Provider Country Measures Taken
by Developped Countries
JBA – Tokyo
2019/02/13

Guillaume FAURE
Ministry for an ecological andsolidary transition
Water and biodiversity Department

Introduction / Plan
Context
Historic and legal framework for ABS implementation
Excluded genetic resources from access measures
A general scheme for wild genetic ressources and traditional knowledge associated to genetic
resources removed from the french territory, used for research and development activities
Specific schemesSpecific measures in french overseas territories

Institutional framework for ABS implementation
Steps to access genetic resources / associated traditional knowledge
Access to genetic resources for research and development without any commercial purpose : adeclarative procedure
Access for commercial purposes : an authorization procedure
Utilisation of traditional knowledge associated to genetic resources (no matter wether the research has
a commercial purpose or not) : an authorisation procedure2

Introduction / PlanCollections
The European regulation n°511/2014
Penalties
Implementation experience in France3

Context
96 countries have ratified the Nagoya Protocol (NP)Rich biodiversity in french overseas territories (Guyana, Wallis andFutuna...)Active public research
Active chemical and cosmetic industries
France : both a source country and a requesting country4Historic and legal Context
1992 : Convention on biological diversity (CDB)
2006 : pionneer ABS system in the national park of Amazonia (french Guyane)2010 : Signing of the Nagoya Protocol in Japan (NP)2011 : France signed the Nagoya Protocol
2014 : the NP entered into force → Regulation (EU) 511/2014 of the European Parliamentand of the Council
2016 : « The recapture of nature, landscape and biodiversity law » (« loi n°2016-1087 du 8août 2016 pour la reconquête de la biodiversité, de la nature et des paysages »)===> France ratified the NP (art. 46)===> Implementation in France of the Nagoya Protocol on Access andBenefit Sharing (ABS)2017 : « Decree n°2017-848 of May 9th 2017, regarding the access to genetic resources
and traditional knowledge and benefit sharing as a result from their use”===> finalisation of the national procedure of declaration and authorisation===> implementation of the european regulation (due diligence)===> the national procedure entered into force on 2017, July the 1st5

Legal framework for ABSimplementation
The 2016 law has excluded a list of genetic resources (out of scope) and distinguished a general schemeand specific schemes.
Genetic resources excluded from access measures– human genetic resources,– genetic resources ruled by specific conventions, such as the International Treaty on Plant genetic
Resources for Food and Agricultre (ITPGRFA)– genetic resources that are not removed from the french territory– genetic resources issued from species used as models in laboratories– genetic resources issued from activites dealing with the protection of defense and national security* coming this year : genetic resources issued from micro organisms collected from mainland
A general scheme for wild genetic ressources and traditional knowledge associated to genetic
resources removed from the french territory, used for research and development activities

Main achievements : a model contract has been issued (timeline, compensation measures...) ; 3
forms regarding declaration and authorisation procedures.

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Legal framework for ABS
implementation
Specific schemes- genetic resources from pathogens collected by laboratories as part of prevention and risk
control for human health : the access will be regulated by the ministry of health → text in
preparation– genetic resources from cultivated and wild relative plants, from domestic animals, fromdomesticated and cultivated miciroorganisms, from cultivated trees and from pathogens
collected by laboratories as part of prevention, monitoring and fight against health danger foranimals, plants and health security for food : the ministry for food and agriculture will only
regulate access for cultivated trees.

7Legal framework for ABS
implementation
Specific measures in french overseas territories– French Polynesia and New-Caledonia = general competence on environmental affairs, thus they havetheir own rules.
. French Polynesia: http://www.environnement.pf/code-de-l-environnement. New Caledonia (Province Nord): https://www.biodiversite.nc/attachment/229854/. New Caledonia (Province Sud) :https://www.province-sud.nc/sites/default/files/758331/Code%20de%20l%27environnementversion%20denv-2009-25%20APS%20M31.pdf– French Guyane and Wallis-and-Futuna Islands = designated as the 2 territories where local
communities may own traditional knowledge.
– French overseas departments : Ministry for an ecological and solidary transition (MTES) is thecompetent national authority (CNA) for those territories.

8Institutional framework for ABS
implementation
PIC granted :- genetic resources removed from the french territory : MTES grants it ;- access to traditional knowledge associated with genetic resources : a public entity representing thelocal community grants it.
CNA :- general ABS scheme : MTES, through DEB, is the CNA ; it is also the CNA to receive declarations ofdue diligence (european regulation) at the stage of final development of a product developed via
the utilisation of genetic resources or traditional knowledge associated with such resources
apa@developpement-durable.gouv.fr- declarations of due diligence (european regulation) from all recipients of research public fundings
involving the use of genetic resources and traditional knowledge associated with genetic resources :Ministry of Researchsi.apa@recherche.gouv.fr
Focal point :MTES,throughtheInternationalandanca.leroy@developpement-durable.gouv.fr

europeanaffairs

department：

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Steps to access genetic resources /associated traditional knowledge
Access to genetic resources for research and development without any
commercial purpose : a declarative procedure•the applicant must fulfill a form : imprimé « CERFA » n°15786*01(https://www.formulaires.modernisation.gouv.fr/gf/cerfa_15786.do),or on line :– legal entities: https://www.demarches-simplifiees.fr/commencer/apa-declaration-pmorale;– individuals: https://www.demarches-simplifiees.fr/commencer/apa-declaration-pphysique•preliminary and technical instruction by MTES : examination of the filecompletion ? in the scope ?
•decision within 2 months : rejection or agreement by a voucher sent tothe applicant. The voucher is then published (« Bulletin officiel ») andsent to the ABS clearing house.
•benefit sharing : non-monetary10Steps to access genetic resources /associated traditional knowledge
Declaration- file by applicant- inquiry by MTES
- voucher11

Steps to access genetic resources /associated traditional knowledge
Access for commercial purposes : an authorization procedure•The applicant must fulfill a form : « imprimé CERFA » n° 15785*01(https://www.formulaires.modernisation.gouv.fr/gf/cerfa_15785.do),or on line :– legal entities : https://www.demarches-simplifiees.fr/commencer/apa-autorisation-pmorale– individuals : https://www.demarches-simplifiees.fr/commencer/apa-autorisation-pphysique•preliminary and technical instruction by MTES : examination of the filecompletion ? in the scope ?
•the applicant and the MTES must negociate an ABS agreement (4months). In case of non agreement, the authorisation is rejected ;12

Steps to access genetic resources /associated traditional knowledge•in case of genetic resources collected in situ in a national park, the park
board meeting must give a formal opinion within 2 months ;•decision within 2 months after the agreement : authorization to accessgenetic resources. The authorization is then published (« Bulletin
officiel ») and sent to the ABS clearing house.
•The benefit sharing may be monetary or non monetary (negociated inthe agreement).

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Steps to access genetic resources /associated traditional knowledge
Authorization(Genetic resources)- file by applicant(business purposes)- inquiry by MTES
- negociation with theapplicant- agreement for benefit
sharing- authorization delivery

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Steps to access genetic resources /associated traditional knowledge
Utilization of traditional knowledge associated to genetic resources (nomatter wether the research has a commercial purpose or not) : anauthorization procedure.
•the applicant must fulfill a form : « imprimé CERFA » n°15784*01(https://www.formulaires.modernisation.gouv.fr/gf/cerfa_15784.do);•preliminary and technical instruction by MTES : examination of the filecompletion ? in the scope ?
•a public local entity (in French Guyane and Wallis-and Futuna-Islands)
that is still to be designated, organizes a prior consultation with the localcommunity (2 to 9 months). Once the local community has delivered its
consent, it negociates an agreement with the public local entity.
•decision within 2 months after the agreement : authorisation to accesstraditional knowledge.

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Steps to access genetic resources /associated traditional knowledge
Authorization(Traditional knowledge)- file by applicant- inquiry by MTES
- consultation of local
communities monitored by
the legal person- minutes & Agreement- authorization

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Collections
For collections established before the publication of the 2016 law, theprocedures apply :•to access, after the publication of the 2016 law, to genetic resources forresearch and development without any commercial purpose(declaration) ;•to access genetic resources for commercial purposes (authorisation),
only in case of a new use (in case of access to carry on research thathave begun before the law, there is no access procedure).

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The European regulation n°511/2014
Users obligations
Exercise due dilligence regarding legality of access (and sharing ofbenefits)
Seek, keep and transfer to subsequent users :- internationally recognised certificate of compliance, where available- if IRCC not available, information on genetic resources or traditional
knowledge associated, date/place of access, source, any rights andobligations, PIC and MAT

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The European regulation n°511/2014
Checkpoints
Monitoring measures : checkpoints
Two checkpoints :- at the stage or research funding whre research involves utilization ofgenetic resources or traditional knowledge associated- at the stage of pre-commercialisation (final stage of development ofthe product)
IT tool developped to facilitate the process of exchange of information(DECLARE)

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Penalties« Art. L. 415-3-1. (code de l’environnement) :I. Shall be punished with one year’s imprisonment and a fine of €150,000 :1) The use of genetic resources or associated traditional knowledge (…) without
the documents mentioned under point 3 of article 4 of (EU) Regulation (2014)
2) Failure to search for, keep or send to subsequents users the relevant
information on access and sharing of benefits for genetic resources or
associated traditional knowledge (…). The fine shall be increased to one millions
euros if use of the genetic resources or associated traditional knowledge has ledto a commercial use
II. The individuals or legal entities guilty of the offences specified under I of thos
article shall also suffer a ban for a period, that may not exceed five years, onrequests for an autorisation to access genetic resources and associatedtraditional knowledge with a view to its commercial use. »20

Implementation experience
To this point :- more than 100 vouchers have been delivered in order to access genetic
resources for research and development without any commercial
purposes- 50 more are being inquired- only a few authorization requests have been submitted until now (toaccess genetic resources) and are being inquired ; no authorization
requests for traditional knowledge have been submitted until now- no agreement has been yet signed

Any question ? apa@developpement-durable.gouv.fr21

Thanks for your attention