The international flow of genetic material and its potential use as a source of income for developing countries has attracted a great deal of interest. Although it is unlikely that bioprospecting will generate nationally significant levels of revenue, or create a powerful incentive for conservation, a strategic approach by developing countries might enable them to derive a number of benefits from biodiversity prospecting. In a recent report funded by the Overseas Development Administration, some concrete policy recommendations are formulated.

The future of the search in the wild for genetic and biochemical resources of value (biodiversity prospecting) is unpredictable, influenced by the scientific and technological developments that affect the economics of product development, by the changing politics of access to biodiversity, and by the extent to which governments, business and civil society co-operate to develop suitable policies and individual agreements.
The wording of Articles 15, 16 and 19 of the Convention on Biological Diversity, which deal with access to biodiversity, the sharing of benefits and technology transfer leaves national governments with considerable discretion as to the extent and manner in which they regulate access to biodiversity and involvement in product development and marketing. The Convention offers little guidance as to the nature and mixture of appropriate benefits, what constitutes a fair and equitable share, and indeed who should be beneficiaries. A number of stakeholders, namely providers, collectors and users, are involved in the discovery and development of products from biodiversity. For bioprospecting to promote sustainable development, all three groups need to be aware of the role they can play in a bioprospecting strategy and in individual agreements.

Providers
Providers are generally departments of federal, state and local governments, managers of protected areas, local and indigenous communities and private landowners. For certain countries, bioprospecting may be one of several sustainable uses of biodiversity that would be appropriate as part of a national biodiversity strategy (see box 1). Governments should ensure that biodiversity policies are well integrated with other relevant areas of policy, such as tenure of land and genetic resources, science and technology, education, health, trade and industry.
In order to assess the country’s potential as a source of biodiversity and services in prospecting, governments should work with provider institutions, whether private or public, to raise awareness about the range of possible markets and the kinds of products and services needed in each sector, to find out about the safety, efficacy and quality regulations for marketing the products, and, most importantly, the quality standards demanded by consumers in each proposed market.
Global annual sales of pharmaceuticals are approximately US$ 200 billion, while an estimated US$ 40 billion is the result of bioprospecting. The pharmaceutical market is likely to be the largest global market for bioprospecting.
The market for seeds is much smaller, as is the contribution made to it by wild biodiversity. In a survey of the source of germplasm for various crop groups for 20 plant breeding and seed companies by the Cambridge University and the World Conservation Monitoring Centre, the companies surveyed obtained 81.5 per cent of all their germplasm from commercial cultivars, the rest originating from wild species maintained in situ and ex situ, in situ landraces, and landraces maintained in genebanks. Figures such as those related to the seed industry suggest that companies’ interest in investing in bioprospecting is limited, but where they are interested, they look for specific features. According to the (then) Business Council for Sustainable Development, companies look for "macroeconomic and political stability, reliable legal and property systems, an educated work force, and an adequate physical infrastructure (roads, power, communications, and so on)". As much as ecological considerations, these factors influence companies’ choice of countries in which to prospect.

Biodiversity strategy Elements for the sustainable use of biodiversity.  Assessment of the opportunities, needs, resources and capacities of the country for the sustainable use of its genetic resources, including bioprospecting; National policies and legislation to require, as a condition for access, a fair share of any benefits arising from the use of genetic resources and knowledge concerning them to be returned to those providing them, and some benefits to be dedicated to conservation; Legislation, policies and incentives to increase national capacities to add value to genetic resources, thus generating greater income and other social and development benefits from environmentally sustainable activities, and encouraging the protection of biodiversity; Identification of institutional links and channels through which the benefits sought by the country could be shared with stakeholders, and mechanisms for negotiating fair and mutually satisfactory bioprospecting partnerships with in-country partners, and foreign companies or other provider or user countries; Creating mechanisms for stakeholders to participate in national strategies for the conservation and sustainable use of biodiversity, in the development of international law and policy to support national interests, and in individual bioprospecting agreements; Identifying sources of funding to initiate sustainable bioprospecting activities and other uses of genetic resources. Source: Ten Kate (1995).

Complex regulations
Collectors and users often complain of the complexity of the regulations and procedures governing access to genetic resources. Within a single country it may be necessary to seek permits from more than half a dozen different government departments at federal, state and local levels.  The rules are frequently unclear, inconsistent, and change constantly. Applying for access even 18 months in advance is sometimes not enough, and permission can be granted only for collectors to find on arrival that the rules have changed. This causes confusion, delay, expense and uncertainty for the collector, and, other than cost-effectiveness of sourcing policies, is perhaps the biggest factor limiting the enthusiasm of potential users for bioprospecting.
Governments can address this problem by designating a national focal point for planning and administration of biodiversity issues, to co-ordinate this spectrum of activities, to streamline access applications and to facilitate partnership with foreign and national stakeholders.

Local and foreign partnerships
Very few developing countries have the technology and financial resources to conduct product discovery and manufacture on its own. It can take 10 years and some US$ 300 million to bring a new pharmaceutical onto the market and a similar amount of time to develop resistance to a particular pest or disease in a crop. Partnership with foreign companies can help developing countries to build their capacity to move from supplying raw biological materials to more added-value products. Additionally, while pharmaceutical companies have little commercial incentive to research cures for diseases peculiar to developing countries, bioprospecting partnerships can involve research in these areas as part of the benefit-sharing deal. In the Costa Rican International Cooperative Biodiversity Groups (ICBG) project, INBio scientists will carry out anti-bacterial and anti-fungal screening, and staff at the University of Costa Rica will carry out anti-malarial and anti-inflammatory screening. Partnership with Bristol-Myers Squibb (UK) will enable any interesting leads to be developed into products. Bristol-Myers Squibb will look for anti-infective and dermatological medicinal compounds, and will also screen for compounds with anti-cancer, cardiovascular, and central nervous system applications. Similarly, as part of its benefit-sharing package with West African collaborators, Shaman Pharmaceuticals (USA) has provided laboratory materials and scholarships to a Nigerian research laboratory that is working on plant treatments for malaria and other diseases prevalent in the tropics of West Africa.
Not all bioprospecting need involve investment from the North. One of its most practical applications may be at the local level. The World Health Organization estimates that 80 per cent of people in developing countries rely on traditional medicine for their primary health care, and about 85 per cent of these medicines involve the use of plant extracts. Working with local herbalists, scientists from the University of Ceara in North-East Brazil have formulated a number of remedies, and, in a basic laboratory constructed by the community, produced approximately 50,000 flasks of syrup for coughs and asthma, over 20,000 lollipops for throat ailments, and over 1000 bags of various herbs to treat specific complaints. Fifty street children have been recruited as ‘health agents’ to sell the products in the local community and disseminate the therapeutic importance of each plant.

Prior informed consent
While the prior informed consent of contracting parties at the national level is a requirement for access, a close reading of the Convention suggests that, at the local level, prior informed consent and benefit sharing are encouraged but not required. Bioprospecting will only generate lasting environmental, economic or social benefits if such benefits are felt by those closest to the biodiversity sources themselves, motivating them to conserve these and enabling them to develop them sustainably. Sharing benefits at the local level and dedicating some benefits to specific conservation measures are thus the key to successful long-lasting bioprospecting partnerships.
Governments should invite and facilitate participation by business, NGOs, and local communities in the formulation of the national biodiversity strategy and in specific bioprospecting projects. INBio, for example, has been involved in the development of Costa Rican policy and legislation related to bioprospecting, and shares benefits by working with the local university and employing over 70 local people, including 46 lay Costa Ricans as ‘parataxonomists’ to collect and prepare specimens for its inventory. Another 28 staff, of whom 12 are professionals and technicians, work in the prospecting department, and four laboratory technicians and six ecochemists on the ICBG collaboration. However, there has been considerable controversy over the lack of involvement of indigenous peoples in Costa Rican prospecting activities.
Local and indigenous communities and NGOs should lobby government for national law, policy and procedures such as those in the Philippines, which require prior informed consent and the sharing of benefits at the local level (see box 2). Such communities can make certain requirements of collectors seeking to work in their area themselves. The Awa in Ecuador and the Kuna in Panama have designed research agreements and codes of conduct for visiting researchers, setting out their research priorities and preferences for benefit-sharing. They have also entered into commercial agreements which contain clauses requiring prior informed consent, technology transfer, and respect of cultural traditions (see box 3).

A Philippine regulatory framework On 18 May 1995, the Philippines adopted a Presidential Executive Order which regulates bioprospecting. It requires prospectors to negotiate a research agreement with the government, and to seek prior informed consent and to share benefits with national stakeholders such as local communities and indigenous peoples. Implementing regulations to put the Order into practice are currently being drafted in the Philippines. The Order includes, among others, the following requirements:  Consent of indigenous cultural communities: Prospecting of biological and genetic resources shall be allowed within the ancestral lands and domains of indigenous cultural communities only with the prior informed consent of such communities, obtained in accordance with the customary laws of the concerned community.  Minimum terms of a commercial research agreement and academic research agreements include:  A limit on the samples that may be collected and exported; A complete set of all specimens to be deposited with the Philippine National Museum; Access to collected specimens and relevant data deposited abroad shall be allowed to all Filipino citizens;  The Collector or Principal must inform the Philippine government and affected local and indigenous communities if a commercial product is derived from its activities; Provision for the payment of negotiated royalties or other forms of compensation to the National Government, local or indigenous cultural community and individual person or designated beneficiary where there is commercial use; The involvement of Filipino scientists in the research and collection process at the cost of the Collector; Transfer of equipment to a Philippine institute where appropriate; A fixed fee must be paid to the Department of Environment and Natural Resources; In the case of endemic species, the technology must be made available to a designated Philippine institution for use locally and commercially without paying a royalty to the Collector or Principal (although other agreements can be negotiated). Sources: Barber and La Viña (1995); Philippines Presidential Executive Order no. 247 (1995).

Collectors and users
Collectors are generally from botanical gardens, university departments, research institutes, private contractors or local and indigenous communities. They should comply with host countries’ laws and procedures governing access to biodiversity and apply for relevant permits. Since many countries have not yet elaborated policies that will promote a fair and equitable sharing of benefits, collectors should in any event abide by a voluntary code of conduct.
The users are the pharmaceutical, seed, agrochemical and biotechnology companies that will develop or market the products resulting from bioprospecting. They often use the services of collectors to get access to samples. Companies can promote bioprospecting that supports sustainable development by publishing a policy statement setting out the company’s practice, and ensuring that the elements of this are integrated into all material transfer and bioprospecting agreements. As part of such a policy they should accept genetic resources and information only from suppliers with permission to collect and supply samples. Additionally, they should ensure that suppliers’ activities are in accordance with the relevant legislation and policy. If the immediate suppliers have themselves entered into supply agreements that entail benefit-sharing with those along the supply chain, companies should endeavour to ensure that benefits are shared ultimately with those that own and protect the resources.
Companies can include in their agreements with suppliers of genetic resources terms that provide for best practice in the fair and equitable sharing of the benefits, including financial consideration in the form of payment for samples, research budgets and royalties, technology transfer, capacity building, and sharing of the results of research.
Through collaborative research and development agreements and joint ventures with the suppliers of genetic resources, business can help its suppliers to build their capacity to add value to raw genetic resources, improve quality control, and share with them the fruits of their own biotechnology and research and development. Where possible, companies should purchase products further up the value chain than raw materials, for example extracted, or processed materials, and should pay for value added through the supply of information related to observations of the behaviour and activity of the biological materials or the results of research and development upon them. This will often be easier for a company when it is in a long-term relationship with a supplier, confident of the quality of the supplier’s service, and with an incentive to invest technology and training in the supplier.

Conditions for bioprospecting The Kuna of Panama In 1988 the Proyecto de Estudio para el Manejo de Areas Silvestres de Kuna Yala (PEMASKY) and the Asociación de Empleados Kunas (AEK) of Panama produced a manual to regulate scientific research in their area.  The manual requires researchers to:  Develop a proposal outlining the timing, extent and potential environmental and cultural impact of a research programme,     for approval by the Scientific Committee of PEMASKY; Secure approval for the collection of species from the Scientific Committee of PEMASKY. Collections may not include     any endangered species, may not be used for commercial purposes and must be done in a non-destructive manner; Undergo an orientation into the culture of the Kuna Yala, and respect the norms of the communities in which they work; Include Kuna collaborators, assistants, guides and informants in their research programme and provide them with training     in relevant scientific techniques; Leave samples of all specimens (for the collections at the University of Panama) and copies of photographs or slides taken     during the research programme with PEMASKY; Provide written reports of the research, and two copies of any publications, in Spanish and descriptions of all species new     to science to PEMASKY; Not to introduce exotic plant or animal species or to manipulate genes. Additionally, research is restricted to certain areas of the reserve, is prohibited in some sites, such as ceremonial or sacred sites, and is controlled in other specific sites, such as some forest areas under community management.  The Awa Federation and the NYBG In April 1993, New York Botanical Garden (NYBG) and the Awa Federation, a legal institution which administers the land held under communal title by the Awa of Cachi in Ecuador, signed a two-year agreement for academic scientific research. The agreement includes the following terms:  All scientists must ask for written permission to carry out studies, setting out a description of objectives, size and     composition of the research party, length of research programme, species or object of study, and the manner in which     this research will benefit the Awa community; The request for permission must be given with a minimum of two months’ notice, since dispersed communities only meet     four times a year for four days. Research groups are limited to five people; Local guides and informants must accompany all scientists; The removal of any object from Awa territory not approved by the federation is prohibited; Payments to the Awa Federation members for their services should be in accordance with a set of prices established by     the Federation; The Awa Federation must receive acknowledgement in all publications. Source: Posey and Dutfield (in press).

Reality
Agreements such as those referred to above illustrate the way in which bioprospecting may contribute to a range of national sustainable development goals: from the inventory of Costa Rican biodiversity subsidized by INBio’s bioprospecting activities, through the training of scientists stipulated in several agreements, to support for research into developing country diseases and health care for local communities. However, no national biodiversity strategies have yet been developed which thoroughly address the sustainable use of biodiversity, and ad-hoc prospecting activities are unlikely to maximize the potential benefits to participating countries and stakeholders. Furthermore, since the terms of most agreements are confidential, it will be difficult to review their contribution to sustainable development. Additionally, it is difficult to predict the future demand by users for access to biodiversity for prospecting activities. The current market for value-added goods and services is certainly limited.
All of this suggests a modest future for bioprospecting. But notwithstanding, if providers, collectors and users take steps such as those indicated, it should enable them to make the most of such opportunities as exist.
Kerry ten Kate

Director Environmental Strategies, Brook House, Crookham Village, Hampshire GU13 OSS, UK. Phone (+44) 1252 613789;
Fax (+44) 1252 815258; E-mail 100427.1507@compuserve.com

Sources
Charles Victor Barber and Antonio La Viña (1995), Regulating Access to Genetic Resources. The Philippine experience. Paper presented at the Global Diversity Forum, Jakarta 4-5 November 1995.

Cambridge University Faculty of Economics and Politics and the World Conservation Monitoring Centre (1994), Sustainable Utilisation for Global, National and Community Benefit. An analysis of utilisation and biodiversity conservation. Case study: The use of plant genetic resources in agriculture. Unpublished draft.

Kerry ten Kate (1995), Biopiracy or Green Petroleum? Expectations and best practice in bioprospecting. London: Overseas Development Administration.

Philippines Presidential Executive Order no. 247 (1995), Prescribing Guidelines and Establishing a Regulatory Framework for the Prospecting of Biological and Genetic Resources, Their By-Products and Derivatives, for Scientific and Commercial Purposes and for Other Purposes. Manila: 18 May 1995

Darrell A. Posey and Graham Dutfield, Beyond Intellectual Property Rights: Towards traditional resource rights for indigenous peoples and local communities. Ottawa: International Development Research Centre (in press).