ICBG Drug Development and Conservation of Biodiversity in Africa: A New Standard of Collaboration with Indigenous PeopleTaken from the ICBG project document by the same title and excerpts from "Health Conservation and Economic Development: The International Cooperative Biodiversity Group - Drug Development and Conservation of Biodiversity in Africa, A Benefit Sharing Plan" by Maurice M. Iwu and Sarah Laird (courtesy Rainforest Alliance, N.Y.).The International Cooperative Biodiversity Group (ICBG) is a program jointly sponsored by the U.S. National Institutes of Health (NIH), the National Science Foundation (NSF), and the U.S Agency for International Development (USAID) to address the related issues of biodiversity conservation and the promotion of sustained economic development through drug discovery from natural products. As described in the ICBG Request for Applications, these goals will be achieved through a combination of the following approaches:1. assisting with the development of drugs while addressing the priority health needs of the United States and the participating countries;2. developing inventories of native species and indigenous knowledge;3. training targeted towards achieving the research goals of the program and meeting the needs of the participating countries; and4. improving the scientific infrastructure within the host country.The program is administered by the Fogarty International Center at U.S. N.I.H. The main focus of the African ICBG project is the establishment of an integrated program for the discovery of biologically active plants for drug development and biodiversity conservation, and at the same time ensuring that local communities and source countries derive maximum benefits for their biological resources and their intellectual contribution.1. Scope and ObjectivesThe ICBG on Drug Development and Conservation of Biological Diversity in West and Central Africa has as its primary aim the development and implementation of an effective and constructive resource management and conservation plan based on an intimate understanding of the key factors driving medicinal plant use and loss of biodiversity. The overriding concept is to increase the net worth of tropical forest as living resource base and to demonstrate the feasibility of an ecological management strategy which uses drug development as a catalyst for the conservation of biological diversity. The ICBG is a highly integrated team which will involve scientists from the participating developing countries in all aspects of the program so that lessons learned from this project can be internalized in Africa and continued even after the end of the proposed project.

Unlike similar projects which involve the collection of plant materials from the project group to be tested in institutions outside the group, in this ICBG most of the processing and biological testing will be performed within the group. The main thrust of this plan was therefore the establishment of a consortium of collaborating scientists who will actually do both the discovery of lead plants and the development of active molecules into drugs. Selected plant products will be developed all the way to pre-clinical stages before negotiation with the commercial partners.

Although the compensation plan remained loyal to the aims and objectives of the funding agencies, a strategy was developed which will ensure benefits to the host country both immediately and in a sustainable manner over a long time. Our compensation plan was based on deriving maximum benefits from the process of drug discovery rather than the promise of huge royalties that may never materialize. The main target therapeutic categories are tropical diseases such as malaria, leishmaniasis and trypanosomiasis. The pharmaceutical companies involved in this ICBG consider their participation not solely for the business interest but as a direct contribution to a serious global health need to find cures for diseases affecting the poor in developing countries. The ICBG program enabled the expansion and elaboration of the already existing collaboration between U.S. and African scientists. The Central Office for the ICBG Program is at the Walter Reed Army Institute of Research. The key institutions and organizations collaborating in this bold initiative include the Division of Experimental Therapeutics of Walter Reed Army Institute of Research, Bioresources Development and Conservation Programme (BDCP), the Smithsonian Institution, the University of Ibadan (Nigeria), University of Yaounde (Cameroon), University of Dschang (Cameroon), Biodiversity Support Program (a consortium of the World Wildlife Fund, Nature Conservancy and World Resources Institute), Pace University New York, Southern Research Institute Alabama, University of Utah and Shaman Pharmaceuticals, Inc.2. Drug Development PlanIn the drug development component of the program, the emphasis is on the identification of new therapeutic leads over as wide variety of plant sources as can be possible with the available resources. Compounds (not crude extracts) with remarkable biological activity would be co-developed with assistance from related drug development programs at the NIH or through the collaboration arrangement with the two participating pharmaceutical companies. By this approach value is added to the plant material before being offered to the commercial partners.Development of Highly Selective Plant Selection Strategy:Four basic methods are generally utilized in the selection of plants to be investigated for biological activity, these are:
1) random selection of plants followed by mass screening; 2)
selection based on ethnomedical uses; 3) leads from literature searches and review of databases; and 4) chemotaxonomic approaches. Most drug development programs based on natural products utilize one or two of these methods to select plants for investigation.The ICBG team has developed a customized approach which involves a carefully designed ethnomedical survey, followed by chemical and biological profile of plant candidates, and finally integrating the result with information from literature and chemotaxonomicalevaluation to generate a highly selective prioritized list. This method has been tested to a limited scale in the search for new antimalarial, antileishmanial and antiviral drugs. In each case the correlation factor was more than 85%. The estimate is to obtain at least 20 very active leads for each therapeutic class at the end of the 2nd year of the project. Some aspects of this plant selection plan was provided by Shaman Pharmaceuticals Inc. as part of its corporate contribution to the ICBG programme. The company also provides high level ethnomedical support to the project's field teams.3. The Beneift Sharing PlanA. General Principles of the Benefit Sharing PlanThe provision of compensation to institutions in source
countries and distribution of royalties have been formulated to ensure that the following principles are adhered to:

1. The distribution of the benefits will ensure that economic benefits are channeled back to the area in which the source plant was found with provision made to compensate individuals, rural communities and local institutions. Modalities will be selected to address each individual circumstance, taking into consideration the fact that cash may not be the most appropriate benefit.

2. Revenues generated from this project will be used solely for projects that will promote conservation of biological diversity and drug development, as well as economic well being of rural communities.

3. Local communities through town associations, village heads and professional guild of healers should be empowered to make decisions regarding compensations and projects in their localities.

4. The African members of this ICBG will be involved at all stages and in all aspects of the drug development process and this experience will enhance their capacity to undertake similar ventures in the future on their own. It is our hope that our work will generate not only pure chemical isolates as pharmaceutical leads but will help the source countries in standardizing their phytomedicines and return such information as benefits to traditional healers. In all cases compensation will be on a case by case basis.

5. While the development of drugs may be the most visible activity under this ICBG, equal importance will be accorded to the conservation and economic development aspects of this project. The ICBG will establish a viable scientific partnership between the United States scientists and their colleagues in Nigeria and Cameroon, which will aim at assisting the source countries scientist to strengthen their capacity to protect the biodiversity in their area now and in the future.

6. All the scientists and individuals who contributed intellectually in the identification and processing of the medicinal plants and their subsequent isolation and development as medicinal agents will be compensated as appropriate. Including traditional healers who assisted in identifying the plant materials and/or contributed in the plant selection process.

7. Appropriate recognition must be given to the contribution of all parties to the development of a therapeutic agent. Individuals who provided information leading to the discovery of an active molecule from a plant must be acknowledged in all publications and patents arising from the work. The community from where the plant was sourced will also be cited in publications and patent applications. The methodology adopted for this project will rely more on information from specialist medicinemen and acquisition from lay people will be minimal.

8. The customary and universal applicable methods of protecting and perfecting intellectual property rights (patents, copyrights, trademarks, trade secrets, and appellation of origin) may not be adequate for the purposes of this ICBG. The Group also recognizes that the need to label ideas, access to instruments of protection and monitoring for possible infringement, expert witness, and legal assistance are necessary factors in equitable distribution of benefits of this project.

9. While the right of individuals to their land and resources derived from it will be respected in the allocation of benefits, the group is cognizant of the fact that information concerning the specific use of plant drug are often not the exclusive property of an individual informant or healer but belongs to the realm of Cultural Resources (CRs) which belongs to the entire community or village. This raises the question of ethics as to the competence of any one person to reveal information which has been entrusted to him as a custodian.
This concern has to be balanced with the fundamental human rights of the professional herbalist to be treated as individuals with rights to their private property and knowledge.B. Ethical Issues and Socioeconomic ConsiderationsSince a significant part of the approach outlined in this project involves the use knowledge collected from indigenous medical practitioners and native populations living in the project area, serious consideration have been given to resolving the enormous ethical and economic issues that are inherent in this approach. As have been pointed out by several investigators exploration of chemical leads in tropical countries poses enormous ethical and political issues which must be addressed in any program that aims to use ethnobotany as a major plant selection criteria. According to Boom (I 990) the ethical issues can be classified into two main areas: I ) the relationship between and host countries, and 2) the relationship between researchers and commercial concerns. A third concern which has been broached by Gollin deals with the modern fundamental issue of ownership patterns in different parts of the world and especially in traditional societies where most of biodiversity belongs to what could be appropriately classified as public domain.These three concerns have been considered very seriously both in the design of the projects outlined here and also in the selection of the diseases to be studied. Steps have been taken to ensure that the royalties derived from this project will be channeled to the benefit of host countries and the local communities near the project sites.In the absence of universally applicable model which addresses these concerns, the Group has adopted a framework for reciprocity and equitable distribution of benefits from biodiversity which addresses our concern for participatory development, environmental sustainability and poverty alleviation.C. Types of Compensation1. Short Term and Immediate Compensation
a) Collection fees to individuals and communities The model used presently by the Bioresources Development and Conservation Programme (BDCP) in its bioresources prospecting projects will be adopted. Plants will be collected directly from local communities and payment and compensation will be effected in three modes. First a "small" cash payment will be made to the informant/collector. Secondly, the community will be assisted in their development projects, and thirdly the medical member(s) of the ethnobotanical team will consult with the local healers and lend help to them in treating some acute life threatening conditions.2. Long Term Benefits - Royalty PaymentsThe royalty derived from licensing drugs developed from any of the leads provided under this ICBG will be distributed between the informant/herbalist, the community and the scientific inventors. The role of the source country scientists in this arrangement is essentially that of facilitating the contact between the ICBG and the healers, not as middlemen or brokers. They will be considered in the same category as their colleagues in the developed countries who contributed intellectually to the development of the drug. The traditional healer or informant is expected to benefit under this category (depending on the extent of his contribution) as well as benefit as a member of the community from where the product is derived. The individual informant will also benefit from bulk recollections. If a drug results from a lead provided by an individual herbalist, 25% of the royalty from the drug discovery will be given to the individual and the rest treated as a communal resource to be distributed and used as determined by the Committee.3. Training and Capacity BuildingThe project provides for various training programs both in-country and in the United States for ecologists, biologists, chemists, pharmacologists, ethnobiologists and field taxonomists. This non-monetary benefit will strengthen the ability of the scientists of the two countries to conduct similar projects in the future.D. Trust Fund Management CommitteeThe royalty generated from the licensing of the drugs developed during this project will be distributed through a legal Trust Fund which will be established for this purpose. The Board of Management will consist of representatives from the U.S.A., Cameroon and Nigeria. The Trust will be completely independent but will administer the funds only for the purposes outlined in its Charter. Most of the work under this ICBG will be carried out in Community Forest Areas (CFAS) and the royalty sharing will be restricted to these local government council areas. Each community will be asked to establish a consultative committee drawn from the executive of the village unions or town associations, village heads and professional guild of healers. It is this village committee which will make decisions and select priorities regarding compensations and projects. BDCP has used this approach in the past with considerable success.It is our position that when determining compensation for access to genetic resources that emphasis should be placed on capacity building rather than short term cash payments. Source countries should endeavour to add value to their resources before trading the samples. The objective is to build a lasting relationship between the parties rather than negotiating for immediate compensation. If properly planned, biological resources could be a viable vehicle for sustainable development.
E. "Process" Benefits: the short- and intermediate-term 1. UniversitiesUniversities in Africa play a special role in both the
conservation of biodiversity and in adapting modern technology to process the plant materials into drugs. Because universities function as part of the educational, cultural, and economic and social systems, the universities are best placed to conduct the multi-disciplinary research needed for sustainable utilization of biological resources and conservation of biodiversity. In recent years African universities have been under tremendous stress due to inadequate funding from their governments and lack of access to international grants and resources. It may be necessary to state here that scientific expertise exists in both Nigeria and Cameroon to undertake the activities outlined in the ICBG program. The ICBG project in Africa has taken the approach of treating the African participants as equal partners, creating a platform for the scientists and field staff to work as a team and having most of the investigation being conducted in the source countries. For the first time in the history of the region, academics, policy makers and field staff share a common forum to design and implement projects that seek solutions to the problem of sustainability.Infrastructure and equipment: The World Health Organization supplies the bulk of laboratory equipment, with the ICBG supplying supplemental computers and funding for basic supplies.2. Local Non-Governmental OrganizationsIn Africa, NGOs have always been actively involved in
nature conservation. There are over 200 NGOs in Nigeria alone. Many of them are regional in both their membership and operation. One of the objectives of the ICBG is the strengthening of the capacity of BDCP, a local network created by University researchers to address the problems of conservation.Bioresources Development and Conservation ProgrammeBDCP, which has now established autonomous branches in both Nigeria and Cameroon (as well as Guinea and South Africa, which are not, however, involved in the ICBG), is also an international umbrella organization which is a primary administrator, monitor, and arbiter of the various interests involved in this ICBG. As a tropical country NGO, however, BDCP is a valuable local institution and, as such, it is worthwhile examining briefly the types of benefits that will accrue to national BDCP organizations.Technology and expertise transfer: This category is, perhaps, not applicable to BDCP's role in this grant, unless one includes the technology and expertise of assembling and administering an unwieldy, multi-institutional grant, coordinating a variety of competing and not always cooperative interest groups, and honing the message of the vastly disparate members of the ICBG "team" into a cohesive and recognizable plan to achieve the extremely broad objectives of drug development, improved health care, conservation and economic development for West-Central Africa. But perhaps "transfer" is a kind way of describing what was in reality a lesson "by fire".Infrastructure and equipment:. The ICBG will provide some basic infrastructure support for existing BDCP programs, such as: cultivation trials for the valuable medicinal species (once used as an ordeal poison)Physostigma venenosum in the Calabar region; assistance provided to local forest communities in acquiring legal rights to communal lands; and farm inventories conducted in both Northeastern and Southeastern Nigeria. The ICBG will also provide BDCP with basic funds to purchase herbarium equipment, which will be used jointly by the University of Nigeria, Nsukka, four-wheel drive vehicles (one each for Nigeria and Cameroon), computers, and basic office costs for the Owerri, Nigeria and Yaounde, Cameroon offices.3. Traditional Healer's AssociationsThe ICBG will be supporting various branches of the
Nigerian Union of Herbal Medical Practitioners, Pilot projects have been initiated with the Enugu State Branch (9th Mile Corner) and the Niger State (Bida) branches. Plans have been made to identify suitable partners in Cameroon for similar collaboration. The funds for the assistance of traditional healers is augmented from direct assistance provided by Shaman Pharmaceuticals through the Healing Forest Conservancy.ICBG has provided immediate reciprocity funds and access fees to the association which the Union used to expand their herbal garden and pharmacy. The funds will also be used in the following on-going project by the Union: a) plant nursery facilities for the ex-situ conservation of plants used by the healers in their practice; b) cultivation of selected medicinal plants as hedges for the demarcation of the herbal garden; and c) preparation and storage of samples in the community based herbal pharmacy.4. "Local Communities"Local communities are important collaborators for the ICBG, particularly in the Nigerian research component, but increasingly in Cameroon, as well. To begin with, it would be useful to define what "local community" means in the context of this discussion, since the dilemma often arises that, while wonderful plans and policies can be made on behalf of "local communities", no one knows what is really meant by the term. Rather than become embroiled in debates a out relative "indigenousness", the ICBG approaches the issue on a practical footing, working with existing local authorities [for example, chiefs, traditional healers, village councils, development associations - can you provide specifics here], in communities in which ownership and authority are generally clearly defined. These communities usually share cultural and tribal ties, have well-structured systems of leadership [chief, which is more a colonial implant, but has some political power, councils, etc .... ], relative areas of specialty and are self-defining entities. It is not our place to go in search of a "community" beyond what local people have defined for themselves, nor to "appraise" the situation in order to decide on their behalf the "truly representative" bodies.In most of Nigeria and Cameroon, communities have been anything but remote from the intense trading, and shifting between populations, that has occurred for hundreds of years, including the most recent colonial influences from Europe. Therefore, while communities may lack access to important technical and legal advice with regards to entering into agreements, the concepts of trade and property raised by the ICBG are not foreign.Perhaps most importantly, the tribal and family ties of African communities means that members of a community can live far away in urban centers, even overseas, but will always return to their "village" which they, and their children, and their children's children, will consider home. Therefore, in West-Central Africa, the cultural and socioeconomic split between urban and rural communities is not as severe, and the exchange of experiences and knowledge more fluid.The African members of the ICBG do not perceive themselves as detached intermediaries between foreign donors and the rural communities. Almost every member of the ICBG team has a village home in the project area of eastern Nigeria and western Cameroon. The working arrangements adopted for the ICBG are the outcome of several months of village meetings, discussion with influential members of the community and negotiation with the appropriate government agencies.B. Long-term benefits By long-term benefits we almost inevitably mean cash.While the process benefits are a guaranteed, and in many ways more fruitful, product of this type of collaboration, it is the fine-workings of the flow of cash that is used as a measure of fairness and responsibility, and which creates the most interest. As a result, there is a popular fixation on documents themselves, to the detriment, in some cases, of the relationships upon which they are based. It took, for example, more than a year? and many contentious meetings? to draft an intellectual property rights agreement for the ICBG protect. This was due largely to the wildly disparate institutions and outlooks involved in the program, and the lack of what Sherbloom (I 99 1 ) referred to as the "careful management of expectations" (see Laird, 1993 and Iwu, 1995).This is not to denigrate the importance of the document itself - it is an important tool for the representation of the ICBG's intent both in the present and in the future, when the individuals involved have long ago moved on to other things. But, as we have said earlier, it must not be emphasized to the exclusion of the "process" benefits that can accumulate along the way, nor must the importance of the man relationships which make up the ICBG be eclipsed.Following is a brief discussion of the elements contained within the Cooperative Research and Development Agreement, or CRADA, with particular attention paid to benefit-sharing. A CRADA is a more elaborate document than a Letter of Intent, and is only considered in cases where projects are in a state of advanced research and development. The CRADA deals directly with issues regarding research scope and administration, intellectual property rights (including licensing, royalty sharing, trademark, copyright, and trade secrets). and sourcing. Following is a brief summary of those aspects of the CRADA with direct relevance to benefit-sharing: the distribution of royalties, trade secrets with regards to traditional knowledge, and sourcing issues. In summary:RoyaltiesIntellectual property will be "managed" by Walter Reed, which must abide by the terms of the CRADA which include: - distributing 20% of all royalties and other considerations generated from licenses of IPR equitably among those parties contributing intellectually to the creation of the IPR, taking into account their relative contribution and ensuring that inventors in each case receive not less than 15%. - donating 50% of all royalty income and other considerations to BDCP to be used solely for pro-rams and projects designed to promote sustainable economic development relating to biodiversity conservation in Nigeria and Cameroon. In order to distribute these benefits, "an independent Trust Fund shall be established as outlined in the "Compensation and Benefit Sharing Plan" [see attached General Principles which will guide the activities of this Trust Fund"].
- 30% of all royalty income and other considerations will be donated to a Tropical Disease Drug Development Program based at Walter Reed in order to further research efforts on, often under-studied, diseases of the developing countries.Trade SecretsConfidential information provided by a source in a source country, particularly a traditional healer, must be preceded by an agreement or the signing of an Informed Consent Form unless the source is a member of the ICBG. SourcingAll licenses shall require ("to the extent it is commercially feasible") that the licensee seek to obtain future supplies of raw materials for R&D, as well as manufacturing, from the Source Country of original sample collection. "Payment for the samples will be determined on a case by case basis. In situations where large samples of plant material will be required for follow-up studies, the licensee will provide a written statement that the material will be collected in a sustainable manner and when appropriate an environmental impact assessment and/or a census of the species will be commissioned or has been conducted to ensure that the plant is not threatened by over-harvesting."In summary, therefore, the CRADA outlines the following forms of benefit-sharing:
- provision of funds for research on tropical country diseases; - reward of actively-involved scientists' intellectual contribution;
- requirement of consent of individuals providing ethnomedical or ethnobotanical knowledge to direct the research, which will likely result in the return of benefits (not detailed in the CRADA).
- provision that companies seek as the first source of raw materials the country of origin (much as in the NCI Letter of Collection).
- provision of 50% of royalties for BDCP work on development and conservation programs. The ICBG research could also have the added benefit of studying and standardizing, as a spin-off to work conducted for the ICBG, local traditional medicines, which could then provide a more affordable, and in some cases more effective, form of health care. The importance of data generated through the pharmaceutical R&D process for the study of traditional medicines for standardization, toxicity and active constituents is often under-estimated. A major part of the arrangement under this ICBG is to pass on information concerning acute toxicity of traditional remedies back to the healers so that they can use such remedies with caution. In most cases, many of the plants can be formulated directly as based on chemical and biological information obtained from phytomedicines based on chemical and biological information obtained from the ICBG results. In this way, both the healers and the health care providers will have at their disposal in a relatively short time readily affordable medicines derived from local herbs.3 Negotiations are on going with two local pharmaceutical companies about distribution and compensation for such remedies. C. Trust Funds: Distributing Financial Benefits Over Time An independent Trust Fund is the proposed mechanism for distributing the 50% royalty destined for BDCP "solely for programs and projects designed to promote sustainable economic development relating to biodiversity conservation in Nigeria and Cameroon," as described in the CRADA. It is intended that, in order to achieve its objectives, this Trust Fund will be fed by other sources, as well. The proposed breakdown of funds accruing to the independent BDCP Trust Fund through the 50% ICBG royalty payment is as follows:

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