Relevance of the Nagoya Protocol on ABS for the Industry

Relevance of the Nagoya Protocol on ABS for the Cosme@c Industry 1st Interna*onal Pacific Cosmetopoeia Conference 22 to 24 November 2016, Lycée hôtelier, Punaauia, Tahi*

ABS capacity development support Bahamas Silvamed SICA CARICOM COMIFAC African Union Commission Seychelles ASEAN Center for Biodiversity Palau Micronesia (FSM) SADC Samoa SPC, SPREP Cook Islands ABS Ini@a@ve ACP countries ABS Ini@a@ve ACP countries with bilateral DC ABS in bilateral DC (outside of ACP)

2015-2020 Interven@on logic of the ABS Ini@a@ve

Nagoya Protocol on ABS of the CBD Adopted October 2010 at COP 10 in Nagoya, Japan Entered into force in October 2014 Currently 89 Ra@fica@ons (as of 7 Nov 2016) 100 raificaions expected by COP-MOP 2 in December 2016 in Cancun, Mexico Objec@ve of the NP the fair and equitable sharing of the benefits arising from the u*liza*on of geneic resources Ø Legal certainty and transparency For providers: ensuring benefit-sharing once GR leave the provider country For providers: preven@ng misappropria@on of GR and associated tradiional knowledge (atk) For users: providing for clear and transparent procedures for access to GR and atk

Nagoya Protocol on ABS Scope GeneIc resources within the scope of Ar@cle 15 CBD and the benefits arising from the uilizaion of such resources Tradi@onal knowledge associated with gene@c resources within the scope of the CBD and the benefits arising from the uilizaion of such knowledge

The ABC of ABS under the Nagoya Protocol Access, Benefit-sharing and Compliance biodiversity-rich countries facilitate access to geneic resources Competent NaIonal Authority (CNA) Provider Gene@c resources /TK PIC / MAT Benefits User Checkpoint(s) technology-rich countries share benefits arising from geneic resources; facilitate the access to technologies and means important for conservaion and sustainable use PERMIT ABS-CH CERTIFICATE

Fair and Equitable Benefit-Sharing under the NP Sharing of benefits upon Mutually Agreed Terms (MAT) with the country providing GR Indigenous peoples and local communi@es holding rights over GR and/or providing atk are to be included in PIC/MAT negoiaion and benefit-sharing Monetary and non-monetary benefits (specified in the Annex): E.g. access fees, upfront and milestone payments, royalies, research funding E.g. research collaboraion, educaion and training, knowledge and technology transfer, access to research findings, joint ownership of intellectual property rights

Possible approaches: Integra@ng ABS in BioTrade Source: Cosi & Oliva, 2016

Possible approaches in ABS and BioTrade: contractual arrangements ABS contract / MAT BioTrade agreements TK Licenses / agreements Object: access, uilizaion and transfer of materials Subjects: State vs Private (research center or company) Cause: R&D and commercializaion (potenially transfer) Applicable law: usually public law + contract law Object: sales of goods and services (e.g. natural ingredients) Subjects: business to business Cause: sourcing, processing & commercializaion (potenially R&D) Applicable law: commercial contract law Object: access to knowledge (intangible) Subject: indigenous and local communiies and Private (research center or company) Cause: R&D, fixaion, producion, commercializaion Applicable law: TK regulaions + private law + customary law Source: Cosi & Oliva, 2016

Example: Benefit-sharing arrangements ABS Monetary Access fees Milestone payments RoyalIes R&D funding Joint ventures Joint IP ownership Non-Monetary Sharing of R&D results ScienIfic collaboraion EducaIon & training Technology transfer Capacity building Local development BioTrade Monetary Linked to the market value Fair Price (products, volume, quality & ethics) Exclusive sourcing Value evolves as we move upward in the value chain Non-monetary Local Employment Local value addiion Sustainable pracices EducaIon & training Technology transfer Capacity building Local development TK Monetary Access fees Licenses fees Joint IP ownership Non-Monetary Moral rights & recogniion Local development Food, seeds and inputs Support to health & livelihoods PreservaIon of TK context Infrastructure Employment Source: Cosi & Oliva, 2016

Marine bioprospec@ng and EEZs in the Pacific

Marine gene@c resources in the cosme@cs Many marine organisms are u@lised for the producion of cosmeics Marine biopropecing mostly takes place in na@onal territories (EEZs), subject to ABS regula@on EEZs contain many deep-sea areas and hydrothermal vent fields, interesing for bioprospecing purposes Na@onal ABS frameworks need to establish structures governing access to marine resources and benefit-sharing Strategies are necessary to avoid overexploita@on and ex@nc@on Monetary and non-monetary benefits should support the protecion of marine geneic resources

The ABC of ABS under the Nagoya Protocol Access, Benefit-sharing and Compliance biodiversity-rich countries facilitate access to geneic resources Competent NaIonal Authority (CNA) Provider Gene@c resources /TK PIC / MAT Benefits User Checkpoint(s) technology-rich countries share benefits arising from geneic resources; facilitate the access to technologies and means important for conservaion and sustainable use PERMIT ABS-CH CERTIFICATE

Implementa@on in the EU Compliance: EU Regula@on 511/2014 + EU Implemen@ng Regula@on 2015/1866 + member state legisla@on Ø e.g. Belgium, CroaIa, Denmark, Finland, France, Germany, Hungary, The Netherlands, Slovakia, Spain, United Kingdom Access & Benefit-Sharing: member state legisla@on Ø e.g. CroaIa, Finland, France, Spain (+ Italy, Greece, Portugal) Member state legisla@on: e.g. France Scope: Access to in situ and ex situ GR including new u@liza@on of French GR in French collec@ons Compliance: Iden@fies na@onal checkpoints in line with EU Regula@on 511/2014 In accordance with the French Cons@tu@on, some overseas collec@vi@es have the competence to regulate ABS on their territory: 1. French Guiana Amazonian NaIonal Park (loi n 2011/884) 2. Polynesian Code of Environment (loi du pays n 2012-5) 3. New Caledonian Code of Environment (délibéraion 06-2009 in the Southern province)

EU Regula@ons Scope & Defini@ons EU ABS compliance rules apply when six condi@ons are met: 1. Access to geneic resource or associated tradiional knowledge "GeneIc resources" means geneic material of actual or potenial value. "GeneIc material" means any material of plant, animal, microbial or other origin containing funcional units of heredity. Ø Access to e.g. oils, isolated biochemicals, heat-treated material maybe under the scope of the provider country s ABS regula@on 2. GeneIc resource accessed is under souvereignty of a State Ø No compliance obligaions in the EU: access to GR in areas beyond naional jurisdicion e.g. in the AntarcIca or the High Sea 3. AquisiIon occurs in a Party to the Nagoya Protocol Ø No compliance obligaions in the EU: access to GR and atk in non-paries 30.11.2015 16

EU Regula@ons Scope & Defini@ons EU ABS compliance rules apply when six condi@ons are met: 4. ABS regulatory framework exists in Party to the NP Ø No ABS framework / no ABS contract no compliance obligaions in the EU 5. Access amer 12 Oct. 2014, i.e. entry into force of NP in EU Ø Exclusion of all GR and atk which were accessed before Ø Exclusion of any future uilisaion of such GR and atk 6. UIlisaIon takes place in the EU UIlizaIon of geneic resources : research and development on the geneic and/or biochemical composiion of geneic resources, including through the applicaion of biotechnology as defined in ArIcle 2 of the ConvenIon; Ø Exclusion of any acivity that is not R&D on the GR, e.g. several ecological and taxonomical methodologies, trade for use in producion process Ø UIlizaIon of commodiies which are GR triggers EU compliance rules 30.11.2015 17

The ABC of ABS under the Nagoya Protocol Access, Benefit-sharing and Compliance biodiversity-rich countries facilitate access to geneic resources Competent NaIonal Authority (CNA) Provider Gene@c resources /TK PIC / MAT Benefits User Checkpoint(s) technology-rich countries share benefits arising from geneic resources; facilitate the access to technologies and means important for conservaion and sustainable use PERMIT ABS-CH CERTIFICATE

NP implementa@on in the Pacific (1) Cook Islands: not signed, not ra@fied, ABS NFP Drag Biodiversity Research and Benefits Bill of 2006: requires redesign Tradi@onal Knowledge Act (2013) establishes a register of TK Na@onal Research Commijee in charge for research permit process Federated States of Micronesia (FSM): ra@fied, ABS NFP Drag ABS policies at federal and state level (Chuuk) since 2013 Fiji: ra@fied, ABS NFP Ad-hoc ABS policy, since 1997, provides basis for ABS approval process Na@onal ABS Commijee oversees process and that benefits are deposited in the Locally Managed Marine Area Network Trust Fund Cer@ficate of origin to accompany export permit Kiriba@: not signed, not ra@fied, ABS NFP No specific ABS policy, no ABS regulatory framework Source: UNEP, 2016

NP implementa@on in the Pacific (2) Marshall Islands: acceded to NP, CBD NFP No specific ABS policy, no ABS regulatory framework Nauru: not signed, not ra@fied, CBD NFP No specific ABS policy, no ABS regulatory framework Niue: not signed, not ra@fied, ABS/CBD NFP No specific ABS policy, no ABS regulatory framework Palau: signed, ABS/CBD NFP Development of ABS regulatory framework ini@ated in 2015 Papua New Guinea: not signed, not ra@fied, CBD NFP Drag PINBio Act establishes PNG BioNET as the na@onal clearinghouse for all research permits and access to PNG s gene@c resources Despite drag status of PINBio Act formal permit procedure in place Source: UNEP, 2016

NP implementa@on in the Pacific (3) Samoa: ra@fied, ABS NFP Drag bioprospec@ng regula@ons since 2001 Detailed CBD implementa@on policy as basis for regula@ng ABS Development of ABS regulatory framework to be compliant with NP ini@ated Solomon Islands: not signed, not ra@fied, ABS NFP Protected Areas Act 2010 empowers the Protected Areas Advisory Commijee to nego@ate permits (including bioprospec@ng permits) and require permit holders to provide reports Bioprospec@ng permits and ABS agreements require endorsement by Cabinet Tonga: not signed, not ra@fied, CBD NFP No specific ABS policy, no ABS regulatory framework Tuvalu: not signed, not ra@fied, ABS NFP No specific ABS policy, no ABS regulatory framework Source: UNEP, 2016

NP implementa@on in the Pacific (4) Vanuatu: ra@fied, ABS NFP Na@onal process for developing the na@onal ABS regulatory framework in compliance with the NP ini@ated Environmental Management and Conserva@on Act of 2002 establishes the Biodiversity Advisory Council responsible, inter alia, for advising the relevant minister on majers rela@ng to bioprospec@ng Biodiversity Advisory Council in charge to issue bioprospec@ng permits Patent Act of 2003 provides that any patent applica@on involving tradi@onal knowledge must include an agreement between the applicant and the tradi@onal/ customary owners, senng out, inter alia, benefit sharing arrangements The Na@onal Cultural Council and the Na@onal Council of Chiefs are authorized to ins@tute civil proceedings on behalf of indigenous peoples in Vanuatu if TK is illegally exploited Source: UNEP, 2016

Thank you!

Sources: Chiarolla, Claudio, 2016. Commentary on the ABS provisions of the dram Bioversity Law of France. InsItut du développement durable et des relaions internaionales (IDDRI), Paris, 21 pp. Cusi, Mariona and Maria Julia Oliva, 2016. BioTrade and ABS: Addressing the linkages. UNCTAD BioTrade & UEBT, presentaion at the FATA Wald, Biodiversität, Klima und UmweltpoliIk 2016 Lernwerkstar Access and Benefit-sharing: Wie werde ich kein Biopirat? UNEP, 2016. RaIficaIon and implementaion of the Nagoya Protocol in the countries of the Pacific Region. Project Document, GEF Project ID: 5634, 107 pp.