OVERVIEW OF THE NAGOYA PROTOCOL ON ACCESS TO GENETIC RESOURCES AND THE FAIR AND EQUITABLE SHARING OF BENEFITS ARISING FROM THEIR UTILIZATION Worku Yifru, Secretariat of the Convention on Biological Diversity, Geneva, 11 June 2018
The CBD tree Nagoya Kuala Lumpur Supplementary Protocol October 2010 Cartagena Protocol on Biosafety January 2000 Nagoya Protocol on ABS October 2010? Convention on Biological Diversity May 1992 United Nations Conference on Environment and Development (UNCED) June 1992
WHY rules on access and benefit-sharing? Providers Genetic resources Open access Needs Equity Users Biotechnology IPR Benefits Loss of biological diversity
CBD on access (Article 15) Sovereign rights over genetic resources Prior informed consent MAIN PRINCIPLES Facilitate access to genetic resources Mutually agreed terms Fair and equitable sharing of benefits
CBD on benefit-sharing (Arts. 15, 8, 16, 19) Main Requirements Research and development results (Article 15(7)) Access to and transfer of technology using genetic resources (Article 16(3)) Participation in biotechnological research on the genetic resources Priority access (Article 19(1)) to results and benefits arising from biotechnologic al use (Article 19(2)) Commercial or other benefits derived from use (Article 15(7)) Traditional knowledge associated with genetic resources (Article 8(j))
The Nagoya Protocol - Objective Fair and equitable sharing of the benefits arising from the utilization of genetic resources Access Transfer of technology Contributing to the conservation of biological diversity and the sustainable use of its components Funding Rights over resources and technologies
The Nagoya Protocol - Scope UTILIZATION
Benefit-sharing Sources of benefit utilization of genetic resources subsequent applications commercialization Types of benefit Non-monetary To be shared with the Party providing the resources The country of origin A Party that has acquired the resources in accordance with the CBD Legislative, administrative or policy measures Mutually agreed terms
Access to genetic resources Sovereign rights over natural resources Domestic ABS legislation or regulatory requirements Prior informed consent (PIC) of the providing Party The country of origin A Party that has acquired the resources in accordance with the CBD Ensure PIC or approval and involvement of IPLCs is obtained
Requiring Prior Informed Consent (PIC)? legislative administrative policy legal certainty clarity transparency Information Decision Clear and transparent written decision by competent national authority How to apply for PIC Criteria and/or processes for obtaining PIC or approval and involvement of IPLCs Issuance of permit or equivalent (at access) Evidence of: decision to grant PIC establishment mutually agreed terms Fair and non-arbitrary Mutually agreed terms Mutually agreed terms may include: dispute settlement benefit-sharing (IPR) subsequent third-party use changes of intent Notify ABS Clearing- House
Compliance With domestic legislation or regulatory requirements on ABS With mutually agreed terms (MAT) With the provisions of the Protocol Encourage inclusion of provisions to cover dispute resolution Ensure opportunity to seek recourse Take effective measures regarding: -access to justice -utilization of mechanisms regarding mutual recognition and enforcement of foreign judgments and arbitral awards
Compliance with domestic legislation or regulatory requirements on ABS Requirements Take appropriate, effective and proportionate legislative, administrative or policy measures Access is in accordance with PIC and that MAT have been established, as required by the domestic access and benefitsharing legislation or regulatory requirements of the other Party Address situations of non-compliance with measures Cooperate in cases of alleged violation of domestic access and benefit-sharing legislation or regulatory requirements Support compliance by taking measures to monitor and to enhance transparency about the utilization
Measures for monitoring (to support compliance) Designation of one or more checkpoints Encouraging users and providers to include provisions in MAT to share information on the implementation of such terms, including through reporting requirements To collect or receive relevant information related to: prior informed consent; the source of the genetic resource; the establishment of mutually agreed terms; the utilization of the genetic resources; To require users of genetic resources to provide the information specified in the above paragraph at a designated checkpoint; To provide such information, including internationally recognized certificates of compliance to: relevant national authorities; the Party providing prior informed consent, and; ABS-CH Encouraging the use of cost-effective communication tools and system Checkpoints must be effective and should have functions relevant to implement the above. Should be relevant to the utilization of genetic resources or to the collection of relevant information at any stage of: - Research - development - innovation -pre-commercialization - commercialization
Internationally recognized certificate of compliance Shall serve as evidence that the genetic resource which it covers has been accessed in accordance with PIC and MAT as required by the domestic legislation or regulatory requirements of the Party providing PIC A permit or its equivalent issued in accordance with Article 6, paragraph 3 (e) and made available to the ABS-CH Currently there are 146 records of permits or certificates published in the ABS-CH by 12 Parties Shall contain, as a minimum, the following information: (a) Issuing authority; (b) Date of issuance; (c) The provider; (d) Unique identifier of the certificate; (e) The person or entity to whom prior informed consent was granted; (f) Subject-matter or genetic resources covered; (g) Confirmation that MAT were established; (h) Confirmation that PI C was obtained; and, (i) Commercial and/or noncommercial use.
NAGOYA PROTOCOL: PROCESS AND STATUS COP 10 COP 12 MOP 1 13-17 October 2014 51 Parties COP 13 COP 14 MOP 2 MOP 3 4-17 December 2016 79 Parties Adoption 29 October 2010 90 days Entry into force 12 October 2014 11 June 2018 105 Parties 17-29 November 2018
NAGOYA PROTOCOL: PROCESS AND STATUS (continued geographical distribution of Parties) Dark green: NP Parties Lime green: NP signatories White: Non-CBD Parties Beige: CBD Parties 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.
NAGOYA PROTOCOL: PROCESS AND STATUS (Parties by Regions) ASIA AND PACIFIC (27/57) AFRICA (42/54) Bhutan Micronesia (Federated States of) Angola Gabon Niger Cambodia Mongolia Benin Gambia (the) Rwanda China Myanmar Botswana Guinea Sao Tome and Principe Fiji Pakistan Burkina Faso Guinea-Bissau Senegal India Indonesia Japan Jordan Philippines Qatar Republic of Korea Samoa Burundi Kenya Seychelles Cameroon Lesotho Sierra Leone Chad Liberia South Africa Comoros Madagascar Sudan Kazakhstan Syrian Arab Republic Congo Malawi Swaziland Kuwait Tajikistan Côte d'ivoire Mali Togo Kyrgyzstan Lao People's Democratic Republic Lebanon United Arab Emirates Democratic Republic of the Congo Mauritania Vanuatu Djibouti Mauritius Viet Nam Uganda Egypt Mozambique Zambia United Republic of Tanzania Marshall Islands Ethiopia Namibia Zimbabwe
NAGOYA PROTOCOL: PROCESS AND STATUS (continued Parties by Regions) GRULAC (13/33) WEOG (15/34) Antigua and Barbuda Belgium Switzerland Argentina Bolivia Cuba Dominican Republic Ecuador Guatemala Guyana Honduras Mexico Panama Peru Uruguay Denmark European Union Finland France Germany Luxembourg Malta Netherlands Norway Portugal Spain Sweden UK
NAGOYA PROTOCOL: PROCESS AND STATUS (ratification/accession trends ) No information available for 29 countries (15%) 28 countries planning to ratify (intention) (14%) Ratification process underway in 34 countries (17%) 105 Parties to the Protocol (54%) As of 22 February 2018 Source: CBD database
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