Guidelines and Model Clauses on Access and Benefit-Sharing and Biotrade in the Lao People's Democratic Republic

Guidelines Model Clauses aCCess Benefit-sharinG Biotrade lao PeoPle’ deMoCratiC rePuBliC AT Printed United Nations, Geneva – 2014377 () – November 2020 – 630 – UNCTAD/DITC/TED/2020/1 Guidelines Model Clauses aCCess Benefit-sharinG Biotrade lao PeoPle’ deMoCratiC rePuBliC AT ii UNCTAD/DITC/TED/2020/1 © 2020, United Nations Conference Trade Development work open access complying Creative Commons licence created intergovernmental organizations, http://creativecommons.org/licenses//3.0/igo/. findings, interpretations conclusions expressed authors necessarily reflect views United Nations officials Member States. designation employed presentation material map work imply expression opinion whatsoever part United Nations legal status country, territory, city area authorities, delimitation frontiers boundaries. publication formally edited. eISBN: 978-92-1-005453-9 iii Contents Acronyms abbreviations ................................................................................................................... iv Acknowledgements ................................................................................................................................ iv 1. INTRODUCTION ................................................................................................... 1 2. ACCESS AND BENEFIT-SHARING IN LAO PEOPLE’ DEMOCRATIC REPUBLIC ........................................................... 2 3. STAKEHOLDER INPUT .......................................................................................... 4 4. ISSUES TO BE ADDRESSED IN CONTRACTS, BASED ON STAKEHOLDER INPUT ...................................................................................... 10 ANNEX 1 RESPONDENT INSTITUTIONS AND COMPANIES ..................................... 12 ANNEX 2 QUESTIONNAIRE – GOVERNMENT AUTHORITIES .................................... 13 ANNEX 3 QUESTIONNAIRE – USERS ................................................................... 14 ANNEX 4 QUESTIONNAIRE – EXPERTS ................................................................ 15 ANNEX 5 MODEL CONTRACT CLAUSES ............................................................... 16 ANNEX 6 LIST OF PARTICIPANTS: CONSULTATION ON THE DRAFT MODEL CONTRACT CLAUSES ........................................................................... 29 Notes .................................................................................................................................................... 30 iv GUIDELINES AND MODEL CLAUSES ON ACCESS AND BENEFIT-SHARING AND BIOTRADE IN THE Acronyms abbreviations ABS Access genetic resources benefit sharing ASEAN Association South East Asian Nations BEI Biotechnology Ecology Institute BTI BioTrade Initiative CBD Convention Biological Diversity GEF Global Environment Facility IPR Intellectual property rights MAF Ministry Agriculture Forestry MoA Memorandum Agreement MoNRE Ministry Natural Resources Environment MoST Ministry Science Technology MoU Memorandum Understanding NAFRI National Agriculture Forestry Research Institute NBSAP National Biodiversity Strategy Action Plan PIC Prior informed consent & Research development SECO Swiss State Secretariat Economic Affairs UNCTAD United Nations Conference Trade Development UNEP United Nations Environment Programme WIPO World Intellectual Property Organization Acknowledgements study prepared Patricia Moore, Consultant BioTrade Initiative Trade, Environment, Climate Change Sustainable Development Branch UNCTAD. study greatly benefited peer reviews substantive inputs : David Vivas Eugui, Legal Officer, Frederic Perron-Welch, Consultant, Trade, Environment, Climate Change Sustainable Development Branch (TED) UNCTAD, Kongchay Phimmakong, Deputy Director General, Department Science, Ministry Science Technology, Lao People’ Democratic Republic Lorena Jaramillo, Economic Affairs Officer, TED UNCTAD. Contributions model clauses received Sivath Sengdouangchanh, Managing Director, Sivath & Associates Sole ., . Support interviews, data collection, stakeholder consultations Helvetas Swiss Intercooperation Biotechnology Ecology Institute, Ministry Science Technology, Lao People’ Democratic Republic. Valuable inputs received variety public, private academic stakeholders civil society, listed Annex 6. UNCTAD gratefully acknowledges support Swiss State Secretariat Economic Affairs SECO development study Global BioTrade Programme: Linking trade, biodiversity sustainable development. Desktop formatting Rafe Dent UNCTAD. information UNCTAD’ BioTrade Initiative consult website: http://www.unctad. org/biotrade contact : biotrade@unctad.org. 28 October 2020 1LAO PEOPLE’ DEMOCRATIC REPUBLIC 1. INTRODUCTION 1. United Nations Conference Trade Development (UNCTAD) launched BioTrade Initiative (BTI) 1996 “... contribute conservation sustainable biodiversity promotion trade investment BioTrade products services line objectives principles Convention Biological Diversity (CBD)”.1 2. BioTrade principles : conservation biodiversity; sustainable biodiversity; fair equitable sharing benefits derived biodiversity; socio-economic sustainability (productive, financial market management); compliance national international regulations; respect rights actors involved BioTrade activities; clarity land tenure, access natural resources knowledge.2 UNCTAD identified criteria BioTrade principle BTI partners promote implementation principles criteria -chain approach, adaptive management approach, ecosystem approach, sustainable livelihoods approach.3 3. BTI, UNCTAD support State Secretariat Economic Affairs SECO implementing programme “Linking trade, biodiversity sustainable development”. programme contributes national regional policy frameworks facilitating access, mobilizing research addressing relevant policy topics required regulations requirements access biological genetic resources benefit sharing (ABS). Project interventions support actions partners ground enable BioTrade-friendly implementation effective ABS regulations. 4. report documents BTI initiative Lao People’ Democratic Republic part - regional collaboration UNCTAD Helvetas Swiss Intercooperation4 Lao People’ Democratic Republic, Myanmar, Viet Nam. UNCTAD- Helvetas Swiss Intercooperation collaboration developed UNCTAD Global BioTrade Programme, Helvetas Swiss Intercooperation project “BioTrade: Ethical Trade Plant-Based Resources”, funded Swiss State Secretariat Economic Affairs SECO. Lao People’ Democratic Republic regulated ABS related traditional knowledge late 2018. , BTI commissioned study provide inputs guidance Government Lao People’ Democratic Republic national ABS stakeholders, develop sample model clauses eventual ABS BioTrade contracts country. report based assessment prior national undertaking developed draft policy decree ABS BioTrade, responses questionnaires interviews conducted jointly Biotechnology Ecology Institute (BEI) Ministry Science Technology (MoST), competent national authority ABS Lao People’ Democratic Republic. Finally, study considered examples ABS contracts guidelines ABS contracts countries regions including UNCTAD BTI experience Peru5 inputs Lao national expert commercial law. , BEI convened consultation draft model clauses held Vientiane, Lao People’ Democratic Republic, 1 November 2019. Annex 6 list participants. BioTrade BioTrade understood include activities related collection production, transformation, commercialization goods services derived native biodiversity (genetic resources, species ecosystems) criteria environmental, social economic sustainability. 2 GUIDELINES AND MODEL CLAUSES ON ACCESS AND BENEFIT-SHARING AND BIOTRADE IN THE 2. ABS IN LAO PEOPLE’ DEMOCRATIC REPUBLIC 5. Lao People’ Democratic Republic countries Parties CBD Nagoya Protocol Access Genetic Resources Fair Equitable Sharing Benefits Arising Utilization (Nagoya Protocol) face, national local levels, significant challenges understanding issues involved ABS differentiating issues involved conserving sustainably biological resources. Lao People’ Democratic Republic acceded Nagoya Protocol Party 20146. preparation Party, support Global Environment Facility (GEF) project7 implemented United Nations Environment Programme (UNEP) executed ASEAN Centre Biodiversity, Lao People’ Democratic Republic developed document contained drafts government policy ABS, law genetic resources, ABS administrative systems, mechanisms public education awareness participation, completed 2013.8 draft law genetic resources adopted ABS regulations, including provisions administrative system ABS, place. increased interest companies institutions seeking access genetic resources country, Lao People’ Democratic Republic develop contractual guidance ABS negotiations efforts adopt national regulatory framework continue. UNCTAD’ BTI providing support process order facilitate compliance ABS requirements BioTrade organisations. report reflects results. 6. barriers implementing Nagoya Protocol Lao People’ Democratic Republic considerable: • national knowledge base implementing Nagoya Protocol; • ABS, traditional knowledge genetic resources, intellectual property rights (IPR) protection traditional knowledge remain issues Lao People’ Democratic Republic. Awareness understanding issues limited government specialists academics. limited, , awareness understanding issues local level, users, mechanisms coordination stakeholder involvement; • policy regulatory framework minimal incomplete, ad hoc, case--case administrative procedures, guidelines users providers. 7. Reconciling Lao People’ Democratic Republic’ predominantly rural population facilitating access genetic resources traditional knowledge sharing benefits major challenge country. Lao People’ Democratic Republic’ rural communities idea biological resources manage, generally unaware potential additional genetic resources. Lao People’ Democratic Republic, globally, generalized lack knowledge exchange information scientific researchers, policy makers decision- makers, private sector, public. country minimal capacity -commercial research commercial research development (&), difficult impossible work required add genetic resources -country. means international collaboration essential generating genetic resources. Implementing Nagoya Protocol require sustained coordination cooperation public private sectors civil society, local people communities stewards biological resources, genetic resources , holders valuable traditional knowledge. 8. Party CBD 19969, Lao People’ Democratic Republic identified ABS part efforts country intends institutionalize biodiversity conservation. 2000-2004, country produced National Biodiversity Strategy Action Plan10 (NBSAP) noted key issues respect ABS: lack regulations relating protection biodiversity traditional knowledge; limited cooperation international partners; insufficient understanding access genetic resources benefit sharing relevant agencies; lack information knowledge genetic resources international level. NBSAP included programme biodiversity management. Objective 5 programme, ensuring social economic benefits genetic material products originating Lao People’ Democratic Republic accrue nation, included actions 2010: draft enact 3LAO PEOPLE’ DEMOCRATIC REPUBLIC legislation ABS genetic resources originating Lao People’ Democratic Republic; establish national rules protection traditional knowledge. 2011 assessment NBSAP11 documented actions identified ABS implemented. NBSAP, period 2016-2025, noted minimal progress ABS set targets enact legislation ABS traditional knowledge.12 9. BTI-Helvetas Swiss Intercooperation collaboration, -- regional workshops organized BioTrade stakeholders Lao People’ Democratic Republic, Myanmar, Viet Nam: ‘Regional Mekong Workshop Access Benefit Sharing’13 ‘Improving coordination technical assistance delivery BioTrade Access Benefit Sharing Southeast Asia’14 June 2018 Luang Prabang, Lao People’ Democratic Republic. coordination meeting, Mekong Plan Action adopted laid groundwork collaboration UNCTAD, Helvetas Swiss Intercooperation regional actors BioTrade ABS. 10. Association South East Asian Nations (ASEAN) Intellectual Property Rights Action Plan period 2016-2025. Strategic Goal 4 calls enhancing regional mechanisms promote asset creation commercialization, geographical indications traditional knowledge. Initiative 19 Strategic Goal 4 calls ASEAN member states develop national policies laws protect traditional knowledge genetic resources. Lao People’ Democratic Republic pilot countries ASEAN initiative. step process Lao People’ Democratic Republic meet commitment regional goal develop national policy traditional knowledge IPR. World Intellectual Property Organization (WIPO) supported Lao People’ Democratic Republic providing technical assistance workshop traditional knowledge genetic resources, Vientiane October 2018. September 2019, policy issued. 11. limited resources substantial gaps regulatory framework institutional individual capacities, Lao People’ Democratic Republic demonstrated progress implementing Nagoya Protocol. country basic elements legal framework implementing Nagoya Protocol, framework incomplete. Article 24 2014 Biotechnology Safety Law enables regulation ABS requires implementing decree. Article 22 law enables protection traditional knowledge genetic resources, national policy traditional knowledge IPR implementing decree. 2017 Law Intellectual Property protects plant breeders’ rights traditional cultural expressions, enable protection types traditional knowledge genetic resources. 12. current institutional context biodiversity conservation Lao People’ Democratic Republic favors inter-ministerial coordination collaboration. Ministry Natural Resources Environment (MoNRE) houses CBD Focal Point. MoST houses focal points CBD protocols ABS biosafety. Ministry Agriculture Forestry (MAF) generally responsible managing biological resources, including protected areas. National Agriculture Forestry Research Institute (NAFRI) established seed bank rice. BEI established Lao People’ Democratic Republic’ national herbarium. Ministry Health, Institute Traditional Medicine, administers list medicinal natural resources includes species important traditional medicine, including endangered species. Representatives institutions responded questionnaire input project ( section 3). 13. 2013, Lao People’ Democratic Republic developed draft regulatory regime administrative systems ABS, adopted ( paragraph 2). absence regulations formal administrative system, BEI created informal administrative procedure enables handle requests access genetic resources case- -case basis. country guidelines directives activities constitute ‘access’ ‘’ genetic resources derivatives, contract license traditional knowledge. registry national supporting institutions. 4 GUIDELINES AND MODEL CLAUSES ON ACCESS AND BENEFIT-SHARING AND BIOTRADE IN THE 3. STAKEHOLDER INPUT 14. UNCTAD, collaboration BEI, carrying study compile inputs process developing model clauses ABS contracts links BioTrade. BEI adapted translated Lao questionnaire similar UNCTAD project Peru.15 Questionnaires prepared target stakeholder groups: government authorities; users genetic resources;16 experts. total 31 individuals, representing 13 government authorities ministries institutions, 14 representatives donors current potential users genetic resources, experts – national international – responded questionnaire. list respondents Annex 1. English translations questionnaires attached annexes 2-4, . 15. questionnaires asked target group 10 issues common groups. questionnaire target group included questions specifically group . responses questions common issues discussed discussion responses target group- specific questions . text italics issue paragraphs 16-28 copied questionnaires. Annex 2, questionnaire government authorities; Annex 3, questionnaire users; Annex 4, questionnaire experts. 16. ABS contracts • questions government authorities : (1) today, ABS contracts signed (2) commercial purposes • questions users : (1) company/institution contracts access genetic resources (2) , genetic resources • question experts : participated negotiating contract access genetic resources , briefly describe experience. ABS contracts signed Lao People’ Democratic Republic – BEI Lao Traditional Medicine Institute, Ministry Health. contracts international users genetic resources, provide eventually commercializing products. national institutions – users government authorities – reported contracts, report multiple Memoranda Understanding (MoU), Memoranda Agreement (MoA), project agreements include working genetic resources. genetic resources involved include plants, animals, microorganisms. international experts reported institutions ABS contract Lao People’ Democratic Republic. expert noted experience negotiating contract positive staff competent national authority professional. 17. Building local capacity obligation ABS contracts • Government authorities experts asked: access contracts obligations building local capacity research development involving genetic resources, derivatives, traditional knowledge • question users : obligations access contracts building local capacity research development involving genetic resources, derivatives, traditional knowledge Government authorities users ABS contracts clear separate obligations providers users. government authorities responding agreed ABS contracts obligation build local capacity, organize communities, assist ABS tool local development. , noted Lao People’ Democratic Republic & experts limited research facilities equipment &, strengthened, country limited finances . Users similarly agreed ABS contracts obligations build local capacity clear provisions contract local partners involved sharing benefits agencies communities. Users noted : sustainable genetic resources priority; users conduct research country, , build local capacity form benefit sharing; users provide feedback providers. user observed providers -monetary benefits easier obtain monetary benefits, monetary benefits easier users provide. 5LAO PEOPLE’ DEMOCRATIC REPUBLIC experts agreed, ABS contracts ensure communities institutions receive benefits complying ABS regulations. international expert disagreed, obligation build local capacity difficult private companies optional. 18. Powers competent national authority Government authorities experts asked: competent national authority functions/duties question asked users. government authorities competent national authority powers addition exercises .17 additional powers include: leading, coordinating, making recommendations government agencies local authorities; advising negotiations; creating database; supporting basic & commercialization; monitoring evaluation. national experts felt competent national authority additional powers, specifically assigning technical team departments support target audiences requirements individual & cases, commercialization, facilitating academic private sector users. international experts competent national authority additional powers. 19. Single authority Government authorities users asked: process physically collecting accessing resources administered authority negotiates access contract question asked experts. majority government respondents national authorities ABS – management/administrative authority scientific/ technical authority. respondents noted good idea separate authorities depend capacity . users single authority. respondents supported single authority current professional. reasons users gave supporting single authority single authority understands regulations understands users . Users noted single authority administrative costs monitoring evaluation inspection easier. user noted preferred single authority long authority capacity resources provide advice. single authority participation local stakeholders. responding user number authorities issue important authority authorities capability required. user respondent supported idea separate authorities guarantee reliability transparency. user noted authorities feasible long authorities information required. 20. Genetic resources traditional knowledge countries Lao People’ Democratic Republic • questions government authorities : (1) cases Lao People’ Democratic Republic access genetic resources countries (2) , cases criteria negotiate agreement • question experts : experience, Lao People’ Democratic Republic handle cases genetic resources / traditional knowledge access requested Lao People’ Democratic Republic, countries similar question asked users. BEI assumes access requested Lao People’ Democratic Republic genetic resources countries; authorities information issue. Government authorities express opinions cases handled. international expert advised Lao People’ Democratic Republic procedures complicated , , users interested genetic resources . international expert opinion special procedures genetic resources countries Lao People’ Democratic Republic. 21. Valuing genetic resources benefits Lao People’ Democratic Republic methodology valuing genetic resources benefits respondents addressed question benefits valued. 6 GUIDELINES AND MODEL CLAUSES ON ACCESS AND BENEFIT-SHARING AND BIOTRADE IN THE target groups asked questions: (1) benefits obtained genetic resources valued (2) benefits obtained genetic resources valued government authorities discussed user based commercialization, discussed users; government respondents information issue. BEI reported , existing ABS contracts, sharing benefits – 70% company 30% government – calls negotiation research results lead marketable product products. user based contribution genetic resources economy environment, noted contribution genetic resources linked commercialization18. users -monetary monetary benefits benefits rural community development. users responded suggestions mechanisms sharing benefits, including: government tax genetic resources ensures benefits disseminated communities conservation genetic resources; biodiversity offsets; environmental protection fees. Experts examples -monetary benefits assign : increased knowledge understanding genetic resources proper protection preservation, including &; capacity building students; publications scientific journals; short reports; communication national newspapers; conferences -country. Indicators benefits include number students trained, number scientific papers published, number communications media. 22. Establishing percentage benefits target groups asked: agree establishing minimum maximum percentage benefits ( , calculated based sales price) limiting factor negotiations majority government authorities responded benefits calculated case--case basis sales price percentage product revenue. suggested benefits depend authority’ capability negotiate maximum benefits Lao People’ Democratic Republic, contributions users providers. government respondents law regulation establish maximum percentage minimum percentage established. regulation set standard benefit detail calculate case-- case basis. Users determining benefits case- -case basis practical setting percentage regulation easier administrators. respondents supported case-- case determination percentage sales price product.19 users responding supported maximum percentage, set regulation. academic respondents maximum percentage acceptable level interesting institutions user noted private sector prefer maximum percentage. user benefits depend period business year investment building capacity communities government authorities. user agree setting percentage benefits, benefit standard benefit percentage ABS contracts. experts agreed establishing percentage benefits; . agreed, maximum percentage favored minimum percentage / -kind benefit. agreed noted : set basic criteria standards benefits fair stakeholders, reference actual practice; percentages categorized applied differently commercial purposes research purposes; case access &, monetary / -kind benefits capacity development. 23. Guidance contract negotiations target groups asked questions: (1) supporting documents ( : guides, methodologies, model clauses) facilitate negotiations (2) documents ( : guides, methodologies, model clauses) facilitating negotiations 7LAO PEOPLE’ DEMOCRATIC REPUBLIC Government respondents guidance – guidelines methodologies, – important model clauses model contract important. government respondent suggested guidance part online system. users responded guidance contract negotiations important noted commercial guidelines model contract model clauses reference . experts documentary guidance contract negotiations important; suggested guidance -developed people understand content waste time. expert additional guidance contract negotiations procedures competent national authority clear. 24. Issues affecting access contracts • questions government authorities : (1) aspects negotiating access contract complicated provider genetic resources (2) institution identified specific issues delay process issuing access contracts (3) provide list issues affecting access contracts institution identified. Government authorities identified issues aspects negotiating access contract complicated providers. respondents monitoring genetic resources contract MoU signed complicated, difficult carry & -country due capacity limitations. government respondents understanding ABS apply related laws regulations negotiation complicated, felt valuing benefits complicated issue. identified issues affect access contracts: clear policy specific regulations guidelines; lack supporting documentation facilitate negotiations publicly easy access; lack clarity competent national authority ; lack coordination; limited understanding ABS limited experience negotiating ABS; reconciling interests users providers. • question users experts : complex aspects process accessing genetic resources user respondents lack clarity project constitutes access complex aspect accessing genetic resources. respondents mentioned issues: difficulty complying legal requirements regulations technical guidelines; challenges establishing monetary -monetary benefits; fact negotiation essential applicants fee agreement facilitation administration national competent authority; providers encouraged participate negotiation process. users noted difficult explain contribute country interested bioprospecting specific target genetic resources outset negotiations. respondent highlighted Forestry Law differentiate plantations wild forests, fees supporting guidelines facilitate BioTrade. mechanism linking ABS sustainable forestry management benefit sharing schemes. user stated difficulties competent national authority documentation required questionnaire applicants clear. experts identified issues responses: lack information scope access requirements ; lack adaptability types users – public research institutions, private research centers, universities, private sector companies. issues experts noted : limitations experience capacity negotiation; lack clarity purpose access basic research commercial application; lack online information procedures. 25. Lessons learned • government authorities users asked: lessons institution/company learned process accessing genetic resources question asked experts. • Users asked related question: Based experience company’/institution’ experience, improved process accessing genetic resources negotiating access contract 8 GUIDELINES AND MODEL CLAUSES ON ACCESS AND BENEFIT-SHARING AND BIOTRADE IN THE government respondents noted staff capacity limited ABS issue . learned importance regulations guidelines; highlighted important users respect recognize providers. lessons include: limited public awareness ABS guidelines accessing genetic resources appropriately; Lao People’ Democratic Republic identify nature genetic resources wild plants plantations; complicated processes system delays projects run slowly difficult access funding; detailed mechanism guidance implementation; Lao People’ Democratic Republic negotiation experts benefit cooperation projects sample contract easy modify negotiations; important initial negotiations , agreements include activities, sharing results sharing benefits, ABS contract clear time signature; understanding monetary -monetary genetic resources challenges limitations negotiations benefit sharing, monetary -monetary. Responding question, users noted important regulations guidelines place requirement public hearings. civil society user pointed guidance government authorities long time. user learned mutual trust important good practice user’ part proves user genuine. Responding question, users learned clear specific regulations guidelines information good practice. applicants understand regulations exporting genetic resources, documents required, accessible information guidance step permitting process. users suggested single window short process access permits , minimum, applicants indication time required process permit access genetic resources. users support government current process clear fast talked competent national authority. Questions specific target groups 26. Government authorities. questions government authorities . 1. guidelines directives activities constitute ‘access’ ‘’ genetic resources derivatives, activities constitute ‘access’ ‘’ Answers: 2. registry National Supporting Insti- tutions Answers: 3. Lao People’ Democratic Republic guidelines contract license traditional knowledge Answers: 4. sufficient require user entering access contract sworn statement user accessed traditional knowledge Answers: government authorities answered question. sworn statement sufficient. statement sufficient performance ABS contracts monitored. 27. Users. questions users . 1. company/institution project genetic resources, project financed company’/institution’ funds answer question . ‘’ ‘partially’, source financing Answers: users responded question. majority projects involving genetic resources financed totally partially sources funds. academic users projects partially fully funded users. 2. company/institution project genetic resources, project designed company/institution aware requirements accessing genetic resources Lao People’ Democratic Republic Answers: respondents aware Lao People’ Democratic Republic’ requirements accessing genetic resources 9LAO PEOPLE’ DEMOCRATIC REPUBLIC designed projects. academic respondents noted aware ABS , factored design cooperation projects. academic respondent aware ABS overseas partners requested access part project Lao national academic learned permit required. 3. process complying requirements negotiating access contract, company/institution support external advisors, process carried company’/institution’ staff Answers: users replied handled process , support competent national authority. reported handled process . users ABS contracts, responding developed MoUs MoAs projects. 4. describe company’/ institution’ experience process negotiating access contract Answers: users process positive support competent national authority arrangements access reflect parties’ agreement. academic users noted takes time develop MoU/contract, delays project implementation, staff limited negotiating skills meant receive benefits partnered - national institutions projects involving genetic resources. 5. benefits access contracts provide company/institution Answers: Information exchange (12 users); prestige (10); links companies (9); ensuring compliance/proof compliance (5); national international partners faith (2). perceived benefits include: building relationships communities long-term cooperation; exchanging research results; responsibility, reliability transparency customers; working closely government. 28. Experts. questions experts . 1. additional functions Nagoya Protocol require included existing system Lao People’ Democratic Republic Answer: monitoring unit monitor genetic resources incoming neighboring countries. 2. experience, step process accessing genetic resources users address distribution monetary -monetary benefits Answers: expert beginning process, objective access obtain develop commercial product, entire process, fourth -party benefit sharing enabled, depending nature transaction. 3. opinion possibility information system managing genetic resources Answers: Experts online information system introduced updated regularly. expert suggested access/contracting procedure online list projects obtained agreements/ contracts. recommended support teams assigned departments/sectors users store access information. 10 GUIDELINES AND MODEL CLAUSES ON ACCESS AND BENEFIT-SHARING AND BIOTRADE IN THE 4. ISSUES TO BE ADDRESSED IN CONTRACTS, BASED ON STAKEHOLDER INPUT 29. input received target stakeholder groups included opinions issues addressed national law / regulations ABS, ABS contract. issues include: • single competent national authority/single window permitting system multiple competent national authorities responsible ABS; • single competent national authority, national registry supporting institutions; • shortened administrative process access -commercial purposes; • powers functions competent national authority authorities ; • indicative timeframe permitting process; • national regulations establish standard monetary benefit minimum / maximum percentage monetary benefits; • tax genetic resources; • Requirement public hearings part process authorizing access genetic resources; • Creating body technical experts / sectoral support teams assist providers negotiating ABS contracts; • Building capacity negotiate ABS contracts; • Creating online information system ABS includes, minimum, technical guidelines ABS, detailed explanation requirements permitting process, list activities permits access genetic resources, information good practice; • Fees charged competent national authority; • Exporting genetic resources; • Lao People’ Democratic Republic handles requests access genetic resources neighboring countries; • Monitoring imports genetic resources countries; • ABS contributes sustainable biological resources country. 2013 draft ABS law ( paragraph 2) multiple competent national authorities MoST central ABS management monitoring authority, generally decentralizing responsibilities provincial, district, municipal levels. 2013 draft provide dealing genetic resources neighboring countries. 30. Stakeholders Lao People’ Democratic Republic technical guidelines aspects ABS, determine: • proposed activity constitutes access; • include provisions traditional knowledge ABS contract. 31. Stakeholder input issues addressed ABS contracts includes: • Provision substantiating user party obtained prior informed consent provider documented; • Provision activities carried contract; • Specific obligations provider; • Specific obligations user; • Differentiated obligations potential user conduct general bioprospecting potential user access specific genetic resource; • Provision genetic resource accessed, contract general bioprospecting; • Differentiated obligations commercial & -commercial research; • Requirement notify competent national authority purpose access -commercial research commercial ; • Specific obligations bioprospecting natural habitats; • Provisions traditional knowledge protected, ; • Obligations build local capacity, involve local partners, communities learn ABS tool community development; • Obligation & carried -country extent ; • Obligations provide updates genetic resources share results; • Provisions stating genetic resources benefits; 11LAO PEOPLE’ DEMOCRATIC REPUBLIC • Establishing percentage monetary benefits; • Defining -monetary benefits; • monetary -monetary benefits distributed providers competent national authority; • Monitoring contract performance, user party genetic resources acquiring . 12 GUIDELINES AND MODEL CLAUSES ON ACCESS AND BENEFIT-SHARING AND BIOTRADE IN THE ANNEX 1 RESPONDENT INSTITUTIONS AND COMPANIES Government Authorities Ministry Science Technology20 Biotechnology Ecology Institute Biotechnology Division Ecology Division Ministry Agriculture Forests Fisheries Livestock Division Agriculture Division Plant Protection Division Protected Area Management Division Ministry Natural Resources Environment Climate Change Division Information Center Ministry Health Institute Traditional Medicine Ministry Industry Commerce Trade Cabinet Office National Agriculture Forestry Research Institute Users National University Laos21 Faculty Environmental Sciences Faculty Sciences Faculty Forestry Lao Biodiversity Association Lao National Chamber Commerce Industry DakDae Social enterprise Burapha Agro-Forestry . . European Chamber Commerce Industry (ECCIL) Lao People’ Democratic Republic French National Research Institute Sustainable Development (IRD) Nimura Genetic Solution ., ., Japan IUCN International Union Conservation Nature World Bank Experts Helvetas Lao People’ Democratic Republic Green Community Development Association French National Research Institute Sustainable Development (IRD) Nimura Genetic Solution ., ., Japan 13LAO PEOPLE’ DEMOCRATIC REPUBLIC ANNEX 2 QUESTIONNAIRE – GOVERNMENT AUTHORITIES Questionnaire ABS-BioTrade Interviews Government authorities: 1. ABS contracs . today, ABS contracts signed . commercial purposes 2. genetic resources determined order negotiate access 3. model clauses / contracts negotiations 4. contracts access genetic resources include obligations strengthen local capacity research development involving genetic resources, derivatives, traditional knowledge 5. Existing access contracts based competent national authority playing role negotiator. . competent national authority additional powers / duties . , additional powers / duties 6. guidelines directives activities constitute ‘access’ ‘’ genetic resources derivatives activities constitute ‘access’ ‘’ 7. . cases Lao People’ Democratic Republic access genetic resources countries . , cases criteria negotiate agreement 8. registry National Supporting Institutions 9. . institution identified specific issues delay process issuing access contracts . provide list issues affecting access contracts institution identified. 10. process physically collecting accessing resources administered authority negotiates access contract 11. . Lao People’ Democratic Republic methodology valuing benefits arise genetic resources . agree establishing minimum maximum percentage benefits ( , calculated based sales price) limiting factor negotiations 12. Lao People’ Democratic Republic guidelines contract license traditional knowledge 13. sufficient require user entering access contract sworn statement user accessed traditional knowledge 14. . aspects negotiating access contract complicated provider genetic resources . documents ( : guides, methodologies, model clauses) facilitating negotiations 15. lessons institution learned process implementing system access genetic resources 14 GUIDELINES AND MODEL CLAUSES ON ACCESS AND BENEFIT-SHARING AND BIOTRADE IN THE ANNEX 3 QUESTIONNAIRE – USERS Questionnaire ABS-BioTrade Interviews Users (Companies, universities, .) 1. . company/institution contracts access genetic resources . , genetic resources 2. . company/institution project genetic resources, project financed company’/ institution’ funds . answer question . ‘’ ‘partially’, source financing 3. company/institution project genetic resources, project designed, company/institution aware requirements accessing genetic resources Lao People’ Democratic Republic 4. process complying requirements negotiating access contract, company/institution support external advisors, process carried company’/institution’ staff 5. describe company’/ institution’ experience process negotiating access contract . Positive. . Negative. . Transcendental – usual scope company’/institution’ experience. . . 6. complex aspects process accessing genetic resources . provide details. . Compliance legal requirements. provide details. . Negotiation . Establishing monetary -monetary benefits . Clarity process . issues. provide details. 7. lessons company/institution learned process accessing genetic resources 8. benefits access contracts provide company/institution . Information exchange . Links companies/institutions . Prestige . . 9. obligations access contracts building local capacity research development involving genetic resources, derivatives, traditional knowledge 10. process physically collecting accessing resources administered authority negotiates access contract 11. . benefits obtained genetic resources valued . agree establishing minimum maximum percentage benefits ( , calculated based sales price) limiting factor negotiations 12. Based experience company’/ institution’ experience, improved process accessing genetic resources negotiating access contract entire process answer question. 13. supporting documents ( : guides, methodologies, model clauses) facilitate negotiations 14. provide comments light BioTrade ABS. 15LAO PEOPLE’ DEMOCRATIC REPUBLIC ANNEX 4 QUESTIONNAIRE – EXPERTS Questionnaire ABS-BioTrade Interviews Experts: 1. . participated negotiating contract access genetic resources . , briefly describe experience. 2. additional functions Nagoya Protocol require included existing system Lao People’ Democratic Republic 3. complex aspects process accessing genetic resources . Lack information (clarity scope, requirements, .) . Lack adaptability types users (research centers, universities, companies, public research institutions, .) . Experience capacity negotiation . purpose access ( basic research commercial application, ) . . provide details 4. access contracts obligations building local capacity research development involving genetic resources, derivatives, traditional knowledge 5. Existing agreements access genetic resources Lao People’ Democratic Republic based fact competent national authority provider negotiator. . competent national authority functions/duties . , functions/ duties 6. . benefits obtained genetic resources valued . agree establishing minimum maximum percentage benefits ( , calculated based sales price) limiting factor negotiations 7. experience, Lao People’ Democratic Republic handle cases genetic resources / traditional knowledge access requested Lao People’ Democratic Republic, countries 8. supporting documents ( : guides, methodologies, model clauses) facilitate negotiations 9. experience, step process accessing genetic resources users address distribution monetary -monetary benefits . beginning project . objective access obtain develop commercial product . process . . 10. opinion possibility information system managing genetic resources 16 GUIDELINES AND MODEL CLAUSES ON ACCESS AND BENEFIT-SHARING AND BIOTRADE IN THE ANNEX 5 MODEL CONTRACT CLAUSES 1. Lao People’ Democratic Republic regulated ABS, legally-binding national obligations ABS contract, required national contract law22, specifies contract : • , family [] addresses contracting parties; • Purpose, price, execution term, payment, delivery; • Scope, quantity quality objective; • Place contract execution obligation notify ; • Form dispute resolution body; • Conditions modification termination contract term. purpose, price term execution contract mandatory types contracts. 2. advisable include ABS contract additional general contract clauses: • Indemnification insurance; • Confidentiality; • Severability; • Governing law. 3. issues stakeholders identified essential ABS contracts addition minimum contract content stipulated national law. exceptions issues stakeholders identified (section 5, paragraph 28) related price , Contract Law, contract: • Provisions stating genetic resources benefits; • Establishing percentage monetary benefits; • Defining -monetary benefits. 4. Government Japan CBD Secretariat commissioned United Nations University - Institute Advanced Studies (UNU-IAS) carry study articles 19 20 Nagoya Protocol23 listed issues included ABS contracts, addition Lao People’ Democratic Republic stakeholders identified: • Definition terms; • Statement principle benefits shared; • Statements intellectual property rights; • Statements fixed benefits shared; • Description variable benefits shared; • Status unused material; • Requirements transfer material research information parties; • Statement related instruments complied requirements met. 5. Additional provisions existing model ABS contracts24 include: • preamble; • requirement user deposit samples genetic resources accessed provider; • Storage genetic resources; • requirement acknowledge contribution provider State; • Dissemination knowledge; • Penalties/consequences breach; • Guaranties/warranties. 6. African Union adopted guidelines implementing Nagoya Protocol include issues listed paragraphs 1-5 Annex provide detailed information rationale .25 7. stakeholder commented model clauses negotiations guidance -developed ( paragraph 21). draft proposed model clauses follow attempt balance simple , time, offer guidance issues Lao People’ Democratic Republic stakeholders identified providing options additional issues, based international experience. drafters ABS contract determine, case- -case basis, clauses relevant situation. contract drafters adapt model clauses, mind contract concrete, clear, specific , create legal certainty parties ensure contract enforceable. 8. clauses required Lao People’ Democratic Republic’ Contract Law identified; standard clauses part contract highlighted optional recommended. draft proposed model clauses presented order occur contract, order changed contract drafted. 17LAO PEOPLE’ DEMOCRATIC REPUBLIC 9. assumed material transfer agreement party applies access biological resources genetic resources situ collections academic, -commercial research, purposes related food agriculture stipulated International Treaty Plant Genetic Resources Food Agriculture,26 model clauses contracts cases access. 10. consultation draft model clauses held Vientiane, Lao People’ Democratic Republic, 1 November 2019, ABS stakeholders Lao People’ Democratic Republic. list participants attached Annex 6. consultations supported Helvetas Swiss Intercooperation organized BEI. substantive comments consultations incorporated draft model clauses . comment noted guidelines separated model clauses. , decided separating existing guidelines text draft model clauses suitable specific ABS regulation. Lao People’ Democratic Republic issues ABS Decree, separate guidelines developed reflect substance ABS Decree. guidelines include structural guidelines caps highlighted gray draft model clauses . 1. Parties Contract : Biotechnology Ecology Institute (BEI) Ministry Science Technology, Doon Taew Village, Km. 14 Thangon Road, Xaythany District, .. Box 2279, Vientiane, Lao People’ Democratic Republic [full acronym abbreviation, complete contact details competent national authority27] : [full acronym abbreviation receiving institution28 complete contact details], collectively referred “ Parties”. 2. Preamble WHEREAS Lao People’ Democratic Republic Party Nagoya Protocol Access Genetic Resources Fair Equitable Sharing Benefits Arising Utilization Convention Biological Diversity seeks ensure access genetic resources, traditional knowledge, territory subject prior informed consent, based mutually agreed terms, results benefits country people; WHEREAS sustainable biological genetic resources Parties’ priority; WHEREAS [insert information interest competent national authority entering contract purpose]; WHEREAS [insert information interest receiving institution entering contract purpose including, specifically, adheres BioTrade principles criteria] [WHEREAS information Parties agree add] Model Clauses ABS Contracts Lao People’ Democratic Republic model clauses follow: text caps highlighted red background information options deleted contract finalized; [Text brackets underlined Parties insert information]. 18 GUIDELINES AND MODEL CLAUSES ON ACCESS AND BENEFIT-SHARING AND BIOTRADE IN THE 3. Purpose required lao people’ democratic republic national contract law purpose contract support academic, -commercial research. purpose contract enable bioprospecting utilization seek identify genetic resources potential development marketable product. purpose contract support -commercial research understanding research identify genetic resources potential development marketable product, case Parties enter contract commercialization. 4. Scope lao people’ democratic republic national contract law lists mandatory scope contract : 1. Document commitment [acronym abbreviation receiving institution] contribute conservation protected area bioprospecting carried , attached Annex [number annex] contract; 2. Define Parties’ mutually agreed terms related bioprospecting [specific area areas country bioprospecting allowed, coordinates, include map maps annex contract]; 3. Define Parties’ mutually agreed terms related access accessed [biological / genetic] resources [, related traditional knowledge], sharing benefits resulting utilization. contract access specific biological genetic resource -situ: scope contract : 1. Document commitment [acronym abbreviation receiving institution] contribute conservation protected area [biological / genetic] resources accessed, attached Annex [number annex] contract; 2. Document prior informed consent provider providers [scientific classification – genus species – biological genetic resource resources accessed], attached Annex [number annex] contract; insert clause traditional knowledge biological genetic resource accessed : 3. Document prior informed consent provider providers traditional knowledge related [scientific classification biological genetic resource resources accessed], attached Annex [number annex] contract; [3. 4.] Document process analysis [acronym abbreviation receiving institution] intends [scientific classification – genus species – biological genetic resource resources accessed] [ traditional knowledge], attached Annex [number annex] contract; [4. 5.] Define Parties’ mutually agreed terms related access [scientific classification – genus species – biological genetic resource resources accessed] [, traditional knowledge], sharing benefits resulting . contract access utilization specific biological genetic resource -situ collection: 1. Document agreement [insert institution holding -situ collection], attached Annex [number annex] contract, provide [scientific classification – genus species – biological genetic resource resources accessed] utilization; 2. Document process analysis [acronym abbreviation receiving institution] intends [scientific classification – genus species – biological genetic resource resources accessed] [ traditional knowledge], attached Annex [number annex] contract; contract bioprospecting specific biological genetic resource targeted: 19LAO PEOPLE’ DEMOCRATIC REPUBLIC 3. Define Parties’ mutually agreed terms related access [scientific classification – genus species – biological genetic resource resources accessed] [, traditional knowledge], sharing benefits resulting . 5. Definition terms terms listed defined 2013 draft proposed abs law. definitions listed cbd nagoya protocol. parties abs contract determine definitions needed, delete definitions , / add definitions required. • “Access” means collecting genetic resources location , -situ -situ. • “Accessed genetic resources” means genetic resources collected basis contract. • “Biological diversity” means variability living organisms sources including, inter alia, terrestrial, marine aquatic ecosystems ecological complexes part; includes diversity species, species ecosystems. • “Biological resources” includes genetic resources, organisms parts thereof, populations, biotic component ecosystems actual potential humanity. • “Bioprospecting” means ways commercialize biodiversity systematic search development economically valuable genetic biochemical resources originating nature.29 • “Biotechnology” means technological application biological systems, living organisms, derivatives thereof, modify products processes specific . • “Country origin genetic resources” means country possesses genetic resources -situ conditions. • “Country providing genetic resources” means country supplying genetic resources collected - situ sources, including populations wild domesticated species, -situ sources, originated country. • “Derivative” means naturally occurring biochemical compound resulting genetic expression metabolism biological genetic resources, functional units heredity. • “-situ conservation” means conservation components biological diversity natural habitats. • “Genetic material” means material plant, animal, microbial origin functional units heredity. • “Genetic resources” means genetic material actual potential . • “-situ conditions” means conditions genetic resources exist ecosystems natural habitats, , case domesticated cultivated species, surroundings developed distinctive properties. • “Protected area” means land, forest coverage including rivers, creeks, rills, channels, lakes, ponds, wetlands, types natural areas government designates category protection level national, provincial, district, municipal, village.30 • “Research development” means work directed innovation, introduction, improvement products processes.31 • “Traditional knowledge” means knowledge, -, skills practices developed, sustained passed generation generation community, forming part cultural spiritual identity.32 • “Utilization genetic resources” means conduct research development genetic / biochemical composition genetic resources, including application biotechnology. 6. Duration required lao people’ democratic republic national contract law contract enter force date signed Parties remain force [ enter period time contract remain force] [ enter termination date]. 7. Place execution lao people’ democratic republic national contract law lists mandatory 1. BEI [acronym competent national authority] carry obligations contract 20 GUIDELINES AND MODEL CLAUSES ON ACCESS AND BENEFIT-SHARING AND BIOTRADE IN THE Vientiane [ names places country, applicable], Lao People’ Democratic Republic. 2. [acronym abbreviation receiving Party] carry obligations contract [ names place places Lao People’ Democratic Republic / country countries, applicable]. 8. Benefits required lao people’ democratic republic national contract law 1. Parties agree benefits obtained contract equitably shared Parties provider providers biological / genetic resources [ provider providers traditional knowledge]. purpose contract enable bioprospecting, collection -situ, obtaining biological genetic resources -situ collection, utilization seeks identify biological genetic resources potential development marketable product: 2. [acronym abbreviation receiving Party] share monetary benefits [BEI] [acronym competent national authority] : lao people’ democratic republic regulated abs legally- minimum maximum percentages sharing monetary benefits stipulation monetary benefits valued basis sales price intermediate final product process resulting contract basis. model provisions modified comply national law / regulations adopted. [. [minimum percentage sales price product process] [maximum percentage sales price] [ range minimum maximum percentage sales price]; [. lump sum equal [ percentage] net profit taxes sale product process.] [. Payments based financial report [reference clause contract corresponds ‘Clause 17. Monitoring contract performance’ model clauses] [ payments – annually, months, month, frequency]. 3. [acronym abbreviation receiving Party] provide -kind / -monetary benefits [ :] [ set Annex [number annex] contract:] addition item ., types -monetary benefits listed , training education, options support communities government institutions [. infrastructure support provider community/communities – community receiving Party provide, : water supply, building school clinic, assistance road construction, . community communities receive assistance, type assistance , , issue related providing support;] [. equipment – detailed list equipment give complete contact information community communities, institution institutions receive equipment]; [. involve Lao scientists research – involved capacities, period time, , issue related involvement research]; [. training – trained, subject matter training, training , training , issue related training -monetary benefit]; [. scholarships / educational opportunities human resource development – receive educational opportunity, field fields individual study, individual study, long individual study, number educational opportunities supported year, / issue related educational benefits -monetary benefit]; [. technical advice support – technical advice support benefits monetary -monetary . 21LAO PEOPLE’ DEMOCRATIC REPUBLIC offered]; [. assistance fund raising – type assistance basis ]; [number/numbers. -kind / -monetary benefit agreed Parties.] 4. [BEI] [acronym competent national authority] entered agreement provider providers biological / genetic resources [ traditional knowledge] attached Annex [number annex] contract, share monetary benefits stipulated agreement. purpose contract support academic, -commercial research monetary benefits share case -commercial research. , clause . , clause deleted: [2. [acronym abbreviation receiving Party] share [percentage lump sum] research funding [BEI] [acronym competent national authority [ :] [ set Annex [number annex] contract:] monetary benefits share, clauses article contract academic, -commercial research : 2. [acronym abbreviation receiving Party] provide -kind / -monetary benefits [ :] [ set Annex [number annex] contract:] addition item ., types -monetary benefits listed , training education, options support communities government institutions [. infrastructure support provider community/communities – community receiving Party provide, : water supply, building school clinic, assistance road construction, . community communities receive assistance, type assistance , , issue related providing support;] [. equipment – detailed list equipment give complete contact information community communities, institution institutions receive equipment]; [. involve Lao scientists research – involved capacities, period time, , issue related involvement research]; [. training – trained, subject matter training, training , training , issue related training -monetary benefit]; [. scholarships / educational opportunities – receive educational opportunity, field fields individual study, individual study, long individual study, number educational opportunities supported year, / issue related educational benefits -monetary benefit]; [. technical advice support – technical advice support offered]; [. assistance fund raising – type assistance basis ]; [number/numbers. -kind / -monetary benefit agreed Parties.] 3. [BEI] [acronym competent national authority] entered agreement provider providers biological / genetic resources [ traditional knowledge] attached Annex [number annex] contract, share monetary benefits stipulated agreement. 9. Activities carried contract contract bioprospecting -situ: 1. [acronym abbreviation receiving Party] obtained required permits [, 22 GUIDELINES AND MODEL CLAUSES ON ACCESS AND BENEFIT-SHARING AND BIOTRADE IN THE attached annexes contract,33] entitled collect specimens [biological / genetic] resources -situ conditions : . Types specimens,34 ; . Number specimens quantity type specimen; . Geographical location collection type specimen;35 . Time period collection type specimen; . Collection method type specimen; contract access specific biological genetic resource -situ: 1. [acronym abbreviation receiving Party] entitled collect specimens [scientific classification – genus species – biological genetic resource accessed] -situ conditions : . Types specimens;36 . Number specimens quantity type specimen; . Geographical location collection type specimen;37 . Total weight characteristics specimens/material transferred;38 . Time period collection type specimen; . Collection method type specimen; contract accessing biological genetic resources -situ collections commercial purpose: 1. [acronym abbreviation receiving Party] entitled obtain [ complete contact information institution holding -situ collection] resources: [scientific classification – genus species – biological genetic resource accessed form accessed]. 2. [acronym abbreviation receiving Party] entitled move accessed resources premises [reference clause contract corresponds ‘Clause 7. Place execution’ model clauses]. [number/numbers. activity activities agreed Parties.] 10. Activities carried contract 1. [acronym abbreviation receiving Party] transfer party [biological / genetic resources] traditional knowledge [BEI] [acronym competent national authority] prior, express written permission transfer [biological / genetic] resources entered contract party, provider providers traditional knowledge prior, express written permission transfer traditional knowledge. 2. [acronym abbreviation receiving Party] accessed genetic resources purpose activity contract prior, written consent [BEI] [acronym competent national authority]. contract academic, -commercial research [acronym abbreviation receiving Party] determines accessed genetic resources commercial purpose, entered contract [bei] [acronym competent national authority] purpose. 3. [acronym abbreviation receiving Party] claim obtain intellectual property rights accessed [biological / genetic] resource part accessed [biological / genetic] resource, explicitly authorized. 4. [BEI] [acronym competent national authority] ,  duration contract, grant party access [biological / genetic] resources area contract applies secures prior, written consent [acronym abbreviation receiving Party]. 5. Party assign rights, benefits, obligations contract party prior written consent Party. 23LAO PEOPLE’ DEMOCRATIC REPUBLIC [number/numbers. activity activities agreed Parties.] 11. Specific obligations BEI [acronym competent national authority] 1. provider providers [biological / genetic] resources prior informed consent [acronym abbreviation receiving Party] entered agreement institution responsible -situ collection access genetic resources, issue permit serve internationally recognized certificate compliance Nagoya Protocol upload Nagoya Protocol ABS Clearing-House; 2. Comply obligations Lao People’ Democratic Republic Nagoya Protocol disclose -confidential information contract ABS Clearing-House; 3. Advise [acronym abbreviation receiving Party] permits required government authorities facilitate contact authorities; [4. obligations agreed Parties]. 12. Specific obligations [acronym abbreviation receiving Party] [acronym abbreviation receiving Party] :39 1. Ensure collection, storage, transport, export accessed biological / genetic resources comply applicable laws Lao People’ Democratic Republic govern issues including limited protection human health environment, endangered species, taxation, customs; 2. Bear costs incurred bioprospecting accessing [biological / genetic] resources -situ -situ collections, delivering duplicate samples, required, [carrying research] [utilizing genetic resources], sharing results; 3. Involve [list full names individual institutional local partners activity activities involved40]; 4. Contribute building capacity Lao People’ Democratic Republic bioprospecting, utilization [biological / genetic] resources, [insert activity specific contract] [ insert specific information receiving Party build capacity] [ set Annex {number annex} contract]; 5. Utilize accessed [biological / genetic] resources Lao People’ Democratic Republic [insert agreement Parties extent utilize biological / genetic resources -country]; 6. Share [BEI] [acronym competent national authority] results [research] [utilization] involving accessed [biological / genetic] resources, including free access online resource results fee, provide [BEI] [acronym competent national authority] assistance required interpret results; 7. Acknowledge contribution Lao People’ Democratic Republic, national scientists researchers, local partners, providers [biological / genetic] resources communications publications activities carried contract; 8. Provide [BEI] [acronym competent national authority] [ institution Parties designate] [number] printed copies publication based accessed [biological / genetic] resources links site sites publication accessed online; contract collecting -situ, academic research commercial purpose, include additional clauses: [number]. alternative collecting legally designated protected area, enter written agreement protected area management authority, attached Annex [number annex] contract, offset mitigate damage caused collection activities contribute conservation protected area. [number]. Involve members [list names communities adjacent areas bioprospecting carried ], [reference clause contract corresponds “Clause 4. Scope” model clauses]. [number]. [time period Parties] time period collection expires, 24 GUIDELINES AND MODEL CLAUSES ON ACCESS AND BENEFIT-SHARING AND BIOTRADE IN THE notify [BEI] [acronym competent national authority] scientific classification resource [acronym abbreviation receiving Party] intends . [BEI] [acronym competent national authority] , [time period Parties], raise objections, case Parties seek agreement [biological / genetic] resources . [number]. Deliver duplicate samples accessed [biological / genetic] resources [BEI] [acronym competent national authority]. Duplicate samples delivered form forms: [insert requirements samples]. [number]. Deliver duplicate samples accessed [biological / genetic] resources [institutions] [institutions] designated [BEI] [acronym competent national authority]: [insert complete / contact information institution designated]. Duplicate samples delivered form forms: [insert requirements samples]. purpose contract support academic, -commercial research enable bioprospecting research development seek identify biological genetic resources potential development marketable product, include additional clause: [number]. Notify [BEI] [acronym competent national authority] purpose access contract -commercial research commercial utilization enter contract commercial utilization. access include traditional knowledge biological genetic resources, include additional clause: [number]. Enter written agreement provider providers traditional knowledge accessed resources describes traditional knowledge expresses provider’ providers’ prior informed consent . [number/numbers. activity/activities agreed Parties.] 13. Delivery lao people’ democratic republic national contract law lists mandatory 1. [acronym abbreviation receiving Party] deliver monetary -monetary benefits [BEI] [acronym competent national authority] stipulated [reference clause contract corresponds “Clause 8. Benefits” model clauses]. 2. [BEI] [acronym competent national authority] deliver monetary benefits providers [biological / genetic] resources [ traditional knowledge] stipulated [reference clause contract corresponds “Clause 8. Benefits” model clauses] [Annex [number annex] contract.] 14. Intellectual property rights41 intellectual property rights arising activities carried execution contract - owned Parties Party advises Party writing interest intellectual property rights. activity contract generates intellectual property rights, rights owned Government Lao People’ Democratic Republic. [BEI] [acronym competent national authority] party participated activity generates intellectual property rights free, -exclusive global license intellectual property. [acronym abbreviation receiving Party] [BEI] [acronym competent national authority] [ [ full party parties eligible license] enter licensing agreement. 15. Communications lao people’ democratic republic national contract law lists mandatory 1. communication Parties related execution contract, including 25LAO PEOPLE’ DEMOCRATIC REPUBLIC limited reports, minutes, records, instructions, notices, advice, correspondence, English. 2. communication Parties directed : Government Lao People’ Democratic Republic [complete receiving institution] [] [] [Title] [Title] [Postal address] [Postal address] [Email address] [Email address] [Telephone fax] [Telephone fax] 16. Dissemination knowledge42 1. Parties disclose digital sequence information genetic resources subject contract [insert text describing Parties agree] [ determined Meeting Parties Nagoya Protocol]. 2. Parties agree, case--case basis, jointly separately publish information results research / & undertaken contract scientific journals, short reports, communication national / international newspapers, / present results academic conferences events Lao People’ Democratic Republic / internationally. [insert text detail extent, timing, nature limits publishing disclosing information, include detail annex contract.] 3. Parties disclose information traditional knowledge accessed [biological / genetic] resources providers traditional knowledge give written prior informed consent disclosure. 17. Monitoring contract performance 1. [BEI] [acronym competent national authority] monitor time activities contract carried Lao People’ Democratic Republic. 2. [acronym abbreviation receiving Party] give [BEI] [acronym competent national authority], persons authorized writing [BEI] [acronym competent national authority], access premises [reference clause contract corresponds “Clause 7. Place execution” model clauses] permit persons participate audits, inspect, copies material relevant contract. 3. [acronym abbreviation receiving Party] maintain records storage transfer accessed genetic resources premises designated [reference clause contract corresponds ‘Clause 7. Place execution’ model clauses] [BEI] [acronym competent national authority] access records 4. [acronym abbreviation receiving Party] report writing [BEI] [acronym competent national authority] [insert reporting period – month, months, period], beginning [insert date report] [insert date final report], providing: . details accessed [biological / genetic] resources including progress [research] [utilization, including steps obtaining intellectual property rights / marketing products processes based accessed biological / genetic resources]; . comprehensive financial accounting related implementation contract results. 5. progress report [acronym abbreviation receiving Party] submits parts: part include -confidential information part include information [acronym abbreviation receiving Party] considers confidential, including financial audit reports, order protect existing future intellectual property rights. 6. Party retain records related execution contract [insert period time] date contract expires terminated reason. 26 GUIDELINES AND MODEL CLAUSES ON ACCESS AND BENEFIT-SHARING AND BIOTRADE IN THE 7. Party request schedule face--face virtual meeting time required discuss contract performance. 18. Guarantees, indemnification insurance 1. [BEI] [acronym competent national authority] guarantee: . quality, viability purity accessed [biological / genetic] resources; . title accessed [biological / genetic] resources; . truthfulness accuracy traditional knowledge information accessed [biological / genetic] resources; . accessed [biological / genetic] resources research utilization infringe party intellectual property rights. 2. [BEI] [acronym competent national authority] liable loss incurred [acronym abbreviation receiving Party] activity carried contract / event bioprospecting identify [biological / genetic] resource utilized. 3. [acronym abbreviation receiving Party] guarantees obtained permits required laws regulations Lao People’ Democratic Republic collect, store, transport, export accessed biological / genetic resources. 4. [acronym abbreviation receiving Party] guarantees facilities [reference clause contract corresponds “Clause 7. Place execution” model clauses] qualifications personnel carry activities [reference clause contract corresponds “Clause 9. Activities carried contract” model clauses] adequate purpose contract. 5. [acronym abbreviation receiving Party] solely responsible insuring personnel, equipment, operations activities contract Lao People’ Democratic Republic premises. 6. contract affect sovereign rights Lao People’ Democratic Republic accessed [biological / genetic] resources [BEI] [acronym competent national authority] retain authority grant party access genetic resources/biological resources type Article [reference clause contract corresponds ‘Clause 10.4. Activities carried contract’ model clauses]. 19. Confidentiality 1. traditional knowledge [biological / genetic] resources accessed contract considered confidential disclosed Party written, prior informed consent provider providers traditional knowledge. 2. Parties designate data, technical specifications procedures, methodologies information related subject contract confidential informing Party writing. 3. Party disclose information Party designated confidential Party holding confidential information prior, written consent disclosure. 20. Severability 1. , provisions contract construed invalid, illegal unenforceable. 2. contract unenforceable, illegal void, severed rest contract remain force. 21. Modification lao people’ democratic republic national contract law lists mandatory 27LAO PEOPLE’ DEMOCRATIC REPUBLIC 1. contract amended time mutual agreement Parties. 2. amendment contract writing signed Parties. 22. Consequences breach purpose contract support academic, -commercial research [acronym abbreviation receiving Party] utilizes accessed [biological / genetic] resources traditional knowledge commercial purpose, entered contract purpose [reference clause contract corresponds ‘Clause 10.2 Activities carried contract model clauses’] breach contract pay [BEI] [acronym competent national authority] [minimum percentage sales price product process] [maximum percentage sales price] [ lump sum equal [ percentage] net profit taxes sale product process] [based financial report [reference clause contract corresponds ‘Clause 17. Monitoring contract performance’ model clauses] [ penalty amount [insert lump sum percentage]. purpose contract enable bioprospecting, collection -situ, obtaining genetic resources -situ collection, utilization seeks identify genetic resources potential development marketable product: [acronym abbreviation receiving Party] utilizes accessed genetic resources traditional knowledge purpose activity authorized contract, breach contract pay [BEI] [acronym competent national authority], addition payments stipulated [reference clause contract corresponds ‘Clause 8. Benefits’ model clauses], penalty amount [lump sum percentage]. 23. Termination lao people’ democratic republic national contract law lists mandatory 1. contract terminated time mutual written agreement Parties. 2. contract terminated default [acronym abbreviation receiving Party] fails satisfy obligations contract: [list provision breach result default]. . case default, [BEI] [acronym competent national authority] give written notice [acronym abbreviation receiving Party] requesting rectify explain satisfaction [BEI] [acronym competent national authority] reasons default. . [acronym abbreviation receiving Party] respond written notice default [insert period time], [BEI] [acronym competent national authority] terminate contract giving written notice [acronym abbreviation receiving Party] termination. . contract terminated default, [acronym abbreviation receiving Party] immediately stop activities involving [biological / genetic] resources subject contract. 3. contract terminate declaration bankruptcy [acronym abbreviation receiving Party]. 4. Termination contract affect obligations / rights due accrue party prior effective date termination. 5. expiration contract termination reason, [acronym abbreviation receiving Party] transfer [BEI] [acronym competent national authority] destroy, discretion [BEI] [acronym competent national authority], accessed genetic resources. operation clause survives termination agreement. 24. Governing law 1. contract governed applicable laws regulations Lao People’ Democratic Republic. 28 GUIDELINES AND MODEL CLAUSES ON ACCESS AND BENEFIT-SHARING AND BIOTRADE IN THE [2. Insert statement includes complete citation legal instrument applies contract.] 25. Dispute resolution lao people’ democratic republic national contract law lists mandatory 1. Party wishes dispute issue interpretation execution contract, Party notify Party writing. 2. dispute interpretation execution contract , practicable, resolved good faith consultation Parties. 3. dispute arising interpretation execution contract settled good faith efforts resolve , referred mediation Vientiane, Lao People’ Democratic Republic stipulated law Lao People’ Democratic Republic force time dispute. 4. dispute interpretation execution contract settled amicably Parties mediation subject jurisdiction competent courts Vientiane, Lao People’ Democratic Republic. 26. Warranty Party warrants Party full powers authority enter contract. 27. Entire agreement contract constitutes entire agreement Parties. SIGNED [NAME] [NAME] [TITLE] [TITLE] behalf Government Lao People’ Democratic Republic behalf [complete receiving institution] [DATE] [DATE] [PLACE] [PLACE] 29LAO PEOPLE’ DEMOCRATIC REPUBLIC ANNEX 6 LIST OF PARTICIPANTS: CONSULTATION ON THE DRAFT MODEL CONTRACT CLAUSES 1 November 2019 . Full Names Positions Organizations 1 Dr. Sourioudong SUNDARA Nagoya Protocol-NFP/Vice Minister Ministry Science Technology 2 Dr. Kosonh XAYPHAKATSA Deputy Director General Biotechnology Ecology Institute 3 Ass. Prof. Dr. Vichit LAMXAY Head Post Graduate Faculty Science, National University Laos 4 Dr. Kongmany SYDARA Director Institute Traditional Medicine, Ministry Health 5 Ms. Kongchay PHIMMAKONG Deputy Director Department Science, MOST 6 Ms. Somphavanh RADAVANH Director Biosafety Division, BEI, MOST 7 Ms. Viengpasith VANISAVETH BCH NFP Ministry Science Technology 8 . Panya BOUPHASIRI Deputy Director Biosafety Division 9 . Somchay INDAVONG Project Official chair Helvetas Lao, BioTrade Project 10 . Phonexay SENGSOULICHANH Project Official Standard Helvetas Lao, BioTrade Project 11 Ms. Khamphachanh SIHAVONG Deputy Director Biosafety Division, BEI, MOST 12 . Khamkeo SENGINVONG Secretariat Vice Minister Ministry Science Technology 13 . Thavisack PANYASACK Technical Staff Biosafety Division 14 Ms. Alounny CHANTHALIDETH Deputy Director General Administration Division, BEI 15 . Khamsalath SOUTHEDLATH Technical Staff Genetic Resource Division 16 Ms. Vilaysoth NORKEOMAMY Technical Staff Genetic Resource Division 17 Ms. Kitsamone SIHAVONG Deputy Director Ecology Division 18 . Keo PHOMMAVONG Deputy Director Biotechnology Division 19 Ms. Kompheng PHONEMAVONG Deputy Director Chemistry Division 20 Ms. Kantheo SENTHAMMAVONG Deputy Director Silk Biotechnology 21 Ms. Phetdalaphone PATHOMTHONG Technical Staff Genetic Resource Division 22 . Khemkham Hongphakdy Technical Staff Plant Genetic Resources Conservation Unit, Rice Research Center 23 Ms. Touktadaling Keobounthanh Technical Staff Agriculture Department, MAF 24 . Soulivanh Larfasanah Head Unit Faculty Science, NUOL 30 GUIDELINES AND MODEL CLAUSES ON ACCESS AND BENEFIT-SHARING AND BIOTRADE IN THE Notes 1 United Nations Conference Trade Development. 2007. UNCTAD BioTrade Initiative BioTrade Principles Criteria. United Nations: York Geneva. . 1. definition BioTrade quoted page document. online : https://unctad.org/en/Pages/DITC/Trade-- Environment/BioTrade/BT-Principles-Criteria.aspx 2 UNCTAD. 2007. 3 UNCTAD. 2007. Page 2. 4 Helvetas Swiss Intercooperation independent Swiss development organization. : https://www.helvetas.org/en/switzerland. 5 information ( Spanish) https://unctad.org/en/pages/MeetingDetails.aspxmeetingid=1887 document Propuesta de Estrategia de Negociació para la Elaboració de Contratos de Acceso los Recursos Genéticos, sus Derivados el Biocomercio para el ú (UNCTAD/DITC/TED/INF/2018/2). 6 : https://www.cbd.int/abs/nagoya-protocol/signatories/default.shtml. 7 Building Capacity Regionally Harmonized National Processes Implementing CBD Provisions Access Genetic Resources Sharing Benefits. 2011-2014. Lao People’ Democratic Republic country component. Project documents GEF website. 8 Ministry Science Technology. Biotechnology Ecology Institute. 2013. Lao National Framework Access Genetic Resources Fair Equitable Sharing Benefit Arising Utilization. Draft dated 30 October. draft chapters : ABS policy; ABS regulatory framework; ABS administrative system; mechanisms public education, awareness, participation. 9 https://www.cbd.int/information/parties.shtml Lao People’ Democratic Republic acceded International Treaty Plant Genetic Resources Food Agriculture (ITPGRFA) 2006 ( http:// www.fao.org/plant-treaty/countries/membership/country-details/en//359312/iso3=LAO). 10 Lao People’ Democratic Republic. 2004. National Biodiversity Strategy 2020 Action Plan 2010. . 11. online: https://www.cbd.int/doc/world/la/la-nbsap-01-en.pdf. 11 IUCN. 2011. NBSAP Assessment: assessment Lao People’ Democratic Republic National Biodiversity Strategy 2020 Action Plan 2010. Gland, Switzerland: IUCN. . 21. online: https://www. cbd.int/doc/world/la/la-nbsap-oth-en.pdf. 12 Ministry Natural Resources Environment (MoNRE). 2016. National Biodiversity Strategy Action Plan Lao People’ Democratic Republic 2016-2025. Vientiane Lao People’ Democratic Republic. Table 18: Strategy 3 - Strengthen knowledge base strategic decision making. . 74. online: https://www.cbd.int/doc/world/la/la-nbsap-v2-en.pdf. 13 https://unctad.org/en/pages/MeetingDetails.aspxmeetingid=1834. 14 https://unctad.org/en/pages/MeetingDetails.aspxmeetingid=1835. 15 UNCTAD Ministerio del Ambiente del Peru (MINAM) [Environment Ministry Peru]. 2018. Propuesta de Estrategia de Negociació para la Elaboració de Contratos de Acceso los Recursos Genéticos sus Derivados (Proposal Negotiation Strategy Develop Contracts Access Genetic Resources Derivatives). September. 16 Lao People’ Democratic Republic, 2019, users genetic resources included private sector companies, National University, central government agencies. 17 Lao People’ Democratic Republic regulated ABS. Article 24 Lao PDR’ Law Biotechnology generally enables ABS. Article 61 law stipulates Ministry Science Technology responsible administering biotechnology. Ministry designated BEI Competent National Authority ABS. Lao PDR regulated ABS, BEI exercises powers administer ABS ad hoc basis. 18 user’ comment implicitly raises issues involved BioTrade. “BioTrade activities characterized respect environmental, economic social criteria. , BioTrade activities maintain characteristics ecosystems natural habitats species collected cultivated. Income generated distributed levels actors chain.” UNCTAD. 2017. BioTrade Access Benefit Sharing: concept practice. handbook policymakers regulators. Box 2. Page 8. https://unctad.org/en/Pages/DITC/Trade--Environment/BioTrade.aspx. 19 BioTrade Initiative notes determination fair pricing biological resources genetic resources important issue regulating ABS. UNCTAD. 2017. BioTrade Access Benefit Sharing: concept practice. handbook policymakers regulators. Box 2. Page 8. https://unctad.org/ en/Pages/DITC/Trade--Environment/BioTrade.aspx. , pages 35-39 discussion fair pricing pages 59, 76, 78 examples countries approached issue. 20 Multiple respondents BEI. 31LAO PEOPLE’ DEMOCRATIC REPUBLIC 21 Multiple respondents faculties. 22 Law Contract Tort . 01/NA, 8 December 2008, Article 16. 23 UNU-IAS report summarized : CBD. 2014. Open-ended ad hoc Intergovernmental Committee Nagoya Protocol Access Genetic Resources Fair Equitable Sharing Benefits Arising Utilization. Report Informal Meeting Implementation Articles 19 20 Nagoya Protocol. UNEP/CBD/ICNP/3/INF/3. online: http://www.cbd.int/icnp3/submissions. 24 Ethiopia Model contract access genetic resources benefit sharing MicroB3 Model Agreement Access Marine Microorganisms Benefit Sharing. online: https://www.cbd.int/icnp3/ submissions/; Model Access Benefit Sharing Agreement Australian Government Access Party. online: www.wipo.int; Swiss Academy Sciences. 2016. Agreement Access Benefit- sharing Academic Research. online: http://www.swiss-academies.ch/dms//Publications/ Reports/AccessBenefitSharing_ABS_Model_Clauses.pdf; Young, .. Tvedt, .. 2017. Drafting successful ABS contracts – practical examples. Fridtjof Nansen Institute. Dakar. 7 March. PowerPoint presentation. online: http://www.abs-initiative.info/fileadmin//media/Events/2017/6-10_ March_2017__Dakar__Senegal/07_Tvedt_17030714_Contracts_for_Dakar.pdf. 25 African Union Commission. 2015. African Union Practical Guidelines Coordinated Implementation Nagoya Protocol Africa. Annexes 3 4. online: http://www.abs-initiative.info/fileadmin// media/Knowledge_Center/Pulications/African_Union_Guidelines/AU_Practical_Guidelines_On_ABS_- _20150215.pdf. 26 Lao People’ Democratic Republic acceded International Treaty Plant Genetic Resources Food Agriculture 2006. http://www.fao.org/plant-treaty/countries/membership/en/. 27 BEI Lao People’ Democratic Republic’ designated ABS Focal Point Competent National Authority. event national ABS decree stipulates national institutions competent national authorities power enter ABS contracts, complete contact details respective contracting authority entered . 28 individual. entity receives genetic resources institution enterprise. 29 Adapted World Health Organization. 2001. TRIPS, CBD Traditional Medicines: Concepts Questions. Report ASEAN Workshop TRIPS Agreement Traditional Medicine. Jakarta. 13- 15 February. Section 2.3. https://apps..int/medicinedocs/en//Jh2996e/6.3.html#Jh2996e.6.3. 30 Adapted Decree Protected Areas . 134/ dated 13/5/2015, articles 3.1, 5, 7. 31 Definition Oxford English Dictionary. Parties replace definition agree. 32 WIPO. Traditional Knowledge. https://www.wipo.int/tk/en/tk/. 33 optional. Model Clause 18 requires receiving Party guarantee obtained required permits. 34 : give scientific classification biological resource plant, animal, fungi, microorganism, including bacteria viruses. parts plants samples animals collected, parts samples. 35 specimens biological resources locations country, resources locations provide GPS coordinates location. 36 plants, , , entire plant collected, leaves, roots, seeds, part plant. fungi, entire organism collected, part. animals, entire animal collected. 37 specimens biological resources locations country, resources locations provide GPS coordinates location. 38 : complete, parts, live, extracts, transformed, . 39 recommended ABS contracts include clauses 1-8. 40 numerous local partners, list annex contract. 41 clause developed agreed stakeholders Lao People’ Democratic Republic reflects current practice country. consist United Nations recommendation matter. 42 Parties ABS contract , , proposed clauses substitute provision agree. Guidelines Model Clauses aCCess Benefit-sharinG Biotrade lao PeoPle’ deMoCratiC rePuBliC AT Printed United Nations, Geneva – 2014377 () – November 2020 – 630 – UNCTAD/DITC/TED/2020/1