, and with assistance from the TBGRI,<br />
registered a trust called the Kerala Kani Samudaya Kshema Trust, comprising<br />
nine members, all of them tribals. The President and Vice President of the trust
are the two Kanis who were responsible <strong>for</strong> telling the TBGRI about<br />
Aarogyapacha (MOEF 2000) . The objectives of the trust deed include:<br />
- welfare and <strong>development</strong> activities <strong>for</strong> the Kanis of Kerala;<br />
- preparation of biodiversity register to document the Kanis’<br />
knowledge base;<br />
- evolving and supporting methods to promote the <strong>sustainable</strong> use<br />
and conservation of biological resources.<br />
(b) The International Cooperative Biodiversity Group (ICGB)<br />
The International Cooperative Biodiversity Group (ICGB) was launched in<br />
1991 with funding from the US government sponsored by the National Institute of<br />
Health (NIH), the National Science Foundation (NSF) and the US Agency <strong>for</strong><br />
International Development (USAID) Under ICGB eight projects have been<br />
currently funded in Suriname, Costa Rica, Argentina, Panama, Chile, Mexico,<br />
Peru, Cameroon, Nigeria, and Vietnam and Laos. Three interrelated goals of<br />
ICGB include health improvement through new drugs from natural sources,<br />
conservation of biodiversity and <strong>sustainable</strong> economic <strong>development</strong> (Rosenthal<br />
1998)<br />
The ICGB has resulted interalia in:<br />
• discovery of numerous bioactive compounds;<br />
• augmentation of technical capacity of developing country participants and<br />
their associated institutions;<br />
• contribution to the scientific and policy process of conservation in<br />
participating countries;<br />
• <strong>development</strong> of important models <strong>for</strong> governments and other<br />
organizations <strong>for</strong> collaborative research that supports multiple objectives,<br />
including those of CBD<br />
The Suriname ICGB`s <strong>bioprospecting</strong> programme was proposed by the<br />
Suriname office of Conservation International (CI) an International NGO and<br />
Saramaka Maroons, a <strong>for</strong>est dwelling community of Suriname. The cooperative<br />
partnership also include the Virginia Polytech Institute and State University,<br />
Missouri Botanical Garden, Bristol Myers-Squibb Pharmaceutical Research<br />
Institute and Bedrijf Genessmiddelen Voorziening Suriname (BGVS), a<br />
pharmaceutical company owned by the Surinamese government.<br />
Through a Statement of Understanding, the Suriname ICGB established a<br />
benefit sharing plan with a US$60,000 total advance payment from Bristol Myers<br />
Squibb Pharmaceutical Research Institute into the Forest People’s Fund (FPF),<br />
with additional contributions of $20,000 a year as the ICBG is renewed. The FPF<br />
is a mechanism, which CI Suriname helped broker, through which ‘up front’
enefits and future royalties from new drugs developed can be returned to the<br />
Saramaka people. Along with compensating the Saramaka Maroons <strong>for</strong> their<br />
ethnobotanical contributions, the FPF creates conservation incentives, finances<br />
<strong>sustainable</strong> management projects, provides research and technology exchanges<br />
and supports other socially and environmentally sound projects.<br />
A board of directors consisting of two representatives from the local<br />
community, two from CI Suriname, and one from Suriname’s Department of<br />
Interior was created to review proposals <strong>for</strong> ways to spend the advance payment<br />
and any future royalties from drug sales. It was agreed that funds would be used<br />
<strong>for</strong> projects involving community <strong>development</strong>, biodiversity conservation and<br />
health care. If any products are commercialized from ethnobotanical collections,<br />
50% of Suriname’s share of any future royalties will go to the FPF and the other<br />
50% will go to various ICGB partners in Suriname. If a drug is derived from<br />
random collections, the FPF’s share is reduced to 30% while 70% goes to other<br />
ICGB partners (Moran 2000).<br />
(c ) The Bioresources Development and Conservation<br />
Programme (BDCP) - Nigeria<br />
The Bioresources Development and Conservation Programme (BDCP) is<br />
a multi ethnic international NGO based in Nigeria with objectives to use local<br />
bioresources and knowledge to target therapeutic categories <strong>for</strong> tropical diseases<br />
in Nigeria.<br />
In 1990, Shaman Pharmaceuticals Inc. established a research relationship<br />
with Nigerian scientific institutions, and the BDCP became the focal point <strong>for</strong><br />
collaborative research. Four ethnobotanical field expeditions were conducted. By<br />
choice of Nigerian collaborators, immediate and medium-term benefits from the<br />
expeditions took the <strong>for</strong>m of workshops and training programmes on public<br />
health, botany, conservation and ethnobotany; support <strong>for</strong> a medicinal plant<br />
reserve; supplies <strong>for</strong> village schools; botanical collection supplies <strong>for</strong> a<br />
herbarium; laboratory equipment <strong>for</strong> scientific research on plants that treat<br />
parasitic diseases prevalent in West Africa and support <strong>for</strong> Nigerian scientists to<br />
apply modern analytical techniques.<br />
In 1997, the BDCP launched the Fund <strong>for</strong> Integrated Rural Development<br />
and Traditional Medicine (FIRD/TM) during an international workshop on<br />
medicinal plants. The FIRD-TM is the vehicle to receive and channel benefits in<br />
an equitable and consistent manner from many contributors. The Fund has an<br />
independent board composed of leaders of traditional healers’ associations,<br />
senior government officials, multiethnic representatives of village councils and<br />
technical experts from scientific institutions. Diverse culture groups in Nigeria will<br />
receive resources from the Fund through traditional healers’ organizations and<br />
villages consistent with their governing customs. Town associations, village<br />
heads and professional guilds of healers are empowered to make decisions<br />
regarding use of the funds <strong>for</strong> projects in their localities. Those funded will follow
the criteria of promoting conservation of biodiversity and drug <strong>development</strong>, as<br />
well as the socioeconomic <strong>development</strong> of rural cultures (Moran 2000)<br />
In early 1999 Shaman Pharmaceuticals abandoned attempts to take any<br />
of its discoveries through the Food and Drug Administration regulatory process,<br />
as future time and costs <strong>for</strong> additional clinical trials proved prohibitive. Shaman<br />
Pharmaceuticals leveraged the company’s research and <strong>development</strong> by<br />
launching its first botanical dietary supplement. The product delivers a<br />
standardized extract from the sap of Sangre de Drago, the Croton lechleri tree, to<br />
prevent fluid loss and promote normal stool <strong>for</strong>mation in the intestine bowel<br />
syndrome.<br />
Lessons learned<br />
‣ The lesson from Suriname case study shows how smoothly the<br />
<strong>bioprospecting</strong> process can move along when time and resources have<br />
been spent be<strong>for</strong>ehand and when stated goals are not in conflict, but<br />
interrelated. In Suriname the drug discovery process creates economic<br />
value <strong>for</strong> biological diversity, which in turn creates <strong>development</strong> funds and<br />
incentives <strong>for</strong> conserving biodiversity, satisfying the goals of stakeholders<br />
‣ The Nigerian case study highlights the opportunities brought about<br />
through <strong>bioprospecting</strong>. A major lesson of this case study is the time,<br />
costs and risks associated with drug discovery, a burden shouldered<br />
primarily by the company, but with critical implications <strong>for</strong> benefit sharing<br />
to source countries and culture groups. Spreading the risks and benefits<br />
among all stakeholders increases opportunities <strong>for</strong> benefits and lessens<br />
risk. Royalties may never materialize due to the tremendous costs, long<br />
time frame, unpredictability and volatility of the market and the many other<br />
potential pitfalls of drug discovery. Some sort of up-front benefits,<br />
monetary or non-monetary, as well as ‘milestone’ payments such as those<br />
that went to Nigeria, are essential.<br />
‣ This case study also demonstrates how biodiversity rich but financially<br />
poor tropical countries, such as Nigeria, can increase conservation and<br />
research funding and gain valuable training and technology. Since the<br />
economic values of biodiversity are seldom accountable in market<br />
valuations, strategies like <strong>bioprospecting</strong> bring added financial support <strong>for</strong><br />
conservation.<br />
‣ The Kani case study brings to light the need <strong>for</strong> multi-stakeholder<br />
framework <strong>for</strong> discussing the scope of access, value addition and benefit<br />
sharing.<br />
‣ The case also illustrates that while intellectual property rights play a<br />
crucial role in generating benefits from biological resources and traditional<br />
knowledge, their role should be balanced with the conservation objective.
‣ In the early stages of the case when many people started buying this plant<br />
at the rate of Rs. 100 per kilogram, the Forest Department had to impose<br />
restriction when they confiscated illegally collected leaves and whole<br />
plants. The offer of the Arya Vaidya Pharmacy of giving a buy back<br />
guarantee to the Kanis alongwith the technology to cultivate and extract<br />
leaves in a <strong>sustainable</strong> manner was a solution to this problem.<br />
‣ The effective protection of intellectual property is a necessary condition <strong>for</strong><br />
generating benefits, but it is not a sufficient condition <strong>for</strong> benefit sharing.<br />
Several additional measures are needed to supplement the role of<br />
intellectual property rights in benefit sharing over biological resources and<br />
traditional knowledge.<br />
‣ The degree of involvement of various tribal settlements and groups could<br />
have been increased. The rights of in<strong>for</strong>mants vis-à-vis the communities<br />
requires more discussion among the communities themselves.<br />
‣ The non-material contribution of benefits by way of empowerment of local<br />
communities deserves to be noted, but several more such benefits could<br />
have been considered. For instance health check-ups <strong>for</strong> the local<br />
communities were urgently needed given the very poor health condition of<br />
many women, children and also some male adults.<br />
‣ The objective of the Kani Samudaya Kshema Trust to establish a<br />
biodiversity register to document the knowledge base of the Kanis must be<br />
pursued with the intellectual property implications of such a register in<br />
mind. Intellectual property questions to be resolved <strong>for</strong> the creation of<br />
such a register include who operates the register, who provides access to<br />
its contents to which parties on what terms, who conducts documentation<br />
of the knowledge, who has the right to authorise documentation on behalf<br />
of the tribes, which knowledge elements will be documented in which<br />
<strong>for</strong>mat, how to deal with local language documentation in relation to<br />
national and international use of the register etc.<br />
‣ In order to meet the demand of regular supply of plant to the<br />
manufacturing unit, it needs to be grown in large quantities. Since, it is a<br />
shade loving plant, it has to be cultivated as an understorey vegetation of<br />
trees in the <strong>for</strong>ests. Local tribals have been encouraged to take up<br />
cultivation of “Arogyapacha” with the active cooperation of Integrated<br />
Rural Development Programme (IRDP) and Forest Department.<br />
Cultivation of these plants provides protection to the associated tree<br />
species, in addition to securing economic uplift of the tribal people in terms<br />
of employment and additional income. Thus modern economic working of<br />
the local knowledge and use of plants leads to conservation of the plant<br />
species as well as its associates. This case study clearly establishes that<br />
conservation and <strong>sustainable</strong> utilization are dependent on long-term<br />
benefits. It illustrates the point that sharing of benefits leads to<br />
conservation and <strong>sustainable</strong> utilization of biological resources.
Future outlook<br />
Benefit sharing can take financial, conservation, social and scientific <strong>for</strong>ms<br />
and must be decided during the prior in<strong>for</strong>med consent process, be<strong>for</strong>e any<br />
<strong>bioprospecting</strong> permits are issued. As case studies demonstrate, opportunities<br />
<strong>for</strong> financial compensation include up-front payments and medium term benefit<br />
sharing as research progresses. Many companies offer stakes in equity, profit<br />
sharing and joint ventures opportunities. Royalties occur only if and when a drug<br />
is marketed, but it is risky to rely only on resources that may never materialize.<br />
Case studies also illustrated how cultural, environmental and biodiversity<br />
conservation can be accomplished, with careful planning. Acknowledging the<br />
contribution of healers supplies proof of the continuation of a traditional<br />
profession. It promises an economic future from preservation of the cultural<br />
patrimony by which healers train and pass on their heritage to future generation<br />
of practitioners.<br />
Bioprospecting is a complex and long – term undertaking. Supportive<br />
macropolicies tied to an integrated programme <strong>for</strong> biological research, business<br />
<strong>development</strong> and technology transfer can link biodiversity and biological resource<br />
users in modern <strong>bioprospecting</strong>. This new breed of research and <strong>development</strong><br />
ultimately depends on implementation of adequate frameworks, good<br />
coordination, multisectoral collaboration.<br />
The economic impact of <strong>bioprospecting</strong> should not be overestimated.<br />
Bioprospecting can only complement other activities designed to advance human<br />
<strong>development</strong> and there<strong>for</strong>e cannot solve conservation and <strong>development</strong> issues in<br />
and by itself. It is important that complemented by science and technology,<br />
<strong>bioprospecting</strong> can work together with other tools to improve national capacities,<br />
support economic growth and generate financial income to conservation<br />
activities.<br />
Collecting bioresources, extracting and testing their constituents (either<br />
chemicals or genes) <strong>for</strong> biological activity, and further developing a product is<br />
long and expensive process, with high opportunities <strong>for</strong> failure as well as success<br />
(Reid et al 1993).It is estimated that only 1 in 10,000 samples show promising<br />
activity; only 10 percent of those may go to clinical trials, and only 10 percent of<br />
those are likely to reach market. The time and cost of developing new medicines<br />
is up to 15 years and about $500-600 million per product (Thayer 1998 a). On the<br />
other hand , <strong>bioprospecting</strong> requires careful design and strategic planning in<br />
order to maximize nondestructive uses. At the same time it encourages the<br />
investment benefits <strong>for</strong> the acquisition of knowledge and the improvement<br />
biodiversity conservation and management. These factors present significant and<br />
immediate challenges to countries and institutions implementing <strong>bioprospecting</strong><br />
programmes. Clear procedures will substantially reduce risks of those interested<br />
in conducting research into <strong>development</strong> of natural resources.
3 Biotechnology, Intellectual Property Rights, Biodiversity &<br />
Traditional Knowledge<br />
IPRs <strong>for</strong> biotechnological inventions raise related but quite distinct sets of<br />
issues concerning equity. Northern firms are accused of pirating and patenting<br />
biological material and traditional knowledge from the gene-rich developing world<br />
<strong>for</strong> profit, without fair and equitable sharing of benefits or the appropriate transfer<br />
of the new technologies as called <strong>for</strong> by the Convention on Biological Diversity<br />
(CBD). The link to IPRs arises from the fact that in many instances, the<br />
bioprospectors or their licensees are granted patent rights over these products,<br />
without any acknowledgement of the contribution of countries/regions of origin or<br />
of indigenous communities ( Watal 2000).<br />
Advances in <strong>biotechnology</strong> and their commercial applications have raised<br />
a variety of difficult issues, including the morality of patents relating to life-<strong>for</strong>ms<br />
and the lack of legal protection <strong>for</strong> biodiversity and traditional knowledge that<br />
may contribute to an invention. Controversy around the nature and role of<br />
patents grows from a number of sources. There are genuine philosophical<br />
objections to granting monopolies on the uses and products of biodiversity by<br />
some. Similarly, there are concerns that the scope of <strong>biotechnology</strong> patents is<br />
expanding with potentially negative impacts such as the hindering of future<br />
research. Others argue that there is an unjust imbalance between the expansive<br />
patent rights available <strong>for</strong> biotechnological inventions and the lack of incentives<br />
available to those conserving biodiversity and associated traditional knowledge<br />
that may serve as an important resource enabling those inventions (Rosenthal et<br />
al 1999)<br />
A general perception that gained currency in developing countries has<br />
been that patents on technological advances derived from the study of biological<br />
organisms represent unfair expropriation of the rights of source countries and<br />
communities. It is, in part, to provide <strong>for</strong> and define this protection that the ICBGs<br />
and other modern <strong>bioprospecting</strong> ventures have relied on contractual<br />
agreements, frequently referred to Access and Benefit Sharing Agreements.<br />
These agreements typically define, among other things, the objectives of the<br />
partnership, terms of material transfer, the rights and responsibilities of the<br />
collaborating organizations, and the types and amounts of benefits to be shared.<br />
Perhaps even more complex than the rights over biological materials and<br />
their products is the contribution of traditional knowledge to the invention<br />
process. Significant anxiety exists among traditional peoples and others that<br />
even when benefits are defined, patents relating to such knowledge may rob<br />
these people of credit <strong>for</strong> their innovations and infringe on their ability to carry out<br />
traditional practices and make innovations based on that knowledge. There is a
need to <strong>for</strong>mally recognize the value of this knowledge, protect the rights of the<br />
providers, and compensate them <strong>for</strong> the use of the in<strong>for</strong>mation. The policy of the<br />
any <strong>bioprospecting</strong> programme should be that when traditional ethnomedical<br />
knowledge is involved in a patentable invention, if the traditional knowledge<br />
provider cannot be recognized as an inventor, the contribution should be treated<br />
as valuable ‘know how’ and the contribution should be credited in any related<br />
publications and in the patent as prior art, and the providers should be<br />
compensated <strong>for</strong> their contributions, as appropriate. Prior art citations <strong>for</strong>malize<br />
the contribution of such knowledge but do not claim any monopoly rights to its<br />
use. The absence of important prior art citations may constitute grounds to deny<br />
or invalidate a patent.<br />
4. India`s legislation on biodiversity<br />
India has been in the process of <strong>for</strong>mulating a legislation on biodiversity<br />
since 1994, when India became a Party to the Convention. Extensive,<br />
transparent and participative consultations were held with eminent experts,<br />
NGOs, different departments of Central Government and State Governments.<br />
The biological diversity legislation introduced in the Parliament is an outcome of<br />
extensive and intensive consultation process involving all stakeholders.<br />
Salient features of the biodiversity legislation are as follows:<br />
- The legislation primarily addresses the issue concerning access to genetic<br />
resources and associated knowledge by individuals, institutions or companies,<br />
and equitable sharing of benefit arising out of the use of these resources and<br />
knowledge to the country and the people.<br />
- The legislation provides <strong>for</strong> setting up of a three tiered structure at<br />
national, state and local levels.<br />
The National Biodiversity Authority will deal with matters relating to<br />
requests <strong>for</strong> access by <strong>for</strong>eign individuals, institutions or companies, and<br />
all matters relating to transfer of results of research to any <strong>for</strong>eigner;<br />
imposition of terms and conditions to secure equitable sharing of benefits<br />
and approval <strong>for</strong> seeking any <strong>for</strong>m of Intellectual Property Rights (IPRs) in<br />
or outside India <strong>for</strong> an invention based on research or in<strong>for</strong>mation<br />
pertaining to a biological resource obtained from India.<br />
State Biodiversity Boards will deal with matters relating to access by<br />
Indians <strong>for</strong> commercial purposes and restrict any activity which violates<br />
the objectives of conservation, <strong>sustainable</strong> use and equitable sharing of<br />
benefits.
Biodiversity Management Committees will be set up by institutions of selfgovernment<br />
in their respective areas <strong>for</strong> conservation, <strong>sustainable</strong> use,<br />
documentation of biodiversity and chronicling of knowledge relating to<br />
biodiversity. Biodiversity Management Committees shall be consulted by<br />
the National Biodiversity Authority and State Biodiversity Boards on<br />
matters related to use of biological resources and associated knowledge<br />
within their jurisdiction.<br />
- All <strong>for</strong>eign nationals/organisations require prior approval of NBA <strong>for</strong><br />
obtaining biological resources and/or associated knowledge <strong>for</strong> any use. Indian<br />
individuals/entities require approval of NBA <strong>for</strong> transferring results of research<br />
with respect to any biological resource to <strong>for</strong>eign nationals/organisations. Indian<br />
citizens and organisations are required to give prior intimation to the concerned<br />
SBB about obtaining any biological resource <strong>for</strong> commercial use, and the SBB<br />
may prohibit or restrict the activity if found to violate the objectives of<br />
conservation, <strong>sustainable</strong> use and benefit sharing. However, local people and<br />
communities of the area, including vaids and hakims to have free access to use<br />
biological resources within the country. While granting approvals <strong>for</strong> access, NBA<br />
will impose terms and conditions so as to secure equitable sharing of benefits.<br />
These benefits interalia include:<br />
grant of joint ownership of intellectual property rights to the National<br />
Biodiversity Authority, or where benefit claimers are identified, to<br />
such benefit claimers;<br />
transfer of technology;<br />
location of production, research and <strong>development</strong> units in such<br />
areas which will facilitate better living standards to the benefit<br />
claimers;<br />
association of Indian scientists, benefit claimers and the local<br />
people with research and <strong>development</strong> in biological resources and<br />
bio-survey and bio-utilization;<br />
setting up of venture capital fund <strong>for</strong> aiding the cause of benefit<br />
claimers;<br />
payment of monetary compensation and other non-monetary<br />
benefits to the benefit claimers as the National Biodiversity<br />
Authority may deem fit.<br />
- The legislation provides <strong>for</strong> setting up of biodiversity funds at central, state<br />
and local levels. Benefits will be given directly to individuals or group of<br />
individuals only in cases where biological resources or knowledge are accessed<br />
directly from them. In all other cases, monetary benefits will be deposited in the<br />
Biodiversity Fund which in turn is used <strong>for</strong> the conservation and <strong>development</strong> of<br />
biological resources and socio-economic <strong>development</strong> of areas from where<br />
resources have been accessed.<br />
- Be<strong>for</strong>e applying <strong>for</strong> any <strong>for</strong>m of IPRs in or outside India <strong>for</strong> an invention<br />
based on research or in<strong>for</strong>mation on a biological resource obtained from India,
prior approval of NBA will be required. The NBA while granting the approval<br />
impose benefit sharing fee or royalty or both or impose conditions including the<br />
sharing of financial benefits arising out of the commercial utilisation of such<br />
rights.<br />
5. TRIPS, Biodiversity and Patent issues<br />
In the recent past, there have been several cases of biopiracy of<br />
Traditional Knowledge from India. First it was the patent on wound healing<br />
properties of haldi (turmeric), now patents have been obtained in other countries<br />
on hypoglyceimic properties of karela (bitter gourd), brinjal etc. An important<br />
criticism in this context relates to <strong>for</strong>eigners obtaining patents based on Indian<br />
biological materials. There is also the view that the TRIPS Agreement is aiding<br />
the exploitation of biodiversity by privatizing biodiversity expressed in life <strong>for</strong>ms<br />
and knowledge.<br />
Patents are granted under national patent laws and have territorial<br />
application only. The TRIPS Agreement provides minimum standards of<br />
protection <strong>for</strong> intellectual property rights including patents, while WTO Members<br />
are free to grant a higher level of protection under their national laws. Thus, India<br />
is free to deny patents on life <strong>for</strong>ms, except on microorganisms and<br />
microbiological and non-biological processes, as per the provisions of the TRIPS<br />
Agreement. At the same time if, <strong>for</strong> example, USA chooses to grant patents on<br />
plants or other life <strong>for</strong>ms, we can not object. Nevertheless, such patents will have<br />
<strong>for</strong>ce only in USA and can not be en<strong>for</strong>ced in India.<br />
To assess the WTO compatibility of a patent granted by a <strong>for</strong>eign patent<br />
office to an invention based on biological material obtained from India, we need<br />
to check whether the criteria of patentability (novelty, non-obviousness and<br />
usefulness) are satisfied, and to challenge it where the criteria are not met. A<br />
patent granted in USA on the wound healing properties of turmeric, <strong>for</strong> example,<br />
was got revoked after such an examination.. The exercise could be extended to<br />
other such patents also. Another possibility, like in the basmati case, is that a<br />
geographical indication specific to India may be subject to misuse abroad. In<br />
such cases, the affected parties (like exporters of basmati rice) could take up the<br />
matter in courts abroad <strong>for</strong> restraining companies abroad from such misuse. This<br />
has been done, <strong>for</strong> example, by successfully challenging some trademark<br />
registrations in UK and other countries.<br />
The problem of bio-piracy may not be resolved with such revocation<br />
actions and domestic biodiversity legislation alone. There is a need to provide<br />
appropriate legal and institutional means <strong>for</strong> recognizing the rights of tribal<br />
communities on their traditional knowledge based on biological resources at the
international level. There is also a need institute mechanisms <strong>for</strong> sharing of<br />
benefits arising out of the commercial exploitation of biological resources using<br />
such traditional knowledge. This can be done by harmonising the different<br />
approaches of the Convention on Biological Diversity on the one hand and the<br />
TRIPS Agreement on the other as the <strong>for</strong>mer recognizes sovereign rights of<br />
States over their biological resources and the latter treats intellectual property as<br />
a private right. India has proposed, in this context, that patent applicants should<br />
be required to disclose the source of origin of the biological material utilized in<br />
their invention under the TRIPS Agreement and should also be required to obtain<br />
prior in<strong>for</strong>med consent of the country of origin. If this is done, it would enable<br />
domestic institutional mechanisms to ensure sharing of benefits of such<br />
commercial utilization by the patent holders with the indigenous communities<br />
whose traditional knowledge has been used. The proposal has not met with<br />
success in the WTO yet, but ef<strong>for</strong>ts are on to <strong>for</strong>ge a consensus on the issue.<br />
Simultaneously, provisions have been introduced <strong>for</strong> disclosure of the source of<br />
biological material and obtaining prior in<strong>for</strong>med consent <strong>for</strong> access to such<br />
material in the amendments proposed to the Patents Act 1970 through the<br />
Patents (Second Amendment) Bill 1999.<br />
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