South Africa’s bioprospecting,access and benefit-sharing

legislation: current realities, futurecomplications, and a proposed

alternative

Neil R. Croucha,b*, Errol Douwesa,c,

Maureen M. Wolfsond, Gideon F. Smithd,e and

Trevor J. Edwardsc

Globally, many nations are legislatingaccess for bioprospecting purposes totheir biological and genetic resources.

South Africa, as a megadiverse country, hasrecently regulated bioprospecting, access andbenefit-sharing activities in accordancewith its obligations as a ratifying party tothe Convention on Biological Diversity. Thecontext and process of key legislation devel-opments in South Africa are discussed, priorto our presenting a critique which emphasizesthe practical impacts, especially on drug dis-covery, arising from the newly introducedsystems. Probable effects on existing bio-resource-based industries within SouthAfrica, together with current as well as futurebioprospecting activities, are assessed.Several practicalities of bioprospecting meth-ods have been poorly accommodated, result-ing in the development of impracticable andunnecessarily restrictive regulations. We con-clude that though well-intentioned, thesenon-facilitative regulations have placed adead hand on value-addition to South Africa’sbiodiversity. Bioprospectors will find it diffi-cult to continue with broad-scale screeningprogrammes given their user insecurity, legaluncertainty, and cost-inefficiency. Existingbioresource-based industries within SouthAfrica face potential closure in view of onerousbioprospecting permit application require-ments. An alternative, practical, CBD-com-pliant model on which to base urgentlyrequired legislative reforms is presented.

IntroductionSouth Africa, considered one of 17

megadiverse countries (nations thatcollectively account for 70% of globalbiodiversity),1 holds the Cape FloristicRegion (CFR),2,3 one of the six most signifi-cant concentrations of plant diversity in

the world, being the smallest but mostdiverse floristic kingdom known. Withover 19 500 indigenous plant species inabout 350 plant families, South Africaindeed has the richest temperate flora inthe world. In addition, three globalhotspots of biodiversity are currentlyrecognized within the country: the CFR,the Succulent Karoo, and Maputaland–Pondoland–Albany.4 Regional biotic ele-ments other than plants are similarlydiverse, exemplified by the fungi whichhave recently been estimated conserva-tively at 200 000 species5 and coastlinemarine life at over 10 000 taxa.6 The richfloristic and geological diversity7 of thecountry supports immensely rich anddiverse faunas, both invertebrate andvertebrate.6 Although the potential fornew commercial product developmentfrom South African bioresources is high,such that South Africa has been, andremains, a country of significant interestto bioprospectors, it may never prove tobe the land of ‘green gold’. Especiallywith respect to the quest for new pharma-co-active materials, it should be remem-bered that behind every commerciallysuccessful bioproduct lies substantialexpenditure in the form of extensivescreening programmes that will havediscarded literally thousands of commer-cially non-exploitable candidates beforediscovering a single commercially ex-ploitable product.

Historically, a lack of bioprospectinglegislation and associated regulations haspermitted almost unconstrained access toSouth African bioresources, with materialsbeing harvested, sometimes in destruc-tively excessive quantities, and beingexported to research and developmentnodes abroad, for innovative value addi-tion, and off-shore financial benefit. Theconsequence has been that the country asa whole, including traditional knowledge(TK)-holding communities and bio-resource providers, have not benefitedequitably from the commercial and othergains derived from local bioresourcecommercialization. Records, fifteen yearsago, reveal that the Dutch flower industryearned almost R300 million annuallyfrom the sale of freesias alone.7 The genusFreesia is near-endemic to South Africa.Similarly, large areas are under cultivation,with Gladiolus, Zantedeschia and Nerineplants in Holland and New Zealand.8

Revenue generated from sales of Pelargo-nium cultivars, derived from South Africanspecies and protected by Plant Breeders’Rights in the Netherlands, Germany andBelgium approximates US$6 billion annu-ally, with no associated revenue returns toSouth Africa.8

Several notable industries have devel-oped within South Africa,9 and havealready brought direct and indirect bene-fits to its citizens: these include the cutflower [primarily fynbos species (proteas,leucospermums and the like)],10 aloe(principally Aloe ferox Mill.),11,12 marula(Sclerocarya birrea (A. Rich.) Hochst. subsp.caffra (Sond.) Kokwaro), honeybush tea(Cyclopia spp.), and rooibos tea (Aspalathuslinearis (Burm. f.) R. Dahlgren)13 industries,amongst others. Recently introducedbioprospecting legislation14 and regula-tions15 in South Africa have sought toredress disparities in the sharing of bene-fits derived from bioprospecting. Theyreflect i) national sovereignty over accessto bioresources, ii) a recognition of tradi-tional knowledge and related intellectualproperty rights (IPR), iii) a need to sharebenefits equitably with stakeholders, andiv) a need to use bioresources sustainably.Each of these elements serves to align na-tional law with the objectives of the Con-vention on Biological Diversity (CBD).16

Broadly speaking, this approach to devel-oping access and benefit-sharing (ABS)legislation is supported increasingly bycountries both rich and poor in bio-resources. What is critical is that the im-plementation of such regulations shouldlead to a positive outcome. An emergingeconomy such as South Africa can illafford to restrain its own bioprospecting

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

aEthnobotany Unit, South African National BiodiversityInstitute, P.O.Box 52099, Berea Road 4007, South Africa.bSchool of Chemistry, University of KwaZulu-Natal,Durban 4041, South Africa.cSchool of Biological and Conservation Sciences, Univer-sity of KwaZulu-Natal, Private Bag X01, Scottsville 3209,South Africa.dResearch and Scientific Services, South African NationalBiodiversity Institute, Private Bag X101, Pretoria 0001,South Africa.eSchweickerdt Herbarium, Department of Botany, Univer-sity of Pretoria, Pretoria 0002.*Author for correspondence. E-mail: crouch@sanbi.org

Abbreviations: ABS, access and benefit-sharing; BSA,benefit-sharing agreement; CBD, Convention on Biologi-cal Diversity, the Rio Convention; CITES, Convention onthe Trade in Endangered Species; DEAT, Department ofEnvironmental Affairs and Tourism; DST, Department ofScience and Technology; DTI, Department of Trade andIndustry; IP, intellectual property; IPR, intellectual propertyrights; MOU, memorandum of understanding; MTA, mate-rial transfer agreement; NEMBA, National EnvironmentalManagement Biodiversity Act (Act 10 of 2004); PIC, priorinformed consent; TK, traditional knowledge; TOPS,Threatened or Protected Species; TRIPS, Agreement onTrade-Related Aspects of Intellectual Property Rights;WTO, World Trade Organisation.

activities through unreasonable and cost-prohibitive regulations. One threatenedprogramme is the Novel Drug Develop-ment Platform (NDDP) (www.sahealthinfo.org/noveldrug/), a broad-based consor-tium of South African researchers fromclinical and scientific disciplines based inlocal parastatals, universities and sciencecouncils. The objective of NDDP researchhas been to develop, from ethnomedi-cinal plants, novel drugs that are effec-tive against serious and comparativelyneglected diseases of the developingworld: malaria, tuberculosis and diabetesmellitus. The Department of Science andTechnology (DST), through the agency ofthe National Research Foundation (NRF),has provided Innovation Funds to sup-port the activities of the NDDP.

A critique of recent South African legis-lation and ensuant regulations governingaccess to biological resources for biopros-pecting purposes, and benefit-sharing, isthe focus of this paper. This review doesnot question the stated intentions of thelegislators. Our emphasis is placed onassessing the practicalities of these newlyintroduced systems, and we discuss theimpact that these are anticipated to haveon existing bioprospecting activities andbioresource-based industries both withinand outside South Africa, now, and intime to come. Particular emphasis isplaced on consequences for drug devel-opment. The implications of this legisla-tion for academic research (expanding theknowledge base of science without aprimary commercial interest) on SouthAfrican biodiversity, and the conservationthereof, form the subject of a separatereview.

Bioprospecting in South Africa:historical context

Bioprospecting involving traditionalknowledge

High costs associated with laboratoryassays, drug trials and subsequent regis-trations have largely limited biopros-pecting for new drugs within SouthAfrica to collaborative efforts betweenresearchers based at science councils,parastatals and universities. Such ven-tures have necessarily applied focusedselection procedures to identify the mostpromising subjects prior to initial screen-ing programmes. This improves cost-effectiveness. These projects focus pre-dominantly on ethnomedicinal knowl-edge, as it is widely acknowledged thatethno-directed approaches provide ad-vantages in the search for novel drugs.17–21

There is a wealth of documented tradi-tional ethnomedicinal knowledge in

South Africa, particularly relating to plantuse.22 That value is indeed inherent in thislocal knowledge base is exemplified bythe study of Fourie and co-workers,23 whoreported that approximately 81% of 300evaluated medicinal plants show biologi-cal activity in a range of target assays.Similarly, considerable success has beenachieved when an ethno-directed ap-proach is adopted for the search for newantimalarial drugs from South Africanplants. Extracts of 49% of all the speciesassayed exhibited promising antiplas-modial activity (IC50 ≤10 µg/ml).24 Theseregional experiences substantiate thenotion that bioresources used within localtraditional medicine systems constitutegood starting points for drug develop-ment research. However, the acceptancethat such selections are starting pointsonly, and not end products of a drugdevelopment pipeline, has fundamentalimplications for interpreting the value ofi) the bioresource, and ii) any traditionalknowledge associated with that resourcewhich may have led to its selection forinvestigation in the first instance. Thesame may be stated of non-medicinalbioprospecting activities for, for example,foods, beverages, fibres, and horticulturalcultivars, all of which require similarlyinnovative and costly research and devel-opment over extended periods. The notionthat bioresources associated with tradi-tional knowledge are for the most partcommercializable entities, simply await-ing ‘cherry picking’ by industry, is false.In reality, only a small minority of initialresearch subjects yield commercial orindustrial products.25 Market forces, toxic-ity and efficacy standards, production,processing and formulation challenges,and the sustainable use/supply of bio-resources are among numerous factorsthat ultimately limit the industrializationor commercialization of any conceptproduct. For CBD-ratifying countries,which include South Africa, further oblig-atory factors apply (Article 8j), namely,the approval and involvement of theholders of related traditional knowledgeand the equitable sharing of benefitsarising from the wider application of suchknowledge.16

Intellectual property rightsSince the signing of the CBD,16 there has

been contention26–28 over how countriesshould secure returns from intellectualproperty rights to ensure equitablesharing of benefits derived from the utili-zation of natural resources and theirassociated indigenous knowledge. It isrecognized that cultural groups who

contribute knowledge regarding the useof bioresources should benefit wheresuch knowledge (intellectual property)29

is the basis of successful new productdevelopments.30 The difficult issues ofdetermining traditional knowledge own-ership may have given rise to the reportedreduction in bioprospecting activities atseveral large pharmaceutical compa-nies.31 Risks faced by companies includefinancial losses, legal conflicts over IPRownership, and negative publicity linkedto perceived biopiracy. The historic ab-sence of formalized means of sharingeconomic benefits derived from the com-mercial exploitation of biodiversity withlandowners and/or custodians of tradi-tional knowledge has led to accusationsthat businesses are involved in bio-piracy.32–35 However, it has been arguedthat many cases of biopiracy have beende facto consequences of clumsy permitsystems that are too costly, time-consumingor impracticable to implement.35 Alongwith several other factors, poor legislationgoverning the use of natural resourcesand traditional knowledge has been citedas a limiting factor in the global advance-ment of bioprospecting.36–38

Bioprospecting industries within SouthAfrica have generally not aligned withbest practice, or shared equitably theirfinancial profits with TK-holding commu-nities from November 1995 to April 2008,this being the period between ratificationof the CBD by South Africa and the imple-mentation of regulations relating to bene-fit-sharing (Fig. 1). Doubtless this relatesin part to problems in identifying the trueholders or owners of the TK. Indirectbenefits (such as improved nutrition andhealth, job creation, and infrastructuraldevelopment through taxation) havenonetheless in the interim been distrib-uted broadly. While IPR returns mayaccordingly facilitate the distribution ofcommercial benefits to TK-holding com-munities, a universally accepted meansof implementing intellectual propertyrecognition is yet to be formulated. Cer-tain provisions made in the 1995 WorldTrade Organisation (WTO) Agreement onTrade-Related Aspects of IntellectualProperty Rights (TRIPS)39 were regardedto conflict with proposals made by theCBD.40 The convention has been seen toenshrine equity, and importantly, accessi-bility to bioresources. In particular, theCBD acknowledges the collective rightsof indigenous and local communities toexchange and develop biodiversity. Incontrast, TRIPS strongly favours privateownership of IPR and profit-based sys-tems.39,40 The absence of legislation pro-

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

tecting private ownership of IPR indeveloping countries was reported to becosting industrialized countries someUS$200 billion in lost royalties per annum.41

TRIPS attempted to narrow the gaps inthe ways these rights were protectedglobally, incorporating them into commoninternational rules. The disparity be-tween TRIPS and the CBD objectives hasled to much debate, particularly whenWTO members have been faced withpossible trade sanctions, if they declinedendorsement of the TRIPS agreement.This agreement did, however, acknowl-edge the right of countries to decide onthe details of their own patent systems40

and have been accordingly advised toexclude all life forms and related knowl-

edge from patentability, as was permittedunder the WTO.42 South Africa’s Depart-ment of Trade and Industry (DTI) hassubsequently published the PatentsAmendment Act of 2005,43 which requiresan applicant for a patent to furnish infor-mation relating to any role played by anindigenous biological resource, or tradi-tional knowledge, that may form part ofthe submitted invention and, if so, pro-vide proof that applicant(s) have receivedpermission to make use of the indigenousresource or traditional knowledge ortraditional use. Furthermore, there hasbeen increased international support foran amendment to the WTO agreement onTRIPS that would require the disclosureof origin of genetic resources and tradi-

tional knowledge. Presently, this amend-ment is supported by nearly 80 of the totalWTO membership of 151.44

Genetic and biological property rightsA new system of property and commer-

cial transactions has been created underthe CBD for genetic resources. The assign-ment of property rights is based on theneed to exercise physical control over theproperty, which in this case is geneticinformation.45 South African legislation—like that of many other countries—doesnot create a property rights system for thiscomponent, but relies on the propertyrights relating to the physical aspect, suchas the biological resource or its parts (suchas seeds) to define the legal status of theirgenetic and biochemical resource.45 Theremay be a basis in the case of geneticresources for distinction between therights over the physical entity (physicalproperty) and over the genetic informa-tion that the resources contain (intangibleproperty), which represents the real valueof the resources, and where the judicialproblems are especially complex.46 Insome countries, notably Ethiopia, thestate is considered the owner of thegenetic resources, although the owner ofthe land, who is deemed to be the ownerof the biological resources, has to be con-tacted to obtain permission to collect thebiological resource.47 In South Africa,legislation14 does not vest ownership ofgenetic resources in the state, unless theyoccur on state land.47 The landowner inSouth Africa, in terms of common law,owns both the biological and the geneticresources on or under his/her property.

Not all ownership cases are clear-cut,particularly with respect to communalland ownership, and related culture-basedconcepts of control. To avoid underminingresource user certainty, especially whenSouth African bioresources are exportedfor the purpose of bioprospecting, it isessential that users and providers sharea common understanding of the exactnature of the rights that are being grantedto the user by the ABS agreement. Accord-ingly, there is a need to determine andlegally acknowledge the differences be-tween the owners of the land from whichthe specimen is collected, the owner ofthe biological resource, and the owner ofthe genetic resource. This problem isexacerbated when one is dealing withtrans-boundary biological and geneticresources where different property regimesexist in different countries. To maximizecertainty, users will naturally tend to seekout resource owners whose ownershipstatus is most straightforward, resulting

Science Policy South African Journal of Science 104, September/October 2008 357

Fig.1. Process and context of development of bioprospecting, access and benefit-sharing legislation in SouthAfrica.

in a marginalization of communal land-owners.

Key legislative developments

White paperThe process and context of the develop-

ment in South Africa of legislation andregulations on bioprospecting, access andbenefit-sharing is summarized in Fig. 1,highlighting key events. A white paper48

on the Conservation and Sustainable Useof South Africa’s Biological Diversity wasgazetted in May 1997, with subsequentminor modifications by Cabinet, andadopted by Parliament.49 This policy48 out-lined the necessity for establishing legisla-tion and institutional structures to controlaccess to South Africa’s indigenous ge-netic resources. In addition, the proposedlegislation was to ensure that benefitsarising from South African bioresourcesserved the nation. Significantly, the whitepaper recognized that it was in the coun-try’s best interest to ensure that access tobiodiversity was not unnecessarily re-strictive, and further recommended thatlegislative conditions should stimu-late economic activity. Our critique con-siders whether these key policy consider-ations have been successfully achieved,given that both legislation (Act 10 of 2004,hereafter referred to as the Act)14 and Reg-ulations15 have subsequently been rati-fied. Relatively few parties to the CBDhave reached this commendable goal,with fewer than 10% of the CBD partieshaving adopted access and benefit-sharing legislation, ten years after theemergence of the convention. Virtuallynone has claimed that their ABS arrange-ments function effectively.50

The National Environmental Manage-ment Biodiversity Act (NEMBA)

NEMBA and the CBDThe draft Biodiversity Bill, formulated

by the Department of EnvironmentalAffairs and Tourism (DEAT), evolvedthrough 13 iterations prior to its releasefor public comment on 1 June 2003.Following inputs received and subsequentamendments made, the Act14 was gazettedin early June 2004 (Fig. 1). Besides regulat-ing bioprospecting, access and benefit-sharing activities involving indigenousbiological resources within South Africa,the Act (Ch. 6) frames Regulations relatingto the export from South Africa of indige-nous biological resources for the purposeof bioprospecting or any other kind ofresearch. The implementation of variouschapters in the Act has been staggered toallow for appropriate regulations to bedeveloped by the DEAT (Fig. 1).

The Act has sought to give effect toratified international agreements (forinstance, CBD, CITES), binding on thecountry, which relate to biodiversity. Itlegislates for, in part, i) the managementand conservation of biological diversitywithin the country and of the compo-nents of such biological diversity, ii) theuse of indigenous biological resources in asustainable manner, and iii) the fair andequitable sharing among stakeholders ofbenefits arising from bioprospectinginvolving indigenous biological resources,coinciding closely with the cornerstonesof the CBD. The convention refers toaccess to genetic resources, but does notdefine either access or use, implying thatit is possible to access biological resourcesfor commercial exploitation, withoutaccess to the genetic resources in thematerial. Accordingly, it is not clear in theCBD to what extent the use of the wholemedicinal plant, herbal plants or nutra-ceutical food is regarded as access. InSouth Africa, however, access legislationrefers to biological resources which, bydefinition, also includes the genetic re-sources.14 The definition of bioprospec-ting qualifies the activities, basing thedistinction on the intended use by theapplicant at the time of access, that is, forbioprospecting or for research other thanbioprospecting. The Regulations developthis further, especially within the exemp-tions included in them.15

Consideration of definitionsCentral to our treatise on the practicalities

of newly implemented systems are defini-tions provided by the Act14 of ‘biopros-pecting’ [Section 1(1)] and ‘indigenousbiological resources’ [Sections 1(1); 80(2)]:

‘bioprospecting’, in relation to indige-nous biological resources, means anyresearch on, or development or applica-tion of, indigenous biological resourcesfor commercial or industrial exploitation,including:

a) the systematic search, collection orgathering of these resources or makingextractions from these resources forpurposes of research, development orapplication;

b) the utilization for purposes of researchor development of any informationregarding any traditional uses of indig-enous biological resources by indige-nous communities; or

c) research on, or the application, devel-opment or modification of, any tradi-tional uses, for commercial or indus-trial exploitation.

In relation to bioprospecting, ‘indige-

nous biological resources’ have beendefined to include:(a)

i) [any living or dead animal, plant orother organism of an indigenous spe-cies]; b) [any derivative of such ani-mal, plant or other organism]; or c) [anygenetic material of such animal, plantor other organism], whether gatheredfrom the wild or accessed from anyother source, including any animals,plants or other organisms of indige-nous species cultivated, bred or keptin captivity or cultivated or altered inany way by biotechnology;ii) any cultivar, variety, strain, deriva-tive, hybrid or fertile version of an in-digenous species or of any animals,plants or other organisms referred toin subparagraph i); and:

iii) any exotic animals, plants or other or-ganisms, whether gathered from thewild or accessed from any othersource which, through biotechnology,have been altered with any geneticmaterial or chemical compoundfound in any indigenous species orany animals, plants or other organ-isms referred to in subparagraph i) orii); but excludes:

(b)

i) genetic material of human origin;

ii) any exotic animals, plants or other or-ganisms, other than exotic animals,plants or other organisms referred toin (a) iii); and

iii) indigenous biological resources listedin terms of the International Treaty onPlant Genetic Resources for Food andAgriculture.

No definitions have been provided inthe Act14 for ‘indigenous community’ or‘commercial or industrial exploitation’.Stakeholders who are expected to benefitfrom entering into benefit-sharing agree-ments (BSAs) with bioprospecting permitapplicants were defined as ‘a person,including any organ of State or commu-nity, providing or giving access to theindigenous biological resources to whichthe application relates [Section 82 (1)(a)],and an indigenous community i) whosetraditional uses of the indigenous biologi-cal resources to which the applicationrelates have initiated or will contribute toor form part of the proposed biopros-pecting; or ii) whose knowledge of ordiscoveries about the indigenous biologi-cal resources to which the applicationrelates are to be used for the proposedbioprospecting’ [Section 82(1)(b)]. TheAct14 requires [Section 82(2)] that the

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

applicant enters into BSAs with the abovestakeholders, as well as a material transferagreement (MTA) with the bioresourceprovider, approved by the minister,before the actual bioprospecting permitapplication will be considered (Figs 2 and3). Of particular significance are twoelements prescribed by the Act for theBSAs: first, [Section 83(1)(d)] that ‘…themanner in which and the extent to whichthe indigenous biological resources are tobe utilized or exploited for purposes ofsuch bioprospecting’ be set out and[Section 83(1)(e)] ‘…the manner in whichand which the extent to which the stake-holder will share in any benefits that may

arise from such bioprospecting’ be given.These onerous requirements well reflectthe ‘cherry picking’ notion of the biopros-pecting process that has been adopted bythe legislators. Indeed, the Act prescribesprocesses that better support the ABScontext of imminent bulk bioresourceextraction rather than the searching ofbioresources for potential value, orbioprospecting. The full benefits that arelikely to arise from the discovery phase ofa bioprospecting project are impossible todetermine, as is the manner and extent towhich the bioresources might be utilized(if, ultimately, at all). Based on the aboveperceptions, realistic BSAs are thus

extremely difficult to negotiate, with theprocess being unduly difficult, costly andonerous for the applicant. To minimizeexpenses associated with MTAs and theirrelated BSAs, applicants will naturallyseek out resource owners whose owner-ship status is unambiguous, and who areleast demanding, complicated, or unob-structive as negotiating partners.

Mandates, responsibilities andprocedures

The Act14 has gone as far as detailingspecific mandates and responsibilities[Section 82(4)], and prescribes variouspermitting procedures (Section 81) that

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 provincialrequirements.

should arguably have been better assignedto the Regulations. The focus on the detailsof processes has detracted effectivelyfrom key principles considered by thewhite paper,48 namely, needs to facilitateaccess and stimulate sustainable economicdevelopment. Although the Act14 hasdelegated a range of responsibilities toundefined ‘issuing authorities’ (Section82), the Regulations15 later make clear[Ch. 2, 6(1)(a)(b)] that the minister of theDEAT is the issuing authority for biopros-pecting permits, as well as for integratedexport and bioprospecting permits. Interms of institutional mechanisms, theAct does not identify a single ‘ABS focalpoint’, a desirable feature stressed by theBonn Guidelines.51 However, the officeof the minister of the DEAT deals withthe issuing of bioprospecting-relatedpermits, and could thus be considered thenational focal point for bioprospectingissues.

Bioprospecting, Access andBenefit-sharing Regulations

Act–Regulations conformityBecause the Act14 prescribes inappropri-

ate and detailed processes, little latitude isavailable for subsequent implementationof a practicable system in terms of regula-tions. Rather than redress the very obviousdeficiencies of the Act’s Chapter 6 throughan immediate legal reform process, theinherent problems have been com-pounded through promulgation of Act-compatible Regulations15 that became ef-fective from 1 April 2008 (Fig. 1). Proce-

dures not prescribed by the Act have beensubsequently detailed by the Regulations,and detailed application forms have beenappended to facilitate permit applicationsof various types, as well as MTAs andBSAs. The minister is required to issuepermits after: i) ensuring that the interestsof stakeholders (including indigenouscommunities) are protected (throughBSAs and MTAs), ii) that prior informedconsent has been obtained, and iii) fulldisclosure of information relating to theproposed bioprospecting has been sub-mitted to the stakeholders (Fig. 2). Thediscovery phase and/or commercializa-tion phase of a bioprospecting projectmay only be initiated with a biopros-pecting permit issued by the minister[Ch. 1, 4(1)].15

Consideration of definitionsA number of definitions not provided

by the Act are contained in the Regulations.Of particular interest in relation to BSAs isthat for ‘indigenous community’, mean-ing ‘any community of people living orhaving rights or interests in a distinctgeographical area within the Republic ofSouth Africa with a leadership structureand a) whose traditional uses of the indig-enous biological resources to which anapplication for a permit relates, haveinitiated or will contribute to or form partof the proposed bioprospecting; or b)whose knowledge of or discoveries aboutthe indigenous biological resources towhich the application for a permit relatesare to be used for the proposed biopros-

pecting.’15 The Regulations do not definethe required ‘leadership structure’ of theindigenous community, to allow for theunambiguous identification of appropriateTK-holding indigenous communitieseligible to enter into BSAs. The ‘commer-cialization phase of a bioprospectingproject’ means ‘any research on, or devel-opment or application of, indigenousbiological resources where the nature andextent of any actual or potential commer-cial or industrial exploitation in relation tothe project is sufficiently established tobegin the process of commercialization’.The definition provided15 for ‘commer-cialization’ (pp. 7–8) includes the follow-ing activities in relation to indigenousbiological resources—

a) the filing of any complete intellectualproperty application, whether inSouth Africa or elsewhere;

b) obtaining or transferring any intellec-tual property rights or other rights;

c) commencing clinical trials and productdevelopment, including the conductingof market research and seeking pre-market approval for the sale of result-ing products; or

d) the multiplication of indigenous bio-logical resources through cultivation,propagation, cloning or other meansto develop and produce products,such as drugs, industrial enzymes,food flavours, fragrance, cosmetics,emulsifiers, oleoresins, colours andextracts.

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 isuncertain.

In relation to this definition (part c),‘product development’ is not defined, butmay reasonably include drug formula-tions, which would in fact be requiredprior to the clinical trial phase. Productdevelopment could also include newproducts based on established and well-branded commodities, such as rooibos:the development of soaps and handcreamsfrom a plant historically marketed as abeverage. Further, in relation to c), theconducting of market research is typicallyundertaken by bioprospectors prior evento embarking on the costly discoveryphase of a project. If there is no marketniche, then there is no motive to develop aproduct. Accordingly, the inclusion ofmarket research as a defined componentof ‘commercialization’ is inappropriate.Similarly, so is part d) of this definition, foragroprocessing research is at times an es-sential prerequisite to determining, dur-ing the discovery phase, whether aproduct can ever be taken beyond thepoint of proof of principle. When regula-tions relating to access to bioresources aretoo commercially biased, they typicallytend to be very restrictive, and impactnegatively on basic research.52,53 Wide-spread suspicion that bioprospecting willtake place under the guise of basic re-search stimulates over-regulation, well-exampled by legislation drawn up byseveral developing nations, including SriLanka, Brazil and the Philippines.53 It istherefore important to designate clearlimits between access to material forbioprospecting purposes and access forany other kind of research. Given thebroad definition of ‘bioprospecting’ in theAct,14 this has largely been achieved—with the exception of research requiredto identify candidate bioprospectingsubjects. Logically, the initial identifica-tion of a bioprospecting subject inevitablyinvolves some research, which by defini-tion [Section 1(1)]14 is bioprospecting.Initially, this research would involvefieldwork that includes interaction withcommunities, as well as mining of dataheld in both public and privileged domains.Basic research of this nature forms a stan-dard and essential part of the discoveryphase of any bioprospecting project. Interms of the Regulations,15 no distinctionis made between the various componentsof the discovery phase, which is defined(p. 9) as: ‘any research on, or developmentor application of, indigenous biologicalresources where the nature and extent ofany actual or potential commercial orindustrial exploitation in relation to theproject is not sufficiently clear or knownto begin the process of commercializa-

tion’. Accordingly, the undertaking ofresearch for the purposes of identifying asubject worthy of further (discoveryphase) bioprospecting is illegal without abioprospecting permit. However, bio-prospectors are nonetheless required toidentify their subjects before applying fora permit,15 placing them in a paradoxicalCatch 22 predicament: they will havecontravened the law in attempting tocomply with it.

The seriousness of this situation may beappreciated when one considers that aperson is guilty of an offence if thatperson, without a permit, undertakesbioprospecting involving indigenousbiological resources [Ch. 4, 20(a)(i)].15 Aperson, so convicted, is liable to imprison-ment for a period not exceeding fiveyears, an appropriate fine, or to both afine and imprisonment [Ch. 4, 21(1)(a)(b)(c)].15 Despite the above implica-tions, ‘research’ is not defined in either theAct or the Regulations. While there is aclear need to ensure that the rights of allstakeholders (sensu Act)14 will be protectedin instances where a commercially orindustrially valuable discovery is madeduring basic research, the researchers, soinvolved, clearly also need protection.The regulations have appropriately madeallowance for serendipitous events whichlead to an application for a bioprospectingpermit, although full explanations re-garding activities leading to such finds arerequired by the minister (Ch. 2, 9(2)(b)].15

Applicants for bioprospecting permits –who need apply?

Importantly, the definition of those whoengage in the multiplication of indige-nous biological resources through culti-vation or propagation to generate prod-ucts as engaging in commercializationrequires that they, too, obtain biopros-pecting permits from the minister. Ac-cordingly, for example, every grower whosupplies the rooibos tea industry withplant material needs to apply for a permit,and to secure BSAs with relevant stake-holders. This outcome raises the issue ofthe identity of the party in the value-adding chain that needs to secure abioprospecting permit to operate withlegal compliance. In this regard, the Regu-lations exempt those who trade in com-mercial products purchased from abioprospector, provided that the biopros-pector has a relevant bioprospectingpermit (Exemptions 2.3).15 However,those involved in the ‘commercializationphase of a bioprospecting project’ would,by definition, include all those who de-velop or apply indigenous biological

resources where the nature of the projectis sufficiently established to start a processof commercialization. Not only wouldgrowers require bioprospecting permits,but also commercial gatherers/wild-crafters, formulators, processors, packag-ing firms, and marketers, besides thosewho hold IPR in the form of patents.Neither contractor nor sub-contractorinvolved in the bioprospecting processappears to be exempted. The requirementin the regulations for non-South Africansto apply for a permit in conjunction with aSouth African judicial body or citizenshould encourage the establishment ofpartnerships, and lead to technologytransfer and information sharing. Suchpartnerships nevertheless place an onerouslegal risk on the South African partyshould the non-South African party(ies)renege on any agreement.

Position of existing industriesIn that a bioprospecting permit is now

legally required for any stage of a bio-prospecting project, definitions providedby the Regulations15 for ‘the discoveryphase of a bioprospecting project’, andthe ‘commercialization phase of a bio-prospecting project’, serving principallyto inform existing bioresource-basedindustries that they are indeed engagedin a commercialization phase, and arerequired to apply for a bioprospectingpermit within six months from 1 April2008 [Section 22(2)].15 This means thatmost existing industries (for example,rooibos, marula, honeybush, Aloe andHoodia) need to take into considerationstakeholder interests [Section 22(3)(a)(b)]:failure to secure BSAs acceptable to theminister, notwithstanding his/her inter-vention, will legally require the indus-try(ies) to terminate their operations[Section 22(4)(a)].15 This positions newly-defined stakeholders who may regardtheir past benefits (if any) to be inequita-ble, to hold a veto on whether establishedindustries may continue their business.Genuine TK-holding communities, inparticular, are now empowered throughbeing dealt an extremely strong negotiat-ing hand by the DEAT. Although exact fig-ures of the size of communities involvedin, for example, the Cape aloes (Aloe ferox)industry in the southern Cape are notavailable, it is likely that several thousandindividuals benefit directly or indirectlyfrom harvesting, processing and sellingaloe juice, and increasingly, aloe gel.11,54,55

Inexplicably, only two industry subdivi-sions have been exempted from the Regu-lations15 (though seemingly withoutundergoing the public consultation pro-

Science Policy South African Journal of Science 104, September/October 2008 361

cess prescribed by Sections 86, 99 and100):14 the aquaculture or mariculturesector that produces material for con-sumption (Exemptions 2.7), and the exist-ing local and international cut flower andornamental plant market segment (andthose who supply them)(Exemptions2.6).15 However, the South African horti-cultural industry has little respite, as itsinherent potential to stagnate is nowframed by the same regulations: thedevelopment of new plant varieties andrelated products—competitive advancesessential for sustaining this fashion-linkedsector—are explicitly not exempted (seeExemptions 2.4.2).15

Practical implications for futurebioprospecting

The Act and Regulations require thatprior to engagement in the discoveryphase of bioprospecting, the applicantneeds to obtain MTAs (which are reason-ably attainable) and BSAs (which havepractical and financial complications). Itdoes not make sense to negotiate a BSAbefore a permit has been granted (ifrequired) to collect a bioresource forresearch purposes. Nor for that mattershould the negotiation of BSAs precedethe assessment of the nature and extent ofany actual commercial or industrial valuein relation to a bioresource, prior to anyprocess of commercialization. Negotia-tions surrounding BSAs will focus in thevast majority of cases on biodiversityelements that make merit-worthy sub-jects for preliminary discovery-phaseresearch—being of unknown value—butin reality may never lead to a commercialor industrial product. As few as one in250 000 plant samples leads directly to acommercial drug.25 Such negotiationsshould take place at the start of the com-mercialization phase rather than priorto the discovery phase, as is currentlyrequired (Fig. 3). Memoranda of under-standing (MOUs) agreeing to negotiateBSAs at a later stage would suffice in thecase of landowners signing MTAs: in-deed, the MOU should be incorporatedinto such MTAs. Further, there is a riskthat considerable resources (both humanand financial) will be wasted if theminister approves a range of negotiatedagreements and a bioprospecting permit,only to have a provincial conservationauthority refuse a collection permit onecological grounds. In the current system(Figs 2 and 3) qualified approval to collectthe amounts required should accordinglyfirst be obtained from the provincialauthorities. However, neither the Act northe Regulations stipulate that bioresource

collection permits are required followingthe successful granting of a bioprospectingpermit. This is currently presumed (Figs 2and 3), particularly in relation to CITESand Threatened or Protected Species(TOPS), and as national legislation (e.g.NEMBA)14 overrules existing provinciallegislation only if the latter is in conflict.Clarity in this respect is essential, as wellas on the nature of related ‘integratedpermits’ provided for in the Act [Section92(1)(b)],14 but surprisingly not dealt within the Regulations.15 Provision for appealsagainst decisions by the minister areaccommodated [Ch. 3(14)(15)]15 (Fig. 2), asare challenges to decisions made by pro-vincial conservation authorities, whichneed be addressed through the Promo-tion of Administrative Justice Act.

Dynamic BSAs make allowance forchanges in benefit-sharing arrangementsas concepts develop towards products.The Act does allow for amendments tosuch BSAs [Section 83 (1)(f)],14 going as farin the Regulations as requiring theirregular review (Annexure 8, 11).15 How-ever, applicants will undoubtedly have todeal with the perceptions of TK-holdingcommunities and/or bioresource provid-ers that bioprospecting generates finan-cial returns in the form of fees, upfrontpayments, milestone payments androyalties. The South African legislation’s‘cherry picking’ construal of the usualbioprospecting process could transfer to aTK-holding community level, especially ifthe legislating department develops andimplements concurring community edu-cation programmes. The very processprescribed by the legislation/regulationswill reinforce this perception, given theinappropriate timing of the BSA negotia-tions (Figs 2 and 3), and the bureaucraticcharacter of the permit process (Annexures2 and 4).15 The prescribed format for BSAs(Annexure 8)15 includes suggestions fornon-monetary and ‘in kind’ benefits, as

well as monetary benefits. The benefitsidentified in BSAs negotiated at the be-ginning of the bioprospecting processcannot realistically consider any majorfinancial returns; the total benefits derivedmay ultimately take the form of only newor augmented information, and voucherand other preserved specimens havingbeen lodged with museums or herbaria.Such actual benefits from the discoveryphase of bioprospecting may be perceivedas irrelevant and insufficient to communi-ties, whose expectations are probablyhigher and financially orientated, giventhe prevalence of rural poverty. How-ever, some international case studies haveshown that some traditional people donot always seek financial rewards in suchsituations.56,57 BSAs and their linked PICcomponent, however, may well prove tobe one of the most complex, cumbersomeand difficult aspects for a bioprospectingpermit applicant. While the regulationsrequire that PIC be obtained from everystakeholder who will be providing thebiological resource and/or the indigenousknowledge, they do not elaborate onthe preferred means of engaging withcommunities.

The Act legislates for the establishmentof a Bioprospecting Trust Fund (Section85)14 into which all moneys arising fromBSAs and due to stakeholders need bedeposited. The Regulations [Ch. 3, 19(3)(b)]require that the director-general shouldmanage and be accountable for the TrustFund, and oversee the payment of what isdue to stakeholders [Ch. 3, 19(4)(c)].15

In addition, it is sometimes very difficultto determine the identity of the bioresourceowner, and more so, the identity of thegenetic resource owner (see Box 1). Suchpotential stakeholders include privatelandowners, tribal authorities, municipal-ities, provincial authorities and the state.In this regard, harmonized benefit-sharinglegislation, compatible with that of adja-

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

BOX 1: Who are the stakeholders?

One of the key difficulties is the identification of all the relevant stakeholders. For example,where data for candidate materials for bioprospecting are obtained from the published litera-ture, many (particularly plants) will likely be recorded as being used traditionally by severalcultural groups, few if any of which are readily traceable to representative ‘indigenous commu-nities’ with what must be assumed to have the requisite leadership structure. The likelihood ofseveral stakeholder groups being only loosely identified is great where a plant has beenreported in the literature as used traditionally by several ethnic groups. An example can befound with ‘Cynodon dactyon DC. [which] is used medicinally by the European in theTransvaal… for heartburn… and as a styptic to wounds.A decoction of the root is a ‘Dutch’ rem-edy for indigestion and a blood purifier…. The Xhosa use a decoction as a lotion for sores andswellings… used by the Sotho in Basutoland against sorcery… and as a charm… a decoctionis used in the Philippines as a diuretic and pectoral… and the plant is used medicinally inIndia’.58 Accordingly, applicants face tough challenges in regard to identifying communities withwhich to establish BSAs, and the validity of community resolutions acquired that give the PIC ofTK-holders.

cent countries, is desirable. Much hingeshere on decisions made at a global scale,particularly with regard to intellectualproperty and the patenting of biologicalmaterial59 as well as the negotiation ofan International Regime on Access andBenefit-Sharing. Whereas individuallandowners signing MTAs may benefitthrough BSAs, the Regulations make noprovision for individual TK-holders (forexample, a traditional healer with uniqueknowledge) entering into a BSA; ratheronly for indigenous communities (An-nexure 8, 4).15 Problems can also arise fromclaimants being located in differentcountries, e.g. Hoodia species are used asappetite suppressants by the San who,

together with Hoodia, are located in sev-eral southern African countries.60,61 Someof these communities may give consentwhile others may not, and others mayremain completely unaware, despite thebest of efforts to inform them. However,assistance may be requested from theminister to attempt to conclude the neces-sary agreements (Annexure 2, Part 1, 34).15

There is also a possibility of identificationor emergence of additional stakeholdersor claimants during a discovery phase ofbioprospecting (which typically extendsfor several years). In addition to TK-holdingcommunities and bioresources providers,there are scientific experts who, throughtheir knowledge of botany, pharmacology,

phytochemistry, and drug development,may be eligible and legitimate claimantsfor benefits, even though they were notidentified in the original approved BSA.These considerations need to be tabledduring reviews of BSAs. By and large,benefits should be directed in such amanner as to promote the sustainable useand conservation of biodiversity (BonnGuidelines, clause 48).51

From the example (see Box 2) it is clearthat the mandatory bioprospectingprocess (Fig. 2) places an impediment onvalue-addition to South Africa’s bio-diversity. Bioprospectors will be disin-clined to continue with broad-scalescreening, given the uncertainty and

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 withcurrent South African bioprospecting regulations (Figs 2 and 3), withthe following illustrative example. Three hundred of approximately20 000 taxa in our national flora are identified as worthy of investigationfor antiplasmodial activity, with the intention of developing a newantimalarial drug, based on information in the public domain andthrough a targeted ethno-directed selection approach. At the projectoutset it is expected that following extensive in vitro (and limited smallmammal in vivo) screening of plant extracts, two leads (from one or twotaxa) will be taken through to the commercialization phase, as definedby the Regulations.But there is no guarantee that any marketable prod-uct will ultimately arise from this work.

The identification of potential localities for the supply of each of the300 taxa is then undertaken, requiring site visits to determine whetherenough material can be collected sustainably from the property of asingle landowner, or whether this needs to be from several providers.One to several MTAs per taxon and one to several BSAs per taxon needto be negotiated with landowners (total of more than 300 MTAs andmore than 300 BSAs). This will require, per taxon, a number of meet-ings at one or several potential collection localities that may be geo-graphically distant from one another. Once the full locality data of theessential bioresources have been determined—a regulatory require-ment (Annexure 7, 4)15—it is necessary to identify all stakeholder com-munities whose TK will contribute to the proposed bioprospecting.More than one community could be identified per use application, asTK is often shared by different user groups within South Africa. BSAswith TK-holding communities need to be signed for each taxon, result-ing in more than 300 BSAs. (Notably, no directory of indigenouscommunities and their appointed representatives is in existence.Presumably, the responsibility for determining whether any given suchcommunity has an acceptable ‘leadership structure’ defaults to theminister, given that this element is not defined.14,15)

Negotiating each BSA will probably require several expensive meet-ings with large community groups, again, perhaps geographicallydistant. Each BSA is only complete when accompanied by a resolutionfrom the TK-holding community that they have identified a representa-tive that is authorized to enter into a BSA on their behalf, that they havefull knowledge of the proposed project, and that they provide theirrecorded consent (Annexure 8, 4.4).15 Accordingly, more than 300resolutions need be acquired. While clearly impracticable, if oneassumes that all MTAs, BSAs and community resolutions are thusobtained (more than 900 legal agreements and more than 300 commu-nity resolutions), these then need to be submitted with a completedbioprospecting permit application (and a R5000 non-refundable fee) tothe minister for consideration. Should the minister be dissatisfied withany one of the 900 plus legal agreements, then he/she is obliged towithhold the permit [Ch. 2, 8(1), 11(1)(a)].15 Alternatively, to minimizethis risk, separate bioprospecting permits may be submitted per taxon,

each with the required fee of R5000. If the permit(s) is/are granted,applications to collect bioresources (at least TOPS taxa) are thenmade to provincial conservation authorities. This is likely to involve allnine of South Africa’s provinces, given the project scale. Collection ofsome taxa will be permitted, whilst others will be declined. Followingbioresource collections at sites that were visited earlier and evaluatedfor harvesting suitability, the discovery phase of the bioprospectingproject then begins with the first legally permitted in vitro test.

After several years of research and development, and obligatoryannual status-reporting to the minister, two leads are discovered thatare worthy of ‘commercialization’, that is, appropriate for patenting oragroprocessing research. In the interim, the Regulations require thateach of the more than 900 MTAs be reviewed by the applicant andrespective stakeholders at unstipulated but regular intervals, andamended where necessary on the basis of new information (Annex-ure 8, 11).15 With only two eventual leads that may be viable, all but ahandful of the 900 plus legal agreements that were negotiated will yieldno future monetary benefits for stakeholders, as research on theirrelated bioresources comes to an end.The fee to the minister of R5000is insignificant relative to other costs that will necessarily be incurred bythe applicant. Conceivably, the cost of conforming to the bureaucraticrequirements of the regulations will be greater by several orders ofmagnitude than the cost of actually undertaking the discovery-phaseresearch.

Multinational industries seeking to bioprospect South African bio-resources, especially its flora, will likely source non-endemic elementsin neighbouring countries and endemic species from existing ex situholdings, particularly in Europe and the U.S., with no direct benefitsreturning to South Africa. In the case of in-country projects such as theNDDP, one wonders whether the local funding body (DST) will continueto invest, given the cost of compliance with these mandatory regula-tions.Historically, the funding focus of such bodies has been innovativeproduct development rather than on i) pre-collection fieldwork, ii) meet-ings to negotiate BSAs and MTAs, and iii) servicing of BSAs—in part,for example, fee provisions, upfront payments, equipment provision,training in scientific, legal and management issues, infrastructuredevelopment, and community development projects (Annexure 8, 9).15

The regulated transformation of bioprospecting activities in SouthAfrica from a product-centred approach to one which is process-drivenhas commendable attributes, for it certainly empowers TK-holdingcommunities.As the Regulations stipulate that a bioprospecting permitcannot be awarded to an applicant unless relevant MTAs and BSAs(with community resolutions) have been concluded to the satisfactionof the minister [Ch. 2, 8(1), 11(1)(a)],15 both communities and bio-resource providers (landowners) effectively hold a veto on potentialinnovation and development of elements of the biota. The minister ofthe DEAT is similarly empowered.

cost-inefficiency. Similarly, bioresourceaccess is affected adversely, which begsthe question of whether South Africa has,in implementing bioprospecting and ABSlegislation and regulations,14,15 ultimatelyfailed to meet its sustainable-use CBDobligations. These require the promotionof the sustainable use of South Africancomponents of biological diversity andensuring the fair and equitable sharing ofbenefits arising out of the exploitation ofgenetic resources (Article 1).16

Alternative regulatory modelLess restrictive, and more appropriate

and practical would be to negotiate BSAsonly after the commercial or industrialvalue of a bioresource has been deter-mined. In the above illustrative example,if only two leads show commercial poten-tial, then between two and seven BSAsare likely to require negotiation. Figure 4presents an alternative model for practicalbioprospecting regulatory processeswhich will conform to CBD objectives. Weinterpret Article 8(j) of the CBD16 as indi-cating that approval and involvement ofholders of TK is required for the widerapplication (namely, commercializationor industrialization), but not for the initialexplorative research (the discovery phase).The research undertaken here is notion-ally distinct from its application; were itnot, then all research associated with bothtraditional knowledge and bioresources(for example, fundamental ethnophar-macology, natural products chemistryand ethnobiology) would be subject to

PIC from TK-holding communities. Theimplementation of this model requiressignificant reform of both the relevantchapters (6 and 7) of the Act14 and Regula-tions.15

The model respects (through MTAs) thebioresource provider ’s permission toaccess bioresources, and positions TK-holding communities—with their vetooption—to offer PIC before the widerapplication of their knowledge. Thesecommunities then also share benefitsaccording to mediated BSAs negotiatedwith the applicants. Mediators involvedin negotiations should include represen-tatives of the DTI, as well as the DEAT.Significantly, once a promising lead hasbeen identified and the commercializa-tion phase is to commence, the BSA-negotiating positions of communitiesand/or bioresource providers becomestrengthened substantially. This is partic-ularly so, given that a large investmentwould already have been made by thebioprospector in the discovery of acommercializable lead. Bioprospectorsmay thus reasonably argue against thisveto clause, and seek instead to resolveBSAs through arbitration, if necessary.However, national CBD compliance maybe compromised thereby. The existingcostly and potentially wasteful require-ment for generating numerous contractsthat could soon become defunct is alsoavoided. Regulatory requirements, suchas monitoring of the BSA agreements andensuring compliance, imply the availabil-ity of informed capacity, as these are not

simple processes to implement. The intro-duction of a system that generates fewerBSAs will ease the workload on the officeof the minister, and release capacitytherein to mediate the conclusion ofMTAs and their regular reviewing, and toliaise further with provincial authoritieswhose permitting decisions may impactupon value-adding activities of nationalrelevance.

According to the model (Fig. 4), a detailedbioprospecting proposal is considered bythe minister, and following authorization,the discovery phase proceeds. This phaseis tracked by DEAT. When the commer-cialization phase of bioprospecting isreached, and appropriate BSAs (with PICfrom TK-holding communities) havebeen negotiated for a particular lead, theminister is then approached for a bio-prospecting permit to continue work. Weadvocate that provisional patents belodged prior to negotiations with eitherthe bioresource providers, or indigenouscommunities, to protect IP generatedthrough innovative research.

Proposed amendments to the Act andRegulations

The National Environment LawsAmendment Bill,62 which was publishedin the Government Gazette No. 31075 of 20May 2008, drafts proposed amendmentsto Chapters 6 and 7 of Act 10 of 2004.These amendments stipulate that anyoneengaging in the discovery phase ofbioprospecting has to notify the minister,providing particulars in a format yet to be

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

Fig. 4. Schematic representation of a rationalized bioprospecting process.

published. Bioprospectors involved inthis discovery phase need to sign acommitment to comply with the legalrequirements when the commercializa-tion phase of bioprospecting is reached.Thus a bioprospecting permit (and theassociated need to negotiate BSAs) wouldonly be required at the start of the com-mercialization phase of bioprospecting.The bill also contains a proposal toexpand the concept of stakeholders toinclude specific individuals whose tradi-tional uses of knowledge of, or discover-ies about, the indigenous biologicalresources will form part of the proposedbioprospecting. The proposed amend-ments would entitle the director-generalof DEAT to appoint a trustee to adminis-ter the Bioprospecting Trust Fund onhis/her behalf, and/or to allow individualtrusts to be established, as long as they aremanaged in compliance with relevantlegislation. Provision is also made for therenewal and amendment of permits, andthe increase in fines. Possibly the mostsignificant proposal relates to the expan-sion of arbitrary powers provided to theminister under Section 86 of an amendedAct:

1) The Minister may by notice in theGazette –

(b) declare that this Chapter [on biopros-pecting, access and benefit-sharing]does not apply to certain categories ofresearch involving indigenous biologi-cal resources or commercial exploitationof indigenous biological resources.

Notably, the minister is still required interms of the Act [Section 86(2)] to follow aconsultative process, in accordance withSections 99 and 10014 prior to publishingan exemption notice. Such consultationincludes giving notice of the proposedexecution of this power through publica-tion in both the Gazette and at least onenational newspaper, allowing due timefor public comment.

The above amendments have beendrafted for public comment, but remain tobe accepted, possibly in modified form.

ConclusionSouth Africa, with its unique and remark-

ably rich biodiversity, and a strong foun-dation of biodiversity research (forexample, in botany63 and horticulture64),could be a source of many new commer-cially exploitable leads and beneficialproducts. Directed research must beallowed to progress with minimal re-straint, especially in our emerging econ-omy. Such development, coupled tosound natural resource management, can

generate both financial and non-financialbenefits. This is desirable in South Africa,where exploitation of bioresources issought in a sustainable manner. The rideris whether the regulations will encouragethose with an interest in biodiversity andits products to act responsibly and equita-bly in sharing the benefits with qualifyingparties. Or will the regulations coerceinterested and affected parties furtherinto a situation where they are tempted,either to ‘fly under the radar’ whenaccessing bioresources (evasion, in pref-erence to compliance) or to seek resourcesfrom adjoining countries with either lessrestrictive laws or a legislative void? It isessential that regulations allow biopros-pectors to comply with regulatory mea-sures with ease. Such facilitative legisla-tion can nurture value-adding activity,both locally and abroad, for the benefit ofSouth Africa as well as the global commu-nity. Current well-intentioned but imprac-ticable legislation14 and regulations15

could impose severe restraint on biopros-pecting activity (and benefits derivedtherefrom) in years to come, besides col-lapsing our existing bioresource-basedindustries within the country. While leg-islators may argue for purposive interpre-tation of their bioprospecting definition,the exemptions given to some indus-tries, and not others, indicate otherwise.Gazetted proposals for expansion of thepowers of the minister to exempt selectedbioprospecting/commercialization activi-ties62 raises uncertainty for bioprospec-ting, given the arbitrary nature of thisprocess. What are the criteria for exemp-tion, and who is deemed eligible thereto?Positive alternatives to the current legisla-tive scenario will require substantial revi-sions of both the relevant chapters of theAct and associated Regulations—be-yond current proposals.62 These includechanges to, or the addition of, definitionsto provide legal certainty: both ‘commer-cialization’ and ‘research’ require recon-sideration as they are critical to the deter-mination of the commercialization phaseof bioprospecting. Crucial to amend-ments would be a fundamental shift inemphasis from an implicit ‘cherry-pick-ing’ perspective of the bioprospectingprocess, to one that recognizes biopros-pecting as a course of action involvingextensive search (prospecting) for valuein bioresources. This search phase re-quires cost-efficient facilitation by regula-tors, providing for user certainty, ratherthan the restrictive and expensive bu-reaucracy that now exists.

We outline an alternative, practicalmodel on which to base legislation that

allows South Africa to add value to itsbiodiversity, while also remaining compli-ant with the CBD. The South Africanlegislature should take heed of the poten-tially detrimental consequences for thenational economy if appropriatelyfacilitative laws and regulations are notput in place with the greatest of speed.

Received 1 July. Accepted 23 September 2008.

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