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![From open access
[…the authority to determine access…] (CBD article 15.1)
[…to create conditions to facilitate access…] CBD art. (15.2)
From open access to sovereign rights (CBD article 15)
Change of paradigm](https://image.slidesharecdn.com/20171027protocolenagoyabelspo-171027133521/75/Protocole-NAGOYA-Le-Point-du-LIEGE-science-park-27-octobre-2017-6-2048.jpg)
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Protocole NAGOYA - Le Point du LIEGE science park - 27 octobre 2017
The document outlines the integration of the Nagoya Protocol's rules into corporate practices regarding genetic resources, emphasizing the importance of fair benefit sharing and sustainable use. It details the legal obligations and corporate policies necessary for compliance with access and benefit sharing regulations in research and development. Additionally, it provides guidance on obtaining prior informed consent and due diligence in the collection and utilization of biological resources.
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Protocole NAGOYA - Le Point du LIEGE science park - 27 octobre 2017
- 1. Biotechnologie - Commentintégrer les règles du Protocole de Nagoya : pour protéger vos investissements R&D Ir Philippe Desmeth - Chargé de Mission, SPP-Politique Scientifique Manager, Coopération internationale des BCCM BELSPO (Belgian Science Policy Office) 27-10-2017 L'Interface vous donne rendez-vous chaque mois au LIEGE science park, pour faire le point, avec un conseiller en innovation, sur une mesure en lien avec vos préoccupations. Une initiative de
- 2. The Nagoya Protocol &R&D Investments ©2017BELSPO Philippe Desmeth MOSAICC, MOSAICS & TRUST Coordinator WFCC Past President 2010-2017
- 3. Legal Context -Change of paradigm Corporate policy about Genetic Resources’ exploitation Adapted procedures OUTLINE Incorporate legal obligations into R&D work programme
- 4. Legal Context -Change of paradigm Corporate policy about Genetic Resources’ exploitation Adapted procedures OUTLINE Incorporate legal obligations into R&D work programme
- 5. 1. Conservation ofbiological diversity 2. Sustainable use of its components 3. Fair and equitable sharing of the benefits CBD Article 1: 3 Objectives Utilization Conservation Benefit Sharing Entry into force: 29 December 1993
- 6. From open access […theauthority to determine access…] (CBD article 15.1) […to create conditions to facilitate access…] CBD art. (15.2) From open access to sovereign rights (CBD article 15) Change of paradigm
- 7. Nagoya Protocol - fairand equitable sharing of the benefits by appropriate access to genetic resources by appropriate transfer of relevant technologies by appropriate funding NP Article 1 : 1 Objective thereby contributing to the 1. conservation of biological diversity 2. sustainable use of its components Nagoya Protocol Utilization Conservation Benefit Sharing Entry into force 12 October 2014
- 8. Nagoya Protocol ABS -Access and Benefit Sharing Quid pro Quo on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization Nagoya Protocol
- 9. Pillars of theNagoya Protocol “the ABC of ABS” Implemented at Member States level Not EU level Subject to contractual agreement EU Regulation 511/2014 & concomitant Access Benefit Sharing Compliance ABS implementation in EU
- 10.
- 11. Commission Implementing Regulation(EU) 2015/1866 European Commission Notice (2016/C 313/01) - Guidance document Regulation (EU) No 511/2014 EU Law Knowledge Based Bio Economy ABS Consultation Forum & Sectorial guidance documents
- 12. Scope of EU511/2014 Within scope Cumulative conditions* Out of scope Geographic scope (provenance of GR**) Access Provider country Provider country Areas within national jurisdiction Party of the Protocol With applicable access legislation Areas beyond national jurisdiction or covered by Antarctic Treaty Not a Party No applicable legislation Temporal scope Access on or after 12 October 2014 Access before 12 October 2014 Material scope - Not covered by a specialized international ABS system - Non human - Obtained as commodities but subsequently subject to R&D - Covered by a specialized international ABS instrument - Human R&D on genetic resources No such R&D Personal scope Natural or legal person utilizing GR Person transferring GR or commercializing products/services based on GR Geographic scope (utilization) R&D within the EU R&D exclusively outside the EU * To be in the scope, all conditions must be fulfilled **GR also including traditional knowledge associated with it
- 13. Legal Context -Change of paradigm Corporate policy about Genetic Resources’ exploitation Adapted procedures OUTLINE Incorporate legal obligations into R&D work programme
- 14. Corporate policy about GeneticResources’ exploitation 1. Acquisition of genetic resources 2. Use of genetic resources 3. Fair and equitable sharing of benefits arising from their use (use = R&D) 4. Commercial use of genetic resources (placing on the market) 5. Curation of data (seek, keep and transfer of info)
- 15. BCCM Corporate Policy aboutGenetic Resources acquisition http://bccm.belspo.be/services/maa
- 16. COLLECTIONS Micro-Biological Resource Centre Customers want Easy access Qualitymaterial Legal certainty IPR Quality assurance Safe & Legitimate access Research Commons CBD / NP Conservation Access Traceability Benefit sharing Biosafety Biosecurity Warranty Depositors want Acknowledgment Preservation Benefit Sharing Legal Services Bundle of rights To facilitate, organize access Deposit
- 17. BCCM Corporate Policy aboutGenetic Resources distribution http://bccm.belspo.be/services/mta
- 18. COLLECTIONS Micro-Biological Resource Centre Customers want Easy access Qualitymaterial Legal certainty IPR Quality assurance Safe & Legitimate access Research Commons CBD / NP Conservation Access Traceability Benefit sharing Biosafety Biosecurity Warranty Depositors want Acknowledgment Preservation Benefit Sharing Legal Services Bundle of rights To facilitate, organize access Distribution
- 19. Legal Context -Change of paradigm Corporate policy about Genetic Resources’ exploitation Adapted procedures OUTLINE Incorporate legal obligations into R&D work programme
- 20. CONTROL OF ACCESSprior to any collecting New rules – New practices CONTROL OF BIOTECH DEVELOPMENTS Prior Informed Consent - PIC CONTROL OF BIOTECH PRODUCTS Benefit Sharing Mutually Agreed Terms – MAT Contracts - MTA Tracking Global Unique Identifiers - GUID
- 21. “Accessing” Obtaining Prior InformedConsent – PIC (1) NAGOYA PROTOCOL Exercise Due Diligence (2) (1) Nagoya Protocol Article 6 (2) European regulation EU 511/2014 Prior to any collecting Obtain authorization of sampling =>>>
- 22. NAGOYA PROTOCOL Microbiologists inquire onthe official website of the ABS Clearing House (ABSCH) https://absch.cbd.int • About the Competent National authority (CNA) • Check the information with the National Focal Point (NFP) • Make efforts to get a PIC from the CNA and other authorization from possible rights holders. Obtaining PIC
- 23.
- 24. NAGOYA PROTOCOL Microbiologists inquire onthe official website of the ABS Clearing House (ABSCH) https://absch.cbd.int • About the Competent National authority (CNA) • Check the information with the National Focal Point (NFP) • Make efforts to get a PIC from the CNA and other authorization from possible rights holders. Exercise Due Diligence In absence of any contact point or information, apply sectoral codes of conduct
- 25. No No Yes Documents valid & sufficient PIC& MAT conditionsAccess free Access regulated (law and regulation in place) Past 10/2014 Party NP Yes No Legal Check on GR (EU 511/2014) (micro)biological material Party NP at sampling date No Yes Yes Yes NagoyaProtocolCompliant NotNagoyaProtocolCompliant No
- 26. NAGOYA PROTOCOL Seek information andauthorization Keep information and paperwork Transfer (made available upon lawful request from competent official Exercise Due Diligence
- 27. No No Yes Documents valid & sufficient PIC& MAT conditionsAccess free Access regulated (law and regulation in place) Past 10/2014 Party NP Yes No Legal Check (EU 511/2014) (micro)biological material Party NP before sampling No Yes Yes Yes NPCompliant NotNPCompliant No
- 28. EU Regulation 511/2014- Article 4 Obligations of Users 1. Users shall exercise due diligence 3. Certificate of compliance or minimum information Minimum Data Set (MDS) Due Diligence & Minimum Data Set WHAT WHEN WHERE FROM WHOM TO WHOM
- 29. Collections’ Mission To proposesolutions by providing services of quality in microbial and genetic resources for academia and industry.
- 30. Fit for PurposeSolutions Legal & Administrative package Scientific & technical package Biological Resources Data Services + after sales Collections’ Mission
- 31. December 1993 CBDcomes into force April 2002 Bonn Guidelines on ABS October 2014 Nagoya Protocol comes into force MOSAICC (1999) Basic procedures Standard contract (Material Transfer Agreement) MOSAICS (2005) Global Unique Identifiers (GUID) Value of Microbial Diversity Bundle of Rights, Microbial Commons TRUST (2015) Global Catalogue of Microorganisms Linkage with ABS Clearing House (ABSCH) Updated Model contracts MTA & MDA Specific procedures (basic research, emergencies, regularization) PROACTIVE STRATEGY
- 32. TRansparent Users-friendly Systemof Transfer TRUST http://bccm.belspo.be/projects/trust
- 33. • Simple, supportlegal certainty Compatible with different legal framework (common & civil law) • Cost-effective Attractive system enforceable without constraints • Efficient, fast Easily applicable in all conditions = flexible • Multipurpose, multi-users Fulfilling the needs of all stakeholders Sector-based Conveyance System for ABS TRUST
- 34. • TRUST guidelinesMarch 2016 Version • TRUST handbook March 2016 Version http://bccm.belspo.be/projects/trust
- 35.
- 36.