oue

Pr

nering for skills transfer and export opportunities; and

ernment initiated and supported the creation of biotech-

impetus. The BRICs are located in the Western Cape the

Review TRENDS in Biotechnology Vol.24 No.12increased foreign investment. Moreover, biotechnology isalso seen as a tool that can be used to address many of themajor challenges facing the developing world, includingSouth Africa, by way of improved food security through thedevelopment of genetically engineered crops and improvedhealth care through the development of vaccines, diagnos-tics and treatments for threatening and current infectiousdiseases (e.g. tuberculosis, malaria and HIV/AIDS).

Cape Biotechnology Initiative (Cape Biotech; http://www.capebiotech.co.za) and in Kwa-Zulu Natal theEast Coast Biotechnology Consortium (EcoBio), operatingunder the trade name LIFElab (http://www.lifelab.co.za).These two BRICs have a strong focus on human healthbiotechnology R&D. The National Innovation Centre forPlantBiotechnology (PlantBio; http://www.plantbio.org.za),also located in Kwa-Zulu Natal, has a focus on plantbiotechnology, whereas the Biotechnology Partnershipsand Development (BioPAD; http://www.biopad.org.za)

Corresponding author: Cloete, T.E. (eugene.cloete@up.ac.za).Available online 30 October 2006.

www.sciencedirect.com 0167-7799/$ see front matter 2006 Elsevier Ltd. All rights reserved. doi:10.1016/j.tibtech.2006.10.009Biotechnology in SThomas E. Cloete, Louis H. Nel and Jacq

Department of Microbiology and Plant Pathology, University of

Since adopting the National Biotechnology Strategy in2001, the South African government has establishedseveral regional innovation centres and has put in placeinitiatives to encourage international partnerships thatcan spur internal development of life science ventures.This strategy seeks to capitalize on the high quality ofresearch carried out in public research institutions anduniversities but is hampered, somewhat, by the lack ofentrepreneurial culture among South African research-ers due to, among other reasons, the expenses involvedin registering foreign patents. Although private sectordevelopment is still relatively embryonic, start-ups arespinning out of universities and pre-existing companies.These represent a vital source of innovations for com-mercialization in the future, provided that the challengesfacing the emerging South African biotechnology indus-try can be overcome.

IntroductionFor many years, South Africa was politically isolated fromthe international community, which caused it to lookinward and to develop its own scientific and technologicalcapacity. The major areas that have benefited from thisapproach were the arms, mining and textile industries. Bycontrast, biotechnology was not seen as essential for thesurvival and self-sufficiency of the country [1,2]. In 1994,the political landscape in South Africa was completelytransformed, and a successful biotechnology industry isnow seen as having the potential to impact positively onthe social and economic development of South Africa [3].Biotechnology is recognized as a profit-generating activitythat can contribute to economic growth, and the establish-ment of new small, medium and micro-enterprises(SMMEs) can provide employment opportunities at differ-ent levels of expertise, thereby contributing to job creationand poverty alleviation. Furthermore, the biotechnologyindustry has the potential to address some of the historicaland socioeconomic imbalances in South Africa: by attract-ing young scholars to the field of science and technology;through skilled job creation; through international part-nology regional innovation centres (BRICs) to act as nucleifor the development of biotechnology and biotechnologyplatforms. From these, a range of businesses offering newproducts and services can be developed [7]. This initiativeinvolves the strategic development of several bioclusters,rather than encouraging clusters to grow under their ownuth Africas Theron

etoria, Pretoria 0002, South Africa

Furthermore, environmental sustainability might beachieved through novel bioremediation or waste usageprocesses that minimize environmental impact [46].Here, the main features of the South African biotechnologyindustry are discussed.

Main features of the South African biotechnology sectorGovernment involvement in biotechnologyIn 2000, the South African government began to focus on,and substantially increased, its research support for bio-technology. This led to the adoption of the 2001 NationalBiotechnology Strategy, a policy framework to createincentives for the biotechnology sector [7], involving sev-eral government departments (Figure 1). Although theDepartment of Science and Technology (DST; http://www.dst.gov.za), the lead department with respect tobiotechnology in South Africa, is responsible for adminis-tering this strategy, the Department of Trade and Industry(DTI; http://www.dti.gov.za) concentrates on innovationand the commercialization of biotechnology. In particular,the DTI is responsible for the Patents Act and, in 2002,through its agency the Industrial Development Corpora-tion, contributed to the establishment of the first dedicatedbiotechnology venture capital fund in South Africa, Bio-ventures (http://www.bioventures.co.za), which providesseed funding and funding for start-up biotechnology com-panies.

The National Biotechnology Strategy addresses humanresource development, funding, regulatory and legalissues; it also endeavours to close the gap between researchactivities and commercialization. To this end, privatepublic partnerships between domestic and internationalstakeholders are being encouraged. Furthermore, the gov-

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558 Review TRENDS in Biotechnology Vol.24 No.12innovation center inGautengmainly focuses onagriculturalbiotechnology, industrial, mining and environmental bio-technology. The South African government has committedan initial R450 million (US$75 million) to these BRICs. Inaddition to the BRICs, a National Bioinformatics Network(NBN; http://www.nbn.ac.za) has been established toaddress specifically the development of capacity and exper-tise in bioinformatics in South Africa.

Various organizations and programmes that are activein funding R&D, research capacity building and technol-ogy transfer have been established by the South Africangovernment. Although the National Research Foundation(NRF; http://www.nrf.ac.za) is the major body responsiblefor funding research and human resource development athigher-education institutions, the Innovation Fund (IF)was established to promote technological innovation,increased networking and cross-sectional collaboration,

Figure 1. An overview of the biotechnology infrastructure of South Africa. Althoug

biotechnology industry, the most relevant biotechnology support structures are t

Centres (BRICs), the National Bioinformatics Network (NBN) and GODISA-funded

transfer. Bioventures, the only niche biotechnology venture capital fund in South Afr

research institutions and universities, which have key roles in biotechnology develo

the research, development and testing of HIV/AIDS vaccines in South Africa, wher

partnership between the Department of Health and a group of healthcare companias well as providing seed and start-up financing for thedevelopment of a product or prototype, proof-of-conceptand initial marketing. The Technology and HumanResources for Industry Programme (THRIP) providesfunding to innovative research programmes that involvean industry partner. The aims of this programme are toincrease the quality and number of appropriately skilledpeople for the management of technology for industry andto promote increased interaction between public research-ers and industry [8]. GODISA (http://www.godisa.net/) is aSouth African initiative, with a series of activities andprograms jointly fundedby theEuropeanUnion (Brussels)and DST, to provide for the nationwide creation of pilotcentres and technology incubators. Two of the incubatorsfocus on the biotechnology sector, namely eGoli BioLife Sciences (http://www.egolibio.co.za) and AcornTechnologies (http://www.acorn.org.za). The aim of theseincubators is to serve as a development conduit forthe commercialization of life sciences research, products,services and technology platforms by supplying businessinfrastructure, strategic guidance and financial or legaladvice. Empirical research has shown the importanceof these close associations for the successful development

www.sciencedirect.comof biotechnology companies in the USA [911] and inGermany [12].

Research institutions and universitiesPublic research institutes, laboratories and universitiesare key players in the biotechnological development ofSouth Africa (Box 1). The government has four mainresearch institutions: the Agricultural Research Council(ARC; http://www.arc.agric.za), which focuses on agricul-tural (plant and animal) research; the Medical ResearchCouncil (MRC; http://www.mrc.ac.za), which targetshuman health research; the Council for Scientific andIndustrial Research (CSIR; http://www.csir.co.za), whichis the largest scientific and technological research devel-opment and implementation organization in Africa; andMINTEK (Council for Minerals Technology; http://www.mintek.co.za), one of the leading technology provi-

relatively large number of government departments are involved in regulating the

ational Research Foundation (NRF), the four Biotechnology Regional Innovation

bators, all of which are active in funding R&D, capacity building and technology

invests in seed and start-up stage biotechnology companies. In addition to different

nt, the South African AIDS vaccine initiative (SAAVI) is responsible for coordinating

the Biologicals and Vaccines Institute of southern Africa (BioVac), a publicprivate

as established in an effort to create local vaccine-manufacturing capacity.ders in the world, specializing in mineral processing andextractive metallurgy. Universities have several roles inthe innovation chain, including education and training,research, and the provision of infrastructure and facilitiesfor projects carried out by research institutes. Although thecountry has contributed only relatively few publications tointernationally peer-reviewed journals, those publicationsare found in some of the most highly cited internationaljournals and have a high average relative impact factorcompared with other developing countries [2,13]. This isclearly indicative of the quality of South African researchand the capacity to develop a competitive biotechnologyindustry.

Private sector biotechnology industryThe entry of South Africa into the modern biotechnologyindustry is recent; therefore, the private sector is still in adevelopmental phase and most of the companies have alimited range of bioproducts. According to the NationalBiotech Survey 2003 [14], there are 106 biotechnologycompanies, including 47 identified as core biotechnologycompanies, that is, the majority of their activities involvedbiotechnology: of these, 37% were spin-offs from another

Review TRENDS in Biotechnology Vol.24 No.12 559Box 1. Biotechnological innovations

The drive by the South African government to extract real economicvalue from developments in the biotechnology field has begun toyield results. Some of the achievements in animal health biotech-nology include the first genome to be sequenced in Africa, byscientists at the Onderstepoort Veterinary Institute and University ofPretoria in collaboration with foreign research institutions. Thebacterium sequenced, Echrlichia ruminantium, causes widespreadand economically devastating heartwater disease in livestock andwild ruminants. The data will be used towards developing a vaccinefor this disease [39]. A novel diagnostic kit, enabling early diagnosisof corridor disease, a highly pathogenic disease of cattle in southernAfrica caused by the protozoan Theileria parva lawrencei, waslaunched during 2005 by its developers, the Onderstepoort Veter-inary Institute, the University of Pretoria, the University of Utrechtand Isogen Life Sciences, a Netherlands-based technology company[40]. In the field of plant biotechnology, scientists at the CSIR havedeveloped, among others, pearl millet resistant to downy mildew,and sorghum with enhanced nutritional quality, whereas scientistsat the Agricultural Research Council (ARC) have developed applesresistant to the false coddling moth, and potato plants that areresistant to the potato tuber moth [41]. In the human healthenterprise; 34%were start-ups; and 29%were spin-offs froma research group. The biotechnology industry sector ismadeup almost exclusively of private companies, most of whichfall into the SMME category (i.e. comprising ten or fewerresearchers). Although they are active in different biotech-nology sectors (Figure 2a), it is estimated that only 10% ofthe biotechnology companies are conducting innovativecutting-edge R&D, with the majority involved in new appli-cations of low-tech modern biotechnology [15]. During thesurvey, 154 biotechnology products and/or services wereidentified, earning revenues of at least R368million (US$61million) [14]. The majority of these products fall under thehuman health (23%) and support services (20%) sectors,followed by the plant biotechnology sector (18%). Theseproducts and/or services predominantly include therapeu-tics, diagnostics, natural health products and phytophar-maceuticals in the human health sector; core technologyservices, contract research and contract manufacture inthe support services sector; and genetically modified (GM)crops, plant growth stimulants, and biological controlproducts in the plant sector (Figure 2b).

biotechnology sector, some successes include the development ofa viable liver support system for patients with liver failure. The Bio-artificial Liver Support System (BALSS), developed at the CSIR withthe assistance of medical and engineering specialists at theUniversity of Pretoria, is undergoing clinical trials [41]. The SouthAfrican Aids vaccine initiative (SAAVI) has designed HIV/AIDSsubtype C candidate vaccines, which are covered by both nationaland international patents. These candidate vaccines have beenmanufactured and are currently undergoing preclinical toxicitytesting and an internal review process (http://www.savi.org.za).Environmental biotechnology achievements include BACOXTM

technology, produced by MINTEK, which uses a unique bacterialcocktail to bioleach gold from ore. This technology has beenlicensed to a gold mine in Australia, and a plant has beencommissioned in China [42,43]. The Rhodes Biosure Process1

[44,45], developed through collaboration with the Water ResearchCommission, Rhodes University and the East Rand Water Carecompany, is the first step in a system for removing heavy metals,aromatic pollutants and pathogens from mine water, to the extentthat it is safe to feed the water back into the environment. Based onthe success of the innovation, a process plant capable of processing10 million litres of mine wastewater per day has been commis-sioned and subsequently launched.

www.sciencedirect.comFigure 2. Overview of the South African biotechnology industry, indicating the

sectorial distribution of (a) core biotechnology companies and (b) biotechnology

products. Although the private sector biotechnology industry comprises 106

companies, 47 of these are classified as core biotechnology companies, of which

the majority are either new start-ups or spin-offs from another enterprise.

Together, these companies produced at least 154 products and/or services,

which are applied predominantly in the human health, support services and plant

sectors (adapted from [14]).Human resourcesA major constraint on the development of biotechnology inSouth Africa is a lack of adequate expertise and skilledpersonnel. Statistics from the most recent national R&Dsurvey indicate that there are 1.88 full-time equivalentresearchers per 1000 employed South Africans, with 7.7full-time equivalent R&D personnel per 1000 in the labourforce [16]. This situation is aggravated by the migration ofprofessionals and skilled personnel out of the country as aresult of limited employment opportunities in the localbiotechnology industry for graduates [17]. Another pro-blem is the difficulty in attracting students to science-based university programs [2]. To address this situation,the Department of Labour (DoL; http://www.labour.gov.za)has committed to funding human resource developmentthrough the Skills Development Act 2003 [18] and theHuman Resources Development Strategy [19]. A nationalScarce Skills financial assistance scheme has also beenestablished by the NRF, in partnership with the DoL andDST, to address skills in short demand, including thoserelevant to biotechnology and bioinformatics.

Biotechnology patenting in South AfricaIn South Africa, scientists are motivated by theirpublication output rather than the commercial value oftheir work. Thus, research in South Africa has notbeen carried out with commercialization in mind andhas, therefore, lacked market focus. Only a small numberof higher-education institutions have a division designed toassist with the management and commercialization ofresearch and intellectual property (IP) emerging from

560 Review TRENDS in Biotechnology Vol.24 No.12the institution. Consequently, South Africa lags farbehind in terms of patent outputs when compared withcountries in the developing [20] and developed world[21,22]. According to statistics published by theUSPatentsand Trademarks Office (USPTO; http://www.uspto.gov/), atotal of 58 biotechnology-related patents were awarded toSouth African inventors between 1976 and 2004, andmanyof these have been assigned to non-South African entities.Similarly, between 1991 and 2003, comparison of the levelof biotechnology patenting among seven developing coun-tries indicated that South Africa had both the secondlowest number of biotechnology patents and patent own-ership among the countries studied [20]. This suggests alimited potential to capitalize on these biotechnologicalinventions because harnessing of this knowledge wouldhave to be negotiated with the foreign collaborators. Con-sidering the fairly recent emphasis on biotechnology inSouth Africa, it will be of interest to see whether the levelsof patenting can be improved and ultimately lead to thecommercialization of new products and processes based onthis knowledge.

However, a potential reason for the low number ofbiotechnology patents is the substantial expense involvedin registering foreign patents. It is estimated that the fullinternational patent filing of a biotechnology patent cancost up to R500 000 (US$84 000) [13]. Consequently,several groups in South Africa indicated that they couldnot afford to patent their IP internationally or were forcedto let their patents lapse owing to financial constraints.Moreover, many entities might not file patents to protecttheir IP beyond the patent expiration date; therefore, thepatent applications do not account for intellectual capital(i.e. knowledge that resides within an individual or groupof individuals and is not in the public domain [14]). It mustbe noted, however, that there is also a substantial amountof ongoing research that is generating an IP pipeline,which might not have yielded protectable IP so far, butmight do so in future. Thus, the patent numbers reportedabove are unlikely to represent the full complement of IPemerging from South Africa.

South African legislation relevant to biotechnologyThe Patents ActPatents in South Africa are governed by the Patents Act1978, with two amendment bills passed in 1997 theCounterfeit Goods Act [23] and the Intellectual PropertyLaws Amendment Act [24] to bring the laws in line withinternational trade obligations under the trade-relatedintellectual property agreement of the World Trade Orga-nization. The Patents Act has recently been amended, withthe aim to protect communities or individuals with tradi-tional knowledge from being exploited by bioprospectors[25]. The Patents Amendment Act 2005 will provide for adisclosure requirement indicating whether a patent appli-cation uses, or is directly derived from, an indigenousbiological or genetic resources and whether the patentrelied on traditional knowledge or traditional use of theseresources. Unless these conditions are met, the registrar ofpatents is empowered to refuse such a patent application.

In addition, the act not only enables the Department ofEnvironmental Affairs and Tourism (DEAT; http://

www.sciencedirect.comwww.environment.gov.za) to impose conditions such asco-ownership, compensation and benefit sharing beforeapproval is granted, it also enables the DEAT to contestthe patent application worldwide if it is based on a SouthAfrican resource. Although this Act intends to protectcommunities and/or individuals from exploitation by bio-prospectors, it is a major disincentive for even consideringbioprospecting. This is unfortunate, particularly given thesmall number of patents emanating from South Africa,because the biodiversity of South Africa is amajor resourcefor biotechnological innovation, and this act could poten-tially nullify this resource.

Spurred on by the low level of patents originating fromgovernment-funded South African institutions, legislationis currently being drafted for a revised IP rights frame-work. The policy will aim to unify the various approachesthat SouthAfrican institutions have taken to protect the IPof their researchers and to share the benefits. It has beenproposed that the new legislation should follow the USBayhDoyle Act, in which universities and research insti-tutions are granted ownership of inventions developedwith government funds, in an attempt to improve theentrepreneurial nature of these institutions. Moreover, itis also proposed that South African biotechnology compa-nies are granted more access to licensing rights when theyhave invested in university research [22].

The Genetically Modified Organism ActSouthAfrica is the onlyAfrican country inwhich geneticallyengineered crops are commercially grown. To date, thecommercial releaseof insect-resistant (Bt) cottonandmaize,herbicide-tolerant (RR) soybeans, cotton and maize, andcotton with the stacked gene (Bt and RR) have beenapproved. It is estimated that these GM crops account for30.5%of yellowmaize, 28.8%ofwhitemaize, 59%of soybeanand 90% of cotton production in South Africa [26]. Concernsregarding commercial releases of genetically engineeredorganisms have led to the drafting of the Genetically Mod-ified Organism Act 1997 (GMO Act), which covers biosafetyissues for most genetically modified products, including therequirement for a full risk assessment before the introduc-tionand commercialization ofGMcrops inSouthAfrica [27].The formal structures for the implementation of this actinclude an executive council, which reviews applications forGMO work, a scientific advisory committee, with an advi-sory role, a registrar to administer the GMO Act, and aninspectorate to monitor function. The act also makes provi-sion for public notification of GMOwork. However, not onlywas the act belatedly implemented in November 1999 butalso thefirstGMOfield trials inSouthAfricawerepermittedin 1994, and several foreign multinational companies (i.e.Monsanto, DuPont, Syngenta, Dow and Bayer) have beenpermitted to grow and import GMOs since 1997 [28].

It has been argued that the regulatory frameworkenshrined in the act does not constitute an adequatebiosafety regime that ensures GMOs are appropriateand do not cause harm to the environment or to humanhealth. In addition, the act only applies to viable, livingGMOs and not to the products of GMOs; it also appears to

absolve the developers of GMOs of liability by shifting theaccountability to the users of GMOs. Consequently, a GMO

to access funding opportunities). There is also a lack of

Review TRENDS in Biotechnology Vol.24 No.12 561Amendment Bill [29] has been introduced in an attempt toensure that South Africa complies with its obligations as asignatory of the Cartagena Protocol. The amendmentshave been rejected by several non-governmental organisa-tions, which cite it as inadequate and call for a completeredraft of theGMOAct. Themain contention is that the actand the proposed amendments are inconsistent with theconstitution and other legislation insofar as they do notgive effect to the rights of citizens to environmental protec-tion, safe and healthy food, administrative justice andaccess to information [30]. Consequently, passing of thebill has been delayed until these concerns have beenaddressed.

Also related to GMOs are the regulations relating to thelabelling of food derived from genetic modification, whichare the responsibility of the Department of Health (DoH;http://www.doh.gov.za). The South African labelling regu-lations [31] adopt the US model, where the use of GMtechniques per se is not itself a trigger for labelling, ratherit is only when there is a significant difference in the finalfood that labelling is required. The circumstances wherefood is considered substantially different are if it hashuman or animal genes, allergens, if it requires differentstorage, preparation or cooking, or if it has an alterednutritional composition. Thus, no GM foods currentlyimported, marketed and released in South Africa qualifyfor mandatory labelling [32].

Owing to its rich biodiversity, South Africa has a longtradition of natural plant research and is actively engagedin bioprospecting [3335]. Access to the biodiversity of thecountry is legally controlled by the recently promulgatedNational Environmental Management: Biodiversity Act2004 [36], which dictates the management, conservationand use of biological diversity within South Africa. It alsopromotes the sustainable use of indigenous biologicalresources and provides for the fair and equitable sharingamong stakeholders of the benefits arising from the bio-prospecting of indigenous biological resources. The act willthus require permits to be obtained for all bioprospectingprojects, and these will only be issued if a benefit-sharingagreement is in place.

Concluding remarksSouth Africa boasts an advanced industry based on firstgeneration biotechnology and exemplified by internationalstandards of water treatment and recycling, thesecond-largest beer brewing company in the world, andinternationally competitive animal and plant breedingcapabilities. Given this platform, South Africa has thepotential to develop and establish a sustainable andglobally competitive biotechnology industry. In fact, SRIInternational (representing the World Bank) has ratedSouth Africa as one of the top five counties for biotechnol-ogy investment among developing nations in 2001, and thecountry is becoming an increasingly popular choice forinvestment and partnering for foreign companies and gov-ernments (e.g. those from Germany, Belgium, Argentina,Cuba, Japan and the USA) [14].

The recent emphasis on biotechnology in South Africa

has led to a plethora of policy documents, strategies, road-maps and plans, which have been developed during the

www.sciencedirect.comexperience in recognizing truly innovative products at anearly stage and fast-tracking these. Generally, public fund-ing of biotechnology R&D and early commercialization(incubation) is inadequate and this is compounded by alack of incentives for privately funded R&D, for example,tax incentives [37,38]. Consequently, the private sector hasbeen looking towards research institutions for developingbiotechnology products to cherry-pick, rather than toinvest in their own R&D programs, which again is alow-risk approach.

Furthermore, academics have traditionally chosen thesafer route of publication rather than patenting, owing tothe performance appraisal mechanisms that steer towardsthe publication of basic research rather than commercialenterprise. This is not surprising because commercializa-tion is not the core business of academics. This mindset isfurthermore entrenched by the complicated and often lim-iting IP issues. IP sharing has become a major contractualconstraint for many researchers and their institutions.Months can be spent on negotiating the IP contract withall the parties involved and, in some cases, these remainunresolved at the expense of potential discovery and inno-vation. Esko Aho, the former Finnish prime minister, isquoted as saying: Research turns money into knowledge,and innovation turns knowledge into money. In the centreof all of this is the researcher, who should be motivated togenerate new knowledge, because without this there isno innovation. Thus, the rules of the game might also haveto be changed to reward entrepreneurship and innovationif biotechnology were to live up to such high expectations.

The initiative of the South African government to boostbiotechnology research has, nevertheless, begun to yielddividends (Box 1). As the biotechnology industry matures,it might live up to the expectations of leading to a vibranteconomic sector in South Africa that will positively affectthe standard of living in the country and, potentially, theAfrican continent.

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our

the history and philosophy of science:

ent in the 19th century by C. Berkowitzingdom Brunel by P. Faras Christian belief by J. van der Heide

Direct, www.sciencedirect.com

Biotechnology in South AfricaIntroductionMain features of the South African biotechnology sectorGovernment involvement in biotechnologyResearch institutions and universitiesPrivate sector biotechnology industryHuman resources

Biotechnology patenting in South AfricaSouth African legislation relevant to biotechnologyThe Patents ActThe Genetically Modified Organism Act

Concluding remarksReferences