Fair Deals in the Search for New Natural Products

Written by Sarah A. Laird

People and Plants is a joint initiative of WWF, UNESCO (United Nations Educational. Scientific and Cultural Organization), and the Royal Botanic Gardens, Kew, UK. The views expressed in this paper are not necessarily those of WWF, UNESCO, or Kew. Any inaccuracies remain the responsibility of the author.

Author's address:
P O Box 4004
Westport
MA 02790 USA

or

Limbe Botanic Gardens
P O Box 437
Limbe South West Province
Cameroon

The following documents have been produced to accompany the present report and are available (in printed form and on diskette [basic text only] in WordPerfect 5.1) to WWF National Organizations, Affiliates, and Country Offices, upon request:

Research agreements for projects, institutions and communities in tropical countries
Commercial agreements for biodiversity prospecting
Sustainable sourcing of raw materials for natural products: weighing the benefits

Related publications available from WWF International:

Ethics, Ethnobiological Research, and Biodiversity. Report as part of the WWF/UNESCO/Kew ‘People and Plants’ Initiative, April 1993. Reprinted as Ethics, Biodiversity, and Natural Products Development, September 1996.

Fair Play, Fair Pay: laws to Preserve Traditional Knowledge and Biological Resources. Research Report, May 1995.

Beyond Intellectual Property Rights: Protection, Compensation, and Community Empowerment.

A joint WWF/International Development Research Centre (IDRC) report, endorsed by COICA (Indigenous Peoples’ Organization), IDRC, Ottawa (in press).

Patents, Genes and Butterflies. Are plants and indians becoming raw materials for the gene industry? Proceedings of WWF-Switzerland, WWF International and Swissaid International Symposium, Berne, 20-21 October 1994, Intermediate Technology, London.

Editing and layout by Tim Davis

ISBN 2-8X0X5-172-6

Originally published May 1995 by WWF-World Wide Fund For Nature, CH-1196, Gland, Switzerland.

Any reproduction in full or in part of this publication must mention the title, and credit the above-mentioned publisher as the copyright owner

Contents

Executive Summary

1. Biodiversity prospecting and conservation

2. What is biodiversity prospecting?

3. Local communities and biodiversity prospecting

4. Benefits resulting from biodiversity prospecting

5. Legal and policy tools for promoting conservation, development, and the equitable sharing of benefits

6. Biodiversity prospecting: Recommendations at WWF Field Project, Country Office, and International level

References

Executive Summary

Biodiversity prospecting is the exploration of biodiversity for genetic and biochemical resources of commercial value. Typically, samples of organisms are collected in countries which are rich in biodiversity, but financially poor, and dispatched for evaluation to laboratories in industrialized countries. Local knowledge may be used to guide this research, for example regarding traditional uses of plants as medicines.

Following the Convention on Biological Diversity (CBD), biodiversity prospecting should be carried out in ways which promote the capacities within source countries to conserve biodiversity, including through sustainable utilization or the development of relevant technical abilities. Biodiversity prospecting is an extractive use of natural resources, and as such has some unusual features: the quantities of material collected are generally very small (at least initially), and the chance of a new commercial product arising from any particular sample is very low, although benefits can be huge if this happens. Benefits to source countries can accrue not only when a new commercial product emerges - which is likely to be many years after collection of the initial sample - but also during the phases of initial collection, screening, and product development.

From the conservation perspective, the most significant categories of potential beneficiaries within source countries are local communities and national institutions concerned with the conservation of biodiversity and related development. Biodiversity prospecting should take place within a framework of agreements and regulations that are already in existence at the time when initial samples are collected.

This paper describes how WWF can help promote such agreements and regulations at project, national, and international levels.

Principal conclusions for the project level are:

1. WWF can play a valuable role to ensure that biodiversity prospecting results in benefits to conservation and development. WWF should not itself be a party to agreements concerning the collection of samples for biodiversity prospecting.
2. Agreements should be between the collectors of the samples (or their sponsoring organizations) and those who are the ‘gatekeepers’ to biodiversity (e.g. Local communities, government agencies). WWF should avoid being a party to agreements because of the potential criticism that WWF is exploiting biodiversity for its own benefit. Suitable roles for WWF are rather as advisor, facilitator, or monitor.
3. There should be agreements which specify benefits for conservation and development for all types of research -carried out on WWF field projects.
4. Agreements should be required even if the research seems to be of a totally uncommercial nature. The boundaries between academic and commercial research are by no means always clear-cut. The manner in which research is conducted within a conserved area creates a framework of control over resource use (by community, project, or government) which is often carried over into commercial agreements, if these develop.
5. Ethnobiological knowledge.

Special care must be taken over the collection of ethnobiological knowledge, for example, regarding the uses of plants medicinally. Once such knowledge is released into the public domain (as through publications and databases), communities lose forever any prospects of control over its commercialization.

Background information on the following subjects is available. upon request, from WWF International to WWF National Organizations and Country Offices:

• Research agreements (with examples)
• Commercial agreements (with examples)
• Sustainable sourcing of biological materials.

Attention is also drawn to the WWF International publication Ethics, Ethnobiological Research, and Biodiversity by Dr A B Cunningham (April 1993; reprinted as Ethics, Biodiversity, and Natural Products Development, September 1996), which describes the processes involved in biodiversity prospecting and gives guidelines for both national regulations and the behaviour expected of collectors and their sponsoring organizations.

1. Biodiversity prospecting and conservation

Once regarded as distinct entities, conservation and development are now seen as inextricably linked. Conservation programmes now often incorporate the ‘use values’ of biological resources into their plans, leaving to the marketplace the more rapid realization of many objectives such as ‘sustainable’ income-generation and increased value for intact ecosystems. Where once conservationists might have stressed existence values, or the ecological functions provided by intact ecosystems, attention is now more pragmatically leveled at the direct and option values held within biologically rich areas. The harvest of timber, fuel wood, medicinal plants, wild foods, or genes and biochemicals are seen as potentially valuable contributions to the conservation of an area rich in biological diversity. The object now is to ensure that these activities are carried out ‘sustainably’, and to assist in the development or increase of the direct value of a larger number of species or products.

Natural products have proven of special interest in the latter category. The scale of revenues generated from a single natural pharmaceutical product transform the economic arguments for conserving biodiversity. How many public information programmes run by conservation organizations speak of the undiscovered ‘wealth’ of species in tropical forests? Concurrently, advances in screening technologies have brought a resurgence of interest in the natural products research programmes of the pharmaceutical industry. With this increased interest have come collections of plant, insect, fungi, and bacteria in the biologically-rich tropical countries, and so a demonstration of their value. Expectations for the returns to conservation that biochemical and genetic resources can provide are probably raised above the realistic. However the process of collecting and researching as well as commercializing natural products can produce a number of important benefits in the short, medium, and long term. Biodiversity prospecting should not be seen as a panacea of any kind, and should always be considered as only one part of a package of economic activities contributing to conservation and development objectives. It is in this context that its benefits as well as costs should be measured.

2. What is biodiversity prospecting?

The term ‘biodiversity prospecting’ describes the collection, screening, and commercialization of natural products. Although it has been used to cover a wide range of commercial uses of biodiversity, it refers in fact to a fairly narrow area of activity, defined, in the 1993 publication Biodiversity Prospecting as "the exploration of biodiversity for commercially valuable genetic and biochemical resources" (Reid et al. 1993).

These genetic and biochemical resources might come from plants, insects, fungi, bacteria, or marine organisms, and are generally supplied for research purposes to the pharmaceutical and agricultural industries.¹ Advances in research techniques have allowed these industries to conduct large-scale natural products screening programmes, which over the past decade have increased demand for natural product samples, many collected from the biologically-rich tropical countries. The bulk of these samples are collected by sub-contracted collectors, most of whom are based in developed countries.²

The collection of biological samples for industry generally involves two or sometimes three direct relationships:

• That between the company and the contracted collector (usually described in a contract which is legally binding under the law of the country in which the company is situated)
• That between an outside collector and in-country collaborators³ (usually more informally defined, although increasingly detailed in agreements of some kind, and regulated by national legislation)
• That between an ethnobotanical collector and local communities that provide traditional knowledge on collected samples which will subsequently be supplied to commercial companies⁴ (rarely defined in any agreement or regulated by national legislation).

The transfer of samples from a collector to a company is the most direct path by which biological and cultural diversity travels to commercial interests, and generally the most direct path upon which benefits return. However, there are many other groups that are indirectly involved in and affected by this exchange that are not written into two-party arrangements, but are increasingly addressed in international and national law and policy:

• Communities that live in biodiversity-rich areas where samples are collected
• National governments which, as written into the CBD, now claim national sovereignty over their country’s genetic and biochemical resources
• The international community which, through documents and agreements such as the CBD, have expressed interest in the conservation and sustainable and equitable use of biodiversity.

3. Local communities and biodiversity prospecting

Local communities play a number of indirect and direct roles in biodiversity prospecting activities. For example:

• Biological samples might be collected from communally-held lands, the product of generations of stewardship
• Traditional knowledge might be recorded and published in academic publications or databases, which are subsequently consulted by industry researchers for leads on promising species⁵
• Intermediary collectors might conduct ethnobotanical studies for commercial companies or research institutions, such as the National Cancer Institute in the US, the products of which are destined for commercial development.

There are generally two main issues as stake in the relationship between local communities and biodiversity prospectors:

• The right of local communities to control over their land and the resources on those lands
• The right of local communities to control over and the receipt of benefits from the recording and use of their knowledge.

Of primary importance is local communities’ right to self-determination and the establishment of land and resource rights. Following on this, traditional knowledge must be recognized as an intellectual creation of communities and not the ‘heritage of mankind’. In addition, communities must be given control over the process by which their knowledge is recorded and used (including the choice of whether or not to participate), and the nature of benefits that will be returned to them. There are a number of international and national laws which might be used to do this, including human rights law, environmental law, intellectual property law, transnational business regulation, and national or local tort and property law, although in each case a fundamental choice must be made between public or private law, national or international law, and state responsibility or corporate/individual liability (Shelton 1993). In many cases, western systems of law may not be appropriate to a particular community, and may not best protect communal systems of knowledge (Brush 1994; Pinel and Evans 1994; Shelton 1993; Posey et al. 1994). A number of communities, such as the Kuna in Panama, and the Awa in Ecuador, have designed research agreements and codes of conduct for visiting researchers, or have entered into commercial agreements, which require respect of cultural norms, prior informed consent, and transfer of technology and expertise.

4. Benefits resulting from biodiversity prospecting

There are numerous benefits that can result from biodiversity prospecting, and can accrue to a variety of players within biodiversity-rich countries. For biodiversity prospecting to maximize its contributions to both conservation and development, however, a wide spectrum of individuals and groups must benefit, often in distinctly different ways, and this must occur in the short, medium and long term. Royalty payments into a global fund ten years down the road, no matter what the magnitude, will never have as great an impact as benefits scattered both spatially and temporally. It is in the wide and creative disbursal of benefits throughout the research and development (R&D), as well as the commercialization, phase that biodiversity prospecting will have the most lasting effect. One must look at the process by which samples are collected, chemicals extracted, and R&D conducted, in order for the many spin-off benefits for biodiversity science, medicinal plant research, conservation, and overall development to become fully apparent.

For example, we need look no further than medicine. The pharmaceutical industry is one of the major international players in biodiversity prospecting. This largely developed country based industry spends more than US$200 million to develop each pharmaceutical drug, devoting its energies to isolating compounds.⁶ Traditional and international herbal medicine, on the other hand, rely on a combination of compounds contained within a single plant, or a combination of plants, to treat disease. Plant-based pharmaceutical drugs were estimated to make up 25 per cent of all pharmaceuticals sold and to generate sales of US$15.5 billion in the United States in 1990 (Principe in Reid et al.1993). Traditional medicine, on the other hand, will not generate any hard currency revenues. Yet according to the World Health Organisation, traditional, largely plant-based, medical systems continue to provide primary health care to over 80 per cent of the world's population. For most biodiversity-rich countries, therefore, traditional medicine is central to national health care, particularly in light of the drain made on national economies from expenditures on imported pharmaceuticals.

On the surface, pharmaceutical drug development appears remote from traditional medicine, however the research conducted by the pharmaceutical industry into local plant medicines, and the technology and expertise that can be transferred to biodiversity-rich regions through biodiversity prospecting collaborations, can have immediate benefits for local primary health care based on traditional medicine. Many of the tropical country research institutions that collaborate on biodiversity prospecting research also conduct programmes to record, scientifically study, and distribute medicines based upon traditional uses of medicinal plants. These programmes shore up and build upon local knowledge of medicinal plants and existing medical systems in order to develop more effective and affordable health care systems within the context of local health, economic, and social conditions. Most of these tropical country research institutions are desperately in need of the type of assistance biodiversity prospecting collaborations can provide, including funds, and the transfer of technology and expertise, and many do not have access to the type of screening and research techniques available in research and commercial laboratories in developed countries.

Agricultural resea.ch institutions and botanic gardens might benefit from biodiversity prospecting through collaborations on the development of sustainable supplies of raw materials for commercial products. The US National Cancer institute, for example, has recently invested in the research and development of a sustainable supply of Ancistrocladus korupensis in Cameroon (a rainforest climber which has yielded a chemical lead for the possible treatment of HIV infection). Ideally, the funds and expertise supplied for this research will help build expertise and capacity within in-country institutions, and will assist in the development of sourcing strategies for other plants of commercial importance.

Biodiversity prospecting can build important collaborations between tropical country researchers and communities and researchers in developed countries. Tropical country researchers and communities must always structure their relationships with commercial partners with care, but the focus of these relationships should not be solely on monetary gains, since many of the spin-off benefits achieved through the research process might prove more significant. It is important for research and conservation organizations to approach biodiversity prospecting with an eye towards the gains that might be achieved from the process of biodiversity prospecting, and not merely from a commercial product that may, or may not, appear at the end of a lengthy R&D phase.

5. Legal and policy tools for promoting conservation, development, and the equitable sharing of benefits

Research agreements

The technologies, expertise, and changes in thinking resulting from biodiversity prospecting will likely far outweigh in importance the commercial revenues. What this means is that a great deal more attention must be paid to the R&D phase of biodiversity prospecting relative to the commercial phase. Although the appropriate commercial relationships must be in place, a research relationship reflecting the best possible terms for local communities and tropical countries must be established long before commercialization.

Tropical country research institutes and conservation projects have long collaborated with outside scientists, and have relied heavily on their expertise to develop their research and knowledge base, and management plans for conserved areas. Tropical countries will continue to depend upon outside expertise, but increasingly this will be done on terms set by tropical country institutions. In order to set these terms, research agreements must be put in place which clearly outline the responsibilities and expectations of each party. The point is not to burden researchers with unnecessary bureaucracy, or to tax research programmes to the point that they cannot function. Rather, it is to create a framework in which all research - whether academic or commercial - contributes in some way to conservation and development activities in the areas in which it takes place, and to transfer the power to determine the nature of these contributions from researchers to local communities, projects, research institutes or, in some cases, governments. These two elements form the basis of research agreements: control by local projects and communities over the nature of research projects, and the use of resulting information, whether commercial or academic (including the choice not to commercialize); and the contribution of research programmes to the management costs or needs of conserved areas, and the equitable return of benefits to local projects and communities from any commercial activity.

It is important for conservation and development projects to tackle the implementation of research agreements as a precursor to any biodiversity prospecting-related programme. The manner in which research is conducted within a conserved area creates a framework of community, project, or government control over resource use which is often carried over into commercial resource use. If communities or other interested parties are not consulted and do not have control over the manner in which academic research is conducted, then they are unlikely to have any say in the extension of this research into commercial areas, or any control over the indirect commercialization that often occurs through academic publications, databases, and other forms of distribution common to ‘pure’ research.

Commercial Agreements

Commercial collections are distinct from research collections, although the division between the two can sometimes blur, and research agreements can form the basis of a relationship which subsequently develops into a commercial relationship under renegotiated terms. Commercial agreements reflect a previously agreed upon relationship, generally between collectors and companies. Biodiversity prospecting contracts are typically structured around the supply of services relating to biological samples. Collectors might agree to collect, taxonomically identify, process, resupply, and in some cases conduct further research in the laboratory on a supply of samples, which are then shipped to soliciting companies for screening. Companies, in turn, might provide collectors with per-sample fees, advance payments, their best efforts to screen samples, reports on the results of their research, training for collaborating scientists, and royalties on any compounds commercialized from the collected samples. Commercial agreements will include provisions not generally part of research agreements, for example advance payments, intellectual property rights, exclusivity, royalties, and future supplies of raw materials.

National policy and legislation

National policy and legislation forms the framework in which research and commercial agreements function. Contract law defines the scope of agreements, how they are formed, and how they are enforced, and creates the background for biodiversity prospecting agreements. However, biodiversity prospecting may be subject to numerous national policies and laws, including intellectual property law, environmental, and natural resource laws (Gollin et al. 1994).

Following on the Convention on Biological Diversity, signatory nations will design national legislation to promote the goals of conservation, sustainable development, and the equitable sharing of the benefits from biodiversity prospecting. As an international treaty, the Convention nationalizes all genetic and biochemical resources, and national legislation will determine the extent to which control over these resources is shared with regional or local governments and local communities, and will include terms for access, and determine rights to commercialization. These laws will generally require collectors to obtain prior informed consent through some type of permit process, and will require payment or other consideration to the government or local population as a condition of obtaining a collection permit. Although each country will likely emphasize different policies in its laws, each will prove critical to the creation of incentives and disincentives for research and commercialization of biological and genetic resources, and the return of benefits to local communities and other stewards of biodiversity.⁷

International policy and legislation

There are a number of international legal standards which will affect biodiversity prospecting activities in the future. Most relevant is the Convention on Biological Diversity, which provides a blueprint for commercialization of biodiversity based on the objectives of conservation of biodiversity, sustainable development, and the fair and equitable sharing of benefits, resources, and technologies. The Convention reflects the principle of reciprocity between access to genetic resources and the transfer of relevant technology, recognizing national sovereignty over these resources. The Convention calls on countries to develop plans, programmes, and policies for conservation and sustainable use (Article 6), to conduct inventory and monitoring of biodiversity (Article 7), and to promote in situ and ex situ conservation (Articles 8 and 9). Countries are directed to analyze and minimize the impact of development on biodiversity (Articles 10 and 14), and to conduct research, training, and education in relevant areas (Articles 12 and 13). Article 15 directs countries to facilitate access, not to "shut the greenhouse door", although access shall be on mutually agreed terms and subject to the prior informed consent of the contracting party (Gollin et al. 1994). Other international legal standards that will influence biodiversity prospecting activities include Agenda 21, the Framework Convention on Climate Change, GATT (now WTO, the World Trade Organization), GATT-TRIPS, and intellectual property treaties such as the Paris Convention and Patent Cooperation treaty on patents, the Berne Convention on copyright, the Madrid Convention on trademarks, and WIPO. In addition, international human rights law, in conjunction with other international law, can provide a framework for the protection of the cultural and intellectual creations of indigenous peoples.

6. Biodiversity prospecting: Recommendations at WWF Field Project, Country Office, and International level

Field project level

1. Design and implement research agreements for field projects

Because field projects operate at the point of collection, it is of primary importance that field managers are well-informed of the implications of research and commercial activities in the areas they manage. Building on this understanding, each field manager should develop research agreements that clearly define the needs and expectations of the project and each visiting researcher. The CBD calls for the development of national conservation strategies, establishing systems of protected areas, and the inventory and monitoring of biodiversity. Over the coming years there will presumably be an increase in research of importance for the management of biodiversity-rich areas. It is important, however, that the most is made of these and other research activities in both the short and long term. All research, whether academic or commercial, should contribute in some way to conservation and development activities in the areas in which it takes place. Subsequently, the power to determine the nature of these benefits should be transferred from the researchers to local communities, ecosystem managers, research institutes or, in some cases, governments. With both research and commercial agreements, it is important that an understanding is reached prior to the initiation of a workplan, since it is very difficult to adequately address many potential complications after they have arisen.

Field managers should be particularly careful about ethnobotanical collections undertaken in collaboration with WWF. Although ethnobotanical information can be extremely useful for protected area management and a wide range of conservation and development activities, field staff must carefully control the collection, dissemination, and use of this knowledge should local communities not undertake these responsibilities themselves. Once released into the public domain, such as through publications and databases, communities lose forever what control they might once have had over its use and commercialization. Although western law, science, and commercial traditions might be foreign to some communities living in these areas, a programme introducing the dynamic of a potentially commercial relationship to communities must also attempt to introduce systems to control and monitor this dynamic.

2. Assist in the development of community institutions

The Convention on Biological Diversity nationalizes biological and genetic resources, and refers only generally to the participation and benefit sharing of local communities. In order to maximize the positive impact of biodiversity prospecting activities on conservation and development, however, communities living in and around biodiversity-rich areas must provide informed consent and share significantly in the benefits resulting from any commercialization of biological resources. The manner in which this occurs will vary by case, and will depend upon local cultural, social, political, and economic conditions.

A number of questions arise when considering the practical manner in which benefits will be distributed (‘in what form’? and ‘to whom?’ are two of the most often cited), but some communities and groups have begun to answer these questions, and there is much to learn from analyzing their efforts (e.g. the Kuna in Panama, the Awa in Ecuador, the Aguaruna in Peru, and the cases resulting from the NSF-NIH-AID international Cooperative Biodiversity Groups in Africa and Latin America).

WWF field programme staff can provide communities with information on the efforts of WWF and other international groups. In cases where it is needed, WWF staff might also act as a catalyst for discussions on the development of creative mechanisms and institutions for the assertion of control over and return of benefits from research and commercial activities, such as community associations, trust funds, and escrow accounts; staff might also provide training and assistance in drafting model codes and agreements, linking communities with scientific, business, and legal expertise, and facilitating and monitoring resulting research and commercial relationships. Each case will vary and it is certain that there is no blueprint for the sharing of benefits with communities. However, specific community initiatives and field projects will play an important role in fine-tuning and defining the parameters of this debate, and WWF staff might be well-positioned to assist in this process.

3. Assist local communities and national research institutions in the development of sustainable sourcing strategies for species of commercial interest

The resupply of samples for research purposes and, subsequently, industrial scale collection or cultivation of plants of the manufacture of commercial products might form one part of a package of economic activities undertaken by groups living in or around biologically-rich areas. The sustainable supply of materials in this form has featured prominently in discussions of the benefits that biodiversity prospecting might produce. It is worthwhile for project managers to critically examine this assumption in light of local conditions. However, should local communities and research institutions choose to proceed, WWF might serve as a useful collaborator, supplying incountry scientists with advice, access to outside experts, and playing a monitoring role in the future production of the product, ensuring environmental and social standards. It is unwise for WWF projects to actively produce and sell raw materials for pharmaceutical or agrochemical companies, but their role as advisor, facilitator, and monitor for local communities and researchers could prove invaluable.

4. Develop collaborations between field projects and national research institutions

Biodiversity prospecting activities are by nature multi-disciplinary, combining a variety of research disciplines, as well as legal and commercial interests, not commonly united on a given project. Unfortunately, research institutes do not generally form multi-disciplinary collaborations; in tropical countries this could prove a major obstacle to the development of in-country biodiversity prospecting capacity. Field projects with specific needs for sciences related to biodiversity prospecting, such as botany, ethnobotany, natural products chemistry, pharmacology, horticulture, and agronomy, can serve an important role in bringing together national researchers in collaboration on projects. Each individual field project will be ill-equipped to develop its own herbarium, natural products laboratory , and team of botanists and horticulturalists, and this would be a waste of limited resources. Projects should make every effort to use in-country expertise and in-country research institutions, building on existing structures, rather than starting from scratch to develop biodiversity prospecting related capability within each project.

5. Assist local communities and research institutes in adding value to biodiversity prospecting samples

Ideally, all biodiversity prospecting samples would be processed to some degree in-country. In order to achieve this most effectively, field projects should work with in-country research institutions to either establish small-scale processing facilities on-site (which might also be used for other programme activities), or in shipping samples to research institutes for processing and further study. ‘Value-added’ samples also include the contributions of traditional knowledge and initial scientific studies conducted by in-country researchers (although this is highly dependent upon the country in question, as there is an enormous range between countries of expertise in natural products chemistry and pharmacology).

Country office level

6. Build capacity within the organization.

Country offices should build expertise within their staff relating to the commercialization of biological resources, including biodiversity prospecting. All field staff should be well-briefed on the implications of collections of both biological materials and traditional knowledge, and information should be provided for discussion among their colleagues in the field.

A working group on issues surrounding commercialization should be established within the country office, so that specific issues might be addressed as they arise, and so that staff will remain abreast of this quickly moving field. This group should formulate a country office policy relating to biodiversity prospecting-related issues, which can be distributed to all country staff and collaborating governmental and non-governmental institutions. Since country offices vary significantly in size and resources, they will not all be able to achieve the same objectives. However, at the very least, a few staff members should be designated contacts for biodiversity prospecting-related information.

7. Educate the scientific community and government officials

Many researchers and government officials that are directly or indirectly involved in biodiversity prospecting activities do not have access to even basic information on the issues raised by this work, the manner in which other groups and governments in the tropics have become involved in biodiversity prospecting, and the real weight of the many costs and benefits involved. WWF country offices could hold informal workshops with various groups involved in biodiversity prospecting. These should include natural products researchers, government officials, local plant medicine companies, national herbaria and botanic garden staff, and conservation and development programme staff.

In addition to providing individuals with a general background on the issues involved, WWF could supply groups, as needed, with sample research agreements, commercial contracts, national legislation, information on ethnobotanical collections and the sustainable sourcing of medicinal plants, and case studies from other regions of the world. WWF International might supply country offices with the materials necessary for this, including the reports on ‘Research agreements for projects, institutions and communities in tropical countries’, ‘Commercial agreements for biodiversity prospecting’, ‘Sustainable sourcing of raw materials for natural products: weighing the benefits’, and other related publications such as those listed inside the front cover of this report.

8. Hold training workshops for selected members of staff, local communities, and researchers in the development and negotiation of commercial relationships

In many cases, the lack of business and legal, rather than scientific, skills limits a country's ability to more actively engage in biodiversity prospecting activities. While attention has been paid to the need for a transfer of technology and expertise necessary for tropical countries to better utilize their biodiversity, little has been directed at the importance of developing business and legal skills. Knowledge of industry, the resource market, and legal precedents in these industries, which will often guide negotiations in the newly established area of biodiversity prospecting, are critical to the development of ‘equitable’ relationships. WWF might hold training workshops specifically on business and legal aspects of biodiversity prospecting for local lawyers, government officials, community representatives, and researchers. Should specific cases arise, WWF, as part of its facilitator role, might link in-country parties and lawyers with pro bono lawyers from outside the country (e.g. INBio relies on lawyers from the United States) who can complement their expertise.

9. Advise the government on the drafting of national legislation and policy

Although a variety of national laws and policies will influence the manner in which biodiversity prospecting is conducted in a country, of most immediate importance in biodiversity-rich countries is the drafting of legislation to implement the objectives of the CBD: conservation of biodiversity, sustainable development, and the equitable sharing of benefits. Most developing country governments are not in a position to draft such legislation, whether from a chronic lack of information, confusion within ministries as to responsibility for this work, or the greater immediate importance of other social, political, or economic concerns. In conjunction with other nongovernmental and governmental bodies, WWF country offices could assist governments, as needed, in collecting relevant information, meeting to discuss key issues, and drafting and reviewing legislation.

As governments become more involved in biodiversity prospecting, they are likely to create or delegate responsibility to, for example, a ‘national biodiversity board’. Such a board might develop and implement a system to monitor and regulate biodiversity prospecting activities nationwide. Whether these duties are delegated or remain in existing government ministries, a great deal of advice and outside assistance will be needed by the government, some of which WWF could provide.

10. In conjunction with governments, provide a facilitating, advisory, and monitoring service for biodiversity prospecting activities

Biodiversity prospecting is an extremely sensitive area, and one which raises numerous concerns regarding national sovereignty and commercial interests. WWF country offices and field projects are not well-suited and are therefore advised not to engage directly in biodiversity prospecting activities. Rather than trying to assemble the natural products, agronomic, business, and legal expertise necessary to properly engage in biodiversity prospecting, WWF is better suited to a position as advisor, facilitator, and monitor of these relationships.

National research institutions, universities, herbaria and botanic gardens are the natural beneficiaries of many of the benefits resulting from biodiversity prospecting. Rather than supplanting the potential contributions of these largely under-funded and 'under-networked' institutions, WWF should support and strengthen them through an advisory and facilitation role; a role which few organizations have assumed, even though there is a demand for it within tropical country institutions. There are numerous researchers and research institutions within tropical countries capable of actively participating in biodiversity prospecting relationships. Often, it is the lack of access to potential collaborators, and the type of infrastructure-building assistance that biodiversity prospecting relationships can provide, rather than a lack of expertise, that limits their involvement. Linking tropical country research institutions with outside collaborators, advising these institutions on these relationships, and monitoring the future activities of these collaborators to ensure that maximum benefits accrue to conservation, research, and local communities, is a role that well suits WWF' s organizational mission.

In many countries governments will monitor biodiversity prospecting relationships. In these cases, WWF should work closely with government officials in the design and implementation of monitoring programmes, to which the international WWF community could contribute a check on the activities of collectors and companies based outside the region.

International level

11. The type of activities described above, at. both the field and country office levels, will require a great deal of support from staff at WWF International. ‘Biodiversity prospecting’ is constantly growing and evolving to include a wide range and- variety of issues relevant to field and country office staff, and at such a rapid rate that in-country staff may have difficulty following developments without outside assistance. Furthermore, the bulk of research and commercial parties actively involved in biodiversity prospecting, and the NGO and governmental community analyzing and meeting to discuss these issues, are based in developed countries. In order to facilitate and monitor biodiversity prospecting relationships effectively, WWF in-country staff will require the multi-disciplinary (scientific, legal, business, and human rights) expertise of a WWF International staff actively involved in a rapidly evolving dialogue. It is too much to expect each country office to acquire or track down the necessary background and expertise each time a crisis arises, or a group asks for advice. Far better for there to exist, somewhere within the WWF ‘family’, a group that could more systematically educate, train, and develop policy relating to biodiversity prospecting, as well as address the specific queries and concerns of field and country staff as they arise. This might initially take the form of an advisory group, but would ideally develop into a working, multi-disciplinary team. There is a great need for such a group to serve both WWF and the conservation-development community at large.

Footnotes

1. The main industries involved in biodiversity prospecting are the pharmaceutical, which generally searches for new chemical leads, and the agricultural, which generally seeks out new genes for breeding programmes or genetic engineering. There is a great deal of overlap in the area of agrochemicals, and a number of companies are involved in both pharmaceutical and agrochemical research and development (R&D). Some areas of biotechnology distinct from these industries, such as oil-spill clean-up, mining, wastewater treatment, and bioremediation, will prove important outlets for natural products in the future (Reid et al. 1993).
2. In large companies, such as Merck and SmithKline Beecham, natural products researchers will form a distinct research group within a much-larger R&D programme. In some smaller companies, such as Shaman Pharmaceuticals and Phytopharmaceuticals, the entire R&D strategy of the company is natural products based. It is important to note this distinction because natural products research programmes within large companies must justify their work in relation to the success of other research programmes - there exists no built-in commitment to natural products within the company. Companies are increasingly involved in natural products research because they see it as a promising and cost-effective area of R&D, although it must continue to prove itself as such.
3. Most companies will not have in-house natural product collecting programmes and will subcontract with reputable, or sometimes not so reputable, collectors. Collectors are generally one of the following:
4. · individuals who collect samples for spot payments

   · universities with plant collection programmes

   · botanical gardens that supplement field research budgets with funds from industry collections;

   · private for-profit ‘brokers’

   · developing country private and public research institutes.

5. The parties to the vast majority of existing contractual agreements for biological samples are developed country companies and collectors. Developed country collectors tend to have long-lived relationships with incountry collaborating collectors, most of whom are affiliated with scientific, usually botanical, institutions. In some cases, however, in-country collaborators are private individuals or businesses.
6. Communities can be written into agreements between collectors and companies as collaborators, or collectors can sign side agreements (as described in Appendix C of Biodiversity Prospecting, Reid et al 1993) with communities that outline the nature of the company-collector relationship, the communities’ role in the collection process, and the benefits that will accrue should a product be developed from their knowledge. Even where formal legal agreements will not be appropriate, communities should be consulted and collectors should clearly specify beneficiaries in written institutional policy before any ethnobotanical information is collected, published, or supplied to databases or companies.
7. For example, research into Catharanthus roseus did not grow out of ethnobotanical surveys conducted by Eli Lilly staff in Madagascar, from where the plant originates, nor even in the Philippines, where its recorded use first interested researchers. Catharanthus roseus was first investigated because researchers in laboratories in North America, conducting a literature search for plants from the Australasian area with "folkloric usage of believable quality and the reported presence of certain types of plant ingredients" read of its traditional use in the Philippines as an insulin substitute (Svoboda 1992).
8. di Masi et al. (1991) estimate that it costs US $ 231 million on an average to develop a marketable pharmaceutical drug, if research failures are factored in.
9. In some areas, a regional approach to the drafting of national legislation following on the Convention of Biological Diversely might make the process easier and the final laws more effective. The Andean Pact prepared a regional model law in April 1994 titled Access to Genetic Resources of the Andean Pact. This document provides for ‘access agreements’ which would cover both in situ and ex situ generic resources, and would have a ‘public interest review’ that would require the responsible agency to consider the national interest and views of potentially affected parties. Member states may subject access to conditions such as benefit sharing, restrictions on transfer to third parties, reporting obligations, obligations related to intellectual property, exclusively, and confidentiality, recognition of the resource in publications, and conservation measures. The parties are directed to adopt common guidelines for access agreements and access determinations, including notification of intent, participation of affected parties, applications, granting of access, and enforcement measures, penalties, and remedies. Various provisions ensure consideration of indigenous peoples’ rights. Members are directed to strengthen capacity for conservation and sustainable use of biodiversity, and for inventory and management. The proposal calls for a regional fund to be fed by a share of royalties, and to be disbursed by members as they agree. The Andean Pact sets forth a regional approach to implementing model national legislation, which makes the process of drafting laws easier, and the likelihood of competition between neighbours smaller (Gollin et al. 1994).

References

Brush S B, "A Non-Market Approach to Providing Biological Resources" in Greaves T (ed), Intellectual Property Rights for Indigenous Peoples, Society for Applied Anthropology, Oklahoma City, OK, 1994.

di Masi J, Hansen R, Grabowski H and Lasagna L, The Cost of Innovation in the Pharmaceutical Industry, Journal of Health Economics 10:107-142, 1991.

Gollin M A, Laird S A, Bouillet-Cordonnier and Randrianwsolo O, "From Global Policy to Local Action via National Legislation for Biodiversity Prospecting", Paper prepared for the WWF Promotion of Ethnobotany and Sustainable Use of Plant Resources Project, WWF, 1994.

Pinel S L and Evans M J, "Tribal Sovereignty and the Control of Knowledge" in Greaves T (ed), Intellectual Property Rights for Indigenous Peoples, Society for Applied Anthropology, Oklahoma City, OK, 1994.

Posey D A, "International Agreements and Intellectual Property Right Protection for Indigenous Peoples "in Greaves T (ed), Intellectual Property Rights for Indigenous Peoples, Society for Applied Anthropology, Oklahoma City, OK, 1994.

Principe P, Monetizing the pharmacological benefits of plants, unpublished manuscript.

Reid W V, Laird S A, Meyer C A, Gamez R, Sittenfield A, Janzen D H, Gollin M A and Juma C, Biodiversity Prospecting: Using Genetic Resources for Sustainable Development, World Resources Institute, Washington DC, 1993.

Shelton D, Legal Approaches to Obtaining Compensation for the Access to and Use of Traditional Knowledge of Indigenous Peoples, Paper prepared for WWF International, Gland, Switzerland, 1993.

Svoboda G, "The Discovery of the Catharanthus roseus Alkaloids and their Role in Cancer Chemotherapy", Paper presented at the Rainforest Alliance Symposium, Tropical Forest Medical Resources and the Conservation, of Biodiversity, New York, 1992.