January 30, 2024

The Nagoya protocol on access to genetic resources and the fair and equitable sharing of benefits arising from their utilization

This article has been written by Mr. Abhishek Singh, a first year student of Banaras Hindu  University, Varanasi.

 

Abstract-

The concept of resources changes with time and with development and as Human greed makes individuals to utilize these resources at unsustainable and imbalanced way, it is necessary to check their greed to ensure that the planet is not endangered by these counter-effective activities. Therefore, to ensure that genetic resources which are a by-product of technological advancement remains equitable and every country is able to enjoy their fruits, Nagoya protocol on access to genetic resources and the fair and equitable sharing of benefits arising from their utilization was framed and enacted. The article aims to trace the historical background of the protocol and its aims. It also analyses some relevant provisions and views its effectiveness in ensuring a common response to public health. The article concludes by observing Indian experiences and restates the relevance of the Protocol

Keywords– Nagoya Protocol, Genetic Resources, Public Health, Traditional Knowledge.

Introduction-

Resources are important for a country’s development as they provide leverage to develop at an exponential rate without jeopardizing other components. These resources are of several types such as natural resources, an example of which is petroleum resources, man-made resources which are in lieu of technological advancements. While natural resources acted as boosters of development in early 18th century, the beacon of development soon changed hands as man-made resources became a determining factor of a country’s pace of development. However, these resources have normally potential of arithmetic growth but genetic resources are of more multifaceted in nature as they promise more equitable and exponential growth. Thereby, to ensure that distribution of the genetic resources is not imbalanced, The Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization was adopted as a supplementary agreement to the Convention on Biological Diversity. 

History

To understand the Nagoya Protocol, it is necessary to understand the convention which serves as its backbone. Convention on Biological Diversity is also known as Biodiversity Convention and aims to address the issues concerning biological diversity as it is a common concern of mankind. The convention came into existence with three primary objectives to achieve which are-

  • Conservation of Biological Diversity.
  • Its sustainable use.
  • Fair and equitable sharing of benefits arising of genetic resources.

While first two of the objectives are dealt under several individual treaties, 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 formulated to deal with the third objective which was to ensure equitable sharing of benefits by taking cognizance of Article 15 of the Convention on Biological Diversity which provides a framework for implementing the third objective of the convention. It is also known as Nagoya Protocol on Access and Benefit Sharing and was adopted in Nagoya, Japan on 29 October, 2010 and has entered into force from 12 October 2014. As of January 2024, the protocol have 141 Parties with 92 signatures and 141 ratification. India too became a ratified it on 9 October, 2012 and became a party of the same on 12 October, 2014.

Negotiations and Process behind the Protocol

Conference of Parties at its fourth meeting established a panel of experts on Access and Benefit sharing to clarify some principles. The concerned panels discussed some pressing issues such as prior-informed consent, benefit-sharing, capacity building among others. On its fifth meeting, the Conference of Parties established an Ad-Hoc open ended group on Access and Benefit-sharing with the aim of formulating guidelines to assist the parties in implementing the access and benefit sharing provisions of the Convention. The Bonn Guidelines on Access to Genetic Resources and Fair and Equitable Sharing of the Benefits Arising out of their Utilization were adopted in 2002, so as to assist parties in establishing administrative, legislative or policy measures on access and benefit-sharing. The Ad Hoc Open-ended Working Group on Access and Benefit-sharing met eleven times from 2005 to 2010 to negotiate an international regime on access and benefit sharing and after several rounds of negotiations, its last meeting was held on 16th October, 2010 in Nagoya, Japan which led to the adoption of 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 on 29 October 2010 by the Conference of Parties at its tenth meeting. 

Aims and Obligation

Article 1 of the protocol enumerates the aims and objectives of the convention as 

  • Fair and equitable sharing of genetic resources.
  • Appropriate access and sharing of technologies responsible for genetic resources development.
  • Funding of technologies
  • conservation of biodiversity and maintaining sustainability.

The Protocol also aims to create legal certainty about the transfer and use of genetic resources-

  • Establishing more predictable access to genetic resources so as to prevent discrimination.
  • Ensure benefit-sharing when genetic resources leave the contracting party providing the genetic resources.
  • Establish incentives for ensuring sustainability of genetic resources in long run.

The scope of Nagoya Protocol is wide enough to cover traditional knowledge along with genetic resources. Therefore, to achieve its objectives, protocol establishes some obligations on the parties.

Obligations to the parties are primarily divided into three sub-heads which are –

  • Access Obligations- Domestic level obligation for the parties are-
    • Create statutory clarity about the genetic resources.
    • The statutes should not be discriminatory to any section.
    • Clear rules and procedures should be established for prior informed consent and mutually agreed terms.
    • Clear guidelines should be established for granting permit.
    • While fulfilling all these obligations, sustainability should be the main motive behind statutory regulations.
    • Ensure surveillance of emergencies which have the potential to threaten the balance between plant, human and animal health.
    • Explore utility of genetic resources in ensuring food security.
  • Benefit sharing Obligations
    • The Party is expected to share benefits arising from the utilization of genetic resources with the contracting party where the benefits is not limited to monetary benefits but also include research and development results.
  • Compliance Obligations-
    • Parties are expected to ensure that the resources present in their jurisdiction is obtained according to the procedure recommended by the protocol.
    • Cooperation between parties should be paramount in cases of alleged violations.
    • Parties are expected to pre-determine procedures which is to be followed in cases of disputes.
    • Measures should be taken by the parties to ensure that justice is accessible.
    • Take measures to monitor the utilization of genetic resources after they leave a country including by designating effective checkpoints at any stage of the value-chain: research, development, innovation, pre-commercialization or commercialization.

 While these obligations are for genetic resources, the Nagoya Protocol also provides provisions for traditional knowledge. The protocol gives local communities who possess the traditional knowledge, a right to grant access, so that they can allow other individuals or parties to use that knowledge. Thereby, an obligation is placed on the contracting parties to ensure that prior informed consent provision is followed along with other provisions in cases of traditional Knowledge, while simultaneously ensuring that customary laws and practices of the community is followed.

Implementation Mechanism for Nagoya Protocol-

Protocol itself provides for the tools and mechanisms for implementation. They are as follows-

  • Establishment of National Focal Points and National Authorities-They acts as link between the parties and grant access or ensure cooperation in cases of violations.
  • Access and Benefit-sharing Clearing-House- They acts as a repository of information regarding domestic rules for access and benefit sharing along with information regarding National Focal Points and competent authorities in a jurisdiction.
  • Capacity- building– According to a country’s own self-assessment, expertise can be provided to develop domestic legislations to implement the Nagoya Protocol, to negotiate mutually agreed benefits and develop in-country research capability and institutions.
  • Increase awareness by information dissemination.
  • Transfer of technology to ensure equity.
  • Targeted financial support for implementing obligations under Nagoya Protocol. 

Nagoya Protocol and public health

Public Health responses to outbreaks of any pathogen depends on the surveillance and timely response against it along with timely information sharing among the countries. Initially, concerns arose regarding the implementation aspect of the Nagoya protocol as it was expected that it would slow down the sharing of pathogen due to –

  • Uncertainty about the jurisdiction of the Protocol.
  • Increased transactional cost in finalizing the Bilateral agreements for access and benefit sharing.
  • Increased complexities in ensuring compliance.

However, reality have been distant from the assumptions as The Nagoya Protocol provided a foundation for a global common approach to accessing pathogens, and sharing benefits arising from their use based on core principles, such as fairness and equity. The protocol helped in establishing a more fair approach in sharing of benefits. Increased clarity, fairness and equity encouraged timely sharing as evident in case of Covid-19, which would support risk assessment and the development of medical countermeasures. In addition, predictable sharing of benefits could improve access to affordable treatments and help build capacities, such as disease surveillance, and research and development, particularly in developing countries. Through the sharing of benefits such as joint ownership of intellectual property, collaboration and acknowledgment of contributions, the Nagoya Protocol provides an opportunity for Member States to establish pathogen sharing systems that support global health equity. Therefore, how the protocol is implemented by the parties of the convention will decide whether the protocol supports public health or not.

Indian Experience

India remained a pioneer in this field too as India framed its law on the subject in 2002 itself. India enacted Biological Diversity Act, 2002 to implement the objectives of the Convention of Biological Diversity. Thereafter, to ensure effective compliance with the provisions Biological Diversity Rules, 2004 were notified so as to provide frameworks for implementation of the objectives enumerated under the Act of 2002. These rules even though were framed before the Nagoya Protocol but they included beforehand, provisions of the protocol. Following the enactment of the protocol, Guidelines on Access to Biological Resources and Associated Knowledge and Benefit Sharing Regulations, 2014 was notified under the 2002 Act. These three instruments together form the Indian Legislative space on the subject. However, they are not exhaustive as Government has authority under the Act of 2002 to frame and enact new guidelines as per the exigencies of the circumstances. Thus, a level of legislative freedom exists. 

Implementation mechanism under Biological Diversity Act, 2002

The Act envisions three tier level for its implementation-

  • National Biodiversity Authority
  • State Biodiversity Boards
  • Biodiversity Management Committees

Sections 3, 7 and 23 of the  Biodiversity Diversity Act, 2002 empowers the authorities to grant approval for access to Genetic resources and associated knowledge. A noble feature of the implementation procedure is the existence of Biodiversity Management Committees as it ensure that local communities are slowly included in the mainstream to provide protection to them and encourage their participation. Over 62,000 BMCs have been constituted so far. Section 2(a) of the Act also defines the benefit claimers and is wide enough to include conservers and protectors so that they too can benefit from the access and benefit sharing. The Act also deals with granting of access to bio-resources. Sections 3 and 6 of the Act, 2002 obligate the user to seek prior approval of National Biodiversity Authority before accessing Genetic resources and/ or associated knowledge for any other enumerated purposes especially for applying for any type of intellectual property right in India or abroad. Sections 19 and 20 prescribes the procedures to be followed by authority while processing such applications. Section 20 (1) and (2) oblige any permit holder for access granted under Section 19 to apply before transfer of any biological resource or Traditional knowledge to any other party. Rules 14 to 19 of the Rules, 2004 lay down the procedures and conditions for such applications. Further, the Schedule incorporated in the Rules prescribes Forms for such applications specific to the purpose of access / permission sought. Section 41(2) provides for Prior Informed Consent while Mutually agreed terms is dealt under Section 21 of the Act, 2002 in conjunction with Rule 14(6). Thus, a cursory glance over the statutes and regulations in India clarifies that even though they were framed and enacted before the implementation of Nagoya Protocol, they are in consonance with the legislative spirit of the Protocol.

 

Conclusion

Summing it up, The Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization is a reflection of the international conscience about the classification of resources and it acts as an evidence of the steps taken by the international community to ensure sustainability and equity in genetic resources. A bright spot in this whole protocol is the due respect that is given to the traditional knowledge held by the local communities. While initially, doubts existed about its effects on the public health but a careful and responsive approach to its implementation by the parties have removed any such concerns and in turn, have propelled and strengthened a collective responsive against the issues prevalent in the Public Health. Therefore, it is without any doubt that the Protocol is an effective piece of legislation which guides countries and parties to adopt sustainable practices in protecting and disseminating their genetic resources. 

 

References-

 

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