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Biotechnologie - Comment intégrer 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
The Nagoya Protocol
& R&D Investments
©2017BELSPO
Philippe Desmeth
MOSAICC, MOSAICS & TRUST Coordinator
WFCC Past President 2010-2017
Legal Context - Change of paradigm
Corporate policy about Genetic Resources’ exploitation
Adapted procedures
OUTLINE
Incorporate legal obligations into R&D work programme
Legal Context - Change of paradigm
Corporate policy about Genetic Resources’ exploitation
Adapted procedures
OUTLINE
Incorporate legal obligations into R&D work programme
1. Conservation of biological 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
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
Nagoya Protocol
- fair and 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
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
Pillars of the Nagoya 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
Regulation EU 511/2014
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
Scope of EU 511/2014
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
Legal Context - Change of paradigm
Corporate policy about Genetic Resources’ exploitation
Adapted procedures
OUTLINE
Incorporate legal obligations into R&D work programme
Corporate policy
about Genetic Resources’ 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)
BCCM Corporate Policy
about Genetic Resources acquisition
http://bccm.belspo.be/services/maa
COLLECTIONS
Micro-Biological
Resource
Centre
Customers want
Easy access
Quality material
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
BCCM Corporate Policy
about Genetic Resources distribution
http://bccm.belspo.be/services/mta
COLLECTIONS
Micro-Biological
Resource
Centre
Customers want
Easy access
Quality material
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
Legal Context - Change of paradigm
Corporate policy about Genetic Resources’ exploitation
Adapted procedures
OUTLINE
Incorporate legal obligations into R&D work programme
CONTROL OF ACCESS prior 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
“Accessing”
Obtaining Prior Informed Consent – 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 =>>>
NAGOYA
PROTOCOL
Microbiologists inquire on the 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
https://absch.cbd.int/
NAGOYA
PROTOCOL
Microbiologists inquire on the 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
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
NAGOYA
PROTOCOL
Seek information and authorization
Keep information and paperwork
Transfer (made available upon lawful request from competent official
Exercise Due Diligence
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
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
Collections’ Mission
To propose solutions
by providing services of quality
in microbial and genetic resources
for academia and industry.
Fit for Purpose Solutions
Legal &
Administrative
package
Scientific & technical package
Biological
Resources
Data Services +
after sales
Collections’ Mission
December 1993 CBD comes 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
TRansparent Users-friendly System of Transfer
TRUST
http://bccm.belspo.be/projects/trust
• Simple, support legal 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
• TRUST guidelines March 2016 Version
• TRUST handbook March 2016 Version
http://bccm.belspo.be/projects/trust
https://absch.cbd.int/
Merci
de votre attention
Protocole NAGOYA - Le Point du LIEGE science park - 27 octobre 2017

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Protocole NAGOYA - Le Point du LIEGE science park - 27 octobre 2017

  • 1. Biotechnologie - Comment intégrer 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 of biological 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 […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
  • 7. Nagoya Protocol - fair and 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 the Nagoya 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
  • 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 EU 511/2014 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 Genetic Resources’ 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 about Genetic Resources acquisition http://bccm.belspo.be/services/maa
  • 16. COLLECTIONS Micro-Biological Resource Centre Customers want Easy access Quality material 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 about Genetic Resources distribution http://bccm.belspo.be/services/mta
  • 18. COLLECTIONS Micro-Biological Resource Centre Customers want Easy access Quality material 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 ACCESS prior 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 Informed Consent – 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 on the 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
  • 24. NAGOYA PROTOCOL Microbiologists inquire on the 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 and authorization 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 propose solutions by providing services of quality in microbial and genetic resources for academia and industry.
  • 30. Fit for Purpose Solutions Legal & Administrative package Scientific & technical package Biological Resources Data Services + after sales Collections’ Mission
  • 31. December 1993 CBD comes 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 System of Transfer TRUST http://bccm.belspo.be/projects/trust
  • 33. • Simple, support legal 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 guidelines March 2016 Version • TRUST handbook March 2016 Version http://bccm.belspo.be/projects/trust