South Africa's Bioprospecting, Access and Benefit-Sharing Legislation

Science Policy South African Journal of Science 104, September/October 2008 355

Historically, a lack of bioprospecting South Africa’s bioprospecting, legislation and associated regulations has permitted almost unconstrained access to access and benefit-sharing South African bioresources, with materials being harvested, sometimes in destruc- legislation: current realities, future tively excessive quantities, and being exported to research and development complications, and a proposed nodes abroad, for innovative value addition, and off-shore financial benefit. The alternative consequence has been that the country as a whole, including traditional knowledge (TK)-holding communities and bio- a,c Neil R. Croucha,b*, Errol Douwes , resource providers, have not benefited Maureen M. Wolfsond, Gideon F. Smithd,e and equitably from the commercial and other gains derived from local bioresource c Trevor J. Edwards commercialization. Records, fifteen years ago, reveal that the Dutch flower industry lobally, many nations are legislating the world, being the smallest but most earned almost R300 million annually access for bioprospecting purposes to diverse floristic kingdom known. With from the sale of freesias alone.7 The genus Gtheir biological and genetic resources. over 19 500 indigenous plant species in Freesia is near-endemic to South Africa. South Africa, as a megadiverse country, has about 350 plant families, South Africa Similarly, large areas are under cultivation, recently regulated bioprospecting, access and benefit-sharing activities in accordance indeed has the richest temperate flora in with Gladiolus, Zantedeschia and Nerine 8 with its obligations as a ratifying party to the world. In addition, three global plants in Holland and New Zealand. the Convention on Biological Diversity. The hotspots of biodiversity are currently Revenue generated from sales of Pelargo- context and process of key legislation devel- recognized within the country: the CFR, nium cultivars, derived from South African opments in South Africa are discussed, prior the Succulent Karoo, and Maputaland– species and protected by Plant Breeders’ to our presenting a critique which emphasizes Pondoland–Albany.4 Regional biotic ele- Rights in the Netherlands, Germany and the practical impacts, especially on drug dis- ments other than plants are similarly Belgium approximates US$6 billion annu- covery, arising from the newly introduced diverse, exemplified by the fungi which ally,with no associated revenue returns to systems. Probable effects on existing bio- 8 resource-based industries within South have recently been estimated conserva- South Africa. 5 Africa, together with current as well as future tively at 200 000 species and coastline Several notable industries have devel- 6 bioprospecting activities, are assessed. marine life at over 10 000 taxa. The rich oped within South Africa,9 and have Several practicalities of bioprospecting meth- floristic and geological diversity7 of the already brought direct and indirect bene- ods have been poorly accommodated, result- country supports immensely rich and fits to its citizens: these include the cut ing in the development of impracticable and diverse faunas, both invertebrate and flower [primarily fynbos species (proteas, unnecessarily restrictive regulations. We con- 6 vertebrate. Although the potential for leucospermums and the like)],10 aloe clude that though well-intentioned, these new commercial product development 11,12 non-facilitative regulations have placed a (principally Aloe ferox Mill.), marula dead hand on value-addition to South Africa’s from South African bioresources is high, (Sclerocarya birrea (A. Rich.) Hochst. subsp. biodiversity. Bioprospectors will find it diffi- such that South Africa has been, and caffra (Sond.) Kokwaro), honeybush tea cult to continue with broad-scale screening remains, a country of significant interest (Cyclopia spp.), and rooibos tea (Aspalathus programmes given their user insecurity, legal to bioprospectors, it may never prove to linearis (Burm. f.) R. Dahlgren)13 industries, uncertainty, and cost-inefficiency. Existing be the land of ‘green gold’. Especially amongst others. Recently introduced bioresource-based industries within South with respect to the quest for new pharma- bioprospecting legislation14 and regula- Africa face potential closure in view of onerous co-active materials, it should be remem- tions15 in South Africa have sought to bioprospecting permit application require- bered that behind every commercially ments. An alternative, practical, CBD-com- redress disparities in the sharing of bene- pliant model on which to base urgently successful bioproduct lies substantial fits derived from bioprospecting. They required legislative reforms is presented. expenditure in the form of extensive reflect i) national sovereignty over access screening programmes that will have to bioresources, ii) a recognition of tradi- Introduction discarded literally thousands of commer- tional knowledge and related intellectual South Africa, considered one of 17 cially non-exploitable candidates before property rights (IPR), iii) a need to share megadiverse countries (nations that discovering a single commercially ex- benefits equitably with stakeholders, and collectively account for 70% of global ploitable product. 1 iv) a need to use bioresources sustainably. biodiversity), holds the Cape Floristic Each of these elements serves to align na- Region (CFR),2,3 one of the six most signifi- Abbreviations: ABS, access and benefit-sharing; BSA, tional law with the objectives of the Con- cant concentrations of plant diversity in benefit-sharing agreement; CBD, Convention on Biologi- vention on Biological Diversity (CBD).16 a cal Diversity, the Rio Convention; CITES, Convention on Ethnobotany Unit, South African National Biodiversity the Trade in Endangered Species; DEAT, Department of Broadly speaking, this approach to devel- Institute, P.O.Box 52099, Berea Road 4007, South Africa. b oping access and benefit-sharing (ABS) School of Chemistry, University of KwaZulu-Natal, Environmental Affairs and Tourism; DST, Department of Durban 4041, South Africa. Science and Technology; DTI, Department of Trade and legislation is supported increasingly by c School of Biological and Conservation Sciences, Univer- Industry;IP,intellectual property;IPR, intellectual property countries both rich and poor in bio- sity of KwaZulu-Natal, Private Bag X01, Scottsville 3209, rights; MOU, memorandum of understanding; MTA, mate- South Africa. resources. What is critical is that the im- d rial transfer agreement; NEMBA, National Environmental Research and Scientific Services, South African National Management Biodiversity Act (Act 10 of 2004); PIC, prior Biodiversity Institute, Private Bag X101, Pretoria 0001, plementation of such regulations should South Africa. informed consent; TK, traditional knowledge; TOPS, lead to a positive outcome. An emerging eSchweickerdt Herbarium, Department of Botany, Univer- Threatened or Protected Species; TRIPS, Agreement on sity of Pretoria, Pretoria 0002. Trade-Related Aspects of Intellectual Property Rights; economy such as South Africa can ill *Author for correspondence. E-mail: [email protected] WTO, World Trade Organisation. afford to restrain its own bioprospecting 356 South African Journal of Science 104, September/October 2008 Science Policy

activities through unreasonable and cost- South Africa, particularly relating to plant contribute knowledge regarding the use prohibitive regulations. One threatened use.22 That value is indeed inherent in this of bioresources should benefit where programme is the Novel Drug Develop- local knowledge base is exemplified by such knowledge (intellectual property)29 ment Platform (NDDP) (www.sahealthinfo. the study of Fourie and co-workers,23 who is the basis of successful new product org/noveldrug/), a broad-based consor- reported that approximately 81% of 300 developments.30 The difficult issues of tium of South African researchers from evaluated medicinal plants show biologi- determining traditional knowledge own- clinical and scientific disciplines based in cal activity in a range of target assays. ership may have given rise to the reported local parastatals, universities and science Similarly, considerable success has been reduction in bioprospecting activities at councils. The objective of NDDP research achieved when an ethno-directed ap- several large pharmaceutical compa- has been to develop, from ethnomedi- proach is adopted for the search for new nies.31 Risks faced by companies include cinal plants, novel drugs that are effec- antimalarial drugs from South African financial losses, legal conflicts over IPR tive against serious and comparatively plants. Extracts of 49% of all the species ownership, and negative publicity linked neglected diseases of the developing assayed exhibited promising antiplas- to perceived biopiracy. The historic ab- ≤ 24 world: malaria, tuberculosis and diabetes modial activity (IC50 10 µg/ml). These sence of formalized means of sharing mellitus. The Department of Science and regional experiences substantiate the economic benefits derived from the com- Technology (DST), through the agency of notion that bioresources used within local mercial exploitation of biodiversity with the National Research Foundation (NRF), traditional medicine systems constitute landowners and/or custodians of tradi- has provided Innovation Funds to sup- good starting points for drug develop- tional knowledge has led to accusations port the activities of the NDDP. ment research. However, the acceptance that businesses are involved in bio- A critique of recent South African legis- that such selections are starting points piracy.32–35 However, it has been argued lation and ensuant regulations governing only, and not end products of a drug that many cases of biopiracy have been access to biological resources for biopros- development pipeline, has fundamental de facto consequences of clumsy permit pecting purposes, and benefit-sharing, is implications for interpreting the value of systems that are too costly, time-consuming the focus of this paper. This review does i) the bioresource, and ii) any traditional or impracticable to implement.35 Along not question the stated intentions of the knowledge associated with that resource with several other factors, poor legislation legislators. Our emphasis is placed on which may have led to its selection for governing the use of natural resources assessing the practicalities of these newly investigation in the first instance. The and traditional knowledge has been cited introduced systems, and we discuss the same may be stated of non-medicinal as a limiting factor in the global advance- impact that these are anticipated to have bioprospecting activities for, for example, ment of bioprospecting.36–38 on existing bioprospecting activities and foods, beverages, fibres, and horticultural Bioprospecting industries within South bioresource-based industries both within cultivars, all of which require similarly Africa have generally not aligned with and outside South Africa, now, and in innovative and costly research and devel- best practice, or shared equitably their time to come. Particular emphasis is opment over extended periods. The notion financial profits with TK-holding commu- placed on consequences for drug devel- that bioresources associated with tradi- nities from November 1995 to April 2008, opment. The implications of this legisla- tional knowledge are for the most part this being the period between ratification tion for academic research (expanding the commercializable entities, simply await- of the CBD by South Africa and the imple- knowledge base of science without a ing ‘cherry picking’ by industry, is false. mentation of regulations relating to bene- primary commercial interest) on South In reality, only a small minority of initial fit-sharing (Fig. 1). Doubtless this relates African biodiversity, and the conservation research subjects yield commercial or in part to problems in identifying the true thereof, form the subject of a separate industrial products.25 Market forces, toxic- holders or owners of the TK. Indirect review. ity and efficacy standards, production, benefits (such as improved nutrition and processing and formulation challenges, health, job creation, and infrastructural Bioprospecting in South Africa: and the sustainable use/supply of bio- development through taxation) have historical context resources are among numerous factors nonetheless in the interim been distrib- Bioprospecting involving traditional that ultimately limit the industrialization uted broadly. While IPR returns may knowledge or commercialization of any concept accordingly facilitate the distribution of High costs associated with laboratory product. For CBD-ratifying countries, commercial benefits to TK-holding com- assays, drug trials and subsequent regis- which include South Africa, further oblig- munities, a universally accepted means trations have largely limited biopros- atory factors apply (Article 8j), namely, of implementing intellectual property pecting for new drugs within South the approval and involvement of the recognition is yet to be formulated. Cer- Africa to collaborative efforts between holders of related traditional knowledge tain provisions made in the 1995 World researchers based at science councils, and the equitable sharing of benefits Trade Organisation (WTO) Agreement on parastatals and universities. Such ven- arising from the wider application of such Trade-Related Aspects of Intellectual tures have necessarily applied focused knowledge.16 Property Rights (TRIPS)39 were regarded selection procedures to identify the most to conflict with proposals made by the promising subjects prior to initial screen- Intellectual property rights CBD.40 The convention has been seen to ing programmes. This improves cost- Since the signing of the CBD,16 there has enshrine equity, and importantly, accessi- effectiveness. These projects focus pre- been contention26–28 over how countries bility to bioresources. In particular, the dominantly on ethnomedicinal knowl- should secure returns from intellectual CBD acknowledges the collective rights edge, as it is widely acknowledged that property rights to ensure equitable of indigenous and local communities to ethno-directed approaches provide ad- sharing of benefits derived from the utili- exchange and develop biodiversity. In vantages in the search for novel drugs.17–21 zation of natural resources and their contrast, TRIPS strongly favours private There is a wealth of documented tradi- associated indigenous knowledge. It is ownership of IPR and profit-based sys- tional ethnomedicinal knowledge in recognized that cultural groups who tems.39,40 The absence of legislation pro- Science Policy South African Journal of Science 104, September/October 2008 357

tional knowledge. Presently, this amendment is supported by nearly 80 of the total WTO membership of 151.44

Genetic and biological property rights A new system of property and commercial transactions has been created under the CBD for genetic resources. The assign- ment of property rights is based on the need to exercise physical control over the property, which in this case is genetic information.45 South African legislation —like that of many other countries—does not create a property rights system for this component, but relies on the property rights relating to the physical aspect, such as the biological resource or its parts (such as seeds) to define the legal status of their genetic and biochemical resource.45 There may be a basis in the case of genetic resources for distinction between the rights over the physical entity (physical property) and over the genetic information that the resources contain (intangible property), which represents the real value of the resources, and where the judicial problems are especially complex.46 In some countries, notably Ethiopia, the state is considered the owner of the genetic resources, although the owner of the land, who is deemed to be the owner of the biological resources, has to be con- tacted to obtain permission to collect the biological resource.47 In South Africa, legislation14 does not vest ownership of genetic resources in the state, unless they occur on state land.47 The landowner in South Africa, in terms of common law, owns both the biological and the genetic resources on or under his/her property. Not all ownership cases are clear-cut, particularly with respect to communal land ownership, and related culture-based Fig.1. Process and context of development of bioprospecting, access and benefit-sharing legislation in South concepts of control. To avoid undermining Africa. resource user certainty, especially when South African bioresources are exported tecting private ownership of IPR in edge from patentability, as was permitted for the purpose of bioprospecting, it is developing countries was reported to be under the WTO.42 South Africa’s Depart- essential that users and providers share costing industrialized countries some ment of Trade and Industry (DTI) has a common understanding of the exact US$200 billion in lost royalties per annum.41 subsequently published the Patents nature of the rights that are being granted TRIPS attempted to narrow the gaps in Amendment Act of 2005,43 which requires to the user by the ABS agreement. Accord- the ways these rights were protected an applicant for a patent to furnish infor- ingly, there is a need to determine and globally, incorporating them into common mation relating to any role played by an legally acknowledge the differences be- international rules. The disparity be- indigenous biological resource, or tradi- tween the owners of the land from which tween TRIPS and the CBD objectives has tional knowledge, that may form part of the specimen is collected, the owner of led to much debate, particularly when the submitted invention and, if so, pro- the biological resource, and the owner of WTO members have been faced with vide proof that applicant(s) have received the genetic resource. This problem is possible trade sanctions, if they declined permission to make use of the indigenous exacerbated when one is dealing with endorsement of the TRIPS agreement. resource or traditional knowledge or trans-boundary biological and genetic This agreement did, however, acknowl- traditional use. Furthermore, there has resources where different property regimes edge the right of countries to decide on been increased international support for exist in different countries. To maximize the details of their own patent systems40 an amendment to the WTO agreement on certainty, users will naturally tend to seek and have been accordingly advised to TRIPS that would require the disclosure out resource owners whose ownership exclude all life forms and related knowl- of origin of genetic resources and tradi- status is most straightforward, resulting 358 South African Journal of Science 104, September/October 2008 Science Policy

in a marginalization of communal land- The Act has sought to give effect to nous biological resources’ have been owners. ratified international agreements (for defined to include: instance, CBD, CITES), binding on the (a) Key legislative developments country, which relate to biodiversity. It i) [any living or dead animal, plant or White paper legislates for, in part, i) the management other organism of an indigenous spe- The process and context of the develop- and conservation of biological diversity cies]; b) [any derivative of such ani- ment in South Africa of legislation and within the country and of the compo- mal, plant or other organism]; or c) [any regulations on bioprospecting, access and nents of such biological diversity, ii) the genetic material of such animal, plant benefit-sharing is summarized in Fig. 1, use of indigenous biological resources in a or other organism], whether gathered 48 highlighting key events. A white paper sustainable manner, and iii) the fair and from the wild or accessed from any on the Conservation and Sustainable Use equitable sharing among stakeholders of other source, including any animals, of South Africa’s Biological Diversity was benefits arising from bioprospecting plants or other organisms of indige- gazetted in May 1997, with subsequent involving indigenous biological resources, nous species cultivated, bred or kept minor modifications by Cabinet, and coinciding closely with the cornerstones in captivity or cultivated or altered in 49 48 adopted by Parliament. This policy out- of the CBD. The convention refers to any way by biotechnology; lined the necessity for establishing legisla- access to genetic resources, but does not ii) any cultivar, variety, strain, deriva- tion and institutional structures to control define either access or use, implying that tive, hybrid or fertile version of an in- access to South Africa’s indigenous ge- it is possible to access biological resources digenous species or of any animals, netic resources. In addition, the proposed for commercial exploitation, without plants or other organisms referred to legislation was to ensure that benefits access to the genetic resources in the in subparagraph i); and: arising from South African bioresources material. Accordingly, it is not clear in the iii) any exotic animals, plants or other or- served the nation. Significantly, the white CBD to what extent the use of the whole ganisms, whether gathered from the paper recognized that it was in the coun- medicinal plant, herbal plants or nutra- wild or accessed from any other try’s best interest to ensure that access to ceutical food is regarded as access. In source which, through biotechnology, biodiversity was not unnecessarily re- South Africa, however, access legislation have been altered with any genetic strictive, and further recommended that refers to biological resources which, by material or chemical compound legislative conditions should stimu- definition, also includes the genetic re- 14 found in any indigenous species or late economic activity. Our critique con- sources. The definition of bioprospec- any animals, plants or other organ- siders whether these key policy consider- ting qualifies the activities, basing the isms referred to in subparagraph i) or ations have been successfully achieved, distinction on the intended use by the ii); but excludes: given that both legislation (Act 10 of 2004, applicant at the time of access, that is, for hereafter referred to as the Act)14 and Reg- bioprospecting or for research other than (b) ulations15 have subsequently been rati- bioprospecting. The Regulations develop i) genetic material of human origin; fied. Relatively few parties to the CBD this further, especially within the exemp- ii) any exotic animals, plants or other or- have reached this commendable goal, tions included in them.15 ganisms, other than exotic animals, with fewer than 10% of the CBD parties plants or other organisms referred to having adopted access and benefit- Consideration of definitions in (a) iii); and sharing legislation, ten years after the Central to our treatise on the practicalities emergence of the convention. Virtually of newly implemented systems are defini- iii) indigenous biological resources listed none has claimed that their ABS arrange- tions provided by the Act14 of ‘biopros- in terms of the International Treaty on ments function effectively.50 pecting’ [Section 1(1)] and ‘indigenous Plant Genetic Resources for Food and biological resources’ [Sections 1(1); 80(2)]: Agriculture. The National Environmental Manage- ‘bioprospecting’, in relation to indige- No definitions have been provided in ment Biodiversity Act (NEMBA) nous biological resources, means any the Act14 for ‘indigenous community’ or NEMBA and the CBD research on, or development or applica- ‘commercial or industrial exploitation’. The draft Biodiversity Bill, formulated tion of, indigenous biological resources Stakeholders who are expected to benefit by the Department of Environmental for commercial or industrial exploitation, from entering into benefit-sharing agree- Affairs and Tourism (DEAT), evolved including: ments (BSAs) with bioprospecting permit through 13 iterations prior to its release a) the systematic search, collection or applicants were defined as ‘a person, for public comment on 1 June 2003. gathering of these resources or making including any organ of State or commu- Following inputs received and subsequent extractions from these resources for nity, providing or giving access to the 14 amendments made, the Act was gazetted purposes of research, development or indigenous biological resources to which in early June 2004 (Fig. 1). Besides regulat- application; the application relates [Section 82 (1)(a)], ing bioprospecting, access and benefit- and an indigenous community i) whose b) the utilization for purposes of research sharing activities involving indigenous traditional uses of the indigenous biologi- or development of any information biological resources within South Africa, cal resources to which the application regarding any traditional uses of indig- the Act (Ch. 6) frames Regulations relating relates have initiated or will contribute to enous biological resources by indige- to the export from South Africa of indige- or form part of the proposed biopros- nous communities; or nous biological resources for the purpose pecting; or ii) whose knowledge of or of bioprospecting or any other kind of c) research on, or the application, devel- discoveries about the indigenous biologi- research. The implementation of various opment or modification of, any tradi- cal resources to which the application chapters in the Act has been staggered to tional uses, for commercial or indus- relates are to be used for the proposed allow for appropriate regulations to be trial exploitation. bioprospecting’ [Section 82(1)(b)]. The developed by the DEAT (Fig. 1). In relation to bioprospecting, ‘indige- Act14 requires [Section 82(2)] that the Science Policy South African Journal of Science 104, September/October 2008 359

Fig. 2. Process prescribed by Regulations to bioprospect South African bioresources. Shaded elements are not prescribed by the Regulations but are potential provincial requirements. applicant enters into BSAs with the above arise from such bioprospecting’ be given. extremely difficult to negotiate, with the stakeholders, as well as a material transfer These onerous requirements well reflect process being unduly difficult, costly and agreement (MTA) with the bioresource the ‘cherry picking’ notion of the biopros- onerous for the applicant. To minimize provider, approved by the minister, pecting process that has been adopted by expenses associated with MTAs and their before the actual bioprospecting permit the legislators. Indeed, the Act prescribes related BSAs, applicants will naturally application will be considered (Figs 2 and processes that better support the ABS seek out resource owners whose owner- 3). Of particular significance are two context of imminent bulk bioresource ship status is unambiguous, and who are elements prescribed by the Act for the extraction rather than the searching of least demanding, complicated, or unob- BSAs: first, [Section 83(1)(d)] that ‘…the bioresources for potential value, or structive as negotiating partners. manner in which and the extent to which bioprospecting. The full benefits that are the indigenous biological resources are to likely to arise from the discovery phase of Mandates, responsibilities and be utilized or exploited for purposes of a bioprospecting project are impossible to procedures such bioprospecting’ be set out and determine, as is the manner and extent to The Act14 has gone as far as detailing [Section 83(1)(e)] ‘…the manner in which which the bioresources might be utilized specific mandates and responsibilities and which the extent to which the stake- (if, ultimately, at all). Based on the above [Section 82(4)], and prescribes various holder will share in any benefits that may perceptions, realistic BSAs are thus permitting procedures (Section 81) that 360 South African Journal of Science 104, September/October 2008 Science Policy

Fig.3.Schematic representation of current South African bioprospecting regulatory process.Note:the requirement indicated to source collection permits from provinces is uncertain. should arguably have been better assigned dures not prescribed by the Act have been pecting.’15 The Regulations do not define to the Regulations. The focus on the details subsequently detailed by the Regulations, the required ‘leadership structure’ of the of processes has detracted effectively and detailed application forms have been indigenous community, to allow for the from key principles considered by the appended to facilitate permit applications unambiguous identification of appropriate white paper,48 namely, needs to facilitate of various types, as well as MTAs and TK-holding indigenous communities access and stimulate sustainable economic BSAs. The minister is required to issue eligible to enter into BSAs. The ‘commer- development. Although the Act14 has permits after: i) ensuring that the interests cialization phase of a bioprospecting delegated a range of responsibilities to of stakeholders (including indigenous project’ means ‘any research on, or devel- undefined ‘issuing authorities’ (Section communities) are protected (through opment or application of, indigenous 82), the Regulations15 later make clear BSAs and MTAs), ii) that prior informed biological resources where the nature and [Ch. 2, 6(1)(a)(b)] that the minister of the consent has been obtained, and iii) full extent of any actual or potential commer- DEAT is the issuing authority for biopros- disclosure of information relating to the cial or industrial exploitation in relation to pecting permits, as well as for integrated proposed bioprospecting has been sub- the project is sufficiently established to export and bioprospecting permits. In mitted to the stakeholders (Fig. 2). The begin the process of commercialization’. terms of institutional mechanisms, the discovery phase and/or commercializa- The definition provided15 for ‘commer- Act does not identify a single ‘ABS focal tion phase of a bioprospecting project cialization’ (pp. 7–8) includes the follow- point’, a desirable feature stressed by the may only be initiated with a biopros- ing activities in relation to indigenous Bonn Guidelines.51 However, the office pecting permit issued by the minister biological resources— of the minister of the DEAT deals with [Ch. 1, 4(1)].15 the issuing of bioprospecting-related a) the filing of any complete intellectual permits, and could thus be considered the Consideration of definitions property application, whether in South Africa or elsewhere; national focal point for bioprospecting A number of definitions not provided issues. by the Act are contained in the Regulations. b) obtaining or transferring any intellec- Of particular interest in relation to BSAs is Bioprospecting, Access and tual property rights or other rights; that for ‘indigenous community’, mean- Benefit-sharing Regulations c) commencing clinical trials and product ing ‘any community of people living or development, including the conducting Act–Regulations conformity having rights or interests in a distinct of market research and seeking pre- Because the Act14 prescribes inappropri- geographical area within the Republic of market approval for the sale of result- ate and detailed processes, little latitude is South Africa with a leadership structure ing products; or available for subsequent implementation and a) whose traditional uses of the indig- of a practicable system in terms of regula- enous biological resources to which an d) the multiplication of indigenous bio- tions. Rather than redress the very obvious application for a permit relates, have logical resources through cultivation, deficiencies of the Act’s Chapter 6 through initiated or will contribute to or form part propagation, cloning or other means an immediate legal reform process, the of the proposed bioprospecting; or b) to develop and produce products, inherent problems have been com- whose knowledge of or discoveries about such as drugs, industrial enzymes, pounded through promulgation of Act- the indigenous biological resources to food flavours, fragrance, cosmetics, compatible Regulations15 that became ef- which the application for a permit relates emulsifiers, oleoresins, colours and fective from 1 April 2008 (Fig. 1). Proce- are to be used for the proposed biopros- extracts. Science Policy South African Journal of Science 104, September/October 2008 361

In relation to this definition (part c), tion’. Accordingly, the undertaking of resources where the nature of the project ‘product development’ is not defined, but research for the purposes of identifying a is sufficiently established to start a process may reasonably include drug formula- subject worthy of further (discovery of commercialization. Not only would tions, which would in fact be required phase) bioprospecting is illegal without a growers require bioprospecting permits, prior to the clinical trial phase. Product bioprospecting permit. However, bio- but also commercial gatherers/wild- development could also include new prospectors are nonetheless required to crafters, formulators, processors, packag- products based on established and well- identify their subjects before applying for ing firms, and marketers, besides those branded commodities, such as rooibos: a permit,15 placing them in a paradoxical who hold IPR in the form of patents. the development of soaps and handcreams Catch 22 predicament: they will have Neither contractor nor sub-contractor from a plant historically marketed as a contravened the law in attempting to involved in the bioprospecting process beverage. Further, in relation to c), the comply with it. appears to be exempted. The requirement conducting of market research is typically The seriousness of this situation may be in the regulations for non-South Africans undertaken by bioprospectors prior even appreciated when one considers that a to apply for a permit in conjunction with a to embarking on the costly discovery person is guilty of an offence if that South African judicial body or citizen phase of a project. If there is no market person, without a permit, undertakes should encourage the establishment of niche, then there is no motive to develop a bioprospecting involving indigenous partnerships, and lead to technology product. Accordingly, the inclusion of biological resources [Ch. 4, 20(a)(i)].15 A transfer and information sharing. Such market research as a defined component person, so convicted, is liable to imprison- partnerships nevertheless place an onerous of ‘commercialization’ is inappropriate. ment for a period not exceeding five legal risk on the South African party Similarly, so is part d) of this definition, for years, an appropriate fine, or to both a should the non-South African party(ies) agroprocessing research is at times an es- fine and imprisonment [Ch. 4, 21(1) renege on any agreement. sential prerequisite to determining, dur- (a)(b)(c)].15 Despite the above implica- ing the discovery phase, whether a tions, ‘research’ is not defined in either the Position of existing industries product can ever be taken beyond the Act or the Regulations. While there is a In that a bioprospecting permit is now point of proof of principle. When regula- clear need to ensure that the rights of all legally required for any stage of a bio- tions relating to access to bioresources are stakeholders (sensu Act)14 will be protected prospecting project, definitions provided too commercially biased, they typically in instances where a commercially or by the Regulations15 for ‘the discovery tend to be very restrictive, and impact industrially valuable discovery is made phase of a bioprospecting project’, and negatively on basic research.52,53 Wide- during basic research, the researchers, so the ‘commercialization phase of a bio- spread suspicion that bioprospecting will involved, clearly also need protection. prospecting project’, serving principally take place under the guise of basic re- The regulations have appropriately made to inform existing bioresource-based search stimulates over-regulation, well- allowance for serendipitous events which industries that they are indeed engaged exampled by legislation drawn up by lead to an application for a bioprospecting in a commercialization phase, and are several developing nations, including Sri permit, although full explanations re- required to apply for a bioprospecting Lanka, Brazil and the Philippines.53 It is garding activities leading to such finds are permit within six months from 1 April therefore important to designate clear required by the minister (Ch. 2, 9(2)(b)].15 2008 [Section 22(2)].15 This means that limits between access to material for most existing industries (for example, bioprospecting purposes and access for Applicants for bioprospecting permits – rooibos, marula, honeybush, Aloe and any other kind of research. Given the who need apply? Hoodia) need to take into consideration broad definition of ‘bioprospecting’ in the Importantly, the definition of those who stakeholder interests [Section 22(3)(a)(b)]: Act,14 this has largely been achieved— engage in the multiplication of indige- failure to secure BSAs acceptable to the with the exception of research required nous biological resources through culti- minister, notwithstanding his/her inter- to identify candidate bioprospecting vation or propagation to generate prod- vention, will legally require the indus- subjects. Logically, the initial identifica- ucts as engaging in commercialization try(ies) to terminate their operations tion of a bioprospecting subject inevitably requires that they, too, obtain biopros- [Section 22(4)(a)].15 This positions newly- involves some research, which by defini- pecting permits from the minister. Ac- defined stakeholders who may regard tion [Section 1(1)]14 is bioprospecting. cordingly, for example, every grower who their past benefits (if any) to be inequita- Initially, this research would involve supplies the rooibos tea industry with ble, to hold a veto on whether established fieldwork that includes interaction with plant material needs to apply for a permit, industries may continue their business. communities, as well as mining of data and to secure BSAs with relevant stake- Genuine TK-holding communities, in held in both public and privileged domains. holders. This outcome raises the issue of particular, are now empowered through Basic research of this nature forms a stan- the identity of the party in the value- being dealt an extremely strong negotiat- dard and essential part of the discovery adding chain that needs to secure a ing hand by the DEAT.Although exact fig- phase of any bioprospecting project. In bioprospecting permit to operate with ures of the size of communities involved terms of the Regulations,15 no distinction legal compliance. In this regard, the Regu- in, for example, the Cape aloes (Aloe ferox) is made between the various components lations exempt those who trade in com- industry in the southern Cape are not of the discovery phase, which is defined mercial products purchased from a available, it is likely that several thousand (p. 9) as: ‘anyresearch on, or development bioprospector, provided that the biopros- individuals benefit directly or indirectly or application of, indigenous biological pector has a relevant bioprospecting from harvesting, processing and selling resources where the nature and extent of permit (Exemptions 2.3).15 However, aloe juice, and increasingly, aloe gel.11,54,55 any actual or potential commercial or those involved in the ‘commercialization Inexplicably, only two industry subdivi- industrial exploitation in relation to the phase of a bioprospecting project’ would, sions have been exempted from the Regu- project is not sufficiently clear or known by definition, include all those who de- lations15 (though seemingly without to begin the process of commercializa- velop or apply indigenous biological undergoing the public consultation pro- 362 South African Journal of Science 104, September/October 2008 Science Policy

cess prescribed by Sections 86, 99 and 100):14 the aquaculture or mariculture BOX 1: Who are the stakeholders? sector that produces material for con- One of the key difficulties is the identification of all the relevant stakeholders. For example, sumption (Exemptions 2.7), and the exist- where data for candidate materials for bioprospecting are obtained from the published litera- ing local and international cut flower and ture, many (particularly plants) will likely be recorded as being used traditionally by several ornamental plant market segment (and cultural groups, few if any of which are readily traceable to representative ‘indigenous commu- those who supply them)(Exemptions nities’ with what must be assumed to have the requisite leadership structure. The likelihood of 2.6).15 However, the South African horti- several stakeholder groups being only loosely identified is great where a plant has been cultural industry has little respite, as its reported in the literature as used traditionally by several ethnic groups. An example can be inherent potential to stagnate is now found with ‘Cynodon dactyon DC. [which] is used medicinally by the European in the Transvaal… for heartburn… and as a styptic to wounds.A decoction of the root is a ‘Dutch’rem- framed by the same regulations: the edy for indigestion and a blood purifier…. The Xhosa use a decoction as a lotion for sores and development of new plant varieties and swellings… used by the Sotho in Basutoland against sorcery… and as a charm… a decoction related products—competitive advances is used in the Philippines as a diuretic and pectoral… and the plant is used medicinally in essential for sustaining this fashion-linked India’.58 Accordingly, applicants face tough challenges in regard to identifying communities with sector—are explicitly not exempted (see which to establish BSAs, and the validity of community resolutions acquired that give the PIC of Exemptions 2.4.2).15 TK-holders.

Practical implications for future collection permits are required following well as monetary benefits. The benefits bioprospecting the successful granting of a bioprospecting identified in BSAs negotiated at the be- The Act and Regulations require that permit. This is currently presumed (Figs 2 ginning of the bioprospecting process prior to engagement in the discovery and 3), particularly in relation to CITES cannot realistically consider any major phase of bioprospecting, the applicant and Threatened or Protected Species financial returns; the total benefits derived needs to obtain MTAs (which are reason- (TOPS), and as national legislation (e.g. may ultimately take the form of only new 14 ably attainable) and BSAs (which have NEMBA) overrules existing provincial or augmented information, and voucher practical and financial complications). It legislation only if the latter is in conflict. and other preserved specimens having does not make sense to negotiate a BSA Clarity in this respect is essential, as well been lodged with museums or herbaria. before a permit has been granted (if as on the nature of related ‘integrated Such actual benefits from the discovery required) to collect a bioresource for permits’ provided for in the Act [Section phase of bioprospecting may be perceived 14 research purposes. Nor for that matter 92(1)(b)], but surprisingly not dealt with as irrelevant and insufficient to communi- 15 should the negotiation of BSAs precede in the Regulations. Provision for appeals ties, whose expectations are probably the assessment of the nature and extent of against decisions by the minister are higher and financially orientated, given any actual commercial or industrial value accommodated [Ch. 3(14)(15)]15 (Fig. 2), as the prevalence of rural poverty. How- in relation to a bioresource, prior to any are challenges to decisions made by pro- ever, some international case studies have process of commercialization. Negotia- vincial conservation authorities, which shown that some traditional people do tions surrounding BSAs will focus in the need be addressed through the Promo- not always seek financial rewards in such 56,57 vast majority of cases on biodiversity tion of Administrative Justice Act. situations. BSAs and their linked PIC elements that make merit-worthy sub- Dynamic BSAs make allowance for component, however, may well prove to jects for preliminary discovery-phase changes in benefit-sharing arrangements be one of the most complex, cumbersome research—being of unknown value—but as concepts develop towards products. and difficult aspects for a bioprospecting in reality may never lead to a commercial The Act does allow for amendments to permit applicant. While the regulations or industrial product. As few as one in such BSAs [Section 83 (1)(f)],14 going as far require that PIC be obtained from every 250 000 plant samples leads directly to a in the Regulations as requiring their stakeholder who will be providing the commercial drug.25 Such negotiations regular review (Annexure 8, 11).15 How- biological resource and/or the indigenous should take place at the start of the com- ever, applicants will undoubtedly have to knowledge, they do not elaborate on mercialization phase rather than prior deal with the perceptions of TK-holding the preferred means of engaging with to the discovery phase, as is currently communities and/or bioresource provid- communities. required (Fig. 3). Memoranda of under- ers that bioprospecting generates finan- The Act legislates for the establishment standing (MOUs) agreeing to negotiate cial returns in the form of fees, upfront of a Bioprospecting Trust Fund (Section BSAs at a later stage would suffice in the payments, milestone payments and 85)14 into which all moneys arising from case of landowners signing MTAs: in- royalties. The South African legislation’s BSAs and due to stakeholders need be deed, the MOU should be incorporated ‘cherry picking’ construal of the usual deposited. The Regulations [Ch. 3, 19(3)(b)] into such MTAs. Further, there is a risk bioprospecting process could transfer to a require that the director-general should that considerable resources (both human TK-holding community level, especially if manage and be accountable for the Trust and financial) will be wasted if the the legislating department develops and Fund, and oversee the payment of what is minister approves a range of negotiated implements concurring community edu- due to stakeholders [Ch. 3, 19(4)(c)].15 agreements and a bioprospecting permit, cation programmes. The very process In addition, it is sometimes very difficult only to have a provincial conservation prescribed by the legislation/regulations to determine the identity of the bioresource authority refuse a collection permit on will reinforce this perception, given the owner, and more so, the identity of the ecological grounds. In the current system inappropriate timing of the BSA negotia- genetic resource owner (see Box 1). Such (Figs 2 and 3) qualified approval to collect tions (Figs 2 and 3), and the bureaucratic potential stakeholders include private the amounts required should accordingly character of the permit process (Annexures landowners, tribal authorities, municipal- first be obtained from the provincial 2 and 4).15 The prescribed format for BSAs ities, provincial authorities and the state. authorities. However, neither the Act nor (Annexure 8)15 includes suggestions for In this regard, harmonized benefit-sharing the Regulations stipulate that bioresource non-monetary and ‘in kind’ benefits, as legislation, compatible with that of adja- Science Policy South African Journal of Science 104, September/October 2008 363

BOX 2: An example of a bioprospecting process We follow the bureaucratic procedures now required to comply with each with the required fee of R5000. If the permit(s) is/are granted, current South African bioprospecting regulations (Figs 2 and 3), with applications to collect bioresources (at least TOPS taxa) are then the following illustrative example. Three hundred of approximately made to provincial conservation authorities. This is likely to involve all 20 000 taxa in our national flora are identified as worthy of investigation nine of South Africa’s provinces, given the project scale. Collection of for antiplasmodial activity, with the intention of developing a new some taxa will be permitted, whilst others will be declined. Following antimalarial drug, based on information in the public domain and bioresource collections at sites that were visited earlier and evaluated through a targeted ethno-directed selection approach. At the project for harvesting suitability, the discovery phase of the bioprospecting outset it is expected that following extensive in vitro (and limited small project then begins with the first legally permitted in vitro test. mammal in vivo) screening of plant extracts, two leads (from one or two After several years of research and development, and obligatory taxa) will be taken through to the commercialization phase, as defined annual status-reporting to the minister, two leads are discovered that by the Regulations.But there is no guarantee that any marketable prod- are worthy of ‘commercialization’, that is, appropriate for patenting or uct will ultimately arise from this work. agroprocessing research. In the interim, the Regulations require that The identification of potential localities for the supply of each of the each of the more than 900 MTAs be reviewed by the applicant and 300 taxa is then undertaken, requiring site visits to determine whether respective stakeholders at unstipulated but regular intervals, and enough material can be collected sustainably from the property of a amended where necessary on the basis of new information (Annex- single landowner, or whether this needs to be from several providers. ure 8, 11).15 With only two eventual leads that may be viable, all but a One to several MTAsper taxon and one to several BSAs per taxon need handful of the 900 plus legal agreements that were negotiated will yield to be negotiated with landowners (total of more than 300 MTAs and no future monetary benefits for stakeholders, as research on their more than 300 BSAs). This will require, per taxon, a number of meet- related bioresources comes to an end. The fee to the minister of R5000 ings at one or several potential collection localities that may be geo- is insignificant relative to other costs that will necessarily be incurred by graphically distant from one another. Once the full locality data of the the applicant. Conceivably, the cost of conforming to the bureaucratic essential bioresources have been determined—a regulatory require- requirements of the regulations will be greater by several orders of ment (Annexure 7, 4)15—it is necessary to identify all stakeholder com- magnitude than the cost of actually undertaking the discovery-phase munities whose TK will contribute to the proposed bioprospecting. research. More than one community could be identified per use application, as Multinational industries seeking to bioprospect South African bio- TK is often shared by different user groups within South Africa. BSAs with TK-holding communities need to be signed for each taxon, result- resources, especially its flora, will likely source non-endemic elements ing in more than 300 BSAs. (Notably, no directory of indigenous in neighbouring countries and endemic species from existing ex situ communities and their appointed representatives is in existence. holdings, particularly in Europe and the U.S., with no direct benefits Presumably, the responsibility for determining whether any given such returning to South Africa. In the case of in-country projects such as the community has an acceptable ‘leadership structure’ defaults to the NDDP,one wonders whether the local funding body (DST) will continue minister, given that this element is not defined.14,15) to invest, given the cost of compliance with these mandatory regula- Negotiating each BSA will probably require several expensive meet- tions.Historically, the funding focus of such bodies has been innovative ings with large community groups, again, perhaps geographically product development rather than on i) pre-collection fieldwork, ii) meet- distant. Each BSA is only complete when accompanied by a resolution ings to negotiate BSAs and MTAs, and iii) servicing of BSAs—in part, from the TK-holding community that they have identified a representa- for example, fee provisions, upfront payments, equipment provision, tive that is authorized to enter into a BSA on their behalf, that they have training in scientific, legal and management issues, infrastructure 15 full knowledge of the proposed project, and that they provide their development, and community development projects (Annexure 8, 9). recorded consent (Annexure 8, 4.4).15 Accordingly, more than 300 The regulated transformation of bioprospecting activities in South resolutions need be acquired. While clearly impracticable, if one Africa from a product-centred approach to one which is process-driven assumes that all MTAs, BSAs and community resolutions are thus has commendable attributes, for it certainly empowers TK-holding obtained (more than 900 legal agreements and more than 300 commu- communities. As the Regulations stipulate that a bioprospecting permit nity resolutions), these then need to be submitted with a completed cannot be awarded to an applicant unless relevant MTAs and BSAs bioprospecting permit application (and a R5000 non-refundable fee) to (with community resolutions) have been concluded to the satisfaction the minister for consideration. Should the minister be dissatisfied with of the minister [Ch. 2, 8(1), 11(1)(a)],15 both communities and bio- any one of the 900 plus legal agreements, then he/she is obliged to resource providers (landowners) effectively hold a veto on potential withhold the permit [Ch. 2, 8(1), 11(1)(a)].15 Alternatively, to minimize innovation and development of elements of the biota. The minister of this risk, separate bioprospecting permits may be submitted per taxon, the DEAT is similarly empowered. cent countries, is desirable. Much hinges together with Hoodia, are located in sev- phytochemistry, and drug development, here on decisions made at a global scale, eral southern African countries.60,61 Some may be eligible and legitimate claimants particularly with regard to intellectual of these communities may give consent for benefits, even though they were not property and the patenting of biological while others may not, and others may identified in the original approved BSA. material59 as well as the negotiation of remain completely unaware, despite the These considerations need to be tabled an International Regime on Access and best of efforts to inform them. However, during reviews of BSAs. By and large, Benefit-Sharing. Whereas individual assistance may be requested from the benefits should be directed in such a landowners signing MTAs may benefit minister to attempt to conclude the neces- manner as to promote the sustainable use through BSAs, the Regulations make no sary agreements (Annexure 2, Part 1, 34).15 and conservation of biodiversity (Bonn provision for individual TK-holders (for There is also a possibility of identification Guidelines, clause 48).51 example, a traditional healer with unique or emergence of additional stakeholders From the example (see Box 2) it is clear knowledge) entering into a BSA; rather or claimants during a discovery phase of that the mandatory bioprospecting only for indigenous communities (An- bioprospecting (which typically extends process (Fig. 2) places an impediment on nexure 8, 4).15 Problems can also arise from for several years). In addition to TK-holding value-addition to South Africa’s bio- claimants being located in different communities and bioresources providers, diversity. Bioprospectors will be disin- countries, e.g. Hoodia species are used as there are scientific experts who, through clined to continue with broad-scale appetite suppressants by the San who, their knowledge of botany, pharmacology, screening, given the uncertainty and 364 South African Journal of Science 104, September/October 2008 Science Policy

Fig. 4. Schematic representation of a rationalized bioprospecting process. cost-inefficiency. Similarly, bioresource PIC from TK-holding communities. The simple processes to implement. The intro- access is affected adversely, which begs implementation of this model requires duction of a system that generates fewer the question of whether South Africa has, significant reform of both the relevant BSAs will ease the workload on the office in implementing bioprospecting and ABS chapters (6 and 7) of the Act14 and Regula- of the minister, and release capacity legislation and regulations,14,15 ultimately tions.15 therein to mediate the conclusion of failed to meet its sustainable-use CBD The model respects (through MTAs) the MTAs and their regular reviewing, and to obligations. These require the promotion bioresource provider’s permission to liaise further with provincial authorities of the sustainable use of South African access bioresources, and positions TK- whose permitting decisions may impact components of biological diversity and holding communities—with their veto upon value-adding activities of national ensuring the fair and equitable sharing of option—to offer PIC before the wider relevance. benefits arising out of the exploitation of application of their knowledge. These According to the model (Fig. 4), a detailed genetic resources (Article 1).16 communities then also share benefits bioprospecting proposal is considered by according to mediated BSAs negotiated the minister,and following authorization, Alternative regulatory model with the applicants. Mediators involved the discovery phase proceeds. This phase Less restrictive, and more appropriate in negotiations should include represen- is tracked by DEAT. When the commer- and practical would be to negotiate BSAs tatives of the DTI, as well as the DEAT. cialization phase of bioprospecting is only after the commercial or industrial Significantly, once a promising lead has reached, and appropriate BSAs (with PIC value of a bioresource has been deter- been identified and the commercializa- from TK-holding communities) have mined. In the above illustrative example, tion phase is to commence, the BSA- been negotiated for a particular lead, the if only two leads show commercial poten- negotiating positions of communities minister is then approached for a bio- tial, then between two and seven BSAs and/or bioresource providers become prospecting permit to continue work. We are likely to require negotiation. Figure 4 strengthened substantially. This is partic- advocate that provisional patents be presents an alternative model for practical ularly so, given that a large investment lodged prior to negotiations with either bioprospecting regulatory processes would already have been made by the the bioresource providers, or indigenous which will conform to CBD objectives. We bioprospector in the discovery of a communities, to protect IP generated interpret Article 8(j) of the CBD16 as indi- commercializable lead. Bioprospectors through innovative research. cating that approval and involvement of may thus reasonably argue against this holders of TK is required for the wider veto clause, and seek instead to resolve Proposed amendments to the Act and application (namely, commercialization BSAs through arbitration, if necessary. Regulations or industrialization), but not for the initial However, national CBD compliance may The National Environment Laws explorative research (the discovery phase). be compromised thereby. The existing Amendment Bill,62 which was published The research undertaken here is notion- costly and potentially wasteful require- in the Government Gazette No. 31075 of 20 ally distinct from its application; were it ment for generating numerous contracts May 2008, drafts proposed amendments not, then all research associated with both that could soon become defunct is also to Chapters 6 and 7 of Act 10 of 2004. traditional knowledge and bioresources avoided. Regulatory requirements, such These amendments stipulate that anyone (for example, fundamental ethnophar- as monitoring of the BSA agreements and engaging in the discovery phase of macology, natural products chemistry ensuring compliance, imply the availabil- bioprospecting has to notify the minister, and ethnobiology) would be subject to ity of informed capacity, as these are not providing particulars in a format yet to be Science Policy South African Journal of Science 104, September/October 2008 365

published. Bioprospectors involved in generate both financial and non-financial allows South Africa to add value to its this discovery phase need to sign a benefits. This is desirable in South Africa, biodiversity, while also remaining compli- commitment to comply with the legal where exploitation of bioresources is ant with the CBD. The South African requirements when the commercializa- sought in a sustainable manner. The rider legislature should take heed of the poten- tion phase of bioprospecting is reached. is whether the regulations will encourage tially detrimental consequences for the Thus a bioprospecting permit (and the those with an interest in biodiversity and national economy if appropriately associated need to negotiate BSAs) would its products to act responsibly and equita- facilitative laws and regulations are not only be required at the start of the com- bly in sharing the benefits with qualifying put in place with the greatest of speed. mercialization phase of bioprospecting. parties. Or will the regulations coerce The bill also contains a proposal to interested and affected parties further Received 1 July. Accepted 23 September 2008. expand the concept of stakeholders to into a situation where they are tempted, include specific individuals whose tradi- either to ‘fly under the radar’ when 1. Mittermeier R. A., Gil P. R. and Mittermeier C. G. tional uses of knowledge of, or discover- accessing bioresources (evasion, in pref- (1997). Megadiversity: Earth’s Biologically Wealthiest Nations. Conservation International, Washington, ies about, the indigenous biological erence to compliance) or to seek resources D.C. resources will form part of the proposed from adjoining countries with either less 2. Cowling R.M. and Richardson D.M. (1995). South bioprospecting. The proposed amend- restrictive laws or a legislative void? It is Africa’s Unique Floral Kingdom. Fernwood Press, ments would entitle the director-general essential that regulations allow biopros- Cape Town. 3. Van Wyk A.E. and Smith G.F. (2001). Regions of of DEAT to appoint a trustee to adminis- pectors to comply with regulatory mea- Floristic Endemism in Southern Africa. A Review with ter the Bioprospecting Trust Fund on sures with ease. Such facilitative legisla- Emphasis on Succulents. Umdaus Press, Pretoria. his/her behalf, and/or to allow individual tion can nurture value-adding activity, 4. Steenkamp Y., Van Wyk B., Victor J., Hoare D., Smith G., Dold T.and Cowling R. (2004). Maputa- trusts to be established, as long as they are both locally and abroad, for the benefit of land-Pondoland-Albany. In Hotspots Revisited: managed in compliance with relevant South Africa as well as the global commu- Earth’s Biologically Richest and Most Endangered legislation. Provision is also made for the nity. Current well-intentioned but imprac- Ecoregions, eds R.A. Mittermeier, P.R. Gil, M. renewal and amendment of permits, and 14 15 Hoffman, J. Pilgrim, T.Brooks, C.G. Mittermeier, J. ticable legislation and regulations Lamoreux and G.A.B. Da Fonseca, pp. 218–229. the increase in fines. Possibly the most could impose severe restraint on biopros- CEMEX S.A. de C.V., Mexico City. significant proposal relates to the expan- pecting activity (and benefits derived 5. Crous P.W., Rong I.H., Wood A., Lee S., Glen H., sion of arbitrary powers provided to the therefrom) in years to come, besides col- Botha W.,Slippers B., De Beer W.Z.,Wingfield M.J. and Hawksworth D.L. (2006). How many species minister under Section 86 of an amended lapsing our existing bioresource-based of fungi are there at the tip of Africa? Stud. Mycol. Act: industries within the country. While leg- 55, 13–33. islators may argue for purposive interpre- 6. Klopper R.R., Smith, G.F. and Van Rooy, J. (2002). 1) The Minister may by notice in the The biodiversity of Africa. In Rebirth of Science in Gazette – tation of their bioprospecting definition, Africa. A Shared Vision for Life and Environmental the exemptions given to some indus- (b) declare that this Chapter [on biopros- Sciences, eds H. Baijnath and Y. Singh, pp. 60–86. tries, and not others, indicate otherwise. Umdaus Press, Pretoria. pecting, access and benefit-sharing] Gazetted proposals for expansion of the 7. Ivey P. (1993). South African petaloid geophytes: at does not apply to certain categories of home and abroad. M.Sc. thesis, Universities of Cape powers of the minister to exempt selected research involving indigenous biologi- Town and Birmingham. bioprospecting/commercialization activi- 8. Jaques R. (1996). The Commercial Use of South cal resources or commercial exploitation ties62 raises uncertainty for bioprospec- Africa’s Horticultural Resources. Genetic Resources of indigenous biological resources. Conservation Workshop Report. Land and Agri- ting, given the arbitrary nature of this culture Policy Centre, Johannesburg. Notably, the minister is still required in process. What are the criteria for exemp- 9. Mander M. and McKenzie M. (2005). Southern terms of the Act [Section 86(2)] to follow a tion, and who is deemed eligible thereto? African Trade Directory of Indigenous Natural consultative process, in accordance with Positive alternatives to the current legisla- Products. Commercial Products from the Wild Sections 99 and 10014 prior to publishing Group, Stellenbosch. tive scenario will require substantial revi- 10. Goldblatt P.and Manning J.C. (2000). Cape Plants. an exemption notice. Such consultation sions of both the relevant chapters of the A Conspectus of the Cape Flora of South Africa. Strelit- includes giving notice of the proposed Act and associated Regulations—be- zia 9. National Botanical Institute, Pretoria. execution of this power through publica- yond current proposals.62 These include 11. Newton D.J. and VaughanH. (1996). South Africa’s Aloe ferox Plant Parts and Derivatives Industry. tion in both the Gazette and at least one changes to, or the addition of, definitions TRAFFIC East/Southern Africa, Johannesburg. national newspaper, allowing due time to provide legal certainty: both ‘commer- 12. Botha M.C. and Kogler L.K. (1998). L’Aloeferox. La for public comment. cialization’ and ‘research’ require recon- Liliacée Miraculeuse du Desert. 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