Nagoya Protocol Enters Into Force, Will Be Tested In Months To Come 09/10/2014 by Catherine Saez, Intellectual Property Watch 8 Comments Share this:Click to share on Twitter (Opens in new window)Click to share on LinkedIn (Opens in new window)Click to share on Facebook (Opens in new window)Click to email this to a friend (Opens in new window)Click to print (Opens in new window)The Nagoya Protocol, a treaty expected to ensure greater access to genetic resources and a mandatory fair benefit-sharing of the benefits that could be derived from those resources, will enter into force on 12 October, almost four years after it was agreed. 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 (CBD) was adopted on 29 October 2010. The aim of the protocol was to prevent the misappropriation of genetic resources, and to ensure fair and equitable benefit sharing with the holders of the resources. In July, the CBD announced in a press release [pdf] that in prior weeks, 12 countries had deposited their instruments of ratification, bringing to 51 the number of parties to the Protocol, which enabled its entry into force and the convening of the “first Conference of the Parties serving as the meeting of the Parties to the Nagoya Protocol on Access and Benefit-Sharing” (COP-MOP1). The Protocol has currently been signed by 92 countries, 53 of which have ratified it so far. The COP-MOP1 is taking place from 13-17 October in Pyeongchang, South Korea, concurrently with the 12th Conference of the Parties to the CBD. According to the CBD, several issues are expected to be discussed during the meeting, including: an access and benefit-sharing clearing-house; voluntary codes of conduct; awareness raising; the need for and modalities of a global multilateral benefit-sharing mechanism; monitoring and reporting; cooperative procedures and institutional mechanisms to promote compliance and to address cases of non-compliance; guidance on resource mobilization for the implementation of the Nagoya Protocol; and guidance to the financial mechanism. The provisional agenda of the Nagoya meeting is here [pdf] Core Obligations for Parties According to the July CBD press release, “The entry into force of the Nagoya Protocol will provide greater legal certainty and transparency for both providers and users of genetic resources, creating a framework that promotes the use of genetic resources and associated traditional knowledge while strengthening the opportunities for fair and equitable sharing of benefits from their use.” With the entry into force of the Protocol, contracting Parties are expected to implement its core obligations, and take measures in relation to access to genetic resources, benefit-sharing and compliance, according to a CBD source. A number of measures are expected to be taken by members of the soon-to-be enforced Protocol. According to a source at the CBD, specific obligations to support compliance with the domestic legislation or regulatory requirements of the contracting party providing genetic resources, as well as contractual obligations reflected in mutually agreed terms, “are a significant innovation of the Nagoya Protocol.” Under the Protocol, the term “utilization” includes research and development on the genetic or biochemical composition of genetic resources as well as the commercialisation of such resources, the source said. Article 5 of the Protocol (Fair and Equitable Access and Benefit-Sharing) provides that the sharing of benefits is subject to mutually agreed terms and that benefits “may include monetary and non-monetary benefits,” aslisted in an annex to the Protocol, including payment of royalties, and the sharing of research and development results. According to the CBD source, contracting parties of the Protocol are supposed to take measures providing that genetic resources utilised 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. Some measures include cooperation in cases of alleged violation of another contracting party’s requirements, ensuring that an opportunity is available to seek recourse under the countries’ legal systems when disputes arise from mutually agreed terms, measures regarding access to justice, the monitoring of the utilisation of genetic resources after they leave a country, and the designation of effective checkpoints at any stage of the value chain, whether it is research, development, innovation, pre-commercialisation or commercialisation, according to the CBD source. Access and Benefit-Sharing Clearing-House The Access and Benefit-sharing Clearing-House (ABS-CH) “is a platform for exchanging information on access and benefit-sharing established by Article 14 of the Protocol,” according to the CBD. Up to now, and since its inception, the ABS-CH has been operating in a pilot phase. Information contained in the ABS-CH include: national focal points; publishing authorities; checkpoints; legislative, administrative or policy measures on access and benefit-sharing; and national websites and databases. With the entry into force of the Protocol, the ABS-CH will move from its pilot phase and become operational, the CBD source said. The ABS-CH “will be enhancing legal certainty and transparency on procedures for access, and for monitoring the utilization of genetic resources along the value chain, including through the internationally recognized certificate of compliance,” said the source. Article 17 (Monitoring the Utilization of Genetic Resources) provides details on checkpoints and the content of the certificate of compliance. Work Remains on Several Issues to be Adopted Meanwhile, an Open-ended Ad Hoc Intergovernmental Committee, set up to prepare the first meeting of the Parties to the Protocol has met three times since June 2011. The third meeting of the committee took place from 24-28 February 2014. The report of this meeting [pdf] contains several recommendations which are expected to be adopted by the COP-MO1. Among them are cooperative procedures and institutional mechanism to promote compliance with the provisions of the Nagoya Protocol and to address cases of non-compliance. The text still bears a number of brackets, signalling disagreements between parties. According to Yoke Ling Chee, Third World Network director of programmes, one of the unresolved issues is the inclusion of representatives of indigenous and local communities in the Compliance Committee. This committee is expected to be established after parties adopt its procedures and mechanisms, she said. The present text says it “shall consist of 15 members nominated by Parties, on the basis of three members endorsed by each of the five regional groups of the United Nations. [Nominees could include representatives of indigenous and local communities]. Another issue, she said, is the voting procedure for the compliance committee, and whether submissions can be made by members of the public or indigenous and local communities. The Global Multilateral Benefit Sharing Mechanism under Article 10 is also an open issue, she said. The Third World Network participated as observer in the ad-hoc committees. Relationship with other International Instruments The relationship of the Nagoya Protocol with other international instruments is documented in Article 4 of the Protocol. In particular, it addresses the relationship with the International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGRFA), and provides that, “The provisions of this Protocol shall not affect the rights and obligations of any Party deriving from any existing international agreement, except where the exercise of those rights and obligations would cause a serious damage or threat to biological diversity.” The Protocol does not make any specific reference to the World Trade Organisation Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) or intellectual property rights, according to the source. The WTO Doha Declaration of 2001 instructed the TRIPS Council to look at the relationship between the TRIPS Agreement and the CBD in the context of the revision of TRIPS Article 27.3 (b) which addresses the patentability or non-patentability of plant and animal inventions, and the protection of plant varieties. Discussions on such revision are still ongoing with no agreement. Pharma Sector Supportive, Calls for Best Practices An industry representative said they are prepared to observe the Nagoya Protocol. “The IFPMA [International Federation of Pharmaceutical Manufacturers & Associations] is fully supportive of the objectives of the Convention on Biological Diversity (CBD) and the Nagoya Protocol,” said Andrew Jenner, executive director, corporate strategy and legal affairs at IFPMA. “Implementation of the Protocol should be based on recognised best practices so that both users and providers can understand ABS rules and obligations, and benefit from necessary flexibility to tailor approaches to specific contexts,” he told Intellectual Property Watch. Image Credits: Flickr – Sue Bowen Share this:Click to share on Twitter (Opens in new window)Click to share on LinkedIn (Opens in new window)Click to share on Facebook (Opens in new window)Click to email this to a friend (Opens in new window)Click to print (Opens in new window) Related Catherine Saez may be reached at firstname.lastname@example.org."Nagoya Protocol Enters Into Force, Will Be Tested In Months To Come" by Intellectual Property Watch is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License.