The Nagoya Protocol on Access to Genetic Resources and Benefit- Sharing & implications for Biotrade

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1 The Nagoya Protocol on Access to Genetic Resources and Benefit- Sharing & implications for Biotrade David Vivas Eugui, Legal Officer, UNCTAD With inputs from John Scott, Programme Officer, Traditional Knowledge Secretariat of the Convention on Biological Diversity

2 Status Definitions & scope Basic obligations ABS TK protection Conservation issues Verification, monitoring and transparency Implications for Biotrade

3 Nagoya Protocol Status of signature, and ratification, acceptance, approval or accession - As of 2 December 2013 CBD Parties that have ratified or acceded to the Protocol: 26 Parties that signed Protocol by closing date for signature (1 Feb 2012) Parties that did not sign and have not yet acceded to the Protocol Countries that are not Parties to the CBD Albania, Bhutan, Botswana, Comoros, Côte d Ivoire, Ethiopia, Egypt Fiji, Gabon, Guinea-Bissau, Honduras, India, Indonesia, Jordan, Lao PDR, Mauritius, Mexico, Micronesia, Mongolia, Norway, Panama, Rwanda, Syrian AR, Seychelles, South Africa, Tajikistan. * DISCLAIMER: The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of the Secretariat of the Convention on Biological Diversity concerning the legal status of any country, territory, city or area of its authorities, or concerning the delimitation of its frontiers or boundaries.

4 Definitions and scope CDB/Nagoya Genetic material: any material of plant, animal, microbial or other origin containing functional units of heredity. Nagoya Protocol Utilization of genetic resources: to conduct research and development on the genetic and/or biochemical composition of genetic resources, including through the application of biotechnology as defined in Article 2 of the Convention; Genetic Reosurce: genetic material of actual or potential value Biotecnology: any technological application that uses biological systems, living organisms, or derivatives thereof, to make or modify Derivative: means a naturally occurring biochemical compound resulting from the genetic expression or metabolism of biological or genetic resources, even if it does not contain functional units of heredity. There is no definition of Asociated TK

5 Nagoya Protocol: access issues The Protocol enhances legal certainty and transparency for users about their ABS obligations by: Requiring Parties to: Establish a national focal point and one or more competent national authority Take legislative, administrative and policy measures on ABS Provide for fair and non arbitrary rules Define clear procedures PIC and MAT It also request Parties to introduce measures to ensure that GRs within their jurisdiction have been accessed in accordance to PIC and MAT It supports ABS provisions of CBD, but full implementation of the NP depends on national ABS laws.

6 Nagoya Protocol: benefit sharing Benefits arising from the utilization of genetic resource as well as subsequent applications and commercialization shall be shared in a fair and equitable way with the Party providing such resources (Article 5.1.) A potential global multilateral benefit-sharing mechanism (transboundary situations or when it is not possible to obtain PIC) (Art.10).

7 Nagoya Protocol: TK protection Parties shall not restrict customary use and exchange of genetic resources (Art. 12) Parties shall establish measures to ensure that benefits arising from the utilization of GRs that are held by indigenous and local communities, (in accordance with domestic legislation), are shared in a fair and equitable way with the communities concerned, based on MATs (Art. 12) Parties shall ensure that access to TK in based on PIC from indigenous and local communities and on MATs. (Art. 12)

8 Nagoya Protocol: conservation issues Parties must encourage research that contributes to conservation and sustainable use of biodiversity (e.g. simplified measures for non-commercial research) (Art. 8). Parties must encourage that benefits arising from the utilization of genetic resources go towards the conservation of biological diversity and the sustainable use (Art. 9)

9 Verification, monitoring and transparency Issuance of permits or equivalent when access is granted It includes internationally recognized certificate of compliance A reinvigorated ABS clearing house mechanism

10 Nagoya Protocol: Implications for BioTrade All these elements can help to: Clarify the issue of scope and when ABS obligations arise Provide information on how to access genetic resources and TK Ensure cooperation on the user country side Promote compliance Implementation of clear, transparent and practical mechanisms for the negotiation of ABS agreements are essential for the success sustainable commercial activities The Nagoya Protocol can assist in building mutual trust between users and providers and thus create new business opportunities

11 Some potential issues for discussion Is there is a need for? Further clarifications and legal development Level of R&D to trigger ABS obligations (e.g. isolation, syntetisation, ex situ reproduction, testing for regulatory approval, etc.) New applications, change in use and dual use Value addition in the chain Transfer of materials and conditions for use Use of material in ex situ collections (after 1992) Cross border traceability and regional arrangements Exploring options for preliminary ABS determinations (prior ruling) and legal restoration mechanisms for previous and/or ongoing utilisation Developing on model clauses when sourcing or trade biological resources is done in parallel to R&D activities Creating capacity in governments, BioTrade organisations and other stakeholders on ABS management when linked to BioTrade Introducing legal incentives for compliance (e.g. exclusive sourcing agreements)