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About

Editor-in-Chief,   Anatole Krattiger

Editorial Board

Concept Foundation

PIPRA

Fiocruz, Brazil

bioDevelopments-   Institute

CHAPTER NO. 16.5

Soejarto DD, C Gyllenhaal C, JA Tarzian Sorensen, HHS Fong, LT Xuan, LT Binh, NT Hiep, NV Hung, TQ Bich, BM Vu, BV South-avong, K Sydara, JM Pezzuto and MC Riley. 2007. Bioprospecting Arrangements: Cooperation Between the North and the South. In Intellectual Property Management in Health and Agricultural Innovation: A Handbook of Best Practices (eds. A Krattiger, RT Mahoney, L Nelsen, et al.). MIHR: Oxford, U.K., and PIPRA: Davis, U.S.A. Available online at www.ipHandbook.org.

© 2007. DD Soejarto et al. Sharing the Art of IP Management: Photocopying and distribution through the Internet for noncommercial purposes is permitted and encouraged.

Bioprospecting Arrangements: Cooperation between the North and the South

Djaja Djendoel Soejarto, College of Pharmacy, University of Illinois at Chicago, U.S.A.

C. Gyllenhaal, University of Illinois at Chicago, Chicago, U.S.A.

Jill A. Tarzian Sorensen, Global Health Initiatives, Johns Hopkins University, U.S.A.

H.H.S. Fong, University of Illinois at Chicago, Chicago, U.S.A.

L.T. Xuan, National Center for Science and Technology, Hanoi, Vietnam

L.T. Binh, National Center for Science and Technology, Hanoi, Vietnam

N.T. Hiep, National Center for Science and Technology, Hanoi, Vietnam

N.V. Hung, National Center for Science and Technology, Hanoi, Vietnam

B.M. Vu, Supporting Center for Community Economic Development, Hanoi, Vietnam

T.Q. Bich, Cuc Phuong National Park, Ninh Binh, Vietnam

B.H. Southavong, Traditional Medicine Research Center, Vientiane, Lao People’s Democratic Republic

K. Sydara, Traditional Medicine Research Center, Vientiane, Lao People’s Democratic Republic

J.M. Pezzuto, University of Hawaii at Hilo, U.S.A.

M.C. Riley, College of Pharmacy, University of Illinois at Chicago, U.S.A.

Show SummaryEditor's Summary, Implications and Best Practices

Abstract

The ICBG (International Cooperative Biodiversity Groups) program, through which institutions located in biotechnology-rich countries in the North collaborate with institutions located in the biodiversity-rich countries in the South (with the support of an industrial partner) to discover and develop natural-product drugs, is an experiment in the design of bioprospecting efforts. This chapter describes the general aims and organization of the ICBGs and describes in great detail the agreements that governed the University of Illinois at Chicago-Vietnam-Laos ICBG. The chapter includes material concerning IP (intellectual property) rights issues, informed consent, various forms of benefit sharing (including the sharing of short- and long-term, namely, royalty, benefits), capacity building, and community reciprocity. It offers a model for other such agreements.

1. Introduction

The term bioprospecting or biodiversity prospecting has been defined as “the exploration of biodiversity for commercially valuable genetic and biochemical resources,”1 or “the search for wild species, genes, and their products with actual or potential use to humans,”2 or the search for commercially valuable biochemical and genetic resources in plants, animals, and microorganisms.

One model of a biodiversity prospecting effort is a program called ICBG (International Cooperative Biodiversity Groups). Based in the United States, ICBG falls under the auspices of the Fogarty International Center (FIC) of the United States National Institutes of Health (NIH). It also collaborates with the National Science Foundation (NSF) and the U.S. Department of Agriculture (USDA).3 A five-year cycle program, it went into operation in 1993 in response to a request for applications issued by FIC in 1992.4 The ICBG second cycle began on 1 October, 1998, as a result of new and recompeting proposals in response to a request for applications issued by FIC in 1997.5 On 17 October 2002, a request for applications for a 2003–2008 ICBG cycle recompetition was again issued.6

2. The ICBG Program

International Cooperative Biodiversity Groups, or ICBGs, address the interdependent issues of drug discovery, biodiversity conservation, and sustainable economic growth. They are founded in the belief that efforts to examine the medicinal potential of the earth’s plants, animals, and microorganisms are urgently needed, and that continuing habitat destruction and ever-diminishing biodiversity will make it increasingly difficult to do so in the future. If bioprospecting directly benefits local communities and source country organizations, ICBGs believe that they will have strong incentives to preserve and support sustainable use of the environment.7

As a result of the 1992 and 1997 ICBG award competitions, eight ICBGs were established.8 Each ICBG has as its administrative base a U.S.-based institution that is paired with other organizations (governmental and nongovernmental, including industrial/pharmaceutical) that are located both inside and outside the United States; one of these organizations is a host institution in one or more developing, biodiversity-rich countries, usually in the South. The personnel, organizational structure, specific aims, and methods of operation of each of these ICBGs have been fully described elsewhere.9

3. The North/South ICBG Bioprospecting Arrangement

ICBG proposals must address access and benefit-sharing (ABS).10 ABS is based on contractual agreements that take into account:

  1. The benefits that may be derived from bioprospecting. These may include royalties from the sales of drugs developed from bioprospecting, advance payments (access fees or payments for samples when a commercial partner is involved), capacity building (equipment, training, infrastructure), and focus on the priority areas in the country(ies) of the host institution(s), such as priority diseases or collections and identification in geographic areas or biological groups that are high priorities for conservation needs.
  2. The recipients of the benefits. These may include individuals and communities, government institutions (including national parks, forest services, national herbaria), and nongovernmental institutions (including universities, conservation and development service organizations, and private companies). Whether or not useful ethnomedical knowledge comes from the bioprospecting efforts, communities must receive both short- and long-term benefits for collaborating in the research process.
  3. The negotiation process. Negotiators should consider the following elements:
    • Informed consent, from informal disclosure of the potential uses of their knowledge offered by individuals or communities, to formal documentation in the form of project descriptions and related materials
    • Consensus building among communities and government and nongovernmental organizations
    • Independent legal advice for all consortium members
  4. The structure of the agreement between the recipients. ICBG models include the one-contract model, the contract wheel, the dual-contract model, and the wheel-triangle model.11 All of these agreements include research and benefit-sharing terms, intellectual property (IP) rights, material transfer, confidentiality, and other terms. Often, specific agreements may address components of the above, including material transfer agreements (MTAs), know-how licenses, and so on.

4. The University of Illinois at Chicago-Vietnam-Laos ICBG

4.1 Background

The members of the UIC ICBG Consortium were the University of Illinois at Chicago (UIC); the Vietnamese National Center for Science and Technology (NCST), based in Hanoi, Vietnam; Cuc Phuong National Park (CPNP), in Ninh Binh, Vietnam; the Traditional Medicine Research Center (TMRC), based in Vientiane, Laos, (formerly named the Research Institute for Medicinal Plants [RIMP]); and Glaxo Wellcome Research and Development (GW), based in Greenford, U.K. (today known as GlaxoSmithKline [GSK]).

The grant award (made on 29 September 1998) represented a cooperative agreement between the U.S. Government and UIC. The letter of award (Terms and Conditions of Award) indicated that the U.S. government agreed to fund the work (via the FIC) of the UIC-based ICBG, so long as certain criteria were met: the principles of ABS were fulfilled, the progress of the project was satisfactory, and funds were available.12

The general background of the ICBG (the events that led to the writing of the proposal, the selection of partner institutions, and the submission of a Letter of Intent to submit a proposal to the FIC), as well it’s the structure of the ICBG (personnel, organization, research plan, and policies toward IP rights and informed consent) have been described in an earlier paper.13

4.2 The aims of the consortium

The specific aims of the UIC-Vietnam-Laos ICBG were:

  • The discovery of biopharmaceuticals in the plants of Vietnam and Laos and the development of drugs to treat cancer, AIDS, malaria, tuberculosis, pain, and diseases that affect the central nervous system (particularly Alzheimer’s disease)
  • Creating a biodiversity inventory and conserving biodiversity, with a specific focus on plants of Cuc Phuong National Park and medicinal plants of Laos
  • Aiding economic development in cooperating communities
  • Capacity building among the collaborating institutions in the host countries

4.3 Negotiations among consortium members

After the Letter of Intent was submitted to the FIC on 3 October 1997, discussions were held between the principal investigator and the director of UIC’s IPO (Intellectual Property Office). An important element of discussions was the principle stated in the so-called Manila Accord (at the 1990 Regional Workshop for the Chemistry of Natural Products in Southeast Asia), which states that at least 51% of the income generated from the commercialization of a drug derived from a plant collected in a particular country should go to the institution located in the plant’s country of origin. The eventual outcome of these discussions was a Memorandum of Agreement (MOA) that bound the five members of the UIC ICBG. The ICBG proposal and the draft MOA (which had been accepted by member institutions but not signed) were sent to the FIC on 20 January 1998.

The new ICBG, Studies on Biodiversity of Vietnam and Laos: The UIC-based ICBG Program, was created on 1 October 1998. Its bio-prospecting program was not fully functional until nine months later, when the MOA was signed by all parties on 28 June 1999. In the negotiation process, the principal investigator of this ICBG advised NCST, CPNP, and TMRC to consult attorneys regarding the draft MOA.20

4.4 The Memorandum of Agreement

The MOA consists of 15 pages of text plus 5 Addenda (which total 5 pages). Addenda I and II are included at the end of this chapter (Figures 1 and 2) and are further discussed below. It should be noted that the natural product program at GSK was phased out in 2000 as a result of the merging of GW and Smith Kline Beecham, so GW/GSK withdrew from the consortium in November of 2001.

Figure 1: Royalties Sharing in the Event that UIC Discovers and Characterizes a Compound, and Glaxo Develops It

Figure 2: Royalties Sharing in the Event that GW Discovers, Characterizes, and Develops a Compound

4.4.1 The MOA structure

The University of Illinois at Chicago, which is bound in a contractual agreement with the U.S. government, is the administrative seat of the consortium. The transfer of funds (grants, not IP rights or benefit-sharing agreements) from UIC to the other member institutions (except Glaxo) was outlined in separate subcontract agreements. Glaxo was not a recipient of ICBG funds and did not provide any funding to the consortium; it did, however, agree to contribute to capacity building of scientists and institutions in Vietnam and Laos.

4.4.2 Clauses of the MOA

Part I of the MOA defines the consortium members’ Scope of Cooperation. Part II defines the General Areas of Cooperation of the consortium members, including the exchange of faculty members or scientific personnel, joint research activities, joint participation in seminars and scientific meetings, the exchange of academic and research materials and other information, and the participation in special short-term academic programs. Part III describes the details of the joint research activities and consists of five sections (III-A/Precedents, III-B/Purpose, IIIC/Objectives, III-D/Responsibilities, and III-E/Finance and Services).

  • III-A/Precedents contains clauses that describe the considerations that led to the cooperation, such as the previous track record of collaboration between UIC and the member organizations, the proposal writing, the funding award, the key personnel and organizational structure/component roles, and a reference to the terms and conditions of the ICBG award.
  • III-B/Purpose defines the purpose of the cooperation: to discover and develop new medicines, to conserve and sustainably use the flora of the Cuc Phuong National Park in Vietnam and the medicinal flora of Laos, and to increase development in both cooperating communities and in the ICBG host institutions.
  • III-C/Objectives spells out the specific aims of the consortium, including its approaches to plant selection, disease targets, the inventory of the seed plants of CPNP, biomass production of biologically active and promising species, capacity building, conservation education, economic improvement of local communities, in the CPNP area in Vietnam, and medicinal-plant inventory and databasing (and community reciprocity) in Laos, as well as human-resource development and infrastructure strengthening of the ICBG host institutions in Vietnam and Laos.
  • III-D/Responsibilities spells out the responsibilities of each member organization and their joint responsibilities.

    - III-D-1 defines the responsibilities of UIC (23 clauses).

    - III-D-2 defines the responsibilities of NCST, IBT, ICH and IEBR (14 clauses).

    - III-D-3 defines the responsibilities of CPNP (12 clauses).

    - III-D-4 defines the responsibilities of RIMP/TMRC (11 clauses).

    - III-D-5 defines the responsibilities of Glaxo/GW (ten clauses).

    - III-D-6 defines the joint responsibilities of the member institutions and the industrial partner (eight clauses). It includes the time period the MOA is in force, conditions for withdrawal of any of the member organizations, amount of samples at initial collection for screening and recollection for isolation and structure determination, conditions for exchange of personnel as part of capacity building, the requirements for technical reports, how the materials and data may be used in the event the agreement is terminated, the limitations on the collaborative use of genetic materials, requirements for acknowledging the grant in publications, and the requirement that international arbitration must be sought in the event of disputes.

  • III-E specifies the source of funding as the FIC/NIH (ICBG Grant 1UO1-TW01015-01).

Part IV defines the period of validity of the MOA; the conditions for termination, extension, and amendment of the MOA; and the number of copies of the MOA that must be signed by members of the consortium.

The signature page states that the five addenda to the text of the MOA will become binding upon the signing of the legal representatives whose names are affixed therein. These include the chancellor and two representatives of the board of trustees (for UIC), the director of the Institute of Biotechnology and an ICBG-NCST liaison (for NCST, representing IBT, ICH, and IEBR), director and vice director of Cuc Phuong National Park, director and deputy director of TMRC, and director for scientific research of GW.

  • Addendum I (Figure 1) describes a long-term benefit-sharing scheme that will go into effect in the event that discovery of a biopharmaceutical is made by UIC (in cooperation with ICH) and that Glaxo develops and commercializes the drug. In this scheme, the royalty stream is distributed among the organization members of the Vietnam-Laos ICBG (excluding Glaxo, which waived its share of any royalties) and the communities in the ICBG host countries.
  • Addendum II (Figure 2) presents a long-term benefit-sharing scheme to go into effect in the event that Glaxo discovers, develops, and commercializes the drug. As in Addendum I, in this second scheme, the royalties are distributed among the member organizations (excluding Glaxo) and the communities in the ICBG host countries.
  • Addendum III grants rights to GW in the event of the licensing of discoveries made at UIC-ICH under the framework of the ICBG and GW’s rights of first refusal.
  • Addendum IV defines the milestone payments that GW will make in the event a drug is discovered at UIC. The amount of payment is determined by the following variables: the site of the screen (UIC versus GW), the selection of compound for clinical trial, entry to Phase II and Phase III clinical trials, and approval of NDA (New Drug Application).
  • Addendum V defines milestone and royalty payments for any drug developed and commercialized by GW. The payments are determined by the patent rights on, and the chemical structure of, the GW development compound, as well as by the target activity (in other words, whether or not the target is one of those in which ICBG is interested). Milestone and royalty payments will be made on new drugs that are derivatives of natural compounds discovered in collected plants, as well as on the natural compounds themselves.

4.5. IP rights issues

In the event of a relevant UIC discovery, the IPO of UIC-PCRPS will determine the ownership of any resulting IP with the assistance of all members of the Group. The named inventors may consist of individuals from any or all of the consortium members. The question of ownership shall be determined in accordance with the applicable laws of the country in which the invention or discovery is made. With the assistance of all members of the consortium, the UIC IPO will obtain patent protection for the invention or discovery and/or seek such other IP protection, as UIC deems appropriate. UIC IPO will be responsible for the management and licensing of the invention or discovery in accordance with the terms of the agreement.

In the event that an invention or discovery is made at GW based on plants that were collected or acquired within the ICBG framework, GW will determine the ownership of any resulting intellectual property with the assistance of all members of the consortium. The named inventors may consist of individuals from any or all of the consortium members. The question of ownership shall be determined in accordance with the applicable law of the country in which any invention or discovery is made. GW will obtain patent protection for such invention or discovery and/or seek such other intellectual property protection, as GW deems appropriate with the assistance of all members of the Group. GW will be responsible for the management and licensing of such protected inventions. The parties further agree that they will make available all relevant information to GW (including the country of origin of the sample and its taxonomic identity, where appropriate) so that GW will be able to register IP rights.

GW will have the rights to file for patent protection for a discovery it makes that is based on plant samples or extracts received by GW under the framework of the ICBG, but it will consult with the consortium in determining co-inventor-ship of the discovery. GW also agrees to notify the consortium in the event a decision is made to proceed with the development of a compound or compounds derived from plants supplied by the ICBG.21

4.6 Informed consent

There are two provisions regarding informed consent in the Vietnam-Laos ICBG agreement: (1) informed consent in the case of collection and use of plant/genetic materials and (2) informed consent of individuals and their communities regarding the traditional medicinal use or uses of a plant.

Thus, in Vietnam, “informed consent (collecting permits) of the Government of Vietnam, the owner of the samples (genetic materials) and derivatives thereof, will be secured before the implementation of the work proposed as described in the ICBG proposal,” and ICBG through IBT, IEBR, and CPNP “will liaison with the Government of Vietnam in matters related to permit for the collection and export of plant samples or their extracts for use in the ICBG project.” In Laos, TMRC/RIMP will collect plant samples from various sites in Laos “through prior informed consent of the Government of Lao PDR, the owner of the samples (genetic materials) and derivatives thereof.” Prior informed consent (collecting permits) will be secured before the implementation of the work. The governments of Vietnam and Laos are acknowledged as the owners of genetic materials and their derivatives in their respective countries.

In Vietnam, ICBG investigators “will seek the informed consent of individuals and/or communities for the recording and use of data on the medicinal and other uses of the plants in the Cuc Phuong National Park, for the intended study as described in the ICBG proposal.” In Laos, ICBG investigators “will seek the prior informed consent of individuals and/or the communities for the recording and use of data on the medicinal and other uses of plants of Laos, for the intended study as described in the ICBG proposal.”

4.7 Royalty distribution

The full scheme of royalty distribution in Addenda I and II of the MOA (Figures 1 and 2) has been presented in an earlier paper.14 At the time of ABS negotiations, UIC channeled the net royalty stream (after deduction of out-of-pocket costs) received from an industrial partner or licensee into two equal portions. The first 50% (referred to as the “common fund”) is to be distributed to the collaborating institutions, the inventors, and the UIC administration, while the other 50% is to flow back to communities in the country of origin of the genetic material of the commercialized product, through a trust fund.

The distribution of the first 50% share may happen in two different ways. In the first scenario, UIC investigators discover a drug, and a pharmaceutical company develops and commercializes the compound. In the second scenario, a drug is discovered, characterized, developed, and commercialized by a pharmaceutical company that is an ICBG industrial partner (in other words, UIC inventors do not hold IP rights).

In the first instance (UIC inventors hold IP rights) the common fund is to be distributed as follows: (1) the inventors will receive a 40% share of the 50% portion (equal to 20% of total net royalty), as an incentive for future inventions; (2) the collaborating institutions (PCRPS and counterpart institutions) will receive a 20% share of the 50% portion (equal to 10% of total net royalty) for their research contributions; and (3) the UIC administration will receive a 40% share of the 50% portion (equal to 20% of total net royalty) for their administration and legal contributions.

In the second scenario (UIC inventors do not hold IPR), the common fund is to be distributed as follows: (1) the collaborating institutions will receive a 40% share of the 50% portion (equal to 20% of the total net royalty); (2) UIC-PCRPS will receive a 20% share of the 50% common fund (equal to 10% of the total net royalty) for its research contribution; and 3) the UIC administration will receive a 40% share of the 50% common fund (equal to 20% of the total net royalty).

The full details of the UIC-based Vietnam-Laos ICBG benefit-sharing scheme are spelled out in a 2002 paper.15 In November 2002, further discussions and analyses of the above royalty distribution schemes at UIC led to the application of the policy to joint drug-discovery efforts: Sixty percent of the split of the net royalty would go to the collaborating institutions, while 40% would go to UIC. Despite the change of this benefit-sharing policy, the original benefit-sharing schemes set down and agreed to by the UIC ICBG consortium and embodied in the ICBG MOA remain in force to this date.16, 22

Funds provided by GSK at the time of its withdrawal are being used to establish two trust funds: the Nature Conservation Foundation (NCF), Vietnam, and the Laos Biodiversity Fund (LBF). The objectives of the NCF and LBF include conservation of resources, capacity building, biodiversity research, and community reciprocity.17 These funds will serve as the conduit for the 50% of the royalties that are due to flow back to the communities in question.

4.8 Community reciprocity

Community reciprocity measures are implemented in the Vietnam-Laos ICBG.18 Both the UIC and the host-country institutions have responsibility for implementing community reciprocity.

5. Conclusion

The success of an ICBG depends on the goodwill and understanding of the collaborating parties toward the achievement of a common goal, namely, the conservation of biodiversity, the discovery and development of pharmaceutically beneficial products, and the equitable sharing of the benefits that may result. In setting up the arrangement, multiple, complex requirements must be satisfied, the most important of which is the contractual agreement. Eight ICBG bioprospecting groups have so far been created, each with various models of contractual arrangement. The common features of these models, however, are their satisfactory arrangements for IP rights issues, informed consent, and benefit sharing.

The UIC-based Vietnam-Laos ICBG is one example of such a North–South collaborative arrangement. Parties to this ICBG have successfully achieved goodwill and understanding. Despite the short time it has been in operation, the accomplishments of this ICBG to date indicate that the ICBG model works.19, 23

Bioprospecting endeavors such as these are also unique in the way in which they involve local communities. In order to effectively carry out this sort of activity, collaboration at the local level—with poor farmers, rural villagers, many of whom have only limited education or opportunities in life—is crucial. The ICBG allows rural villagers participation in conservation, economic and development initiatives in a way that is not often seen in “macro,” nation-wide efforts to promote conservation, development or new economies. (Often, villagers are told what to do or are displaced by these new initiatives.) And the ICBG also allows villagers input on a number of issues—health care delivery, education, local economics, conservation, and development—which is a natural by-product of forming the ICBG project and determining what benefits “make the most sense” to the local communities with which the ICBG works.

Often times in the implementation of international, national or even provincial development, conservation or economic initiatives, the peasant-farmer is left out of the dialogue entirely, or is told to change/is displaced from life-long patterns of living and working. Under these circumstances, the peasant-farmer does not have a voice, and new schemes for economy, conservation, and development are imposed upon villages from the outside rather than collaboratively developed with villagers, in accordance and consideration of the local needs of villagers in different regions of the country. Projects such as the ICBG can provide a model for how to successfully implement national policy initiatives at the “micro” level—that is, figuring out the best ways to improve health care access and delivery systems, or to implement new economic, development, and conservation initiatives that are in keeping with local village practices and rhythms of life, especially when it turns out that local villagers have their own, traditional practices that may directly or indirectly contribute to conservation, economic, and development efforts. While the governments of Vietnam and Lao PDR do attempt to take into consideration the

needs of local villagers when implementing new policies designed to improve the quality of life in rural areas, projects such as the ICBG can act as a model for obtaining additional data on the actual living conditions of rural villagers, and how to work with and for local communities, because of the close association between the ICBG and local village authorities and councils.

Moreover, the rural villagers begin to see themselves as stakeholders interested in the outcomes of conservation, economic, development, and health care delivery efforts because of their direct participation on the process of locally implementing national policies. Instead of feeling alienated by the process of reform, rural villagers realize their direct contribution to the process itself when they are actively engaged and participating in local projects—and when their contributions to the process are valued.

The ICBG might not be the only model for implementing change at the local level, and in a way that is welcomed and guided by villagers (since it is in cooperation with improving the quality of life at the village level); but it is a model currently in use and from which lessons and “best practices” may be gleaned and then replicated elsewhere worldwide. In this way, the ICBG contributes to the larger knowledge base of solutions for effective cooperative endeavors between North and South.

Acknowledgements

The UIC-based Vietnam-Laos ICBG is funded by U.S. government grant 1-UO1-TW-01015-01 (1998-2003) through funds from the National Institutes of Health (NIH), the National Science Foundation (NSF), and the Foreign Agriculture Service of the U.S. Department of Agriculture (FAS/USDA) and is administered by the Fogarty International Center of the NIH. The authors express deep appreciation to all members24 of the UIC-Vietnam-Laos ICBG for their goodwill, understanding, hard work, and dedicated effort during the structuring of the MOA presently in force and the implementation of the project activities. Thanks to Dr. Joshua Rosenthal, ICBG Program Director, Fogarty International Center, for kindly reviewing the manuscript.

The authors wish to thank BIOTEC (National Center for Genetic Engineering and Biotechnology), 113 Thailand Science Park, Phaholyothin Road, Klong 1, Klong Luang, Pathumthan 12120, Thailand, for the invitation and partial sponsorship in the presentation of this paper in the BioThailand Conference in Bangkok on July 17, 2003, and for permission to reproduce this paper, originally published in the BioThailand 2003 Proceedings, and edited for this Handbook by MIHR/PIPRA.

Edited and reprinted with permission from the National Center for Genetic Engineering and Biotechnology (BIOTEC), 113 Thailand Science Park, Phaholyo-thin Road, Klong 1, Klong Luang, Pathumthan 12120, Thailand.

Endnotes

All referenced Web sites were last accessed between 1 and 10 October 2007.

1 Reid WA, SA Laird, R Gamez, A Sittenfeld, AH Janzen, MA Gollin and C Juma. 1993. A New Lease on Life. In Reid WA, SA Laird, CA Meyer, R Gamez, A Sittenfeld, AH Janzen, MA Gollin, and C Juma, Biodiversity Prospecting: Using Genetic Resources for Sustainable Development. World Resources Institute: Washington DC.

2 Sittenfeld A and R Gamez. 1993. Biodiversity Prospecting by INBio. In Reid WA, SA Laird, CA Meyer, R Gamez, A Sittenfeld, AH Janzen, MA Gollin, and C Juma, Biodiversity Prospecting: Using Genetic Resources for Sustainable Development. World Resources Institute: Washington DC.

3 Anonymous. 2003. Fogarty International Center Web site. http://www.fic.nih.gov/programs/research_grants/icbg/index.htm.

4 Grifo FT. 1996. Chemical Prospecting: An Overview of the International Cooperative Biodiversity Groups Program. In Biodiversity, Biotechnology, and Sustainable Development in Health and Agriculture: Emerging Connections (ed. J Feinsilver). Pan American Health Organization: Washington, DC. pp 12-26.

Rosenthal JP. 1997. Integrating Drug Discovery, Biodiversity Conservation, and Economic Development: Early Lessons in the International Cooperative Biodiversity Groups. In Grifo F and J Rosenthal, Biodiversity and Human Health. Island Press: Washington, DC. pp 281-301.

Rosenthal JP, DA Beck, A Bhat, J Biswas, L Brady, K Bridbord, S Collins, G Cragg, J Edwards, A Fairfield, M Gottlieb, LA Gschwind, Y Hallock, R Hawks, R Hegyeli, G Johnson, GT Keusch, EE Lyons, R Miller, J Rodman, J Roskoski, and D Siegel-Causey. 1999. Combining High Risk Science with Ambitious Social and Economic Goals. Pharmaceutical Biology 37(Supplement):6-21.

5 See Rosenthal et al. in supra note 4.

6 www.grants.nih.gov/grants/guide/rfa-files/RFA-TW-03-004.html and http://www.fic.nih.gov/programs/research_grants/icbg/index.htm.

7 Rosenthal JP. 1997. Equitable Sharing of Biodiversity Benefits: Agreements on Genetic Resources. Presentation at the International Conference on Incentive Measures for the Conservation and the Sustainable Use of Biological Diversity in Cairns, Australia, 25-28 March 1996. Investing in Biological Diversity: Proceedings of the Cairns Conference. OECD: Paris.

8 See Rosenthal, et al. in supra note 4.

9 Berlin B, EA Berlin, JC Fernandez Ugalde, L Garcia Barrios, D Puett, R Nash, M Gonzalez-Espinosa. 1999. The Maya ICBG: Drug Discovery, Medical Ethnobiology, and Alternative Forms of Economic Development in the Highlands Maya Region of Chiapas, Mexico. Pharmaceutical Biology 37 (Suppl.): 127-144.

Kingston DGI, M Abdel-Kader, B-N Zhou, S-W Yang, JM Berger, H Van der Werff, JS Miller, R Evans, R Mittermeir, L Famolare, M Guerin-McManus, S Malone, R Nelson, E Moniz, JE Wisse, DM Vyas, JJK Wright, and S Aboikonie. 1999. The Suriname International Cooperative Biodiversity Group Program: Lessons from the first five years. Pharmaceutical Biology 37 (Suppl.): 22-34.

Kursar TA, TL Capson, PD Coley, DG Corley, MB Gupta, LA Harrison, E Ortega-Barria, and DM Windson. 1999. Ecologically Guided Bioprospecting in Panama. Pharmaceutical Biology 37 (Suppl.): 114-126.

Lewis WH, G Lamas, A Vaisberg, DG Corley, C and Sarasara. 1999. Peruvian Medicinal Plant Sources of New Pharmaceuticals (International Cooperative Biodiversity Group-Peru). Pharmaceutical Biology 37 (Suppl.): 69-83.

Schuster BG, JE Jackson, CN Obijiofor, CO Okunji, W Milhous, E Losos, JF Ayafor, and MM Iwu. 1999. Drug Development and Conservation of Biodiversity in West and Central Africa: A Model for Collaboration with Indigenous People. Pharmaceutical Biology 37 (Suppl.): 84-99.

Sittenfeld A, G Tamayo, V Nielsen, A Jimenez, P Hurtado, M Chinchilla, O Guerrero, MA Mora, M Rojas, R Blanco, E Alvarado, JM Gutierrez, and DH Janzen. 1999. Costa Rican International Cooperative Biodiversity Group: Using Insects and other Arthropods in Biodiversity Prospecting. Pharmaceutical Biology 37 (Suppl.): 55-68.

Soejarto DD, C Gyllenhaal, JC Regalado, JM Pezzuto, HHS Fong, GT Tan, NT Hiep, LT Xuan, DQ Binh, NV Hung, TQ Bich, NN Thin, PK Loc, BM Vu, BH Southavong, K Sydara, S Bouamanivong, MJ O’Neill, J Lewis, X-M Xie, and G Dietzman. 1999. Studies on Biodiversity of Vietnam and Laos: The UIC-based ICBG Program. Pharmaceutical Biology 37 (Suppl.): 100-113.

Timmermann BN, G Wächter, S Valcic, B Hutchinson, C Casler, J Henzel, S Ram, F Currim, R Manak, S Franzblau, W Maiese, D Galinis, E Suarez, R Fortunato, E Saavedra, R Bye, R Mata, and G Montenegro. 1999. The Latin American ICBG: The First Five Years. Pharmaceutical Biology 37 (Suppl.): 35-54.

10 Anonymous. 1997. International Cooperative Biodiversity Groups (ICBG): RFA TW-98-001. NIH Guide 26. Anonymous. 2002. International Cooperative Biodiversity Groups (ICBG)- RFA: TW-03-004. grants1. nih.gov/grants/guide/rfa-files/RFA-TW-03-004.html.

11 See supra note 7.

12 See supra note 10.

13 See Soejarto et al. in supra note 9.

14 Soejarto DD, LT Xuan, BM Vu, LX Dac, TQ Bich, BH Southavong, K Sydara, S Bouamanivong, HJ Zhang, HHS Fong, G Tan, J Pezzuto, SG Franzblau, C Gyllenhaal, MC Riley, NT Hiep, PK Loc, and NV Hung. 2002. Implementing IPR and Benefit-Sharing Arrangements: Experiences in the University of Illinois at Chicago-Vietnam-Laos ICBG Program. In Anonymous. Intellectual Property Rights and Traditional Knowledge on Genetic Resources in Pharmaceutical and Cosmetic Business. JBA/NITE, International Symposium 2002, Tokyo, Japan, 14 November 2002. pp. 47-83.

15 Soejarto DD, JA Tarzian-Sorensen, C Gyllenhaal, GA Cordell, NR Farnsworth, HHS Fong, AD Kinghorn, and JM Pezzuto. The Evolution of University of Illinois’ Policy of Benefit-Sharing in Research on Natural Products. Proceedings of the 7th International Congress on Ethnobiology, Athens, Georgia, 23-27 October 2000. University of Georgia Press: Athens, Georgia. pp. 21-30.

16 See supra note 14.

17 See supra note 14.

18 See supra note 14.

19 See supra note 14 and Soejarto DD, C Gyllenhaal, JC Regalado, JM Pezzuto, HHS Fong, GT Tan, NT Hiep, LT Xuan, NV Hung, TQ Bich, PK Loc, BM Vu, BH Southavong, K Sydara, S Bouamanivong, MJ O’Neill, and G Dietzman. 2002. An International Collaborative Program to Discover New Drugs from Tropical Biodiversity of Vietnam and Laos. Natural Product Sciences 8:1-15.

20 The 1998-2003 UIC ICBG is referred to as UIC ICBG Phase I. On 1 October 2003, a new funding as a result of 2003-2008 re-competition was awarded; the 2003-2008 UIC ICBG is referred to as PHASE II. In Phase II, UIC, NCST [this institution name was changed in 2004 to VAST (Vietnamese Academy of Science and Technology)], CPNP, and TMRC continued to be members of the consortium, with Purdue University added as a new member, and Bristol-Myers Squibb (B-MS) Pharmaceutical Co. became the industrial partner.

21 The terms and conditions of Phase II UIC ICBG are, in large part, similar to the 1998-2003 Phase I, with the exception that, in Phase II, each member of the consortium has the right to file an IP protection.

22 In Phase II, the percentages of the royalty stream also flow to Purdue Universty; B-MS waived the rights to any royalties.

23 The accomplishments of the UIC ICBG (Phase I and Phase II) were examined in a 2006 paper: Soejarto DD, HJ Zhang, HHS Fong, GT Tan, CY Ma, C Gyllenhaal, MC Riley, MR Kadushin, SG Franzblau, TQ Bich, NM Cuong, NT Hiep, PK Loc, LT Xuan, NV Hai, NV Hung, NQ Chien, LT Binh, BM Vu, HM Ly, B Southavong, K Sydara, S Bouamanivong, JM Pezzuto, WC Rose, GR Dietzman, BE Miller, and TV Thuy. 2006. Studies on biodiversity of Vietnam and Laos 1998-2005: Examining the impact. Journal of Natural Products 69: 473-481.

24 Funding of Phase II UIC ICBG through NIH grant 2-UO1-TW001015-01 (2003-2008) is also acknowledged with thanks.

Soejarto DD, C Gyllenhaal C, JA Tarzian Sorensen, HHS Fong, LT Xuan, LT Binh, NT Hiep, NV Hung, TQ Bich, BM Vu, BV South-avong, K Sydara, JM Pezzuto and MC Riley. 2007. Bioprospecting Arrangements: Cooperation Between the North and the South. In Intellectual Property Management in Health and Agricultural Innovation: A Handbook of Best Practices (eds. A Krattiger, RT Mahoney, L Nelsen, et al.). MIHR: Oxford, U.K., and PIPRA: Davis, U.S.A. Available online at www.ipHandbook.org.

© 2007. DD Soejarto et al. Sharing the Art of IP Management: Photocopying and distribution through the Internet for noncommercial purposes is permitted and encouraged.

User Comments and Uploads RSS

7 comments including 6 uploads.

 

Admin (24/09/2010 10:24:04)

 

Handbook Editors (24/09/2010 10:26:48)

North-South research co-operation is very much on the agenda of those interested
in the development of science in general and of those with a developmentoriented
agenda in research and research capacity building – albeit for different
reasons. A study of the impacts of donor-initiated programmes for research capacity in the South, a report from an expert meeting on the issues and challenges of North-South research partnerships, a paper on how to make North-South research networks actually work, the results of a conference on research co-operation with developing countries at the European level, not to mention a previous review of the subject at the Academy some years ago and, last but not least, the unesco and World Bank studies on the role of knowledge and knowledge-generating systems in development.

Related upload: 20021020.pdf (1004K) -- .

 

Handbook Editors (24/09/2010 10:28:03)

The large number of international environmental agreements has been negotiated without explicit measures to resolve the frequently overlapping and conflicting goals of economic regimes.1 The relative strength between environmental and economic regimes, whether in terms of power and interest structure or in terms of normative persuasion, has yet to be put to any ultimate test. This article examines the interrelationship between one environmental and one trade-related regime, dealing with biodiversity and intellectual property rights respectively. In response to the rapid loss of species and ecosystem decay world-wide, the Convention on Biological Diversity (CBD) was agreed to in Rio in 1992. Two years later the Trade-Related Aspects of Intellectual Property Rights (TRIPs)—a formal agreement under the World Trade Organization (WTO)—was established. How do the functional scopes of these institutions overlap and what are the implications for the implementation of the objectives of the CBD?

Related upload: A-00199.pdf (107K) -- .

 

Handbook Editors (24/09/2010 10:31:22)

Most pharmaceutical research carried out today is focused on the
treatment and management of the lifestyle diseases of the developed
world. Diseases that affect mainly poor people are neglected in
research advancements in treatment because they cannot generate
large financial returns on research and development costs. Benefit
sharing arrangements for the use of indigenous resources and
genetic research could only marginally address this gap in research
and development in diseases that affect the poor. Benefit sharing as
a strategy is conceptually problematic, even if one, as we do, agrees
that impoverished indigenous communities should not be exploited
and that they should be assisted in improving their living conditions.
The accepted concept of intellectual property protection envisages
clearly defined originators and owners of knowledge, whereas the
concept of community membership is fluid and indigenous knowledge
is, by its very nature, open, with the originator(s) lost in the
mists of time. The delineation of ‘community’ presents serious conceptual
and practical difficulties as few communities form discrete,
easily discernable groups, and most have problematic leadership
structures. Benefit sharing is no substitute for governments’ responsibility
to uplift impoverished communities. Benefit sharing arrangements
may be fraught with difficulties but considerations of respect
and equity demand that prior informed consent and consultation
around commercialisation of knowledge take place with the source
community and their government.

Related upload: besha2006.pdf (108K) -- .

 

Handbook Editors (24/09/2010 10:32:22)

The issue of biological diversity constitutes one of today’s greatest challenges, for the following main reasons:
· First, the concern about biodiversity stems largely from an increased awareness and scientific agreement that the current rate of species extinction is extremely high compared to the natural average rate.
· Second, as the new biotechnologies greatly enhance the potential utility areas of the world’s genetic resources, the economic interests linked to these resources are soaring.
· One combined effect of these two trends is a greatly enhanced interest in intellectual property rights and access to genetic resources.
A number of international instruments deal with the various facets of biodiversity
management. The central treaty is the Convention on Biodiversity (CBD) that was signed in Rio de Janeiro in 1992 and provides an overall legal framework for the issue area.

Related upload: convention_on _biodiversity.pdf (74K) -- .

 

Handbook Editors (24/09/2010 10:33:50)

The international interchange of knowledge for technological innovation involves a complex, dynamic and asymmetric set of flows and relationships, mainly from North to North. However, the issue of the movement of knowledge, and the asymmetries that these movements produce between North and South is an important issue. In this paper we address a rather complex converging trend:
that one embracing several types of knowledge movements (formal and informal, refered here as relevant knowledge) between the South and the North, closely linked to the local availability of natural resources and its concomitant knowledge of the former. These movements are-closely linked to the advancement of the new technologies at the industrialised countries. The increasingly interest of the North to be connected with some selected semiperipheral economies is closely related to the need to access to these new” iputs as fast as possible in order to create or sustain –directly or indirectly- the competitive advantages of the firms. Within this logic, countries mainly of semiperiphery, with an endowment of biodiversity, indigenous knowledge and a minimal scientific infrastructure are being strategically selected. At a broader dimension, this may have to do with the
rivalry among the great central economies, as stated in the modern world economic system. Both the position of the included or excluded peripheral and semiperipheral countries within the new international division of labour, and some kind of asymmetric integrating processes -we argue here-,
seems to be closely linked, trhough this way, to the technological change.

Related upload: S22p04.pdf (81K) -- .

 

Handbook Editors (24/09/2010 10:35:50)

Modern biotechnology in agriculture came into prominence in the 1990s.
From 1986 to 1997, approximately 25,000 transgenic crop field trials were conducted in 45 countries on more than 60 crops with 10 different agronomic traits. Seventy-two percent of all transgenic field trials were conducted in the
United States (James 1997). Approximately 40 percent of field trials being conducted in developing countries are for virus resistance, the balance being for herbicide-resistance crops (25 percent), and for insect resistance (25 percent)
(Sasson 1999). By late 1997, 48 transgenic crops involving 12 cultivars and six traits were approved for commercialization in at least one country. More than 90 percent of the owners of this technology were private-sector operators (James 1997). The crops included soybean, cotton, oilseed rape, potato, corn, tomato, papaya, and squash. Agronomic traits included insect, virus, and herbicide tolerance, delayed ripening, male sterility, and changes in oil composition (Nutfield
Council on Bioethics 1999; Sasson 1999). Research on the genetic modification of rice, cassava, banana, oil palm, yam, and sorghum is being undertaken in public and private sector institutions.

Related upload: Sittenfe.pdf (165K) -- .