Building TRUST Literally & Practically Philippe Desmeth World Federation for Culture Collections 1
Contents CBD - Nagoya Protocol European regulation on ABS TRUST - Literally TRUST - Practically
Nagoya Protocol Article 1 : Objective fair and equitable sharing of the benefits arising from the utilization of genetic resources, by appropriate access to genetic resources by appropriate transfer of relevant technologies by appropriate funding thereby contributing to the conservation of biological diversity and the sustainable use of its components. Conservation Use of GR Benefit Sharing
Nagoya Protocol Article 33 : Entry into force 90th day after 50th instrument of ratification, acceptance, approval or accession => 12 October 2014 => Countries with specific ABS legislation in place Colombia Denmark European Union French Polynesia Nicaragua Switzerland
CULTURE COLLECTIONS IMPLEMENTING THE NAGOYA PROTOCOL contributing to the conservation of biological diversity and the sustainable use of its components = mission of culture collections appropriate access to genetic resources appropriate transfer of relevant technologies = our daily work appropriate funding = our main concern Our new Challenge: How to adjust CC operations to simplify the Nagoya Protocol implementation
Contents CBD - Nagoya Protocol European regulation on ABS TRUST - Literally TRUST - Practically
European Regulation on the Nagoya Protocol Regulation of the European Parliament and of the Council on Compliance Measures for Users from the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of benefits arising from their Utilization in the Union Compliance measures for users = What users must do in their country to abide by the Nagoya Protocol Role assigned to collections
European Regulation on the Nagoya Protocol Preambles (27) The collection of genetic resources in the wild made mostly by academic, university and non-commercial researchers or collectors (28) Collections are major suppliers of genetic resources and associated traditional knowledge (28) System of registered collection within the Union - establishment of a voluntary register of collections - to be maintained by the Commission. - Member States verify inclusion of collection in EU register
European Regulation on the Nagoya Protocol Preambles (28) Users that obtain a genetic resources from a collection included in the register = Considered to have exercised due diligence as regards the seeking of all necessary information. (33) Effectiveness of the regulation to benefit academic, university and non commercial researchers and small and medium-sized enterprises.
European Regulation on the Nagoya Protocol Definitions (9) "collection" means a set of collected samples of genetic resources and related information that is accumulated and stored, whether held by public or private entities; (11) "internationally recognised certificate of compliance" means a permit or its equivalent,
European Regulation on the Nagoya Protocol Obligations of Users (Article 4) 1. Users shall exercise due diligence 3. Certificate of compliance or minimum information Minimum Data Set 7. Users obtaining a genetic resource from a collection included in the register of collections within the Union referred to in Article 5(1) shall be considered to have exercised due diligence as regards the seeking of information listed in paragraph 3 of this Article. 8. Emergencies
European Regulation on the Nagoya Protocol Register of collections (Article 5) 1. the register 2. A Member state shall consider the inclusion 3. Criteria to be registered into the EU register Catalogue, Minimum Data Set, MAA and MTA MAA = Material Accession Agreement = In MTA = Material Transfer Agreement = Out
European Regulation on the Nagoya Protocol Register of collections (Article 5) Art. 5.3 Criteria to be registered into the EU register: a collection shall demonstrate its capacity to: a) apply standardised procedures for exchanging samples of genetic resources and related information with other collections, and for supplying samples of genetic resources and related information to third persons for their utilisation in line with the Convention and the Nagoya Protocol; MOSAICC + TRUST b) supply genetic resources and related information to third persons for their utilisation only with documentation providing evidence that the genetic resources and the related information were accessed in accordance with applicable access and benefit sharing legislation or regulatory requirements and, where relevant, with mutually agreed terms MAA & MTA + Minimum Data Set + Customer list + deliveries recorded ;
European Regulation on the Nagoya Protocol Register of collections (Article 5) Art.5.3 Criteria to be registered into the EU register: a collection shall demonstrate its capacity to: c) keep records of all samples of genetic resources and related information supplied to third persons for their utilisation MTA +customer list + delivery notes d) establish or use unique identifiers, where possible, for samples of genetic resources supplied to third persons; Catalogue + MAA e) use appropriate tracking and monitoring tools for exchanging samples of genetic resources and related information with other collections. MAA & MTA
European Regulation on the Nagoya Protocol Best Practices (Article 8) 1. Interested Parties submit application to the Commission 2. The Commission shall grant recognition of best practices 6. Internet-based register of recognised best practices MOSAICC - TRUST
European Regulation on the Nagoya Protocol Complementary measures (Article 13) The Commission and Member States shall, as appropriate: (b) encourage the development of sectoral codes of conduct, model contractual clauses, guidelines and best practices, particularly where they would benefit academic, university and non-commercial researchers and small and medium-sized enterprises; MOSAICC, TRUST (c) cost-effective communication tools and systems GLOBAL CATALOGUE (f) Promote measures in support of collections that contribute to the conservation of biological diversity and cultural diversity
Contents CBD - Nagoya Protocol European regulation on ABS TRUST - Literally TRUST - Practically
TRUST, literally Objective : managing the incidence of the CBD and Nagoya Protocol on the activities of culture collections, and on the daily life of microbiologists.
TRUST, literally Stands for Transparent User-friendly System of Transfer o Transparency => legal certainty in ABS and IPR o Truth = Provide valid, reliable, true data => cumulative research o Trust between partners => lasting cooperation
Contents CBD - Nagoya Protocol European regulation on ABS TRUST - Literally TRUST - Practically
CC initiatives relevant to the Nagoya Protocol 20 Codes Guidelines Best Practices Standards MOSAICC WFCC Guidelines OECD Best practices MINE, CABRI MOSAICC MAA - MTA Catalogues Global Catalogue MOSAICC + TRUST 19 Model Contractual clauses Material Accession Agreement MAA Material Transfer Agreement MTA Legal processing MOSAICC Technical processing MOSAICS Global Catalogue of Microorganisms
TRUST Practically 1 Objective What & How 3 Scope Ambiguities about timeframe and CBD Article 15 interpretation 1. FrameWork 20 Codes, Guidelines, Best Practices, Standards MOSAICC - Overarching initiative 02 Use of Terms Definitions of NP & CBD 19 Model Contractual Clauses Material Accession Agreement Material Transfer Agreement 05 Fair & equitable BS Refer to Annex Monetary and Non-monetary Benefits LEGAL PROCESSING CHECK LIST 8 Special considerations - Research, Emergencies, Food TECHNICAL PROCESSING 2. Work 18 20 15 16 12 4 04 Compliance with MAT Flaw in MTA because - Jurisdiction - Applicable law Compliance with domestic legislation on ABS Compliance with domestic legislation on ABS for TK & GR TK associated to GR Relationship with international agreements and instruments Budapest treaty - IDA - Patents 06 07 17 Access to Genetic Resources - Description of Material in MAA - Attribution of GUID Access to TK associated to GR Monitoring use of GR MTA transfer rules - no transfer to 3rd parties - MAA + GUID + MTA 11 Transboundary cooperation WFCC-WDCM GCM => Global Catalogue of Microorganisms LEGAL CAPACITY TECHNICAL CAPACITY 13 National Focal Points and Competent National Authorities 09 Contribution to conservation and sustainable use WFCC guidelines for the establishment and operation of CC 3. NetWorks 14 10 ABS Clearing House & Information sharing Global Multilateral Benefit- Sharing Mechanism 21 09 22 Awareness-Raising Targeting microbiologists Capacity WFCC guidelines about ABS 09 Technology Transfer, Collaboration 23 & Cooperation WDCM Global Catalogue 4. Workouts 29 Monitoring & Reporting Quality Management System 30 Procedures & Mechanisms to promote compliance to NP Articles 24, 25, 26, 27, 28, 31, 32, 33, 34, 35 and 36 are above the level of decision of culture collections or not relevant.
Flow chart - FrameWork 1 Objective What & How 3 Scope Ambiguities about timeframe and CBD Article 15 interpretation 20 Codes, Guidelines, Best Practices, Standards MOSAICC - Overarching initiative 02 Use of Terms Definitions of NP & CBD 19 Model Contractual Clauses Material Accession Agreement Material Transfer Agreement 05 Fair & equitable BS Refer to Annex Monetary and Non-monetary Benefits LEGAL PROCESSING CHECK LIST 8 Special considerations - Research, Emergencies, Food TECHNICAL PROCESSING 18 20 15 Compliance with MAT Flaw in MTA because - Jurisdiction - Applicable law Compliance with domestic legislation on ABS 06 07 Access to Genetic Resources - Description of Material in MAA - Attribution of GUID Access to TK associated to GR Monitoring use of GR
Flow chart - Work 19 Model Contractual Clauses Material Accession Agreement Material Transfer Agreement 02 05 Use of Terms Definitions of NP & CBD Fair & equitable BS Refer to Annex Monetary and Non-monetary Benefits LEGAL PROCESSING CHECK LIST 8 Special considerations - Research, Emergencies, Food TECHNICAL PROCESSING 18 20 15 16 12 4 04 Compliance with MAT Flaw in MTA because - Jurisdiction - Applicable law Compliance with domestic legislation on ABS Compliance with domestic legislation on ABS for TK & GR TK associated to GR Relationship with international agreements and instruments Budapest treaty - IDA - Patents LEGAL CAPACITY 06 07 17 Access to Genetic Resources - Description of Material in MAA - Attribution of GUID Access to TK associated to GR Monitoring use of GR MTA transfer rules - no transfer to 3rd parties - MAA + GUID + MTA 11 Transboundary cooperation WFCC-WDCM GCM => Global Catalogue of Microorganisms TECHNICAL CAPACITY 13 National Focal Points and Competent National Authorities 09 Contribution to conservation and sustainable use WFCC guidelines for the establishment and operation of CC
legislation on ABS for TK & GR Flow TK chart associated to - GR NetWorks 12 4 04 Relationship with international agreements and instruments Budapest treaty - IDA - Patents LEGAL CAPACITY - MAA + GUID + MTA 11 Transboundary cooperation WFCC-WDCM GCM => Global Catalogue of Microorganisms TECHNICAL CAPACITY 13 National Focal Points and Competent National Authorities 09 Contribution to conservation and sustainable use WFCC guidelines for the establishment and operation of CC 14 10 ABS Clearing House & Information sharing Global Multilateral Benefit- Sharing Mechanism 21 09 22 Awareness-Raising Targeting microbiologists Capacity WFCC guidelines about ABS 09 Technology Transfer, Collaboration 23 29 Monitoring & Reporting Quality Management System & Cooperation WDCM Global Catalogue 30 Procedures & Mechanisms to promote compliance to NP Articles 24, 25, 26, 27, 28, 31, 32, 33, 34, 35 and 36 are above the level of decision of culture collections or not relevant.
National Focal Points and Flow 13 chart Workouts Competent National Authorities 14 10 ABS Clearing House & Information sharing Global Multilateral Benefit- Sharing Mechanism 09 21 09 22 Contribution to conservation and sustainable use WFCC guidelines for the establishment and operation of CC Awareness-Raising Targeting microbiologists Capacity WFCC guidelines about ABS 29 Monitoring & Reporting Quality Management System 09 Technology Transfer, Collaboration 23 & Cooperation WDCM Global Catalogue 30 Procedures & Mechanisms to promote compliance to NP Articles 24, 25, 26, 27, 28, 31, 32, 33, 34, 35 and 36 are above the level of decision of culture collections or not relevant.
TRUST 1 Objective What & How 3 Scope Ambiguities about timeframe and CBD Article 15 interpretation 1. FrameWork 20 Codes, Guidelines, Best Practices, Standards MOSAICC - Overarching initiative 02 Use of Terms Definitions of NP & CBD 19 Model Contractual Clauses Material Accession Agreement Material Transfer Agreement 05 Fair & equitable BS Refer to Annex Monetary and Non-monetary Benefits LEGAL PROCESSING CHECK LIST 8 Special considerations - Research, Emergencies, Food TECHNICAL PROCESSING 2. Work 18 20 15 16 12 4 04 Compliance with MAT Flaw in MTA because - Jurisdiction - Applicable law Compliance with domestic legislation on ABS Compliance with domestic legislation on ABS for TK & GR TK associated to GR Relationship with international agreements and instruments Budapest treaty - IDA - Patents 06 07 17 Access to Genetic Resources - Description of Material in MAA - Attribution of GUID Access to TK associated to GR Monitoring use of GR MTA transfer rules - no transfer to 3rd parties - MAA + GUID + MTA 11 Transboundary cooperation WFCC-WDCM GCM => Global Catalogue of Microorganisms LEGAL CAPACITY TECHNICAL CAPACITY 13 National Focal Points and Competent National Authorities 09 Contribution to conservation and sustainable use WFCC guidelines for the establishment and operation of CC 3. NetWorks 14 10 ABS Clearing House & Information sharing Global Multilateral Benefit- Sharing Mechanism 21 09 22 Awareness-Raising Targeting microbiologists Capacity WFCC guidelines about ABS 09 Technology Transfer, Collaboration 23 & Cooperation WDCM Global Catalogue 4. Workouts 29 Monitoring & Reporting Quality Management System 30 Procedures & Mechanisms to promote compliance to NP Articles 24, 25, 26, 27, 28, 31, 32, 33, 34, 35 and 36 are above the level of decision of culture collections or not relevant.
Legal Processing & Capacity Building 20 MOSAICC Codes, Guidelines, Best Practices, Standards 19 Model Contractual clauses Material Accession Agreement Material Transfer Agreement 18 Compliance with MAT MOSAICC 05 Fair & equitable BS & 10 Global BS Mechanism MOSAICS Cost/Benefit Business model Administrative flow
Technical Processing & Capacity Building 20 Codes, Guidelines, Best Practices, Standards TRUST 06 Access to GR & 17 Monitoring use of GR Identification >> Minimum Data Set + GUID Catalogue 22 Capacity Technology transfer, 23 Cooperation, Collaboration 5d) Internet based solutions Global Catalogue of Microorganisms - GCM 5g) Technology transfer = WDCM WFCC - GCM Minimum, Recommended, Extended Data Set Database linkage
www.wdcm.org 22 GUID Tracking R&D developments Cataloguing - Access Tracking Uses
The role of the infinitely small is infinitely large Louis Pasteur Thank you 2001 Cony Decock Philippe Desmeth Uncinula necator (powdery mildew) BCCM /MUCL All Rights Reserved