Prospecting biodiversity in the search for new products Industry and Academia.

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1 The sustainable use of biodiversity Industry and the CBD. Ameenah Gurib-Fakim, Faculty of Science, University of Mauritius, Reduit, Mauritius. Abstract: The Convention for Biological Diversity (CBD) is a treaty between Governments, but it is of central importance for business. One of the key features of the CBD is the integration of conservation and sustainable use as well as calling for fair and equitable sharing of genetic resources. It is a fact that the private sector is a major user of genetic resources but nonetheless, the participation in scientific research conducted by industry and the transfer of technology developed in the private sector are among the best ways to share benefits. The views of the private sector on the CBD and the nature of commercial partnerships will inevitably have a bearing on the manner in which benefits are shared in practice. They will also influence the extent to which biological resources are used sustainably and whether this will create incentives for conservation. This paper will present the impact of corporate policies on access to genetic resources, traditional knowledge and benefit-sharing. Introduction: It is a fact that biologically diverse countries are those residing in the South. The world s least developed countries, with a few exceptions, are also generally least equipped to contribute to major technological and scientific advancement and as such do not make optimal use of their significant genetic resources. The latter is much sought after by companies and research institutions based in developed countries, for new lead molecules. Several examples to date are available to demonstrate the contribution of biodiversity from the South in the development of new drugs and other economically useful products. Well-known examples of plant-derived medicines from tropical plants include Quinine, Codeine, Reserpine and Morphine amongst others. New additions comprise Vincristine, Vinblastine which are very useful in cancer treatment. Other important plant-derived and commercially useful compounds include the Pyrethrins, compounds having powerful knock-down effects on insects. The impact of products derived from genetic resources on market figures also varies significantly between sectors. In the pharmaceutical industry, natural products contribute somewhere between 25-50% of the total sales of the products on the market. Commercial botanical medicines, ornamental horticultural products and sales of agricultural seed are 100% natural products, natural personal care and cosmetic products make up less than 10% of global sales in this sector today (Blumenthal, 1999). Despite the colossal financial returns of industry, it is also a known fact that the financial returns or otherwise have been very thin or almost non-existent for many of the provider countries. The Convention of Biological Diversity (CBD) promotes more equitable use

2 and exchange of genetic resources, redrawing ethical and legal norms established over a long history of genetic resource trade and commercialization, and seeking to balance the needs of both technologically and biologically endowed countries. History has recorded that the trade and commercial use of genetic resources is as old as human civilization. One of the first plants referred to here is Boswellia from Egypt to modern days Somalia. During the colonial era, there has been massive collection of a number of species and crops and the eventual transfer to countries other than their own, was common practice. In the 18 th century, botanic gardens of such resources were often attached to Universities and included species like Coffee, Oranges, Bananas, Mahogany amongst others. Decades of exchange across cultures and continents have meant that genetic resources of several countries are now found in ex-situ collections housed in many developed countries. Collection activities have now become an issue of concern. The commercial exploitation of genetic resources by multinationals is nowadays considered as Biopiracy. The reasons behind this are that the legal and policy environment do not adequately ensure Prior Informed Consent (PIC) and adequate Benefit-Sharing. Many private and public institutions in developed countries have shown that when sharing takes place within the context of a suitable policy framework, it can be of interest to Governments, research institutions, communities and companies in both provider and user countries. However, the deficient legal framework, poor understanding of the markets, dearth of experience in establishing partnerships and inadequate or unclear policy framework mean that there are few success stories to support this position (ten Kate & Laird, 2000). Prospecting biodiversity in the search for new products Industry and Academia. Biodiversity prospecting involves the investigation of genetic resources or biochemicals for new commercial leads. Academic research may involve the study of genetic resources and may give rise to commercial applications but research only becomes biodiversity prospecting once the researchers spot the commercial potential and conduct their investigations with this in mind. Biodiversity prospection encompasses a wide range of fields ranging from pharmaceutical, biotechnology, botanical medicines, cosmetics etc. As a matter of fact the lines between the various sectors are becoming increasingly blurred. In recent years we have witnessed the emergence of new terms like cosmeceuticals, nutraceuticals amongst others. This coupled with mergers and acquisition of several companies and the commercial sectors have made the demarcations increasingly difficult. New synergies are being developed in order to develop new ideas and generate new knowledge and novel products. The pharmaceutical industry is perhaps the industry that has received attention in directed at biodiversity prospecting and in fact, represent just a part of a diverse range of the use of commercial activities involving the use of genetic resources. Despite the fact that many industries such as those trading in botanical medicines, personal care, cosmetics

3 and horticulture depend on floral and faunal biodiversity, it is interesting to note nonetheless, that awareness of the CBD amongst them is significantly low (Iwu et al, 1998). Understanding the commercial use of genetic resources is a critical prerequisite for equitable agreements, effective national laws and realistic assessments of national, institutional and community objectives associated with these activities. It can help to provide the basis from which can structure equitable relationships with national strategies that simultaneously promote domestic and international research on native genetic resources, the conservation of biodiversity and the fair and equitable sharing of the results arising from its use. One area where the need for fair and equitable sharing is felt and can be addressed is that of the botanical medicines. Botanical medicines Botanical medicines can take a number of forms, but in all cases are produced directly from whole plant material and contain a large number of constituents and active ingredients working in conjunction with each other, rather than the single, isolated compound as in the case of pharmaceuticals. They are raw herb material, extracts, standardized extracts, phytomedicines etc. and are usually developed in a highly focused manner, based on existing academic research and potential consumer demand as determined by marketing departments. The sourcing of cultivated material as opposed to wild crafting will also become an issue with respect to the sustainability. In spite of reticence by individuals, institutions for the very popular use of phytomedicine, it is agreed that research on botanical medicines is likely to increase in the coming years. In this field, a core suite of species, usually with a long history of traditional use, are studied in academic research programmes, which validate traditional applications or develop new ones. The results are published and companies, including intermediary companies in business to supply new product ideas and raw materials to large manufacturing and marketing companies. Consumer demands are assessed and only in the event of interest that large demand of product is sought. Among the most common botanicals one notes the following: Ginseng, Echinaceae, St.John s Wort, Garlic etc. They are also among the top ten sellers and which dominate the market. Sales in the global botanical medicine industry are estimated to grow to US$ 22 billion by the year These figures show that the possibilities of developing new drugs from floral and faunal biodiversity should feature in any calculations of their true worth. Europe dominates the market with US$ 7.2 billion in 1997 and sales 50% of which are contributed by Germany. Asian markets were roughly US$ 3 billion in 1997 and Japanese US$ 2.5 billion. The Chinese-finished Traditional Medicine (TCM) sector was estimated to have US$ 3.7 billion in sales in Fastest growth in the botanical medicine industry is found in the United States where the annual growth rate averages between 10-

4 20% during The 1998 figures for the United States alone stand at an estimated US$ 3.87 billion (Blumenthal, 1999). It is worth pointing out that the sales of botanicals represent a cosmopolitan global economy. As an example, the top-ten selling botanicals in the Europe represent approximately 1/3 of the total market. In the US alone, the top 10 best sellers represent somewhat more than 50% of the annual sales. Most of the top-selling botanical medicines are derived from species native to or derived from species native to or naturalized in the regions where they are grown. Although out of the 2000 species being sold, 2/3 are from Europe, it must be pointed out that Asian species are playing an increasing role due to the rise of the popularity of TCM. African and Latin American species tend to have a smaller role although the potential of development is there. Increased academic research on species from high biodiversity areas have meant growing commercial interest in those that have shown promise in the laboratory and among them one notes Piper methysticum (Kava kava). It is an undeniable fact that botanical medicine make use of endemic species and relies heavily on traditional knowledge to validate safety and efficacy, assist in the formulation, market products to consumers and in some cases build reliable supplies of raw materials. These activities reflect the spirit of the access and benefit-sharing provisions of the CBD. Unlike the pharmaceutical industry, botanical medicines can always be traced back to their country of origins. For example, the geographic and traditional cultural ties of the Devil s Claws (Harpagophytum procumbens) to South Africa, Cat s Claws (Uncarina spp.) to Peru and Kava (Piper methysticum) to the South Pacific. The fact that the botanical medicine industry depends on supplies of the raw materials, make the provisions of the CBD enforceable. Current trends in the botanical medicine industry with relevance to the demand for new natural products (ten Kate, 2000). Current trends include the following: Increased acceptance of botanical medicines by national and commercial insurance companies Increasing consumer demand for alternative as a complement to pharmaceutical drugs and modern health care, which are perceived as limited in scope and having severe side effects Expanded research has improved the legitimacy of botanical medicines; many of the top selling botanical medicine products are popular due to research results produced primarily in European laboratories The rise in green consumerism has increased the demand for natural medicine Increased advertising budgets and media attention have attracted consumer interest

5 In the US, changes in the regulatory environment have made the manufacture and marketing of botanical medicine more attractive The entry of large pharmaceutical and over-the-counter (OTC) companies has helped spur expansion of the botanical medicine industry within the mass market Globalization and consolidation at all levels (including retail, wholesale and supply of bulk ingredients and raw materials) is on the rise Increased emphasis on safety, efficacy and quality has changed the types of product in demand and requirements placed on suppliers of raw material and bulk ingredients. CITES and threatened botanical medicine species. As a result of the commercial pressures on wild populations, a number of medicinal species have been placed on CITES (Convention on the International Trade in Endangered Species of Wild Fauna and Flora) appendices. CITES regulates international trade in animal and plants through a system of permits, licences, protecting species from excessive trade by listing them in appendices. Appendix I includes species which are threatened with extinction and for which trade is generally prohibited. Appendix II includes species like Prunus africana, Aloe ferox etc. and species which can be traded provided the proper licences have been obtained. A significant minority of companies still does not agree with the principles of sovereignty over genetic resources enshrined in the CBD. Another major barrier to progress has been the lack of factual information on which to base negotiations. Corporate policies on access to genetic resources, traditional knowledge and benefitsharing. ten Kate and Laird (2000) have reported on a study made on five corporate policies introduced in response to the CBD. The response had been published and it shows that few companies have developed policies in response to the CBD, let alone clear and detailed public documents designed to ensure that the acquisition of the materials complies with the CBD and national laws of access. The regulations within these companies also do not spell out the concept of fair and equitable benefit sharing and what it means in practice. Nonetheless in the Botanical Medicines Industry, there is potential to generate significant and long term benefits for source countries and communities in ways that tie geographic and cultural provenance to commercial product development. Financial benefits will not approach those of the pharmaceuticals but can generate forge innovative partnerships with source countries for the supply of raw materials. Companies can build the capacity to conduct research and manufacture products for domestic use and ensure a greater portion of benefits are retained in countries and communities of origin. This pragmatic and holistic approach will ensure both biodiversity conservation and sustainable development.

6 Corporate policies addressing issues related to environmental and social issues. A number of companies in the botanical medicines and personal care and cosmetics sectors, also participate in industry-wide efforts to promote environmentally and socially responsible business practices. Some companies have developed and have adopted the CERES (Coalition for Environmentally Responsible) principles. These principles are divided into 10 categories: 1. Protection of the biosphere 2. Sustainable use of natural resources by developing the Green label 3. Reduction and disposal of wastes 4. Energy conservation 5. Risk reduction 6. Safe products and services 7. Environmental restoration 8. Informing the public 9. Management commitment and 10. Audits and reports. A number of corporate and institutional policies and guidelines developed for these sectors are relevant to the conservation and sustainable use objectives of the CBD. In response to the growing concerns of the part of the consumers and some companies that species are over-exploited in the wild, a number of industry and conservation groups have drafted policies to promote sustainable and high quality sources of raw materials. Non Profit Organizations, conduct research and promote education relating to threatened medicinal plant species in trade and produce guidelines for ethical wild-crafting of species. These usually involve sustainable harvesting but can also include the fair sharing of benefits with harvesters. Professional codes of conduct related to access to genetic resources, traditional knowledge and benefit sharing. It is a fact that very few companies have corporate policies but still many industry researchers have participated in the drafting of professional society codes of conduct. These Guidelines promote the facilitation of technology transfer and the fair and equitable sharing of results and benefits and results arising from the utilization and commercialization of source country natural resources. Staff from several leading organizations have helped in the drafting of this document. These Codes of Conduct help to encourage members to obtain (Prior Informed Consent) PIC and to share benefits with source country institutions and communities (Posey, 1994). Prototype Agreement contains the following provisions (Laird, 2002). IPR s (involving the payment of royalties and possibilities for joint ownership of patents).

7 Technology transfer, training and capacity building (involving training of source country scientists in their respective laboratories) e.g NCI Confidentiality of ethno-botanical data including PIC from traditional healers prior to publication and adequate acknowledgement of their contributions; Joint research, Communication of research results to source country institutions, Re-supply (collaboration over the re-supply of additional material for discovery, development and scale-up manufacture), Obligations of 3 rd Party licensees to share benefits with the source country. Conclusions: The botanical industry, just like the cosmetic and personal care industries, incorporate increasing quantities and varieties of natural products. This is largely due to the response in consumer demands for natural and therapeutic products, but also an expression of the capacity to analyze and understand natural products. The botanical industry has a green image but nonetheless, sustainable and ethical sourcing are now coming to the fore. Traditional knowledge relating to species use, efficacy, safety and sourcing is an important element of product development in this industry and is regularly used in marketing products. Interest in species new to international markets is also likely to increase in coming years due to a number of factors including consumer awareness, expanding markets, improved scientific techniques to study medicinal properties of plants and increasing academic research on geographically diverse medicinal species. Thus Governments should develop access, benefit-sharing measures and ensure sustainability of bioresoures. Government should also seek as their primary objectives the promotion of partnerships that build capacity within high biodiversity countries to work at a higher level in this industry (and not solely as raw material suppliers). Partnerships should also build capacity in areas of domestic importance (eg standardizing traditional medicine, developing affordable plant-based botanical medicines for the domestic markets; building industries based on local biodiversity and conducting research on tropical diseases amongst others.). In this way, there will be more incentives for biodiversity conservation and sustainable development over time. Reference. Blumenthal M (1999). Herb market levels after 5 years of boom : Herbalgram, No. 47. Iwu MM, Laird S (1998). Health conservation and economic development: The international cooperative of biodiversity groups. Drugs development and biodiversity conservation programme in Africa. Secretariat to the CBD, 4 th COP, Slovakia. Laird S (2002). Biodiversity and Traditional Knowledge. Equitable Partnerships in practice. Earthscan Publications Ltd., London, UK

8 Posey DA(1994). International Agreements and Intellectual Property Rights protection for indigenous peoples in Biodiplomacy, Genetic Resources and International Relations, ACTS Press, Nairobi, Kenya. Ten Kate K, Laird S (2000). The Commercial use of biodiversity. Access to genetic resources and benefit-sharing. Earthscan, London, UK.

9 As biotechnology becomes ubiquitous in industry, virtually all commercial sectors make use of genetic resources in some manner. Researchers are constantly exploring new uses of genetic resources such as their potential for development of components of the automobile industry, agriculture etc.