Facilitating BioTrade in a Challenging Access and Benefit Sharing Environment

AT Facilitating BioTrade Challenging Access Benefit Sharing Environment Note designations employed presentation material imply expression opinion part United Nations legal status country, territory, city area, authorities delimitation frontiers boundaries. Material publication freely quoted reprinted, acknowledgement requested, copy publication quotation reprint UNCTAD secretariat. unedited publication. UNCTAD/WEB/DITC/TED/2016/4 UNITED NATIONS PUBLICATION Copyright © United Nations, 2016 rights reserved Acknowledgements scoping study prepared Manuel Ruiz Muller, Director Biodiversity, Director Principal Researcher International Affairs Biodiversity Program Peruvian Society Environmental Law (SPDA) cooperation Veronique Rossow, Head Research Development PhytoTrade Africa David Vivas Eugui, Legal Officer (UNCTAD) guidance Bonapas Onguglo Head ., Trade, Environment, Climate Change Sustainable Development Branch, Division International Trade Goods Services, Commodities (DITC) UNCTAD. Mariona Cusi, Technical Expert, UNCTAD, substantive inputs orientation. Case studies prepared Maria Julia Oliva (UEBT), Veronique Rossow (PhytoTrade Africa) Balakhrishna Pishupati (UNEP). Additional comments scoping study UNCTAD Expert Peer Review Meeting implementation Nagoya Protocol impact aspects BioTrade, held 24 November 2015, Geneva, Switzerland experts: Paolo Bifani ( UNEP staff Professor UAM), Marco ´Alessandro (FOEN), Nicolas Guigas, (SECO), Claude Hemio ( World Bank staff), Lorena Jaramillo (UNCTAD), Harmut Meyer (GIZ), Viviana Muñoz (South Centre), Valerie Normand (CBD Secretariat), Marí Julia Oliva (UEBT) Nguyen Thi Dang Thu Cuc (BCA, Viet Nam). presentations information Expert Peer review : http://unctad.org/en/pages/MeetingDetails.aspxmeetingid=953. Vanessa Ingar (BioTrade Coordinator), Emma Rivas (Biotechnology Specialist) Dora Velásquez (Access Benefit Sharing Specialist) Ministry Environment Peru (MINAM) comments. formatting document cover page design Rafe Dent Lirong Zang, UNCTAD. UNCTAD gratefully acknowledges support Swiss State Secretariat Economic Affairs (SECO) phase BioTrade Facilitation Programme (BTFP III), framework scoping study prepared. Guillermo Valles Director Division International Trade Goods Services, Commodities 31 , 2016 Wichtiger HINWEIS ! Innerhalb der Schutzzone (hellblauer Rahmen) darf kein anderes Element platziert werden! Ebenso darf der Abstand zu Format- resp. Papierrand die Schutzzone nicht verletzen! Hellblauen Rahmen der Schutzzone nie drucken! Siehe auch Handbuch „Corporate Design der Schweizerischen Bundesverwaltung“ Kapitel „Grundlagen“, 1.5 / Schutzzone www. cdbund.admin.ch iii Contents Note ........................................................................................................................................................ ii Acknowledgements ................................................................................................................................. ii Acronyms ................................................................................................................................................ Executive summary ................................................................................................................... vi 1. IntroductIon ................................................................................................... 1 1.1 overview BioTrade developments ........................................................................... 1 1.2 international foundations BioTrade: Convention Biological Diversity forums ............................................................................................................................ 3 2. understandIng access BenefIt sharIng rules nagoya Protocol aPPly BIotrade actIvItIes ............... 5 2.1. access benefit sharing provisions affect BioTrade ....................................................... 5 2.2. rationale Nagoya Protocol ............................................................................................... 6 2.3. Nagoya Protocol provisions affect BioTrade ................................................................ 6 3. natIonal access BenefIt sharIng regulatory frameworks BIotrade: theIr relevance users ProvIders ................................. 9 4. settIng BoundarIes coverage ..................................................... 12 4.1. Definitions examples ................................................................................................................ 12 4.2. elements BioTrade businesses ................................................... 14 4.3. ow genetic resources biochemicals industry research development ......................................................................................................... 14 4.4. regulators receiving access applications .......................................... 16 5. BenefIt sharIng challenge ................................................................... 18 5.1 Monetary -monetary benefits ............................................................................................. 20 6. PIc mat PrIncIPles: exIstIng aPProaches oPtIons BIotrade ............................................................................................... 22 7. comPlIance measures theIr ImPlIcatIons BIotrade ..................... 24 8. IndIgenous PeoPle, local communItIes BIotrade: challenges oPtIons aPPlyIng conventIon BIologIcal dIversIty nagoya Protocol PrIncIPles local level................................ 28 9. role Intellectual ProPerty certIfIcatIon BIotrade ............ 30 10. Issues consIderatIon stePs ................................................. 32 iv List figures Figure 1. Broadening intersection access benefit sharing BioTrade ..................................... 5 Figure 2. Benefit sharing BioTrade chain phases .................................................................. 19 List boxes Box 1. BioTrade Principles 3 7 respective criteria benefit sharing, access genetic resources traditional knowledge .............................................................................. 2 Box 2. goals Aichi Biodiversity Targets ......................................................................................... 3 Box 3. Case study BioTrade access benefit sharing: natural blue colorant derived Genipa americana .................................................................................................. 7 Box 4. Samples regulatory trends scope coverage ABS frameworks provider countries, applicable BioTrade: examples Andean Community, African Union, Brazil, South Africa, Kenya, Ethiopia, Peru Viet Nam ..................................... 9 Box 5. Understanding coverage scope Nagoya Protocol ...................................................... 12 Box 6. Case study BioTrade access benefit sharing: Fresh plants Namibia Europe ....... 23 Box 7. sample regulatory trends user countries (European Union, Norway Switzerland) applicable BioTrade ....................................................................................... 25 Box 8. Case study BioTrade access benefit sharing: Medicinal plants Viet Nam .................... 28 Box 9. intellectual property “kick ” ........................................................................................ 30 Box 10. Certification, standards mark schemes relevant BioTrade ...................................................... 31 Acronyms ABS Access benefit sharing BCA Biodiversity Conservation Agency BHB Bosque úmedo Biodiverso BTFP BioTrade Facilitation Program CAF Andean Development Corporation CBD Convention Biological Diversity CITES Convention International Trade Endangered Species Wild Fauna Flora COCOMACIA Consejo Comunitario Mayor de la Asociació Campesina Integral de Atrato CSD Commission Sustainable Development EU European Union FAO United Nations Food Agriculture Organization FOEN Federal Office Environment Switzerland GEF Global Environment Facility GIZ German Federal Enterprise International Cooperation (Gesellschaft ü Internationale Zusammenarbeit) IGC Committee Intellectual Property Genetic Resources, Traditional Knowledge Folklore IP Intellectual property ITPGRFA FAO International Treaty Plant Genetic Resources Food Agriculture LMMC Group -Minded Megadiverse Countries MINEPDED Ministry Environment, Nature Protection Sustainable Development MAT Mutually agreed terms MDG Millennium Development Goals MTTI Ministry Tourism, Trade Industry Uganda NTFP -Timber Forest Products OTCA Organization Amazon Cooperation Treaty PIC Prior informed consent & Research Development REDD Reduced Emissions Degradation Deforestation SDG Sustainable Development Goals TK Traditional knowledge UAM Universidad Autónoma de Madrid UEBT Union Ethical BioTrade UNCED United Nations Conference Environment Development UNCTAD United Nations Conference Trade Development UNCCD United Nations Convention Combat Desertification WIPO World Intellectual Property Organization vi executIve summary Legal uncertainty, lack clarity administrative inaction good recipe facilitate sustainable biodiversity businesses. entering force CBD Nagoya Protocol Access Genetic Resources Fair Equitable Sharing Benefits Arising Utilization, opportunity improve synergies access genetic resources benefit sharing (ABS) context BioTrade, turn contribute legal certainty important matter sustainable biodiversity. historically BioTrade moved realm sustainable biodiversity businesses, biological resources ecosystem services, questions remain genetic resources part BioTrade importantly, ABS policy legal frameworks applicable . Nagoya Protocol Access Benefit Sharing multilateral environmental agreement CBD, seeking clarify definitions, issues scope coverage ABS, specific actions user provider countries biodiversity resources. rapid implementation Protocol European Union Switzerland placing considerable pressure providing countries adjust, develop implement effective efficient ABS frameworks national level consistent Protocol benefit . Implementing Protocol BioTrade require guidance BioTrade ABS positively interact generate complementarity. ABS requirements applicable BioTrade key creating enabling policy regulatory environments. scoping study offers overview key issues connections BioTrade ABS framework Nagoya Protocol, challenges faced interested actors suggestions ways address , including terms interpretation, implementing policies legal reforms. Examples, figures case studies clarify points raised suggestions . 1Challenging aCCess Benefit sharing environment 1. IntroductIon relationship BioTrade1 ABS continues challenge policy makers, entrepreneurs, communities, project managers academics alike. launching 1996 UNCTAD´ “BioTrade Initiative”, BioTrade demonstrated importance multiple forms conservation sustainable- biodiversity ecosystems oriented businesses. key challenge clarify BioTrade account mandatory ABS principles, accordance Convention Biological Diversity (CBD) Nagoya Protocol Access Genetic Resources Fair Equitable Sharing Benefits Arising Utilization.2 parallel limited interaction, BioTrade projects, businesses ABS frameworks, expanded regions countries. definite answer quintessential question “ ABS laws regulations apply BioTrade project business activity” remains elusive. National ABS frameworks unclear BioTrade activities covered scope. result, legal uncertainty prevails regard clarity applicable ABS norms regulations, exclusions, obligations, rights benefit sharing criteria. Nagoya Protocol addition complex international, regional national “ABS architecture” defines conditions genetic resources biochemicals accessed utilized – potential implications BioTrade.3 scoping study offers overview challenges faced options implement BioTrade ABS principles CBD Nagoya Protocol coherent manner. examples challenges addressed. study overview current state---art discussions issues order facilitate understanding manage interphase BioTrade ABS practice. scoping study output BioTrade Facilitation Programme’ phase (BFPT III), seeks “mainstream BioTrade relevant multilateral, regional national processes strengthen policy regulatory environment BioTrade sectors. key stakeholders (governments companies) advantage policy options strategies BioTrade sectors”. 1.1 overview BioTrade developments BioTrade seeks promote trade investment biodiversity products services sustainable development reduce poverty line main objectives CBD: conservation biodiversity, sustainable components benefit sharing utilization genetic resources. BioTrade place common definition, promulgated UNCTAD, BioTrade “activities collection, production, transformation, commercialization goods services derived native biodiversity criteria environmental, social economic sustainability”.4 BioTrade activities projects cover sectors food agriculture; natural ingredients cosmetics pharmaceuticals; ecotourism; fashion accessories handicrafts; sustainable trade wildlife. BioTrade activities, emphasis process, distinct stages phases5; native biodiversity6 business, catering social, environmental economic sustainability. , entrepreneurs businesses engaged sustainable biodiversity-based enterprises necessarily knowing details CBD, BioTrade Nagoya Protocol. inspiration national BioTrade programs practitioners, common set agreed Principles Criteria approaches developed UNCTAD 2007.7 relevance BioTrade – ABS connection8 Principle 3 benefit sharing Principle 7 clarity rights ( Box 1). Principles Nagoya Protocol, relevant ABS. BioTrade Principles Criteria voluntary nature form private standards simply part corporate social responsibility strategy company group companies. Principle 3, benefit sharing limited genetic resources established Article 1 CBD. , benefit sharing applies biodiversity broader terms.9 include genetic resources, biological resources defined CBD environmental ecosystem services.10 Principles Criteria address land rights, compliance international national legislation, protection intellectual property recognition traditional knowledge (TK) indigenous peoples 2 Facilitating Biotrade communities substantial inputs BioTrade activities projects. Actors BioTrade chain include indigenous people, farmers communities providers () raw biological materials; collectors intermediaries gather transport bulk quantities materials; researchers; processors transformers; distributors , ultimately, traders. part process subject national international regulations apply stages, including extraction, collection, bioprospecting activities, processing commercialization. Box 1: BioTrade Principles 3 7 respective Criteria benefit sharing, access genetic resources traditional knowledge Principle Criteria 3. BioTrade activities involve commercialization genetic resources linked benefit sharing objective CBD. Equitable benefit sharing arises context sustainable biodiversity. Benefit-sharing important activities dealing biological resources, form vast majority BioTrade activities. 3.1 organization interact involve actors chain, . reduces asymmetries ensures negotiation fair equitable monetary -monetary benefits, weakest links chain. 3.2 Income generated chain, contributing position -added products market, transparent conditions, condition benefit sharing. 3.3 Information knowledge target markets shared actors, enable access market opportunities. 7. Clarity rights access important. long-term investments management measures implemented ensure sustainability. time, clarity issue means responsibilities actor established. 7.2 Access biological genetic resources sustainable subject prior informed consent. CBD requires access distribution benefits relation genetic resources. cases, consent relevant national authorities provider country obtained. cases regulated national legislation, line CBD. 7.3 Access traditional knowledge granted prior informed consent verified. traditional knowledge , organization follow regulations established procedures ensure rights actors providing knowledge recognized, including prior informed consent relevant stakeholders, indigenous local communities, subject domestic law. Traditional knowledge valued rewarded manner. Note: summary prepared authors. Highlights added authors. 3Challenging aCCess Benefit sharing environment time, support UNCTAD collaboration national, regional international partners, progress defining concept BioTrade supporting wide range technical cooperation activities, projects, businesses world.11 BioTrade Programmes,12 collaboration relevant conventions CBD Convention International Trade Endangered Species Wild Fauna Flora (CITES), BioTrade congresses,13 emergence Union Ethical BioTrade (UEBT),14 considerable body literature studies, helped cement presence influence BioTrade. differentiate practice BioTrade activities capital “” biotrade “” small letters. occurs economic actors involved, practitioners specific projects apply BioTrade Principles Criteria established UNCTAD partner organizations. understood trading biodiversity products services necessarily applying sustainability criteria including trade commodities. 1.2 international foundations BioTrade: CBD forums initial BioTrade Principles ( conservation, sustainable benefit sharing) match respond objectives CBD, difference benefit sharing principle extends utilization biodiversity, including species ecosystems levels, genetic resources . context, UNCTAD, BioTrade Initiative, works closely CBD establish positive synergies. manifested CBD COP Decisions framework engage BioTrade activities related business involvement incentives enhance biodiversity conservation, sustainability benefit sharing.15 international forums instruments recognize role BioTrade play promoting conservation, sustainable development benefit sharing. United Nations Commission Sustainable Development (CSD) stressed develop incentives stimulate conservation sustainability support improvements biodiversity markets. BioTrade acts medium implement United Nations Millennium Development Goals (MDG) reconciling goals environmental sustainability development poor, rely extensively biodiversity survive.16 goals replaced set Sustainable Development Goals (SDG), Transforming World - 2030 Agenda Sustainable Development. global goals include specific references conservation biodiversity integral dimension sustainable development.17 specifically target 15.6 SDGs calls international community “Promote fair equitable sharing benefits arising utilization genetic resources promote access resources, internationally agreed”. addition, international agreements, including CITES, United Nations Convention Wetlands International Importance, Waterfowl Habitat (RAMSAR Convention, 1971) United Nations Convention Combat Desertification (UNCCD, 1994), provide policy framework BioTrade support. discussions negotiations climate change Reduced Emissions Degradation Deforestation role conservation, sustainable management forests enhancement forest carbon stocks developing countries (REDD+) schemes, BioTrade Box 2: Goals Aichi Biodiversity Targets • Strategic Goal : Address underlying biodiversity loss mainstreaming biodiversity government society. • Strategic Goal : Reduce direct pressures biodiversity promote sustainable .  • Strategic Goal : improve status biodiversity safeguarding ecosystems, species genetic diversity.  • Strategic Goal : Enhance benefits biodiversity ecosystem services.  4 Facilitating Biotrade contribute projects initiatives.18 World Intellectual Property Organization (WIPO) ongoing process develop international regime protection TK International Committee Intellectual Property Genetic Resources, Traditional Knowledge Folklore (IGC), relevant future BioTrade activities relate TK. Finally, 2010, parties CBD adopted Strategic Plan Biodiversity including Aichi Biodiversity Targets 2011-2020 period. targets ( Box 2) offer solid policy legal guidance implement BioTrade related activities part conservation, sustainability benefit sharing goals. BioTrade positioned promote sustainable trade investment biodiversity-based products services global goals policy framework institutions involved biodiversity conservation. Key messages Benefit sharing BioTrade adds concept ABS CBD Nagoya Protocol. BioTrade voluntary scheme process, reflected chain, respecting series Principles Criteria developed UNCTAD, sustainable native biodiversity benefit sharing chain stands critically important. Due broad scope, BioTrade activities subject set complex, albeit supportive, international frameworks (CBD, CITES, RAMSAR, WTO agreements, .) national regulations. BioTrade increasingly explicitly recognized international forums enabler sustainable businesses, initiatives projects. 5Challenging aCCess Benefit sharing environment 2. understandIng access BenefIt sharIng rules nagoya Protocol aPPly BIotrade actIvItIes 2.1 access benefit sharing provisions affect BioTrade CBD, Nagoya Protocol national ABS frameworks, ABS obligations apply distinct phases stages BioTrade chains.19 Generally, genetic resources utilized20 (.. biotechnological &), person institution undertaking activities comply existing ABS regulations procedures aware benefit sharing obligation triggered. include & biochemical composition genetic resources (.. natural occurring biochemical compound), classified “derivatives” Protocol,21 depending national implementing legislation. ABS national regulations, national competent authority negotiate ABS contract reflects mutually agreed terms (MAT) issue permit authorization, reflect Prior Informed Consent (PIC). , TK involved access genetic resources sought indigenous peoples local communities’ lands, parallel agreements required, customary law principles, depending national legislation. Ad hoc agreements (.. material transfer agreements) needed genetic resources biological samples sought situ facilities (.. seed bank botanical garden). regard, ABS regulations procedures regulatory framework BioTrade Initiative initiated operates .22 , boundaries BioTrade ABS se subtle analyzed case--case basis. instance, BioTrade project involve -Timber Forest Products (NTFP), Brazilian nut Amazon, require concession permit proceed regulations forestry ministry department. , project involve collecting kernels Argan tree Morocco, require authorizations agriculture environment ministries. Bixa orellana (achiote), collected Amazon processing natural dye food ingredient, fall classic BioTrade activity require permit agriculture environmental sector. examples, company decided undertake line & identify specific molecules incorporated pharmaceutical, cosmetic product, ABS frameworks apply. , set obligations procedures Figure 1: Broadening intersection access benefit sharing BioTrade Source: UNCTAD (2016). ABS Post CBD BioTrade ABS Post Nagoya BioTrade 6 Facilitating Biotrade met, possibly –depending specific national frameworks involving set State entities authorities. regard, mind & basic science applied science linked commercial objectives includes product services development. Figure 1 shows intersection possibilities ABS BioTrade grown part broader scope coverage Nagoya Protocol ( national frameworks) proposing. due Nagoya Protocol’ references research development ‘biochemical’ composition genetic resources ‘derivatives’ naturally occurring biochemical compounds. UNCTAD’ BioTrade Principle 3, benefit sharing “triggered” reflected process. Monetary -monetary benefits shared distributed chain biodiversity . projects businesses fall scope BioTrade based direct utilization processing biological resources, chain.23 , activities include trade native grains fruits sourcing natural ingredients existing natural pharmaceuticals. , reference “biodiversity” Principle 3 situations circumstances addressed BioTrade. include, instance, payment ecosystem conservation schemes ecotourism activities based biodiversity potential values. , BioTrade activities centered transformation biological resources derived products inputs wide range industries trades, sustainable tourism. 2.2 rationale Nagoya Protocol Nagoya Protocol result developing countries realizing insufficiency partial ineffectiveness national ABS legal frameworks securing benefit sharing. year 2000 , albeit highly scrutinized, examples ABS legislation regulations applied limited success.24 early 2002, calls international regime ABS ensure equitable fair benefit sharing shift burdens responsibilities realization benefit sharing user countries.25 2.3 Nagoya Protocol provisions affect BioTrade Arguably, important political milestone adoption Nagoya Protocol Cancun Declaration Group -Minded Megadiverse Countries 2002, members26 expressed “concern limitations international instruments protect effectively legitimate interests countries origin biodiversity” called “creation international regime effectively promote safeguard fair equitable sharing benefits arising biodiversity components. regime contemplate, inter alia, elements: certification legal provenance biological materials, prior informed consent mutually agreed terms transfer genetic material, requirements application granting patents, strictly accordance conditions access agreed countries origin.” important specific reference included Plan Implementation World Summit Sustainable Development (2002) call “negotiate framework Convention Biological Diversity, bearing mind Bonn Guidelines, international regime promote safeguard fair equitable sharing benefits arising utilization genetic resources.”27 Nagoya Protocol affect BioTrade-related activities ways. , Protocol reflects original interests biodiversity rich countries placing obligations responsibilities countries utilize undertake & genetic resources. means user countries adopt measures ensure users jurisdiction respect ABS requirements provider countries. centralized check point sectors customs controls, phytosanitary health-safety authorities, intellectual property (IP) offices check points compliance related requirements implemented. consequences BioTrade chains & commercialization BioTrade products takes place user countries. , coverage Nagoya Protocol interpreted “ cascade” linking definitions “utilization genetic resources”, “biotechnology”, 7Challenging aCCess Benefit sharing environment “derivatives”. enables inclusion biochemicals, , instances, key inputs products BioTrade activities, foods, cosmetics, nutraceutical natural medicine sectors. Thirdly, Nagoya Protocol -executing. Countries develop national laws, regulations administrative measures implement obligations. effects Nagoya Protocol depend ABS frameworks developed nationally operate practice. compliance measures effective, provider Box 3: Case study BioTrade ABS: natural blue colorant derived Genipa americana Description: Ecoflora Cares Colombian company developing producing natural colors ingredients cosmetics food industries. widely recognized innovative sustainable Colombia’ biodiversity, sourced partnerships indigenous peoples local communities. flagship colors Ecoflora Cares natural blue colorant food applications, developed extracted fruit Genipa americana, Colombian tropical rainforests. natural alternative indigotine, artificial colorant food ( blue jeans). Interface BioTrade ABS: Ecoflora Cares’ work Genipa americana responds aim enhance sustainable Colombia’ biodiversity increasing added natural resources. context, sourcing, research, development commercialization activities linked project framed UNCTAD’ BioTrade Principles Criteria. Ecoflora Cares member UEBT 2009. result, company developed supply chain collaboration local communities, support local NGOs working ethical sourcing natural ingredients. place biodiversity management system integrates Ethical BioTrade principles supply chain. Finally, measures support fair equitable sharing benefits sourcing activities, including creation community entrepreneurial initiative. efforts ethical sourcing biodiversity established solid basis Ecoflora Cares’ compliance requirements access genetic resources Colombia. secured permits agreements utilization Genipa americana, based legal framework established Andean Decision 391 implementing rules. 2011, Ecoflora Cares received permit - commercial research development natural colorants fruit Genipa americana. 2013, company concluded series agreements sharing monetary -monetary benefits local communities. Finally, 2014, Ministry Environment Sustainable Development Colombia subscribed contract Ecoflora Cares, authorizing commercial Genipa americana basis natural colorant. Lessons learnt: companies committed BioTrade engage &, experience issues linked conservation sustainable biodiversity fair equitable benefit sharing constitute solid basis compliance ABS requirements. , companies working BioTrade context tend higher awareness importance procedures ABS, benefit sharing part principles criteria BioTrade. understanding important navigate complex administrative procedures. , partnerships local communities facilitate consultations equitable trade practices enhance complement benefit sharing agreements. Source: UNCTAD UEBT (2016) based information Ministry Environment Sustainable Development Colombia, Fondo para la Acció Ambiental la Niñez (2015). 8 Facilitating Biotrade countries countries origin place national ABS frameworks operational ensure legal certainty actors involved BioTrade chains. Box 3 Nagoya Protocol affect BioTrade business practice. Key messages Depending national ABS frameworks define scope, distinct phases BioTrade chains affected provisions. BioTrade benefit sharing broader ABS applies biodiversity, including species ecosystems. Benefit sharing BioTrade chain varies considerably case case, terms monetary - monetary dimensions present. Nagoya Protocol , essence, developed contribute legal certainty safeguard interests providing countries action user countries. shoul dbe noted countries users providers. Nagoya Protocol broad scope practice , depending national implementation, cover range BioTrade activities products. Nagoya Protocol -executing. Compliance measures effective providing countries define implement national ABS / BioTrade regulatory frameworks. 9Challenging aCCess Benefit sharing environment 3. natIonal access BenefIt sharIng regulatory frameworks BIotrade: theIr relevance users ProvIders considerable attention paid set initiatives compliance (stimulated Nagoya Protocol), measures effective countries origin provider countries place legislation clear, transparent , importantly, applicable enforceable. , countries origin place effective national legislation regulations implement Nagoya Protocol, measures implemented user countries effect. interpretations utilization genetic resources (GR) provider countries users comply ABS requirements provider countries. Box 4 shows samples scope coverage national ABS frameworks. frameworks pre-Nagoya Protocol adjusted adequately respond obligations. Box 4 demonstrates, BioTrade activities affected ABS legislation progress chain. legislations vary Box 4: Samples regulatory trends scope coverage ABS frameworks provider countries applicable BioTrade: examples Andean Community, African Union, Brazil, Costa Rica, India, South Africa, Kenya, Ethiopia, Peru Viet Nam Law regulation Specific provision() Andean Community Decision 391 (1996) Article 1 (Definitions). Derived product: molecule, combination mixture natural molecules, including crude extracts live dead organisms biological origin derived metabolism living beings. Article 3 (Scope). Decision applicable genetic resources Member Countries countries origin, derived products … Law 7788. Biodiversity Costa Rica (1998) Article 7 (Definitions) 1. Access biochemical genetic elements: Action obtaining samples wild domesticated elements biodiversity, situ situ conditions, knowledge, purpose basic research, bioprospecting economic exploitation. 3. Bioprospecting: systematic search, classification research commercial purposes sources chemical compounds, genes, proteins, microorganisms, products potential actual economic , biodiversity. Biodiversity Act (2002) Rules (2004) India 2. Definitions. () “commercial utilization” means biological resources commercial utilization drugs, industrial enzymes, food flavours, fragrance, cosmetics, emulsifiers, oleoresins, colours, extracts genes improving crops livestock genetic intervention, include conventional breeding traditional practices agriculture, horticulture, poultry, dairy farming, animal husbandry bee keeping; Chapter II. Regulation ABS 3.1. person referred -section (2) , previous approval National Biodiversity Authority, obtain biological resource occurring India knowledge thereto research commercial utilization bio-survey bio-utilization. 10 Facilitating Biotrade Environmental Management - ordination (Conservation Biological Diversity Resources, Access Genetic Resources Benefit Sharing) Regulations, Kenya, (2006) Part .2 Definitions: “Access” means obtaining, possessing genetic resources conserved, derived products , applicable, intangible components, purposes research, bioprospecting, conservation, industrial application commercial ; benefit sharing” means sharing benefits accrue utilization genetic resources; Access Genetic Resources Community Knowledge, Community Rights Proclamation . 482/2006 Ethiopia (2006) General provisions, 2. “Access” means collection, acquisition, transfer genetic resources / community knowledge; Scope: Proclamation apply access genetic resources   situ   situ conditions community knowledge. Order . 18, biodiversity law Viet Nam (2008) Article 3.29 (Definitions) Access genetic resources: means activities investigating collecting genetic resources research development production commercial products. Article 44.1 (Sustainable Development Species) conditional exploitation wild species nature comply law forest protection development, law fisheries relevant laws. Supreme Decree 002-2009-MINAM, ABS regulation Peru (2009) Article 4 (Scope). regulation applies genetic resources Peru country origin, derived products, intangible components genetic resources migratory species … Article 5 (Exclusions). Excluded regulation : ) Activities imply exploitation -timber natural resources produce natural products (nutraceuticals functional foods). African Union (AU) Strategic Guidelines Coordinated Implementation Nagoya Protocol Access Benefit Sharing (2015) 9. AU Member States countries origin countries acquired genetic resources accordance Convention Biological Diversity resolve prior informed consent required access genetic resources genetic resources utilized authorized prior informed consent mutually agreed terms […] 22. African Union Member States domestic legislation require mutually agreed terms provisions fair equitable sharing benefits arising utilization genetic resources, including naturally occurring biochemical derivatives, subsequent applications commercialization derivatives products resulting utilization genetic resources traditional knowledge. 11Challenging aCCess Benefit sharing environment considerably country country. Peru, instance, exception ABS framework activities involving utilization -timber forest products (NTFP) production nutraceuticals functional foods.28 Costa Rica, bioprospecting applies type research broad range biodiversity components purpose commercial exploitation. South Africa, ABS regulations cover BioTrade-related activities natural ingredients products formulation research development inputs industrial sectors. India hand, developed broad -embracing ABS legislation, applies activities biodiversity components (including biological resources) purpose intended, including commercialization. Brazil applies ABS principles activities result commercial exploitation products derived genetic resources. Brazil shifted system focused access phase, system places emphasis benefit sharing aspects. examples include situations common occurrence BioTrade chain processes. Amendments Biodiversity Act . 10, bioprospecting ABS South Africa (2015) Chapter 1. (Definitions). 1. Biotrade: Means buying selling milled, powdered, dried, sliced extract indigenous genetic biological resources commercial exploitation. (Application regulations). 3.1. regulations apply () commercial industrial sectors utilize indigenous genetic biological resources biotrade research, application development drugs, complementary medicines nutraceuticals, industry enzymes, food flavors, fragrances, cosmetics, emulsifiers, oleoresins, colors, extracts essential oils. Law 13.123 ABS Brazil (2015) Article 1. (General provisions). law applies rights obligations related : IV. economic exploitation final product reproductive material derived genetic patrimony … . fair equitable benefit sharing related economic exploitation final product reproductive material derived genetic patrimony … Article 2.. (Definitions). Genetic patrimony: information genetic origin plant, animal, microbial species, including substances originated metabolism living beings. Note: case South African, Viet Nam African Union, translations legal texts -official. Highlights included authors. Key messages ABS regimes vary considerably worldwide terms scope coverage, administrative procedural elements. Compliance measures Nagoya Protocol effective countries origin providers clear operational ABS regimes place, including precise definitions covered scope. considerable implications BioTrade activities cases covered ABS legislation, mandatory application. countries pre-Nagoya ABS legislation revise regulations order align definitions obligations Nagoya Protocol provide clarity interphase ABS BioTrade-related activities. Countries ABS legislation inevitably required regulate ABS Parties Nagoya Protocol adopt compliance measure jurisdictions. regional approaches implementation Nagoya Protocol support management shared resources, reduce transaction costs harmonize standards. 12 Facilitating Biotrade 4. settIng BoundarIes coverage 4.1 Definitions examples assess potential impacts ABS Nagoya Protocol BioTrade-related activities, understanding definitions scope essential. margins CBD Nagoya Protocol, responsibility Contracting Parties define boundaries ABS requirements set cover & commercialization activities. National biodiversity ABS authorities responsibility providing coherent interpretations implementation regulations. Lack inconsistent responses, excessive delays unclear responses guidance contribute potential projects, businesses entrepreneurships cancelled lost countries. scope BioTrade projects, hand, broad, comprising biodiversity related activities conservation, sustainable benefit sharing phases components – specimens ecosystems. Understanding Box 5: Understanding coverage scope Nagoya Protocol Nagoya Protocol Examples BioTrade-type activities potentially related Protocol provisions Scope Protocol (Article 3): Protocol apply genetic resources scope article 15 Convention [CBD] benefits arising utilization resources. Protocol apply traditional knowledge genetic resources scope Convention benefits arising utilization knowledge. • Accessing undertaking & extracts medicinal plants, identifying active compound plant microorganism. • Obtaining TK indigenous community orient guide initial phases & processes (.. , characteristics, dosages medicinal plants). Utilization genetic resources (Article 2): Conduct research development genetic / biochemical composition genetic resources, including application biotechnology defined article 2 Convention. • Undertaking & specific, isolated compounds natural extracts maca (Lepidium meyenii), ñ de gato (Croton lecheri), hercampuri (Gentianella alborosea), medicinal plants sourced Amazon Andes. • Undertaking research extraction processes plant extract, leading potential compositional variations. Centella asiatica extracts compositions vary depending source, extraction process harvesting practices. • Plant animal breeding biotechnology. Biotechnology (Article 2): technological application biological systems, living organisms, derivatives thereof, modify products processes specific . • biotechnology process enzymes lyse plant cells separating hydrophilic lipophilic fractions kernels, leaves, seeds, . • action specific enzymes (.. elongase, desaturase ) transform naturally occurring composition vegetable oil give fatty acid profile. • Insect reproduction genetic modification pest control. Extraction processes analysis compositions. 13Challenging aCCess Benefit sharing environment Derivative (Article 2): naturally occurring biochemical compound resulting genetic expression metabolism biological genetic resources, functional units heredity. • Triglycerides (vegetable oils Argan oil, Marula oil, .). • Phospholipids cell membranes (fractions vegetable oils. • Saps (Aloe Vera juice ). • Secondary metabolites (.. Polyphenols). Fair equitable benefit sharing (Article 5.1): accordance article 15, paragraphs 3 7 Convention, benefits arising utilization genetic resources subsequent applications commercialization shared fair equitable Party providing resources Party acquired genetic resources accordance Convention. sharing mutually agreed terms. " • Providing money capacity building communities actors chain, commercial success product generates income resources. • Involving national researchers upstream research development. • -authoring research papers publications national researchers. • Sharing results research local authorities local indigenous communities. Fair equitable benefit sharing (Article 5.2): Party legislative, administrative policy measures, , aim ensuring benefits arising utilization genetic resources held indigenous local communities, accordance domestic legislation established rights indigenous local communities genetic resources, shared fair equitable communities concerned, based mutually agreed terms. • Establishing law regulation community funds distribute benefits compensate indigenous local community accessing genetic resources natural resources lands territories. • Providing law regulation communities participating bioprospecting project receive - monetary benefits part projects, including training, supporting local infrastructure development, providing free products derived accessed resources, . • Developing national legislation recognizes biocultural community protocols tools empower support benefit sharing local level, utilize soft IP tools geographical indications collective marks options capture culture local values. Fair equitable benefit sharing (Article 5.3): implement paragraph 1 , Party legislative, administrative policy measures, . • Enacting law, regulation, strategy, plan action administrative measure addresses benefit sharing dimensions. Note: -exhaustive list policy/measure related practical examples: ways implementing Nagoya Protocol provisions. 14 Facilitating Biotrade BioTrade-related activities ABS ( Nagoya Protocol provisions) overlap intersect challenge, Box 5. examples Box 5, helpful understand Nagoya Protocol BioTrade-related activities converge. BioTrade activities phases, involving access utilization genetic resources biochemicals (.. & product development) fall national ABS frameworks , Nagoya Protocol. hand, trade commodities direct sale biological resources (.. dried fruits seeds) processed foods (.. meat, bottled juices, food preparations) scope ABS. , cases India Brazil, case. strict legal terms, options interpretation covered Nagoya Protocol, subject national legislative developments definitions, line thought, “cascade type interpretation” Protocol,29 considers scope extends genetic resources se, biochemicals . traditional modern biotechnology research product development indication activity covered Protocol. instance, imply undertaking & DNA strands, RNA, isolated genes complete genomes biochemical compositions genetic resource (.. derivatives). case biochemicals general, include & undertaken classes molecules result metabolisms related genetic expression. include simple complex mixtures molecules resins, saps, oils, hemoglobin, enzyme antibodies. expand examples, enzymes related biological activities widely industry. Research conducted change composition naturally occurring protein obtain specific peptides. change composition vegetable oil digest molecules (.. pectine) fruit pulps. Tellingly, cases genetic resources DNA involved, derivative biochemical. lies importance expansive scope Protocol national ABS frameworks. “cascade interpretation” (noted earlier) universally accepted, helpful purpose providing coherent interpretation Nagoya Protocol dealing dynamic sectors, evolution treatment materials samples. 4.2 elements BioTrade businesses accordance Nagoya Protocol, examples Box 5, considerable set activities BioTrade warrant ABS-induced benefit sharing arrangements implementing laws regulations. , & kind, including biotechnology, applied point BioTrade chain genetic resources, biochemicals , depending case, derivatives, 30 actor participating phase chain comply legislation follow ABS procedures. foreseen ante project product development phase. occur & undertaken progresses time. case negotiate -negotiate ABS conditions. BioTrade projects businesses aware prepared address transaction costs circumstances entail terms time spent administrative procedures, legal counsel costs, fees, . Regulators aware informal questions coverage application ABS laws formal request . Regulators explore options introducing preliminary assessments activity formal request order avoid investment “chilling” effects national foreign users. 4.3 genetic resources, biochemicals derivatives industry & natural interactions humans genetic resources transformed industrial sectors wide range consumer products. Curiosity, inventiveness sectorial led research order assess required claims (.. nutritional compositions specific physiological properties anti-oxidant, anti-inflammatory 15Challenging aCCess Benefit sharing environment activities, blood pressure regulation). cases, research inspired TK ancestral medicinal practices exist world. Examples include Ayurveda Yogi tradition India, traditional Chinese medicine TK ancestral Amazon communities. Depending ultimate purpose acquiring genetic resources, biochemicals / derivatives, additional research activities conducted stages chain, order ensure safety consumers, prior commercialization. true European Union Switzerland, industrialized countries, companies selling raw materials, ingredients advanced products facing levels regulatory obligations ABS , linked industrial sector operate. cosmetic personal care industry, products articles intended “applied human body [...] cleansing, beautifying, promoting attractiveness, altering appearance”,31 plants derivatives endless sources inspiration , , innovations. extract forms, cosmetic ingredients developed provide formulators tools achieve successful cream, lotion, lipstick, . wax, naturally present leaf, key ingredient “long-lasting” lipstick composition demonstrates film-forming properties. indigenous flower skin magnifying properties, illustrated natural beauty local populations (.. Tahiti Tiaré flower). composition fruit oil, traditionally heal wounds, assessed, cosmeceutical formulas. performance angle research process, actor chain legal obligations comply relevant regulation Registration, Evaluation, Authorization Restriction Chemicals (REACH)32 European Union regulation cosmetics33. implies building comprehensive knowledge biochemical composition related safety ingredient prior entering European Union market commercial quantities. information generated level confidentiality, prevents free access stakeholder forms commercial agreements. food industry, research process straightforward, leads outcome easily stakeholders involved chain. main user markets (European Union North America), importer ingredient approved application (.. 2015 Food34 European Union, Generally Recognized Safe (GRAS)35 United States). , prior commercial activity, genetic resource biochemical purpose food require compositional safety tests. general terms, approval validated, remains simple conditions importers product. Additional research steps conducted sector-specific performance claims. Depending nature material evaluated (.. ’ fruit, extract fruit), research outcome freely benefit entire chain (fruit), remain property user applied - raw material add extract. food supplements sector mimics food sector process, regulated environment moves similar safety constraints pharmaceutical industry, purpose related & process extent dimensions “simpler” food sector: actors involved chains, extraction purification processes applied natural resource compulsory research (physiological effects safety assessment) proprietary - (.. confidential) applied research steps. , discoveries innovations & processes lead commercial activities. Processes years completed natural resource (.. genetic resources compound) limited identifying naturally occurring active molecule, chemically synthesized. Significantly, costs & billions dollars takes decade product ready commercialization. Conversely, herbal medicine “-sector”, years highly regulated users countries, focuses raw materials TK . & process decreases timeframes access utilization relies highly providers’ TK. sectorial genetic resources biochemical compounds ways 16 Facilitating Biotrade operating links BioTrade ABS principles. require levels financial investments actors seeking access utilization. Sources biological genetic resources vary considerably sectors. instances, situ sources relevant situ cultivated sources. , addition generated resource travels chain final varies drastically sectors. Highly dependent results obtained performance-oriented research (.. functional active properties), addition ( profits generated) limited investment users safety-related research compulsory user countries. differences chains & process considered policy makers regulators negotiating drafting regulations, negotiating access benefit sharing contracts. Lastly, important issue industry practices type samples “evolve” chain transferred shared researches, universities, situ centers, . Research development processes dynamic constantly changing. , & genetic resource, biochemical / derivative lead lines research product development originally planned envisioned, years research process. situations, provisions Nagoya Protocol, internationally recognized certificate compliance ( traceability legal certainty purposes), checkpoints measures compliance important.36 4.4 regulators receiving access applications Regulators processing applications fully cognizant exact scope coverage national ABS frameworks. case, legislations vary covered ABS. National ABS frameworks step evaluate ABS application contract . Administrative practice critical define scope coverage. frameworks clear coherent, lead complex uncertain situations shown Box 5. instance, processing trade biological resources biochemicals covered national ABS legislation, BioTrade activities subject ABS. ABS frameworks practices limited access utilization genetic resources foreseen Nagoya Protocol, probability affecting BioTrade businesses . BioTrade projects enterprises offer, -front, indication ABS legislation bearing . , biotechnology involved, & product/ output generated derives biodiversity genetic resources, intellectual property (IP) involved ( patents plant breeders rights37), offer guidance coverage Nagoya Protocol ABS frameworks applicable . coverage national ABS laws regulations countries world varies considerably continue changing adapt Nagoya Protocol´ provisions. regulatory examples explicit reference BioTrade se, implications specific BioTrade projects businesses utilization & undertaken biochemicals genetic resources chain indications suggested met.38 Key messages National policy makers develop clear ABS frameworks. Clarity scope, coverage definitions critical step ensuring effective efficient ABS regimes. Regulators apply implement reasonable coherent manner. logical straightforward practice. BioTrade activities fall scope NTFP legislation dealing biological resources. fall ABS Nagoya Protocol framework, depending countries adjust scope coverage flexibilities. examples -encompassing embracing law regulation BioTrade activities” . cases, biotechnology assess gene, active compound molecule 17Challenging aCCess Benefit sharing environment indication ABS frameworks applicable. , intellectual property rights (IPRs) product output provide indications ABS application. & processes vary considerably sectors dynamic change chain. Genetic resources biochemicals part complex & chain technological innovation dramatically changing original, natural form. sector specificities terms safety, regulatory requirements confidentiality. Traceability “” finished product ingredients’ origins necessarily obvious, multi-stakeholder chains transboundary genetic resources derivatives. 18 Facilitating Biotrade 5. BenefIt sharIng challenge normal circumstances, enterprise business, monetary benefits shared chain, responding market price demand forces. nature business. actors chain paid, profits taxes collected State. CBD Nagoya Protocol referring type “regular” benefit sharing. day clear meant “fair equitable” benefit sharing.39 obvious benefit sharing context ABS BioTrade means “ ”, additional extra normal circumstances negotiated commercial agreement transaction. BioTrade Principles Criteria offer guidance “additionality” benefits enabled facilitated providing information, community providers ( strengthen negotiating positions), generating income phases chain, awareness actors potential existing market opportunities. BioTrade, benefit sharing process oriented single act moment chain. Actors prepared demand participate equitable fair benefit sharing scheme. materialize, participation communities business planning, continued technical legal assistance, monitoring reporting tools facilitate communities informed involvement benefit sharing process. case Nagoya Protocol ABS , benefit sharing triggered utilization genetic resources. Utilization means research development genetic biochemical composition genetic resources. implies research development genetic resources biochemicals share benefits . research stage, practice, imply distribution -monetary monetary benefits.40 , commercialization takes place, monetary benefits shared terms original ABS agreement(). Depending national ABS frameworks, benefits negotiated shared State. generally defined contract, permitting fund/ taxing system. indigenous local communities, genetic resources territories TK involved, entitled benefits. depend national ABS frameworks. Nagoya Protocol includes annex describes types monetary - monetary benefits considered national legislation / specific ABS projects initiatives. circumstances , part BioTrade project, ABS obligations triggered specific utilization genetic resources biochemicals commercialization resulting product. deemed “additional” benefit sharing situation BioTrade adding chain. Figure 2 shows illustration BioTrade chain evolve, specific genetic resources application biotechnology involved trigger additional benefit sharing – BioTrade chain. , BioTrade activities sourcing stage (phase 1) materials harvested, collected stocked; processing phase (phase 2) materials transported, transformed processed; research product development phase (phase 3) specific & takes place , finally manufacturing final product commercialization phase (phase 4) sales marketing occur. process, instances (phase 2 / phase 3) specific & takes place triggers access benefit sharing obligations. products sold phase 1 (.. raw materials fruits nuts), processed situ buyer buyer chain. intention buyer diverse. intention simply processing manufacturing methods, risk triggering ABS41 price raw material paid. BioTrade products sold phase 2 level processing manufacture occurred (.. direct sale essential oils), &. cases, Nagoya Protocol provisions triggered. intention undertake & phases 1 2 chain, activity trigger ABS regulations. Phase 3 represents addition ingredient obtained 19Challenging aCCess Benefit sharing environment Phase 2. considered & fully covered ABS regulations. & occurs genetic resources biochemical stage chain, initially anticipated, ABS frameworks respond circumstance change intention . include cases resources leave providing country. important note practice chains linear sample change, phases chain ( figure 2) undertaken actors. Depending law provider user countries, level responsibility chain fall primarily hands actor() “utilizing” genetic resources biochemicals. basically means undertakes & responsibility ensuring legality access activity country. , actors accountable due diligence obligations regional national regulations, aware buying selling conditions sample received travels chain. ABS occur specific stages BioTrade chain. National legislations regulations provide guidance actors stage comply ABS requirements benefits shared . instance, benefits downstream chain (.. Figure 2: Illustration benefit sharing BioTrade chain phases Source: UNCTAD PhytoTrade Africa (2016). 20 Facilitating Biotrade commercialization stage) actors participated process. benefits shared upstream reach community case negotiate ABS agreement point State users share benefits & undertaken country providing original genetic resource benefits generated national jurisdiction address complex questions, case case solutions accumulation experience required. option considered ABS Brazilian law ( Box 4), establish funding mechanism fixed “royalty” payments, monetary benefits distributed, stakeholders farmers, indigenous peoples communities. main advantage option precludes complex ABS negotiations analysis chain identify ABS contracts required. main difficulty option determine “royalty” paid. Brazilian law global sales, difficult determine practice, case multinationals. options include share “ tax” income generated key users “special added tax” biodiversity based products. creative options benefit sharing explored reduce transaction costs timeframes prior informed consent contract negotiations, key concerns businesses. Finally, due increasing regulatory constraints, safety, traceability chain, reliability shared information, strategic selection criteria users BioTrade, responsibility place consumer products markets. uncertainties sourcing legal duties, including ABS obligations, lead collapse liabilities BioTrade project enterprise.42 chains remain long complex, intermediaries activities potentially trigger ABS obligations adding resource product. , products multiple ingredients, reliability, transparency availability information increases exponentially. , time, business endeavor, confidentiality actors chain effect information availability. case ABS, Nagoya Protocol, Article 14, established ABS Clearing House43 means sharing information related ABS, requires Parties ABS Clearing- House information: national focal points competent national authorities, ABS legislative, administrative policy measures, permits equivalent issued time access. Nagoya Protocol rules, permit equivalent granted accessing genetic resources BioTrade project phase, country issuing permit required ABS– CH. permit equivalent internationally recognized certificate compliance article 17.2 Protocol.44 5.1 Monetary -monetary benefits “Benefit sharing” context BioTrade access genetic resources dimension, additional classical commercial relationships, actor chain focuses making profitable business acquired produced. Benefit sharing forms expressed money - money terms. BioTrade, perception brought receiver benefits defines actual . cases, monetary benefits arise stages chain highest final commercialization phase natural resource product, added. essential element chain, actor supposed receive compensation payment services products . ideal scenario, actor reach profitable stage chain development process. Prices based mutually agreed terms ( contractual), buyers aligned sellers’ offer specifications. , parties capacity negotiate respective interest. regular business practice responds market forces, positively influenced fair trade principles, good business practices, sustainability criteria, exclusivity contracts, local employment addition preferences, considerations core BioTrade enterprises seeking improve asymmetries relations actors chain. 21Challenging aCCess Benefit sharing environment case monetary benefit sharing, classical commercial industrial ABS BioTrade projects ( nuances),45 money generated. commercial success product determine monetary benefits shared upstream, researchers / communities, farmers materials & process, including situ centers. , indirect benefits depending nature business project. “ kind” (.. -monetary), equipment improve process improve quality control. “intangible”, form knowledge sharing (training, building capacity local level, improving production methods, diversification products, developing marketing strategies, identifying market opportunities, .). forms -monetary benefits potentially create strengthen local capacities, result favorable conditions place negotiating parties similar level strengths protect respective commercial interests. types benefits lead adding locally, placing seller higher stage chain. Key messages Fair equitable benefit sharing classical access genetic resources projects BioTrade responds commercial transaction market driven negotiation result. Benefit sharing obligations Nagoya Protocol triggered moment utilization genetic resources, biochemicals component covered national ABS frameworks. BioTrade chain, ABS situation imply additional sharing benefits calculated chain, specific phase chain. BioTrade, benefit sharing process oriented series conditions suggested Principles Criteria facilitate . Fairness equity dimensions blurred analysis. , BioTrade Principles Criteria targeted enabling conditions facilitate support equity fairness chain. Benefits chain extremely varied diverse, direct payments, funding mechanisms, -monetary forms benefits. -monetary benefits incentive based means revalue biodiversity. Legal uncertainty main reason inhibiting projects business making enterprises BioTrade ABS collapse altogether. “Benefits” “profits” , , direct taxing systems affect competitiveness. 22 Facilitating Biotrade 6. PIc mat PrIncIPles: exIstIng aPProaches oPtIons BIotrade Benefit sharing, prior informed consent (PIC) mutually agreed terms (MAT) core international ABS frameworks CBD, International Treaty Plant Genetic Resources Food Agriculture (ITPGRFA) Nagoya Protocol. inform national legal regulatory schemes ABS. Generally, PIC reflects, administrative procedure, acceptance State authorities cases indigenous peoples ABS activities place. regard MAT, terms invariably translate bilateral agreements contracts ABS conditions specifically defined bind State actors involved ABS, depending specifics legislation regulations. explicitly implicitly elaborated detail, existing ABS policy legal frameworks based principles. BioTrade Principles Criteria, BioTrade projects businesses apply, broadly, basics PIC (consent) MAT (agreement) principles chain. indigenous people participate providers genetic biological resources related TK. BioTrade projects businesses operate basis contracts, permits, authorizations material transfer agreements ( shown case study Box 6). , utilization genetic resources biochemicals arise chain, application ABS principles mandatory national ABS legislation regulations. Options MAT PIC vary considerably national legislation. , MAT PIC required simultaneously State providers genetic biological resources. cases, agreement State’ competent authority suffice legitimize genetic biological resources. , required law, specific agreement reflects MAT PIC needed indigenous people local communities TK accessed . entry force Nagoya Protocol European Union Directive implementation Protocol (511/2014 EU) clear unequivocal MAT PIC important, part set measures evaluated condition enter European Union. noted case BioTrade projects business arrangements, type PIC MAT obtained required national ABS laws. sense, policy makers regulators ways PIC MAT BioTrade projects, businesses enterprises, regularized validated simple practical administrative procedures purposes ABS law. Future regulations seek recognize type PIC MAT agreed BioTrade project “sufficient” purposes fulfilling ABS regulations undertake PIC MAT, implies direct benefits State. approach continuation businesses, employment addition time fulfill spirit ABS regulatory objectives.46 Key messages Nagoya Protocol, minimum legal requirements access genetic resources PIC MAT – granted negotiated State entity. expressed permit, material transfer agreement, authorization / access contract. National ABS legislations world vary considerably PIC MAT expressed materialized. BioTrade incorporates PIC MAT principles, easier fulfillment ABS requirements. , type PIC MAT actors granting required national ABS law. Regularization recognition PIC MAT BioTrade projects enable continuation business, employment addition. 23Challenging aCCess Benefit sharing environment Box 6: Case study BioTrade ABS: Imports fresh plants Namibia Europe Summary project/business: farm Namibia, producing selling plants herbal supplements European Union United States, expand activity offer markets. looked endemic plant, easy reproduce, sap skin healing properties. extraction methods locally accessible order develop extract. Eager enter cosmetic industry innovative competitive ingredient, ’ve requested support trade association (PhytoTrade Africa). project design, decided extraction methods possibly outsource. investigation, process identified relevant project. SME providing required services identified contracted European Union order conduct extraction trials related analytical work. kilograms fresh plants imported order run extraction tests. BioTrade ABS considerations: Namibia party Nagoya Protocol 2014. National ABS measures place, law discussion, retroactivity utilization -situ collection pre-Nagoya potentially part national ABS law. specific project, anticipate ABS obligations arising development process, recipient fresh plants European Union, Material Transfer Agreement (MTA) commercialization purposes signed PhytoTrade Africa behalf farm. document, purpose transfer material explicitly “compositional activity research material potential product development”. , details processes tested. farm granted research permit exact purpose written MTA. -disclosure agreement contract signed European Union-based SME providing services. Prior physical import, European Union’ Council Directive 2000/29/EC, PhytoTrade Africa contacted Competent Authorities comply due diligence importing fresh plants. outcome shared farm apply Export Phytosanitary certificate. Fresh plants traveling original copy Export Phytosanitary certificate. document customs point entry European Union. clear material, statement importer required mention outcome due diligence 2000/29/CE, plant , imported plant parts, importer, contact details final destination intended . unsuccessful attempts due logistics problems resulted destruction plants, kilograms fresh plants finally reached final destination. Main lesson: case illustrates provider user ABS regulations ( Europe). shows importance fulfilling obligations international trade export Europe (.. due diligence), customs institutions check-point. case interesting involves MTA means securing MAT, anticipates potential ABS duties arising BioTrade process, requires export phytosanitary permit ensure legal export fresh material Europe, highlighting pragmatic potential developing “-stop-shop” approach providing countries. Source: UNCTAD PhytoTrade Africa (2015). BioTrade Biodiversity project approved : http:// phytotrade./news/biotrade--biodiversity-project-approved-2/). Names actors case study confidential. 24 Facilitating Biotrade 7. comPlIance measures theIr ImPlIcatIons BIotrade47 rationale development compliance measures ( referred “user measures”) based fact countries origin, relying national ABS legislation , limited possibilities ensure interests benefit sharing effectively realized. genetic resources leave national jurisdictions, monitoring enforcing ABS contractual obligations highly problematic, complex & chain include, , subsequent transfers biological genetic resources, related innovations.48 Ensuring compliance ABS legislative regulatory requirements challenge. reasons ABS frameworks defensive restrictive regulatory approach, overlooked principle CBD calls access facilitated - boundaries. Article 15.7 CBD offers legal foundation developing compliance user measures establishing : “ Contracting Party [ users providers] legislative, administrative policy measures, , […], aim sharing fair equitable results research development benefits arising commercial utilization genetic resources […]”. [Highlight authors] Article 15.7 stresses actions needed Contracting Parties user countries ensure realization benefit sharing objective CBD. Initial proposals ideas “user measures” received reluctance, open opposition receive support developed nations 1990´.49 , time Bonn Guidelines approved, user measures firmly established part policy conceptual discussions ABS. Examples user measures originally focused developments adjustments IP (patent breeders rights) laws regulations support defensive protection biodiversity TK. Bonn Guidelines included specific section measures implemented user side support realization benefit sharing, compliance PIC MAT, .50 Ironically, user measures developed implemented provider countries.51 Nagoya Protocol refined mandatory series compliance measures , account countries users providers, important developed countries terms legal certainty developing countries terms benefit sharing safeguarding interests genetic resources ( TK).52 response obligations Nagoya Protocol, European Union adopted Directive implementation Protocol (511/2014 [EU]) comprehensive compliance oriented framework offers guidance member states making Protocol work practice, users jurisdictions. Users countries required exercise due diligence ascertain genetic resources accessed accordance relevant legal regulatory mandates. instance, situ collections registered comply standards exercise due diligence management transfers genetic resources collections. Designated checkpoints contribute implementation Nagoya Protocol. Checkpoints effective collect receive information users , inter alia, stage research, development, innovation, pre- commercialization commercialization. checkpoints public funding institutions ( researchers apply funds required ensure documentation order undertake research activities genetic resources). checkpoints : competent national biodiversity authority user country; research institutions subject public funding; publishers entities engaged publication research results related utilization genetic resources; intellectual property offices; / authorities regulate grant authorization selling products market. measures, European Union countries world, “defensive protection” IP procedures ( patents), , de facto, 25Challenging aCCess Benefit sharing environment Box 7: sample regulatory trends user countries (European Union, Norway Switzerland) applicable BioTrade Regulation (EU) . 511/2014 compliance measures users genetic resources Nagoya Protocol (2014) (21): view implementing Nagoya Protocol, users genetic resources traditional knowledge genetic resources exercise due diligence ascertain genetic resources traditional knowledge genetic resources accessed accordance applicable legal regulatory requirements ensure , relevant, benefits equitable shared. context, competent authorities accept internationally-recognized certificates compliance evidence genetic resources covered legally accessed mutually agreed terms established user utilization . (23): due diligence obligation apply users irrespective size, including micro, small medium-sized enterprises. Regulation offer range measures tools enable micro, small medium-sized enterprises comply obligations affordable cost high level legal certainty. Article 2.1 (Scope): Regulation applies genetic resources States exercise sovereign rights traditional knowledge genetic resources accessed entry force Nagoya Protocol Union. applies benefits arising utilization genetic resources traditional knowledge genetic resources. Article 4.3. (Obligations users): purpose paragraph 1, users seek, transfer subsequent users: internationally-recognized certificate compliance, information content mutually agreed terms relevant subsequent users. Article 5 (Register collections) 5.1: Commission establish maintain register collections Union (“ register”) […] Article 5.3 order collection part collection included register, collection demonstrate capacity : ) apply standardized procedures exchanging samples genetic resources related information collections, supplying samples genetic resources related information persons utilization line Convention Nagoya Protocol. ) supply genetic resources related information persons utilization documentation providing evidence genetic resources related information accessed accordance applicable access benefit sharing legislation regulatory requirements , relevant, mutually agreed terms. Article 7 (Monitoring user compliance): 1. member States Commission request recipients research funding involving utilization genetic resources traditional knowledge genetic resources declare exercise due diligence accordance Article 4. 26 Facilitating Biotrade Patent Act Norway, Act . 9 1967 patents, amended 2015 Section 8 . invention concerns biological material traditional knowledge, patent application include information country inventor collected received material knowledge ( providing country). national law providing country access biological material traditional knowledge subject prior consent, application state consent obtained. providing country country origin biological material traditional knowledge, application state country origin. country origin means biological material country material collected natural environment traditional knowledge country knowledge developed. national law country origin requires access biological material traditional knowledge subject prior consent, application state consent obtained. information set subsection , applicant state . Patent Act Switzerland, amended 2012 Article 49..II. Information source genetic resources traditional knowledge. 1. patent application information source: - genetic resource inventor patent applicant access, invention based resource; - traditional knowledge indigenous local communities genetic resources inventor patent applicant access, invention based knowledge. 2. source unknown inventor patent applicant, patent applicant confirm writing. Note: side note article 49. highly relevant purpose . Federal Act Protection Nature Cultural Heritage Switzerland (amended 2014) Article 23n 76, 1 (Due diligence requirement): person accordance Nagoya Protocol utilizes genetic resources derives benefits utilization (users) apply due diligence circumstances ensure : . resources accessed lawfully; . mutually agreed terms fair equitable sharing benefits established. Article 23o 77 (Notification requirement): Notification compliance due diligence requirement FOEN market authorization obtained , authorization required, commercialization products developed basis utilized genetic resources. Note: Highlights authors. countries Europe, including Belgium, Sweden, France, Netherlands Germany, included similar provisions legislation, linking ABS IP. official translations. 27Challenging aCCess Benefit sharing environment check point legitimate genetic resources biochemicals verified granting exclusive rights. important aspect compliance measures link national regulation provider country. Article 15 (Compliance Domestic Legislation regulatory Requirements ABS)53 Article 16 (Compliance Domestic Legislation regulatory Requirements ABS TK)54 Protocol, users countries required adopt measures ensure national legislation provider countries complied jurisdictions. , Parties required adopt measures address situations -compliance cooperate cases alleged violations. means user country limit responsibility verification countries national law mechanism place verify legality flows resources countries (.. measures place users). important note Nagoya Protocol implementing regulations European Union Switzerland retroactive effect. means apply Post-Nagoya situations. measures main effects. , ensure legal certainty providers users. , importantly, provider countries obliged enact ABS legislation ensure operational, including PIC, MAT, benefit sharing , issuance permit equivalent time access mandated Nagoya Protocol. effective actions measure users providers Nagoya Protocol realized. Key messages Compliance measures common. implications BioTrade practitioners respect ABS requirements provider user countries alike. important Parties Protocol considered potential providers users genetic resources TK comply obligations. Typical compliance related measures include defensive measures IP system ( patent procedures ) due diligence requirements. Parties establishing checkpoints facilitate monitoring utilization genetic resources chain implement Article 17 Protocol. European Union Switzerland rapidly advancing adopting regulations developing guidelines implement compliance measures Nagoya Protocol. flip side user measures effective efficient national ABS frameworks provider export countries. 28 Facilitating Biotrade 8. IndIgenous PeoPle, local communItIes BIotrade: challenges oPtIons aPPlyIng cBd nagoya Protocol PrIncIPles local level existing BioTrade projects businesses relate extent indigenous people local communities chain. initial stages biological materials sought required. , TK support complement research development. cases, TK defines good practices methods production processing scientific evidence doesn’ exist support validate effectiveness. Consent agreements indigenous people local communities, local authorities, legitimize interactions define form type benefit sharing place. practice, PIC MAT place regulatory vacuums specific normative guidance . countries Costa Rica, Peru Panama, regional blocs African Union, specific legislation place pertaining TK protection. Experience BioTrade projects shows trust constructed users communities projects businesses develop. BioTrade Principle 7 offers guidance regard. TK subject PIC indigenous people communities accessed part adding chain. Box 8 offers BioTrade enterprise medicinal plants traditional industrialized commercialized Viet Nam. Box 8: Case study BioTrade ABS: Medicinal plants Viet Nam Description: Traphaco SaPa Viet Namese company specializing sourcing natural ingredients Traphaco Group, largest traditional medicine producer Viet Nam. Traphaco Group conducts research development food, cosmetics pharmaceutical products herbal plants. hundreds internal research projects, collaborations government institutions, including explore develop gene pool valuable medicinal plants Viet Nam, including Dioscorea persimilis ( type yam) Coix lacryma-jobi (commonly English Job’ tears). Interface BioTrade ABS: Traphaco SaPa responsible implementing Traphaco Group Green Plan Project, focuses improving practices sourcing, research development medicinal plants. advance objectives, Traphaco SaPa member Union Ethical BioTrade (UEBT) 2014. UEBT member, Traphaco SaPa working mechanisms ensure monitoring prices paid producers systematize support producers local development capacity building. reviewing practices integrate Ethical BioTrade requirements biodiversity-based research development. , support Helvetas BioTrade project, Traphaco SaPa focused improving practices Ampelopsis cantoniensis supply chain. medicinal herb scientific books journals Viet Nam herbal medicine treat gastric intestinal inflammation. Helvetas BioTrade project conducted assessment socio-economic aspects mapping actors supply chain, served basis improving practices. Traphaco SaPa developed mechanism build direct dialogue collector groups, supporting organizational mechanisms, technical training capacity development. Traphaco SaPa agreements place, collector groups local authorities linked ethical BioTrade practices. 29Challenging aCCess Benefit sharing environment support implementation Nagoya Protocol respect TK, Protocol suggests instruments TK protected. Community biocultural protocols, customary practices model contractual provisions options countries . case TK widely disseminated distributed communities jurisdictions, Protocol avenue address specific situation context transboundary cooperation. 55 Key messages examples exist effective national TK protection frameworks. time, BioTrade, TK governed MAT (contracts) communities TK accessed . , widely shared, disseminated TK difficult identify single, legitimate holder TK. Nagoya Protocol offers considerable guidance includes substantive provisions TK protection (.. PIC community protocols), benefit sharing (.. MAT) compliance aspects. Traphaco SaPa received training concepts requirements linked access genetic resources fair equitable benefit sharing (ABS). result, contact Biodiversity Conservation Agency Viet Nam follow implementation 2008 Biodiversity Law development rules procedures ABS, part Viet Nam’ commitments Party Nagoya Protocol. Lessons learnt: case study shows business engagement BioTrade increases awareness ABS facilitates eventual compliance ABS requirements. important point role traditional knowledge research development natural ingredients. project include direct relationships traditional knowledge holders. due traditional knowledge related plants widely , shared Viet Nam, difficult define legitimate holders potential benefit recipients traditional knowledge. Source: UNCTAD UEBT (adapted http://ethicalbiotrade.org/helvetas-Viet Nam-interview--rik- kutsch-lojenga-executive-director-uebt/), Helvetas Viet Nam BioTrade Project (https://Viet Nam. helvetas.org/en/activities/projects_in_Viet Nam/biotrade/), Traphaco Group (http://www.traphaco. .vn/en/product/phamaceutical/herbal-tonic-products). 30 Facilitating Biotrade 9. role Intellectual ProPerty certIfIcatIon BIotrade BioTrade projects businesses world forms IP protect innovations promote marketing products ( Box 9). common tools patents trademarks. existence patent breeders rights obtained based genetic resources biochemicals implies “utilization” Nagoya Protocol. impossible generate inventions plan varieties genetic resources biochemicals level access physical material level &, information accessed transferred genetic information chemical biochemical formulas.56 UNCTAD developed Handbook Convention Biological Diversity Nagoya Protocol: Intellectual Property Implications -depth analysis interaction IP regime obligations Protocol57. guidance considered assessing IP tools engaging BioTrade. cases BioTrade, form certification social/market recognition scheme highlight reputation sustainable product process. tools vary widely objectives voluntary, summarized terms providing advantage added product process appreciated market consumers ( Box 10). Box 9: IP “kick ” BioTrade biodiversity-based project business IP subject matter protected Phase project business IP sought Aldivia (France): www.aldivia. Trademarks (.. Ubuntu) covering range ethically sourced ingredients – ethic claim substantiate charter Commercialization Aldivia (France): www.aldivia. Patent (FR2883003A11, jointly filled Aldivia PhytoTrade Africa) discovery derivative fraction research commercialization Hersil SAC (Peru): www.hersil..pe trademark, “Schuler”, commercializes ointments dietary supplements Prior commercialization Peruvian Seaweed (Peru): http://www.pswsa./ natural molecule, extracted marine algae, named trademark “Marintec”, identified biotechnology division, bioactive natural compounds wide range products. Prior commercialization Key messages IP plays key role BioTrade classical ABS projects. Innovations require IP protection marketing strategies IP tools. forms certification, BioTrade processes products , important promote products chain means gain market share convince consumers. 31Challenging aCCess Benefit sharing environment Box 10: Certification, standards mark schemes relevant BioTrade Tool Objective Union Ethical Biotrade (UEBT) www.ethicalbiotrade.org UEBT international, -profit association promotes “Sourcing Respect” ingredients biodiversity. Ethical BioTrade advances sustainable business growth, local development biodiversity conservation. UEBT members, include companies sourcing natural ingredients food, cosmetics pharmaceuticals, commit Ethical BioTrade Standard, based BioTrade principles Criteria. FairTrade (Fair Trade Labelling Organization International) www.fairtrade.net FairTrade international organization sets standards seek : ensure producers receive prices cover average costs sustainable production; provide additional Fairtrade Premium invested projects enhance social, economic environmental development; enable pre-financing producers require ; facilitate long-term trading partnerships enable greater producer control trading process; set clear core development criteria ensure conditions production trade Fairtrade certified products socially, economically fair environmentally responsible. Fair Wild www.fairwild.org FairWild Standard Certification System  sustainable management collection wild plants, FairWild Foundation promotes sustainable wild- collected ingredients, fair deal involved supply chain. Fair Life www.fairforlife.net Fair Life Social & Fair Trade Certification Programme offers operators socially responsible projects solution brand neutral party inspection certification initial production, manufacturing trading. combines strict social fair trade standards adaptability local conditions. system designed food -food commodities ( cosmetics, textiles tourist services). Forest Stewardship Council (FSC) www.fsc-uk.org/-- fsc.73.htm FSC international NGO dedicated promoting responsible forestry. FSC certifies forests NFTP world ensure meet highest environmental social standards.  International Federation Organic Agriculture Movements (IFOAM) www.ifoam.bio IFOAM international federation organizations dedicated promotion organic production. IOAS, certifies organic standards met certification bodies worldwide. International Standards Organization (ISO) www.iso.org ISO international organization sets process/product quality standards applied certification organizations. relevant BioTrade, ISO 9000 environmental quality management standards. Country Mark Trademark (.. Marca Peru, Beautiful Malaysia, Ecuador, Magic Colombia). distinctive sign identify country specific features, values, culture, tradition, excellence, . Source: Produced authors. 32 Facilitating Biotrade 10. Issues consIderatIon stePs Nagoya Protocol entered force, . Mukisha Kituyi, Secretary-General UNCTAD, hailed “…historic achievement annals multilateral environmental agreements. expressed protocol “… major … positive implications genetic resource flows, trade biodiversity-based products related & activities. strengthen conservation biodiversity, sustainable ensure equitable access sharing benefits communities companies.” Nagoya Protocol pillar realization key principles CBD. strengthen multilateralism coordination coherent national actions. responds wake- call United Nations 2030 Agenda Sustainable Development placing biodiversity responsible, equitable ethical approach biodiversity conservation sustainable support improved livelihoods. order improve understanding advance practical options implement ABS obligations CBD Nagoya Protocol BioTrade principles coherent mutually supportive manner, issues considered decision makers, regulators, international governmental organizations UNCTAD, BioTrade businesses relevant stakeholders: ) CBD Nagoya Protocol principles interpreted systematically. Parties entitled regulate access genetic resources biochemicals , time, facilitate access means generate share benefits equitably. clear compliance obligations introduced Nagoya Protocol Parties users genetic resources, biochemicals TK, provider country ABS requirements restrictive. contribute legal certainty parties actors involved utilization genetic resources. Decision makers regulators ensure ABS frameworks adequately respond aspects overstress regulation control , decades limited effectiveness generate benefits facilitate sharing. Incentives promote ABS compliance rules put place motion order promote legal, sustainable, equitable ethical flows trade genetic resources biochemicals. ) Access benefit sharing regimes transparent, clear, operational applicable practice enhance legal certainty actors. goals Nagoya Protocol. time, regulators implement regimes logical coherent manner. Compliance measures called Nagoya Protocol, developed implemented countries, demand effectiveness efficiency ABS regimes procedures provider countries. ) Support continuously decision makers regulators alike BioTrade- friendly implementation Nagoya Protocol, initial stages enforcement Protocol. Firstly, UNCTAD develop set indicators checklist guide decision makers / regulators close BioTrade activity coverage national ABS regulations procedures. , UNCTAD develop synthesis case studies examples countries determining connections interlinkages BioTrade projects businesses ABS frameworks. Finally, lessons existing experiences benefit sharing BioTrade case studies examples disseminated ABS policy makers regulators extract lessons existing experiences, BioTrade offers proven enabling environment support realization benefit sharing. substantially improve synergies complementarities ABS BioTrade. ) Authorities responsibility BioTrade- related activities ABS rules procedures communicate coordinate regular manner ensure coherent implementation rules procedures. Duplication procedures unnecessary transaction costs act disincentive undertaking research, developing productive commercial activities avoided. ) Understanding changing diverse & landscape important determine connections BioTrade ABS 33Challenging aCCess Benefit sharing environment occur. intention moves unplanned research areas state art technologies, relevant entities illustrate landscape assess specific relevance BioTrade. Starting cosmetics, nutraceutical natural products industries offer insights intricacies & enable understanding importance context BioTrade ABS interface. ) UNCTAD undertake assessment determine analyze TK relates interface BioTrade-related activities ABS. assessment include analysis PIC, MAT benefit sharing place context indigenous peoples communities participating BioTrade chains specific ABS projects . ) Decision makers regulators ways PIC MAT BioTrade projects business arrangements regularized validated simple practical administrative procedures. light rapid implementation Nagoya Protocol, prove ensure continuation businesses, employment addition. facilitate market accessibility, Europe Switzerland products developed BioTrade covered ABS laws regulations. ) -monetary benefits generate underappreciated rarely linked providers’ national scientific, technology, development biodiversity strategies, plans programs. Decision makers regulators develop implement measures strongly encourage specific measurable -monetary benefits means support sustainable biodiversity-based economy. ) Clear easy procedures obtain permits equivalent evidence decision grant PIC establishment MAT , -selected checkpoints critical ensure proper traceability frameworks. measures create incentives comply bringing legal certainties required users. ) UNCTAD, CBD relevant entities intensify efforts activities related awareness raising capacity building BioTrade actors, including national authorities, Nagoya Protocol. existing experiences demonstrate BioTrade activities business quick adapting responding series national regulatory legal requirements (.. obtaining concessions, formalizing organizations chain, forming alliances partnerships communities, paying taxes, complying phytosanitary norms, obtaining commercial authorizations, .), difficulties specifically seeking comply ABS frameworks. BioTrade entrepreneurs, businesses, projects related actors fully aware connections activities ABS dimensions demand additional efforts comply regulatory procedural ABS requirements national level ( user provider countries). 34 Facilitating Biotrade References Cabrera, Jorge (2013) El Protocolo de Nagoya: Opciones para su Implementació Política en érica Latina. Proyecto GEF sobre Acceso Recursos Genéticos Distribució de Beneficios para érica Latina del Caribe - GEF ABS LAC. UICN, GEF. Quito, Ecuador. http://www.portalces.org/sites/default/files/ migrated/docs/Doc_Tec_PN_Retos_AL.pdf. CBD. Business 2010. Magazine Business Biodiversity. Special Focus Biotrade. , 2010. https://www.cbd.int/doc/newsletters/news-biz-2010-05-en.pdf. Correa, Carlos (2011) Implications BioTrade Nagoya Protocol Access Genetic Resources Fair Equitable Sharing Benefits Arising Utilization. United Nations, York Geneva. http://www.biotrade.org/ResourcesPublications/UNCTAD_DITC_TED_2011_9.pdf. De Jonge, Bram (2009) Plants, Genes Justice. Inquiry Fair Equitable Benefit Sharing. Thesis, Wageningen University, Netherlands. Pastor, ., Ruiz, . Development International Regime Access Genetic Resources Fair Equitable Benefit Sharing Context Technological Developments. Initiative Prevention Biopiracy. SPDA. Year IV . 10 April 2009. : https://www.cbd.int/abs/doc/serie-iniciativa-2009- 04-en.pdf. Pistorious, Robin (1997) Scientist, Plants Politics: History Plant Genetic Resources Movement. IPGRI, Rome, Italy. Ruiz, Manuel (2015). Genetic Resources Natural Information. Implications Convention Biological Diversity. Earthscan Routledge. Oxon, York. Tobin, Brendan (1997) Certificates Origin: Role IP Regimes Securing Prior Informed Consent. : Mugabe, ., Barber, ., Henne, ., Glowka, ., La Viñ. . (Eds.) Access Genetic Resources: Strategies Benefit Sharing. ACTS Press. Nairobi, Kenya. , https://www.academia./6636676/ Certificates_of_Origin_A_role_for_IPR_Regimes_in_Securing_Prior_Informed_Consent. UNCTAD (2014). Convention Biological Diversity Nagoya Protocol: Intellectual Property Implications - Handbook Interface Global Access Benefit Sharing Rules Intellectual Property. UNCTAD, Geneva, Switzerland. http://unctad.org/en/PublicationsLibrary/diaepcb2014d3_en.pdf. Union EthicalBioTrade. Frequently Asked Questions Nagoya Protocol ABS. UEBT. http://ethicalbiotrade.org/dl/benefit-sharing/ABS_FAQ_2014.pdf. Vivas Eugui, David Cusi, Mariona. Nagoya Protocol potential BioTrade vehicle promote ABS compliant chains, CBD business .2020, Vol. 10 - Issue 1, Nov. 2015. https://www.cbd. int/doc/newsletters/news-biz-2015-11-en.pdf. Notes 1 BioTrade refers “activities collection, production, transformation, commercialization goods services derived native biodiversity criteria environmental, social economic sustainability”. Chapter 1 study information. 2 CBD signed June 1992, part series international instruments adopted United Nations Conference Environment Development (UNCED), held Rio de Janeiro, Brazil, “Rio 92”. Nagoya Protocol adopted Tenth Conference Parties CBD held Nygoya, Japan, October 18-29, 2010. Protocol entered force October 12, 2014. 3 Regional frameworks include Andean Decision 391 African Union Model Law access biological genetic resources. National frameworks place Australia, Plurinational State Bolivia, Brazil, Colombia, Costa Rica, Ecuador, India, Panama, Peru, South Africa, Philippines, Bolivarian State Venezuela, . addition, International Treaty Plant Genetic Resources Food Agriculture (ITPGRFA), adopted November 3, 2001, ABS instrument targeted specifically plant genetic resources food agriculture. 4 UNCTAD. BioTrade Initiative, Principles Criteria. Geneva, York, 2007. http://www.biotrade.org/ ResourcesPublications/UNCTAD_BT_PC_en.pdf. 5 BioTrade activities sourcing stage (phase 1) materials harvested, collected stocked (prophase 1); processing phase (phase 2) materials transported, transformed processed; research product development phase (phase 3) specific & takes place , finally manufacturing commercialization phase (phase 4) sales marketing occur. process, instances (phase 3) specific & takes place triggers benefit sharing obligations. 35Challenging aCCess Benefit sharing environment 6 “Native” understood biodiversity unique singular country ( “ country origin” literal terms) time adapted environment native naturalized. instance, Peru country origin cocoa cocoa native crop. , BioTrade projects focusing Peruvian cocoa adapted, diversified country “” native time. country origin plant crop, crop “native” terms BioTrade definition. 7 UNCTAD. BioTrade Initiative, Principles Criteria. Geneva, York, 2007. http://www.biotrade.org/ ResourcesPublications/UNCTAD_BT_PC_en.pdf. 8 Vivas Eugui, David Cusi, Mariona. Nagoya Protocol potential BioTrade vehicle promote ABS compliant chains, CBD business .2020, Vol. 10 - Issue 1, Nov. 2015. 9 Article 1 CDB establishes : objectives Convention, pursued accordance relevant provisions, conservation biological diversity, sustainable components fair equitable sharing benefits arising utilization genetic resources, including access genetic resources transfer relevant technologies, account rights resources technologies, funding. 10 definition “biological diversity”, CBD refers levels: diversity ecosystems, species genetic level. “Biological resources” defined including “genetic resources, organisms parts thereof, populations, biotic component ecosystems actual potential humanity”. entrepreneurship undertaken native biodiversity – levels – accordance BioTrade Principles, fall scope. 11 http://www.biotrade.org/aboutINTRO.asp 12 include Andean BioTrade Program (2010-2014) CAF/GEF (Colombia, Ecuador, Peru) (http://www.biocomercioandino.pe/proyecto-biocomercio-andino/descripci%C3%B3n-del-proyecto.aspx), national program Peru (http://www.biocomercioandino.pe/biocomercio-en-%C3%BA/programa- nacional-de-promoci%C3%B3n-del-biocomercio.aspx), BioTrade support program Viet Nam (https://vietnam.helvetas.org/en/activities/projects_in_vietnam/biotrade/), . Depending BioTrade program, exclude activities involve genetic resources generation genetically-modified organisms. 13 BioTrade Congress held Rio de Janeiro, Brazil, 2012 (http://r0.unctad.org/biotrade/ congress/event3rdCongress.htm); BioTrade Congress held Geneva, Switzerland, 2013 (http://r0.unctad.org/biotrade/congress/event.htm). BioTrade Congress held Pyeongchang, South Korea, 2014 (http://r0.unctad.org/biotrade/congress/event3rdCongress.htm) 14 UEBT key promoter implementer BioTrade principles, direct action business community social actors. membership structure includes large, medium small businesses, natural ingredients cosmetics sector countries, strict verification program, UEBT successful supporting sustainable international trade biodiversity. UEBT developed Verification Standard, “measure” BioTrade Principles Criteria implemented, means shape inform sustainable sourcing practices. , http:// ethicalbiotrade.org/verification/ethical-biotrade-standard/ 15 , COP 10 Decision /21 (2010) Business Engagement explicit reference BioTrade Initiative ( initiatives institutions) role supporting incorporation biodiversity dimensions business practices. includes COP 12 Decision XII/10 (2014), Business Engagement, recognizes “[…] Biotrade Initiative United Nations Conference Trade Development, existing initiatives promote corporate social responsibility greening supply chains…”. mentions BioTrade “ importance engine sustainable biodiversity conservation involvement private sector”. Similarly, COP 12 Decision XII/6 (2014) encourages business “increase, , participation cooperation , BioTrade Initiative (…) national, regional global levels committed sustainable biodiversity, sustainable harvesting practices, access benefit sharing framework Nagoya Protocol (…)”. 16 MDGs adopted Millennium Summit 2000, York. 17 goals approved United Nations General Assembly September 25, 2015. Specifically relevant targets SDGS 15 include: target 15.1 halting loss biodiversity; target 15.6 fair equitable sharing benefits; target 15.9 integrating ecosystem biodiversity values national planning. relevant, albeit indirectly, SDG 12 (Responsible Consumption Production), 14 (Marine resources conservation) Goal 17 (Partnerships). details process https://sustainabledevelopment..org/topics. specific goals targets https:// sustainabledevelopment..org/menu=1300 36 Facilitating Biotrade 18 identification synergies REDD + BioTrade activities place Brazil, Colombia Ecuador, http://www.biotrade.org/ResourcesPublications/webditcted2015d5_en.pdf BioTrade Congress addressed issue, reflected report, http:// unctad.org/en/PublicationsLibrary/ditcted2014d6_en.pdf 19 Correa, Carlos (2011) Implications BioTrade Nagoya Protocol Access Genetic Resources Fair Equitable Sharing Benefits Arising Utilization. United Nations, York Geneva. http://www.biotrade.org/ResourcesPublications/UNCTAD_DITC_TED_2011_9.pdf 20 Genetic resources include specific genes strand DNA seed . Basically, material biological origin functional units heredity, defined CBD. 21 naturally occurring biochemical include polyphenols, polysaccharides fatty acids. natural sap extract plant, tree biological specimen, broadly considered derivative covered Nagoya Protocol. 22 countries South Africa, BioTrade ABS governed single institutional setting administrative procedure; countries, ABS BioTrade regulated legal frameworks. , collecting -timber forest products (NTFP) Peru ( BioTrade activities fall category) falls forestry regime agricultural sector, ABS specific legislation place involves Ministries Agriculture, Environment Production. , promotion NTFP falls competences Ministry Commerce, Industry Tourism, specific commission . 23 expressly recognized BioTrade Initiative page 5 Introduction Principle 3 document UNCTAD. BioTrade Initiative, Principles Criteria. Geneva, York, 2007. 24 examples included: Executive Order 247 regulation Philippines (1996), Andean Decision 391 common regimen ABS (Plurinational State Bolivia, Colombia, Ecuador, Peru Bolivarian Republic Venezuela) (1996), Provisional Measure 2.186-16 ABS Brazil (2001), African Union Model Law access genetic biological resources (2000), Executive Decree 257 ABS Panama, . Costa Rica biodiversity law 7788 (1998) regulations effective ( terms number ABS contracts signed), due specific institutional administrative structure focusing activities undertaken National Biodiversity Institute (INBIO). 25 countries users providers genetic resources alike, users Nagoya Protocol based assumption , historically, genetic resources moved primarily Southern, biodiversity rich countries, Northern, industrialized nations. 26 Group -Minded Megadiverse Countries formed : Plurinational State Bolivia, China, Colombia, Costa Rica, Democratic Republic Congo, Ecuador, India, Indonesia, Kenya, Madagascar, Malaysia, Mexico, Peru, South Africa Bolivarian Republic Venezuela. https://www.environment. gov.za/likeminded_megadiversecountries_lmmc 27 Bonn Guidelines Access Genetic Resources Fair Equitable Sharing Benefits Arising Utilization, approved Decision VI/24 COP 6 CBD, held Hague, Netherlands, 2002, include specific provisions user measures. https://www.cbd.int/ decision//default.shtmlid=7198 28 , natural molecules accessed biological sources medicinal plants, algae, native crops microorganisms utilization cosmetic, pharmaceutical, bio-remediation breeding industries, excluded national ABS framework Peru. 29 , Cabrera, Jorge (2013) El Protocolo de Nagoya: Opciones para su Implementació Política en érica Latina. Proyecto GEF sobre Acceso Recursos Genéticos Distribució de Beneficios para érica Latina del Caribe - GEF ABS LAC. UICN, GEF. Quito, Ecuador. http://www.portalces.org/sites/default/ files/migrated/docs/Doc_Tec_PN_Retos_AL.pdf 30 coverage “derivatives” relate biochemicals, depend national/ regional ABS regulations. Literally speaking, “derivatives” , ’ generic word. “biochemicals” bears scientific connotation, implying adding step occurred allowed scientifically define matter ( , beeswax derivative sense secreted bees Apis mellifera species - biochemical put category oils & fats & steps allowed defined biochemical composition. controversy “biochemical compositions” include derivatives, derivatives, contrary, “objects”. resolved national regional level ABS legislation. CBD COP Decisions provide technical guidance matter Parties. important explicit incorporation “derivatives” generate clear expansion type activities covered ABS regulation. 37Challenging aCCess Benefit sharing environment 31 definitions Food Agriculture Administration United States, http://www.fda.gov/ Cosmetics/GuidanceRegulation/LawsRegulations/ucm074201.htm#Definecosmetic 32 REACH regulation EC 1907/2007 http://ec.europa.eu/growth/sectors/chemicals/ 33 European Union regulation Cosmetics EC 1223/2009 http://eur-lex.europa.eu/LexUriServ/LexUriServ.douri=OJ::2009:342:0059:0209:EN:PDF 34 Food Regulation European Union http://eur-lex.europa.eu/legal-content/EN/TXT/qid=144 9760581954&uri=OJ:JOL_2015_327_R_0001 35 GRAS USA http://www.fda.gov/Food/IngredientsPackagingLabeling/GRAS/ 36 Article 15 Nagoya Protocol compliance national legislation ABS regulatory requirements Article 17 monitoring utilization genetic resources. 37 application patent breeder consequence successful & process. obtain invention plant variety degree &. 38 South Africa continued references addresses biotrade ( “BioTrade”) ABS framework (Amendments regulation bioprospecting ABS, Government Gazette, 2015). 39 date, limited studies address “fairness equity” dimensions benefit sharing. “Fairness” “equity” , practice, negotiated agreed BioTrade ABS project. insights fairness equity ABS , De Jonge, Bram (2009) Plants, Genes Justice. Inquiry Fair Equitable Benefit Sharing. Thesis, Wageningen University, Netherlands. 40 bioprospecting projects , include milestone payments related commercialization, advances adding chain genetic resource(). International Cooperative Biodiversity Group Program (ICBG) project Peru, 1990´ explored Amazon communities land medicinal plants, offered series annual payments, directed indigenous communities, progress research. payments approximately $ 30,000. similar arrangements set cases & process, successful commercial products IP generated. 41 noted hold true TK involved. country regulation protecting TK TK involved, probable regulation apply activities chain phase 1 onwards. 42 examples world biodiversity-related projects successful factors. examples ProBenefit Project – Implementing CBD Ecuadorean Amazon (Ecuador), carried 2003 2007. project basically succeed inability unable define exact scope, coverage administrative procedures secure legally access Ecuadorean genetic resources. Similar situations happened Peru, Plurinational State Bolivia Bolivarian State Venezuela parts world. 43 https://absch.cbd.int/ 44 internationally recognized certificate compliance, incorporated ABS- CH, issued India National Biodiversity Authority. instrument offers information resources, PIC MAT. https://www.cbd.int/doc/press/2015/pr-2015-10-07-abs-en.pdf 45 case BioTrade, principle, actors chain full participants process responsibility success operation. , simple receivers money applications commercialization place. 46 prior informed consent (PIC) mutually agreed terms (MAT) expressed varies considerably depending national frameworks. “ PIC MAT negotiated expressed” answers. , case BioTrade, level set principles applicable converge similar authorities actors. cases, State key PIC provider negotiates MAT; cases, communities, institutions individuals participate PIC related procedures MAT negotiations. 47 countries users providers biological genetic resources extent. , idea “user measures” responds historic trend Southern countries contributed substantially international flows resources. , Pistorious, Robin (1997) Scientist, Plants Politics: History Plant Genetic Resources Movement. IPGRI, Rome, Italy. 48 “omics” revolution (genomics, proteomics, proto-boleomics), genetic engineering , , bioinformatics, radically altered & undertaken genetic resources rendered monitoring complex research chains problematic. , Pastor, ., Ruiz, . Development International Regime Access Genetic Resources Fair Equitable Benefit Sharing Context Technological Developments. Initiative Prevention Biopiracy. 38 Facilitating Biotrade SPDA. Year IV . 10 April 2009. : https://www.cbd.int/abs/doc/serie-iniciativa-2009-04-en.pdf 49 User measures proposed Andean Community, part negotiations Decision 391 ABS. , defensive protection ensuring IP regimes account ABS frameworks pre-condition granting rights, patents. , Tobin, Brendan (1997) Certificates Origin: Role IP Regimes Securing Prior Informed Consent. : Mugabe, ., Barber, ., Henne, ., Glowka, ., La Viñ. . (Eds.) Access Genetic Resources: Strategies Benefit Sharing. ACTS Press. Nairobi, Kenya. , https://www.academia./6636676/ Certificates_of_Origin_A_role_for_IPR_Regimes_in_Securing_Prior_Informed_Consent 50 Bonn Guidelines, section II (Roles responsibilities ABS), numeral 16, paragraph ) establishes : Contracting Parties users genetic resources jurisdiction legal, administrative, policy measures, , support compliance prior informed consent Contracting Party providing resources mutually agreed terms access granted. countries , inter alia, measures: - Mechanisms provide information potential users obligations access genetic resources; - Measures encourage disclosure country origin genetic resources origin traditional knowledge, innovations practices indigenous local communities applications intellectual property rights; - Measures aimed preventing genetic resources obtained prior informed consent Contracting Party providing resources; - Cooperation Contracting Parties address alleged infringements access benefit-sharing agreements; - Voluntary certification schemes institutions abiding rules access benefit-sharing; - Measures discouraging unfair trade practices; - measures encourage users comply provisions subparagraph 16 () . 51 specific user measure traced Supreme Decree 008-1996-ITINCI, national plant breeder´ regulation Peru, 1996. established application breeders country origin provide legal proof genetic resources variety ( related knowledge, including TK), obtained legally. milestone influenced Andean Community´ Decision 391 , importantly, Andean Decision 486 2001, Common Regime Industrial Property Regime, IP norm world condition granting patents legal access genetic resources TK case biotechnological inventions. Examples multiplied , IP frameworks biodiversity related laws regions, including Europe. 52 Article 15 Protocol develops series provisions compliance domestic legislation regulatory requirements ABS; article 16 develops provisions compliance domestic legislation regulatory requirements TK; article 17 focuses monitoring genetic resources national checkpoints; article 18 focuses compliance MAT. 53 Article 15. Compliance Domestic Legislation Regulatory Requirements Access Benefit-sharing 1. Party , effective proportionate legislative, administrative policy measures provide genetic resources utilized jurisdiction accessed accordance prior informed consent mutually agreed terms established, required domestic access benefit-sharing legislation regulatory requirements Party. 2. Parties , effective proportionate measures address situations - compliance measures adopted accordance paragraph 1 . 3. Parties , , cooperate cases alleged violation domestic access benefit-sharing legislation regulatory requirements referred paragraph 1 . 54 Article 16. Compliance Domestic Legislation Regulatory Requirements Access Benefit- sharing Traditional Knowledge Genetic Resources 1. Party , effective proportionate legislative, administrative policy measures, , provide traditional knowledge genetic resources utilized jurisdiction accessed accordance prior informed consent approval involvement indigenous local communities mutually agreed terms established, required domestic access benefit-sharing legislation regulatory requirements Party indigenous local communities located. 2. Party , effective proportionate measures address situations - compliance measures adopted accordance paragraph 1 . 39Challenging aCCess Benefit sharing environment 3. Parties , , cooperate cases alleged violation domestic access benefit-sharing legislation regulatory requirements referred paragraph 1 . 55 Article 10 Nagoya Protocol, Global Multilateral Benefit Sharing Mechanisms suggests “Parties modalities global multilateral benefit-sharing mechanism address fair equitable sharing benefits derived utilization genetic resources traditional knowledge genetic resources occur transboundary situations grant obtain prior informed consent. benefits shared users genetic resources traditional knowledge genetic resources mechanism support conservation biological diversity sustainable components globally.” read conjunction Article 11 establishes “ 56 technological scientific paradigms bioinformatics, proteomics, genetic engineering, , creating powerful & platforms natural information key asset interest biotechnology industry. , Ruiz, Manuel (2015). Genetic Resources Natural Information. Implications Convention Biological Diversity. Earthscan Routledge. Oxon, York. 57 http://unctad.org/en/pages/PublicationWebflyer.aspxpublicationid=1040