Queensland Biotechnology Code of Ethics

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Table of contentsForeword

Legislative reviews

Organisations covered by the Code

Public register of organisations covered by the Code

Breaches of the Code or relevant laws

Complaints

Monitoring and Reporting

General principles ofthe Code

lntegrity of research and product testing, risk assessment and risk management 7

Research into Genetically Modified organisms (GMOs)

Biodiscovery

Care and protection of staff and the public

Care and protection of animals

Transport of materials

Supporting discussion of ethical issues and resourcing ethics committees 8

Intellectual property and commericalisation 9

Consumer and patient information

Biotogicat weapons

lmport and quarantine controls

International obligations

Agriculture, food and the environment

Biodiversity and sustainable agriculture

Consumers

AgriculturaI and veterinary chemicals

Bioremediation and bioprocessing

Medical research and health care

Genetic testing

Gene therapv

Cloning and related technologies

Xenotransplantation 17

AppendixOne: Keysteps In managingconflictsoflnterest 12

Glossary and Abbreviations

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Statement of lntent

) Queensland Biotechnology Code of Ethics updated 2006 (

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The Honourable Peter Beattie MPPremier and Minister for Trade

'Definitions oftechnicalwords can be found in the glossaryatthe end ofthis document.

The Code, a Government direct ive, has mandatory apptication

to al[ organisations undertaking biotechnology that receive

State Government funding or assistance. Organisations

undertaking biotechnology that are not State agencies or

not in receipt of State funding are also strongly encouraged

to subscribe to the Code as a voluntary commitment to the

principtes set forth in the document.

Al l organisations that are bound by the Code under Cabinet

direction, orvoluntarity subscribe to the Code are identified in

a Pubtic Register of Biotechnology Organisations available on

the internet or from the Department of State Development.

As the Code is not a legistat ive instrument, fai lure to compty

with i t wit t not attract legat sanctions. However, the State

reserves the r ight to review and withdraw funding provided to

any organisation undertaking biotechnologywhich is found

to be in breach ofthe Code.

Enquir ies about the operation and application ofthis Code and

any complaints about non-compliance with the Code should be

directed to the Department of State Development:

The Director-General

Department of State Development

PO Box 15168

CITY EAST QLD 4ooz

Telephone: (o7) 3zz5 8825qtdbiotech@qld.gov.au

We commend the Code to al l organisations conducting

biotechnotogy in Queensland.

ForewordThe Queensland Government has [ong recognised the

importance of biotechnology' and the posit ive effects i t

has on the State's economic, health and sociat wetlbeing.

The Government also recognised that for the State to be

a biotechnology leader, i t woutd need to progress the

development of robust and workable standards relat ing to

safety and bioethics. In achieving this end the QueenslandGovernment reteased the Code of Ethicol Practice forBiotechnology in Queensland in zoot.

As biotechnology is a rapidly devetoping area, the Code of

Ethical Practice for Biotechnology in Queenslond, has been

updated to take account of scienti f ic, legislat ive and pol icy

developments. l t is now cal led the Queensland Biotechnology

Code of Ethics (the Code).

The Code declares the fundamentat ethicat framework

that shoutd guide the development of biotechnotogy in

Queensland, where necessary making appropriate reference

to legislat ive controls. l t refers to a[[ major sectors of

the indus t ry inc lud ing heat th and med ica l app l i ca t ions ,

agriculture, food and food manufacturing, the environment

and industr ial Drocesses.

The Honourable John Micket MPMinister for State Development,Employment and lndustrial Retations

r Queensland Biotechnology Code oi Ethics updated zoo6 <

Legislative reviewsI t i s expec ted tha t b io techno logy organ isa t ions w i t l befami l ia rw i th and ab ide by cur ren t na t iona l and s ta teteg is ta t ion . To th is end, p tease be adv ised tha t :

The Commonweatth's Gene Technology Act 2ooo is currently

under review and the Queenstand Gene Technology Act zoot

was independent ly rev iewed in August zoo6, in accordance

with section r94 of the Gene Technology Act zoot (QId),

The Commonwealth's Research lnvolving Human EmbryosAct 2oo2 and the Prohibition of Human Cloning Act zooz arecurrently under review and there is a statutory obtigation toreview Queensland's Research Involving Human Embryos andProhibit ion of Human Cloning Act zoo3.

As biotechnology is a developing enterprise, the QueenslandBiotechnology Code of Ethics will be reviewed in five years( in zor r ) ,

Organisations coveredby the CodeBy d i rec t ion o f S ta te Cab ine t , th is Code has mandatory

app l ica t ion to a [ [ :

a ) Queens land Government agenc ies , research cent res ,

labora tor ies and pub l ic hosp i ta ts tha t conduct

b io techno logy ac t iv i t ies '

b ) Compan ies , academic ins t i tu t ions and research bod ies

that receive f inancial assistancer from the QueenslandGovernment to under take b io techno logy ac t iv i t ies

c) Research organ isa t ions inc lud ing CRCs and Cent res o f

Excettence that receive f inanciaI assistance from the

Queens land Government to under take b io technotogy

ac t iv i t ies , and or tha t conduct b io technotogy ac t iv i t ies

tha t have a Queenstand Government body or o f f i cer as a

par t i c ipa t ing member .

For the purpose of the Code, al l organisations described

above are referred to as "Queenstand biotechnology

organisations".

A [ [ compan ies and research ins t i tu tes under tak ing

b io technotogy ac t iv i t ies in Queens land tha t a re no t descr ibed

above are s t rongty encouraged to subscr ibe as a vo lun tary

demonst ra t ion o f the i r commi tment to e th ica I p rac t ice .

Subscript ion is by way of signing a Statement of Intent (refer

to pages 15 and 16) to comply with the Code. Organisations

that voluntari ly subscribe to the Code are referred to in the

Code as "subscr ib ing b io technotogy organ isa t ions" .

For s impt ic i t y , where appropr ia te , Queens land b io technotogy

organ isa t ions and subscr ib ing b io technotogy organ isa t ions

wil t be referred to cotlect ively as biotechnology organisations

in the Code.

Biotechnology organisations shatf be enti t led to promote

themselves as, or refer to themsetves as QueenslandBio techno logy Code o f E th ics compl ian t o rgan isa t ions so

long as they compty w i th the Code and are no t in b reach o f

relevant laws or under investigation for a serious breach.

Public register of orgonisotions covered hy the CodeOrganisations covered by the Code are identi f ied in a pubtic

register of biotechnotogy organisations which is open forpub l ic sc ru t iny . Cop ies o f the Pub l ic Reg is te r a re ava i lab le on

the internet at www.biotech.qtd.gov.au or by contacting the

Department of State Development.

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' "activities" include biodiscovery, biotechnology research or development, and the manufacture or provision of biotechnology goods or services. We acknowledgeihat not all biotechnology research may attract significant commercial interest. Research may be pure or strategic, or may be undertaken solely for communityservice or public benefit reasons. We affirm that this type of research has value and importance, even where it does not result in commercial returns to theorganisation or to the State.

3 "financial assistance" includes financial grants for research, infrastructure, planning, training or administrative purposes; financiaI incentives; and in-kindassistance such as provision of [and, accommodation or other facilities.

> Queensland Biotechnology Code of Ethics updated 2006 (

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Breaches of the Code orrelevant lawsThe Code requires biotechnotogy organisations to estabtish

internal procedures for identi fying and recti fying breaches

of the Code and a l [ o ther s tandards , gu ide l ines and laws

relevant to the safe and ethicaI conduct of biotechnology.

As the Code is not a legistat ive instrument, fai lure to

compty with the Code wit[ not attract legaI sanctions.

Notwithstanding, the Code refers to a wide range of tegal

controls appticable to biotechnology activi t ies in Queenstandundervarious Commonwealth and state [aws. Faiture to

comply with these laws may result in a biotechnotogy

organisation being prosecuted by Commonweatth or state

author i t ies under re tevant [eg is ta t ion ,

The Code does no t d isp lace codes o f p rac t ice , gu ide l ines ,

standards or regutations appticable to biotechnotogy

activi t ies in Queensland under nationa[, state or local

au thor i ty leg is la t ion . In the event o fan incons is tency

between the Code and tegatty prescribed standards, the

latter take precedence.

ComplaintsAt any t ime, a compla in t about a b io techno logy organ isa t ion

fai l ing to comply with the Code may be made to the

Depar tment o f S ta te Devetopment . The compla in t must be

made in wr i t ing , and inc lude the name and contac t de ta i l s o f

the comptainant. Complaints received wil l be reviewed by apanet compr is ing sen io r representa t ives o f the Depar tment

of State Development, Queenstand Heatth, Environmental

Protection Agency, Off ice of Fair Trading, Department of

Pr imary Indus t r ies and F isher ies , Depar tment o f M ines and

Energy, and Workplace Heatth and Safety Queenstand.+As part of the review process, the Committee wil I referthe

compta in t to the independent Queens land B io techno logy

Advisory CounciI for advice, and wil l take the Counci l 's advice

into consideration when report ingthe resutts of the review

to Cabinet.

Gu ide l ines fo r reso lv ing compla in ts a re ava i lab le f rom the

Depar tment o fS ta te Devetopment o r th rough the in te rne t a t

www.biotech.qld.gov.au

Monitoring ond reportingTo assist the Department of State Development undertake i ts

mon i to r ing respons ib i l i t i es , the Code requ i res b io techno logy

organisations to:

. Estabtish internal procedures for report ing and recti fying

breaches ofthe Code and other relevant standards,

guidel ines, and laws retated to biotechnotogy.

. Provide reasonable assistance to the Department of

S ta te Deve lopment about compl iance or non-compl iance

with the Code, inctuding for the purpose of reviewing any

compla in t tha t may be made.

. Promptly noti fy the Department of State Devetopment of

any instance where the organisation has been prosecuted,

sanctioned or penatised for fai lure to comply with any [aw,

regutation or legal code relat ingto biotechnology.

r Submi t an annua l repor t to the Depar tment o f S ta te

Deve lopmentw i th in th ree months o f the end

of the f inanc ia I year on :

. measures taken to implement the Code

. the na ture and scope o fany compta in ts to the

organ isa t ion about non-compl iance w i th the Code and

measures taken to address the comptaints

. any un in ten t ionaI b reaches o f the Code and measures

taken to address the breach.

AnnuaI repor ts do no t need to be h igh ty de ta i ted bu t shou ld

contain suff icient information to enable a reasonable

assessment of the organisation's performance in comptying

with the Code.

Shoutd a b io techno logy organ isa t ion fa i I to honour the

Code ( in ful[ or in part) or any Commonwealth, state or locaI

authority law relat ing to biotechnology, the Queensland

Government wit[ review, as appropriate, state funding

provided to the organisation for biotechnology activi t ies and

the State Government's associat ion with, or part icipation in,

biotechnology activi t ies conducted by the organisation.

a Biotechnology organisations should also notifyWorkplace Health and Safety Queensland or appropriate OccupationaL Health and Safety Regulatorwhere a breach ofthe Code endangers or constitutes an unacceptable riskto the health and safety ofstaffor others.

> Queens land B io techno logy Code o f E th ics upda led 2oo6 (

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Generalprinciplesof

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the CodeAs a b io techno logy organ isa t ion , we w i t l observe thefo t low ing pr inc ip les :

lntegri ty - maintaining honesty and respect for the truth.

Beneficence and non-maleficence - achieving the greatest

poss ib le good wh i le do ing the teas t poss ib le harm. '

Respect for persons - treating patients, ct ients, research

sub iec ts and consumers as au tonomous agents hav ing

f reedom o f cho ice , d ign i ty and human r igh ts .

Respect for the law and system of government - comptying

with relevant laws and standards, fostering public

par t i c ipa t ion and t ransparency in dec is ion mak ing ,

and demonst ra t ing accountab i t i t y fo r ac t ions and

use of resources.

f ust ice - recognising wider community interests beyond

the in te res ts o f the ind iv idua l , o rgan isa t ion or corpora t ion ,providing redress for the vulnerabte, and promoting

eouitable access to resources.

Care and protection of animals - ensuringthat the welfare

of animals used for scienti f ic purposes is respected.

Hav ing regard to these fundamenta l p r inc ip les , and theconduct ou t l ined in th is Code, we w i t l pursue b io techno logy

ac t iv i t ies w i th po ten t ia t to improve human hea l th , enhancequat i t y o f l i fe , suppor t the env i ronment (by observ ing theprecautionary principle, preserving ecosystem health

and biodiversity), and promote sustainable agriculture

and indus t ry .

) Queensland Biotechnology Code of Ethics updated 2oo6 (

The CodeBy subscr ib ing to the Code, o rgan isa t ions agree to thefoItowing undertaking:

Integrity of research and product testing,risk assessment and risk managementr. We wil t ensure that staff are made aware of the Code

and a[[ other laws, standards and guidetines retevant tothe safe and ethicaI conduct of biotechnology activi t iesconducted by the i r o rgan isa t ions .

z. We witt ensure that research and product test ing areperformed by quati f ied persons to optimal scienti f icstandards and are conducted with integri ty and with fultregard to relevant facts and data.

3 . We wi t t ma in ta in accura te and comprehens ive recordsof research and product test ing, (both posit ive andnegative) and wil l report fut ly and accuratety on theresults of research, product tr ials and cl inical tr ials asrequired by the appropriate regulatory authorit ies andprofessional standards.

In the conduct of research, product tr ial t ing,manufacturing or other biotechnotogy activi t ies,potential confl icts of interest may arise. Whilst notnecessari ly unethical, confl icts of interest may resultin poor decisions or, at worst, misleading or corruptbehaviour. We wil l manage and disctose such confl icts ofinterest to ensure that the integri ty of research, product

tr ials, manufacturing or other biotechnology activi t ies,conducted by our o rgan isa t ion is ma in ta ined.

We wil t establ ish systems to ensure that confl icts orpotential confl icts of interest are disclosed and thatreasonable steps are taken to address and resolveany confl ict. There steps are outl ined in Appendix I ofth is Code.

We wiltwork with relevant state and federat authorit ies(for example statutory regulators) and relevant advisorybodies (for example Human Research Ethics Committeesand Institutional Biosafety Committees) to ensurethat biotechnology products and other biotechnotogyactivit ies are fully assessed for adverse impacts onhuman or animal safety or the environment. To the futlestextent possible, we witl address [ong-term as we[[ asshort - term impacts, inctuding consequences that maynot be immediate ly apparent . Risk assessments wi t lbe conducted in accordance with accepted scientif icpr inc iptes. Where r isks are ident i f ied, we wi l I ensurethat these risks are acknowledged through an openand accountabte process and that they are managedin an appropr iate manner to min imise the impacts ofthese risks.s

We witt not proceed with product development whereassessed risks outweigh benefits, orwhere productdevelopment or commercial retease is not approved byretevant regulatory authorit ies.

We witt promptty report any risk or adverse consequenceassociated with research, or product development, tothe retevant authority responsible for product oversight,regulation, risk assessment or risk management. lf,fotlowing product approval, we become aware of risks oradverse consequences associated with the product thatwere not known or fulty apparent at the time of approval,we wil l promptly inform the relevant authority.

Research into genetically modifiedorganisms (GMOs)The Queenstand Government developed the Gene Technology

Act 2oo7 (Qtd) as part of the national ly consistent approach

to regulat ing GMOs. The scheme was establ ished by theCommonwealth and al l state and terr i tory Governments

and is based on a sc ience-based r i sk assessment p rocess

overseen by the independent Gene Technology Regulator.

The purpose o f th is scheme is to ensure tha t gene techno logyresearch and i ts products are regulated and managed tomin imise impacts on human sa fe ty and the env i ronment .

9 . We wi t t ensure tha t research in to GMOs meets a l l the

requ i rements o f the scheme, no t ing tha t fa i lu re to

comply with the scheme may attract severe penalt ies.

In par t i cu la r :

. We w i l l no t conduct research in to GMOs untess our

organisation is accredited by the Gene Technology

Regulator. As part of the accreditat ion process, we wil l

establ ish Inst i tut ionaI Biosafety Committees ( lBCs) to

oversee and monitor research within the organisation

and to he tp ensure tha t the requ i rements o f the na t iona l

scheme are observedo.

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5 .

5 The Australian New Zealand Standard on Risk Management AS/NZS 436o:zoo4 may provide a useful tool which includes sound risk management principles.6 Smaller institutions may use another organisation's Institutional Biosafety Committee ifthis is approved by the OGTR.

I Queens land B io technotogy Code o f E th ics updated 2o06 (

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We wi [ [ no t conduct con ta ined research on GMOs un lessour [aboratories are cert i f ied by the Gene TechnorogyRegulator to the appropriate containment level.We witt not undertake contained research, f ield tr iats,or commerciaI releases of GMOs unless these activi t ieshave been reviewed and, where appropriate, l icensed.Where contained research, f ietd tr ials or commercialreleases are approved, we wil I compty with anycondit ions establ ished by the Gene TechnologyRegulator, report any breaches ofthese condit ions .and witt undertake any corrective action necessarv oras d i rec ted .

We wil l cooperate with Commonwealth off icersappointed by the Gene Technotogy Regulator to monitorcompt iance w i th the na t iona l scheme.

BiodiscoveryArticle 15 ofthe United Nations Convention on BiologicalDiversity (r993) (the Convention) recognises the sovereignr ights ofstates over thei r naturaI resources and thei rauthority to determine access to genetic resources. TheCommonwealth has ratif ied the Convention, the objects ofwhich are the:

conservation of biotogicat diversity

susta inable use of the components of b iodivers i ty

fair and equitabte sharing of benefits arising from the useof genetic resources.

ro. In this regard, the State Government develooed theBiodiscovery Act 2oo4.fhe Biodiscovery Act zoo4 (eld)creates a streamlined, environmentally responsibteaccess regime to permit collection of native biotogicatmaterial and requires sharing of benefits derived from thestate's biodiversity.

We witt compty with the Biodiscovery Act zoo4 (eld).We wilt coltect native biological material from state landand Queensland waters onty with the prior informeoconsent of the state.Before collecting samples from privately owned land,we witl ensure that the prior informed consent of thelandowner is obtained and we witt negotiate reasonablebenefit sharing arrangements with the landowner inreturn for access to the samples.We recognise that there may be culturatty significantaspects ofthe knowledge ofAboriginat and Torres Straitlstander peopte, that we wilt treat in a sensitive andrespectful manner if used in the course of biotechnotogy.

Where in the course of biodiscovery we obtain and usetradit ional knowledge from indigenous persons, we wil lnegotiate reasonable benefi t sharing arrangements withthese persons or communi t ies .

In the course of biodiscovery activi t ies we wit l comptywith the Native Title Act 19% (Cth).

We wi l l no t commi t ac ts o f b iop i racy and w i l t no t ass is t athird party to commit such acts.7

Care and protection of staff and the publicr r . We w i t l compty w i th a t t re levant requ i rements o f the

Workplace Health and Safety Act 1995 (eld) and wiI seekto compty with relevant Austral ian Standards governinglaboratory safety.

rz. We wil l inst i tute adequate safety measures, and conductour work in such a way as to ensure the heatth and safetyo f our s ta f f and o ther persons , and we w i t l ensure tha t ourstaff are properly trained in safety procedu res.

Care and protection of animalsr3 . To ensure tha t the we l fa re o f an ima ls used fo rsc ien t i f i c

purposes is respected, we wil I comply with the AnimalCore and Protection Act zoot (Qld) and the AustralianCode o fPrac t ice fo r the Care and Use o fAn imals fo rScienti f ic Purposes.8

Transport of materials14. When t ranspor t ing b io tog ica t mater ia ls o r subs tances

ctassif ied as dangerous, we wil t compty with att relevantin te rna t ionat , Commonweal th and Sta te gu ide t inesgoverning safety in transport.e

Supporting discussion of ethical issues andresourcing ethics committeesr5. We witl encourage consideration and discussion of

eth ica l issues.

16. We uphold the right of all persons to contribute to thedebate and d iscussion about the eth ica l chal tengescreated by biotechnotogy. We agree that many ethicalissues cannot be resolved purety by the organisation orrelevant profession engaged in the research, and thatbroader perspectives need to be engaged. We wilt seek toinclude these broader perspectives in our considerationof ethical challenges.

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7 "Biopiracy" refers to the appropriation of developments or discoveries invotving biologicat resources by another party without consent.s The Australian code of Practice for the care and lJse ofAnimols for scientific Puiposesias been endorsed by the N HMRc, cSl Ro, Austratian Research counciI andthe Australian Vice Chancellors' Committee. The Code aims to ensure that the welfare ofanimals used in research is considered, the use ofanimals is justified, painordistress to animals is avoided, and the numberof animals used in proiects is minimised.e For example, the Transport Operotions (Road use Management - Dongerous Goods) Regulation rygB (Qld) and The Australian Dangerous Goods code, 5th Edition.

r Queensland Biotechnology Code of Ethics updated 2oo5 (

12. We witl ensure that att ethics and biosafety committeesestablished within our organisation under relevantlaws and guidelines, or under the Code, are given thesupport necessary to futfit their responsibil i t ies. Thisincludes ensuring that they have adequate resources,have sufficient standing in the organisation, and haveful[ and appropriate access to senior management. Thesecommit tees inc lude Human Research Eth ics Commit tees,Animat Ethics Committees, Institutional BiosafetyCommittees and any committee or body estabtished bythe organisation for the purpose of promoting interrialdiscussion of ethicaI issues or overseeingimplementation of the Code.

lntellectual property and commercialisationr8. We wit l endeavour to ensure that new discoveries by

Queensland researchers are devetoped in ways thatprovide appropriate returns to the state and, whereappropriate, retain control ofthe intettectual property

within Queensland. Where, despite best endeavours,i t is not possible to develop our discoveries within

Queensland, we wil l aim to l icense rather than setl theintel lectual property. lo

r9. Recognising that many non-western and developing

count r ies a re a lso seek ing to improve the i r b io techno logycapacity, we wil l support exchange oftechnotogy

between countr ies, including developing countr ies, forthe broader benefi t ofthe world economv and

social develooment.

Consumer and patient informationzo. We wi[[ provide clear, honest and verif iable information to

consumers, patients and recipients about our products,the technologies emptoyed, the materials used, and anyrisks or side effects,

zz. We wil l aim to ensure that biotogicat controI agentsdirected at environmentaI protection and agriculture(for example in relation to the control of pests) areecologically sustainable. We will ensure that suchapptications comply with retevant laws and biosafetyreq uirements.

lmport and quarantine controls23. We witl comply with all national standards administered

by the Australian Quarantine and Inspection Service,Biosecurity Australia and the Australian Customs Servicewhen importing or exporting biotechnology products ormaterials.

I nternationaI obligations24. We witt observe a[[ relevant laws and standards

appticable to other countries in which we conductbiotechnology activit ies or to which we exportbiotechnology research or products."

Agriculture, food and the environment25. Where we deal with agricutturat, food and environmental

biotechnology, we wil [ aim to produce animal diagnostics

and vaccines, crop variet ies and biotechnology solut ions

that benefi t consumers, improve agricultural productivi ty

and sus ta in the env i ronment .

Biodlvercity ond sustalnoble agriculture26. Having regard to the uniqueness of the Austrat ian

environment. we wil[ seek commerciaI release inAustralia of genetically modified plants, animals or otherorganisms only where they have undergone adequatef ie td t r ia l t ing underAustra l ian condi t ions in accordancewith requirements set down by the Gene TechnologyRegulator.

27. We witl seek to ensure that plants, animals and otherorganisms produced through gene technology do notinteract with natural ecosystems in ways that maydiminish Australia's natural ecological capitat.

Biotogical weaponszr. Noting that Australia is a signatory to the Geneva Protocol

(1925) and the Biologicol Weapons Convention G97z),we wil[ not use biotechnology to develop or producebiotogical weapons for use in warfare or terrorism, andwill not assist any other organisation, person or countryto develop, produce, duplicate, stockpile, acquire, retainor use such weapons in Australia or elsewhere.

'o For more information, refer to Chapter 3.3 Ownership of Inteltectual Property, Queensland Public Sector Inteltectual Propefi Guidelines.11 For example the United Nations Educational, Scientific and Cultural Organisation's (UNESCO) Universal Dectaration on Bioethics and Human Rights(http://www.pre.ethics.gc.ca/english/pdf/links/Unescodeclaration_zoo5.pdfl .

' Q u e e 1 \ l a n d B i o t e c h - o l o g y ( o o e o f L I r i c s L F O J l e d r o o 6 (

28. A key communi ty concern is the r i sk o f un in tended mix ing

on fa rms and a tongthe suppty cha in o f the harves tedproducts from geneticalty modif ied (GM) crops and

t rad i t iona I c rops . ln add i t ion to the quat i t y assuranceprotoco[s, market pressures, and common law provisions

that faci l i tate the adoption of coexistence measures,

the Government has develop ed A framework to develop

co-existence strategies for GM and non-GM crops in

Qu ee nslan d Io ensure effect ive segregation" aton g

the supp ly -cha in and to p rov ide agr icu l tu ra l p roduc ts

that meet market requirements. We witt work with thb

Queensland Government to support the Coexistence

Framework.

29. l f prescribed by the Gene Technology Regulator, we wit l

es tab l i sh and main ta in adequate bu f fe r zones aroundgeneticatly modif ied crops to minimise unwanted transfer

to conventiona[ crop variet ies, other organisms, or the

environment, and witt comply with al l relevant condit ions

estabtished by the Gene Technology Regulator.

3o . Where we use gene techno logy app l ica t ions in an ima ls

we wil [ refer to the Gene Technology Regulator, the Animal

Care and Protection Act zoot (Qtd), the Australian Code

of Practice for the Care and Use of Animals for Scienti f ic

Purposes , and requ i rements o f the loca t An imat E th ics

Committee and Inst i tut ionaI Biosafety Committee.

3r . Recogn is ing tha t some t rad i t iona l technotog ies have had

s ign i f i can t env i ronmenta I and eco log ica l impacts tha t

have onty become apparent over t ime, we wil t cooperate

wi th na t iona l and s ta te au thor i t ies in mon i to r ing the

long te rm eco log ica I impact o f modern agr icu l tu ra l

biotec h n ologi es.

Consumers32. Where we deatwith food products developed using gene

technology we wil [ ensure that the food products meet

the highest standards of safety, nutr i t ion and benefi t

for consumers, and comply with relevant standards

developed by Food Standards Austral ia New Zeatand(FSANZ) and approved by the Austrat ia New Zealand FoodRegu la t ion Min is te r ia l Counc i t .

33. To ensure consumers have freedom of choice, we wit l

compty w i th the s t r i c t mandatory labet t ing requ i rements

outt ined in the Austral ia New Zealand Food Standards

Code (FSANZ Standard r.5.2) which requires genetical ly

mod i f ied food and ingred ien ts to be tabet ted as such.

" Effective segregation is defined in the Queensland Government publication Developing strategies for GM ond non-GM crops in Queensland - Aframeworkfor co-existence as the "ability to grow and manage along the supply chain both GM and non GM crops in a way thai avoids unwanted mixing and delivers products belowpredetermined market thresholds".'3The National Stotement on Ethicol Conduct in Research lnvolving Humans (t9gd is currently under review (http://wwwz.health.gov.au/nhmrc/publications/humans/contents.htm).'4 In the event that consent is not readily obtainable, we will look to the Guadionship ond Administrotion Act 2ooo (Qld), the Powers of Attorney Act 1998 (QLd), tneNotional Stotement on Ethicat Conduct in Research lnvolving Humans.'5 Disclosure of personal information is subject to guidelines outlined in the National Statement on Ethical Conduct in Research lnvolving Humans. DiscLosure ofpatient data held by Queensland Government health authorities is governed by legal protections prescribed inthe Health ServicesActlggl (Qld).

Ag ri cultu ro I and vete ri n a ry chem i cols34. We wi t t ensure tha t agr icu l tu ra l o r ve ter inary chemica ls

produced through biotechnotogy are submitted to the

Aust ra l ian Pes t ic ides and Veter inary Med ic ines Author i ty

for pre-market safety assessment and registrat ion.

Bi oremed i ation o n d bi opracessi n g35. We suppor t the deve lopment o f b io techno logy so lu t ions

tha t de l i ver c leaner indus t r ia l and mun ic ipa I p rocesses

to p ro tec t the env i ronment and promote sus ta inab le

indus t r ies .

36 . Whi te acknowledg ing the po ten t ia l fo r b ioprocess ing

technotog ies to p romote eco log ica I and indus t r ia I

sus ta inab i l i t y (by e l im ina t ing harmfu I was te and

generating alternative energy sources) we wil l seek

to ensure tha t these techno log ies do no t themse lves

threa ten the env i ronment o r human hea l th o r sa fe ty .

For example , we w i l l ensure tha t fe rmenta t ion , b iogasproduc t ion , and o ther b io log ica l p rocesses employed

do no t pose unacceptab te hea l th r i sks to s ta f f o r o therpersons , and tha t deve lopment o f new or enhanced

b ioprocess ing indus t r ies u t i l i s ing agr icu l tu ra l p roduc ts

are assessed fo r the i r impact on agr icu l tu ra I sys tems,

ecosystems, [and clearing, and water resources.

Medical research and health care37. We wit l conduct any research involving humans with the

highest standards of safety, integri ty and respect for

human d ign i ty and w i t [ compty w i th a l I re levant Nat iona l

Hea l th and Med ica I Research Counc i l (NHMRC) gu ide l ines

as enforced from t ime to t ime, in part icular th e National

Statement on Ethical Conduct in Research lnvolvinq

Humans G99il ."

38 . To ensure b io technotogy-based med ic ines andprocedures meet the highest standards of safety and

efficacy, we will comply with the Therapeutics Goods Act

tgSg (Cth) and any requirements ofthe Therapeutics

Goods Admin is t ra t ion .

39 . We wi t t ensure tha t research invo tv ing humans is

conducted onty with the free, informed and voluntary

consent o f ind iv iduats par t i c ipa t ing in the research . '+

4o. We wi t l no t a l low unauthor ised access , use , mod i f i ca t ion

or d isc losure o f personaI iden t i f y ing in fo rmat ion ga ined

or used in the course o f research w i thout the consent o f

the ind iv idua ls ident i f ied bv tha t in fo rmat lon . '5

> Queens land B io techno logy Code o f E th ics updated 2oo6 (

Genetic testingWe acknowtedge the principte in the Universol Declarationon the Human Genome and Human Rights (199) thal"everyone has a r ight to respect for thei r d igni ty and for thei rrights regardless oftheir genetic characteristics and thatd igni ty makes i t imperat ive not to reduce indiv iduats to thei rgenet ic character is t ics and to respect thei r uniqueness anddiversity". '5

4r. We witl not conduct tests for genetic conditions, orpotent ia l d isease t ra i ts in ind iv iduats or thei r of fspt ing,wi thout the f ree, in formed, and voluntary consent of theindiv iduats to be tested.

42. We wi t t not d isc lose personal , ident i fy ing data f romgenet ic tests to th i rd par t ies wi thout consent of theindiv iduals concerned - rest r ic t ions on d isctosureare necessary to maintain patient confidentiality andensure that the resul ts of genet ic test ing are not usedto stigmatise individuals or cause discrimination (forexample, wi th respect to accessing l i fe insurance oremployment) .

43. We wi l t prov ide appropr iate counsel l ing and support toindividuats prior to and after genetic testing to assistind iv lduals to decide whether they wish to undergogenet ic test ing and to help them assess and manage theresults of genetic tests.

44. We wi t l respect the r ight of each indiv iduat to decidewhetherornot to be in formed of the resul ts ofgenet ictest ing, and the resul t ing consequences wi l I beresoected.

45. Counsel l ing wi l l address the t imi tat ions of genet ictesting as we[[ as the potential benefits - patientsshould be advised that genetic testing does not, ina l l c i rcumstances, prov ide cer ta inty that the persontested or thei r of fspr ing wi t l develop par t icu lar d iseases(condi t ions may be l inked to mul t ip le rather than s inglegenes; envi ronmental factors may a lso p lay a s igni f icantor dominant ro le in whether par t icu lar people developdiseases for which they may have genet ic suscept ib i t i ty) .

Gene theropy46. We wi l t no t under take somat ic ce t l gene therapy

unless the proposal has been reviewed and approved

in accordance w i th NHMRC gu ide t ines . Th is requ i res

consideration by the relevant Human Research Ethics

Commi t tee , the NHMRC's Gene and Re la ted Therap ies

Research Advisory Panet, the Therapeutics Goods

Admin is t ra t ion and where re levant the Gene

Technology Regulator.

Cloning ond reloted technologies47. We wilt comply with the Gene Technology Act zooo

(Cth)' , the Gene Technology Act 2oo1 (Qtd) and the

Gene Technology Regulation zooz (Qtd). We will also

comply with the Research lnvolving Human Embryos and

Prohibition of Human Cloning Act zooj (Qld) which bans

human c ton ing , germ l ine gene therapy and ensures tha t

research invo lv ing human embryos is s t r i c t ty regu la ted .

Xenotransplontotion48. We acknowtedge that concerns exist about the safety and

eff icacy ofxenotransplantat ion (for example, the r isk of

animaI retroviruses being transmitted to humans through

xen otra nsp lants).

49 . We wi t t ab ide by the NHMRC's dec is ions on issues

sur round ing xenot ransp lan ta t ion inc lud ing the f i ve year

ban (un t i l zoro) on conduct ing human c t in ica l t r ia ls

invo lv ing an ima[ - to -human whote organ t ransp lan ts .

5o. We wit l only use animats in xenotransplantat ion research

if suitable atternative therapies are not avai labte. We wit l

make every effort to keep the number of animats used in

xenotransolantat ion research to a minimum and to ensure

tha t these an imals a re p rov ided w i th as h igh a quat i t y o f

l i fe as possible.

5r. We note that research proposals involving

xenotransplantat ion must be considered under

ar rangements admin is te red by the NHMRC and tha t

the NHMRC requires al l research proposats invotving

xenotransptantat ion to be referred to the Gene and

Retated Therapies Research Advisory Panet (GTRAP) for

sc ien t i f i c , med ica I and techn ica l adv ice in the fo rmula t ion

and ethical review ofthe research. We also note that no

Human Research Ethics Committee shoutd approve any

research proposaI invo tv ing xenot ransp lan ta t ion w i thout

f irst seeking this advice.

'6 Article 2, Universal Declaration on the Humon Genome and Human Rights Q,99).'7 lncludingthe principles underthe Gene Technology Ethic Committee DraftNational Frameworkforthe DevelopmentofEthical Principles in GeneTe ch n ology I an uary 20 o 6.

I Quc I rs ian t l B io tec l r ro iogy i r :d , : o i ! i l r i r - . u f ia i ; r t0 r j rJo5 (

Appendix One: Key stepsin managing conflicts ofinterestPoint 5 underthe Section lntegrity ofResearch and Product

Testi n g requires that biotechnology organisations establ ish

systems to ensure that confl icts or potential conft icts of

interest are disctosed and that reasonabte steps are taken to

address and resolve any confl ict. These steps include:

Requir ing staff 's to disclose possible confl icts of interest.

- Requir ing staff to disctose their pecuniary interests( inc tud ing any bus iness assoc ia t ions , sharehotd ings ,

sponsorsh ips , donat ions , payments o r fees) .

ln oar t i cu ta r cases :

determining whether a confl ict or perceived confl ict of

interest exists that might catt into question the integri ty

of the work; or

where appropriate, direct ing or advising a staff

member to cease involvement in the work or to divest

him or herself of external interests that are seen as

incompatibte with the integri ty of the work; or' determining that a confl ict (or perceived conft ict)

of interest is acceptable or unavoidable in the

circumstances, is not detr imentat to the integri ty of the

work , and is appropr ia te ly d isc losed.

In cases where a confl ict of interest exists or may exist, or

where the circumstances could give r ise to a reasonable

perception of confl ict, the biotechnology organisation should

disclose the circumstances to relevant authorit ies having

oversight ofthe activi ty concerned. The relevant authorit ies

i nc lude:

The ethics committee responsibte for approval and/

or mon i to r ing o f b io technotogy ac t iv i t ies w i th in the

organisation'o, where the circumstances relate to a matter

or matters for which the committee has responsibi l i ty.

An external research funding inst i tut ion, where the

circumstances relate to an activi ty funded, or proposed to

be funded, by the ins t i tu t ion .

A regulatory authority where the circumstances relate to

scienti f ic advice or assessments that could be used by

the authority to approve or monitor research or product

release.

An ed i to r o r p roducer o f a p ro fess iona l iourna l , pub l i ca t ion

or media report, where the circumstances relate to

scienti f ic advice or assessments proposed for report ing in

the iourna l , pub l i ca t ion or med ia repor t .

An advisory board or government authority where the

circumstances relate to the provision of scienti f ic adviceprovided to the board or authority (for example, where

a member o f our o rgan isa t ion is engaged or appo in ted

to provide scienti f ic advice on biotechnotogy matters in

relat ion to which he or she may have, or may be seen to

have, a beneficiaI interest).

The organisation's f i nancial administrator, where

biotechnology products or services are purchased, or are

being considered for purchase, from an external source in

relat ion to which the purchasing off icer has, or may have, a

beneficiaI interest.

As a genera l ru te , b io technotogy organ isa t ions shoutd

disclose to relevant authorit ies att funding sources

associated with research activi t ies ( irrespective of whether a

confl ict of interest may exist or is perceived to exist).I

;

' , 's taf inc ludes management.'"Such committees include the relevant Institutionat Biosafety Committee; the Animal Ethics Committee and the Human Research Ethics CommitteeReferto paragraphs 9, 13 and 3Z ofthe Qtd Biotechnology Code of Ethics foran outline ofthese committees.

> QueensLand Biotechnology Code of Ethics updated 2oo5 (

Glossary andI I I . . .ADDrevraUOnS

BiodiscoveryBiodiscovery has the meaning given in the BiodiscoveryAct 2oo4 (Qtd) and inctudes the analysis of motecular,

biochemical or genetic information about native biotogicatresources for the purpose of commercial ising the materiat. , '

BiotechnologyBiotechnology is formalty defined as the science of usingl iving things, and components of l iv ing things, to producegoods and services. l t invotves manipulat ing and modifyingorganisms, often at the molecular level.

Practicatty, modern biotechnotogy includes techniquesranging from chemistry through molecular and cel lularbiotogy, biochemistry and immunology to biologicalappl icat ions of information technotogy and the developmento f med ica l ins t rumenta t ion . l t s app l i ca t ions span hea l th ,agriculture, industry and the environment."

CloningThe process of producing genetical ly identical organismsthrough var ious techn iques , inc tud ing cu l tu re o f spec i f i ccetls, art i f ic ial division of a single embryo, or cel l nucleartransfer, that is, transferr ing the nucleus of a somatic cel l intoan oocyte (the mature femate germ cel l or egg) from whichthe nuc leus has been removed.

CoexistenceCoexistence is defined as the abi l i ty to grow and manage

a long the suppty cha in bo th genet ica t ly mod i f ied and non-genetical ly modif ied or tradit ionat crops in a way that avoidsunwanted mixing and del ivers products below predetermined

market specif i cat ion or thresholds. ' :

CultureThe growing of micro-organisms, t issue cel ls, or otherl iving matter in a special ly prepared nutr ient medium (an

in te rven ing subs tance th rough wh ich someth ing e lse istransmitted or carr ied on).

" Biodiscovery Act 2oo4 (Qld)

" Queensland Government Qoeensland Biotechnology Strategic Plan 2005-2015: Biotechnology - sefting New Horizons': Queensland Government Developing strategies for GM and non-GM crops in Queensland - A ftameworkfor co-existence'4 Biotechnology Australia - Glossary of Terms (www.biotechnology.gov.au)'5 Biotechnology Australia - Glossary of Terms (www.biotechnology.gov.au)'6 Australian Food Standards Code Standard 1.5.27 ib id

GeneA sequence of DNA, located on a chromosome, which codes

for the synthesis of a specif ic protein or has a specif ic

regulatory function. '4

Gene technology reseorchStudy involving the manipulation, modification and transferof genes or segments of DNA or RNA.

Gene therapyTreating or preventing genetic diseases by changing the

expression ofa patient 's genes through the introduction of

DNA or RNA into the oatient 's celts.

G e n eti c ch o ro cte ri sti cA trait (dist inguishing feature) of an organism determined bygenetic inheritance.

Genetic inheritonceThe acquir ing of a set of physical or behavioural

characterist ics from a parent

Genetic modificationAny process altering the genetic material of livingorganisms.'s This process al lows genes to be isolated,

amptif ied and transported into new locations, even between

species, to effect desired characterist ics in organisms.

Examples include the duplication, insert ion, or delet ion ofgenes from another species, in situ in either microbes, plants

or an ima ls (humans inc luded) . Where th is i s done in humans,i t is gene therapy, and only human genes are used.

Genetically modifi ed foodA food produced using gene technology as'a food whichhas been derived or developed from an organism which hasbeen modified by gene technology'. This definit ion does notinclude a food derived from an animal or other organismwhich has been fed GM feed, unless the animal or organismitsetf is a product of gene technotogy.'6

Genetically modified organisn (G MO)An organism (ptant, animat, bacteria orvirus) that has hadits genetic material attered either by duplication, insertionor deletion of one or more new genes, or by changing theactivit ies of an existing gene.'z

r Queens land B io techno logy Code o f E th ics updated 2006 ( 13

* '%"

Genetic testingGenet ic tes t ing has cons iderab le po ten t ia t in hea l th care as

a means o f iden t i f y ing ind iv iduats 'genet ic make-up, and

enabling early prevention strategies to be targeted at persons

or offspring most at r isk of genetical ly determined diseases.

Geneticolly modified cropsModifying the genetic code of agricuttural crops to produceimproved characterist ics such as pest and disease

res is tance, d rought and sa l t to le rance, h igher y ie tds orgreater nutr i t ionaI value.

Samatic cellAny cel l in a mult icel lular organism except a sperm oregg cett.

XenotronsplantationThe term used to describe any procedure that involvesthe transptantation of l ive cells, t issues, or organs fromone species is to another , inc luding animat to humantransplantation (for example, from pigs to humans - animat-to-human t ransptantat ion) . '8 Xenotransplantat ion inc ludes:

animal to human whole organ t ransplants

animal ce l lu lar therapies - are procedures in which animaIcetts are transplanted or implanted into a human patient tocompensate for deficient functioning of the patient's owncelts (for example, pancreatic istet cells to treat peopte withdiabetes, or brain cetls to treat peopte with Parkinson'sDisease) and

animal externa[ therapies - are a range of proceduresinvolv ing contact between human and animal ce[ [s ortissues outside the body of the patient (for example, cellsor f luids from the patient are perfused through animal cellsand returned to the patient).

'8 Biotechnology Australia - Glossary of Terms (www.biotechnology.gov.au)

AbbreviationsAEC An imal E th ics Commi t tee

AHEC Aust ra l ian Hea l th E th ics Commi t tee

ARC Austrat ian Research Counci l

CRC Cooperative Research Centre

CSIRO Commonweal th Sc ieh t i f i c and Indus t r ia t

Research Organisation

DNA Deoxyr ibonuc le ic Ac id

FSANZ Food Standards Austral ia New Zealand

GM Geneticatty Modif ied

GMO Geneticalty Modif ied Organism

GTRAP Gene and Retated Therapies Research

Advisory Panel

HREC Human Research Eth ics Commi t tee

IBC Insti tut ionat Biosafety Committee

NHMRC Nat iona l Hea l th and Med ica l Research Counc i l

OGTR Off ice ofthe Gene Technology Regulator

RNA Ribonuc le ic Ac id

74 > Queens land B io technotogy Code o f E th ics updated 2o06 (

Statement of IntentPlease complete and sign the Statement of Intent below. Alternativeln you may downtoad and print the Statement of Intentfrom www.biotech.qld.gouau. Please return the completed Statement to:

The Office of BiotechnologyDepartment of State DevelopmentPO Box 15168City East Brisbane QLD 4ooz

THIS STATEMENT OF INTENT is made bv

of in the State ofQueensland ("the Queensland biotechnology organisation")4

WHEREAS

A. TheQueenslandBiotechnologyCodeofEth icsdeclaresthefundamentateth ica l f rameworkthatshouldguidethedevelopment of biotechnology in eueensland.

B. The Queensland biotechnology organisation endorses the development ofthe Queensland biotechnology industrywithin a strongand transparent ethical framework and has agreed to carry out its activit ies in accordance with the principles set out in the Code.

C. This Statement evidences the Queensland biotechnotogy organisation's intent to compty with the Code.

I1{TERPRETATION

In th is Statement of In tent :

"Code" means the Queensland Biotechnology Code of Ethics approved by State Cabinet on z7 March zoo6.

"Department" means the Department ofState Development.

OPERATIVE PART

r. COMPLIANCE WITH CODE

The Queensland biotechnology organisation witt comply with the Code in the conduct of its activit ies and witt establishprocedures for reporting and rectifuing non-compliance with the Code and all other appticable standards, guidetines and lawsrelating to biotechnotogy.

z. REPORTING

The Queensland biotechnotogy organisation wilt report to the Department within seven (7) days after the imposition of anysanction or penalty imposed on the Queenstand biotechnology organisation for the faiture to comply with any law relating toits biotechnology related activit ies. A report wilt also be made if any complaints of non-compliance are made against theQueensland biotechnology organisation outl ining measures taken by the Queensland biotechnology organisation to addresssuch complaint. The Queensland biotechnology organisation's report to the Department witl contain sufficient information toenable assessment of the Queensland biotechnology organisation's performance in comptying with the Code.

Please turn over for execution clauses

'zeRefer to page 4 for outline of what constitutes a ..eueensland biotechnology organisation".

75> Queens land B io techno logy Code o f E th ics upda led zoo6 <

Executed as a Statement of Intent as fo[[ows:Executed by

acting by the following persons or, if the seat isaffixed, witnessed by the fotlowing persons:

Signrtur. of iuttrorisea peiion

ofnce neiO

flame of iutt'or-ised person (print)

Signature of authorised person

Office hetd

Itame oEuthorised persor(print)

Executed byacting by the following persons or, if the seal isaffixed, witnessed by the following persons:

-gnature of Oirectot

Name of director (print)

Signature of director/company secretary

Name of director/company secretary

t5 > Queensland Biotechnotogy Code of Ethics updated 2006 (