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A lead provided by a tribal community, Kani tribe, inhabiting the Southern-Western Ghat region of Kerala, relating to the restorative, immuno-enhancing, anti-stress and anti-fatigue properties of a wild plant arogyapaacha (Trichopus zeylanicus) has led to a bioprospecting and development of a scientifically validated drug “Jeevani” by the Tropical Botanic Garden and Research Institute (TBGRI). The TBGRI in consultation with the tribal community has worked out an arrangement for benefit sharing. According to this arrangement, the TBGRI has agreed to share 50 per cent of the licence fee and royalty with the tribal community.
This is just one of the examples where the use and economic exploitation of genetic resources and related traditional knowledge has brought a wide range of benefits to local communities and societies alike, including economic benefits. Biotechnology and non-biotechnology developments over the past few years have contributed significantly to the generation of these benefits. At the same time, these developments have also intensified debates over the control of biological and genetic resources and use of intellectual property rights (IPRs) over biological and genetic materials and the products derived from them.
Biodiversity Convention
The Convention on Biological Diversity (CBD) is the first global comprehensive agreement to address all aspects of biological diversity, including conservation of biological diversity, sustainable use of its components, and fair and equitable sharing of benefits arising from its use. The Convention was signed by nations during the 1992 Rio Earth Summit. Since its entry into force in 1994, the CBD has been ratified by 180 Parties. India is a Party to the Convention on Biological Diversity.
One of the three objectives of the Convention on Biological Diversity, as set out in its Article 1, is the “fair and equitable sharing of the benefits arising out of the utilization of genetic resources, including by appropriate access to genetic resources and by appropriate transfer of relevant technologies, taking into account all rights over those resources to technologies, and by appropriate funding.”
A framework for the implementation of this third objective of the Convention with respect to access to genetic resources is provided in Article 15 of the Convention. In addition, Article 8(j) contains provision to encourage the equitable sharing of the benefits arising from utilization of knowledge, innovations and practices of indigenous and local community embodying traditional lifestyles relevant for conservation and sustainable use of biological diversity.
Access and Benefit Sharing
Access to genetic resources and sharing of benefits arising out of the use of these resources form the core of the CBD. Operationalising the benefit sharing provisions of the CBD, however, has been beset with many complexities, and therefore not much progress could be made in implementation of this core objective of the CBD even after ten years of entry into force of the Convention.
The main challenge in implementing the Access and Benefit Sharing (ABS) principles under the CBD is to determine how the benefits, in terms of sharing research results, capacity building, monetary income and IPRs, are to be effectively shared among users and providers of these materials.
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.
Legal framework
To ensure this, India, along with the support of other like-minded developing countries, has been advocating in various international fora that Article 29 of the TRIPs (Trade-Related Aspects of Intellectual Property Rights) agreement dealing with disclosure in patent application should require mandatory disclosure in patent application of the origin of biological resources / traditional knowledge used in the technological invention, and an undertaking that the prevalent laws and practices of the country of origin have been respected.
With the enactment of the Biological Diversity Act (2002), it has become necessary to take the prior approval of National Biodiversity Authority 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.
As a result of India’s strong arguments in meetings under the aegis of the CBD as well as in WSSD (World Summit on Sustainable Development), the 7th Conference of Parties (CoP-7) to the CBD took a landmark decision regarding development of an international regime on access and benefit sharing, after almost ten long years of entry into force of the Convention.
Megadiverse Countries
Recognizing the urgent need to develop human resources, capabilities, and legal and public policy to enable countries rich in biodiversity to take an active part in the new economy associated with the use of biological diversity and biotechnology, seventeen countries rich in biological diversity and associated traditional knowledge have formed a group known as the Like Minded Megadiverse Countries (LMMCs).
In the New Delhi Ministerial Declaration of Like Minded Megadiverse Countries on Access and Benefit Sharing, issued on January 21, 2005, LMMCs have agreed to join efforts as a Group for effectively negotiating the development of an international regime on access and benefit sharing (ABS), including legally binding instruments in the forthcoming meetings of the Ad-hoc Open ended Working Group under the aegis of Convention on Biological Diversity, so as to safeguard the interests of LMMC countries and peoples.
The New Delhi Ministerial Declaration also stated that the proposed international regime on access and benefit sharing (ABS) should include “mandatory disclosure of the country of origin of biological material and associated traditional knowledge in the IPR (Intellectual Property Right) application, along with an undertaking that the prevalent laws and practices of the country of origin have been respected and mandatory specific consequences in the event of failure to disclose the country of origin in the IPR application”.
The meeting, hosted by India, from 17th to 21st January 2005, in its capacity as the President of the Group, helped in evolving a common position of the LMMCs for developing an international regime on Access and Benefit Sharing (ABS) and resulted in finalization and adoption of the New Delhi Ministerial Declaration of Like Minded Megadiverse Countries on Access and Benefit Sharing.
Conclusion
New industrial sectors such as nutraceuticals, biofuel, cosmetics, crop protection, genetic engineering and bioremediation have all opened new possibilities for generating substantial economic benefits. These possibilities highlight the need for new options on the participation in these benefits by those countries, which have contributed to the material wealth of these sectors through their genetic resources and derived biological materials.
The development of a legal regime, which assigns rights to indigenous peoples over access to and use of their traditional knowledge and which grants protection to countries over their biological resources would ensure an equitable sharing of benefits from the flows of genetic resources worldwide.(PIB Features)
**Information Officer, PIB , New Delhi
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