To balance regulation and compliance

Published : Dec 09, 2000 00:00 IST

The Biodiversity Bill now before Parliament incorporates several progressive elements, but a number of provisions in it require further strengthening.

THE latest draft of the Biodiversity Bill, now in Parliament, is marked by specific progressive elements, which reflect the consultative process undertaken by the government and positive engagement by groups and individuals. The Bill represents the gover nment's efforts to actualise the objectives of the Convention on Biological Diversity (CBD), by providing the framework for a regime governing access to, and use of, biological resources and associated knowledge. The question is whether the current draft realises the objectives of the Convention and whether other institutions/laws will be supportive or pose hurdles.

The successes with regard to overturning patents in the West, as in the case of turmeric, basmati 1 and neem, are but piecemeal achievements and insufficient in terms of a long-term strategy to stall misappropriation and biopiracy. Repeated fo rays into courts in the West are expensive and definitely not something that the government, domestic companies or communities can afford - a point recognised by the Indian government in a recent submission to the World Trade Organisation's Commission on Trade and Environment (WTO, 2000). Hence, beyond being a useful public relations success there is little comfort or gain in these victories.

The need to have a legal framework must be well appreciated. Without a national (and hopefully a regional) regime controlling transactions involving biological resources and associated knowledge, nothing can be achieved in terms of recognising and/or rew arding communities and indigenous peoples or in securing the sustainable utilisation of biological resources. There is much at stake - even in a simple economic sense, global estimates of the market for plant-derived pharmaceuticals is estimated at $40 b illion (UNDP, 1994) 2. Agreeably, a national and/or regional regime is constrained by the absence of an adequate and legally binding international framework, particularly in countries where patents are secured - it is in these markets that the potential revenues reside.

THERE are several progressive elements in the Bill. Two specific provisions that lead to the empowerment of communities are notable. Clause 41 provides for locally constituted Biodiversity Management Committees that are directed towards "promoting conser vation, sustainable use and documentation of biological diversity... and chronicling of knowledge relating to biological diversity". The National Biodiversity Authority (NBA) and its counterparts in the States are obliged to consult the committees while taking decisions concerning biological resources and associated knowledge within their respective territorial jurisdiction. Importantly, committees may charge a levy for access and collection of biological material and associated knowledge. Further suppo rt for communities and indigenous peoples comes in the form of provisions for the Central government to "respect and protect the knowledge of local people relating to biological diversity" through measures that include appropriate legislation (for exampl e, a sui generis legislation), administrative steps such as registering innovations (for example, the Honey Bee Network) and compilation of biodiversity registers (for example, the Karnataka case) (Clause 36). The inclusion of these provisions in the dra ft is an important development reflecting the government's eventual, but belated, appreciation of a range of possibilities. These provisions finally bring to bear on domestic legislation some of the rhetoric the government articulates in international fo rums, namely, its submissions at the WTO (Protection of biodiversity and traditional knowledge - The Indian experience: Submission by India to the Committee on Trade and Environment, Council for TRIPS; WT/CTE/W/156 & IP/C/W/198; 2000; Item 8: The relatio nship between the TRIPs agreement and the Convention on Biological Diversity: Submission by India to the Committee on Trade and Environment. WT/CTE/W/65; 1997).

Existing literature suggests that empowering communities requires a framework overseeing processes and procedures concerning access to, and benefit-sharing from, the use of biological resources and associated knowledge (Posey, 1996; Mugabe et al., 1997), which has become a central feature of biodiversity-related legislation following the ratification of the CBD (L. Glowka, 1998). It is felt that these access regimes will form the basis for stopping biopiracy.

At a fundamental level the Bill seeks to prohibit the movement of biological material and associated knowledge occurring in India without the previous approval of the NBA, irrespective of whether the request is for research or commercial exploitation (Cl ause 3(1)). Provisions concerning intellectual property rights (IPRs) strengthen this principle - prior approval of the NBA is required by persons seeking IPRs on "inventions based on any research or information on a biological resource obtained f rom India". The NBA is obliged to consult the State and local Biodiversity Committees while making its decision. Further, the NBA is empowered to establish benefit-sharing arrangements and/or royalty payments with respect to the commercial utilisation of such rights (Clause 6). The revenues generated from benefit-sharing arrangements could accrue directly to specific individuals and/or groups where they are identifiable; in other instances the revenue will enter a National Biodiversity Fund (Clause 21(2 )).

Quite apart from efforts directed at conservation and sustainable utilisation of biological resources, the Bill is aimed at biopiracy-related issues. Not only is the transfer of biological resources and associated knowledge prohibited, but applications f or IPRs on 'derivative' inventions require prior approval from the NBA. Chapter V of the Bill, which outlines the approval process to be developed by the NBA, reiterates this thrust of stopping biopiracy. The NBA is required to scrutinise all application s for obtaining and transferring biological material and associated knowledge, and also oversee applications for IPRs on inventions derived from, or based upon, biological material and associated knowledge obtained in India. Interestingly, the Bill empow ers the NBA to "take any measures necessary to oppose the grant of IPRs in any country outside India on any biological resource obtained from India or knowledge associated with such biological resource which derived from India" (Clause 18(4)).

The latter provision is worthy but should not be considered as the primary means to stop biopiracy as it will lead the government into an expensive and time-consuming process of litigation. At best, selective use of the courtroom needs to be attempted, p artly for the public relations victory and to establish crucial legal precedence in terms of standards of patentability. Closely related to the three thrusts identified above is the effort to secure revenue streams. Clearly, the pristine principle aimed at the recognition of the contributions made by communities, indigenous peoples and individuals to inventions has been supplemented by demands for sharing in the financial benefits arising from the commercial exploitation of the end product. The massive global market in products based on, or derived from, biological resources and associated knowledge is clearly there for the picking. The Bill reasserts this principle of recognition accompanied by benefit-sharing through a number of provisions, some of w hich have been noted above.

There are several provisions in the Bill that require further strengthening. One of these involve the need to develop cross-linkages with other pieces of legislation. Biological resources and associated knowledge are widely used in different sectors of t he industry. Naturally, a successful legal framework for access and benefit-sharing must impinge on these other sectors. The Bill attempts this in a number of ways, in particular by requiring prior informed consent of the NBA (and the relevant communitie s) for obtaining and transferring biological resources and/or associated knowledge and when IPRs are applied for. The real problem is two-fold:

* will individuals and companies seeking IPRs on derivative-inventions fulfil the stipulated obligations of the Biodiversity Bill?

* even if the various institutions set up under the provisions of the Bill function efficiently and effectively, will the functioning of other relevant institutions undermine the principles of the Bill?

As regards the first, there is no basis for a priori assumptions that individuals and/or companies, Indian or foreign, will voluntarily behave in a manner consistent with the provisions of the Bill.

Contemporary practice and widely publicised instances of misappropriation of biological resources and associated knowledge are adequate testimony to this allegation. Yet, consistent guidelines across all relevant institutions (that is, in particular the IPRs granting offices) could induce the necessary (voluntary) compliance. As regards the second, one cannot be sure that grants of IPRs do not jeopardise the objectives of the Bill. In this regard, the NBA is empowered to provide prior approval to releva nt applications for IPRs. Quite apart from requiring the NBA to be ever vigilant, are there measures to ensure compliance at the stage at which IPRs are granted?

Ensuring the latter, that is, a means of effective cross-linkage, requires specific provisions governing the process of securing IPRs. Here some, though not adequate, support is present in the proposed amendments to the Patent Act of 1970:

* disclosure of the source of origin of the biological material involved in the subject matter of their application 3, and

* declaration that the prior informed consent of the country of origin has been adequately fulfilled4.

While these measures are fundamental, one remains cautious for the following reasons:

* other IPRs system, namely, plant breeders' rights (PBRs), do not have these provisions; hence, the required cross-linkages are now incomplete,

* measures to ensure that the IPRs granting offices will seek to verify the authenticity of the declarations made by applicants are insufficient, and

* there is a case to reconsider the conditions for patentability in the class of inventions involving biological resources and associated indigenous knowledge.

As regards the latter point, one recommends the following two complementary solutions, which can be also gleaned from legislative effort in other countries, namely, Costa Rica (Rivera and Cordero, 1999 BIOIPR):

* To simplify the task facing IPRs granting offices, the statutory submission of a certificate of clearance issued by the relevant biodiversity authority of the country of origin, which will fulfil the requirement of a declaration that prior informed con sent has been secured.

* A solution to the problem of standards of patentability requires a reconsideration of what should be considered inventive in the class of inventions involving biological resources and associated traditional knowledge. Apart from overhauling the patent system - a strategy that should not be entirely avoided - it might be worth the while to involve the NBA in all IPRs applications that have such subject matter.

The cross-linkage recommended here involves closer cooperation between the NBA and all offices granting IPRs. In the absence of this cross-linkage one suspects that the objectives of the Bill will not be met. Yet, it is important to realise that complian ce of IPRs offices outside India, the real bone of contention, is another matter entirely. Hence the need to pursue urgently multilateral negotiations after having set right the domestic institutions.

Despite the many measures aimed at empowering communities that are noted above, one feels that there is still ground for some improvements. For example, the members constituting State Biodiversity Boards include non-governmental 'experts', which some obs ervers note might subtly disenfranchise local communities from participating in the Boards (Kothari, 2000). Another possible improvement would be to use existing local institutions, such as gram sabhas and joint forest management systems, as ways to devo lve the task of overseeing compliance. Local governance is recognised as a means of 'spreading the risks' of compliance and securing wider participation. In this regard, Kothari (as above) makes a useful suggestion: to empower citizens to approach the co urts if they detect violations of the provisions of the Bill.

STRIKING the appropriate balance between regulation and compliance so as to ensure that the wider objectives of the Bill, such as securing recognition and reward for local communities, are met is a difficult task. There is an urgent need for an adequate legal framework to control access to, and use of, biological resources and associated knowledge as means to provide equitable benefit-sharing and ensure sustainable use. The current draft does include specific progressive elements that require implementa tion - though these require further strengthening. More important, the implementation of this legislation in India will have critical global relevance and provide the necessary impetus for renewed pressure to clarify principles concerning the grant of IP Rs on subjects involving biological resources and indigenous knowledge.

Even while the draft is progressive, particularly in contrast to most initiatives concerning biological resources and communities, one feels the real test is in the directives concerning the implementation of the law. However, there are important changes required if the objectives of the Bill are to be met. Two broad sets of revisions have been noted here: (a) better cross-linkages with other institutions and laws and (b) greater democratisation.

Dr. Dwijen Rangnekar is a Research Fellow at the School of Public Policy, University College, London.

The Economic Times

2 A more recent statistic suggests the global market is valued at over $500 billion (Peter Crane, 2000). All such estimates are highly suspect for a number of reasons. Further, one should be aware that in all instances of use of traditional knowledge the original users are legally entitled to compensation. Either way, there is a significantly large global market in pharmaceutical, chemical and cosmetic products derived from, and dependent on, patterns of use of biological resources pioneered by indigeno us communities.

3 Gadgil and Devasia (1995) provide a useful and early articulation of the possibilities of using certificates of origin as a means of identifying misappropriation of biological resources and associated knowledge.

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