Health Articles

Unep.org

Benefit Sharing in ABS:
Options and Elaborations
This report was written by
MS Suneetha, Biodiplomacy Programme, United Nations University Institute of Advanced Studies, and
Balakrishna Pisupati, Division for Environmental Law and Conventions, United Nations Environment Programme
Acknowledgements
The authors would like to thank David Leary, Claudio Chiarol a, Geoff Burton, Sam Johnston and Hiroji Isozaki
for their comments on the draft paper. Thanks are also due to the participants at the national workshop on ABS for implementing the National Biodiversity Act in India for their inputs and suggestions to make the arguments based on real-life examples. Grateful thanks are due to Prof. A.H. Zakri, former Director of UNU-IAS for his support and encouragement to develop this report. Support from the Japan Society for the Promotion of Science for the postdoctoral research work of the first author is grateful y acknowledged.
Disclaimer
The views presented in this document are those of the authors and do not represent or reflect those of the
institutions they belong to.
Copyright 2009 UNU-IAS All Rights Reserved Design and Layout: Jose T. Badel es Copy Editing: Rachel Schutte Benefit Sharing in ABS:
Options and Elaborations
MS Suneetha
2. Global Policy Framework for ABS Implementation
2.1 Benefit Sharing within the Convention on Biological Diversity 2.2 Benefit Sharing within the FAO International Treaty on Plant Genetic Resources for Food and Agriculture 2.3 Benefit Sharing within the World Intel ectual Property Organization 3. Benefit Sharing Principles
3.1 Access to and Ownership of Genetic Resources 3.2 By-Products (Derivatives) 3.3 Benefit Sharing 3.4 Third Party Transfers of Research Results 3.5 Intel ectual Property 4. Sectoral Approaches to Benefit Sharing: Some Reflections
4.1 Economic Value of Biodiversity 4.2 Actors in Benefit Sharing 4.3 Benefit Sharing—Examples by Industry 4.4 Recent Developents in Corporate Policies towards Benefit Sharing Annex 1 Country Legistlation Related to Benefit Sharing
Endnotes
The United Nations University Institute of Advanced UNU-IAS and UNEP have been working on issues of Studies (UNU-IAS) and the Division of Environmental ABS for the past several years with a strong emphasis Law and Conventions (DELC) of the United Nations on capacity building and awareness raising through Environment Programme (UNEP) are happy to present the development of knowledge, methodologies and this very important report on issues related to benefit action plans designed to aid in the implementation sharing that arise from the use of genetic resources. It of ABS provisions at all levels. Its work is recognized is especial y relevant at a time when the international as pioneering in areas such as certificates of origin, negotiations on developing an international regime policy and legal aspects of ABS, and links to traditional on access to genetic resources and benefit sharing (ABS) are at a critical juncture to finalise the regime by the year 2010.
This report attempts to provide inputs into the much needed discussions on how to deal with benefit As those of you fol owing the ABS discussions under sharing provisions within the ABS framework. It is the Convention on Biological Diversity (CBD) may based on research undertaken by UNEP and UNU-IAS know, there has been limited progress under the together with several governments and agencies CBD on implementation of the ABS provisions, working on ABS issues, in particular with the Ministry which is one of the three founding principles of the of Environment and Forests of the Government of CBD. Though various reasons are cited for such slow India, for which UNEP and UNU-IAS are together progress, the key reason has been the lack of clarity providing technical support to develop and and experience in understanding and applying ABS implement national ABS guidelines. provisions at national and local levels. In spite of adopting the Bonn Guidelines on ABS, countries are We hope the work undertaken by the authors of this still struggling to understand various dimensions of report will help to provide inputs for the ongoing the ABS issues. In addition, much of the debate so negotiations on further defining the international far has been on issues of access to genetic resources, regime on ABS until 2010 and beyond, and that this while there has been very limited focus on issues of report will be helpful in addressing social and ethical benefit sharing.
dimensions of the CBD.
Govindan Parayil Director, UNU-IAS Director, UNEP-DELC The third objective of the Convention on Biodiversity requires the active participation of experts from (CBD) to ensure "the fair and equitable sharing of multiple disciplines and different ministries at the the benefits arising out of the utilization of genetic national level to devise comprehensive policies resources, including by appropriate access to genetic and administrative procedures. It also necessitates resources. " has taken centre stage now with appropriate and sufficient support from global negotiations in full swing to develop an international mechanisms to implement the provisions of the Bonn regime on Access and Benefit Sharing (ABS) by the Guidelines while strengthening efforts to adopt and year 2010. While some progress has been achieved on implement an international regime on ABS.
negotiations related to access regulations, discussions on benefit sharing are still evolving. The provisions of the CBD and its Bonn Guidelines on ABS (Guidelines on Access to Genetic Resources and Fair and Equitable Sharing of the Benefits Arising out of their Utilization) provide direction to the measures that countries may implement to achieve fair and equitable sharing of benefits among the different stakeholders. Other international instruments, such as the Food and Agriculture Organization's (FAO) International Treaty on Plant Genetic Resources (ITPGR) and the World Intel ectual Property Organization (WIPO) through its Inter-Governmental Committee on Intel ectual Property and Genetic Resources, Traditional Knowledge and Folklore (IGC), also address issues related to the implementation of benefit sharing measures. Despite developments in deliberations on benefit sharing in such fora, countries are found to be cautious to implement measures related to benefit Based on the experiences of implementing provisions of the international instruments and national measures, an attempt has been made to assess and analyse the issues related to benefit sharing, the entry points for discussions on the issues and the possible considerations that national implementing authorities should make before deciding on benefit sharing principles and policies. The principles are discussed under five topics in the order of a typical scheme in a bio-prospecting exercise: (i) Defining ownership over resources and related knowledge; (i ) By-products/Derivatives; (i i) Benefit sharing; (iv) Third Party Transfer of research results; and (v) Intel ectual Property concerns. Issues that need to be considered under each context in addition to distinct and suitable examples have been quoted highlighting potential scenarios that national implementing agencies will be faced with. This therefore provides a framework for nations to assess their options of dealing with such It is also important to account for and reflect on the differences in benefits, costs and approaches to benefit sharing between various prominent sectors that use biological resources for their research and development ventures such as pharmaceuticals, botanicals/nutraceuticals, food and agriculture, natural personal care and cosmetic products as well as academia. As such, any particular scenario related to ABS is specific to sectors, locations, scales and policies, which highlights the need for an integrated approach by stakeholders at various levels to ensure effective implementation of ABS provisions. This According to various estimates, the potential value The Guidelines on Access to Genetic Resources and of biological diversity and genetic resources ranges Fair and Equitable Sharing of the Benefits Arising anywhere between US$ 800 bil ion to US$ 1 tril ion out of their Utilization (Bonn Guidelines) that (Costanza et.al., 1997; ten Kate and Laird 1999; were adopted by the Parties to the CBD in 2002 to Balmford et al, 2002). However, this potential is not provide a voluntary set of guidelines and principles, currently available in a form for us to use directly including some clear mandates, are not being but is based on the careful prospecting of genetic effectively implemented. Some reasons for poor resources for products, derivatives and services. implementation include the voluntary nature of the The use and non-use values of biodiversity provide Guidelines, unclear legislation, asymmetries in market humanity with a range of options to deal with information and resultant uncertainty over the livelihood and economic securities. Humans used this likelihood of receipt of benefits commensurate with variability in biological systems to their advantage the costs of regulation and the complexity of dealing over time. New technologies such as biotechnology, with sub-national bodies such as states and local nanotechnology, pharmaceuticals and others add communities and private landowners.
value to biodiversity and genetic resources. With the advent of novel technologies, countries face new The World Summit on Sustainable Development chal enges to ensure equity amidst the different (WSSD) in 2000 cal ed on nations to negotiate an stakeholders using biological resources. This has international regime to promote and safeguard resulted in the adoption of new rules in the game of fair and equitable sharing of benefits arising out of who gains access to such resources, how such access utilization of genetic resources under the auspices of is made available, what benefits will accrue to the the CBD. The eighth Conference of Parties (COP) of the providers and users of the resources, and how the CBD through its decision (VI I/ 4) mandated Parties to benefits will be shared. complete the negotiations for an international regime in time for its tenth meeting of the Conference of The Convention on Biological Diversity (CBD) is an Parties in 2010. As per this mandate, discussions are almost universal y accepted international agreement underway to develop such a regime by the year 2010. (with 191 countries Parties to the Convention as of October 2008) that provides countries with a set of In order to progress on ABS issues, it is important principles, obligations and responsibilities on how for countries to gain more experience on how to access to genetic resources be provided and benefits operationalise the principles of ABS at national arising from use of such resources be shared. The levels without waiting for the ‘perfect' system to third objective of the CBD seeks to ensure "the fair be designed. These can be sui-generis systems but and equitable sharing of the benefits arising out discussions under the international regime are to of the utilization of genetic resources, including provide some operational principles. Innovative by appropriate access to genetic resources and by approaches such as the creation of best practice on appropriate transfer of relevant technologies, taking ABS through the Swiss funded International Institute into account all rights over those resources and to for Sustainable Development ABS Management technologies, and by appropriate funding." Tool- Best Practice Standard and Handbook for Implementing Genetic Resource Access and Benefit- In an era that facilitates privatization of knowledge sharing Activities provide a comprehensive approach and resources, governments have the sovereign to operationalising ABS measures.2 Nevertheless, a right over exploitation of their natural resources comparison of the different benefit sharing measures and accordingly must decide how access is given to within the ABS provisions of a sample of countries, people to prospect and use genetic resources and how based on their legislation (in Appendix), shows that benefits are shared based on a set of agreed norms while all the countries have fulfil ed the minimum and principles derived from ethics and equity.1 requirement for ensuring fair and equitable benefits, adequate laws providing minimum principles to be The CBD attempts to facilitate such access and adhered to during negotiations are either absent or benefit sharing mechanisms and does not provide not ful y coherent in several cases.3 for restrictive scenarios. However, in the absence of clear principles of what constitutes a fair benefit Benefit Sharing: Need for specific guidelines sharing deal and how one can foresee the potential of genetic resources in realising benefits, countries Provider countries are faced with the task of making are concerned about the entire provision of access decisions related to benefit sharing during any ABS and benefit sharing (ABS) within the CBD. Owing activity. By focusing on issues related to benefit to the lack of clarity, many countries have found sharing, this paper provides a framework set of it chal enging to implement relevant provisions of principles and options to facilitate fair and equitable the CBD. Some countries, such as India, introduced benefit sharing. The paper also briefly highlights strategic national instruments such as the National sectoral differences in product development, the Biodiversity Act (2000) to provide policy guidance on resultant costs, benefits accrued and feasible shares issues of ABS. However, much needs to be done to between the stakeholders. It also seeks to address operationalise the principles surrounding ABS.
the gap between policy and practice through the elaboration of major issues of concern in benefit sharing negotiations and what principles may be fol owed to address them. In this sense, it aims to facilitate discussions on the international regime (IR) The fol owing section discusses the global policy framework and the guiding principles for implementation of ABS provisions with an emphasis on the CBD, Food and Agriculture (FAO) and World Intel ectual Property Organization (WIPO) processes. Section 3 discusses various principles on benefit sharing that need to be taken into account and different scenarios that national policies should anticipate to chart guidelines for implementation of ABS provisions. Section 4 examines the rationale for fixing benefit sharing norms in ABS discussions, including modes and amounts of payment, arguing for a sectoral estimation of potential value of benefits. Care is taken to identify elements of the sections that are in tune with the ongoing discussions under the international regime.
2. Global Policy Framework for ABS Implementation
Intergovernmental, global processes determine the practices that may be fol owed in the implementation policy direction that individual countries shall take of the different provisions such as PIC, MAT, benefit to deal with implementation at local levels. In the sharing, traditional knowledge, conservation and case of access to biodiversity, use of the resources sustainable use. Specifical y, the Management Tool and sharing the benefits of such use, three major clearly highlights that fair and equitable benefit processes influence country level implementation. sharing is required to ensure compliance with the These are the Convention on Biological Diversity third objective of the CBD; it is provided based on the (CBD), the International Treaty on Plant Genetic stages of value addition and should involve different Resources for Food and Agriculture (ITPGRFA) and stakeholders who may have contributed to the the Inter-Governmental Committee on Intel ectual "resource management, scientific and commercial Property and Genetic Resources, Traditional Knowledge and Folklore (IGC) of the World Intel ectual Property Office (WIPO) that deals with ownership and Given the role of the sovereign right to exploit intel ectual property rights issues related to genetic genetic resources as enshrined in Article 3 of the resources and traditional knowledge. CBD, it is important that every country assesses the way it wants to apply the principle in terms 2.1 Benefit Sharing within the
of its constitutional provisions. The complexity Convention on Biological Diversity
comes from the variety of ways countries are constitutional y organized to deal with ownership. The Convention on Biological Diversity (CBD) There are sub-national bodies such as states or addresses Benefit Sharing through Articles 8(j), 15(4), provinces, indigenous and local communities 15(5), 15(7), 16 (3), and 19(1), 19(2) of the CBD text. and private property land owners. It is therefore Article 15 provides guidance when benefits arise from important that the ownership and/or other property different kinds of utilization of genetic resources and rights of the resources be clearly defined in the PIC on essential principles of obtaining informed consent and MAT applications. One of the critical chal enges on mutual y agreed terms (Tvedt and Young, 2007). for countries is to define community ownership of The Bonn Guidelines on Access to Genetic Resources genetic resources, where applicable. In the absence of and Fair and Equitable Sharing of the Benefits Arising clear guidance on the ownership of resources, there is out of their Utilization that were adopted by the always scope for confusion in sharing the benefits.
COP of the CBD in 2002 were developed to serve as guidelines for, among other measures, ‘contracts and When defining the details of distribution, it is other arrangements under mutual y agreed terms for important to have clear guidelines on when and access and benefit-sharing.' how the benefits are distributed. In instances where local devolution of power is envisaged and local With ABS debates based on issues of Prior Informed communities provide PIC and negotiate MAT, the type Consent (PIC), Mutual y Agreed Terms (MATs) and and kind of benefits can be decided in consultation Material Transfer Agreement (MTA), it is worthwhile with such communities.
to revisit how these issues are being addressed within the Bonn Guidelines. The Bonn Guidelines indicate Ideal y, mechanisms for ensuring benefit sharing that ‘mutual y agreed terms should be set out in should be flexible, variable to suit stakeholder a written agreement' with ‘guiding parameters in interests, include research co-operation, joint contractual agreements' and provide ‘an indicative ventures, and preferential terms (Bonn Guidelines, list of typical mutual y agreed terms' which may be 2002). One needs to be innovative in defining applicable in contracts regarding access to genetic the mechanism in order to maximize benefits. resources. They provide basic requirements in Experiences have shown that wider stakeholder the development of MATs for ABS, including legal consultations will be needed to define various certainty, awareness, institutional mechanisms, and mechanisms. Each of the potential options above an indicative list of elements that could be included provides an opportunity to maximize the benefits, as MATs. These elements range from resources that given market capitalization and cost constraints. can be accessed to issues of ownership over the final product, terms to use and transfer the material and An additional example of a benefit sharing benefit sharing. A separate section on benefit sharing mechanism currently being tested is the mechanism highlights what could be covered under the terms within the International Treaty on Plant Genetic including type (monetary types and non-monetary Resources for Food and Agriculture (ITPGRFA). It types of benefits), timing (short-term, medium or is discussed below in detail to provide some ideas long-term benefits) and distribution mechanisms for defining benefit sharing regimes both for the among the different stakeholders (including international regime on ABS as well as for national government, indigenous and local communities, benefit sharing system development. It should be industry, etc.) to ensure that the sharing process is fair clearly noted that the discussions under the Treaty and equitable.4 The ABS Management Tool provides relate to the crops that are listed in Annex 1 of the practical guidance for users of genetic resources to be ITPGRFA. However, the principles underlying each compliant with the Bonn Guidelines, including best of the options under the Treaty are different from the ABS principles under the CBD. Additional y, 2.2.2 Compulsory Benefit Sharing
discussions within ITPGRFA on "certificate of origin" might provide some ideas for ABS discussions under The Treaty provides for a compulsory benefit sharing the CBD whereby countries can, as a starting point, scheme with a provision for an alternative payment begin to address the possibility of defining sets of scheme under Article 6.11. Article 6.7 of the SMTA genetic resources. However, we cautiously note the states that compulsory benefit sharing payments of details that need to be worked out to put forward 1.1% of sales income are subject to the requirement this idea formal y within the discussions under the that the commercialised "Product" incorporates international regime while recognizing this as a "the Material" received from the Multilateral possible option.
System. A "Product" must 1) incorporate the material received from the Multilateral System or any of 2.2 Benefit Sharing within the FAO
its genetic parts or components; and 2) be ready International Treaty on Plant Genetic
for commercialization implying that PGRFA under Resources for Food and Agriculture
development are excluded. The incorporation includes progeny and unmodified derivatives (including genetic parts and components of the material). What The FAO Treaty provides an international y agreed the Multilateral System captures is the added value framework for the conservation and sustainable that has been created from the development and use of crop diversity, and the equitable sharing of use of a new or modified crop. This also provides benefits, consistent with the Convention on Biological some direction to the discussions on by-products and Diversity.6 In the exercise of their sovereign rights, the derivatives within the CBD-ABS.
Contracting Parties of the FAO Treaty have decided to facilitate access to the 64 most important crops 2.2.3 Alternative Payment Scheme
and forages to ensure worldwide food security. Such resources are listed in Annex I of the FAO Treaty. Part In the alternative payment scheme, recipients may IV of the FAO Treaty establishes a Multilateral System choose as their option to make voluntary payments (MLS) of Access and Benefit Sharing. Under the MLS, a as provided for in Article 6.11 of the SMTA. Under this recipient of material from the MLS is obliged to share voluntary option, recipients share the benefits arising benefits only if s/he restricts access to the material from the commercialisation of any products that are in the form received. It therefore aims to ensure free PGRFA regardless of 1) whether or not such products access of materials. Some of the options under the can be freely used for further research and breeding;8 Treaty for benefit sharing include: scope for sharing and 2) whether or not such products incorporate non-monetary benefits in addition to monetary the material received from the Multilateral System.9 benefits arising from the use of Plant Genetic Article 6.11 provides that benefit sharing payments Resources for Food and Agriculture (PGRFA) (Article must be calculated at the discounted rate of zero 6.9 of the Standard Material Transfer Agreement point five percent of the overall sales of any products (SMTA), and encourages recipients to make voluntary pertaining to the same crop species received by the payments into the trust fund administered by the FAO recipient. For example, if the recipient is a rice breeder for such purpose (Article 6.8 of the SMTA).
that receives rice accessions under this option, the breeder's payments must be calculated on the basis of 2.2.1 Access Restriction Requirement
their overall sales of rice.
Under Article 6.7 of the SMTA, payments are due only Users may want to take advantage of this alternative when a "Product" is not freely available for further payments scheme for two reasons: 1) the discounted research and breeding.7 In essence, this scheme entails rate for such benefit sharing payments is considerably the existence of a patented product (legal restrictions) lower than the one provided under Article 6.7 of or restrictions deriving from Genetic Use Restriction the SMTA; and 2) the Recipient will only have to Technologies (GURTs) (technological restrictions) or comply with a single benefit sharing obligation, certain licensing practices (contractual restrictions). no matter how many SMTA s/he has entered into, However, technological and contractual forms of expressly excluding cumulative payments. 10,11 It is protection are normal y used in addition to and not as key to distinguish this system from the underlying a substitute for patent protection or plant breeder's assumption of the CBD's ABS provisions. The FAO rights. Countries need to consider provisions under Treaty obtains a share in benefits from the sale of International Union for Protection of New Varieties of the improved bulk commodity and the benefits Plants (UPOV) when using this system. For countries so obtained do not directly go back to the in-situ with sui generis provisions, it is important to link the provider country or local owner; whereas under the provisions under the national plant variety protection CBD, the focus is on capturing a share in the value of and related rights (including farmers' rights).
the discovery made from genetic resources, which is directly given to the in-situ providers, and distributed based on national guidelines.
2.3 Benefit Sharing within the World
Intellectual Property Organization
(WIPO IGC)
The World Intel ectual Property Organization (WIPO) has done considerable work on the protection of traditional knowledge (TK) and intel ectual property issues related to benefit sharing through the Intergovernmental Committee on Intel ectual Property and Genetic Resources, Traditional Knowledge and Folklore (IGC). The IGC works closely with the CBD in identifying feasible options for the protection of genetic resources and associated traditional knowledge (TK) in the context of access and benefit sharing. It examines the feasibility of using various forms of intel ectual property rights as effective tools for benefit sharing. Towards this, the IGC has published reports on contract based intel ectual property protection and benefit sharing, defensive and positive protection options for genetic resources and TK.12 One of the issues that the IGC deals in detail is the use of TK as prior art and how it can be effectively included in patent databases. The IGC's recommendations related to intel ectual property protection and benefit sharing are quoted, wherever appropriate, in the fol owing sections.
3. Benefit Sharing Principles
Based on the experiences of implementing the Bonn is cal ed for in instances where the community Guidelines and the terms for benefit sharing set out members col ectively own resources and knowledge under the FAO Treaty, in this section we attempt related to resources; co-ownership is cal ed for when to expand on, assess and analyse the issues related ownership rights overlap between communities to benefit sharing, the entry points for discussions and other stakeholders such as the State, Research on issues, and the possible considerations that institutes and even other communities. Although this national implementing authorities should make might be considered a time-consuming and difficult before deciding on the benefit sharing principles task, it is important that the guidelines provide for and policies. We suggest that the discussions here such eventualities.
be used to address benefit sharing issues under the international regime on ABS that is being elaborated The creation of intel ectual property rights is and negotiated currently.
the usual method for crystal izing the economic value of scientific research and development. The Bonn Guidelines provide a blueprint to enter Reaching agreement on how to share benefits from into negotiations on MATs on various aspects of ABS. exploitation of these intel ectual property (IP) rights However, national and international discussions on will be vital in ensuring an equitable and effective operationalising the provisions, especial y related outcome of a benefit sharing negotiation. This can to benefit sharing, indicate the need for pragmatic entail agreeing on the value and level of contribution measures in terms of policy development and the of each party to the access and benefit sharing design of implementation guidelines. The fol owing arrangement. There is a wide range of potential seeks to identify the issues that need to be addressed factors to be discussed and weighed when assessing in the development of benefit sharing guidelines, an the relative contribution of various parties. Some important sub-component within ABS. Each topic key questions that need consideration include: is represents some of the difficult issues that need to access being provided to the genetic resource and/or be resolved to ensure transparent and comfortable associated traditional knowledge? Could associated transactions between the providers and users of TK contribute directly and significantly to an invention genetic resources. We are hopeful that this will based on the resource so that the TK provider is provide a useful checklist of principles or issues that actual y a co-inventor? Does the implementing should be addressed prior to the implementation of authority provide for options to deal with PIC, MATs benefit sharing provisions of national legislations. and MTA that is based on genetic resources and Attempts have been made to provide relevant case studies to highlight possible scenarios that may be encountered during implementation of laws related 3. Defining possible solutions for genetic resources to benefit sharing.
that occur across countries (transboundary similarities) and thereby involve ownership 3.1 Access to and Ownership of Genetic
issues in resources and/ or knowledge This issue is critical to effective implementation of Issues that need consideration: ABS regulations/legislations especial y with issues related to ABS discussions across countries and 1. Defining ownership across provinces within countries. In many cases, countries exercise their sovereign rights over genetic The transfer of Genetic Resources (GRs), which occurs resources as rights of ownership or in a manner in accordance with the concerned legislation of the indistinguishable from such rights. Unless a country country, does not necessarily entail "the conveyance owns all living examples of a given species it cannot of title or rights in the transferred material" (Chiarol a, legitimately claim to ‘own' the genetic resources of 2007). In most of the cases, MTAs transfer only the that species. Therefore, ownership of material vested possession and not the ownership of the material. with communities that are residing in more than Hence, sovereign rights over GRs may rest with the one country/state or province, and the negotiation National Government. It is also important to clarify on benefit sharing arrangements by the respective the differences in ownership claims over ‘genetic authorities need careful consideration to ensure resources which are examples of a species' and ‘of no confusion exists with respect to benefit sharing the Species itself' (which is a rare occurrence) to avoid arrangements. It is therefore pertinent to make unrealistic ownership claims.
provisions in benefit sharing measures anticipating circumstances where resources and related 2. Defining concepts of collective and co- knowledge are common to different communities ownership of resources and knowledge living in different countries. An example is shown in the Draft Bangladesh Law that al ows for co- In cases where a resource and related knowledge may operation and co-ownership between communities be shared between communities, it is pertinent to in such instances, resulting in benefits accruing to the reach an agreement on the col ective or co-ownership different stakeholders involved.13 between the stakeholders. Col ective ownership 3.2 By-Products (Derivatives)
plant is sacred to their community. But the scientists obtained the information based on their goodwill Issues that need consideration: and an oral commitment to share any returns accrued from use of the plant. They found that the leaves of 1. Definition of by-products and derivatives and the the plant also had similar properties and used them in scope of a product qualifying to be a derivative/by- the development of a poly-herb drug, Jeevani, which is marketed as an anti-fatigue drug (same use as in TK). The drug was licensed for commercial production to an Discussions on this issue need to be informed of established private Ayurvedic company. TBGRI shared differences and/or similarities between by-products 50% of its receipts with the Kani community through a and derivatives. Countries could consider inclusion Trust Fund established in the name of the community of ‘derivatives' within the definition of ‘by-product' (Pushpangadan,P et al, 1988).
or attempt to define them separately. This should be clarified before agreeing on a MTA and benefit sharing 2. The Gram Mooligai Company Limited (GMCL) is a public company registered in India. Its shareholders are made up of small groups of members of a community Definition of by-product and derivative
of medicinal plant gatherers. GMCL procures plants For example, a by-product can be defined as any part and plant products (sold as unmodified by-products) taken from biological and genetic resources such as directly from these groups, at remunerative rates but hides, antlers, feathers, fur, internal organs, roots, specifies the quality parameters. The company also trunks, branches, leaves, stems, flowers and the promotes sustainable harvesting practices among the like, including compounds indirectly produced in a communities. The company sells the herbs and shares biochemical process or cycle. A derivative can be defined 70% of the returns with the communities. In addition as something extracted from a biological or genetic to this, the company is also involved in the production resource such as blood, oils, resins, genes, seeds, of simple medicinal formulations based on traditional spores, pol en and the like taken or modified to form a knowledge (unmodified TK use). These formulations are distinguishable product. now available in the mainstream markets. This is also an example that indicates how a domestic company 2. Terms for unmodified by-products (from original can involve local communities in the development of material and/or from leads from traditional products and markets, with an emphasis on sustainable knowledge) use of genetic resources and equity in transactions. It is also an instance of how knowledge related to genetic The status of by-products that are unmodified from resource use can be effectively utilized to widen the their original ‘biochemical' form or when a resource is economic opportunities of the communities (Personal used for the same purposes as in original traditional knowledge will have to be clarified. Countries could choose to deal with such examples of biotrade 3. Terms for modified by-products (from original through laws dealing with the conservation and material and/or from traditional knowledge leads) sustainable use of biodiversity and the protection of Modified by-products refers to changes in information encoded in the resource, either as synthetic or analogue, or in its use which is different from its Consider the fol owing examples from India that purpose in TK. The MTA and benefit sharing discussion highlight the scenario and attempts at benefit sharing should deal with such modified by-products clearly.
in the context of biotrade uses of traditional knowledge, albeit at a local level. The first example is a case study of Unintended use
how a herbal medicine was developed from a resource The fol owing example from Madagascar shows how a used in TK, with the product being put to similar use as plant is shortlisted as a candidate for drug development in TK. The second example pertains to products being due to its use in traditional communities, but later gives developed using modern technologies and markets rise to successful products that are different in form and but based exclusively on TK related to resources and use from TK. The products therefore are modified from processes of product development.
the original resource and related knowledge.
1. Members of Kani community in Kerala state of The indigenous communities of Madagascar use the India have a rich herbal medicine tradition. They use plant Catharanthes roseus as an antidiabetic. ‘Vincristine' the berries of Trichopus zeylanicus ssp.travencorius and ‘Vinblastine' are anti-cancerous alkaloids (different (Arogyapacha) for its anti-fatigue properties. This use from TK) developed from the plant. These products was observed by scientists of TBGRI (Tropical Botanic were isolated and identified for their potential by Eli Garden and Research Institute, a government research Lil y Pharmaceutical Company based on an indirect institute), during a botanical exploration together lead obtained from the indigenous communities (Reid, with members of the community. The identity of the 1994). There was no benefit sharing involved with the plant was not initial y revealed by the Kanis as the communities or the country. This is an instance of a foreign researcher/ commercial body interacting with long-term research and development col aborations traditional communities, and developing a product with Australian domestic partners (Personal different from original use. The contribution of TK Communication, Geoff Burton, 2008). in this case lies in providing a lead candidate for drug development, and thereby increasing the probability of 3. Identification of various ABS scenarios In the development of benefit sharing guidelines, it 3.3 Benefit Sharing
is relevant to anticipate possible scenarios that the national authority may be faced with. These could Issues that need consideration: include scenarios where the bioprospector wishes to gain access to resources only for documentation Discussion under benefit sharing should address the purposes, to scenarios where the user develops fol owing key questions.
analogues for commercialization from resources using traditional knowledge. Some of the possible scenarios 1. Under what circumstances is benefit sharing are highlighted below. Although the scenarios are individual y indicated, guidelines may be developed for several of them in toto. This forms the underlying basis for any benefit sharing arrangement. It would be futile to claim a. Terms when original genetic resource is only used benefits for access to genetic resources that are for research purposes normal y traded commodities (that are traded regularly in various markets). By the same logic, it Access to genetic resources may be sought purely is unfair if access to new resources and/or related for the purposes of research, training, education, knowledge is not compensated.
etc., with no commercial intent. However, there is a possibility for commercial applications at a 2. For whom is benefit sharing warranted? later date, by users of the research information. Therefore, ABS negotiators and implementers a. For foreigners: For instance, the Indian need to consider such un-intended product and Biodiversity Act and Rules are oriented towards process development (different from the original regulating the prospecting norms for foreigners, intent), while providing access and in dealing while the Brazilian Act is oriented towards all with MATs, and MTAs. Examples on terms to be Users, foreign or domestic.
adhered to by users for non-commercial research purposes and if the research product is intended b. For domestic researchers and companies: For to be commercialized or transferred can be found instance, in India, domestic researchers and in the legislation and regulations of countries companies are only required to inform the such as Australia.
respective State or Provincial Biodiversity Boards of their research intentions, although they Negotiating Access for Research
are expected to comply with benefit sharing Development of biodiversity registers and related principles in the event of accessing community inventories, herbaria, and bioactivity studies are resources or knowledge. Hence, benefit examples of how information on resources and sharing norms for different actors need to be associated traditional knowledge can be used for research purposes where the genetic resources accessed are used only for research purpose and do not enter into It has to be noted that in discussions during the commercial stream in the short-term. However, the 6th Working Group on ABS held in January it is necessary to negotiate terms in the event of 2008, interventions were made to reassess the potential commercialization of the scientific or research discriminatory nature of provision of access. Such information in the future.
discussion will have implications for linking to World Trade Organization (WTO) based debates as wel . WIPO addresses such concerns by suggesting the Countries such as Australia have applied national fol owing benefit sharing mechanism: treatment (as per WTO obligations) requiring that "An initial agreement may concentrate on issues that foreign or domestic applications be treated the same do non-IP related benefit-sharing, such as research and are subject to the same rights and obligations. cooperation, evaluation of resources, training and Thus, under Australia's national ABS law (the education and technology transfer, and the parties Environment Protection Biodiversity Conservation may agree to negotiate a separate commercialization Regulations 2000) all applicants are treated equal y. package (including agreement on ownership of IP, This approach has the advantage of encouraging right to license the IP, benefit-sharing arising out of any investment and scientific col aboration with licensing agreement etc.) at a later date, should the foreign-based companies and international research need arise, once initial research leads to commercial organisations. For example, AstraZeneca and the possibilities. " (WIPO/GRTKF/IC/7/9).
USA's National Institutes of Health have independent b. Terms when original genetic resource is agreement on the extent to which benefits may be claimed on the commercial value realized. This refers to the commercial use of the genetic f. Terms when a by-product analogous to the resource in its original form.
original molecule isolated is developed and Negotiating Access for Commercialization
Such scenarios could especial y arise with respect to Commercialization of analogous
micro-organisms and genetic resources whose utility can be commercial y exploited in the form discovered. Consider the hypothetical example given below: The fol owing is an example of a related scenario: A molecule that shows anti-cancerous activity is isolated Bayer company filed a patent on a novel process to from a genetic resource. Later, an analogue of it with manufacture acarbose, a drug for Type II diabetes. The higher activity is developed and commercialized. Clearly, process involved the use of a Actinoplanes sp. bacteria the technology and costs involved in the development strain cal ed SE50 from Kenya's Lake Ruiru. The strain of the analogue are different, although the lead to its of bacteria possesses unique genes enabling the development was obtained from the original genetic biosynthesis of acarbose in fermentors. No benefit resource. Negotiators and decision-makers may have to sharing arrangement is apparent in this case (McGown, take into account the relative contribution of the genetic resource to the development of the final product in deciding norms for extent of benefits to be shared.
c. Terms when information on original genetic resource is commercialized g. Terms when research product developed has same uses as TK information accessed (direct/ Use of information for commercialization
There are examples of how databases can be used for commercial gain, which indicates the need for Commercialization of product developed
negotiations on the compilation of information, who using traditional use
gains access to it, what parts of the database is open for In the Kani case study referred to earlier, during access to all and other related aspects. For instance, from the process of bio-exploration and related their interviews with pharmacies using ethno-botanical ethnopharmacological work, the TBGRI also developed knowledge, ten Kate and Laird (1999) report that 80% several other research products, all of which were not of these companies rely on secondary sources for their commercialized. The uses of these products are in line data requirements, such as databases and published with the traditional uses for the genetic resources by literature, rather than field data col ections. This often the Kani community (Pers. Comm. Dr.S.Rajashekaran, absolves them of any obligation to compensate the TBGRI, 2001). This is an instance where TK has directly originators or custodians of knowledge.
enabled research. Terms for benefit sharing will have to account for degree of ownership over the product d. Terms when a natural by-product of genetic between the research institute and TK-holders, and the resource is developed and commercialized future commercial use of the product, apart from other research collaboration benefits.
Commercialization of natural by-product
For instance, powders or aqueous extracts of a h. Terms when research product developed plant identified for medicinal properties may be with same uses as TK information accessed is commercialized in foreign markets. Terms for such simple and linear value addition will have to be discussed. It is worthwhile to reiterate that value Commercialization of product developed by
addition can range from simple processes directly using modifying traditional use
the resource to more sophisticated processes including The fol owing are examples of research products that the development of synthetic molecules or analogues, were developed from TK and later commercialized. They whose action may or may not be directly related to the also serve to highlight what kind of chal enges are faced original material and related knowledge.
in the light of inadequate policy measures to ensure that benefits are shared with the TK-holders for their e. Terms when a synthetic by-product of genetic resource is developed and commercialized 1. The San tribe of South Africa uses the Hoodia plant as Commercialization of synthetic by-product
an appetite suppressant, which was used by the Council Consider the hypothetical example given below: for Scientific and Industrial Research (CSIR) of the An active ingredient of a medicinal plant may be country to develop an anti-obesity drug. This drug was identified and later isolated. This isolate may then be then licensed to a private international pharmaceutical synthetical y produced using various technological company (Suneetha, 2004). Initial y there was no benefit processes. It is then necessary to have terms of sharing with the San tribe, but later, with advocacy and pressure, CSIR negotiated a benefit sharing deal with the tribe. This example also highlights the issue exploited at a later time. It is therefore in the best of co-ownership of resources between the State and interests of a provider country to negotiate on two communities and the need for reaching an agreement terms: 1) on a commitment for renegotiation of an on such issues.
agreement in the event of commercialization; and 2) to enter into a benefit sharing arrangement that will 2. Extracts from a medicinal plant Artemisia judaica provide a share of benefits at every stage of value from Libya, Egypt and other North African countries addition and market capitalization.
for the treatment of diabetes was patented by a UK company, Phytopharm Plc. The company admits It is often difficult to fathom the likely value of to knowing that the plant has been used in Libyan benefits at the start of a research activity, resulting traditional medicine for the treatment of diabetes, in benefit sharing deals that misrepresent the share although no benefit sharing deal is apparent (McGown, of the resource or related knowledge. During various Jay, 2006). This example is also indicative of the stages of the research and product development col ective ownership over resources/ related knowledge cycle, the value of the resource might increases between communities of different countries and of the due to increased information, and the negotiating need to ensure that sufficient policy space is provided to power of the supplier is further strengthened. Hence, address such issues, when they crop up. milestone payment streams based on appropriate economic valuation of the product at each stage i. Terms when research product developed has uses could ensure a higher rate of return to the supplier. different from TK information accessed (indirect/ This should also be preferable to users over deterrent upfront payments on products, whose value, though promising, is still vague. This does not suggest doing This refers to cases where research is carried out away with upfront payments and other modes of with contributions from TK, but the final non- benefit sharing, but draws attention to the merits commercialized research product developed has of including higher negotiating bases during various uses different to the original use in TK.
milestones of a research process, when stronger likelihoods of success improves the product value.
Commercialization of product based on
modified TK usage
4. Identify baseline typology of benefits (What), Consider the hypothetical example below: timing (When), and volume (How much) For instance, an antihistaminic drug could be developed from a herb used by a TK community for treating injuries/ A baseline indicates the modes and mechanisms burns. The drug, however, is not yet commercialized. by which benefits can be shared. If identified This in a sense makes the contribution of TK ‘indirect' deliberately, it can provide crucial guidance to to the product development process. The terms for providers and users of genetic resources and ownership rights over the product between TK-holders associated knowledge. Some of the broad categories and researchers will not be considered as in a ‘direct' of benefits include: contribution scenario, and terms for future commercial use would also vary.
a. Monetary benefits- upfront payments, milestone payments, funds, supply contracts/ linkages, IP j. Terms when research product developed with uses different from TK information accessed is b. Institutional benefits- such as venture capital funds, enterprise development; c. Capacity building- at various levels; Commercialization of product with different
d. Access to and transfer of technologies; use than originally accessed for
e. Sharing and exchange of information.
This scenario is best il ustrated with the example of the development of ‘Vincristine' and ‘Vinblastine' from It will be useful for countries to base decisions, Catharanthes roseus, for use in hypertension. The plant especial y with regard to monetary benefits, by was original y used by traditional communities as an devising a system to value potential benefits from antidiabetic, and was hence a candidate for further the bioprospecting activity. This will also enable in testing. While the case did not see any sharing of identifying lacunae in capacities and institutions, benefits, it is imperative for negotiators/ implementing which can be addressed in the benefit sharing agencies to anticipate and set guidelines under such One reason why these scenarios make reference to commercial and non-commercial activities is in order to capitalize on the market returns of the product during various stages of value addition. Hence, some of the scenarios may be part of a continuum, where a non-commercialized product is commercial y 3.4 Third Party Transfers of Research
micro-organism to Genencor that took a patent on it, and cloned it to produce the enzyme which is used for fading jeans and as an ingredient in a detergent (Lacey, Issues that need consideration: Marc, 2006). This resulted in a stand-off between Kenyan authorities and the company.
1. Define third party transfer The example indicates the need for a provider country to include in transfer agreements clauses for renegotiation A comprehensive definition of who constitute a third and arbitration in the event of commercial transfers, and party and what is entailed by third party transfer is for users to be explicit and transparent in their resource sourcing trails.
2. What is transferred 3.5 Intellectual Property
Each of the fol owing and any related product will Issues that need consideration: need to be defined in the light of transfer: 1. Joint Ownership of IP a. Original material; a. Define joint ownership: this should include c. Research product; what is intended by the term and how it will be d. Derivatives/ By-products; e. Intel ectual Property rights (IP).
b. Under what circumstances is joint ownership prescribed? This should include specifical y what Third Party Transfers
circumstances call for joint ownership such as in WIPO identifies the need for broad based negotiations the event of unmodified product development in third party transfers. To quote WIPO on academic or modified products but of the same use as in publishing and transfer: accessed TK. Joint ownership is a sensitive issue "If the research activities are whol y academic in nature, with product developers and hence needs to be and are not aimed at the development of new products careful y negotiated.
or processes, it is nonetheless likely that the parties will wish to create and publish articles and associated data, Ownership and Intellectual Property
giving rise to copyright in those publications and related An instance where joint ownership was practised transfer or licensing issues" (WIPO/GRTKF/IC/7/9).
between the different stakeholders is narrated below: Joint ownership was claimed and assigned on plant anti- 3. Under what circumstances are terms for transfer set? malarial know-how in the USA between Washington University (WU) in St. Louis, USA, Universidad Peruana Clarity on the conditions for third party transfers is Cayetano Heredia (UPCH) and Universidad Nacional required. For instance, negotiators and implementing Mayor de San Marcos, Museo de Historia Natural (USM), authorities will need to arrive at an understanding and Confederación de Nacionalidades Amazónicas if the terms are set only in the event of commercial del Perú (CONAP, that represented four groups of the transfers, or any other transfer such as transfer of indigenous Aguaruna community in Peru). The four research results, etc.
institutions were partners in one of the International Co-operative Biodiversity Groups' (ICBG) projects which 4. What are baseline terms for transfer? involved research partnerships leading to commercial products between a US University, a commercial The terms on which third party transfer can occur, company dealing with bio-products, and universities/ including the type of resources, products, in whose organizations in biodiversity supplying countries such presence, authority to be intimated, type of benefits as in Latin America. (Lewis, Walter H and Veena Ramani, to be shared, obligation of receiver to honour benefit 2003). This particular case indicates the possibility of sharing agreements, and such related terms need joint ownership of a product between scientists and to be negotiated. It is also important to negotiate local communities.
terms for commercial transfers and research product WIPO has dealt at length on the implications of Joint Research Product commercialized
ownership in its document WIPO/GRTKF/IC/7/9 (quoted The fol owing example provides an il ustration of a scenario where a research product was transferred for "Joint ownership of IP rights is one legal option, and may commercial application: be preferred as one way of ensuring that the provider A micro-organism (that produced enzymes to fade retains a distinct stake in the outcomes resulting from colours) from a research inventory of a Kenyan researcher on extremophile microorganisms from a On the other hand, joint ownership can lead to Kenyan lake was sold by her professor at a London unexpected practical problems and limitations, and university to a Dutch firm. The Dutch firm later sold the may not always be an appropriate benefit-sharing outcome or mechanism. For example, joint ownership reference to the overall arrangements set for access and does not necessarily create an entitlement to receive benefit-sharing. For instance, some agreements require benefits from the other owner's exploitation of the that any licensing of patents derived from the access common IP rights. In some jurisdictions, joint ownership to genetic resources should refer back to the original of patent rights does not require one owner to share access and benefit-sharing agreement." economic benefits with the other owner. In cases of joint ownership, the provider and user of the resources 2. Certificates of Origin/ Source/ Legal Provenance should consider how the responsibilities flowing from co-ownership of IP rights will be apportioned, There seems to be a growing consensus among as ownership general y brings with it the costs and countries that in order to ensure compliance to responsibilities of securing and maintaining rights, as the various provisions on ABS, implementation well as enforcing them; of a system of certification that proves the origin Ownership can provide reassurance to the resource of genetic resources, or source of the material or providers that they will retain a say over how the associated knowledge, or geographical origin (legal resources are developed and used, and how any new provenance) of the genetic resource may be worth technology derived from the genetic resources are pursuing (Tobin, 2008). These certificates, when used developed, used and disseminated. On the other hand, in conjunction with check-points such as applications ownership of patents derived from access to genetic for patents or product approval could prove effective resources is unlikely in itself to generate tangible in ensuring compliance with ABS measures. This is or sufficient benefits for the resource provider, in particularly so when the use of such certificates is the absence of a strategy for managing actively matched by the availability to electronical y verify the a patent portfolio. One practical consideration is existence and terms of such certifications (Personal that maintaining and exercising a patent portfolio, Communication, Geoff Burton, 2008).
potential y in several countries, can be complex and entail significant investment. Joint ownership of patents is one possibility, but the implications of various ways of structuring ownership should be considered in advance. One of the key chal enges in implementing an In some jurisdictions, if there is more than one owner effective benefit sharing scheme is providing an of IP, then the consent of the other owner(s) must be appropriate and adequate mechanism that will ensure obtained for an assignment or license; i.e. the agreement compliance by all parties with an agreement. While of all owners is required for effective development and certificates of origin is one example of a measure to exploitation of the patent. In other cases, unless the ensure compliance, other options that will ‘facilitate joint owners have agreed differently, each one is free to access to justice and support mutual recognition use the patented invention without being accountable and enforcement of judgments across jurisdictions' to the others. It may be difficult to arrange three-way are essential (CBD, 2009). It is important, as pointed partnerships between potential licensees and third out in the Report of the Technical and Legal Experts parties. For this reason, it can be more practical for on Compliance in the context of the International one co-owner to license or sell his or her interest in the Regime on ABS, to examine the options considering patent to the other co-owner, subject to continuing issues related to political and economic feasibility access to the technology, payment or other conditions. (CBD, 2009).
In some cases, it may be more advantageous to concede ownership of any resulting patent in return for other Some of the options currently being examined include benefits, such as a free license to use the patented a call for co-operation among the Parties to the CBD product, process or technical solution, or broader to address cross-jurisdiction issues; perhaps obligate benefits such as guarantees of access to technology domestic laws to ensure that users comply with ABS for certain third parties, such as public authorities, laws of the provider country; provide for legal aid to developing country enterprises or non-commercial affected stakeholders who cannot afford the costs of litigation; public listing of defaulters of ABS contracts, Normal y, a patent owner bears the financial and etc. Respecting customary law in ABS agreements administrative obligations to maintain and to enforce and the recognition of rights of indigenous people that patent, although contractual agreements can are some concerns that need to be addressed to provide for other arrangements. In cases of joint ensure that international measures are sensitive to ownership, the parties will need to consider how indigenous cultures. Countries are also examining certain responsibilities are shared, such as making and scenarios to ensure compliance where no ABS maintaining a patent application, enforcing the patent in contract or agreement exists.
the event of infringement, and negotiating and agreeing the terms of any subsequent licensing arrangement - the organization that carries out research on genetic material may not be competent to develop a commercial product arising out of any successful research, so third parties may need to be involved. How these detailed arrangements are settled should be determined with 4. Sectoral Approaches to Benefit Sharing: Some Reflections
4.1 Economic value of biodiversity
4.3 Benefit Sharing—examples by
industry
In natural resource economics or environmental economics literature, the economic value of Global y, the demand for ‘bio-products' is on the rise biodiversity broadly comprises of its use value (value (Christie and Mitchel , 2004). These are products that ascribed due to direct or indirect use, be it in trade essential y are developed from genetic resources and commerce, or for cultural and spiritual purposes) but have undergone various degrees of value and non-use value (value ascribed due to its inherent addition. The economic value of bio-products varies nature and to maintain populations and ecological with sectors using the resources that range from medicines, nutraceuticals, cosmetics, agricultural biotechnology, academic or research products. A brief Currently, policies related to benefit sharing outlook of each of these sectors on how the benefit arrangements general y identify a fixed percentage sharing principles could work is highlighted in the of gross sales of commercial product as a minimum fol owing paragraphs.
requirement. This, however, does not ful y reflect the economic potential of the resource. For instance, It is noteworthy that not all sectors that use genetic a prospecting firm may identify several potential resources or traditional knowledge for development candidate resources for the development of a drug of products enjoy similar economic revenues. for a particular disease condition. Not all of the Pharmaceutical products are medicines and the candidates will prove successful. The probability of demand for medicines is inelastic, al owing the success could improve with information from local sector to realize sales on set prices, in the absence users of the resources and with additional tests or of substitute medicines. However, in the case of experiments. That is, with additional information or products from other sectors, the demand is elastic, knowledge added, the probability of success rises, implying that the consumers shift al egiance to and that increases the value (worth) of the accessed a product for attractive substitutes. Conversely, resource. This increase in value with additional the cost factors also vary commensurately, with information is termed quasi-option value of the pharmaceutical products being more expensive to resource (Mitchell and Carson, 1989), and it will be to produce and involving longer timelines in production. the advantage of users and providers of the resource The implications of these cost and returns factors to assess and utilize this value to arrive at a benefit should be reflected appropriately in any benefit sharing stream. Resorting to periodical valuation sharing arrangement. This therefore cal s for a of the economic value will help in determining and systematic and evaluative approach to define a realizing realistic estimates of benefits derivable benefit sharing stream, towards which adequate from the accessed resources and thereby benefits baseline guidelines should be provided in anticipation accruable to the country and communities of origin of potential commercial or non-commercial product of the resource or knowledge. This argument further development scenarios. Towards this end, it is useful strengthens the previous argument that the economic to consider some modes of benefit sharing currently scope offered by milestone payments is fairly wide in vogue by the various sectors.
and should be effectively capitalized by both the users and providers and genetic resources.
4.2 Actors in Benefit Sharing
Drawing an analogy of bio-product development Pharmaceuticals can be considered the largest users to an industrial value chain, it can be argued that of biodiversity resources. It has been estimated that every actor who has contributed to the development over 70% of the drugs developed so far are based of a final product is a factor of production, be it in on or derived from natural products (Newman terms of labour or capital. By this argument, the and Cragg, 2007). The development of a single ‘income' derived from commercial use of biodiversity drug requires the screening and analysis of at least should be distributed as ‘returns' to the various 10,000 resources. The various stages involved in the ‘factors of production', proportional to the extent development of a drug include lead discovery, the of contribution. The actors will therefore include pre-clinical phase, the clinical and post-marketing ‘direct factors' such as local communities that share phase (PhRMA, 2007).
knowledge and resources, researchers and institutions and ‘supportive factors' such as the government, Predictably, the costs involved and the time taken equipment and infrastructure. The extent of for the development of a drug are high. The contribution can be determined by the extent to Pharmaceutical Manufacturers Association in the USA which the probability of product development was reports that the cost of the development of a drug enhanced due to the role played by the respective is US$ 1.2 bil ion over a period of 10-15 years (PhRMA, ‘factors of production'.
ibid). Around 50% of this amount is spent for the screening and optimization phase and the remainder for the pre-clinical and clinical test phases. Typical y, the probability of successful drug development Types of Benefits shared ranges from .0001 to 0.2 during the drug licensing stage (PhRMA, ibid).
Industry representative organizations such as International Chamber of Commerce (ICC, 2005) Given the uncertainties involved at each stage, support the principles of the CBD, while at the same pharmaceutical companies are inclined to avoid time cal ing for implementation of adequate IP or defer further commitments such as sharing protection for their products. The concern voiced by benefits with local communities. The contribution industrial sources relates to legal uncertainties in of traditional knowledge largely involves the ABS negotiations. The pharmaceutical industry has expansion of the probability of drug development by far more instances of benefit sharing examples at the lead discovery stage (sometimes as high as among the various sectors that utilize biological 0.5 or a 50% chance of success, (Reyes (1996) , and resources for commercial gain (ten Kate and Laird, thereby reducing attendant costs and time taken 1999, Finston, 2005). Monetary benefits include a host for the initiation of the drug development process. of options such as sample fees; research grants that Successful pharma products have the potential to covers salaries of researchers, funds for laboratory earn significant revenue (estimated to be around US$ equipment and their maintenance, expenditure 100 mil ion per annum per drug), which is usual y related to field surveys and related costs, access to played out in benefit-sharing negotiations. The scientific literature; equity stakes, profit sharing, joint pharmaceuticals are required to pay upfront lump ventures, royalties, and employment opportunities sums of money and other benefits even before any (ten Kate and Laird, 1999). Non-monetary benefits conclusive results are obtained. This is believed to be that pharmaceuticals have agreed to share include discouraging pharmaceuticals in undertaking natural technology transfers, sharing of research results, product development related research (Finston, 2005).
training, capacity building, and support for conservation projects. Benefits in kind are also shared The value of the global Biopharmaceutical market is and include establishment or provision of services estimated to be around US$ 430 bil ion (Datamonitor, such as medical facilities, facilitating infrastructure 2005). Traditional y, pharmaceutical companies such as roads and warehouses. Ownership of the obtained genetic resources from biodiversity rich intel ectual property rights of the products rests countries for their natural products development usual y with the companies, and in rare cases is shared work. However, with advances in combinatorial with local communities (e.g. Aguaruna communities chemistry and relevant technologies, coupled with case in Lewis and Ramani, 2003).
stringent terms for accessing genetic resources, they seem to have cut down on such research work 4.3.2 Botanicals / Nutraceuticals
(Finston,2005). Stil , experts argue that natural products research is vital to identify novel products to al eviate human health problems (Cooper, 2004; Newman and Cragg, 2007). It is therefore unlikely Botanicals are herbal medicines representing raw to fade away and encourages bioprospecting for herbs, tinctures, extracts, and phytomedicines (ten useful compounds in various ecosystems- inter alia Kate and Laird, 1999). Hence, while these products can forest, soil, desert and marine ecosystems (Cooper, claim medicinal properties, they are considered health 2004). Increasingly, pharmaceutical companies are supplements, and therefore do not require extensive targeting rare ailments or niche remedies for specific trials and testing as in the case of pharmaceuticals. populations with specific ailments (Economist, The cost of development of a botanical is therefore 28 July 2007) i.e., "personalized medicines". These not as high as a pharmaceutical and is estimated to specialty drugs or targeted therapies have accounted be less than US$ 10 mil ion (ten Kate and Laird, 1999). for two-thirds of the total revenue growth in 2006 Companies that sought to bring out products as (Economist, ibid). This is in line with traditional pharmaceuticals have reclassified them as botanicals medical philosophies and is indicative of potential to tide over the cost factor, a classic example being fruitful col aborations between the various medical the re-categorization and marketing of Sangre de Drago by Shaman pharmaceuticals (ten Kate and Laird, 1999). The global market for this sector is in the Studies highlight the need for biotechnology (broadly vicinity of US$ 62 bil ion (Patwardhan et al, 2005).
encompassing all bio-products research) firms to address their benefit sharing obligations towards Traditional knowledge is extensively used in the various stakeholders in the value addition chain, development of these products, as stated by major including direct stakeholders such as employees, industry players in a survey undertaken in the late suppliers, local communities, to indirect stakeholders 1990s (ten Kate and Laird, 1999). These products such as governments for their supportive functions.14 could also include traditional medicine products and The obligations could be ethical, economic and/or products derived or modified from them. Usual y, political and it necessitates decision making on which these products are developed from previously known of the stakeholders should be a party to the benefit properties of genetic resources and take between sharing process and to what extent.
two years to seven years to develop (ten Kate and Laird, 1999, Suneetha, 2004). Hence the probability of Another active sub-sector of agricultural developing a successful product is fairly high. A closely biotechnology is biotechnology for ornamental related class of products include nutritional foods, horticulture purposes, as for flowers and fragrances. termed nutraceuticals, functional foods or designer This sector also uses genetic resources for unique foods, which include food and dietary products characteristics such as colour, flower shape, form and fortified with nutrients not normal y found in that food. These are consumed for their prophylactic and therapeutic properties, and constitute a US$ 11.7 Types of Benefits Shared bil ion global industry, that includes among others cereals, soups, beverages, probiotics, soy additives, Monetary measures of benefit sharing undertaken juices and extracts (Freedonia, 2006).
by agricultural biotechnology firms for the germplasm they receive is in the form of germplasm Types of Benefits shared fees, license fees, research grants, and research contracts. Typical y, the fees are paid to col aborating Examples of benefit sharing in Botanical medicine institutions or breeders. Reciprocal access to / Nutraceuticals sectors are not common. However, germplasm is apparently the most common form of there are instances where commercial benefits have non-monetary benefit shared within this sector (ten been shared with local communities (e.g. Shaman Kate and Laird, 1999). Other benefits include access pharmaceuticals shares a percentage of its benefits to information on research results and training, with communities it works with global y through joint research, and access to technology. Ownership The Healing Conservancy Funds; the TBGRI with the over the varieties is chiefly held by the companies. Kani tribes in the Kerala state of India). Monetary However, arrangements such as free access (through benefits shared by this sector include apart from Humanitarian Use Licenses as in the case of Golden prices paid for the resource, royalties on sales of Rice), conditional property rights (in the event of products, share of license fees, advance payments, IP claims over varieties derived from varieties in employment opportunities through commercial public repositories as described by the ITPGR,and partnerships. Non-monetary benefits include training exemptions (such as exemption for breeders to and capacity building for communities and host conduct research or farmers for consumption or non- country institutions, support for the establishment commercial use) are also observed in this sector.
of small scale enterprises based on medicinal plants and related resources. IP ownership of the product is 4.3.4 Natural Personal Care and Cosmetics Products
retained primarily by the companies.
4.3.3 Food and Agriculture Biotechnology
Natural care products and cosmetics include a broad range of products such as cosmetics, toiletteries, fragrances and the like. Manufacturers The market for products of agricultural biotechnology resort to various means to obtain samples for is estimated to be around US$ 6.2 bil ion (Financial product development, including field surveys to Times, 2006). The Biotech seed market alone is worth sub-contracting. Prime sources of information are US$ 5.3 bil ion (Crop Life International, 2005). The cost databases and literature on chemicals and leads from and timelines involved in the development of a new, traditional uses (ten Kate and Laird, 1999). This sector transformed varieties is between US$ 100 to 200 is apparently growing at the rate of approximately mil ion (Jay, 2001) over a period of 8 to 15 years (ten 9% per annum with the US market alone worth US$ Kate and Laird, 1999). The starting varieties are usual y 3.8 bil ion in 2003, and expected to be around US$ 6 obtained from public sources, CGIAR deposits and bil ion by 2008 (Decision News Media, 2005). Research from landraces. Biotechnology products also include costs are less than US$ 10 mil ion and take between 2 a class of products termed Novel foods (chiefly in the to 5 years to develop (ten Kate and Laird, 1999).
EU for foods not commonly consumed within the EU before 15 May, 1995) or genetical y modified foods. Types of Benefits Shared There is an increasing overlap between medicine and food, with the development of ‘biopharmaceutical Benefit sharing is not common within this industry crops" (e.g. new advances in including vaccines in and includes sample prices or fees, advance payments rice grain by Japanese researchers (Economist, 2007) . and humanitarian and environmental donations The tools of biotechnology are being used by public through Foundations (ten Kate and Laird, 1999). health researchers to enable fast and effective Non-monetary benefits include assured markets, health delivery systems. However, such foods are development of local enterprises and support to still the subject of consumer censure and stringent community projects.
government regulations such as in the European Union (Biotrade, 2009). 15 4.3.5 Research and Academia
Access to genetic resources and knowledge is also sought by research institutions across their territorial borders for the development of products for non- commercial purposes to advance the purpose of science and knowledge. Academic societies such as International Society for Ethnobiology (ISE) encourage the use of equitable and ethical standards while pursuing research on genetic resources or using traditional knowledge (ISE Code of Ethics, 2006).16 This includes a set of guiding principles that recognize rights of indigenous peoples over their resources and decision making, their rights to be active participants in all stages of the project, and hence their right to full information as regards the project. It also recognizes that the communities could prohibit publication of information they do not wish to be made public. Another useful resource is the Swiss Academy of Science's Access and Benefit Sharing: Good practice for academic research on genetic resources that provides a step-by-step guide for academic researchers to adhere to ABS measures (Biber-Klemm and Martinez, 2006).17 Types of Benefits Shared Some of the common benefits shared with provider countries include col aborative research with a host country university or research institution, transfer of relevant technologies, joint publications and/or co- ownership of research outputs.
4.4 Recent Developments in Corporate
Policies towards Benefit Sharing
Companies indulge in corporate social responsibility (CSR) practices, and for now appear to consider benefit sharing a part of CSR activities. Some companies have published Sustainability Reports and Corporate Social Responsibility Reports that highlight their social and financial commitments to local communities (e.g. Novo Nordisk's Annual Report (2006), Novozyme's Social Responsibility Report (2005), Syngenta's Corporate Social Responsibility Report (2006). Efforts on social responsibility by companies include host country university partnerships, enabling the development of services such as water and land quality, the provision of fel owships through funds established for charitable purposes, the non-pursuance of patents in least developing countries, transfer of technologies, the creation of foundations that enable enterprise development, and the pursuit of public policy (such as in health policy) related initiatives of the host or provider countries.
Having considered the national and international 4. Complexity should not be an excuse for inaction: scenarios in terms of access to genetic resources Several countries are postponing national actions and benefit sharing, it is clear that there are many on ABS issues, either waiting for the completion examples and models available for countries to use. of negotiations for an international regime However, each of these is sector specific, location or for want of experience. Realising ABS is a specific, scale specific or policy specific. There is no contentious and complex issue; however actions single model of access provision and benefit sharing should be implemented – however imperfect that can provide the answer to questions being raised they may be – to build experience and progress. on how to implement ABS provisions.
Local and national actions al ow countries to build experience that enhances their ability to Considering the difficult as well as crucial timing participate in discussions on further developing of negotiations under the development of the and negotiating the international regime on ABS.
international regime on ABS, it is important for countries to undertake actions on the fol owing 1. Implement provisions under Bonn Guidelines on ABS: Many countries are hesitating to implement the Bonn Guidelines due to potential changes in the ABS regime. Though voluntary in nature, the Guidelines provide distinct opportunities for countries to implement ABS provisions. Countries should recognize that this will be the case even with the adoption of an international regime on ABS and make effective use of existing provisions 2. Development of ABS guidelines and regulations requires multi-disciplinary teams: One of the key chal enges countries face is the establishment of teams to develop ABS principles and guidelines. It must be understood, from the examples provided above, that ABS issues are not just the prerogative of Ministries of Environment and conservation experts, but require the involvement of experts from legal, social, policy and financing fields. In the absence of col ective thinking on how to deal with ABS issues, countries will be left with more questions than answers to implement ABS provisions, even in the event of an international regime being put into place. Therefore countries should consider preparing such teams of experts to begin discussions on ABS issues.
3. ABS is an issue that also links to markets and market economies: From the examples above, it may be clear that if countries are seriously interested in making use of the genetic resources they are endowed with, they have to provide for access on clear and defined terms. Without provision of access there is no debate on benefit sharing. Markets and market economics play an important role in ABS debates. Holders and providers of genetic resources should understand that in the absence of demand or a market for resources and products, debates on ABS are futile. However, one should not over-emphasise the issue of efficiency in markets in subversion of issues related to equity.
Balmford, A., Bruner, A., Cooper, P., Constanza, R., Farber, S., Green, R.E., Jerkins, M., Jefferiss, P., Jessamy, V., Madden, J., Munro, K., Myers, N., Naeem, S., Paavola, J., Rayment, M., Rosendo, S., Financial Times, Nov 15, 2006, Monsanto: Roughgarden, J., Trumper, K., Turner, K., 2002, giant of the $6.15bn GM market, from http:// Economic reason for conserving wild nature. Science 297: 950-953.
id=fto111520061720014783 last visited 3 Jan, 2008.
Biber-Klemm, Susette and Sylvia Martinez, 2006, Finston, Susan King, 2005, Relevance of Genetic Access and Benefit Sharing Good Practice for Resources to the Pharmaceutical Industry, academic research in genetic resources, Swiss Discussion Paper at the International Expert Academy of Sciences from http://abs.scnat.ch./ Workshop on Access to Genetic Resources and downloads/ABS_Brochure.pdf. last visited 20 Benefit Sharing, convened by the Secretariat of August 2008.
Convention on Biodiversity at Cape Town, South Biotrade Initiative, Novel Foods from http://www.
biotrade.org/BTFP/btfp-novelfoods.htm last visited Freedonia, 2006, World Nutraceuticals to 2010, from 15 January 2009.
Chiarol a, Claudio, 2007, Benefit Sharing within the International Treaty on Plant Genetic Resources and Lessons for CBD's International Regime on Access GTZ, 2006, Access and Benefit Sharing (ABS) in and Benefit Sharing, Working Paper, United Nations Africa- Cases of bioprospecting and AS legislation in University-Institute of Advanced Studies.
Eastern and Southern Africa :Presented at Regional Access and Benefit Sharing Capacity Building Christie Peter and Hol y Mitchel , 2004, Primer Workshop for Eastern and Southern Africa, held in on Bioproducts, Pol ution Probe and BIOCAP Addis Ababa, Ethiopia, Oct 2-6, 2005.
Canada Foundation, Canada, from http://www.
I SD and Cabrera, Joerg, 2007, ABS - Management Tool Best Practice Standard, from http://www.i sd.
Convention on Biological Diversity, 2009, Report of org/pdf/2007/abs_mt_standard.pdf last visited 30 the Meeting of the Group of Legal and Technical August 2008.
Experts on Compliance in the context of the International Regime on Access and Benefit- International Chamber of Commerce (ICC), 2005, Access and Benefit Sharing: Special Disclosure requirements in Patent Applications Cooper, Edwin L, 2004, Drug Discovery, CAM and Natural Products, Editorial, Evidence based sourcedisclosure25may05.pdf,last visited 20 Complementary and Alternative Medicine, 1(3):215- October 2008.
International Society of Ethnobiology (2006), Cosmetic –Design Europe, 2005, Global International Society of Ethnobiology Code of Ethics Organic cosmetic market blooms, http:// (with 2008 additions). http://ise.arts.ubc.ca/global coalition/ethics.php last visited 15 January 2009.
ng.asp?id=60389-global-organic-cosmetic last visited 7Jul, 2008.
Kesan, P Jay, 2001, Intel ectual Property Protection and Agricultural Biotechnology A Multidisciplinary Costanza, Robert, Ralph d'Arge, Rudolf de Groot, Perspective, Working Paper No.00-22, Law and Stephen Farber, Monica Grasso, Bruce Hannon, Economics Working Papers Series, Col ege of Law, Karin Limburg I, Shahid Naeem, Robert V. O'Neil , University of Ilinois.
Jose Paruelo, Robert G. Raskin, Paul Sutton, Marjan van den Belt, 1997, The value of the world's Lacey, Marc, 2006, Washday miracle? Kenya wants ecosystem services and natural capital, Nature, 387.
profit share The New York Times.
Crop Life International, Global Market Overview, Lewis, Walter H and Veena Ramani, 2003, Ethics and 2005, from http://www.croplife.org/website/ practice in Ethno biology: Analysis of the international cooperative biodiversity group project in Peru, Paper presented at the Biodiversity and Biotechnology and the Protection of Traditional Knowledge, Washington Decision News Media, 2005, Global organic cosmetic University in St. Louis, USA.
market booms, http://www.cosmeticsdesign- MacDonald, Chris, The Stakeholder Concept in Suneetha.M.S, 2004, Economic Valuation of Medicinal Biotechnology from www.biotechethics.ca/papers/ Plants in the context of Convention on Biodiversity stakeholder.html. last visited 20 July 2008.
and IPR rights, Ph.D thesis (Unpublished), University of Agricultural Sciences, Bangalore.
McGown, Jay, 2006, Out of Africa: Mysteries of Access and Benefit Sharing, Edmonds Institute and African ten Kate, Kerry and Sarah Laird, 1999, The Commercial Centre for Biosafety.
Use of Biodiversity: Access to Genetic Resources and Benefit Sharing, Earthscan Publications Ltd, London.
Mitchel , R.C and Carson, R.T, 1989, Using surveys to value public goods: The Contingent Valuation Tobin, Brendan, 2008, Monitoring Compliance Method. New York: Resources for the Future.
under An International ABS Regime: The Role of an International Cerificate Scheme, Asian Moore, Gerald and Tymowski, Witold 2005, Biotechnology and Development Review, Vol 10(3): ‘Explanatory Guide to the International Treaty on Plant Genetic Resources for Food and Agriculture ‘, IUCN Environmental Policy and Law Paper No. 57. Tvedt, Morten and Tomme Young, 2007, Beyond IUCN, Gland, Switzerland and Cambridge, UK.
Access: Exploring Implementation of the Fair and Equitable SharingCommitment in the CBD, ABS Newman, David J and Gordon M.Cragg, 2007, Natural Series No.2, IUCN Environmental Policy and Law Products as Sources of New Drugs over the Last 25 Paper No.67/2, IUCN.
Years, Journal of Natural Products, 70: 461-477.
Visser Bert, Pistorius Robin, Van Raalte Rob, Eaton Patwardhan, Bhushan, Dnyaneshwar Warude, Derek and Louwaars Niels, Options for Non- P. Pushpangadan, and Narendra Bhatt, 2005, Monetary Benefit-Sharing - An Inventory, CGRFA Ayurveda and Traditional Chinese Medicine: Background Study Paper No. 30, Rome 2005.
A Comparative Overview, Evidence Based Complementary Alternative Medicine. 2005 December; 2(4): 465–473.
Pharmaceutical Research and Manufacturers of America, Pharmaceutical Industry Profile, 2007, Washington, D.C.
Physicians for Social Responsibility, Oregon Pushpangadan,P, S.Rajashekaran, P.K.Ratheshkumar, C.R.Jawahar, V.Velayudhan Nair, N.Lakshmi and L.Sarada Amma, 1988, ‘Arogyapacha' (Trichopus zeyalnicus Gaertn), The ‘Ginseng' of Kani Tribes of Agasthyar Hil s (Kerala) for Ever green Health and Vitality, Ancient Science of Life, Vol 8, No.1, 13-16.
Reid, Walter V, 1994, Biochemical Prospecting, Strategies for Sharing Benefits, Biopolicy, International Series No.16, African Centre for Technology Studies (ACTS) Press, Kenya.
Reyes, Viki, 1996, The Value of Sangre De Drago, www.
grain.org/publications/mar963-en.cfm last visited 15 June 2008.
Secretariat of the Convention on Biodiversity, 2002, Bonn Guidelines on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits arising from their Utilisation, from http://www.
visited 8 September 2008.
Annex 1 Country Legislation Related to Benefit Sharing
Legislation/ Rules
Applicable to whom
Monetary elements of Benefit sharing
Non-monetary elements of Benefit sharing
Ownership rights (IPRs/ sui generis)
Environment Protection and Department of the To any users who wish 1. Up-front payments 1. Sharing in research and development results Joint ownership of relevant intel ectual 50 penalty units, discussions Biodiversity Conservation Act (EPBC Environment, Water, Heritage to conduct research 2. Milestone payments 2. Col aboration, cooperation and contribution in scientific R&D programmes, on between Commonwealth Act),1999, (Section 301) and EPBC and development on Government and States for higher Regulations, 2000 (Part 8 A) native species of genetic 4. Research funding 3. Biotechnological research activities, where possible penalties to deter non-compliance resources or their 5. License fees in case of commercialization 4. Participation in product development col aboration, cooperation and contribution biochemical compounds 6. Special fees paid to trust funds supporting in education and training from Commonwealth 7. Conservation and sustainable use of 5. Admittance to ex-situ facilities of genetic resources and to databases transfer to the provider of the genetic resources of knowledge and technology 8. Salaries and preferential terms 6. Facilitate abilities of Indigenous and local communities to conserve and 9. Joint ventures sustainably use their genetic resources 7. Institutional capacity building 8. Training related to genetic resources with the full participation of providing 9. Information relevant to conservation and sustainable use of biological diversity, including biological inventories and taxonomic studies 10. Contributions to the local economy 11. Institutional and professional relationships that can arise from an access and benefit sharing agreement and subsequent col aborative activities 12. Social recognition Provisional Act No 2,186-16, 2001 The Genetic Heritage Governing Brazilian or Foreign entity 1. Sharing of profits 1. Access and transfer of technologies To be specified in Contract for Use of Genetic Offender to pay compensation (Title 7 -Articles 24 to 29) Council, under the Ministry who make economic use 2. Payment of royalties 2. licensing without cost, of products and processes Heritage and Benefit sharing @ 20% of gross income of of Environment (aka The of product/ process from 3. Capacity building of human resources receipts from product/ royalties Management Council) resource/ associated TK irrespective of IP rights Biodiversity and Community National Biodiversity Authority To all those who seek 1. Not less than 50 % of net monetary gain 1. Technology transfers 1. Recognizes col ective/ community IP rights Varies from written warnings, Knowledge Protection Act of access for commercial 2. Compensation for ecological or 2. Knowledge transfer 2. Co-ownership rights over biological fines, revocation of permits, and environmental costs incurred 3. Royalty free access to technology for domestic institutions in case of endemic resources, knowledge and innovation confiscation to perpetual ban, defined between communities, with State with widespread publicity given in and with communities from other countries international foras.
National Environmental Policy of The Genetic Resources and Foreign applicants Only access regulations defined- the Environmental Management Act Biotechnology Committee (GRBC) of the National Research Council of Malawi (NRCM) The Environmental Management National Environment Any person who intends 1. Sharing R&D results Joint ownership where relevant Liable to imprisonment and Co-ordination (Conservation of Management Authority to access genetic 2. Up-front payments 2. Col aborative research projects in S&T Biological Diversity and Resources, resources in Kenya (except 3. Milestone payments 3. Participation in product development Access to Genetic Resources and by local communities 4. Access to ex situ facilities of genetic resources and databases Benefit Sharing- Regulations, 2006 for own consumption 5. Transfer of knowledge and technology under fair and most favourable terms of the Environmental Management and approved research 6. Fees to trust funds to support conservation 6. Capacity development for technology transfer and Co-ordination Act (1999) (Part activities for Kenyan 7. Institutional capacity development educational purposes) 7. Research funding 8. Joint ventures Costa Rica
Biodiversity Law (No. 7788)- Articles National Commission for the All who seek access to 1. 10% of research budget to National System 1. Technology transfer 1. Recognizes community intel ectual Offenders to pay fines between Management of Biodiversity genetic resources and of Conservation Areas one and twelve salaries; can be related knowledge 2. 50% of bonus to NSCA 2. Recognizes mere existence of cultural charged by the Penal Code and 3. Administrative costs practice or knowledge related to GR and biochemicals and does not require any formal system of registration (Art 82) Environmental Protection Environmental Protection All except local and 1. Inclusion of local counterparts and institutions or individuals in research activities Offenders to pay a fine between (Bioprospecting) Regulations, 2001 indigenous peoples 2. Any other financial benefits 300,000 to 750,000 dol ars and (Part II , section 17, 18) engaged in traditional 3. Share to Government on commercial profits 3. Periodical reports and final reports on activity face imprisonment for one year Access to Genetic Resources and Institute of Biodiversity All those who seek to 1. 50% of benefits (to be shared with state) in 1. Joint ownership of IP Recognition of community rights in customary Suspension or termination of Community Knowledge and 2. Employment opportunity practices and norms Access agreement and prohibit Community Rights Proclamation 3. Research participation of Ethiopian nations access to GR and associated (No.482/ 2006)- Articles 9, 18, 19 3. Upfront payment 4. Priority to supply raw materials for production processes 4. Milestone payment 5. Training to enhance local skil s in GR conservation etc 6. Equipment, technology support 6. Research funding Supreme Decree NO.24676, National Secretary if Natural Natural persons and legal 1. Royalties 1. Transfer of technologies Recognition of col ective rights of community Written reprimands, progressive Regulation of Decision 391 on the Resources and the Environment foreigners 2. S&T capacity development of national universities over existing natural resources and associated fines, suspension of activities, Common Regime for Access to 3. Drugs at cost (tax exempted) intangible components revocation of authorization are Genetic Resources (1997)- (Chapter 6, 4. Involving domestic personnel in research, including indigenous representative as various measures to tackle various degrees of offenses / infractions.
Implementing Rules and Regulations Inter-Agency Committee Both domestic and foreign 1. Equity 1. Regular reports Varying from criminal prosecution on the Prospecting of Biological and on Biological and Genetic bioprospectors, except 2. All discoveries of commercial product/s derived from Philippine GR to be made (without required Agreements or Genetic Resources (Department Resources (under Dept of 3. Submit performance, compensation, available to government and local communities PIC), cancel ation or revocation Administrative Order No.96-20), Environment and Natural ecological rehabilitation bond on MAT 3. Col aborative research with domestic institutions of agreement (non-compliance 1996- Articles 8.1(8, 9, 13), 8.2(2, 3, 4) 4. Royalty free access to technology measures) and duly reported to 5. Donate equipments Biological Diversity Act, 2002 and National Biodiversity Authority Primarily for Foreigners 1. Transfer of technology Joint ownership wherever relevant Varying from criminal prosecution Biological Diversity Rules, 2004 (Art 2. Monetary benefits- upfront, milestones, 2. Col aborative research with domestic institutions, (research and local) to imposition of fines royalty, etc.
3. Education and awareness raising 3. Joint ventures 4. Product development 5. 5% of assessed benefits to be given to NBA 6. Venture capital funding Legislation/ Rules
Applicable to whom
Monetary elements of Benefit sharing
Non-monetary elements of Benefit sharing
Ownership rights (IPRs/ sui generis)
Environment Protection and Department of the To any users who wish 1. Up-front payments 1. Sharing in research and development results Joint ownership of relevant intel ectual 50 penalty units, discussions Biodiversity Conservation Act (EPBC Environment, Water, Heritage to conduct research 2. Milestone payments 2. Col aboration, cooperation and contribution in scientific R&D programmes, on between Commonwealth Act),1999, (Section 301) and EPBC and development on Government and States for higher Regulations, 2000 (Part 8 A) native species of genetic 4. Research funding 3. Biotechnological research activities, where possible penalties to deter non-compliance resources or their 5. License fees in case of commercialization 4. Participation in product development col aboration, cooperation and contribution biochemical compounds 6. Special fees paid to trust funds supporting in education and training from Commonwealth 7. Conservation and sustainable use of 5. Admittance to ex-situ facilities of genetic resources and to databases transfer to the provider of the genetic resources of knowledge and technology 8. Salaries and preferential terms 6. Facilitate abilities of Indigenous and local communities to conserve and 9. Joint ventures sustainably use their genetic resources 7. Institutional capacity building 8. Training related to genetic resources with the full participation of providing 9. Information relevant to conservation and sustainable use of biological diversity, including biological inventories and taxonomic studies 10. Contributions to the local economy 11. Institutional and professional relationships that can arise from an access and benefit sharing agreement and subsequent col aborative activities 12. Social recognition Provisional Act No 2,186-16, 2001 The Genetic Heritage Governing Brazilian or Foreign entity 1. Sharing of profits 1. Access and transfer of technologies To be specified in Contract for Use of Genetic Offender to pay compensation (Title 7 -Articles 24 to 29) Council, under the Ministry who make economic use 2. Payment of royalties 2. licensing without cost, of products and processes Heritage and Benefit sharing @ 20% of gross income of of Environment (aka The of product/ process from 3. Capacity building of human resources receipts from product/ royalties Management Council) resource/ associated TK irrespective of IP rights Biodiversity and Community National Biodiversity Authority To all those who seek 1. Not less than 50 % of net monetary gain 1. Technology transfers 1. Recognizes col ective/ community IP rights Varies from written warnings, Knowledge Protection Act of access for commercial 2. Compensation for ecological or 2. Knowledge transfer 2. Co-ownership rights over biological fines, revocation of permits, and environmental costs incurred 3. Royalty free access to technology for domestic institutions in case of endemic resources, knowledge and innovation confiscation to perpetual ban, defined between communities, with State with widespread publicity given in and with communities from other countries international foras.
National Environmental Policy of The Genetic Resources and Foreign applicants Only access regulations defined- the Environmental Management Act Biotechnology Committee (GRBC) of the National Research Council of Malawi (NRCM) The Environmental Management National Environment Any person who intends 1. Sharing R&D results Joint ownership where relevant Liable to imprisonment and Co-ordination (Conservation of Management Authority to access genetic 2. Up-front payments 2. Col aborative research projects in S&T Biological Diversity and Resources, resources in Kenya (except 3. Milestone payments 3. Participation in product development Access to Genetic Resources and by local communities 4. Access to ex situ facilities of genetic resources and databases Benefit Sharing- Regulations, 2006 for own consumption 5. Transfer of knowledge and technology under fair and most favourable terms of the Environmental Management and approved research 6. Fees to trust funds to support conservation 6. Capacity development for technology transfer and Co-ordination Act (1999) (Part activities for Kenyan 7. Institutional capacity development educational purposes) 7. Research funding 8. Joint ventures Costa Rica
Biodiversity Law (No. 7788)- Articles National Commission for the All who seek access to 1. 10% of research budget to National System 1. Technology transfer 1. Recognizes community intel ectual Offenders to pay fines between Management of Biodiversity genetic resources and of Conservation Areas one and twelve salaries; can be related knowledge 2. 50% of bonus to NSCA 2. Recognizes mere existence of cultural charged by the Penal Code and 3. Administrative costs practice or knowledge related to GR and biochemicals and does not require any formal system of registration (Art 82) Environmental Protection Environmental Protection All except local and 1. Inclusion of local counterparts and institutions or individuals in research activities Offenders to pay a fine between (Bioprospecting) Regulations, 2001 indigenous peoples 2. Any other financial benefits 300,000 to 750,000 dol ars and (Part II , section 17, 18) engaged in traditional 3. Share to Government on commercial profits 3. Periodical reports and final reports on activity face imprisonment for one year Access to Genetic Resources and Institute of Biodiversity All those who seek to 1. 50% of benefits (to be shared with state) in 1. Joint ownership of IP Recognition of community rights in customary Suspension or termination of Community Knowledge and 2. Employment opportunity practices and norms Access agreement and prohibit Community Rights Proclamation 3. Research participation of Ethiopian nations access to GR and associated (No.482/ 2006)- Articles 9, 18, 19 3. Upfront payment 4. Priority to supply raw materials for production processes 4. Milestone payment 5. Training to enhance local skil s in GR conservation etc 6. Equipment, technology support 6. Research funding Supreme Decree NO.24676, National Secretary if Natural Natural persons and legal 1. Royalties 1. Transfer of technologies Recognition of col ective rights of community Written reprimands, progressive Regulation of Decision 391 on the Resources and the Environment foreigners 2. S&T capacity development of national universities over existing natural resources and associated fines, suspension of activities, Common Regime for Access to 3. Drugs at cost (tax exempted) intangible components revocation of authorization are Genetic Resources (1997)- (Chapter 6, 4. Involving domestic personnel in research, including indigenous representative as various measures to tackle various degrees of offenses / infractions.
Implementing Rules and Regulations Inter-Agency Committee Both domestic and foreign 1. Equity 1. Regular reports Varying from criminal prosecution on the Prospecting of Biological and on Biological and Genetic bioprospectors, except 2. All discoveries of commercial product/s derived from Philippine GR to be made (without required Agreements or Genetic Resources (Department Resources (under Dept of 3. Submit performance, compensation, available to government and local communities PIC), cancel ation or revocation Administrative Order No.96-20), Environment and Natural ecological rehabilitation bond on MAT 3. Col aborative research with domestic institutions of agreement (non-compliance 1996- Articles 8.1(8, 9, 13), 8.2(2, 3, 4) 4. Royalty free access to technology measures) and duly reported to 5. Donate equipments Biological Diversity Act, 2002 and National Biodiversity Authority Primarily for Foreigners 1. Transfer of technology Joint ownership wherever relevant Varying from criminal prosecution Biological Diversity Rules, 2004 (Art 2. Monetary benefits- upfront, milestones, 2. Col aborative research with domestic institutions, (research and local) to imposition of fines royalty, etc.
3. Education and awareness raising 3. Joint ventures 4. Product development 5. 5% of assessed benefits to be given to NBA 6. Venture capital funding 1 See Article 3 of the Convention on Biological Diversity. 17 http://abs.scnat.ch./downloads/ABS_Brochure.pdf last visited 2 For more details, see http://www.i sd.org/pdf/2007/abs_mt_ 20 August 2008.
standard.pdf, last visited on 20 October 2008.
3 The list of countries who have passed legislation related to ABS in the Appendix is not exhaustive. The information in the Appendix intends to provide a broad overview of the different approaches taken by countries to implement CBD provisions through national laws. It is also worth noting the differences among countries in addressing various dimensions of the issues related to benefit sharing.
(specifical y section D.41-44 on MAT) last visited on 8 September 5 This section draws heavily from Chiarol a, Claudio, 2007.
6 The Treaty was adopted by the FAO Conference on 3 November 2001. It entered into force on 29th June 2004.
7 Under Available without restriction, Article 2 of the SMTA states: A Product is considered to be available without restriction to others for further research and breeding when it is available for research and breeding without any legal or contractual obligations, or technological restrictions, that would preclude using it in the manner specified in the Treaty. 8 Article 6.11.d states: The payments to be made are independent of whether or not the Product is available without restriction  i.e. such payments are due regardless of whether access to such products is limited by any legal, contractual or technological restrictions as provided for in Article 6.7.
9 Hence, payments must be made not only when a Productunder the definition of Article 2is commercialised. They will be calculated based upon the Sales of any other products that are Plant Genetic Resources for Food and Agriculture belonging to the same crop [] to which the Material [received] belongs. See Article 6.11(c). This is a type of provision that is fairly common in the commercial practice: the rights that it provides are cal ed reach-though rights. Normal y, recipients must pay fees or royalties on products discovered through the use of the material even though the material is not part of the product or necessary to manufacture the product. 10 Article 6.11(f) provides that: The Recipient shall be relieved of any obligation to make payments under Article 6.7 of this Agreement or any previous or subsequent Standard Material Transfer Agreements entered into in respect of the same crop. 11 Appendix 3, paragraph 5, of the SMTA states: Where the Recipient has entered or enters in the future into other Standard Material Transfer Agreements in relation to Material belonging to the same crop[s], the Recipient shall only pay into the referred mechanism the percentage of sales as determined in accordance with this Article or the same Article of any other Standard Material Transfer Agreement. No cumulative payments will be 12 Latest updates on WIPOs recommendations can be obtained id=12522 last visited on 28 February 2008.
13 Biodiversity and Community Knowledge Protection Act of Bangladesh, 1998 (See Table in Appendix for more details.) 14 MacDonald, Chris, from www.biotechethics.ca/papers/ stakeholder.html last visited 10 September 2008.
15 See for example Physicians for Social Responsibility, Oregon at http://www.oregonpsr.org/csf/ 16 http://ise.arts.ubc.ca/global coalition/ethics.php last visited 15 January 2009.
The United Nations University Institute of Advanced Studies (UNU-IAS) is a global think tank whose mission is "to advance knowledge and promote learning for policy-making to meet the challenges of sustainable development." UNU-IAS undertakes research and postgraduate education to identify and address strategic issues of concern for all humankind, for governments, decision makers and, particularly, for developing countries.
The Institute convenes expertise from disciplines such as economics, law, social and natural sciences to better understand and contribute creative solutions to pressing global concerns, with research focused on the following areas: • Biodiplomacy Initiative • Ecosystem Service Assement • Education for Sustainable Development • Sustainable Development Governance • Science and Technology for Sustainable Societies • Sustainable Urban Futures printed on Forest Stewardship Council (FSC) certified paper using soy-based ink

Source: http://www.unep.org/environmentalgovernance/Portals/8/documents/UNU_ABS_Report_Final.pdf