The Nagoya Protocol on Access and Benefit Sharing is an international agreement adopted at the CBD-COP10 in Nagoya, Japan in Oct 2010. The 2010 Nagoya Protocol is a key element in the global framework for sustainable development. It enhances legal certainty and transparency for users and providers of genetic resources. It thus supports the implementation process of Access and Benefit Sharing (ABS) on the national level and the achievement of the third objective of the Convention on Biological Diversity (CBD).Despite the final success, the road leading to this international agreement was long.
By July 2014, over 50 states had ratified the Nagoya Protocol which ensures its entering into force. Subsequently, in October 2014, the Conference of the Parties serving as the meeting of the Parties to the Protocol (COP-MOP) took place in Pyeongchang, Republic of Korea. The adoption of the Nagoya Protocol spanned over eight years of negotiations and intense disagreement between developed countries (users) and developing countries (providers), given the fact that developed (i.e.industrialised) countries had placed more emphasis on facilitated access, whereas developing countries stressed the need for a better mechanism to recognize benefit sharing and compliance (Richerzhagen,2014).
The Nagoya Protocol is a supplementary agreement to the Convention on Biological Diversity(CBD). India signed the Nagoya protocol on May 2011, being fifth country to ratify the 2010 protocol.
Aim of the protocol is “To provide a legal framework for the implementation of one of the three objectives of the CBD: the fair and equitable sharing of benefits arising out of the utilization of genetic resources, thereby contributing to the conservation and sustainable use of biodiversity”.
The Protocol comprises 27 clauses in the preamble, 36 articles containing operative provisions and one annex containing a non-exhaustive list of monetary and non-monetary benefits. The Nagoya Protocol relates to the utilisation of genetic resources and traditional knowledge associated with genetic resources. A genetic resource is defined as any non-human genetic resource. ‘Utilisation’ refers to research and development on the genetic and/or biochemical composition of genetic resources. The Protocol, therefore, relates to both commercial and academic research.
The Nagoya Protocol gives provider countries the rights to control access to genetic resources found within their jurisdiction. Basically there are two categories of provider countries:
An originating country where the genetic resource exists in situ, i.e. genetic resource exists in its natural habitat. An originating country where the genetic resource exists ex situ, i.e. genetic resource exists outside of its natural habitat. A country falling within this category must have obtained the genetic resource from an originating country under the CBD.
The user/researcher should show that the genetic resource on which research is being conducted was legally obtained in accordance with the Nagoya Protocol.
In order to do this, a user must obtain the prior informed consent (PIC) of a providing country (i.e. the country where the genetic resource exists in situ) before access to a genetic resource is permitted. Provide a fair and equitable share of the benefits which arise from utilisation of the genetic resources. Such sharing shall be upon mutually agreed terms (MATs). The benefits can be either commercial (e.g. monetary) or non-commercial, including the sharing of data or a transfer of intellectual property rights.
The effect of the Nagoya Protocol is to make it illegal to perform research and development on a genetic resource that has not been accessed in accordance with the Nagoya Protocol.
India has been a victim of misappropriation or biopiracy of our genetic resources and associated traditional knowledge, which have been patented in other countries (well known examples include neem and haldi). It is expected that the Nagoya Protocol on ABS which is a key missing pillar of the CBD, would address this concern.
The Nagoya Protocol sets out core obligations for its contracting Parties to take measures in relation to access to genetic resources, benefit-sharing and compliance.
Domestic-level access measures are to:
- Create legal certainty, clarity and transparency
- Provide fair and non-arbitrary rules and procedures
- Establish clear rules and procedures for prior informed consent and mutually agreed terms
- Provide for issuance of a permit or equivalent when access is granted
- Create conditions to promote and encourage research contributing to biodiversity conservation and sustainable use
- Pay due regard to cases of present or imminent emergencies that threaten human, animal or plant health
- Consider the importance of genetic resources for food and agriculture for food security.
Domestic-level benefit-sharing measures are to provide for the fair and equitable sharing of benefits arising from the utilization of genetic resources with the contracting party providing genetic resources.
Utilization includes research and development on the genetic or biochemical composition of genetic resources, as well as subsequent applications and commercialization. Sharing is subject to mutually agreed terms. Benefits may be monetary or non-monetary such as royalties and the sharing of research results.
Specific obligations to support compliance with the domestic legislation or regulatory requirements of the contracting party providing genetic resources, and contractual obligations reflected in mutually agreed terms, are a significant innovation of the Nagoya Protocol.
Contracting Parties are to:
- Take measures providing that genetic resources utilized within their jurisdiction have been accessed in accordance with prior informed consent, and that mutually agreed terms have been established, as required by another contracting party
- Cooperate in cases of alleged violation of another contracting party’s requirements
- Encourage contractual provisions on dispute resolution in mutually agreed terms
- Ensure an opportunity is available to seek recourse under their legal systems when disputes arise from mutually agreed terms
- Take measures regarding access to justice
- 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
Nagoya protocol and traditional knowledge
The Nagoya Protocol addresses traditional knowledge 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.
Criticisms aka disadvantages
From a global perspective, the Protocol is a ground-breaking achievement as it is the only form of international law that addresses the access and benefit-sharing (ABS) process. However, despite the Protocol’s significant emphasis on the importance of preserving biodiversity and its attempt to provide legal certainty and transparency for both providers and users of genetic resources, it has left great uncertainty and definitional ambiguities. These have largely impacted on the ability of both users and providers of genetic resources to effectively implement their ABS framework in their national context.
The main criticism, with respect to the Protocol, is that the terms are vague and too wide in scope. Article 15 of the CBD, does not specify the scope of the subject matter of genetic resources. It merely reiterates members’ rights to regulate access to genetic resources under their national jurisdiction through national law. Marine genetic resources located beyond national jurisdiction are not covered by the Protocol. Protocol is unclear as to whether recent innovations like synthetic biology and digital genetic information would fall within the ambit of genetic resources under Article 3.
In ABS with traditional communities, the Protocol encourages parties to take appropriate measures to ensure that the PIC or approval and involvement of indigenous and local communities are obtained for access to genetic resources , it does not state what constitutes ‘appropriate measures’.
A degree of uncertainty persists with respect to the value of genetic resources in instances in which a set methodology is not provided under the Protocol in the case of benefit sharing
The Protocol has failed to respect and recognise IPRs in its ABS framework. Article 29 of TRIPS requires the mandatory disclosure of origin requirement for patent applications containing genetic resources and/or associated traditional knowledge (TK). Nagoya Protocol does not require any mandatory disclosure of origin or source under its ABS framework. This omission would certainly lead to less transparency in the patent application process and especially in benefit-sharing arrangements.