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Interim National Reports on the Implementation of the Nagoya Protocol
(NR)
last updated: 16 Feb 2018
France Interim national report on the implementation of the Nagoya Protocol
Person:Mme. Anca LeroyLawyer - Policy Advisor, Ministry of Environment/Directorate of European and International AffairsGrande arche, la défense cedex,
92055,Phone: + 331.4081.3149,Fax: + 334.081.1610,Website:
To view the current National Focal Point information, click
here.
Yes
Partially yes. No CHM number for the moment (work in process)
Yes
1. EU Regulation N°511/2014 of the European Parliament and of the Council on the compliance measures for users from the Nagoya Protocol on Access to Genetic Resources and Fair and Equitable Sharing of Benefits Arising from their Utilisation in the Union of 16 April 2014 applies also within the French legal system (due diligence obligation for users)
2. Commission Implementing Regulation N°2015/1866 of 13 October 2015 laying down detailed rules for the implementation of EU Regulation 511/2014 regarding register of collections, monitoring user compliance and best practices applies also to France.
3. European Commission Guidance document on the scope of application and core obligations of Regulation (EU) 511/2014 (2016/C 313/1)
4. Law on biodiversity n° 2016-1087 published on the Official Journal on 9 /08/ 2016 (Loi n°2016-1087 du 8 août 2016 pour la reconquête de la biodiversité de la nature et des paysages – Titre V "Accès aux ressources génétiques et partage juste et équitable des avantages") completed by:
The Decree n° 2017- 848 published on the Official Journal on 10/05/2017 and entered into force on July 1st 2017 regarding ABS procedures related to genetic resources and traditional knowledge (Décret d’application n° 2017-848 du 9 mai 2017 relatif à l’accès aux ressources génétiques et aux connaissances traditionnelles associées et au partage des avantages découlant de leur utilisation)
An Administrative order n°0228 published on the Official Journal 29/09/2017 (Arrêté du 13 septembre 2017 fixant le contrat type de partage des avantages découlant de l’utilisation de ressources génétiques prélevées sur le territoire national, mentionné à l’article R. 412-20 du code de l’environnement)
Specific measures are foreseen in :
French Polynesia - Code de l’environnement de la Polynésie française - Livre I, titre II, chapitre 5.
New Caledonia - Code de l’environnement de la Province Sud de Nouvelle-Calédonie. Implementing Decree N° 2017-956 du 10 establishing the applicable conditions of articles L. 251-1 of the Research Code regarding scientific marine research. Draft texts under preparation within the Province Nord and Loyauté islands.
Yes
Yes
In France a distinction has been made between the tasks of the National Focal Point (art. 13.1 of Nagoya Protocol, mainly general ABS information, responsible for the liaison with the Secretariat, international aspects of Nagoya Protocol – COP/MOP, Compliance Committee) and the tasks of the Competent National Authority in charge of the implementation of the French law on biodiversity transposing Nagoya Protocol in France (access and benefit procedures, permits, ABS contracts, etc.).
Mrs. Anca LEROY is designated National Focal Point of Nagoya Protocol in France.
Contact details:
Anca LEROY, Lawyer - Policy Advisor
Ministère de l’environnement / Ministry of environment
Direction des affaires européennes et internationales
Directorate of European and International Affairs
anca.leroy@developpement-durable.gouv.fr
Phone : + 33 1 40 81 31 49 / Fax : + 33 40 81 16 10
Grande Arche, 92 055, La Défense Cedex FRANCE
Based on the EU ABS Regulation 511/2014 requirements, France designated two national competent authorities:
The Ministry of Environment / Ministère de la Transition écologique et solidaire / https://www.ecologique-solidaire.gouv.fr
Direction générale de l’aménagement, du logement et de la nature / Direction de l’eau et de la biodiversité / Bureau de l’encadrement des impacts sur la biodiversité
Tour Sequoia / 92 055 La Défense Cedex / FRANCE
Contact person :
M. François MITTEAULT, Directeur (chargé de l’exécution de l’arrêté du 13 septembre 2017 fixant le contrat type de partage des avantages découlant de l’utilisation de ressources génétiques prélevées sur le territoire national)
francois.mitteault@developpement-durable.gouv.fr
Mr. Bernard MOUTOU, ABS Policy Officer (in charge of the ABS applications and the implementation of the French Law on biodiversity – 2016)
bernard.moutou@developpement-durable.gouv.fr
Phone : + 33 1 40 81 92 34
Competent Authority regarding the due diligence declaration (stage of research funding) and the registration of the collections at the EU level (EU ABS Regulation 511/2014):
Ministry of Research / Ministère de l'Enseignement Supérieur, de la Recherche et de l'Innovation
Contact person: Mrs. Florence HERVATIN, Ph.D, ABS Policy Officer
florence.hervatin-queney@recherche.gouv.fr
Phone: + 33 1 55 55 84 05
1 rue Descartes – 75 231 Paris Cedex 05 / FRANCE
In New Caledonia : Haut Commissaire de la République en Nouvelle-Calédonie, 2, bis, Felix-Russeil BP36 98 835 Nouméa / BP M2 98 849 Nouméa.
On the basis of Art. L412-15 of the French law on biodiversity, competent authorities might be completed later for the overseas territories.
Applications for access and benefit sharing in France are to be addressed to :
apa@developpement-durable.gouv.fr
si.apa@recherche. gouv.fr
No selection made
No
Not yet available on the CHM.
The procedure to register permits into the CHM is currently under way.
Not applicable, since no access requirements are in place
No
The procedure to register permits into the CHM is currently under way.
Yes
Art. L. 412-18 (II) from the French Law on biodiversity (2016) transpose article 17 of Nagoya Protocol (monitoring of the utilisation of genetic ressources) and designates the following “monitoring” checkpoints :
The Ministry of Research for all recipients research funding (Art. L412-18), where such research involves utilisation of genetic resources and traditional knowledge associated with genetic resources. They are requested to declare that they exercised due diligence under the EU ABS Regulation 511/2014. The template for this declaration is contained in the Commission Implementing Regulation (EU) 2015/1866 of 13 October 2015 (Annex II).
French competent authorities designated for the implementation of the EU ABS Regulation 511/2014, are the French Ministry of environment and Ministry of Research. They gather due diligence declarations from all users.
The National Institute of industrial property (INPI) – Patent Office and the National competent authority for the market approval are also monitoring checkpoints designated under the French Law on biodiversity.
(Art. L412-18. « Lorsque cette utilisation conduit à une demande de brevet, les informations mentionnées au premier alinéa du présent II sont adressées à l’Institut national de la propriété industrielle à la seule initiative du déclarant. L’Institut national de la propriété industrielle procède aux démarches normales de l’examen de la demande de brevet et à l’attribution d’une date de dépôt et transmet les informations sans examen à l’autorité compétente chargée de l’application des règles édictées par l’Union européenne visant à ce que chaque État membre contrôle que l’utilisateur sur son territoire de ressources génétiques et, le cas échéant, de connaissances traditionnelles associées à ces ressources y a eu accès dans le respect de toute disposition législative ou réglementaire alors applicable.
Lorsque cette utilisation conduit à une demande d’autorisation de mise sur le marché, les informations mentionnées au même premier alinéa sont recueillies par l’autorité compétente pour la mise sur le marché, qui les transmet sans examen à l’autorité compétente mentionnée à l’avant-dernier alinéa du présent II.”)
According to Nagoya Protocol, the monitoring checkpoints collect or receive relevant information and transmit this information to the relevant national competent authority for compliance checking. If the information is not confidential, the competent national authorities transfer it to ABS Clearing House.
No additional information provided
Yes
The French law on biodiversity (2016) regulates access to genetic resources (in situ and ex situ) for their utilisation as well as access to traditional knowledge associated with genetic resource (GR) (detailed at point 39 hereafter).
The scope of application of the French Law on biodiversity is detailed in Art. L. 412-5.
PIC is required under the French national law for the utilisation of genetic ressources and traditional knowledge associated with genetic ressources.
Specific provisions in the French law for GR from domesticated and cultivated species, GR from crop wild relatives used for plant breeding, GR used for sylviculture, pathogens which presents high risks for human, animal and plant health and food safety.
A list of exclusions is also contained in the law (Art. L. 412-5 II. and III.)
The digital sequence information, notion which is not included in the definition of genetic ressource contained in the Convention on biological diversity, does not fall within the scope of Nagoya Protocol.
On that basis EU ABS Regulation 511/2014 transposing within the EU and its Member states the compliance pillar of Nagoya Protocol (through the due diligence obligation) does not regulate issues concerning digital sequence information. The use of digital data obtained from gene sequencing frequently stored in publicly available databases are not covered by the scope of the EU ABS Regulation 511/2014.
Therefore, French law on biodiversity (2016) does not cover digital sequence information as such. It covers situations where there is a "tangible" link to the genetic ressource (in situ and ex-situ collections).
Yes
Yes
An e-mail box has been put in place for ABS applications in France : apa@developpement-durable.gouv.fr
Yes
Specific administrative forms are under finalisation (CERFA).
Yes
0
None at this stage.
Yes
A standard contract has been published on the Official Journal on 29/11/2017 (“Arrêté du 13 septembre 2017 fixant le contrat type de partage des avantages découlant de l’utilisation de ressources génétiques prélevées sur le territoire national, mentionné à l’article R. 412-20 du Code de l’environnement). This administrative order implements Mutually Agreed Terms obligations under Art. 18 of Nagoya Protocol.
No selection made
No benefits received. It is too early to assess this aspect.
No additional information provided
N/A
Yes
Yes
Specific situations exist in the overseas territories.
Yes
L.412-4.3c of the French law on biodiversity n° 2016-1087 of August 8,2016 and the ABS Implementing Decree N°2017-848 of May 9, 2017 define the concept of benefit sharing. The benefits araising from the utilisation of a traditional knowledge associated with a genetic ressource have to be shared with the local communities.
The standard contract foreseen by the Administrative Order of September 13, 2017 entered into force on 29th of September 2017 applies also to the utilisation and benefit sharing of traditional knowledge.
For the utilization of traditional knowledge, a specific written procedure is detailed in the implementing Decree n° 2017-848 of May 9, 2017 (Art. R.412-28 to R.412-38) in order to ensure the approval of communities for the utilisation of their traditional knowledge. A legal entity is been created (“personne morale de droit public”) to support concerned communities in the procedure of access and the negotiation of the benefit sharing contract.
The Decree n° 2017-848 of May 9, 2017 foresees also a provision (Art. R.412-32) where the practices of communities embodying traditional lifestyles have to be taken into consideration and the information provided has to be in the language or the dialect they understand.
Therefore, in the French legislation, the involvement and approval of the holders of traditional knowledge associated to a genetic resource have to be obtained by the users prior to the utilisation of the traditional knowledge.
Art. 412-14 of the French law foresees the obligation that the benefits araised from the utilisation of traditional knowledge are to be directly shared with the concerned communities holding the traditional knowledge.
No additional information provided
Yes
Yes
Regulation (EU) 511/2014 on compliance measures for the users from the Nagoya Protocol on Access to Genetic Resources and Fair and Equitable Sharing of Benefits Arising from their Utilisation in the Union entered into force on 12 October 2014. It applies also to the French users.
Commission Implementing Regulation (EU) 2015/1866 laying down detailed rules for the implementation of Regulation (EU) 511/2014 as regards register of collections, monitoring user compliance and best practices entered into force on 9 November 2015 applies also to the French users.
Additional national measures have been necessary to be taken for the implementation of certain provisions of the EU ABS Regulation 511/2014 as follows:
French law on biodiversity n° 2016-1087 of August 8, 2016 (Title V "Access to genetic ressources and benefit sharing"), published in the Official Journal on August 9, 2016 :
Art. L412-6 (collections)
Art. L412-18-II (national competent authorities for the implementation of the EU Regulation 511/2014), Art. L 412-20-I (European register of collections), Art. L415-1 to Art. L. 415-3 (sanctions).
No
Yes
Yes
No
ABSCH-MSR-EU-201808-6
ABSCH-MSR-EU-204508-6
Both the ABS Regulation (EU) 511/2014 and Implementing Regulation 1866/2015 are applicable to genetic resources and to traditional knowledge associated with the genetic resources. They transpose in the EU compliance obligations foreseen in art.16.1 of Nagoya Protocol and they also apply to France.
In order to utilise a GR and/or a TK associated with a GR, the user is obliged to ensure the respect of the provider country legislation through a due diligence obligation.
In case of non compliance, several steps are foreseen in the French legislation (2016), including sanctions.
Art. L 415-3 of the biodiversity law foresees :
1) A formal notice to give the user a deadline to comply with the ABS provisions before applying sanctions
2) In case of non compliance:
Administrative sanctions (withdrawal of the permit)
Criminal sanctions effective and proportionate to the circumstances of the situation (a fine of 150 000 € - 1 year imprisonment)
Depending on the circumstances, the judge can decide on the application of a fine up to 1 million € in case of commercialisation without benefit sharing (illegal utilisation) and can prohibit the access to GR and/or TK during 5 years.
Yes
In line with Article 7(1) and (2) of Regulation (EU) 511/2014, users need to provide information as required by Article 17(1) of the Nagoya Protocol to monitoring checkpoints for the utilisation designated and then, final compliance checking by the French Ministry of environment.
Annexes II and III to the EU Implementing Regulation provide for the list of information requested from researchers and end-users respectively (this includes also information related to PIC, the source of genetic resource, to the establishment of MAT and to utilisation of genetic resources).
Yes
In addition to the above and based on Article 9 of Regulation (EU) 511/2014, competent authorities in France are obliged to perform checks on user compliance in accordance with a periodically revised risk-based plan.
Yes
No
3 monitoring checkpoints are designated by the French Law on biodiversity that are detailed above at point 9.
1) Ministry of research for all recipients of public research funding
2) Patent office
3) National competent authority for market approval
These monitoring checkpoints transmit the relevant information to the Ministry of environment for the final compliance checking.
Yes
Yes
Article 13 of Regulation 511/2014 obliges the European Commission and Member States, as appropriate, to promote the development and use of cost-effective communication tools and systems in support of monitoring and tracking the utilisation of genetic resources and traditional knowledge associated by genetic resources by collections and users.
The EU “DECLARE” system is likely to be used for the due diligence obligation.
An electronic declaration system is being implemented at the national level for the permits (CERFA forms).
No additional information provided
Not applicable, since no access requirements are in place
Yes
Article 6 of the standard contract foresees a dispute resolution procedure (Arrêté 13/09/2017 Art. R.412-20 Code Environnement)
Yes
Article 7 of the standard contract foresees already the possibility to seek recourse in case of a dispute (Arrêté 13/09/2017 Art. R.412-20 Code Environnement).
Yes
Yes
France is a contracting Party to international conventions on mutual recognition and enforcement of foreign judgements. In case of non compliance with contractual obligations, enforcement of contracts is possible through the French jurisdictions. All depends on the law of the contract.
Arbitration is also a possibility but as this is a distinct procedure from the common law procedure it depends on the choice made by Parties to the contract.
No additional information provided
Yes
Art. L412-7.I of the French law on biodiversity foresees a declarative procedure for non commercial research.
Yes
Article 4(8) of Regulation (EU) 511/2014 provides for a short temporal derogation from the duties of its Article 4(3) and 4(5) for users acquiring a genetic resource that is determined to be, or is determined as likely to be, the causing pathogen of a present or imminent public health emergency of international concern.
Art. 412-7.III of the French law on biodiversity foresees a simplified procedure (declaration) for access to this type of genetic resources when emergency of the situation is justified.
Yes
Art. L. 3115-13.(Code de la Santé publique)
An order of the Minister of health determines the modalities of quick access to the biological resources useful to fight against the international spread diseases, in order to transmit these resources to reference laboratories of third countries or designated by the World Health Organisation.
The World Health Organisation regulations primarly applies in this situation.
Yes
Recital 12 of Regulation (EU) 511/2014 recalls Article 8(c) of the Nagoya Protocol explains that the ITPGRFA is a specialised instrument within the meaning of Article 4(4) of the Nagoya Protocol. The Regulation also recognises that where Parties to the Protocol have decided to use the standard material transfer agreement for plant genetic resources for food and agriculture which are not covered by ITPGRFA, but which are under their control and management and in public domain, submission of due diligence declarations is not required.
French law on biodiversity (2016) foresees specific provisions for access to certain genetic resources for food and agriculture (listed in Art. L 412-5 III) as explained at point 11 that are to be implemented by the Ministry of agriculture in compliance with France obligations under other international treaties.
No additional information provided
Yes
Given the diversity of situations within the overseas and in order to ensure legal certainty for users, it was necessary that the law on biodiversity gives a definition of the terminology "indigenous and local communities".
The expression retained and defined in Art. L. 412-4 of the French law is “communautés d’habitants”.
No
No selection made
No selection made
Art. L412-3 of the French law (2016) - Genetic ressources in France are considered being common heritage of the French nation.
According to the CBD, the principle of sovereign rights of the State over the genetic ressources applies.
Yes
Art. L. 412-9 to L. 412-14 of the French law on biodiversity (2016) completed by the implementing Decree N° 2017-848 of May 9, 2017 (R.412-28 to R. 412-38 of the Environmental Code) ensure that traditional knowledge is accessed with the approval of communities and benefit sharing agreed in a written contract with the legal representative of the community.
Yes
Please refer to the details given in paragraphe 22 above.
Yes
No selection made
Yes
The Ministry of environment does not intervene in the development of community protocols as such but encourage the concerned communities to do it in order to ensure a better protection of their traditional knowledge and customary practices.
Yes
Yes
Yes
Art. 412-5-II. 2 of the French law on biodiversity (2016) foresees the situation where customary use and exchange of genetic resources and/or traditional knowledge within and among local communities are not restricted.
No selection made
No additional information provided.
Yes
In line with Article 13 of Regulation (EU) 511/2014, the Commission and the Member States shall encourage users and providers to direct benefits from the utilisation of genetic resources towards the conservation of biological diversity and the sustainable use of its components in accordance with the provisions of the Convention.
Art. 412-17- IV of the French Law on biodiversity foresees that the benefits shall be used for the conservation and sustainable use of genetic resources and traditional knowledge associated. This provision is taken into consideration at Art. 3 of the Standard Contract (MAT) established by Administrative order of September 13, 2017 (contrat type de partage des avantages découlant de l’utilisation des ressources génétiques prélevées sur le territoire national; l’article R. 412-20 du code de l’environnement).
No answer provided
At this stage it is too early to assess the contribution of Nagoya Protocol in France. However, as mentioned at point 45 above, there is a binding obligation in the French law, to use the benefits generated for the conservation and sustainable use of biodiversity.
The ABS system is conceived in France as a tool aiming to the financing of projects for the conservation and sustainable use of biodiversity. The monetary benefits are to be managed by the French Biodiversity Agency that will be in charge of their implementation.
The benefits araising from the utilisation of traditional knowledge are to be directed towards local communities and managed at the level of the communities.
No additional information provided.
Yes
This situation will be dealt with on a case by case approach on the basis of a bilatéral cooperation agreement.
Not applicable, since there are no indigenous and local communities in my country
Yes
This situation will be dealt with on a case by case approach on the basis of a cooperation agreement.
No additional information provided
Yes
In line with Article 13 of the Regulation (EU) 511/2014, the Commission and the Member States encourages development of codes of conduct, model contractual clauses, guidelines and best practices, particularly when they would benefit to academics, university and non-commercial researchers and small and medium-sized enterprises.
In the French legal framework a standard contract has been developed in order to ensure legal certainty for users and to support the implementation of the benefit sharing directed towards the conservation and sustainable use of biodiversity and the protection of traditional knowledge.
Yes
In line with Article 13 of the Regulation (UE) 511/2014 the Commission and the Member States encourages development of sectoral codes of conduct, model contractual clauses, guidelines and best practices, particularly to benefit for academics, university and non-commercial researchers and small and medium-sized enterprises.
No additional information provided
Yes
Yes
Training seminars on ABS and awarness-raising strategy are currently being developed.
Yes
Yes
ABS projects for capacity building.
No
Yes
Financial contribution to the ABS GEF Fund to support developing countries to ratify Nagoya Protocol.
Financial Contribution to the GIZ ABS Initiative
Financing of two important ABS projects through the French Environmental Fund (“Phytotrade Africa” project and “Sud Expert Plantes Développement Durable” (SEPDD) project - French Development Agency)
No additional information provided
Yes
Projects mentioned at point 57.
No additional information provided
Yes
The French Biodiversity Agency (created by the Law on biodiversity – 2016) is designated to receive monetary benefits and to use them for conservation and sustainable use of biodiversity.
Yes
Yes, financial resources have been made available throug a specific trust fund (explained in para. 57 above)
Yes
Yes
Yes
No information provided
No information provided
Yes
Less than 10
Less than 10 persons at central level (different ministries).
A case by case situation in the overseas.
No information provided
No information provided
