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AustralianBiotechnology

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© Commonwealth of Australia 2000

ISR 2000/036

ISBN 0 642 72028 2

This work is copyright. Apart from any use as permitted under the Copyright Act

1968, no part may be reproduced by any process without prior written permission

from the Commonwealth available through AusInfo. Requests and inquiries

concerning reproduction and rights should be addressed to the Manager, Legislative

Services, AusInfo, GPO Box 1920, Canberra ACT 2601.

Design and production: Big Island Graphics and Corporate Communications.

Printing: Paragon Printers Australasia

MINISTERIAL INTRODUCTION 4

BIOCOG FOREWORD 6

GOVERNMENT'S VISION FOR AUSTRALIAN BIOTECHNOLOGY 7

AUSTRALIA'S OPPORTUNITY AND CHALLENGE 8

What is Biotechnology? 8

International Pace of Change in Biotechnology 9

Why Biotechnology is Important to Australia 9

Australia's Biotechnology Assets 10

Challenges for Australian Biotechnology 11

Development of the National Biotechnology Strategy 11

BIOTECHNOLOGY IN THE COMMUNITY 13

Raising Public Awareness and Informing a Community Dialogue 13

Consideration of Ethical Issues 14

Impacts of Agriculture and Food Biotechnology on Rural and Regional Australia 14

Pursuing Australia’s Health Objectives 15

Sustainability and Public Good Applications ofBiotechnology 15

ENSURING EFFECTIVE REGULATION 16

Developing a Rigorous, Efficient and TransparentRegulatory System 16

Environmental Risk Assessment 17

BIOTECHNOLOGY IN THE ECONOMY 18

Addressing the Commercialisation Gap 18

Developing Biotechnology Networks and Clusters 19

Strengthening Intellectual Property Management 19

Applying Biotechnology in Australian Industry 20

AUSTRALIAN BIOTECHNOLOGY IN THE GLOBAL MARKET. 21

Biotechnology International Marketing andInvestment Promotion 21

Improving the Assessment of Developments in Food Markets 22

Maintaining an Active Role in International Fora 22

International Research Cooperation 23

RESOURCES FOR BIOTECHNOLOGY 24

Human Resources for Biotechnology Development 24

National Biotechnology Research Cooperation 25

Research for Competitive and Sustainable Agriculture Production and Food Processing 25

Access to Biological and Genetic Resources 26

MAINTAINING MOMENTUM AND COORDINATION 27

Biotechnology Australia and Australian Biotechnology Advisory Council 27

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Contents

On behalf of my colleagueson the Commonwealth

Biotechnology MinisterialCouncil, I am pleased to presentthe National BiotechnologyStrategy which outlines theGovernment's vision and supportfor biotechnology.

Biotechnology is a key technologyof the future. It presentsenormous opportunities as wellas great challenges.Biotechnology holds the promiseof improved health and welfarefor all Australians through betterunderstanding of disease,improved diagnosis, andtreatment with more specificbiopharmaceutical products.Biotechnology, including thegenetic modification ofagricultural and food products,also has the potential to deliverproductivity, competitiveness andsustainability benefits toAustralia. The technology offersimproved resistance to insects

and disease, and new uses foragricultural products, improvedfood qualities, reducedenvironmental impact andbioremediation are all possible.

Australia has developed worldclass strengths in biotechnology-related medical, agricultural andenvironmental research. We mustbuild on these strengths for theresponsible development andmanagement of biotechnology inAustralia. Through biotechnologywe are developing innovativeproducts, building fast-growingenterprises, attractinginternational investment andcreating high value employment.The Government will work toensure that Australians haveaccess to the skills andknowledge they need to keeppace with this global revolution.

We believe it is also important tosafeguard the health of ourcommunity and the environment

and that Australia is well servedby a range of regulators who areworking together to provideassurance that biotechnology issafe for our country.

The Government ensures rigoroushuman health and environmentalassessment of GMO releases, andwill undertake research to improvethe knowledge base and managerisks in the field.

The National Biotechnologystrategy provides a framework forGovernment, working with keystakeholders, to capture thebenefits of biotechnologydevelopment for Australia. Thestrategy addresses the presentsituation in a rapidly changingenvironment, and will be a livingdocument, able to address newchallenges as they arise.

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Australian Biotechnology

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The Hon Dr David Kemp

Minister for Education, Training and Youth Affairs

The Hon Dr MichaelWooldridge

Minister for Health and Aged Care

The Hon Warren Truss

Minister forAgriculture,

Fisheries and Forestries

Senator The HonRobert Hill

Minister for the Environmentand Heritage

Senator The Hon Nick Minchin

Chairman

BiotechnologyMinisterial Council and Minister for

Industry Science and Resources

Ministerial Introduction

The BiotechnologyConsultative Group

(BIOCOG) supports theGovernment's vision to develop aNational Biotechnology Strategyand has contributed to itsformulation over the last year. Theissues which require the greatestattention include:

◗ Ensuring effective regulationof biotechnology research andapplication.

◗ Providing balancedinformation to the public onbiotechnology issues.

◗ Addressing the critical gap inearly stage funding andmanagement and the creationof competitive biotech clusters.

Global biotechnology innovationand growth continues toaccelerate. The United States,Canada, UK, and Germany, forexample, are reaping tremendous

benefits from major governmentprograms and growing privatesector commitments to developindustries utilising biotechnology.Effective commercialisation of thetechnologies developed inAustralia is necessary to generatea return from our investment andparticipate in the globalbiotechnology marketplace. Thepotential rewards are enormous:one biotech-basedpharmaceutical, erythropoietin,generated world-wide marketsales in excess of $A5 billion in1999, equivalent to the totalworld export sales of Australiangold in that year.

We believe that biotechnology-based technologies andindustries will create new highvalue employment, generatehealth and environmentalbenefits, and provide a strong

basis for continued economicgrowth. These are importantpriorities for Government. Arequisite step will be enhancedcooperation between theCommonwealth, the States,research organisations, and theprivate sector.

Tony BatesChair,Biotechnology Consultative Group

The Biotechnology ConsultativeGroup was formed in 1999 toadvise Biotechnology Australiaand the CommonwealthBiotechnology Ministerial Councilon the development of theNational Biotechnology Strategy.The Group consists of 22members from the research andbusiness sectors, includingethicists and nutritionists.

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Foreword by the BiotechnologyConsultative Group

Consistent with safeguardinghuman health and ensuring

environmental protection, thatAustralia capture the benefits ofbiotechnology for the Australiancommunity, industry and theenvironment.

This vision, which is based on theresponsible use of biotechnologyto drive economic andcommunity benefit, is supportedby the Government’s goals forbiotechnology which are:

◗ To ensure that in research into,and in applications ofbiotechnology

– human health and theenvironment aresafeguarded, in particularthrough a rigorous, efficientand transparent system ofregulation for genetechnology research and forgenetically modifiedorganisms and products;and

– the highest ethicalstandards are observed.

◗ To ensure that the communityhas access to qualityinformation aboutbiotechnology, the potentialrisks and benefits of itsapplications, the ethical issuesthey raise, and has confidencein the way risks are assessedand managed

– and that it can contribute topublic policy in this area.

◗ To enhance the economic andcommunity benefits ofbiotechnology through

– an internationallycompetitive environmentfor investment andenterprise development;

– stronger links between thebiotechnology researchsector and industries thatapply biotechnology; and

– better management ofintellectual property.

◗ To maintain and develop theinfrastructure for generatingbiotechnology applicationsthrough

– productive investment inbiotechnology research anddevelopment;

– world class education inbiotechnology;

– secure access to genetic andbiological resources; and

– conserving genetic andbiological resources.

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Government's Vision forAustralian Biotechnology

What isBiotechnology?Biotechnology is a broad term fora group of technologies based onthe application of biologicalprocesses. It has diverseapplications in medicine,agriculture, food processing,manufacturing andenvironmental management. Theterm "modern biotechnology" isused to distinguish recent,research based activities fromtraditional fermentationtechnologies such as bread,cheese or beer making, andanimal and plant breeding, whichwere the first examples ofbiotechnology. Modernbiotechnology includes a range oftechniques from recombinantDNA technology, molecular andcellular biology, biochemistry andimmunology through to

information technology. Genetechnology is a specific subset ofbiotechnology, based on themanipulation and modification("recombination") of the geneticmaterial of living organisms todevelop new characteristics,processes and products.

Biotechnology is a powerfulenabling technology, withapplications that have thepotential to revolutionise manyindustry sectors includingagriculture, forestry, fishing,pharmaceuticals and health,chemicals, textiles, foodprocessing, environmentalindustries, energy and mining.

Biotechnology is alreadyresponsible for a growing rangeof new and better treatments forcommon diseases. There are morethan 350 biotechnology drug

products and vaccines currently inhuman clinical trials, more than ahundred products already on themarket and hundreds more inearly development in the UnitedStates alone. These medicines aredesigned to treat various cancers,Alzheimer's disease, heartdisease, diabetes, multiplesclerosis, AIDS, obesity and otherconditions.

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Australia's Opportunity and Challenge

There are now more than100 biotechnology-basedpharmaceutical productson the market and 350 indevelopment.

Biotechnology is responsible forhundreds of medical diagnostictests that detect diseases earlier,thereby ensuring more successfultreatment, and that keep theblood supply safe from viruses.Home pregnancy tests are alsobiotechnology diagnosticproducts. In the foreseeablefuture biotechnology promises toenable the prediction and earlyprevention of many diseases,developments that will radicallyreshape the health industry.

International Pace of Change inBiotechnologyBiotechnology developmentaround the world is moving fast.

It is less than 20 years since thelaunch of the world’s firstbiotechnology medicine, aninsulin product, in 1982. In 1998Australian farmers first usedcotton plants which had beengenetically modified to be pestresistant, which has enabledthem to reduce their use ofpesticides. While biotechnologywill continue to be dependent onlengthy research and

development efforts, we are nowon the threshold of a majorexpansion in the number andcommercial value of applications.

In 1999, total biotechnologyrevenues in the United Statesincreased by 16% to $US18.6billion. The 1283 biotechnologycompanies in the US spent$US9.9 billion on R&D in 1999and increased employment by 9%to 153,000. Europe and Canadahave experienced equallyimpressive ongoing growth andmajor Japanese companies haveinvested heavily in biotechnologyfor the food and pharmaceuticalindustries.

Why Biotechnology isImportant to AustraliaAustralia’s industrialcompetitiveness, and hence ourstandard of living, will be stronglyinfluenced by whether we cangrasp the opportunitiespresented by biotechnology, andunderpinned by the knowledgeand skills of our researchers.Biotechnology promises to be thenext great wave of technologicalchange, bringing changes asradical and pervasive as thosewrought by the IT revolution.

Australia is at the forefront ofthese developments. We have anexcellent institutional base, and anumber of innovative smallcompanies which, given the rightcircumstances, could lead thegrowth of the new industries.

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Biotechnology derivedpregnancy kits areassisting in early andsimple detection.

An environment that encouragesresponsible biotechnologydevelopment, and fostersinvestment in infrastructure, R&Dand commercialisation will driveeconomic growth and maximiseAustralia’s opportunities to be aproducer and exporter of keytechnologies.

Australia'sBiotechnology AssetsAustralia has substantial researchinfrastructure in the universities,the CSIRO, Co-operative ResearchCentres and Commonwealth andState funded research anddevelopment organisations.Commonwealth expenditure on

biotechnology research anddevelopment is in excess of $250million per year through a rangeof programs, with private sectorspending of a similar order.

Australia has a robust andinternationally compatibleintellectual property protectionsystem. This is particularlyimportant in an area whereresearch and development areexpensive, require long lead timesand products are focussed onglobal markets.

Australia has a sound regulatoryframework on which to base itsmanagement of the risks andethical issues associated withgenetic research.

The Australian biotechnologysector has registered somesignificant successes in recentyears that are contributing toindustry and investor confidence.Most of the more than 130 corebiotechnology companies inAustralia are small, with highlevels of research anddevelopment spending.

There has been an increase in thesupply of venture capital in recentyears, encouraged in part bygovernment policy; but thedemand for capital is growingeven more strongly. Changes tothe Capital Gains Tax provisionsare expected to significantlyimprove the availability ofventure capital in Australia.

Most of the major multinationalpharmaceutical and agribusinessfirms are active in Australia, andhave research collaborations withlocal firms and researchorganisations.

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Government invests over$250m per year inbiotechnology R&D.

Challenges forAustralianBiotechnologyAustralia has a strong foundationfor developing and applyingbiotechnology. We have a very realopportunity to be a significantparticipant in this dynamic globalindustry - an opportunity tocapture health andenvironmental benefits, todevelop new enterprises, newindustries, new bases forcompetitiveness in existingindustries and new internationalcollaborative relationships.

In some sectors, for exampleagriculture and mining, Australiaenjoys significant comparativeadvantage. However ourcomparative advantage in suchareas may face serious challengeif we do not capitalise on theinnovations offered throughbiotechnology. In others sectorswhere we do not currently enjoyparticular advantages - such aspharmaceuticals, health andenvironmental industries -biotechnology offers substantialopportunities to improve ourcompetitive position. Thechallenge will be to seize theseopportunities.

Australian firms often lack thefinancial depth and themanagement and marketexpertise to take a product frominvention to market; muchbiotechnology intellectual propertyis licensed to overseas companies.Such partnerships can be valuableand will continue to be important.But we are not always capturingthe maximum commercial andcommunity benefits arising fromour research. Australia faces achallenge to extract more valuefrom its intellectual property andinvestment in R&D.

Genetic research and itsapplication also open significantethical and consumer issues andthere are potential risks to theenvironment which need to bemanaged. The Australiancommunity needs to be engagedin an informed debate on theethical and regulatory issues. Achallenge for Australianbiotechnology will be to workwith the community and earn itsconfidence as consumers andinvestors.

Development of theNationalBiotechnologyStrategy Australian investment in modernbiotechnology began in the 1980sand broadened in the 1990s.Biotechnology is now asignificant element ofCommonwealth research,training, innovation, regulatoryand business support programs.These programs, along withexamples of the activities theysupport, are outlined in thepublication: AustralianBiotechnology: Progress andAchievements.

In 1999 the Governmentestablished BiotechnologyAustralia and the CommonwealthBiotechnology Ministerial Councilto coordinate governmentbiotechnology activity and todevelop a national biotechnologystrategy. The Government also

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established the BiotechnologyConsultative Group (BIOCOG), apanel of experts from industryand the scientific and researchcommunity, to provideindependent advice togovernment.

The strategy, which builds on thecurrent substantialCommonwealth support forbiotechnology, seeks to:

◗ Capitalise on our existingadvantages in biotechnology.

◗ Achieve sustainable growth forestablished and new industrysectors.

◗ Strengthen coordinationamong CommonwealthGovernment activities andpartnerships with StateGovernments.

◗ Build on industry commitmentand active participation.

◗ Develop a catalytic role forgovernment.

◗ Provide a basis for ongoingconsultation and strategydevelopment.

In developing the NationalBiotechnology Strategy the viewsof stakeholders were soughtthrough an extensiveconsultation process. ADiscussion Paper "DevelopingAustralia's Biotechnology Future"was published in September1999, submissions were invitedand forums were held in allcapital cities. Considerable inputwas received from a wide range oforganisations and from manyindividuals. BIOCOG andrepresentatives of the States andTerritories provided additionaladvice and consultation ondevelopment of the NationalBiotechnology Strategy. Membersof BIOCOG also provided valuableinput, along with industryexperts, on issues such as thecommercialisation of publicsector research. In addition, arange of background studies werecarried out by BiotechnologyAustralia or commissioned fromindependent consultants.

In the area of regulation ofbiotechnology, effectivecommunity consultation wasachieved by the Interim Office ofthe Gene Technology Regulator(IOGTR) gathering communityinput into draft legislation andrelated matters.

The National BiotechnologyStrategy addresses the six keythemes that emerged fromconsultations and assessments:

◗ Biotechnology in theCommunity,

◗ Ensuring Effective Regulation,

◗ Biotechnology in the Economy,

◗ Australian Biotechnology inthe Global Market,

◗ Resources for Biotechnology,and

◗ Maintaining Momentum andCoordination.

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Raising PublicAwareness andInforming aCommunity Dialogue

ObjectiveIncrease the public’s generalawareness of biotechnology and itsapplications, and of the regulationsthat safeguard people and theenvironment in order to facilitateinformed debate and decisions.

Consumers are seeking balancedinformation on biotechnologyranging from the basics of genetechnology to details of theregulatory processes. The issue ofgenetically modified food appearsto be a particular concern. There isa strong preference from thecommunity for the Governmentto be the primary source ofinformation on gene technology.In order that there is publicconfidence in biotechnology, it isessential that the communitycontinue to contribute to thedevelopment of Governmentpolicy.

Strategies◗ Engage the community in

discussion of regulatoryprocesses, including testingand labelling of GM foods, andassessing and managing risksto human health and theenvironment.

◗ Build community confidence inbiotechnology, its regulation,the industry, and the way risksare assessed and managed.

◗ Inform consumer discussionsand listen to communityconcerns.

◗ Encourage public contributionto policy decisions.

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Overall objectives◗ Increase the public’s general

awareness of biotechnologyand its applications, and ofthe regulations thatsafeguard people and theenvironment in order toenable informed debate anddecisions.

◗ Address ethical concernsrelating to biotechnologyresearch and to its potentialapplications.

◗ Address the concerns of ruraland regional Australia aboutagricultural and foodbiotechnology, includingpotential socio-economiceffects of biotechnology, andmanage any adverseimpacts.

◗ Pursue the economic andcommunity benefits ofimproved health throughbiotechnology.

◗ Ensure recognition of thecapacity of biotechnologyresearch to addresssustainability and naturalresource management issues.

Biotechnology in the Community

Biotechnology can improverural sustainability andcompetitiveness.

Consideration ofEthical Issues

ObjectiveAddress ethical concerns relatingto biotechnology research and toits potential applications.

Modern biotechnology raisessignificant ethical issues whichneed to be addressed and openlydiscussed.

Strategies◗ Consult and liaise widely with

the community on ethicalissues.

◗ Strengthen and enhanceethical standards and existingapproaches to ethical issues.

Impacts of Agricultureand FoodBiotechnology on Ruraland Regional Australia

ObjectiveAddress the concerns of rural andregional Australia aboutagricultural and foodbiotechnology, including potentialsocio-economic effects ofbiotechnology, and manage anyadverse impacts.

Biotechnology has directimplications for rural and regionalAustralians including the impactof the technology upon theviability of the family farm, the

local community and relatedbusinesses. These concerns willrequire on-going attention as theissues evolve with the technology.

Strategies◗ Identify and address relevant

issues for rural and regionalAustralians through continuedmonitoring and publicawareness activities.

◗ Identify, monitor and assessthe opportunities andchallenges of biotechnology-related changes in theagriculture and food industriesto inform policy responses.

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Biotechnology could helpcontrol feral animals withenhanced protection ofendangered species.

Strategy◗ Strengthen Australia’s

expertise in medical genomicsand biotechnology within ourexisting health and medicalresearch sector.

Sustainability andPublic GoodApplications ofBiotechnology

ObjectiveEnsure recognition of the capacityof biotechnology research toaddress sustainability and naturalresource management issues.

Pursuing Australia’sHealth Objectives

ObjectivePursue the economic andcommunity benefits of improvedhealth through biotechnology.

The Australian Health System ishaving to respond to an ageingpopulation and the associateddemands that places on ourhealth budget. Biotechnology cancontribute to better health careby improving our knowledge ofthe basis of health and diseaseand offering better treatmentoptions in some areas. Forexample, an early and accuratediagnosis of disease can bothimprove patient health and leadto significant health savings.

The capacity of biotechnology tocontribute to environmentalsustainability, natural resourcemanagement, and protection ofbiodiversity has not been fullyrecognised. It is important torecognise and publicise the publicbenefits of much biotechnologyresearch.

Strategy◗ Develop indicators to measure

the public benefits thatbiotechnology can deliver insustainability, natural resourcemanagement and biodiversityconservation and publicisethese benefits.

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Biotechnology research isimproving our knowledgeof disease and could leadto better treatment.

Biotechnologyapplications have thepotential to addressagricultural andenvironmental issues,including salinity.

Developing a Rigorous, Efficientand TransparentRegulatory System

ObjectiveEstablish a permanent Office ofthe Gene Technology Regulator(OGTR) and develop associatedlegislation.

Currently, there is a range ofregulatory agencies which controlgenetically modified organismsand their products, depending onthe end use. Genetically modifiedfoods are controlled by the

Australia New Zealand FoodAuthority (ANZFA), GM medicinesby the Therapeutic GoodsAdministration (TGA), GMagricultural and veterinarychemicals by the NationalRegistration Authority (NRA), GMindustrial chemicals by theNational Industrial ChemicalNotification Assessment Scheme(NICNAS), and border control ismanaged by the AustralianQuarantine and InspectionService (AQIS) and AustralianCustoms Service (ACS). There isalso an expert advisorycommittee, the GeneticManipulation AdvisoryCommittee (GMAC), whichprovides advice to these agenciesand oversees the research anddevelopment stage of geneticallymodified organisms.

As the technology develops, newissues arise that are not coveredby other regulatory agencies. For

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Overall objectives◗ Establish a permanent

Office of the GeneTechnology Regulator(OGTR) and developassociated legislation.

◗ Institute a system thatensures that potential risksfrom the introduction ofgenetically modifiedorganisms (GMOs) areaccurately assessed and aremanaged effectively.

Ensuring effective regulation

The Therapeutics GoodsAdministration (TGA) is one ofthe partners that regulatesgenetically modified productsand organisms.

this reason, the Government hasannounced that it will establish apermanent Office of the GeneTechnology Regulator andassociated legislation by January2001. This Office will replace theadvisory system of GMAC andcomplement the other regulatoryagencies. The Office will provide agreater level of transparency andaccountability at the research anddevelopment stage and will alsohave a coordinating function tominimise regulatory duplication.

Strategies◗ In collaboration with the

States and Territories introducea nationally enforceablesystem of regulation thatsafeguards the communityand the environment againstpossible risks, whileacknowledging thecommercial needs of thebiotechnology industry.

◗ Consult with Commonwealthagencies, State and Territorygovernments, and a broadrange of non-governmentstakeholders to determine howethical and socio-economicissues can be incorporated inthe regulatory process.

Environmental RiskAssessment

ObjectiveTo institute a system that ensuresthat potential risks from theintroduction of geneticallymodified organisms (GMOs) areaccurately assessed and aremanaged effectively.

Regulatory decision-making forgene technology should be basedon sound scientific riskassessment. Therefore, we mustbuild on the system that ensuresthat risks in the field have beenaccurately assessed and are beingmanaged effectively. There is aneed to enhance monitoringresearch on GMOs released intothe environment to determine ifthere are any unforeseen orunintended consequences and toinform the regulatory process.

Strategies◗ Establish a framework and a

methodology for riskassessment.

◗ Identify priorities for anenvironmental risk assessmentprogram.

◗ In collaboration with CSIROand other agencies, improvebasic knowledge and assessenvironmental risks associatedwith genetically modifiedorganisms.

◗ Monitor and evaluate anyimpacts.

◗ Monitor the effectiveness ofthe regulatory system toensure that it continues tocover the field.

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Potential risks fromintroducing geneticallymodified organisms needto be rigorously assessedand managed.

Addressing theCommercialisationGap

ObjectiveOvercome the critical gap for proofof concept funding andmanagement at the early stage ofproduct and commercialdevelopment.

A major obstacle to the effectivecommercialisation of Australia’shigh quality biotechnology R&Dis the deficiency in funding at thepre-seed or ‘proof-of-concept’stage of product development.Many early stage discoveries arenot exploited, or are licensedprematurely, because they lackthe funds needed to prove theresearch concept, identifypotential markets and develop asuitable investment proposal.Improving biotechnologycommercialisation in Australiawill improve the returns on publicinvestment in R&D.

Strategy◗ Collaborate with State and

Territory Governments andprivate sector investors toprovide proof of concept fundsto increase the number ofinvestment-ready proposals forventure capital funds and forprograms such as R&D Start.

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Biotechnology in the Economy

Overall objectives◗ Overcome the critical gap for

proof of concept fundingand management at theearly stage of product andcommercial development.

◗ Establish a critical mass forbiotechnology research,commercialisation andapplication through thedevelopment of clusters,incubators and networks.

◗ Strengthen capabilities forthe commercial andstrategic management ofIntellectual Property inbiotechnology.

◗ Promote the responsibleuptake of biotechnology forproduct and processdevelopment in industry.

Increasedcommercialisation ofbiotechnology requiresearlier access toinvestment capital.

DevelopingBiotechnologyNetworks and Clusters

ObjectiveEstablish a critical mass forbiotechnology research,commercialisation and applicationthrough the development ofclusters, incubators and networks.

Biotechnology research andcommercialisation arecharacterised by specialistknowledge and by collaborationbetween research organisationsand industry which helps toachieve the critical mass that isimportant for majorbreakthroughs and rapidprogress. Internationally theseclusters include universities andother research organisations,companies involved in thedevelopment and application ofbiotechnology, companies thatprovide specialist inputs, andsupporting legal, financial andbusiness organisations. It is thepresence of these factors thathave helped develop strongbiotechnology clusters inparticular regions of the UnitedStates, UK and Germany.

Strategies◗ Collaborate with the States

and Territories to facilitate thedevelopment and nationalcoordination of clusters andnetworks.

◗ Strengthen the mechanismsfor co-operation betweenresearch funders, researchproviders and industry onbiotechnology research andcommercialisation

StrengtheningIntellectual PropertyManagement

ObjectiveStrengthen capabilities for thecommercial and strategicmanagement of IntellectualProperty in biotechnology.

The development of capabilitiesfor the effective management ofIntellectual Property (IP) is animportant element in securingthe benefits of public and privatesector research in biotechnologyfor the Australian community,industry and the environment.

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Biotechnology willimprove the internationalcompetitiveness of manyestablished industries.

Strategies◗ Analyse biotechnology IP

management needs ofresearchers, technologymanagers and otherstakeholders, identify IPmanagement requirements forkey export markets, andsupport development of pilotprograms to address theseneeds.

◗ Identify impediments causedby R&D lead times andregulatory delays that mayaffect the effective patent lifeof biotechnology innovations.

◗ Promote opportunities forresearch and industry groupsto share experiences in IPmanagement from innovationthrough to commercialisation.

ApplyingBiotechnology inAustralian Industry

ObjectivePromote the responsible uptake ofbiotechnology for product andprocess development in industry.

The major economic benefitsfrom a new technology arise fromits rapid and widespread diffusioninto the broader industrialcommunity. As an enablingtechnology, biotechnology willhave a major impact on thecompetitiveness of many firms insuch established industries asforestry, environmentalmanagement, food processing,mining and chemicals.

Strategies◗ Encourage access to

biotechnology by Australianindustries.

◗ Generate specificbiotechnology market sectorinformation.

◗ Ensure innovative approachesto farm/industry extension foragriculturalists to understandthe issues and the strictrequirements on the use of thetechnology.

◗ Encourage the developmentand operation of segregatedsupply chains for foodproducts.

◗ Undertake technologyforesight studies to identifytechnological and commercialtrends and opportunities.

◗ Promote biotechnologydemonstration projects thatlead to the integration ofmodern biotechnology intoexisting industry.

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Australia has a growingnumber of innovativebiotechnologycompanies.

BiotechnologyInternationalMarketing andInvestment Promotion

ObjectiveAttract essential foreigninvestment and developmentpartners to add commercial valueto Australian biotechnology R&Dand to develop key overseasmarkets.

Australian biotechnologydevelopment often requiresinternational commercial partnersfor investment in researchcommercialisation, productdevelopment, regulatory approvaland marketing. There is a need toraise international awareness ofthe growing opportunities inAustralia for collaboration andinvestment in biotechnology R&Dand commercialisation withinAustralia.

Strategies◗ Coordinate Invest Australia,

Austrade, BiotechnologyAustralia, State and Territoryorganisations and industryapproaches to internationalmarketing and investmentattraction.

◗ Identify Australianbiotechnology trade andinvestment opportunities.

◗ Promote Australianbiotechnology sectorcapabilities in key overseasmarkets.

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Australian Biotechnology in the Global Market

Overall objectives◗ Attract essential foreign

investment and developmentpartners to add commercialvalue to Australianbiotechnology R&D and todevelop key overseasmarkets.

◗ Develop understanding ofthe changes in domestic andinternational markets forgenetically modified andnon-GM agriculture andfood products and improvemanagement of productidentification.

◗ Ensure decisions ininternational fora do notdisadvantage the tradingenvironment for AustralianGM agriculture and foodproducts.

◗ Strengthen Australiancollaboration withinternational biotechnologyresearch centres andprograms and buildrelationships for technologydevelopment partnerships.

The Institute ofMolecular Bioscience isunder construction inBrisbane.

Improving TheAssessment ofDevelopments in Food Markets

ObjectiveDevelop understanding of thechanges in domestic andinternational markets forgenetically modified and non-GMagriculture and food products andimprove management of productidentification.

Timely information on the sizesand trends of markets forgenetically and non-geneticallymodified products, and onconsumer attitudes underlyingthe markets, is vital to manageuncertainty. The issues ofsegregation, preservation ofidentity and certification of origingo to the heart of any decision tosupply markets for bothgenetically modified and non-genetically modified product. Agood understanding of thedifferentiation of products wouldenable Australian agriculture andfood enterprises to manage andprofit from these markets.

Strategies◗ Establish a cross-industry

export market accesscommittee to monitor andreport to industry andgovernments on trends ingenetically modified, non-genetically modified and co-mingled markets.

◗ Facilitate an on-goingexamination of the costs andbenefits of supplyinggenetically modified productand on establishing identitypreservation within Australia’smajor agriculture and foodindustries.

Maintaining an Active Role inInternational Fora

ObjectiveEnsure decisions in internationalfora do not disadvantage thetrading environment forAustralian GM agriculture andfood products.

International frameworks thatwill shape biotechnologypatenting, regulation and tradewill be determined in ongoingnegotiations in a range ofinternational fora including theOrganisation of Economic

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Regulatory agenciescontrol the use ofgenetically modifiedorganisms such as GMsoybeans.

Cooperation and Development(OECD), the World IntellectualProperty Office (WIPO), the WorldTrade Organisation (WTO) and theUnited Nations fora. Australia'sposition in international foradealing in GM products is thatprotection of human health andenvironment safety can beachieved through science-basedrisk analysis without imposingunjustified barriers to trade inthese products.

Strategies◗ Continue to pursue a strong

presence in regional andmultilateral fora to seekrecognition and adoption ofAustralia's position.

◗ Continue to work bilaterally toensure access to foreignmarkets for Australianagriculture and foodbiotechnology products.

◗ Report regularly to industryand governments on directionand trade implications for theagriculture and food sector ofinternational negotiations.

International Research Cooperation

ObjectivesStrengthen Australiancollaboration with internationalbiotechnology research centresand programs and buildrelationships for technologydevelopment partnerships.

Linkages with major internationalcentres of research are vital forthe robust development ofAustralian biotechnology.Building on Australia’s strongresearch capacities provides theopportunity to participate ininternational research programs -for example, the EU FifthFramework Program - and tostrengthen relationships withneighbours in the Asia-Pacificregion.

Strategies◗ Facilitate and support

Australian participation ininternational projects in keyareas such as bioinformatics,proteomics and through accessto major research facilities.

◗ Develop biotechnologycollaboration within existingbilateral research programs.

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The pharmaceuticalindustry is an earlyadopter of biotechnologyinnovations.

Human Resources for BiotechnologyDevelopment

ObjectiveEnhance management skills in thebiotechnology sector, attract highquality researchers and experiencedleaders, encourage entrepreneurship,and monitor demand and supplyfor specialist skills.

Australia is a small country withhigh quality but limited resourcesin the rapidly developing area ofbiotechnology research andcommercialisation. Strongmanagement andentrepreneurial capacity, andavailability of required specialistskills, are vital for success.

Strategies◗ Improve management of

research, intellectual property,and technology withinestablished firms and newenterprises.

◗ Develop, attract, motivate andretain high quality researchers,particularly in those fieldswhere Australia has strongcapacities to commercialiseresearch outcomes.

◗ Maximise technologicalawareness and capabilitiesthroughout industries that willbe developing and applyingbiotechnology.

◗ Develop programs and systemsto foster entrepreneurship.

◗ Monitor emerging skills needsin the biotechnology sector anddevelop appropriate responses.

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Overall objectives◗ Enhance management skills

in the biotechnology sector,attract high qualityresearchers and experiencedleaders, encourageentrepreneurship, andmonitor demand and supplyfor specialist skills.

◗ Facilitate greatercooperation among majorresearch funders andperformers to identify thescope for joint funding andcollaborative conduct ofbiotechnology research andinfrastructure development.

◗ Encourage biotechnologyresearch and developmentthat contribute todeveloping internationallycompetitive andenvironmentally sustainableagriculture and food sectors.

◗ Develop measures toenhance access to Australianbiological resources

Resources for Biotechnology

NationalBiotechnologyResearch Cooperation

ObjectiveFacilitate greater cooperationamong research funders andperformers to assess and supportbiotechnology research.

High quality research is critical toAustralian competitiveness in thebiotechnology sector. WhileAustralia is a strong performer inbiotechnology research, and inthe basic research underpinningit, the country’s research baseremains small. We must activelyseek opportunities to enhanceresearch performance includingthrough greater cooperation andcollaboration.

Strategy◗ Facilitate greater cooperation

among major research fundersand performers to identifyscope for joint funding andcollaborative conduct ofbiotechnology research andinfrastructure development.

Research forCompetitive andSustainableAgriculture Productionand Food Processing

ObjectiveEncourage biotechnology researchand development that contributeto developing internationallycompetitive and environmentallysustainable agriculture and foodsectors.

Australian industry faceschallenges in adaptingbiotechnology research fromother countries into itsagricultural and food products fora number of reasons. Theseinclude ecosystem incompatibilityand the occasional reluctance of

foreign firms to incorporate theirbiotechnology into locallyadapted conventional material.Local research on biotechnologydevelopments that are suitablefor adaptation to ourenvironment would assistAustralia to maximise economicand environmental benefits.

Strategy◗ Encourage continuing research

leading to the introduction ofbiotechnology into agricultureand food production andprocessing systems,particularly through the ruralResearch and DevelopmentCorporations.

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Gene technologyresearchers havedeveloped cotton that isresistant to Heliothis.

Management andentrepreneurial skills canenhance Australia’s strongresearch base.

Access to Biologicaland Genetic Resources

ObjectiveThe development of measures toenhance access to Australianbiological resources.

Future development of Australia’sinterests in biotechnology,particularly in the environmentalmanagement, pharmaceutical,forestry, fisheries, aquacultureand agriculture sectors, will befacilitated by clear andtransparent terms of access andconditions for the use ofAustralia’s marine and terrestrialbiological resources.

Strategies◗ Resolve legal issues on the

ownership of Australianbiological resources.

◗ Work with sectoral interests toidentify their resource needs inbiotechnology, including in theutilisation of Australianindigenous and exoticbiological resources.

◗ Work with the States andTerritories to achieve nationallyconsistent regimes on access.

◗ Develop appropriatedocumentation, managementand access protocols.

◗ Address matters involvingindigenous people and theirownership of biologicalresources.

◗ Address issues of access tobiological resources withinCommonwealth areas,including through regulationsunder the EnvironmentProtection and BiodiversityConservation Act 1999.Au

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Matters involving accessto biological resourcesare important issues forAustralia.

Biotechnology Australiaand AustralianBiotechnology AdvisoryCouncil

ObjectiveSupport the ongoing coordinationand review of Commonwealthbiotechnology policy andprograms and support the work ofthe Biotechnology AdvisoryCouncil.

Biotechnology Australia, alongwith its five memberdepartments, will have the keyrole in implementing andevaluating the NationalBiotechnology Strategy and incoordinating and managing thegovernment’s non-regulatorybiotechnology activities.

Strategies◗ Establish a high level

Biotechnology Advisory Councilto advise on non-regulatorybiotechnology issues -including research anddevelopment, internationallinks, commercialdevelopments, public interestissues and ethical issues.

◗ Coordinate Commonwealthbiotechnology-related policiesand activities, and maintaincooperation between theCommonwealth and the Statesand Territories.

◗ Support the ongoingevaluation and development ofthe National BiotechnologyStrategy, including throughbenchmarking Australianbiotechnology developmentwith internationalperformance.

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Maintaining Momentum and Coordination

The molecule responsiblefor protecting coral fromthe sun is being used todevelop sunscreenproducts for humans.

Photo creditsPage 2: University of Queensland

Page 8: CSIRO Health Sciencesand Nutrition

Page 13: Agriculture, Fisheries andForestry — Australia

Page 14: Clive Marks, VictorianInstitute of Animal Science

Page 15: (top right): CSIROMathematical and InformationSciences; (lower left): University ofQueensland

Page 16: Therapeutic GoodsAdministration

Page 17: Biota Holdings Ltd

Page 19: CRC for Bioproducts

Page 20: CSL Ltd

Page 21: University of Queensland

Page 22: Tyson Sadlo Photography

Page 25: CSIRO Plant Industry

Page 26: SG Szabo

Page 27: Australian Institute ofMarine Science

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A Federal Government Initiative