Access To Genetic Resources And Benefit-sharing From Their .

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FNI Report 5/2015Access to genetic resources andbenefit-sharing from their use (ABS) –state of implementation and researchgapsChristian Prip and Kristin Rosendal

Access to genetic resources and benefitsharing from their use (ABS) – state ofimplementation and research gapsChristian [email protected] [email protected] commissioned by PBL NetherlandsEnvironmental Assessment AgencyAugust 2015

Copyright Fridtjof Nansen Institute 2015TitleAccess to genetic resources and benefit-sharing from their use (ABS) - stateof implementation and research gaps.Publication Type and NumberFNI Report 5/2015Pages38AuthorsChristian Prip and Kristin RosendalISBN978-82-7613-698-2ISSN 1893-5486AbstractCommissioned by the PBL Netherlands Environmental Assessment Agencythe report provides an international review of the current situation in accessand benefit sharing (ABS) related to genetic resources and the research needsin this field. The report concludes that even if an international ABS regimehas been in place for more than 20 years, implementation at the national levelhas been slow both in terms of enacting access legislation and legislation tosupport compliance with access legislation. A fairly large amount ofbioprospecting activities have been generated but - apparently - few with acommercial intent and thus with few examples and low amounts of monetarybenefits. Research on ABS has mainly been theoretical and less research hasbeen conducted on ABS in practice. Main research gaps are: 1) Actual andpotential contribution of ABS to conservation and sustainable use ofbiodiversity; 2) ABS, equity and standard setting; 3) ABS beyond geneticresources; 4) Business approaches to ABS; 5) Mapping the value chain ofgenetic/biological material from its collection to an end product.Key WordsGenetic resources, biological resources, biodiversity, ecosystem services,international envrionmental governance and law.

ContentsExecutive SummaryviiAcronymsxPrefacexi1Introduction12State of the art in access to genetic resources and benefitsharing from their utilization (ABS)22.1 The Convention on Biological Diversity (CBD)22.2 From the CBD to the Nagoya Protocol (NP)52.3 The Nagoya Protocol on Access to Genetic Resourcesand the Fair and Equitable Sharing of Benefits Arisingfrom their Utilization72.4 Interaction and complexity: ABS and other internationalregimes2.4.1 The International Treaty on Plant Genetic Resourcesfor Food and Agriculture (ITPGRFA)2.4.2 FAO Commission on Genetic Resources for Foodand Agriculture (CGRFA)2.4.3 World Health Organization (WHO)2.4.4 International fora on intellectual property rights(TRIPS, WIPO and UPOV)2.4.5 United Nations Convention on the Law of the Sea(UNCLOS)399111212142.5 Perceptions of ABS by the business sector and othernon-state actors14ABS in practice163.1 Background163.2 Trends in use of genetic resources163.3 ABS case studies3.3.1 The Merck/InBio agreement3.3.2 The Teff case3.3.3 The Hoodia case171718183.4 ABS domestic legislation3.4.1 Examples of national legislation to regulate accessto genetic resources3.4.2 Concluding remarks on domestic access legislation3.4.3 Examples of national legislation to regulate usersof foreign genetic resources under the country’sjurisdiction3.4.4 Concluding remarks on user-country legislation1920252829

viChristian Prip and Kristin Rosendal43.5 ABS between equity and ecosystem services293.6 Benefit sharing beyond genetic resources31General concluding remarks31References33

Access to genetic resources and benefit-sharingExecutive SummaryThe Fridtjof Nansen Institute (FNI) has been commissioned to prepare areport for the PBL Netherlands Environmental Assessment Agency onthe current situation in access and benefit sharing (ABS) related togenetic resources.Genetic resources are essential for a significant proportion of the world’seconomic activity. They are used for a wide variety of purposes, rangingfrom basic research to the development of products in sectors such aspharmaceuticals, agriculture, horticulture, agriculture, cosmetics andbiotechnology. The combined annual global markets for products derivedfrom genetic resources have been estimated at between USD 500 and 800billion.Developing countries saw the Convention on Biological Diversity (CBD)as an opportunity to achieve fair and equitable sharing of the benefitsderived by developed countries from the use of genetic resourcesstemming from developing countries. And indeed, they succeeded ingetting this concept included as the third objective of the CBD, togetherwith conservation and sustainable use. The CBD establishes that stateshave sovereign rights to genetic resources; further, that access to thesefrom outside the country is subject to prior informed consent (PIC) fromthe provider country and mutually agreed terms (MAT) on benefitsharing with the user. One reason for the strong insistence on the part ofthe developing countries on this approach was the desire to counterbalance the rapid expansion of intellectual property rights ownership toliving material mainly through patents and plant breeders’ rights.ABS remained controversial after the CBD entered into force in 1992.Developing countries, as the main providers of genetic resources, heldthat the main users – the developed countries – were not doing enough tosupport compliance with the access regulations of provider countries, andwanted a legally binding ABS regime to set user-country measures. Theresult was the 2010 Nagoya Protocol on Access to Genetic Resources andthe Fair and Equitable Sharing of Benefits Arising from their Utilization,aimed at further developing the legal ABS of framework provided by theCBD on this and other measures. The Protocol now has 55 Parties.The CBD/Nagoya Protocol ABS regime cuts across several otherinternational regimes with sectoral approaches. This has led to turfbattles, but also to the advancement of ABS approaches. The FAOInternational Treaty on Plant Genetic Resources for Food and Agriculture(ITPGRFA) is an ABS treaty for one specific type of genetic resources;the Nagoya Protocol provides that other specialized ABS instrumentsmay be developed and may prevail over the Protocol, if they areconsistent and do not run counter to the Protocol’s objectives. Amongother regimes with close relations to the CBD/NP regime are the WHO’sPandemic Influenza Preparedness (PIP) Framework for the Sharing ofViruses and Access to Vaccines and Other Benefits, the WTO Agreementvii

viiiChristian Prip and Kristin Rosendalon Trade-Related Aspects of Intellectual Property Rights (TRIPS), theUnion for the Protection of Plant Varieties (UPOV), the UN WorldIntellectual Property Rights Organization (WIPO) and the United NationsConvention on the Law of the Sea (UNCLOS).The ABS concept arose from the great demand in the late 1980s forbioprospecting – the examination of organisms, molecules and genes witha view to determining their medicinal, industrial and other values – andthereby high expectations of ‘green gold’. However, the last 20 yearshave seen rapid developments in relation to the use of genetic resources,changing the initial conditions for the ABS regime. Patenting of biological products and processes has increased. Biotech and pharmaceuticalcompanies have merged into a few big companies, and ex situ collectionsof genetic material have expanded. At the same time, science and technology have developed, implying greater speed, scale and efficiency inresearch – and in turn requiring lesser amounts of genetic material. Still,more than 50% of pharmaceutical products are derived from geneticresources; and the cosmetic industry, for example, has experienced anincrease in the need for genetic resources due to growing consumerinterest in natural products and traditional knowledge.Awareness of and commitment to the ABS regime have generally grownwith the Nagoya Protocol, and the basic elements of ABS are widelyaccepted as standard practice in many industries.However, even though the ABS regime has been in place for more than20 years, only 57 countries have enacted ABS legislation of some kind.Besides the complexity of the ABS issue and lack of capacity in developing countries, this may also be due to the ongoing negotiation processtowards a final ABS regime.Very few states have implemented user-country measures to supportcompliance with provider-country legislation – which was the primaryreason for the developing countries’ call for a supplementary ABSagreement to the CBD. Following the Nagoya Protocol, the EU hasenacted a Regulation on compliance measures for users from the NagoyaProtocol; more generally, in many countries the Protocol has created newmomentum for taking national ABS measures.Studies of countries with legal and administrative ABS frameworks inplace show that these have generated a fairly large number of bioprospecting activities, many of them with benefit-sharing arrangements,but – apparently – few with a commercial intent and thus with fewexamples and low amounts of monetary benefits shared.Research on the ABS regime has been mainly theoretical, withconsiderable focus on the international legal implications, the negotiatingprocess and the interaction with other international regimes. Lessresearch has been conducted on ABS in practice. Below are proposals forresearch areas to fill this gap: Actual and potential contribution of ABS to conservation andsustainable use of biodiversity – could ABS serve as payment for

Access to genetic resources and benefit-sharingecosystem services and thereby as an innovative financialmechanism for conservation and sustainable use? ABS, equity and standard setting – ABS as a parameter for corporatesocial responsibility? ABS beyond genetic resources – could benefit sharing in a widercontext than genetic resources serve as an instrument to address theequity deficit within the green economy? Business approaches to ABS – what is the awareness and motivationof businesses to apply ABS and how could awareness andmotivation be enhanced? Mapping the value chain of genetic/biological material from itscollection to an end product.ix

xChristian Prip and Kristin RosendalAcronymsABSAccess and Benefit SharingBSABenefit Sharing AgreementCBDConvention on Biological DiversityCGENGenetic Heritage Management Council (Brazil)CGRFACommission on Genetic Resources for Food andAgricultureDEADepartment of Environmental Affairs (SouthAfrica)FNIThe Fridtjof Nansen InstituteGRGenetic resourcesGRFAGenetic resources for food and agricultureILCsIndigenous peoples and local communitiesITPGRFAInternational Treaty on Plant Genetic Resourcesfor Food and AgricultureIPRIntellectual property rightsLMMCLike-minded megadiverse countriesMATMutually agreed termsMLSMultilateral systemMTAMaterial transfer agreementNBANational Biodiversity Authority (India)NPThe Nagoya ProtocolPICPrior informed consentPGRFAPlant genetic resources for food and agricultureR&DResearch and developmentTEEBThe Economics of Ecosystems Services andBiodiversityTRIPSTrade-Related Aspects of Intellectual PropertyRightsUETBTUnion for Ethical Bio TradeWSSSDWorld Summit on Sustainable Development

Access to genetic resources and benefit-sharingPrefaceThe Fridtjof Nansen Institute (FNI) has been commissioned to prepare areport for the PBL Netherlands Environmental Assessment Agency(PBL) that aims at the following topics:The report looks into the state of the art in access and benefit sharing(ABS) along the following dimensions:-ABS in environmental governance of genetic resources-the interaction with other international institutions/agreements ina situation of international institutional complexity-the role of key actors (users and providers of genetic resources),with special focus on the role of business-ABS relating to biological resources and conservation ofbiodiversity.Central questions here are:-What opportunities does ABS offer for achieving the CBDobjectives of conservation and sustainable use of biodiversity?How is ABS contributing to more equitable biodiversity governance?-What are best practices in ABS governance among resource usersand providers?-Might ABS have a broader approach and lessons beyond geneticresources?xi

11Introduction‘Genetic resources’ – biological materials of actual or potential valuecontaining functional units of heredity1– are essential for a significantproportion of the world’s economic activity. They are the basis forimprovement of agricultural crops and for development of traditionalmedicines on which the majority of the world’s population still depend.They are used for a wide variety of purposes ranging from basic researchto the development of products in various sectors such as pharmaceuticals, agriculture, horticulture, agriculture, cosmetics and biotechnology. The combined annual global markets for the products derivedfrom genetic resources have been estimated at between USD 500 and 800billion (ten Kate and Laird, 1999). (See also Table 1.)Table 1: Market Sectors and the Importance of Genetic Resources2SectorSize of total market in2006Importance of geneticresourcesPharmaceuticalUSD 640 billion20–25% derived fromgenetic resourcesBiotechnologyUSD 70 billion frompublic companies aloneMany products derivedfrom genetic resources(enzymes, microorganisms)Agricultural seedsUSD 30 billionAll derived from geneticresourcesPersonal care,botanical, andfood and beverageindustriesUSD 22 billion forherbal supplementsSome products derivedfrom genetic resources:represents ‘natural’component of themarketUSD 12 billion forpersonal careUSD 31 billion for foodproductsSource: Greiber et al. 2012. pp. 4–5, based on P. ten Brink, ed., 2011: TheEconomics of Ecosystems and Biodiversity in National and International PolicyMaking. Abingdon, Routledge.1Definition of genetic resources in CBD Article 2.Note: The following figures provide estimates for various categories of products derivedfrom genetic resources. It should be noted that the market