34 Cartagena and Nagoya Protocol

Manoj Kumar Sharma

Cartagena and Nagoya Protocol

Biological diversity is of utmost importance for the existence and resilience of ecosystem. It is important also for the survival of ecosystem and its ability to prevent and recover from disasters. Biological diversity refers to diversity in varied kinds of genes and species. It includes within itself infinite variety of life forms; variety of species in flora and fauna; variety of ecosystem; variations of genes in individual species etc. Various human activities have direct and indirect impact on biological diversity and it is in this context that on 5th June 1992 more than 150 countries signed Earth Summit in Rio De Jenario under the title Convention On Biological Diversity(CBD). Though the convention was finalised in Nairobi in May 1992 but it was opened for signature on 5th June in Cartagena. CBD was developed for providing international Biodiversity protection and regulatory regime. As a matter of fact this was not the first international treaty dealing with the protection of species or ecosystem. Prior to 1992 various other efforts were made for protection of nature and wild life particularly after Stockholm declaration of June 1972 i.e. convention regarding protection of World Culture and Natural Heritage 1972; Convention on International Trade in Endangered Species (CITES)1973; The Berne Convention on Conservation of European Wild Life and their Natural Habitats 1979 etc. (Biodiversity and Human Environment). CBD entered into force on 29th December 1992. It provided a comprehensive and holistic approach to conservation of Biological diversity while focusing on sustainable development. CBD called for sustainable use of Natural Resources and equitable sharing of benefits arising from the use of genetic resources (Preamble). CBD, Article 19 Para 3 dealt with Biosafety. Biosafety implies the need to protect environment and human health from the adverse effects of biotechnology.

Learning Outcomes

The aim of the paper is to apprise the learner about the provisions and obligations under the Cartagena Protocol and the procedure for regulating the transboundary movement of the Living Modified Organisms. The paper also aims to analyse Nagoya Protocol and the obligations under the Protocol. Further the Indian position regarding both the Protocols shall be analysed. The discussion has been divided into following topics

Introduction

Cartagena Protocol

• Objectives of the Protocol 
• Application of the Protocol
• Advanced Informed Agreement Procedure
• LMOs intended for Direct use as Food/Feed/Processing 
• Other Features
•  Indian Position

Nagoya Protocol 

• Objectives
•  Nagoya and Other International Agreements 
• Obligations under Nagoya Protocol
•  Indian Position

Conclusion

Introduction

Advancements in biotechnology raised new hopes regarding fulfilment of the needs of mankind, in particular food requirements. However like other scientific advancements, advancements in biotechnology had their own perils on human health and environment. Therefore, there was a need of reconciling advancements in modern biotechnology, economic interest and safety and protection of human health environment and biodiversity. Use of Living Modified Organisms (LMO) as a result of modern biotechnology, Genetically Engineered Crops and the trade in them necessitated regulatory mechanism on Biosafety.

In pursuance of the provisions contained in CBD, efforts began in 1994 for development of Protocol on Biosafety. A working group was formed for considering the Protocol which met six times between 1996 and 1999 to develop and adopt the Protocol. The Protocol was scheduled to be adopted in Cartagena however due to clash of economic interest, the negotiations could not be materialized and the extraordinary meeting had to be temporarily suspended in 1999. A compromise was reached in Montreal on 29th January 2000 and the Protocol i.e. Cartagena Protocol on Biosafety to the convention on Biological diversity. The Protocol entered into force on 11th September 2003.

The Cartagena Protocol governs and regulates the movements of LMOs from one country to another thereby reducing the potential adverse effects of LMOs on biodiversity. Common LMOs include the agricultural crops which have been genetically modified for resistance to diseases, pests and for better productivity such as Corn, Tomato, Soyabean, Brinjal, Cotton etc. Genetic Engineering primarily involves transferring and developing traits and injecting them into another species to develop desired traits resulting into development of genetically modified organisms.

Objectives of Cartagena Protocol

The objective of Cartagena Protocol is to ensure safety and protection in transfer of LMOs by regulating their transboundary movement. The aim of the Protocol is to ensure safe handling and transboundary movement of LMOs who have the potential of having adverse impact on biodiversity, human health and environment. The Protocol has been developed in accordance with precautionary principles spelt out in principle 15 of Rio Declaration on Environment and Development (Article1).

Application of the Protocol

The Protocol applies to transboundary movement, transit, handling and use of all LMO that may have adverse effects on the conservation and sustainable use of Biological diversity, taking also into

account risks to human health (Article 4). Article 5 of the Protocol excludes the application of this Protocol to the transboundary movement of LMOs which are pharmaceuticals for humans and are covered by the other international agreements.

The Cartagena Protocol takes into account and recognizes precautionary principles in transboundary movement and handling of LMOs. The Protocol has mandated the establishment of Biosafety Clearing House for exchange of information regarding LMOs etc.

Advanced Informed Agreement (AIA)

The Protocol has developed advanced informed agreement procedure which applies to international transboundary movement of LMOs for the first time into the environment of the country of import. AIA does not apply to the following:

• LMOs in transit – Article 6 excludes the application of AIA procedure in case of LMOs in transit. However the Protocol recognizes the sovereignty of the states over their territory and it recognizes their right to regulate the transit of LMOs through their territory (Article 6).
• LMOs for contained use – Article 3 of the Protocol defines contained use which implies any operation which is under controlled circumstances in any facility or undertaking thereby limiting the contact of LMOs with the external environment (Article 3). The Protocol excludes the operation of AIA procedure to transboundary movement of LMOs destined for contained use. This is however subject to the sovereign rights of the party to subject LMOs to risks assessments (Article 6).
• LMOs intended for direct use as food or feed or for processing – The AIA procedure does not apply to LMOs intended for direct use as food or feed or for processing (Article 7).The procedure regarding these is specified in Article 11 of the Protocol.
• The AIA procedure is as under:
  • Notification by the party of export in writing to the Competent National Authority of the party of import. Article 8 requires a notification in writing by the party of import before intentional boundary movement of LMOs for introduction into the environment of party of import. The notification shall contain the following information
    • Name, address and contact details of the exporter
    • Name, address and contact details of the importer
    • Name and identity of the LMO including domestic classification
    • Expected date/dates of the transboundary movement
    • Centres of origin and centres of genetic diversity of the recipient organism and/or the parental organisms and a description of the habitats where the organisms may persist or proliferate.
    • Taxonomic status, common name, point of collection or acquisition, and characteristics of recipient organism or parental organisms related to biosafety
    • Taxonomic status, common name, point of collection or acquisition, and characteristics of the donor organism or organisms related to biosafety.
    • Description of the nucleic acid or the modification introduced, the technique used, and the resulting characteristics of the LMO.
    • Intended use of the LMO or products thereof, namely, processed materials that are of LMO origin, containing detectable novel combinations of replicable genetic material obtained through the use of modern biotechnology.
    • Quantity or volume of the LMO to be transferred.
    • Risk assessment report
    • Measures and methods regarding safe handling, storage, transport and use
    • If any notification has been sent by the exporter to other states, the result of such notification and the purpose thereof
    • Regulatory status of the LMOs in the State of export
    • A self-declaration

•  The party of import is required to acknowledge the notification in writing to the party of export within 90 days of the receipt (Article 9). The acknowledgment shall contain the following:
  •   The date of receipt of notification
  •   Whether notification contains the requisite information

It has been specifically provided that the failure to acknowledge the notification within the stipulated period (90 days) shall not imply consent for international transboundary movement.

•   Decision is to be taken by the party of import within 270 days of the date of receipt of notification (Article 10). The party of import may decide
  • Conditional/Unconditional approval
  • Prohibit the import
  • Additional information may be requested
  • Period of 270 days be extended further by certain period
• The decision of party of import shall be communicated in writing to the exporter and also to  Biosafety  Clearing  House  (BCH).  In  case  of  approval  of  import  with  condition, prohibition of import and extension of time, the decision shall also state the reasons on which the decision is based. Failure to communicate the decision within 270 days shall not imply consent of party of import to international transboundary movement. Para 6 of Article 10 recognizes precautionary principle and empowers the party to take decision based on precautionary principle in the event of lack of scientific certainty regarding the potential adverse effects of LMOs on sustainable use of biodiversity, human health and conservation of biodiversity.

• Party of import has been empowered to review and change its decision subsequently in the light of new scientific information on potential adverse effects of LMOs on conservation and sustainable use of biodiversity and human health (Article12). In such a scenario the party of import is required to inform the exporter and BCH. The decision shall contain the reasons and the grounds. The exporter may request for review of the decision on the ground of availability of additional scientific or technical information and request for risk assessment in the light of changed circumstances. In such a Scenario party of import is required to intimate its decision on such request within 90 days of the receipt of request along with reasons.
• Party of import may exempt certain imports of LMOs from AIA procedure and specify the cases in which international transboundary movement of LMOs may take place at the same time when movement is notified to the party of import. The intimation is required to be sent to BCH (Article13).

LMO Intended for direct use as food or feed or for processing (Article 11)

Separate simplified procedure for transboundary movement of LMOs intended for direct use as food or feed or for processing is provided in Article 21. Under Article 11, the party which makes a final decision regarding domestic use of LMOs which may be subject to transboundary movement for direct use as food or feed or for processing, is required to intimate the parties through BCH within 15 days. The information shall contain the following:

• The name and contact details of the applicant
• The name and contact details of the authority responsible for the decision Name and identity of the LMO
• Description of the gene modification, the technique used, and the resulting characteristics of the LMO
• Any unique identification of the LMO
• Taxonomic status, common name, point of collection or acquisition, and characteristics of recipient organism or parental organisms related to biosafety
• Centres of origin and centres of genetic diversity, if known, of the recipient organism and/or the parental organisms and a description of the habitats where the organisms may persist or proliferate.
• Taxonomic status, common name, point of collection or acquisition, and characteristics of the donor organism or organisms related to biosafety.

If any party informs the secretariat in advance that it does not have access to BCH, the party who has made a decision under Article 11 is required to furnish the above information in writing to the National Focal Points to all such parries who have informed the Secretariat.

Any party may request for additional information and make a decision on the import of LMOs intended for direct use as food or feed or for processing under its domestic regulatory framework. The domestic regulatory framework is required to be consistent with the objective of Cartagena Protocol. Each party is required to make available to BCH copies of its National Laws, Regulations applicable to LMOs intended for direct use as food or feed or for processing (FFP). A developing country in the absence of domestic regulatory framework can inform the BCH that it will take its decision on the first import of LMOs for direct use as FFP on the basis of risk assessment within the stipulated time not exceeding 270 days. Like Article 10, Article 11 also recognizes precautionary principles and empowers the party to make its decision on precautionary principles in the absence of lack of scientific certainty on the potential adverse effects by LMOs for direct use as FFP on conservation and sustainable use of biodiversity and human health.

Other Salient Features of Cartagena Protocol

Other salient features of Cartagena Protocol are discussed in brief here under:

• Bilateral, Regional and Multilateral agreements – the parties can enter into bilateral, regional and multilateral agreements regarding intentional transboundary movement of LMO’s provided they contain adequate provisions for biosafety. The parties are required to inform regarding such agreements to BCH (Article 14).
• Unintentional transboundary Movements and Emergency Measures (Article 17)-whenever there is an occurrence of release of LMO’s within the domestic jurisdiction of the party which may result into unintentional trans boundary movement of LMO’s which may have significant adverse effects on biodiversity and human health of other states, the Party where the release have occurred shall inform BCH and states affected thereby. The notification shall contain the following:
  • Available relevant information on the estimated quantities and relevant characteristics and/or traits of the LMO;
  •  Information on the circumstances and estimated date of the release, and on the use of the LMO in the originating Party;
  •  Any  available  information  about  the  possible  adverse  effects  on  the conservation and sustainable use of biological diversity, taking also into account risks to human health, as well as available information about possible risk management measures;
  •  Any other relevant information; ando A point of contact for further information
• Handling, Transport, Packaging and Identification of LMO’s – The Protocol provides for taking of necessary measures for safe handling, transport, packaging and identification of LMO’s for intentional transboundary movement to ensure biosafety. The requisite documents should accompany the transboundary movement of LMO’s intended for direct use as Food, Feed or Processing (FFP); LMO’s destined for contained use and; intended for intentional transboundary movement. The Meeting of Parties has been authorized to finalize the modalities with regard to handling, packaging, transportation and identification of LMO’s (Article 18)
• Biosafety Clearing House (BCH) – Article 20 established BCH for facilitating exchange of scientific, technical, environmental and legal information regarding LMO’s. The BCH is to assist the parties in implementing the Cartagena Protocol. The BCH is required to take into consideration special needs of least developed countries, developing countries and economies in transition and countries that are centres of origin and also genetic diversity (Article 20). Each country is required to designate National Focal Point to liaise with Secretariat and Competent National Authority to carry out the obligations under the Protocol. (Article 19)The parties are required to make available to BCH the information pertaining to AIA procedure, bilateral, regional and multilateral agreements, results of risk assessment of LMO’s and other reports. The BCH serves as a mechanism to provide access and information to the parties and also for exchange of biosafety information.
• Confidential  Information  –  As  discussed  earlier,  before  the  first  intentional transboundary movement of LMOs, the exporter is required to notify the party of import in writing containing the requisite information. The notifier can identify and intimate which part of this information is to be treated as confidential. The obligation is cast upon the party  of  import  to  permit  the  exporter  to  identify  such  information  and  request confidentiality of such information. If such a request has been received the party of import may  require  the  notifier/exporter  to  justify  or  give  reasons  for  confidentiality.  If  the country of import wishes to disclose such information, it shall consult the notifier of its decision and shall also inform him before disclosing the information. Obligation is cast upon the party of import to protect the confidential information in the same manner as it protects confidential information pertaining to LMO’s produced domestically. The party of import cannot use such information for commercial purposes without the consent of the notifier/exporter. However, the following shall not be treated as confidential except in the case when the notifier withdraws the notification:

• The name and address of the notifier
• General description of LMO’s
• Summary of risk assessment
• Methods and plans for emergency response (Article 21)

It must be noted here that the information submitted to BCH will not be considered as confidential information.

• Capacity Building – The Protocol emphasizes on capacity building for ensuring biosafety and for effective implementation of the Protocol. For this purpose, the Protocol mandates the taking into account of the needs and requirements of developing countries and in particular, least developed countries and economies in transition. The Protocol emphasizes cooperation in capacity building including scientific and technical training in proper and safe management of biotechnology for ensuring biosafety. (Article 22)
• Socio-economic Considerations – The Protocol encourages the parties to cooperate and promote research and information exchange regarding socio-economic impacts of LMO’s on indigenous and local communities. The parties taking a decision on import of LMO’s are required to provide their views and case studies regarding socio-economic impacts of LMO’s. The information is required to be shared with BCH (Article 26). The Ad hoc Technical Expert Group on Socio-Economic Consideration (AHTEG) has been set up to study the socio economic impact of LMO’s. The AHTEG was convened in Seoul in February 2014. Online discussion was held with AHTEG by Meeting of Parties (MOP) in June 2016 regarding socio-economic impact of LMO’s.
• Liability and Redress – The MOP was mandated to adopt a process for evaluating the liability and redress for damages resulting from transboundary movements of LMO’s in its first meeting. It was required to lay down rules and procedures in this regard and to complete this process within four years (Article 27). In accordance with this obligation, the MOP established an Open Ended Adhoc Working Group of Legal and Technical Experts. This working Group submitted its report to the 4th MOP in May 2008. After resolution of all issues, a supplementary Protocol i.e. Nagoya Kuala Lumpur Supplementary Protocol on Liability and Redress to Cartagena Protocol on Biosafety was adopted on 15th October 2010.

Indian Perspective India signed Cartagena Protocol on 21st January 2001 and ratified it on 17th January 2003. It entered into force on 11th September 2003. India has designated Ministry of Environment, Forest and Climate Change (MoEFCC) as Competent National Authority and Biosafety Clearing House (BCH – FP) as National Focal Point. Genetically Modified Organisms (GMOs) are regulated in India under Environment (Protection) Act, 1986. Under the Act MoEFCC has framed Rules regarding Genetically Engineered Organisms i.e. Rules for the Manufacture, Use, Import, Export and Storage of Hazardous Microorganisms, Genetically Engineered Organisms or Cells, 1986 which provides the regulatory framework in India. India has constituted Recombinant DNA Advisory Committee, Institutional Biosafety Committee, Genetic Engineering Approval Committee, Review Committee on Genetic Manipulation, State Biotechnology Coordination Committee and District Level Committee as Regulatory mechanism for achieving the objectives of the Protocol.

It must be noted here that parties to WTO Agreement have liability to ensure open access to markets within the terms of WTO instruments. However, the Protocol recognizes sovereign rights of States to ensure that LMO’s entry into their environment by way of import is regulated, governed and is restricted on the basis of scientific evidence regarding their adverse impact on biosafety and human health. In the absence of certainty regarding adverse impacts of GE products containing LMOs, State may restrict the import and entry of these products on the basis of precautionary principle with a view to ensure biosafety.

Nagoya Protocol

As stated earlier, CBD was enacted as an instrument for dealing with Biological diversity. CBD was basically enacted with the following main objectives:

•  Conservation of bio-diversity
•  Sustainable use of bio-diversity and its components
•  Fair and equitable sharing of the benefits arising from the utilization of genetic resources

In the context of the third objective an Adhoc Open-ended Working Group on Access and Benefit Sharing under the CBD was constituted in 2004 in the seventh meeting of the Conference of Parties. After six years of arduous negotiations, 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 was adopted on 29th October 2010 in Nagoya, Japan at the tenth meeting of the conference of parties.

The Protocol recognizes the Sovereign rights of states over their natural resources and the interdependence of all countries with regard to genetic resources for food and agriculture, for attaining food security. The Protocol also recognizes the interrelationship between genetic resources and

sustainable use of genetic resources and TK and the role of Access and Benefit Sharing (ABS) in conservation and use of Biodiversity (Preamble).

Objectives of the Nagoya Protocol

Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits arising from their Utilization was adopted on 29th October 2010 and it entered into force on 12th October 2014. The Protocol was adopted with the following objectives;

•  To ensure fair and equitable sharing of benefits arising from the utilization of Genetic resources;
•  To promote technology transfer and cooperation for ensuring conservation of biodiversity and sustainable use of biodiversity.
•  To ensure fair and equitable access to traditional knowledge associated with genetic resources.

(Article 1).

The Protocol applies to genetic resources, benefit sharing arising from the utilization of genetic resources. The Protocol also applies to TK associated with genetic resources and the benefit arising from the utilization of TK (Article 3).

Protocol defines ‘utilization of genetic resources’ to mean conducting research and development on genetic and/or biochemical composition of genetic resources, including through the application of biotechnology Article {2(c)}.

Nagoya Protocol and Other International Agreements

Nagoya Protocol does not affect the rights and liabilities of parties under other international instruments/agreements unless they pose serious threat to biodiversity. Protocol also recognizes the rights of the parties to negotiate and enter into other international agreements including specialized benefit sharing agreements subject however, to the condition that they are not inconsistent with Nagoya Protocol. The Nagoya Protocol emphasizes mutual supportiveness of international instruments. Thus where a specialized benefit sharing instrument is entered into and which is not inconsistent with Nagoya Protocol, the Protocol does not apply to parties of such specialized agreement on the topics covered by such specialized agreement. (Article 4)

Obligations under Nagoya Protocol

As stated earlier, Nagoya Protocol provides for access to genetic resources and TK and for benefit sharing arising out of utilization of genetic resources/TK. In this context, various obligations are cast upon the parties to Protocol. These obligations can be categorized as:

• Access Obligations
• Benefit Sharing Obligations o Compliance Obligations

Access Obligations

Protocol provides for access to genetic resources and TK associated with genetic resources. The Protocol, as stated earlier, recognizes sovereignty of the States over their natural resources and the right of the states to exploit them. In this context, Protocol provides that access to genetic resources shall be subject to Prior Informed Consent (PIC) of the State of origin of genetic resources i.e. the country providing genetic resources. In other words, party desiring to access genetic resources for their utilization need to apply and obtain the permission of the country of origin of genetic resources. (Article 6)

Accordingly, Protocol requires that each state party shall undertake the following legislative, administrative or policy measures as may be required:

• To ensure that there is legal certainty, clarity and transparency of ABS legislation and regulatory requirements
•  To ensure that the rules and procedure of accessing genetic resources are fair and non-arbitrary o To make available information regarding procedure, requirements and format of obtaining PIC o  To make arrangements for designation of Competent National Authority and National Focal Point (Article 13) and to ensure that written decision on application is taken within reasonable time and that the decision is fair, non-arbitrary and transparent
• To make arrangement for issuance of permits/licences to evidence the grant of PIC o To notify the establishment of ABS Clearing House
• To provide for the establishment of clear rules and procedures for establishing Mutually Agreed Terms. These terms are required to be reduced into writing and these may provide for
• Dispute Settlement Clause o Terms of benefit sharing o Terms on third party use
• Terms on changes of intent etc.
• To set out criteria/process for obtaining PIC and also for involvement of indigenous and local communities for access to genetic resources (Article 6).
• To ensure that TK associated with genetic resources held by indigenous people or local communities is accessed with their prior and informed consent and also to ensure their involvement
• To create suitable conditions for encouraging and promoting research in biodiversity, particularly in developing countries so as to promote conservation and sustainable use of biodiversity
• To encourage access to genetic resources through simplified procedures for non-commercial research purposes
•  To keep in mind and make arrangements for dealing with immediate or imminent emergencies threatening human, animal or plant health
• To consider the importance of genetic resources for food and agriculture keeping in mind their role in food security (Article 8)

Benefit Sharing Obligations

The Protocol has been adopted with an object to ensure fair and equitable benefit sharing. Benefits may include monetary as well as non-monetary benefits. Monetary benefits may include the following (as explained in Annex to the Protocol)

•  Access fee
•  Upfront Payments
• Payment of royalties
•  License Fee
•   Milestone payments
• Salaries and preferential terms, if mutually agreed
•  Joint Ventures
•  Research Funding
•  Joint ownership of intellectual property rights
• Special Fee

The above list is not exhaustive.

Non-monetary benefits are also outlined in the Annex to the Protocol. These include the following

•  Sharing of Research and Development Results
• Collaboration in scientific research and development programmes especially pertaining to biotech research
• Food and livelihood security benefits
• Contribution to the local economy
• Participation in product development
•  Technology and knowledge transfer to genetic resource provider state
• Capacity building
•  Training in genetic resources
•   Access to scientific information etc. (Annex)

Regarding Benefit sharing, the Protocol casts an obligation on State parties

•  To ensure that benefits arising from the exploitation of genetic resources are shared in a fair and equitable manner with the country of origin
•  To ensure that sharing of benefits is upon Mutually Agreed Terms
•  To ensure that benefits arising from genetic resources which are held by indigenous people orlocal communities are shared in a fair and equitable manner with them on mutually agreed terms. States are obligated to initiate appropriate legislative and administrative measures in this context
•  To ensure that benefit arising from utilization of TK associated with genetic resources is shared with indigenous and local communities in a fair and equitable manner. States are obligated to take appropriate legislative and administrative measures in this context

Compliance Obligations

The protocol also requires the party accessing genetic resources to ensure compliance with the domestic legislation of the party providing genetic resources upon mutually agreed terms. The following obligations are imposed upon the parties:

•  To ensure that customary laws of local and indigenous communities, so far they are recognized in the domestic laws, are complied with
•  To ensure that genetic resources accessed in the jurisdictions of a state are accessed in accordance with PIC and to ensure that Mutually agreed terms have been established as per the law of the state of origin of genetic resources (Article 15)
•  To make effective arrangements for dealing with non-compliance with the obligations o To cooperate in case of violation of ABS requirements (Article 15)
• To ensure compliance with Mutually Agreed Terms. These should include o Provisions relating to resolution of disputes
• The applicable laws
• Jurisdictional issues and
• Provision of Alternative Dispute Resolution Methods (Article 18)
• To ensure that each party has recourse to legal rights and remedies in case of dispute and have access to justice
• To ensure the implementation and enforcement of foreign judgments and arbitral awards o To lay down model contractual clauses (Article 19)
• To ensure monitoring and transparency regarding the utilization of genetic resources including establishment/designation of check points where the information relating to PIC and other information can be collected or received (Article 17)
• To make available requisite information to ABS clearing house established under Article 14 including information on domestic laws and policies concerning ABS; information regarding National Focal Point and Competent National Authority; information regarding permits/licences; information regarding model contractual clauses etc.
•  To encourage the development, updation and use of voluntary codes of conduct, guidelines and best practices in relation to ABS (Article 20)
•  To take measures for raising awareness regarding importance of genetic resources and ABS issues including promotion of the Protocol; dissemination of information through National Clearing House; establishment and maintenance of helpdesk for all the stakeholders; education and training of users; promotion of exchange of experience etc. (Article 21)
•  To ensure that parties cooperate in capacity building, development and strengthening of human resources and institutional capacity, in particular in developing countries
• The States are required to identify National capacity needs and priorities
• To collaborate and cooperate in biotech research and technology transfer (Article 23)

Genetic resources and TK associated with genetic resources are of wide importance in pharmaceutical, agriculture, bio-technology, cosmetic, food, beverages etc. In this context, the Protocol seeks to ensure that access to genetic resources is with the PIC of the country of origin/country providing genetic resources and the benefits arising out the utilization of genetic resources should be shared with resource provider country in a fair and equitable manner. In the past few years, the demand for natural/green products is on the rise leading to increased tapping of these resources.

Indian Position

India ratified Nagoya Protocol in October 2012. Nagoya Protocol entered into force at a time when India was presiding over the COP. Nagoya Protocol is hailed as a big victory for developing countries especially India who will benefit from the sharing of benefits arising out of the use of natural resources and their commercial derivatives (The Hindu, 2010). India has enacted Biological Diversity Act, 2000 and rules thereunder. Chapter II of the Act provides for regulation of Access to Biodiversity. Act has established National Biodiversity Authority and State Biodiversity Board. The Act makes domestic provisions for ABS of genetic resources. In pursuance of Nagoya Protocol, the government of India has promulgated “Guidelines on Access to Biological Resources and Associated Knowledge and Benefit Sharing Regulations, 2014” on 21st November 2014 to ensure compliance with the obligations under the Protocol.

Conclusion

Convention on Biological Diversity (CBD), 1992 was adopted with three main objectives i.e. conservation of biodiversity; sustained use of its components and; fair and equitable sharing of benefits arising out of the utilization of genetic resources. Cartagena Protocol is supplementary agreement to CBD and was adopted in 2000 to ensure biosafety in transboundary of LMO’s so that the environment of the importing state can be protected from unauthorized entry of such LMO’s without the AIA of the importing State.

Nagoya Protocol is also supplementary agreement to CBD whose aim is to ensure that the access to genetic resources must be with PIC of the country of origin of genetic resources and to ensure that the benefits arising from utilization of the genetic resources and TK associated with them is shared with the country of origin in a fair and equitable manner. For these purposes, the Protocol obligates the states to take appropriate legislative, administrative and policy measures.