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Development of the National Raising Public Awareness and Informing Impacts of Agriculture and Food Biotechnology Sustainability and Public Good Applications of Developing a Rigorous, Eff

Biotechnology

Australian Biotechnology

a n a t i o n a l s t r a t e g y

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Development of the National

Raising Public Awareness and Informing

Impacts of Agriculture and Food Biotechnology

Sustainability and Public Good Applications of

Developing a Rigorous, Efficient and Transparent

AUSTRALIAN BIOTECHNOLOGY IN THE

Human Resources for Biotechnology

Research for Competitive and Sustainable

MAINTAINING MOMENTUM AND COORDINATION 27Biotechnology Australia and Australian

On behalf of my colleagues

on the CommonwealthBiotechnology Ministerial

Council, I am pleased to present

the National Biotechnology

Strategy which outlines the

Government's vision and support

for biotechnology

Biotechnology is a key technology

of the future It presents

enormous opportunities as well

as great challenges

Biotechnology holds the promise

of improved health and welfare

for all Australians through better

understanding of disease,

improved diagnosis, and

treatment with more specific

biopharmaceutical products

Biotechnology, including the

genetic modification of

agricultural and food products,

also has the potential to deliver

productivity, competitiveness and

sustainability benefits to

Australia The technology offers

improved resistance to insects

and disease, and new uses foragricultural products, improvedfood qualities, reduced

environmental 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 biotechnology

we are developing innovativeproducts, building fast-growingenterprises, attracting

international 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 served

by 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

The Hon

Dr Michael Wooldridge

Minister for Health and Aged Care

The Hon Warren Truss

Minister for Agriculture, Fisheries and Forestries

Senator The Hon Robert Hill

Minister for the Environment and Heritage

Senator The Hon

The Biotechnology

Consultative Group(BIOCOG) supports the

Government's vision to develop a

National Biotechnology Strategy

and has contributed to its

formulation over the last year The

issues which require the greatest

attention include:

of biotechnology research and

application

information to the public on

biotechnology issues

early stage funding and

management and the creation

of competitive biotech clusters

Global biotechnology innovation

and growth continues to

accelerate The United States,

Canada, UK, and Germany, for

example, are reaping tremendous

benefits from major governmentprograms and growing privatesector commitments to developindustries utilising biotechnology

Effective commercialisation of thetechnologies developed inAustralia is necessary to generate

a return from our investment andparticipate in the global

biotechnology marketplace Thepotential rewards are enormous:

one biotech-basedpharmaceutical, erythropoietin,generated world-wide marketsales in excess of $A5 billion in

1999, equivalent to the totalworld export sales of Australiangold in that year

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

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

Tony Bates

Chair, Biotechnology Consultative Group

The Biotechnology ConsultativeGroup was formed in 1999 toadvise Biotechnology Australiaand the CommonwealthBiotechnology Ministerial Council

on the development of theNational Biotechnology Strategy.The Group consists of 22

members from the research andbusiness sectors, includingethicists and nutritionists

Consistent with safeguarding

human health and ensuring

environmental protection, that

Australia capture the benefits of

biotechnology for the Australian

community, industry and the

environment

This vision, which is based on the

responsible use of biotechnology

to drive economic and

community benefit, is supported

by the Government’s goals for

biotechnology which are:

through a rigorous, efficient

and transparent system of

regulation for gene

technology research and for

genetically modified

organisms and products;

and

– the highest ethical

standards are observed

has access to qualityinformation aboutbiotechnology, the potentialrisks and benefits of itsapplications, the ethical issuesthey raise, and has confidence

in the way risks are assessedand managed

– and that it can contribute topublic policy in this area

community benefits ofbiotechnology through– an internationallycompetitive environmentfor investment andenterprise development;

– stronger links between thebiotechnology researchsector and industries thatapply biotechnology; and– better management ofintellectual property

infrastructure for generatingbiotechnology applicationsthrough

– productive investment inbiotechnology research anddevelopment;

– world class education inbiotechnology;

– secure access to genetic andbiological resources; and– conserving genetic andbiological resources

What is

Biotechnology?

a group of technologies based on

the application of biological

processes It has diverse

applications in medicine,

agriculture, food processing,

manufacturing and

environmental management The

term "modern biotechnology" is

used to distinguish recent,

research based activities from

traditional fermentation

technologies such as bread,

cheese or beer making, and

animal and plant breeding, which

were the first examples of

biotechnology Modern

biotechnology includes a range of

techniques from recombinant

DNA technology, molecular and

cellular biology, biochemistry and

immunology 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 range

of 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

on the market and 350 in development.

Biotechnology is responsible for

hundreds of medical diagnostic

tests that detect diseases earlier,

thereby ensuring more successful

treatment, and that keep the

blood supply safe from viruses

Home pregnancy tests are also

biotechnology diagnostic

products In the foreseeable

future biotechnology promises to

enable the prediction and early

prevention of many diseases,

developments that will radically

reshape the health industry

International

Pace of Change in

Biotechnology

Biotechnology development

around the world is moving fast

It is less than 20 years since the

launch of the world’s first

biotechnology medicine, an

insulin product, in 1982 In 1998

Australian farmers first used

cotton plants which had been

genetically modified to be pest

resistant, which has enabled

them to reduce their use of

pesticides While biotechnology

will continue to be dependent on

lengthy research and

development efforts, we are now

on 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 is Important to Australia

Australia’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

An environment that encourages

responsible biotechnology

development, and fosters

investment in infrastructure, R&D

and commercialisation will drive

economic growth and maximise

Australia has substantial research

infrastructure in the universities,

the CSIRO, Co-operative Research

Centres and Commonwealth and

State funded research and

development organisations

Commonwealth expenditure on

biotechnology research anddevelopment is in excess of $250million per year through a range

of 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 research

Challenges for

Australian

Biotechnology

Australia has a strong foundation

for developing and applying

biotechnology We have a very real

develop new enterprises, new

industries, new bases for

competitiveness in existing

industries and new international

collaborative relationships

In some sectors, for example

agriculture and mining, Australia

enjoys significant comparative

advantage However our

comparative advantage in such

areas may face serious challenge

if we do not capitalise on the

innovations offered through

biotechnology In others sectors

where we do not currently enjoy

particular advantages - such as

pharmaceuticals, health and

environmental industries

-biotechnology offers substantial

opportunities to improve our

competitive position The

challenge will be to seize these

opportunities

Australian firms often lack thefinancial depth and themanagement and marketexpertise to take a product frominvention to market; muchbiotechnology intellectual property

is 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 engaged

in 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 the National

Biotechnology Strategy

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 the

publication: Australian

Biotechnology: Progress and Achievements.

In 1999 the Governmentestablished BiotechnologyAustralia and the CommonwealthBiotechnology Ministerial Council

to coordinate governmentbiotechnology activity and todevelop a national biotechnologystrategy The Government also

established the Biotechnology

Consultative Group (BIOCOG), a

panel of experts from industry

and the scientific and research

Commonwealth support for

biotechnology, seeks to:

advantages in biotechnology

established and new industry

sectors

among Commonwealth

Government activities and

partnerships with State

Governments

and active participation

government

consultation and strategy

Discussion Paper "Developing

Australia's Biotechnology Future"

was published in September

1999, 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 Members

of 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:

Community,

the Global Market,

Raising Public Awareness and Informing a Community Dialogue

Objective

Increase the public’s general awareness of biotechnology and its applications, and of the regulations that safeguard people and the environment in order to facilitate informed debate and decisions.

Consumers are seeking balancedinformation on biotechnologyranging from the basics of genetechnology to details of theregulatory processes The issue ofgenetically modified food appears

to be a particular concern There is

a strong preference from thecommunity for the Government

to 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

discussion of regulatoryprocesses, including testingand labelling of GM foods, andassessing and managing risks

to human health and theenvironment

biotechnology, its regulation,the industry, and the way risksare assessed and managed

and listen to communityconcerns

and its applications, and of

the regulations that

safeguard people and the

and regional Australia about

agricultural and food

biotechnology, including

potential socio-economic

effects of biotechnology, and

manage any adverse

sustainability and natural

resource management issues

Biotechnology in the Community

Biotechnology can improve rural sustainability and competitiveness.