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Biopiracy, an inherently contentious issue, embodies the misappropriation of genetic bio-resources and Traditional Knowledge (TK), often driven by the misuse of intellectual property rights. This global concern is frequently intertwined with the shadow of bio-colonialism, a term that underscores the exploitative dynamics reminiscent of historical colonialism.[1] These practices primarily involve large corporations from developed countries, who exploit the knowledge and resources of communities and tribes often residing beyond the reach of legal protection.
The notion of bio-colonialism points to a troubling parallel: just as colonial powers exploited indigenous lands and resources for their own gain, modern bio-pirates exploit TK and genetic resources. This exploitation occurs, notably, in developing nations, where communities often lack the legal safeguards needed to protect their intellectual and biological wealth.
The subsequent shift takes us from this theoretical context to the specific Indian scenario. India, like many other countries, has faced the adverse effects of biopiracy due to globalization and weak intellectual property rights regulation. Despite its participation in international agreements like the Convention on Biological Diversity, it struggled to protect its wealth of TK and bio-resources.
Indian involvement: leading or lagging?
Biopiracy has had adverse impact on India in the past due to globalization coupled with weak IPR regime.[2] However, one must not underappreciate the vastness of this problem since it is this very vastness that has, as much as it as, allowed for a help. The worldwide push for this protection resulted in multi-lateral treaty, namely, Convention of Biological Diversity (CBD).[3] India has been a relatively active member of the same, even hosting COP 2011 in Hyderabad.[4] In furtherance of its obligations within the treaty, India enacted Biological Diversity Act, 2002.[5] The same had several provisions aiming to achieve protection of the knowledge and also giving back the credit for its regulated usage to the local communities. However, the ‘commendable move’ was soon flooded with criticism for its cumbersome approvals and mechanism, hurdling scientific innovation, collaboration and business ease. The critics also highlighted the inefficiency of the legislation due to no real credit going back to the community under vastly corrupt bureaucracy.[6]
To address all these concerns, the government recently brought in an amendment. However, it did not address the former inefficiencies, rather chose to step back in its very object and obligations conferred through the CBD. This piece serves as the critique of this amendment.
Access restrictions for foreign elements vis-à-vis object of the Act
In furtherance of the Act’s object, Section 3 of the Act mandated approval from NBA for ‘access’ to biological resources for companies either not registered in India or registered but with participation for non-Indians in share capital or management.[7] This provision was the core basis of litigation against MHSC which had obtained indigenous varieties of Egg Plant for making of Bt. Brinjal.[8] MHSC was owed 26% by the American Company Monsanto Co, also registered as a Company in India. It also allowed Andhra Pradesh Government State Diversity Board (SSB) to ger royalty payments in Cotton Bt. case for such usage as allowed by the BD Act.[9] However, as the present amendment would allow such companies to hide behind the Companies Act definition of clause 27, Section 2, which requires one to reach the threshold of ‘control’ by majority shareholding or otherwise.[10]
[Image Sources: Shutterstock]
Before we analyze section 6, due regard must be given to Section 7, which allows for commercialization, utilization of any biological resource and its associated knowledge. The language of the section is exclusionary for entities covered under Section 3(2) [ones with any non-Indian aspect].[11] This exclusion reaffirms the original object of both CBD and the Act, viz, exclusion of grant of patent to foreign entities.
With respect to change in Section 6, the changes can be summarized in two broad categories. First change by bringing in Section 6(a)(1A) allows any entity under Section 7 to apply for a patent without a prior approval, by mere registration of the information with NBA [unlike ones covered under Section 3(2), as amended].[12] In conjunction with this, the second change brought in by Section 6(a)(1B) requires a prior approval before commercialization of the same.[13] This, in conjunction, is a welcome change since a middle path now decreases number of approvals but with no harm due to the second provision.
No more indigenous rights over codified traditional knowledge?
The Amendment Act dilutes the Access and Benefit Sharing (ABS) requirements by creation of distinction between codified and uncodified TK.[14] It is argued that this distinction is solely based on ease of business objectives to ease FDI inflow in the sector.[15] This leads to erosion of rights of minority with no benefit to them. It is argued that the legislature has misread and nitpicked the ‘interests’ and ‘rights’ recognized in CBD and reaffirmed in Nagoya Protocol. The author discerns two such interests, first, recognition of sovereign rights; second, recognition of rights of traditional communities. However, one leads to another. One aspect of sovereign rights is based on rights of the traditional communities/indigenous groups exercised within and via the domain of the sovereign. The second aspect flows from protection of exercise of sovereignty on this knowledge, namely, exclusion of use by others. It is argued that this exclusion has been misread as exclusion based on territory of the sovereign itself. Rather, this exclusion is based on use, translating into use based on permission or by transfer of benefit to the traditional communities or indigenous groups.
With this Amendment, the definition of benefit claimers now excludes codified TK only for Indians. Before we proceed to analyse this exclusion, it would be eased by dealing with the confusion regarding the meaning of the phrase ‘only for Indians’. For the purpose of our analyses, it is presumed to mean that such codified TK can only be used by Indians. Such codification is not defined and would generally include all codifications in scriptures like that of Unani medicine or otherwise. With its vast net caste over, the government now allows all Indian pharmaceutical companies to monetize this knowledge without any prior approval or benefit to the local communities. This is in contravention to the very idea of providing Fair and Equitable Benefit Sharing (FEBS), both under CBD and Nagoya Protocol.[16] This is ironical as the Amendment specifically considers the Act in furtherance of Nagoya Protocol on access to genetic resources and equitable sharing of benefits.
The exemption is further broadened by exclusion of AYUSH practitioners. This exclusion does not come with any proviso explaining of detailing the exclusion. Rather, it is another blanket net cast over wide. One must appreciate the core nature of AYUSH medicines, which is primarily plant and biological resources based developed with TK across ages.[17] This would allow major pharmaceuticals to commercialize ayurvedic medicines, like Himalaya Pharmaceuticals. It is true that this step would now attract more investment, both foreign and domestic, into the sector, but the same comes at cost of derogating and disrespecting the rights of traditional communities over their knowledge without any benefit sharing.[18]
Concept of Normally Traded Commodity
The core idea behind NTC is designating certain biological plants/commodities as items tradable normally in the market and get out of ambit of the Act. This provision simply allows the trade of the item itself and not anything derived from it. As per 2016 regulations of NBA, this derived product can also be treated as NTC provided that the claimant proves that this is within common practice.[19]
The recent Amendment has provided a loophole in this process by not mandating this burden of proof.
Erosion of ‘say’ of benefit holders
Pre amendments, 41(2) required NBA to consult Biodiversity Management Committee (BMCs) for taking decisions regarding local biological resources and related traditional knowledge. The BMC was constituted by local bodies with aim of conservation and sustainable development of resources. What comprised of the local bodies was unclear, but the amendment succinctly mentions “the local body at the Gram Panchayat level in rural areas and at the Nagar Panchayat or Municipal Committee at Municipal Corporation level in urban areas shall constitute the BMC.” The Amendment further provides the clarity as to composition, etc. of the Committee.
The sub section (2) provides for consultation with the BMC before NBA or state board takes any decision. This consultation has been a mandatory requirement. However, consultation is not concurrence. A mere consultation only allows for an opportunity of discussion with no real hold of power with the BMC since the ultimate decision lies with the NBA or the state board. Moreover, the Nagoya Protocol emphasizes on a prior informed consent of the relevant communities. Therefore, it is safe to conclude that the ‘say’ of communities in this preservation is a façade with the arbitrary powers of the NBA in the back.[20]
Conclusion
In summary, the recent amendments to the Indian Biological Diversity Act have raised significant concerns about the protection of indigenous knowledge and resources. These changes impact access restrictions for foreign entities, the differentiation between codified and uncodified traditional knowledge, and the concept of Normally Traded Commodities. They also question the effectiveness of local bodies in decision-making.
These amendments need careful reconsideration to strike a balance between promoting economic growth and protecting the rights of indigenous communities. Ensuring alignment with international agreements, such as the Convention on Biological Diversity and the Nagoya Protocol, is crucial. A more nuanced and equitable approach is necessary to address the challenges of biopiracy while upholding principles of fairness and justice for all stakeholders.
Author: Neeraj Kumar, in case of any queries please contact/write back to us via email to chhavi@khuranaandkhurana.com or at Khurana & Khurana, Advocates and IP Attorney.
[1]Ashleigh Breske, Biocolonialsim: Examining Biopiracy, Inequality, and Power, Global Politics and Societies, Hollins University 2018.
[2]Shahnaz Kaushar, Bio-Piracy in India: A Practice of Patenting TK For Profit, Vol. I Issue I, IPR Journal.
[3]Convention of Biological Diversity, December 29, 1993,C.N.29.1996.
[4]Convention of Biological Diversity, COP 11 Hyderabad, India.
[5] The Biological Diversity Act, 2002 (hereinafter referred as ‘The Act’)..
[6]India’s Biodiversity Law Has Turned Out to Be a Nightmare for Scientists and Businesses – Parliament Should Repeal It – Spicyip
[7] The Act, Section 3.
[8]Bt Brinjal biopiracy case: Apex court restores PIL in Karnataka HC after nearly a decade (downtoearth.org.in)
[9]GRAIN | Andhra Pradesh files case against Bt cotton royalty
[10]The Act, Section 2(27).
[11]The Act, Section 3(2).
[12]The Act, Section 6(a)(1A).
[13]The Act, Section 6(a)(1B).
[14]Where to lean on? The Biological Diversity (Amendment) Bill 2021 or the Landmark Cases? – Spicyip
[15]Id.
[16]Amendments to law could make bio-diversity vulnerable- The New Indian Express
[17]Modi government’s new environmental laws a threat to India’s biodiversity and forests – Frontline (thehindu.com)
[18]Corporate control over biodiversity? That’s what this new Bill would like to see – Frontline (thehindu.com)
[19]National Biodiversity Authority, Regulation, 2016
[20]Environment Support Group ‘Writ Petition No, 41532/2012’ http://esgindia.org/sites/default/files/campaigns/bi odiversity/legal/esg-pil-biopiracy-hc-kar-oct-2012final.pdf.