Analysis of Nagoya Protocol from Traditional Knowledge policy imperatives
Dr. Topi Basar
Introduction
Traditional Knowledge (hereafter TK) is no longer an alien term in the IP paraphernalia. In the last two decades, TK has acquired its own prominent place within the dynamic domain of IP law and it figures prominently in all crucial national and international discourse much interestingly. For which due credit goes to the developing countries like India, Brazil, South Africa, Peru, Philippines, South America etc. for being the strong proponents of global recognition of contribution of TK and need for its adequate protection. The matters of Genetic resources, Traditional Knowledge and Folklore or Traditional Cultural Expressions occupy center-stage position in the present knowledge based global economics. It is difficult to accurately mention when all these became a part of larger policy framework of Intellectual Property Laws. In 1998-1999, WIPO came out with a “Report on Fact-Finding Missions on Intellectual Property and Traditional Knowledge” which can be aptly described as the post WTO development. This was particularly in response to several bio-piracy or misappropriation cases that generated widespread debates on dangers of IPR and technological advancement and its impact on natural resources and TK whose main proponents were the developing nations.
Definitional context
Some of the well-known definitions of TK are:
United Nation Convention on Biological Diversity (UNCBD) defines TK as “knowledge, innovations and practices of indigenous and local communities embodying traditional lifestyles relevant for the conservation and sustainable use of biological diversity and promote their wider application with the approval and involvement of the holders of such knowledge, innovations and practices and encourage the equitable sharing of the benefits arising from the utilization of such knowledge innovations and practices.
UNESCO, “Traditional knowledge is a cumulative body of knowledge, know-how, practices and representations maintained and developed by peoples with extended histories of interaction with the natural environment. These sophisticated sets of understandings, interpretations and meanings are part and parcel of a cultural complex that encompasses language, naming and classification systems, resource use practices, ritual, spirituality and worldviews”.
The World Intellectual Property Organization (WIPO) defines TK:
As the content or substance of knowledge resulting from intellectual activity in a traditional context, and includes the know-how, skills, innovations, practices and learning that form part of traditional knowledge systems, and knowledge embodying traditional lifestyles of indigenous and local communities, or contained in codified knowledge systems passed between generations. It is not limited to any specific technical field, and may include agricultural, environmental and medicinal knowledge, and knowledge associated with genetic resources.
The working definition of WIPO is the key rallying point of the ongoing draft negotiation on TK underway at WIPO.
Key issues and problems
The issue of TK is an offshoot of industrial development and search for newer innovation and technology based on scarce natural resources and quest for new products and industrial processes to fulfill the growing demand of the world. In today’s knowledge and information hungry society every single information of potential commercial value becomes the bone of contention. TK adequately fulfils such quest in many fields by providing valuable leads and informational content to the needy. TK is deeply rooted in community’s way of life and culture. When such knowledge systems are misused or illegally exploited without any consent or approval or any compensation by others, it gives rise to feeling of utter helplessness and loss of immense cultural treasures. India experienced it already in the past in regards to neem, turmeric and basmati patent cases. These cases are famously known as famous TK biopiracy cases fought by India across the foreign shore. The growth of IPR in manifold after the TRIPS agreement’s inception in 1994-95 led to emergence of new policy discourse on TK which was not there before. Therefore, bio-piracy or misappropriation of resources and related TK within the country as well as outside the country is definitely a big problem today. Besides this, many other complex issues are there in case of TK which require a proper legal and administrative mechanisms to deal with the entire gamut of TK centric problems in a holistic way. Another, core issues related to TK is its continuity itself i.e. what happens to TK when the custodian dies? How to ensure that its continuity is preserved? How can TK be made to be beneficial to mankind as a whole without compromising on the rights of the custodian to be compensated for the conservation of TK as a cultural heritage passed down by their forefathers? All these are rather complex matters not easy to devise a perfect solution. However, much headway has been already made in the last few decades.
Pre-Nagoya developments
There are several initiatives at the international level recognizing the significance of TK and matters related to it that is worth mentioning. The most important milestone so far in relation to TK is the adoption of CBD by the UN members in 1992. For the first time, an international treaty like this recognized the importance of TK and the need for its respect, protection, preservation and continuance in Article 8 (j) of CBD.
The Conference of the Parties (COP) has established a working group specifically to address the implementation of Article 8 (j) and related provisions of the Convention. This working group is open to all Parties and, indigenous and local communities’ representatives play a full and active role in its work. Traditional knowledge is considered a "cross-cutting" issue that affects many aspects of biological diversity, so it will continue to be addressed by the Conference of the Parties and by other working groups as well. The Conference of the Parties requested the Ad Hoc Working group on Access and Benefit-sharing with the collaboration of the Ad Hoc Working Group on Article 8 (j) and Related provisions to elaborate an international regime on access to genetic resources and benefit sharing with the aim of adopting an instrument/instruments to effectively implement the provisions in Article 15 and Article 8 (j) of the Convention and the three objectives of the Convention. This is an ongoing priority of the Convention.
Similarly, WIPO is also actively involved with issues on TK mainly with the intellectual property aspects of TK protection. WIPO provides a forum for international policy debate and development of legal mechanisms and practical tools concerning the protection of TK and traditional cultural expressions (folklore) against misappropriation and misuse, and the intellectual property (IP) aspects of access to and benefit sharing in genetic resources. In 1998 and 1999, WIPO consulted a wide range of stakeholders, such as indigenous peoples and local communities, NGOs, governmental representatives, academics and the private sector, to identify the IP needs and expectations of the holders of TK and cultural expressions. Currently, the WIPO Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore (the IGC), which met for the first time in 2001, is discussing draft provisions for the enhanced protection of TK and traditional cultural expressions against misappropriation and misuse.
Convention on Biological Diversity (CBD), 1992
The CBD came in to force from 29 December 1993. Originally signed by 150 government leaders at the 1992 Rio Earth Summit. It is dedicated to promoting sustainable development and conceived as a practical tool to realize the principles of Agenda 21 in to reality. Currently the CBD has 193 state parties. India ratified the treaty on 18 February 1994. The CBD is an international treaty to sustain the diversity of life on Earth. The three main objectives of CBD are:
1. The conservation of biological diversity
2. The sustainable use of its components
3. The fair and equitable sharing of benefits arising from genetic resources.
By far this is the most important international treaty having some strong relevance on TK and other issues connected to it.
Relevant CBD Provisions on TK
The CBD is the primary international instrument with the mandate to address issues regarding the respect, preservation and maintenance of knowledge, innovations and practices of indigenous and local communities embodying traditional lifestyles relevant to the conservation and sustainable use of biological diversity. The most important articles of CBD pertaining to TK protection is article 8(j) and provisions relating to Access and Benefit Sharing contained in arts.15, 16, 17 and 19 of the convention.
Article 8(j) calls upon the parties to establish mechanisms to respect, preserve and maintain traditional knowledge of indigenous and local communities, to promote its wider application, with prior informed consent and to provide for equitable sharing of benefits arising from use of such knowledge. This mandate is subject to the member states national framework and shall not in any way interfere with their sovereign rights to establish its own suitable domestic measures. Article 8(j) is more of directive in nature. It lays down basic guiding principles for the members. It is not stating any mandatory legal requirement. But, even if it lacks legal sanctity its noble values are respected by the parties that have ratified the treaty. As many countries have implemented Article 8(j) within its domestic laws as a basic premise to build on the legal framework on TK.
The CBD has a reporting mechanism under it whereby the parties do periodic reporting on the status of its implementation of Article 8(j). Out of 193 CBD parties, 4 regions (African Union, Andean Pact, Central American Countries, and Nordic Region) and 41 countries have implemented CBD’s mandate on TK and ABS in varied ways and means. Many other countries are in the process of implementing it realizing the fact that protection of TK and equitable ABS are both international as well as national requirement. However, there remain several challenges and obstacles facing countries in the implementation of Article 8(j) ranging from financial, capacity, social, political, public awareness and demographic obstacles. Poverty also remains a high challenge, particularly among African countries.
1. Article 10 (C): Calls upon the parties to protect and encourage the customary use of biological resources as per its traditional cultural practices that are compatible with conservation or sustainable use requirements. This is of special relevance to indigenous and local people and their TK. They are the real holders of vast repository of TK in varied fields. They are guided by the principle of conservation and sustainable use of resources in their cohesive social existence. The continuance of their traditional cultural practices and way of life is essential for all. The indigenous and traditional communities play a key role in the preservation of TK. They are an important link between biodiversity and sustainable management or use of it.
2. Article 15: This Article deals with the most important aspect i.e. access to genetic resources.It is of great significance to both genetic resource rich countries and the party who want to access it. The authority to decide who shall access the genetic resources rests with the country that owns it. It recognizes national sovereignty over one’s own genetic resources. It is not treated as common heritage of mankind. The principle reflects the assertion of GR rich countries to be in a better bargaining position vis-à-vis developed countries with rich technology to harness GR. The access of GR, if granted, should be on mutually agreed terms (MAT) and prior informed consent (PIC) of the contracting party providing such resources. Any scientific research based on GR will have to be carried out with the full participation of the contracting party who provides such GR. Parties will have to take adequate measures for equitable benefit sharing arising from R&D results and commercial utilization of GR based on MAT.
The sharing of genetic resources and access and benefit sharing of GR and associated TK have always been a contentious issues with the parties of CBD. As already discussed in chapter 4, the parties have been engaged in negotiation for almost a decade to establish an ABS regime at the international level, but they disagreed on many aspects of the proposed regime that has delayed the adoption of any law. However, on March 2010, at the Cali meeting of CBD working group on ABS, a draft protocol for an international regime of ABS has been agreed upon by the negotiators that will be further deliberated upon before its final adoption on October 2010 at Nagoya Japan. Still there are many contentious issues in the draft protocol that raises doubts on its final adoption.
3. Article 16: States that the contracting party taking GR from the provider country should make available access to and transfer of technology developed from the use of GR of provider country. The parties have recognized the relationship of intellectual property systems and the CBD and the possibility of the former to influence the implementation of the convention. They are of the view that IP regime must be supportive of the Convention and complement its objectives. Patents are mainly claimed for inventions arising from the application of GR. Hence, it is important to ensure that these laws do not run counter to the objective of the Convention. Community and individual concerns over, and claims to, intellectual property relevant to traditional knowledge should be acknowledged. Knowledge holders should be allowed to retain existing rights, including the determination of intellectual property rights, over their traditional knowledge.
4. Article 19: Provides that the Contracting Party receiving a genetic resource shall take legislative, administrative or policy measures as appropriate, to promote and advance priority access on a fair and equitable basis by Contracting Parties, especially developing countries, to the results and benefits arising from biotechnologies based upon genetic resources provided by those Contracting Parties. Such access shall be on mutually agreed terms. The growth of biotechnology and genetic engineering is largely dependent on the biological or genetic resources largely available only in the developing countries. Therefore, handling of biotechnology and equitable distribution of its benefits is an important concern for all. The GR rich countries must have adequate legal framework on access; benefit sharing measures and the user country must be obliged to respect them.
Commencement of Nagoya
The Nagoya Protocol was adopted at the tenth meeting of the Conference of the Parties (CoP) to the Convention on Biological Diversity (CBD) held in Nagoya in October 2010. The Protocol significantly advances the objective of the Convention on the fair and equitable sharing of benefits arising from the utilization of genetic resources by providing greater legal certainty and transparency for both providers and users of genetic resources including researchers and industry. By promoting the use of genetic resources and associated traditional knowledge, and by strengthening the opportunities for fair and equitable sharing of benefits from their use, the Protocol will create incentives to conserve biodiversity, sustainably use its components, and further enhance the contribution of biodiversity to sustainable development and human well-being. The Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization to the Convention on Biological Diversity is an international agreement which aims at sharing the benefits arising from the utilization of genetic resources in a fair and equitable way. It entered into force on 12 October 2014, 90 days after the date of deposit of the fiftieth instrument of ratification.
Its importance
The Nagoya Protocol will create greater legal certainty and transparency for both providers and users of genetic resources by:
• Establishing more predictable conditions for access to genetic resources.
• Helping to ensure benefit-sharing when genetic resources leave the country providing the genetic resources
By helping to ensure benefit-sharing, the Nagoya Protocol creates incentives to conserve and sustainably use genetic resources, and therefore enhances the contribution of biodiversity to development and human well-being.
Relevance for TK
Relevance for TK
The Nagoya Protocol addresses TK associated with genetic resources with provisions on access, benefit-sharing and compliance. It also addresses genetic resources where indigenous and local communities have the established right to grant access to them. Contracting Parties are to take measures to ensure these communities’ prior informed consent, and fair and equitable benefit-sharing, keeping in mind community laws and procedures as well as customary use and exchange. This is by far the most important international legal instrument which explicitly recognizes the rights of indigenous and local communities on its TK.
The NP has some key features relevant for TK, namely-
1. Each Party shall take legislative, administrative or policy measures, as appropriate, with the aim of ensuring that benefits arising from the utilization of genetic resources that are held by indigenous and local communities, in accordance with domestic legislation regarding the established rights of these indigenous and local communities over these genetic resources, are shared in a fair and equitable way with the communities concerned, based on mutually agreed terms.
2. In accordance with domestic law, each Party shall take measures, as appropriate, with the aim of ensuring that traditional knowledge associated with genetic resources that is held by indigenous and local communities is accessed with the prior and informed consent or approval and involvement of these indigenous and local communities, and that mutually agreed terms have been established.
3. Parties shall in accordance with domestic law take into consideration indigenous and local communities’ customary laws, community protocols and procedures, as applicable, with respect to traditional knowledge associated with genetic resources, effective participation of the indigenous and local communities concerned, Community protocols in relation to access to traditional knowledge, minimum requirements for mutually agreed terms to secure the fair and equitable sharing of benefits, not restrict the customary use and exchange of genetic resources and associated traditional knowledge within and amongst indigenous and local communities.
4. to provide that traditional knowledge associated with genetic resources utilized within their jurisdiction has been accessed in accordance with prior informed consent or approval and involvement of indigenous and local communities and that mutually agreed terms have been established, as required by domestic access and benefit-sharing legislation or regulatory requirements of the other Party where such indigenous and local communities are located.
Reflection on Indian Position in light of Nagoya Protocol
India has been a victim of misappropriation or bio piracy of our genetic resources and associated traditional knowledge as discussed before. It is expected that the Nagoya Protocol on ABS which is a key missing pillar of the CBD, would address this concern.
In order to prevent bio piracy, the Government of India in 2002 brought out domestic legislation for ABS, namely, Biological Diversity Act, 2002. After requisite number of ratifications of Nagoya Protocol and its becoming an international law from 12th October, 2014, this will supplement our domestic efforts.
In order to prevent bio piracy, the Government of India in 2002 brought out domestic legislation for ABS, namely, Biological Diversity Act, 2002. After requisite number of ratifications of Nagoya Protocol and its becoming an international law from 12th October, 2014, this will supplement our domestic efforts.
Pursuant to the Convention on Biological Diversity (CBD), India enacted the Biological Diversity Act in 2002 and notified the Rules (Biological Diversity Rules) in 2004 to give effect to the provisions of the Convention including those relating to Access and Benefit Sharing (ABS). The Nagoya Protocol on ABS is also being implemented through the Biological Diversity Act, 2002 at the national level.
The Biological Diversity Act, 2002 is implemented through a three-tier institutional mechanism: The National Biodiversity Authority (NBA) at the national level; State Biodiversity Boards (SBBs) at the provincial (State Government) level; and the Biodiversity Management Committees (BMCs) to be set up by the elected bodies at the local level. While all the provincial Governments (29 in all) have set up SBBs, setting up of BMCs is an ongoing process. So far, over 62,000 BMCs have been constituted by the local bodies in 26 states. For the implementation of various provisions of the Biological Diversity Act, 2002 several notifications have been issued so far. The Guidelines on Access to Biological Resources and Associated Knowledge and Benefit Sharing Regulations, 2014, (hereinafter referred to as ABS Regulations, 2014) prescribe the scheme of processing the applications, along with template and terms for benefit sharing.
The Biological Diversity Act and the Rules have been critically examined before by the Author which remains the same even after the commencement of Nagoya Protocol and its ratification by India. In many States of India, the so called “Biodiversity hotspot” namely North Eastern region the laws on biodiversity and its implementation is dismally low except for Sikkim and Meghalaya who have made some progress by constituting BMCs and also having its State biodiversity policy. Despite the absence of specific laws on TK in the country, in other words existing gaps in the existing laws as cited above, the community practices or systems embodying TK in itself by the indigenous community offers much scope and potential in protecting TK. Many indigenous communities of North East States have well established community protocols or customary laws governing natural resources and its sustainable utilization of which TK forms an integral part. This is in fact well recognized by the Nagoya Protocol also as discussed before, however the Rules of 2004 fails to take account of that. The community protocols and systems of TK management at the local level must be further strengthened and empowered by a proper policy based on the existing Act and Rules in line with the Nagoya Protocol. India might be a global champion for protection of Nations TK but somewhere we have been ignoring the real interest of the community who have nurtured it or kept it alive. So far, it is mainly a government driven initiative for the sake of showing mandatory requirement like State or National reporting to CBD but the real stakeholders are left out in the bargain.
Challenges and opportunities of Nagoya Protocol
According to a study commissioned by Centre for International Sustainable Development Law (CISDL) titled, “overview of national and regional measures on access to genetic resources and benefit-sharing, Challenges and Opportunities in Implementing the Nagoya Protocol, 2012” it reviews the ABS measures in countries from Latin America and the Caribbean, Asia, the South Pacific, Africa, Europe and North America as well as the regional measures of the Andean Community, ASEAN, the African Union, European Union and the Nordic countries. Its findings are:
• Most of ABS regulations provide for legal certainty, clarity and transparency of domestic requirements in a clear and simple manner. However, in some cases there are some difficulties related to the institutional arrangements in place in the country to handle the request due to lack of internal coordination.
• Most countries provide for non-arbitrary rules and procedures for accessing to genetic resources. In most countries, the applicant can either be a local or a foreigner person, but natural persons are often required to be affiliated to an institution/legal person.
• A few countries addressed the issue of transboundary GR or associated TK, especially Peru, the Andean Community and the Central American Protocol (this regional measures in a general manner).
• Most of ABS regulations provides for PIC and benefit-sharing agreement between the applicant and the provider.
• Most of ABS regulations provide for the establishment of a benefit-sharing agreement between the applicant and one or several provider or proof that benefit sharing has been established with relevant providers (India).
• The Andean Community common regime, Peru, and Brazil’s regulations also recognize and protect the rights of the indigenous peoples to decide about their innovations, practices and knowledge associated with genetic resources. In some countries specific legislation exists to guarantee the right of Indigenous peoples over their TK or genetic resources located in their lands, in addition to the broader ABS measures (e.g. Venezuela, Panama, Peru, Philippines).
• However, very few laws set out procedures for obtaining PIC of ILC and very few other countries have developed model contractual clauses for MAT (Australia, Costa Rica, the Andean Community and Peru).
• Specific recognition of customary law or community protocols is provided indirectly in some ABS systems, but there is a lack of detailed guidance on these issues.
• Few of the national and regional ABS measures contain clear compliance related provision.
• Ownership of genetic resources will have to be fleshed out in order to meet the Protocol’s obligation related to genetic resources owned by ILC.
• Concrete measures should be put in place to create more equity and legal certainty in the negotiations, particularly by improving opportunities for indigenous peoples and local communities and empowering them properly.
In context of Malaysia, an expert said the facts that the current National Policy on Biological Diversity does not provide enough attention to the protection of traditional knowledge may have reflected the government’s concern on the issue. Nonetheless, protection of traditional knowledge requires more than just a policy declaration. The establishment of an inventory of traditional knowledge on the use of species and genetic diversity is extremely crucial where bio piracy is imminent. Likewise, to provide an effective Access and Benefit Sharing regime, new legislation (or enhancement of present legislations) must be introduced to protect the ownership rights of these indigenous communities accruing from their associated traditional knowledge on genetic resources. This holds same for India also as for legal enforcement of TK related provisions indirectly provided in other Acts which are not meant for TK exclusively is a big setback for the proper implementation of the principles enshrined under the CBD and legal obligations imposed under the NP. Even the courts and tribunals will be handicapped to protect the interest of stakeholders of TK in the absence of clear sui generis law. When India can enact a sui generis law on Geographical Indication and Plant Variety and Farmers Rights why the same is not done for TK? It should never be a centralized system like BDA on the contrary, local panchayats and communities should be legally empowered to manage and control TK at the village level with full autonomy and decision making power and a proper plan allocation be made for this purpose. The customary laws and protocols if any must be duly recognized by the State. Unfortunately, even after the inception of NP whose core objective is to ensure benefit sharing, it is still a far off dream for the community stakeholders whereas transfer of genetic resources via illegal trading and trafficking of bio resources having valuable medicinal property under the nose of the State government is a rampant practice. Sometimes, the innocent community also fall prey to illegal bio traders mainly in north eastern hilly regions and sell off the valued bio resource in exchange of a small amount of money. Many researchers undertake bio survey and research even without due process of clearance and permission due to absence of proper institutional mechanisms in place at the local level. There is also a very low level of awareness of relevant laws at the local administration and even State for that matter. Most officials are of the view that the matter pertains to the forest and laws on conservation of forest which is totally a wrong approach. There is an urgent need to deal with matters of TK independent from forest and biodiversity whose scope is much broader, whereas TK has direct link with cultural heritage and livelihood and ones way of life to put in simply.
Conclusion
In the absence of a sui generis IP law on TK, the existing IP laws in the country is the last resort to extend legal protection wherever possible. There is a need to develop a new jurisprudence on TK to ensure IP rights of the indigenous community who has developed, preserved and sustained traditional knowledge base of India’s rich civilization. This will mean a new outlook in administering IP laws and its interpretation by the Courts and Tribunals in India. It would also mean bringing more awareness about the social, cultural and economic benefits of IPR to the indigenous people in general and to bridge the gap between the industrial approach to modern day IP and that of customary traditional approach of community IP rights. A new jurisprudence in this aspect will not only protect the rich traditional heritage of the tribal but sustain the nation’s cultural plurality. Question is not what traditional knowledge got to do with IPR? On the contrary, what is IPR without innovation and creativity which is infused by the rich TK and cultural heritage?
The State Biodiversity Board and its subordinate body like BMC in the State need to be made functional in real sense not only on paper. The SBB should be headed by an eminent expert in the field of biological diversity and TK and BMCs formed at the local level with the direct involvement and supervision of village panchayat. A clear policy guideline in this regard is imperative and a clear interface of customary laws and institutions and the State laws in order to bring about legal coherence in these matters is much needed. Since the legal jurisprudence in this branch of IPR is in its early stage in India its all the more necessary for the State to formulate its policy approach in the light of peculiar social and cultural contexts prevailing in the State. A bottom up approach will be the way forward.
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