new zealand biotechnology strategy - university of canterbury

Publ ic D iscuss ion Paper

New ZealandBiotechnology StrategyNew ZealandBiotechnology Strategy

20926 Morst Bio Strategy Final 11/10/02 4:00 pm

Published in October 2002 by theMinistry of Research, Science and Technology

PO Box 5336, Wellington, New Zealand

ISBN 0-477-01971-4

This document is available on the Ministry of Research, Science and Technology’s website:

www.morst.govt.nz


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ForewordNew Zealand is a country built on an exceptional ability to add value to natural products by applyingbiological knowledge. We are fortunate in possessing an equable climate, but we are even more fortunateto possess the know-how to make optimum use of it. And we have been doing it for decades - milkproducts, kiwifruit and pine trees are just a few examples. More recently, New Zealand researchers havebeen involved in the creation of world-class human health, pharmaceutical and environmental research, all ofwhich involve biotechnology. As Minister of Research, Science and Technology I have been privileged tovisit our universities, Crown Research Institutes and knowledge based companies, witnessing theoutstanding and exciting science that is being done in this country.

Developments in biotechnology move swiftly. We will need to work hard to keep abreast because thosedevelopments will bring great opportunities. They can also carry risks. It is important that a balancedapproach to biotechnology is taken so that our economic, social, environmental and cultural values are givenequal consideration. That is why we have developed this strategy.

The Royal Commission on Genetic Modification recommended the development of a biotechnology strategyand in its report emphasised a theme of preserving opportunities. While biotechnology is much more thangenetic modification this strategy is also about preserving opportunities.

The Growth and Innovation Framework launched by the Prime Minister in February 2002 also recognises theimportance of biotechnology to New Zealand’s future. Across many sectors of our economy, includingagriculture, forestry, health, justice, industrial manufacturing, right through to environment and conservation,applied biological knowledge will have an increasingly important role to play in achieving our economic,social and environmental aspirations.

A biotechnology strategy can help us responsibly use our world-class biological knowledge and technologiesto achieve our goals. This discussion paper is your chance to have your say on how this might be done, andI urge you to do so.

Pete HodgsonMinister of Research, Science and Technology

October 2002


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Table of contentsHow To Make A Submission 6

Introduction 7• What is biotechnology?

• A Biotechnology Strategy for New Zealand

• Scope of the discussion paper

• Relationship to Public Consultation on “Improving the Operation of the HSNO Act for New Organisms”

Part 1 - New Zealand Biotechnology Now 9• Why biotechnology is important to New Zealand

• International context

• Key features of New Zealand biotechnology

• Opportunities and challenges for New Zealand biotechnology

Part 2 - Elements of a New Zealand Biotechnology Strategy 20• Vision, Goals and Principles

• Progress of the Strategy to date

• The community and biotechnology

• Effective regulation to manage emerging biotechnologies

• Growing New Zealand’s biotechnology sector

• Co-ordination of the Biotechnology Strategy and links with other strategy and policy development

Annex 1 - Diagram showing the current regulatory framework for approvals for the research, 38development and commercial marketing of new products.

Glossary and Technical Definitions 39

Pull-out Submission Form 43


Invitation for written submissionsIndividuals and organisations are invited to makewritten submissions on this discussion paper. The closing date is 30 November 2002.

You can post submissions to:Biotechnology Strategy GroupMinistry of Research, Science and TechnologyPO Box 5336WellingtonOr e-mail to: [email protected]

Copies of this paper and associated information onbiotechnology in New Zealand can be found athttp://www.morst.govt.nz.

Copies of the paper can also be requested onfreephone 0508 400 805.

Format of SubmissionsTo help you make your submission we haveincluded, at the back of this booklet, pull-out pageswhich set out the numbered questions and spacefor responses. If you do not wish to use theseplease ensure that you refer to question numbers inyour responses.

Please include an address, telephone number andemail contact address in case we need to get intouch with you to clarify any matter in yoursubmission.

If you are making a submission on behalf of anorganisation, please tell us:

• how many people you represent

• what process your organisation has gone throughin order to arrive at the views in the submission.

Please note that the Ministry’s policy on disclosure ofsubmissions is to treat any written material given tous as being in the public domain and thereforeavailable to any other person on request, for the costof photocopying. You should therefore indicateclearly if your comments are commercially sensitive,or if, for some other reason, you consider theyshould not be made public.

Next StepsThe Ministry of Research, Science and Technologywill summarise submissions and make thesummary publicly available on its web site and byhard copy on request. The Government intends tofinalise the Biotechnology Strategy in early 2003,after analysing submissions and assessing policyoptions, including the work of the BiotechnologySector Taskforce.

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How to make asubmission

An on-line submission form is available on the MoRST website, www.morst.govt.nz which we encourage you to use.


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IntroductionWhat is biotechnology?Biotechnology is a broad term for a group oftechnologies that are based on applying biologicalprocesses. It involves the use of living things ortheir derivatives to solve problems and makeproducts.

Biotechnology has been with us for centuries.Traditional biotechnologies include fermentationapplications such as beer, cheese, bread-making andcosmetics, as well as animal and plant breedingtechniques.

The term “modern biotechnology” is used todistinguish recent research-based activities. It includes a range of techniques from DNAtechnology, molecular and cellular biochemistrythrough to gene technology.

Some people mistakenly think that biotechnologyand genetic modification (GM) are the same thing.In fact GM is only one specific aspect of modernbiotechnology. Examples of modern biotechnologyand its current uses are outlined further in Part One.

A Biotechnology Strategy for New ZealandBiotechnology opens up the possibility of newdevelopments and applications that can benefit thewealth, health and environment of New Zealandersnow and in the future.

To realise these benefits in a responsible manner,the Government is developing a biotechnologystrategy for the growth and management ofbiotechnology in New Zealand.

The Government has asked the Ministry ofResearch, Science and Technology (MoRST) to leaddevelopment of a strategy that sets out a vision andgoals for biotechnology in New Zealand and maps away forward to achieve a responsible, growingbiotechnology sector of which New Zealand can be proud.

The strategy will address key themes inbiotechnology that have emerged through the RoyalCommission on Genetic Modification (RCGM), the

former Independent Biotechnology Advisory Council(IBAC) and the development of the Growth andInnovation Framework (GIF) announced by theGovernment in February 2002. These themesinclude:

• fostering community awareness and engagementon biotechnology issues

• harnessing New Zealand’s strengths in biologicalknowledge, research and innovation

• managing risks and having regard for ethical,cultural and spiritual dimensions

• strengthening the contribution of New Zealand’sbiotechnology sector to our economic prosperityand social well-being.

The development of the strategy also acknowledgesBiotech21, the strategy set out last year by Biotenz,the industry grouping of New Zealand providers ofbiotechnology.

Scope This discussion paper is in two parts.

Part One provides background information for thestrategy. It examines New Zealand’s use ofbiotechnology and identifies key strengths andissues.

Part Two, on which feedback is sought, sets out thestrategy framework. It provides a vision, goals andguiding principles for the development and use ofbiotechnology in New Zealand. This offers aframework to bring together the social, economic,environmental and cultural dimensions ofbiotechnology in this country.

The goals reflect the themes and focus attention on:

• better connections between New Zealandcommunities and the biotechnology sector

• effective regulation to manage the developmentand introduction of new biotechnologies

• growing the commercial value of thebiotechnology sector.


The paper identifies and seeks feedback on keyissues and challenges related to each goal. It indicates actions that have already been initiated.Broad directions to address the issues and furtherthe first two goals are outlined. Detailed targets andactions for developing and growing the sector - thethird goal – will, however, come from theBiotechnology Sector Taskforce, established in May 2002, and co-chaired by the Minister ofResearch, Science and Technology, Hon PeteHodgson, and Biotenz Chair, Bill Falconer. The framework concludes with an outline oflinkages to other key government strategies.

This strategy discussion document has beenprepared with input from individual and workshopdiscussions with community and sector participantsheld earlier this year. Its release now offersstakeholders and the wider public an opportunity toprovide feedback on the directions required toachieve a responsible, vibrant biotechnology sectorthat benefits New Zealanders.

Individuals and organisations are invited to makewritten submissions on this discussion paper by theclosing date of 30 November 2002.

Relationship to Public Consultationon “Improving the Operation of theHSNO Act for New Organisms”The consultation on the Biotechnology Strategy willpartially overlap consultation on the Government’sresponse to recommendations of the RoyalCommission on Genetic Modification in relation tothe operation of the HSNO Act, as well asconsultation on a Ministry of EconomicDevelopment discussion paper on bioprospecting.The HSNO amendments cover details related togenetic modification research controls, legislativetechnicalities and specific GMO issues such asconditional release and liability.

Biotechnolgy is much broader than the currentdebate on genetic modification and will require inputfrom a range of sectors, community groups andindividuals. While the differences in stakeholderfocus and level of technical detail mean that theconsultations are being run separately, officials fromthe Ministry of Research, Science and Technology,will ensure that the consultations are run in acomplementary fashion.

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PART ONE

New ZealandBiotechnology Now

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This part of the discussion paper provides background information for the strategy. It examines New Zealand’s

biotechnology position now and identifies key strengths and issues for biotechnology in New Zealand.

Feedback is not being sought on Part One.


Why biotechnology is important to New ZealandNew Zealand has an economy strongly based on

biology. Our wealth has come from applying

biological knowledge to add value to agriculture and

natural products. Biotechnology applications have

also been used in New Zealand in many other areas

including health care, forensic testing and

environmental management. New emergingapplications have the potential to further transformmany industries, using biological processes insteadof machinery to enhance the quality of life.Examples include improved diagnostic medicine andpharmaceuticals, pest control, industrial processeswith reduced waste streams and the developmentof biodegradable products.

Some current uses of biotechnology are:

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Sector Application

Health • Diagnostic tools for the testing and treatment of genetic diseases (e.g. cystic fibrosis)

• New and improved vaccines

• Research into the causes of serious diseases such as cancer, diabetes and multiple sclerosis

• New drug development

• Biosurgical devices and imaging equipment

Agriculture • Vaccines and diagnostic tests for animal disease

• Identification of the source of valuable traits in commercial and animal species

• Confirmation of pedigree livestock such as deer or cattle and plant cultivars such as thePacific Rose apple

• Crops which are resistant to disease (e.g. virus resistant squash)

• Research and screening of safe and effective natural pesticide products from plants

• Biological control agents to manage pests

• Improved grape cultivars for wine production

Environment • Bioremediation of oil, chemicals and heavy metals

• Conversion of waste to energy

• Research into the possibility of “low methane sheep” to meet climate-change obligations

• Improving water quality

• Preservation of near-extinct strains through cloning (e.g. the rare Enderby cattle line)

• Biosecurity and pest management (e.g. improving detection of pests and diseases at the border)

Justice/Police • DNA fingerprinting and forensics to connect suspects with “scene of crime” evidence

• Maintenance of a police database of DNA profiles for use in investigation of offences

Food and • Screening and identification of natural products for health supplements

• New foods (e.g. new varieties of kiwifruit)

Industry/ • New enzymes and biomaterials (e.g. bioceramics)

• Improved production of high-value products (e.g. lipids from milk, biodegradable plastics)

• Improved industrial processes for dairy and meat industries

manufacturing

beverage


DNA tracking a confidencebooster for UK consumersA New Zealand-developed DNA tracking

system is allowing British meat buyers to

trace the cut they buy right back to the

New Zealand processing plant and even the

farm it came from.

Knowing for sure that their meat came from

New Zealand, which is known internationally

for its high quality meat and disease-free

animals, gives cautious consumers greater

confidence in their purchase.

Under the easiTrace system, blood samples

from carcasses going through a meat

processing plant are incorporated with

details of the farm, and time and date of

processing, on a special tag which is then

stored for later reference.

Wholesalers or retailers wanting to trace a

cut of meat can scan the batch label and

send back a DNA sample that is then

matched to the corresponding DNA sample

held back in New Zealand.

The easiTrace system was developed by

AgResearch, a Crown Research Institute, in

conjunction with New Zealand meat

company Richmond Ltd.

“We’re very pleased with the end product

that is fully auditable, robust and cost

effective,” says AgResearch easiTrace

scientist Dr Mike Tate.

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New Zealanders’ standard of living will be stronglyshaped by how effectively we create and use theopportunities presented by new technologies.Biotechnology, like information and communicationtechnology (ICT) and creative industries, will bringdevelopments that open up new opportunities.

New Zealand’s strength is its biological base inagriculture, forestry, fishing, pest and environmentalmanagement. We have held our edge in theseareas because of sound scientific, research-basedand innovative approaches to animal and planthealth. These have extended into world-leadinghuman health research and techniques.

New Zealand is in a position to build on itsstrengths. In February 2002, the Governmentannounced a Growth and Innovation Framework –Growing an Innovative New Zealand. Prime MinisterHelen Clark identified biotechnology as one of thethree areas of the economy most likely to have amaterial impact on our economic growth. For thisreason, the Government established theBiotechnology Sector Taskforce to focus effort andmomentum on developing high-value, internationallycompetitive domestic biotechnology businesses.

New Zealand is unique: geographically isolated,New Zealand is home to many species of plantsand animals not found elsewhere, and has a diversemix of cultures drawn from people of Maori, Pacific,European, Asian and other origins. This offers special opportunities to usebiotechnology but also special responsibilities to dothis wisely.

International context • Biotechnology has been a growth sector in the

United States and Europe for more than 20years. The United States, European andCanadian biotechnology sectors haveexperienced impressive ongoing growth inboth revenue and employment.

• Many countries, both developed anddeveloping are now focusing on biotechnologyas a key sector for their future economicgrowth. For example, Australia announced anational strategy in 2000 to guide futuredevelopment of its biotechnology sector.

• Advances in genetic knowledge, including thesequencing of the human genome, mean theworld is on the threshold of a major expansionin the number and commercial value ofbiotechnology applications.

case study 1


Methane busting holdseconomic promiseThe methane emissions of New Zealand’ssheep and cattle have generated their shareof jokes, but they are the subject of somevery serious scientific research.

Methane produced in the rumens, or firststomachs, of sheep and cattle is in fact thiscountry’s main greenhouse gas source. In line with its planned ratification of theKyoto Protocol, the Government hascommitted itself to reducing greenhousegas emissions - and so it is important forscientists to look closely at ways of limitingthe production of farm methane.

The AgResearch Crown Research Institutehas found that while some bacteria in thestomachs of ruminant animals producemethane, other bacteria inhibit itsproduction. The compounds produced bythese bacteria are now being tested aspossible control agents against themethane-producing bacteria.

In the future, these compounds may be ableto be delivered to animals through slow-release devices placed in their stomachs.

“Farmers will benefit from the reduction ofmethane emissions because the five-tenpercent of forage energy presently lost asmethane will be channelled into increasedanimal performance,” says AgResearch’s Dr Keith Joblin.

“A reduction in methane emissions wouldalso mean our farmers could sell their meatand wool products as ‘low methane’ or‘methane free’. This way they can gain aglobal marketing advantage,” he says.

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• Keeping abreast of international developmentsin biotechnology will be critical if New Zealandis to continue to hold a competitive edge inthe development of new biologically basedproducts.

• Opportunities exist for strengthening New Zealand’s expertise by developinginternational partnerships for collaboration andjoint ventures. International linkages could helpoptimise New Zealand’s position andattractiveness by way of regional clusteringand joint showcasing, e.g. with Australia.

• New Zealand can also benefit from looking athow other countries are managing thechallenges of modern biotechnology. Certain applications, particularly thecommercial use of GM crops and food, andstem cell research, have led to public concernsabout aspects of modern biotechnology. These concerns have led countries, includingthe United States, Canada and the EuropeanUnion (EU), to review their strategies toensure arrangements are in place to giveadequate consideration to ethical and safety issues.

• Issues related to biotechnology have beendiscussed in a number of internationalorganisations and bodies of which New Zealand is a member, and efforts arebeing made to facilitate international dialogueand cooperation. Forums with an interest inbiotechnology include the Convention onBiological Diversity, the Food and AgricultureOrganisation, Codex Alimentarius Commission,the International Plant Protection Convention,the Organisation for Economic Cooperationand Development, the United NationsEducational, Scientific and CulturalOrganisation, the World Trade Organisation,the World Intellectual Property Organisationand Asia Pacific Economic Cooperation (APEC).

• Examples of initiatives arising from thesediscussions include the conclusion in January2000 of the Cartagena Protocol on Biosafety.The Biosafety Protocol, which has yet to enterinto force, addresses the safe transfer,handling and use of living modified organismsthat may have an adverse effect onbiodiversity, and taking into account risks tohuman health, with a specific focus ontransboundary movements. The CodexAlimentarius Commission has made good

case study 2


Natural antibiotics offer newtreatment optionsThe discovery by New Zealand researchersof natural antibiotics in saliva may offersignificant advances in the battle againstbacterial infection.

The breakthrough follows a quarter of acentury of research led by OtagoUniversity’s Professor John Tagg intostreptococcus, the bacteria that can causethroat infections, rheumatic fever andrheumatic heart disease.

The Otago team’s work revealed that somepeople have in their saliva beneficial bacteriacalled streptococcus salivarius K12. These produce protein molecules that fightharmful bacteria. The molecules werechristened Bacteriocin-Like InhibitorySubstances, and in 2000 the acronymbecame the name of a new listed company,BLIS Technologies Ltd, which was createdto build on the Otago University research.

BLIS has filed international patents and isnow marketing throat lozenges containingthe beneficial bacteria. The company is alsodeveloping a product based on the sameprocess that targets tooth decay, and isworking on a number of other BLISapplications.

Together these products have the potentialto reduce the occurrence of bacterialinfections and lessen dependence ontraditional antibiotics. They may also proveto be a substantial income-earner for New Zealand.

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progress in developing international guidelinesfor safety evaluations of foods derived frombiotechnology and work is ongoing on thedevelopment of guidelines for the labelling offoods obtained from biotechnology. The UnitedNations has established a working group toconsider the need for an internationalconvention against human cloning.

• While international policy forums have begundiscussing a number of specific policy issuesarising from biotechnology, this is an areawhere there is only limited internationalconsensus. To date, countries have exhibited arange of different attitudes to biotechnologyissues. In some cases these attitudes havebeen defined by the absence or presence ofsignificant export interests in, for example, GMcrops. In other cases they reflect ethical andreligious concerns.

• National regulatory approaches are at variousstages of development worldwide and eventhe better established systems are in a state offlux. They can be expected to continue tochange as regulatory experience and marketreaction to new technologies evolve. The international market in which developers,investors and consumers operate is likely todrive pressure for greater harmonisation ofinternational standards and practices.

Key features of the New Zealandbiotechnology sector Excellent research

• Most of New Zealand’s biotechnologyknowledge comes from research inuniversities, CRIs and a few private researchinstitutes. Government largely funds thisresearch, through grants from a variety oforganisations including funding from theFoundation for Research, Science andTechnology (FRST), New Economy ResearchFund, the Marsden Fund, and the HealthResearch Council. Overall, in 2001, there wasaround $186m of government funding onbiotechnology-related research.

• Private expenditure on research anddevelopment (R&D) is low by internationalstandards, although it is increasing. It comesmainly in the form of company R&D, venturecapital and angel investment. Vialactia, aresearch arm of Fonterra, is a significantexample of privately funded R&D.

case study 3case study 3


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Growing range of applications

• The major industry users of biotechnology inNew Zealand are agricultural, horticultural andforestry industries, reflecting the importance oftechnology-driven primary production to New Zealand. Many commercial developmentsfrom biotechnology in these industries to datehave been applications based on theproduction or recovery of high-value, naturallyoccurring bioproducts, rather than through theuse of biotechnologies arising out of geneticmodification. Growing knowledge of molecularand genetic structures is providing the basisfor growth in the diagnostic sector thatservices these industries.

• Other important industries in New Zealand thatuse biotechnology include environmental andwaste management industries (e.g.bioremediation of soil). Crime detection andforensic applications are also significant.

• The contribution to the human diagnostics andbiomedical services sector is one of the fastestgrowing biotechnology areas in New Zealand,though still small by international standards.Many companies in this sub-sector are start-upcompanies, associated with and clusteredaround the universities of Otago and Aucklandand also linked to CRIs.

Long lead times to commercialisation

• In New Zealand, as in all countries,biotechnology has commercial characteristicsthat need to be considered when determininga strategic direction. These include:

- the development path for applications ofbiotechnology discoveries which result inlong lead times to commercialisation(typically 10-20 years from discovery to market)

- strict regulatory approvals

- the high failure rate of many good ideas,particularly in the biomedical field

- the capital requirements are significant atthe front-end of some biotechnologyprojects

- the need to attract and retain highlyskilled scientists

• New Zealand produces world-class research inaspects of molecular biology. For example,two research groupings were recentlyselected as Centres of Research Excellence:the Allan Wilson Centre for Molecular Ecologyand Evolution (Massey University) and theCentre of Molecular Biodiscovery (AucklandUniversity).

• Farming and forestry productivity andinnovation often drive New Zealand researchin biological processes. Human healthoutcomes are a further significant factor. Most health research is government-funded atthe fundamental level. Major multinationalpharmaceutical companies are not very activein New Zealand biotechnology R&D. While involvement in clinical trials has declinedin recent years, it is important to note theincreasing interest of pharmaceuticalcompanies in funding or collaborating withresearchers at different stages. Recent examples include the GlaxoSmithKlinefunding for the asthma research beingconducted by Professor Richard Beasley of theMedical Research Institute of New Zealandand the Pharmacia links with the LigginsInstitute research programme in Auckland.

• In recent years there has been an increasingemphasis on more closely linking government-funded basic research to commercialapplications through initiatives such as theTechnology New Zealand Fund, Grants forPrivate Sector R&D scheme, and FRSTpromotion of research and industry consortia.This has encouraged the establishment ofcommercial subsidiaries and start-upbiotechnology companies associated withuniversities (particularly at Auckland andOtago) and research institutes.

• A key aspect of New Zealand’s success in theapplication of biological knowledge has beenthe development of regulatory and ethicalreview processes that create and protect safe,healthy and ethical environments for humansand animals. This can enhance New Zealand’scredibility as a place to carry out biotechnologyR&D, however, if perceived as overlystringent, it can also decrease New Zealand’sattractiveness.


Using science to catchcriminals DNA profiling is giving police the chance to

eliminate suspects and successfully

prosecute hundreds of offenders who might

otherwise escape justice.

Since the 1996 establishment of the

National DNA Databank by the Crown

Research Institute ESR and the

New Zealand Police, more than 1900

unsolved crimes have been linked to

individuals on the database. The Databank

has also helped confirm the innocence of

many people who were potential suspects.

DNA profiling compares genetic information

obtained from biological evidence such as

blood, tissue or hair found at crime scenes

against the DNA of suspects. DNA profiles

from individuals and from unsolved crime

scenes are stored on the two databases

that comprise the National DNA Databank.

At present there are DNA profiles from

around 26,000 convicted offenders and

volunteers, and around 4500 crimes.

A reported match between two profiles

(crime to crime or crime to person) means

there is an enormously high probability that

the same person was involved.

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- the commercial value lies in the patentsand intellectual property associated withthe successful products. There is a needto recover enough value through these toreward investors and encourage re-investment.

• Low capitalisation may also have constrainedcommercial growth. There are only five publiclylisted biotechnology companies in New Zealand. Two of these (Genesis andBlisTech) are listed on the main New Zealandstock exchange board; the others are listed onNew Zealand’s secondary board.

The biotechnology sector is underdeveloped relativeto its potential

• New Zealand has gained comparativeadvantage and strength in dairy, agriculture,forestry and horticulture products throughquality farming and smart use ofbiotechnology.

• Future wealth and sustainable development islikely to come from applying new biologicalknowledge and technologies to familiarproducts and problems; problems likepossums, cancer, methane emissions,diabetes and asthma.

• A benchmark survey of modern biotechnologyactivity in New Zealand was conducted byStatistics New Zealand in 1999. This estimatedthe income of the modern biotechnologysector in the year to June 1999 to be $475m(compared with, for instance, the furnituremanufacturing industry whose income was$938m for the same period). This survey is dueto be repeated in 2004.

High level of public interest

• The work of the former IBAC and the RCGMhas raised the profile of biotechnology issuesand stimulated community discussions. The Royal Commission provided anindependent forum to address public concernsabout genetic modification.

• New Zealanders have a history of high uptakeof technology (especially in fields such asinformation technology, agriculture andhorticulture).

• There is growing interest in medicalapplications of biotechnology.

• Social science research is developing toexamine relationships between science andsociety, and different cultural values.

case study 4


New Zealand anti-HIV drug inUS clinical trialsAuckland company Virionyx is developing a

drug that it believes has the potential to

make substantial inroads against HIV-Aids.

Virionyx founding director Frank Gelder says

its anti-HIV drug HRG214 has shown the

ability to destroy the HIV virus and prevent

further infection of healthy cells. Existing

anti-HIV drugs that seek to slow the

replication of the virus have not been

effective in preventing HIV from attacking

healthy cells, he says.

The company is currently taking its drug -

which is derived from purified plasma

extracted from immunised goats - through

gruelling US Food and Drug Administration

clinical trials. Phase one, designed to test

the product’s safety, has already been

successfully completed at Harvard Medical

School. Now the process is moving to

phase two, the twice-weekly injecting of 40

US HIV patients over eight months.

From the project’s inception to the

completion of phase one trials cost Virionyx

$NZ18 million and the company is now

seeking some $70 million to take the project

through to market, possibly in 2005.

The company’s Penrose laboratories have

been upgraded so further development and,

it hopes, commercial production of HRG214

can be carried out in New Zealand.

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Opportunities and challenges for New Zealand biotechnology Biological knowledge earns New Zealanders

income, for instance, through farming, fishing,

forestry and ecotourism, and it keeps our

environment and people healthy.

Modern biotechnology provides opportunities for us

to build on this strong biological base. While

recognising the benefits biotechnology can bring, it

is equally important to recognise that there are

ethical, safety and environmental issues that must

be addressed and managed.

Successful development of the biotechnology

sector will require close and positive connections

with communities, explicit ethical principles and

robust processes for identifying and managing

potential risks to safeguard the community and the

environment. Care will also be required to ensure

that decisions enhance and support other

government policies such as the provision for

public health priorities and maintaining

New Zealand’s biosecurity.

Some of the major strengths, opportunities,

weaknesses and challenges facing the

Government, community, industry and researchers,

as identified in our preliminary discussions, are

outlined in the following section. These are

discussed in more detail under Elements of a

Biotechnology Strategy.

Further issues may be identified during this

consultation and by the work of the Biotechnology

Sector Taskforce.

case study 5


Biotechnology takes “good”bacteria to new marketsNew Zealand Milk, a strategic business unit

of Fonterra, has found a way of

incorporating the best sorts of “good”

probiotic bacteria found in yoghurt into other

dairy products such as milk powder and

cheese.

Over five years a team from the Fonterra

Research Centre in Palmerston North looked

at hundreds of different strains of probiotic

bacteria and finally isolated two with specific

disease-fighting qualities that strengthen the

immune system. These have been named

DR10 and DR20.

A health and safety study carried out on

DR10 in Taiwan showed that it considerably

boosted adult immune systems.

The next step was to expand the potential

market for products containing probiotic

bacteria. Scientists developed two different

milk powders containing DR10 and a cheese

- Balance Mainland - containing DR20.

Investigations into other probiotic bacteria

food applications are underway.

These sorts of new products have

considerable consumer appeal in traditional

dairy markets and also mean the benefits of

“good” bacteria can be taken to regions

such as Asia where yoghurt is not a

popular food.

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New Zealand strengths in biotechnology • Excellent, robustly regulated and ethically guided

science, which is world-class and relatively low cost.

• New Zealand has the world’s bestunderstanding of sheep breeding and dairyhusbandry, as well as livestock free of many ofthe world’s most serious diseases (e.g. no BSE,scrapie or foot and mouth disease.)

• Genomic research in apples, kiwifruit, sheep,and deer.

• Primary industries that are well connected toglobal markets and responsive to consumers.

• Biomedical research at the discovery end ofdevelopment.

• Desirable site for clinical trials.

• Some natural clustering of companies andscience providers.

• New Zealand, through the RCGM, hassuccessfully conducted a communityconversation on genetic modification, withextensive consideration given to the pros andcons.

New Zealand weaknesses in biotechnology • A culture that tends to be critical of both

entrepreneurial success and failure.

• A poor understanding generally of commercialand venture capital business drivers.

• Insufficient commercial skills; in particular, lackof sophisticated skills in protecting intellectualproperty rights.

• Internationally competitive markets make itdifficult to attract and retain top level scientists.

• A low profile and weak connections to theglobal biotechnology market.

• Low critical mass and a risk of fragmentedapproaches to business development andmarketing.

• A weak venture capital market to expand NewZealand biotechnology.

• A regulatory system that is perceived by someto be complex, with uncertain timeframes forapprovals, thus adding compliance costs.

• Many in the community do not understandbiotechnology or scientific processes.

case study 6


Immobilised enzymes makefor industrial cost savingsAuckland University’s School of Engineeringhas found an effective way of saving moneyfor industries that use enzymes -biocatalysts - in manufacturing processes.

Traditionally, enzymes are mixed into aproduct - for instance, during the making ofhydrolysed milk products for people withlactose intolerance - and then “turned off”by heating or other processes once thedesired changes have taken place. This means that some of the potential of theenzyme is wasted.

However, work carried out by Professor XiaoDong Chen and PhD student Quinn Zhouhas led to enzymes being placed into acolumn similar to a large computer printerink cartridge. The enzymes are fixed inplace on a fibrous core and the milk or otherproduct is passed through the cartridge.The enzymes do not have to be “turned off”and can therefore keep functioning for theirwhole natural life, or for as long as they arefree from microbe contamination.

“We are able to show substantial costsavings from the process,” Professor Chensays.

Immobilised enzymes can be used in themanufacture of milk products, beer andother food and industrial products.Professor Chen says their greatest potentiallies in small-scale applications where boththe enzymes and the product have high value.

The process has the added advantage overconventional food manufacturingtechnologies of requiring relatively lowtemperatures, and in some cases it mayallow manufacturing without the addition of“foreign” ingredients.

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Opportunities for New Zealand biotechnology • Increase competitive advantage by building on

biological knowledge to improve productivity of

our primary industries.

• Create new products and new ways of making

products that are smarter, more efficient, more

environmentally friendly and sustainable.

• Access the funding for R&D of global

companies, such as pharmaceutical companies.

• Boost biomedical work and capture for

New Zealand the intellectual property benefits

of related drug discovery.

• Promote business expansion opportunities

through the newly established Venture

Investment Fund and the New Zealand Stock

Exchange’s New Capital Market.

• Foster geographical clusters to achieve

critical mass.

• Strengthen sector networks to disseminate

information, encourage collaboration and spread

industry best practice.

• Provide a single branding for New Zealand

biotechnology.

• Develop and foster international partnerships

and joint ventures, in particular build on the

growing interest in biotechnology partnerships

between businesses in New Zealand and the

United States.

• Optimise Australian, Pacific and Asian linkages

to build up regional clusters, especially through

joint showcasing.

• High degree of public interest in biotechnology

and GM matters provides a basis for

strengthening links between the sector and the

broader community, and developing community

understanding of potential economic,

environmental and social benefits and risks.

case study 7


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Threats to New Zealand biotechnology • Lack of support for a long-term direction could

affect New Zealand’s capacity to build and

sustain a healthy biotechnology sector.

Investment may be scared off if biotechnology

policy changes every three years.

• Competition to recruit New Zealand trained

scientific talent, especially from Australia

(Melbourne, Sydney, Queensland clusters) and

Singapore.

• Commercial vulnerability of small biomedical

research and development sector which is

generally not well linked to drug delivery.

• Reliance on enabling technologies owned by

major international companies.

• Risks of selling intellectual property either too

early (risk of undervaluing) or too late (risk of

competition).

• Failure to identify and develop key niches.

• Negative perceptions held by potential overseas

investors. This includes perceptions of

New Zealand approvals legislation as prohibitive

rather than enabling. This may also go hand in

hand with poor understanding of access and

benefit sharing provisions, especially in relation

to Maori.


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PART TWO

Elements of a New ZealandBiotechnology StrategyPart Two sets out the strategy framework. It provides a vision, goals and guiding principles for the

development and use of biotechnology in New Zealand.

This section of the paper identifies and seeks feedback on key issues and directions related to each goal.

The paper indicates actions that have already been initiated. Further broad directions to address the issues

and further the first two goals are outlined. Detailed targets and actions for developing and growing the

sector - the third goal - will, however, come from the Biotechnology Sector Taskforce, established in

May 2002. The framework concludes with an outline of linkages to other key government strategies.


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Government goals forbiotechnology Three goals support the vision.

Build understanding and positiveconnections between the community andthe biotechnology sector.

Understanding and positive connections need to befostered through:

• community access to quality information aboutbiotechnology developments and their potentialbenefits and risks

• active engagement and dialogue between sectorparticipants and the community

• opportunities to enable and encourage New Zealanders to contribute to public policyissues and biotechnology directions

• strengthening ways to foresee new and emergingbiotechnologies, assess potential opportunitiesand risks, and consider cultural, ethical andspiritual issues.

Manage the development and introductionof new biotechnologies with a regulatorysystem that optimises opportunities andinnovation while safeguarding health andthe environment.

This requires an effective, efficient and transparentregulatory, ethical and audit framework.

Grow New Zealand’s biotechnology sector

As well as the above, an internationally competitivebiotechnology research and production sector mustbe backed by:

• capability in science education, research,enterprise and commercial skills

• productive investment in basic research andstrong links between research and industry

• clarity about access to and use of genetic andbiological resources

• effective identification and use of intellectualproperty

• resources focused on increasing global

connections, attracting and retaining investment

and building on world-class niche strengths.

Guiding principles for theBiotechnology StrategyThe Government will be guided by a commitment

to:

Benefit for New Zealanders – focus on outcomes

from biotechnology that benefit the wealth, health

and environment of New Zealanders.

Sustainable development – meet the needs of the

present without compromising future generations,

through integrating economic growth, social equity

and environmental and cultural well-being.

Responsibility – responsible use and uptake of

biotechnology, safeguarding human health and the

environment through the identification and effective

management of risks and uncertainty.

Innovation – foster and encourage innovative

developments in biotechnology.

Biological diversity – to protect biological diversity,

particularly New Zealand’s unique flora and fauna.

Ethics – development of biotechnology that takes

account of ethical concerns.

Participation – involve citizens in biotechnology

public policy and ethical issues, through open

information and participation processes that

acknowledge the diverse community interests.

Treaty of Waitangi - respect for the principles of the

Treaty of Waitangi.

A Vision for Biotechnology in New ZealandNew Zealand responsibly applies our world-class biological knowledge, skills, innovationand technologies to benefit the wealth, health and environment of New Zealanders, now and in the future.


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Progress of the Strategy to date • The Government has announced a Growth and

Innovation Framework in which the biotechnologysector is identified as one of the three keysectors targeted for growth.

• A Biotechnology Sector Taskforce has beenappointed to address barriers to growing thesector.

• A Bioethics Council is being set up to advise andpromote dialogue on the ethical, spiritual andcultural aspects of biotechnology.

• A Royal Commission of Inquiry has been held toconsider strategic options for New Zealand withrespect to genetic modification (GM). The Commission recommended a precautionaryapproach that preserved options for the future.The Government has endorsed this approach. The Commission considered that New Zealand’sregulatory system and institutions provided anappropriate framework for controlling the use ofGM but recommended some changes to improvethe system. Government actions on these aredetailed in the section on the regulatoryframework.

• The Government has set in place a constraintperiod (expiring October 2003) during which noapplications (with limited medical exceptions) forrelease of genetically modified organisms will beconsidered by regulatory authorities. During thisconstraint period, in addition to implementingmany of the Royal Commission’s recommended

policy and legislative changes, the Government

has adopted the Royal Commission’s

recommendation for an enhanced research

programme. Work is being undertaken on a

number of projects, including horizontal gene

transfer and the co-existence of GM and

non-GM farming.

• A new $450,000 per annum fund (in Vote RS&T)

has been established, aimed at supporting and

enhancing dialogue initiatives around new and

emerging areas of science.

• Government research funding is being more

strongly focused on biotechnology research.

FRST and HRC have recently announced funding

for research projects with a strong emphasis on

biotechnology, including research examining

social and cultural aspects of biotechnology.

Two of the five recently announced Centres of

Research Excellence have a focus on using

modern biotechnology as a research tool.

• A Venture Investment Fund (VIF) of NZ$100m has

been established which will be combined with

private local and overseas venture capital.

Negotiations are currently being conducted with

five fund managers to establish the combined

private/public VIF Seed Capital funds. These funds

have the capability of identifying commercial

opportunities out of New Zealand’s research,

much of which is focused in biotechnology and

agritechnology.

Enhanced wealth, health and environment of New Zealand

Vibrant and responsiblebiotechnology sector

Communityunderstanding and

connection

Effective Regulation Growth

FuturewatchInformationEthicsParticipationDemonstration ofbenefits

Education, research,and business skillsBasic researchCapital investmentIP managementGlobal connections

Safeguards health,environment, andsocial valuesOptimises opportunitiesEfficient andtransparent


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• The Government amended the taxation regimefrom April 2001 to align more closely the taxationtreatment of R&D expenditure with accountingtreatment. The changes allow businesses tomake an immediate tax deduction for R&Dexpenditure that is expensed for accountingpurposes. The changes make this area of tax lawclearer and more certain, and underpin growth inhigh-value, high technology industries.

GOAL 1 The community and biotechnologyThere is increasing understanding internationallythat a well functioning society is one that balancessocial, economic and environmental considerationsinstead of according undue weight to one over theothers. Achieving this ideal will come throughcommitment to the first goal of the BiotechnologyStrategy, which is to:

Build understanding and positive connectionsbetween the community and the biotechnology sector.

Biotechnology has given us powerful tools that arenow part of our everyday lives. With their powercomes the potential to do much good, but alsoresponsibility for ethical and safe use.

Modern biotechnology is a relatively young field,and, as with any new technology, its long-termeffects can be uncertain or unknown. The risks andbenefits will occur unevenly throughout society on acase-by-case basis. The impact of the products ofmodern biotechnology on society and, critically, onwhat it means to be human, challenges us todevelop clear values about our responsibilities towider society and the environment.

Biotechnology research and development needs tobe considered in partnership with broader society. It must go hand in hand with an informed, inclusiveapproach to decision-making about its uses andtake into account factors beyond those of individualchoice. It is therefore essential that consumers andthe community have information and opportunitiesfor discussion in order to:

• understand and assess the benefits and risksassociated with the application of particulartechnologies

• have confidence in regulatory mechanisms

• have the chance for effective input to the policy-making process.

It is also important that the biotechnology sector:

• seeks out and takes account of the views of thecommunity

• helps to bring issues to the attention of thepublic early on in the development of potentialnew products and processes.

Key challengesExperience in New Zealand and overseas points toa number of factors which are important in buildinga better relationship between the community andthe biotechnology sector:

• Trust - Trust between broader society and thebiotechnology sector is essential. Trust can bebuilt and maintained by information sharing andhonest debate, open processes, mutualunderstanding and responsiveness, earlyattention to issues and an appropriate andrigorous regulatory system.

• Diverse perspectives - Broad and diverse skills andknowledge need to be brought to bear ondecision-making processes and sectordevelopment. Approaches that rely on narrowtechnical expertise have significant shortcomings.The ability to integrate knowledge from otherdisciplines, work across cultures and worldviews, meld facts with values, and communicateto non-scientific audiences need not be arequirement of every individual scientist, butshould be present at the institutional level.

• Community engagement seen as an opportunity notjust a cost - Engagement with society can provideuseful insights into problem definition and thedevelopment and use of biotechnologies. Debateabout the wisdom and value of technologicalapplications can be healthy and is often theprecondition for confidence and trust. The key isto channel the debate in constructive directionstowards overall benefit and find effective andefficient ways to manage engagementprocesses.

Developing stronger and more positive connectionsbetween the biotechnology sector and broadersociety is in everyone’s interest because of theenormous potential biotechnology has to keep onchanging our everyday world. It is particularlyimportant in New Zealand to ensure that Maori arewell connected and play a key part in biotechnologydevelopment, bringing to bear Matauranga Maoriconcepts together with specialised biologicalknowledge.


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Matauranga Maori is a Maori world view that

embraces science and the development of science

from within a cultural framework. It provides a link

to the vision for biotechnology through the

following concepts:

• He tangata, responsiveness to people

• Mauri and wairua, the essential uniqueness andimportance of individuals

• Ihi, striving for excellence

• Manawhenua, connection to the land andprinciples of life of the hapu/iwi of theirwhakapapa ancestry

• Te Ao Marama, the world of reality. This worldrecognises:

- Matariki, the cycle of life

- Matakite, the ability to progress into the future,to be entrepreneurial

- Manaaki, the requirement to exercisestewardship and retain balance

• Tapu and noa, distinctions that can clarify what isvaluable to retain and what may be added to orchanged.

Actions already underwayRecent initiatives focusing on enhancing therelationship between the biotechnology sector andsociety in New Zealand include:

• The establishment of the Bioethics Council toprovide advice and promote dialogue and publicparticipation on the cultural, ethical and spiritualaspects of biotechnology.

• Work toward amending the HazardousSubstances and New Organisms (HSNO) Act1996 to better reflect the relationship with theTreaty of Waitangi.

• The establishment of a new $450,000 per annumfund (in Vote RS&T) aimed at supporting andenhancing dialogue initiatives around new andemerging areas of science, includingbiotechnology.

• Increased research efforts in the area of socio-economic, ethical and environmental aspects ofbiotechnology.

Other possible actionsOther actions to support the goal of buildingunderstanding and positive connections betweenthe community and the biotechnology sector mightinclude:

• Strengthen New Zealand’s biotechnology futurewatchcapability

While the Bioethics Council will have afuturewatch role, there may be a case forbroadening and strengthening this capability. This could involve either a new body or enhancedfuturewatch roles for existing bodies. Enhanced capability would enable anticipation offuture opportunities and risks from biotechnology,identification and interpretation of trends andevents from the technological, social, economic,environmental, and political spheres ofbiotechnology and distribution of information tothe public, business and science institutions.

• Develop a ‘one-stop shop’ website for New Zealandbiotechnology

This could be a site where New Zealand oroverseas people could go to find information onbiotechnology in New Zealand and how it ismanaged, including information and links to thebusiness, regulatory, ethical, research, andparticipatory aspects of biotechnology.

• Support further research on approaches to foster trustin the biotechnology sector in New Zealand

This may be particularly relevant with respect tothe growing commercial involvement inbiotechnology and the need for a practicalunderstanding of how trust is developed andmaintained in a New Zealand context.

• Support secondary and tertiary level biotechnologyeducation to include awareness of social as well asscientific considerations

This could involve the development of new broad-based biotechnology resources for schools orintroducing or offering new science modules forschools that encompass social aspects ofbiotechnology. At the tertiary level it could involvegreater opportunities for all science students toinclude ethics and related social aspects in their training.


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• Support the development of effective dialoguebetween the community and the biotechnology sector

The Bioethics Council will be making a significant

contribution here. Other actions could include the

development of guidelines for the biotechnology

sector to encourage best practice in consultation

and participation.

• Support the development of Maori initiatives todevelop effective communication models andresources that will foster constructive engagementwith Maori communities on science and researchgenerally, as well as specifically on biotechnology

This could involve support for initiatives by

organisations such as the National Association of

Maori Mathematicians, Scientists and

Technologists (NAMMSAT) and Nga Kaihautu, the

Maori Advisory Committee to ERMA.

• Support for research into indigenous cultural practicesin relation to the use of natural resources, such asMaori medicinal and therapeutic use of native plants

This would provide a practical opportunity to

strengthen connections and also link with

development objectives.

• Strengthen or clarify Government’s expectations ofsocial responsiveness of biotechnology-related workby Crown-owned research and education institutions

This could be achieved through ensuring

well-rounded membership of Boards or through

changes to accountability documents such as

Statements of Intent to place greater emphasis

on social responsiveness indicators such

as ‘trust’.

• Develop a code of best practice for the biotechnology

sector incorporating ethical, social, economic,

environmental and cultural considerations

This code could include:

- agreements on ethically and culturally

appropriate and inappropriate applications and

conduct in biotechnology

- statements outlining accepted practice and

regulations for gaining approvals for ethical

and safety approvals for research trials

- guidelines on when, how and why public

engagement or participation should occur.

The code could be developed as a partnership

between the biotechnology sector, the public and

the Government.

• Expand and extend the contribution of CRIs and

university outreach programmes to secondary school

education in ways that also promote closer

engagement between the biotechnology sector and

society

This could involve the expansion of existing

outreach programmes to provide greater coverage

and the development of opportunities for input

from schools and their communities to be provided

back into CRIs and universities.


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THE COMMUNITY AND BIOTECHNOLOGY -QUESTIONS FOR FEEDBACKQ1 How can information on biotechnology be delivered in ways that are easily understood

and trusted?

Q2 What role can the media, schools, universities, Crown Research Institutes, the biotechnologysector and government agencies play in increasing awareness and understanding ofbiotechnology?

Q3 Opportunities for public input into advice around biotechnology are incorporated into the work ofthe Bioethics Council, as well as into HSNO Act processes. What other avenues for policy inputdo you think would be useful?

Q4 How can Maori perspectives and principles best be incorporated in decisions made onbiotechnology?

You have the option of answering these questions by writing on the forms provided at the back of the document and posting to

Biotechnology Strategy GroupMinistry of Research, Science and TechnologyPO Box 5336Wellington or simply visit www.morst.govt.nz and answer online.


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GOAL 2Effective regulation to manageemerging biotechnologiesThe regulatory framework is where innovation andopportunity meet society’s safety and ethicalconcerns. The challenge is to ensure that thedesign and operation of regulation achieves anappropriate balance. Commitment to this balance isreflected in the strategy goal:

Manage the development and introduction of newbiotechnologies with a regulatory system thatoptimises opportunities and innovation whilesafeguarding health and the environment.

This section examines the framework related toregulatory approvals for new developments. There is a range of other legislative provisions thatimpact on biotechnology development includinggeneral business and tax law, intellectual propertyand patent law, as well as bioprospectingprovisions. The Government has considered manyof these other areas in specific reviews, including areview of business compliance costs, and currentreviews of the Patents Act and bioprospecting.

The focus in this paper is on the regulatory approvalsystem that is required to support the strategy goal.

The current New Zealand regulatory framework forapproving new biotechnology developmentsThe diagram in Annex 1 summarises the maincomponents of the regulatory system governing theintroduction of new bioproducts andbiotechnologies. The framework shows thedifferent approval processes and institutions forfood, animal, crop and medicinal developments.

It should be noted that the Royal Commission onGenetic Modification examined the regulatoryframework with specific reference to geneticallymodified organisms and found that the basicframework was generally sound, and keyinstitutions were conscientious in carrying out theirfunctions. The Royal Commission proposedamendments requiring specific consideration andcontrols for field-testing and release of geneticallymodified organisms. The annex diagramincorporates those amendments that have been orare in the process of being enacted.

The development of the biotechnology strategyoffers the opportunity to take a somewhat widerlook at the approval system, to see how it sits inrelation to what happens in other parts of the world

and to also consider how well the system supportsinnovation while safeguarding health and theenvironment.

Note was made earlier of initial regional andinternational efforts to move towards sharedstandards and regulatory approaches. New Zealandalready works jointly with Australia on foodstandards and the New Zealand and AustralianGovernments have agreed in principle to establish aTrans-Tasman Therapeutic Goods Agency for jointmedicine approvals. There is also growing globalconsumer preference for products and services thathave been robustly tested for safety andenvironmental effects, and which supportsustainable development. These consumerpreferences are likely to encourage developmentthat meets international best practice. Many companies ‘self-regulate’, going beyondmandatory government standards or requirementsin response to consumer preferences in order togain market advantage.

New Zealand’s regulatory framework has beenlargely built by using existing legislation. There arespecific pathways for transparent case-by-caseevaluation of GM products to manage potentialrisks of new organisms and food arising fromgenetic modification. Fast routing is available forthe development of low risk GM organisms and isbeing considered for the importation of low risk GMorganisms for research purposes.

The case-by-case approach used by ERMA andFood Standards Australia New Zealand (FSANZ) issimilar to that used in a number of countries,including Canada, Australia, Japan and theEuropean Union, although the specific regulatoryrequirements may differ. For example, Canadaregulates novel traits regardless of thetechnological process by which the trait isproduced. A case-by-case assessment is alsoconsistent with the approaches agreedinternationally in the Cartagena Protocol onBiosafety and guidelines being developed by theCodex Ad Hoc Task Force on Foods Derived fromBiotechnology.

To progress the strategy we also need to assesshow well the current framework enables innovationwhile safeguarding health and the environment.This assessment needs to include the broadercontext such as research protocols, incentives andprofessional body requirements that also affect thebehaviour of the sector.


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Some strengths and issues associated with the presentNew Zealand framework The strengths and issues outlined below reflectsome of the tensions between the perspectives ofdevelopers and the wider community. Initial discussions with stakeholders havehighlighted the following features:

Strengths• The existing system is considered to be

fundamentally sound in achieving safety andenvironmental objectives. The Royal Commissionon Genetic Modification echoed this. In respect ofmanaging the risks, HSNO and FSANZ providestringent regulatory regimes, based onprecautionary approaches, and the Medicines Acthas the potential to offer broad coverage inrespect of biotechnologies developed for a“therapeutic purpose”.

• The framework provides for transparent attentionto products of genetic modification.

• The system is participatory and providesstructured opportunities for public consultationand submissions, especially with both HSNO andFSANZ.

• Maori are involved in HSNO approval processesas well as medical ethical approvals. FSANZ alsohas a Maori reference group for consulting onfood issues.

• New Zealand’s health research ethical processeshave a good international reputation. There is arobust regime for dealing with medical ethicsissues including informed patient consent and privacy.

• The regulatory system provides a high level ofanimal welfare protection for animals used inresearch.

• A considered balance between self-regulation(which includes professional and institutional) andstatutory regulation is used.

Identified Issues• There is little integration between the regulation

of medical applications andagricultural/environmental applications withmultiple potential applications. There may bebenefits from greater co-ordination andstreamlining between distinct regulatory streamsin instances when products of biotechnology haveto meet the requirements of more than one pieceof legislation. The Government is already

investigating ways to streamline approvals for livenew organism medicines, which are currentlyrequired to obtain dual approval under HSNO andthe Medicines Act.

• Ethical approvals for human research are basedon institutional processes and protocols, ratherthan legislative requirements. While this approachis generally acknowledged as providing robustconsideration of ethical issues, some people haveexpressed concern as to whether, in some areas,such as human cloning, legislative guidance isrequired. Human reproductive cloning is nowprohibited through recent legislative amendmentto the Medicines Act. Policy work is underway onother human biotechnology issues, including theidentified gap in legislation for managingtherapeutic use of organs and tissues and human-assisted reproduction. There may be other areasof human research that it could be argued need alegislative basis.

• Under the Medicines Act no consultation isrequired on potential public-wide effects. There ispotential for some therapeutics derived throughbiotechnology (and other processes) to affect agreater proportion of the population than just theindividual being treated (e.g. gene therapy usingviral vectors). There is a case for clarifying whenpublic consultation in respect of such therapeuticsis appropriate.

• Also related to the issue of potential public-wideeffects, some people have noted a possible riskarea in the provision for clinicians to be able totreat individual patients with new (biotechnology)therapies without being required to go throughthe clinical trial approval process.

• There are differing perceptions about complianceprocedures and costs. From the perspective ofthose pursuing new developments many perceiveHSNO timeframes and consultation processes asunwieldy, with uncertain timeframes. While thereare relatively lower compliance costs in respect ofmedical applications, compliance issues havebeen raised about ethics approval processes,including timeliness and the confusion about thelevels and purposes of the various approvals.

• Researchers wanting to develop new productsbased on biotechnology see the current regulatorysystem as quite complex. Researchers anddevelopers consider that there is a lack ofmechanisms promoting greater transparency andbest practice in the sector for safety and ethicalapprovals. This includes lack of a single body


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Actions already under wayThe following legislative initiatives are underway.

Primary Legislation Purpose of Amendment Status

HSNO Act 1996* To allow time, before any application for a GMO release is considered by ERMA, to put in place research programmes, make further amendments to the HSNO Act 1996, establish a Bioethics Council and undertake other work on issues in response to the Royal Commission. The HSNO (Genetically Modified Organisms) Amendment Bill:

- places a restricted period on the release of GMOs by preventing ERMA from receiving applications to release GMOs until after 29 October 2003 (with limited exemptions for human and animal medicines)

- requires ERMA to consider additional matters when considering applications for field tests of GMOs

- imposes additional mandatory controls on the containment and clean up of field tests and developments outside the laboratory.

HSNO Act 1996* To implement matters requiring legislative change from the Government’s response to the RCGM, including conditional release, information protection, streamlining GM medicine approvals, extending grounds for call-in, and gaps, e.g. human cell lines.

HSNO (Low-Risk To simplify the approval processes for low-risk GM Genetic Modification) developments without changing the scope ofRegulations 1998/SR216 developments considered low-risk.

HSNO Act 1996* To amend the HSNO Act to more appropriately reflect the Treaty of Waitangi relationship.

providing practical advice to the biotechnologysector and prospective investors on the regulatoryframework, lack of an Industry Code and lack of a

transparent mechanism to constantly audit andstreamline the regulatory system to aid efficiencyand effectiveness.

Public consultationunderway. Changes tobe in place by October2003.

Consultationcompleted February2002. Cabinet approvedamendments in May2002. Regulationsbeing drafted.

Maori Reference Group established toassist in developmentof options foramendments.

Introduced inDecember 2001.Enacted in May 2002.


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Patents Act 1953* To update the Act to take into account new social and technological developments which affect intellectual property rights and management. Stage 3 of the review deals with a number of biotechnology-related issues, including the patenting of living organisms and genetic material. This review is linked with a parallel review of the Plant Variety Rights Act 1987.

Medicines Act 1981* Prohibits clinical xenotransplantation and “germ-cell genetic procedure” (including human reproductive cloning) unless specific Ministerial authorisation has been given (Medicines Act 1981 amendment). This is a temporary amendment pending development of a more comprehensive legislative framework for dealing with these technologies.

Human Tissue Act* To update the Act in light of new social and (1964) (plus possibly technological developments in relation to human cell Medicines Act and tissue research including the collection, storage, use Health Act) and disposal of bodies, organs, tissues and tissue

samples.

Assisted Human Legislation to regulate human reproductiveReproduction technologies and the delivery of fertility services in Technologies Bill(s) New Zealand.

* Some or all of the proposed amendments arose out of the Government’s consideration of the RoyalCommission on Genetic Modification.

Stages 1 and 2 complete. Stage 3discussion documentreleased for public consultation April 2002.Any amendments to beintroduced during 2003parliamentary term.

Enacted May 2002with the HSNO(Genetically ModifiedOrganisms)Amendment Bill.

Early policy work hasbegun.

Drafting of an SOP to implement Cabinetdecisions is underway.

Other possibilities for changeA significant amount of legislative review and policydevelopment is already underway to ensure thatNew Zealand has a robust regulatory frameworkthat optimises innovation while safeguarding healthand the environment. As indicated, there is currentlyconsiderable focus on implementing amendmentsto HSNO (being consulted on separately - publicdiscussion paper entiltled Improving the Operationof the HSNO Act for New Organisms), as well aspolicy work on human biotechnology issues that willbe reflected in legislation. The Government has alsocommitted to a review of ERMA.

Further possible directions, apart from those alreadybeing consulted on to improve the HSNO Act, thatcould be considered include actions to:

• Address any further areas of concern in thecurrent regulatory framework by amendingexisting legislation or improving itsimplementation, for instance by:

- defining firmer timeframe provisions for HSNO approvals

- examining the potential for any further streamlining of double-ups in approval processes (i.e., under HSNO, the Medicines Act, the FSANZ Food Code and the Agricultural Compounds and Veterinary Medicines Act 1997 (ACVM))

- incorporating an efficient public consultation process in respect of therapeutic biotechnology products which may have a public wide effect (noting that this is already necessary for live new organism therapeutics)

- specifying which innovative medicines are exempt from the clinical trial process and that healthy participants taking part in clinical trials are covered by the Medicines Act.


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• Identify more clearly the responsibility for anumber of overview, audit and co-ordinationfunctions, in order to support the overall deliveryof an efficient and effective regulatory system forbiotechnology. These functions include:

- raising public awareness in respect of thecurrent regulatory framework

- anticipating potential legislative implications ofemerging technologies

- providing targeted industry advice onbiotechnology related legislation

- co-ordinating interaction between regulatorybodies

- auditing implementation of regulation

- maintaining an overview of the overalleffectiveness and efficiency of the regulatorysystem.

Responsibility for these functions would notnecessarily require a statutory approach, nor liewith just one agency. For instance, targetedindustry advice on relevant legislation could be

provided through a biotechnology unit in anappropriate government agency; anticipatingpotential legislative implications could becomepart of the brief for futurewatch activities by theBioethics Council and agencies could bemandated by Government to conduct specificaudits of the legislation. The Ministry of EconomicDevelopment already has a mandate to keep anoverview on business compliance costs andERMA has functions relating toauditing/monitoring and education about theHSNO Act.

Although there is no intention to establish newinstitutions it would still be possible to implementa “system guardian” function which auditscompliance with government policy, legislation orsome other specific interest. In terms of thebiotechnology strategy, such a systems auditcould be broadly configured to assess whetherthe system is achieving the appropriate balancingof innovation and assurance. An option forconducting such a systems audit would be tocommission it from the Office of the AuditorGeneral, whose office has a broad mandate tocarry out audit activity.



Q5 How well does the current regulatory system support innovation while safeguarding health andthe environment?

Q6 What do you think are significant strengths of the present system and why?

Q7 What do you think are significant problems for the present system and why?

Q8 What is the appropriate way for Maori interests to be taken into account in the regulatory system?

Q9 What are effective ways to provide information on biotechnology regulation to industry and thecommunity?

Q10 What are effective ways to get better overview and co-ordination of the system?

REGULATION FOR EMERGINGBIOTECHNOLOGIES-QUESTIONS FORFEEDBACK


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GOAL 3Growing New Zealand’sbiotechnology sectorInitial discussions with the sector have highlightedthe following opportunities and challenges inmeeting the third goal of the Strategy:

Growing New Zealand’s Biotechnology Sector

Feedback on these issues will be directed to theBiotechnology Sector Taskforce, who areconsidering these matters and developing practicalresponses.

Strengths• Overall capability in biotechnology is underpinned

by strong basic research. Specific capability ispatchy, particularly in the areas where researchdisciplines converge such as bioinformatics.

• New Zealand has niche strengths and capability inresearch-based primary production, biomedicalresearch and diagnostics, environmentalbiotechnology, including bioremediation andruminant biotechnology research, forensics, and anumber of new and emerging biotechnologies,including links with nano-technology.

• New Zealand has high international standards anda sound reputation in biosecurity, animal and planthealth, nutrition and animal husbandry.

Challenges• Human resources - New Zealand is challenged to

retain and enhance the critical mass and mix ofskills necessary for sustaining a well functioningbiotechnology sector. This challenge covers:

- the extent and quality of science education inNew Zealand

- the linking of science education to other keydisciplines and skills, including bio-informatics,business and commercial management skills

- information and brokering services that enablescientists, entrepreneurs and business peopleto be aware of and connected with New Zealand-based biotechnologyopportunities and businesses.

• Cost of research and development - Being at thecutting edge of research is costly. These costsare exacerbated by the long-term nature ofbiotechnology research, the cost of high-techresearch equipment and long or uncertain

timeframes for regulatory approvals. Given New Zealand’s small size and relative wealthbase, this suggests a need for focus,collaboration and co-ordination, as well asoverseas sources of investment and finance.

• Commercialisation ‘savvy’ - Taking biotechnologyinventions to market requires a sophisticated setof commercial skills and knowledge. A key themein discussions with the sector is a strong needfor “on-the-ground” assistance to facilitatecommercial knowledge and connections relevantto the sector, to spread best practice andincrease commercial confidence. Crucially theseareas of knowledge include:

- intellectual property management

- knowledge and management of regulatoryapprovals

- understanding of and links with internationalcapital markets

- global links with biotechnology product andservice manufacturers and distributors.

• Geographical clustering - Biotechnology clustersin other countries have been demonstrated tobuild connections and critical mass. Clusters helpovercome scale and resource constraints andlead to increased productivity and innovation. The Dunedin biotechnology industry hadformalised its cluster network with the creationof Bio South. Palmerston North has a naturalclustering of research institutes. In Auckland anumber of biotechnology firms have expressedan interest in co-locating, a step which could befacilitated through the joint efforts of theAuckland City Council, Competitive Auckland andIndustry New Zealand.

• Presence in international biotechnology - New Zealand needs to have a strong presenceoverseas at conferences and showcases, as wellas a clear domestic entry point for overseasinterest. The UK, Denmark, Germany, Singapore,Australia and the US are very aggressive infostering modern biotechnology and facilitatinginvestment. Early New Zealand initiatives includeadvancing discussions with Australia on thepotential of Trans Tasman co-operation in thebiotechnology sector and the Ministerialdelegation to BIO 2002 in Toronto. However, sustained and comprehensive effortswill be needed to achieve an effectiveinternational presence.


33



• Expansion capital - New Zealand’s capital marketinfrastructure for biotechnology isunderdeveloped. The poor savings base of NewZealanders and structural aspects of New Zealandmanaged funds contribute to a lack of “secondround” funding, identified at the $15-60 millionmark. This lack of funding is made worse bypatchy understanding among New Zealandinvestors of the long-term nature of thedevelopment path for biotechnology applicationsand the high failure rate of ideas. However, VIFhas been identified as a good initiative forexpanding seed capital.

In terms of accessing overseas capital (apart fromassisting with making the connections), a keyneed identified is to increase the levels ofknowledge, skills and sophistication of NewZealand biotechnology companies in dealing withoverseas investors. This includes understandingthe commercial business drivers of the venturecapital and corporate investment community, theability to develop and present well-formulatedbusiness plans and knowledge of best practice indeal structures. The expanded InvestmentPromotion agency to operate under InvestmentNew Zealand and report to the Industry NewZealand Board, is expected to play a major role infacilitating their international engagement.

• Clarity about access to and use of genetic andbiological resources - As both a supplier andimporter of genetic resources, New Zealandneeds to clarify its interests in these resources.

This is important if New Zealand is to negotiateeffectively in international forums on behalf of themany industries in which biotechnology will beused. The interests and concerns of Maori needto be taken into account.

• Maori participation in biotechnology - Maori holdsubstantial and significant ownership of naturalresources, as well as holding traditionalknowledge about these resources. A key themeduring initial discussions with Maori was the needto explore constructive ways of usingbiotechnology to further Maori developmentaspirations and enhance cultural practices. Thiscould for instance involve support for researchinto indigenous cultural practices in relation to theuse of natural resources, such as Maori medicinaland therapeutic use of native plants.

• Biomedical commercial issues - A recurrenttheme during discussions with the sector was thefragility of this end of the industry. Most are still inthe early stages of drug discovery, a long wayfrom delivery and commercialisation. This raisesquestions of where New Zealand should focus itsefforts on the ‘value added chain’. There seemsto be a growing view in this sector that NewZealand should focus its efforts on research anddiscovery through to Stage 1 clinical trials, andthen on negotiating licensing deals withpharmaceutical companies and other players forsubsequent development, approval anddistribution.

GROWING NEW ZEALAND’SBIOTECHNOLOGY SECTOR - QUESTIONS FOR FEEDBACKQ11 What challenges do you regard as most significant for growing the sector?

Q12 How can we ensure a research infrastructure that builds scientific capability and retains goodscientists, given New Zealand’s small size and limited resources?

Q13 What is needed to build successful clusters of biotechnology companies?

Q14 How can New Zealand attract and retain overseas investment without losing small biotechnologycompanies to offshore?

Q15 What are effective ways to foster Maori participation in biotechnology research and commercialdevelopment?


34

Co-ordination of the strategy andlinkages with other strategy andpolicy developmentThe Biotechnology Strategy highlights several co-ordination functions that the government might play:

• shared responsibility for a vision and strategy

• implementing a common framework throughpolicy and operational activities

• increasing public awareness and providingaccurate information and opportunities forcommunity engagement about biotechnology

• external face/portal for biotechnology bothdomestically and internationally

• focus for regulatory information and industryassistance.

Currently at least ten government departments havepolicy or operational responsibilities for some aspectof biotechnology, although five (the Ministry ofAgriculture and Forestry (MAF), the Ministry for theEnvironment (MfE), the Ministry of Health (MoH),the Ministry of Research, Science and Technology(MoRST), and the Ministry of EconomicDevelopment (MED)) would regard it as being a key

function. In addition to departments there are anumber of Crown agencies and Ministerial advisorybodies with biotech related responsibilities. These include research purchase agents (FRST,HRC), regulatory bodies (ERMA, Medsafe, FSANZ)industry development (Industry NZ, TradeNZ,TechNZ), ethical bodies (Bioethics Council, NationalEthics Committee on Assisted Human Reproduction(NECAHR)) and research providers (CRIs andTertiary Education Institutes).

As the strategy work progresses it will be importantto ensure a deliberate approach to co-ordinating themultidimensional functions of government.

A model that has been adopted by a number ofother countries, including Australia, Canada and theUK is to establish a ‘formal’ Ministerial grouping onbiotechnology, which can enable in depthconsideration of the broad context and variousperspectives before decision making by Cabinet.Such an option could be part of the final strategy.

Illustrating the extent of linkages, the table belowoutlines other areas of related policy developmentand their timeframes (the following table should beread in conjuction with the specific legislative actionalready underway that is set out in the regulatorysection).


35

Policy Links Objective Current status

Toi Te Taiao: To establish a Bioethics Council to Terms of reference approved.Bioethics Council advise Ministers on ethical, cultural Chair appointed and membership being

and spiritual aspects of biotechnology. finalised.

Coexistence To explore strategies to enable Investigation and report to Cabinet on issuespractice for coexistence. and practicalities by March 2003.agri/horticulture

Intellectual To address issues through the review Discussion documents on the reviews of theproperty issues of the Patents Act and an in-tandem Patents and Plant Variety Rights Acts

review of the Plant Variety Rights Act, released April 2002.including: Submissions closed July 2002.- exclusion of patentability of human Any amendments introduced during the 2003

beings parliamentary term.- setting up a Maori consultative

committee to assist with patent applications.

To address proposals in respect of Participate in work of World Intellectual “cultural and intellectual property Property Organisation and other international rights” through participation in existing processes as opportunities arise.international processes including World Intellectual Property Organisation.

To determine the Wai 262 claim. Crown response filed. Waitangi Tribunal plansinterim report by end of 2002.

Research To establish or enhance existing Approx $1.2m of new GM-related impacts initiatives research programmes in areas research will begin in July 2002 on risk around GM identified by the Royal Commission. perceptions and vertical and horizontal gene

transfer. A further $1m will be appropriated toVote RS&T in 2002/03, rising to $2.5m per annum in 2003/04 and outyears to undertake multidisciplinary research into the socio-economic, ethical and environmental impacts of genetic modification and other emerging biotechnologies.

Economic Report to government in early 2003 on Complete research through a combination ofanalyses project to examine the economic risks in-house research and contract work. around GM and opportunities of the release of Report to Cabinet - February 2003.

genetically modified organisms.

Liability issues The Royal Commission took the view While the Law Commission identified somerelated to GM that the current liability regime is potential components of possible liability

adequate and recommended that, for regimes, a number of fundamental matters the time being, there was no need to remain to be addressed before deciding change the existing liability rules. whether or not changes to the existing liabilityIt also suggested that the matter regime are required. Officials are undertakingbe referred to the Law Commission further work and will provide an interim reportfor further work. The Law to Cabinet in December 2002. Commission’s study paper has been publicly released.


36

Policy Links Objective Current status

Biosecurity Development of a vision and approach Draft strategy is being developed. This will beStrategy for managing biosecurity risks into the consulted on in the latter part of 2002.

foreseeable future.

Bioprospecting To review the regulatory framework for Consultation process in the latter part ofPolicy bioprospecting (examination of 2002.

biological resources [e.g. plants, animals, micro-organisms] for features that may be of value for commercial development).

Sustainable Being done in 2 phases. Phase 1 is a Phase 1 report considered by Cabinet in July.Development report on the Government’s approach Further policy work following the Strategy to sustainable development. Phase 2 Johannesburg conference.

will occur following the World Summit on Sustainable Development in Johannesburg in August, and will involve engagement with the community leading to a draft strategy.

Oceans Strategy To establish a framework for integrated Vision/goals agreed. Policy work on management of the oceans. (Oceans management framework is underway.which are 15 times our land mass currently have no integrated management framework).

Tertiary Education To establish goals and objectives for Final strategy launched in May 2002.Strategy tertiary education, including a direction Performance based research funding now

for how tertiary education can in development.contribute to national development goals.

Trans-Tasman New Zealand and Australian Submissions for consultation closed August 2.Therapeutic Goods Governments have agreed in principle Report to Cabinet before the end of 2002. Agency Project to establish a Trans- Tasman

Therapeutic Goods Agency. The project, involving New Zealand and Australian officials, will develop the detail of how the agency would operate and new legislation to regulate therapeutic goods in both countries.


37

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38

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d E

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g


39

ABBREVIATIONSACVM Agricultural Compounds and Veterinary Medicines Act 1997

DG Director General

CRI Crown Research Institute

ERMA Environmental Risk Management Authority

ESR Institute of Environmental Science and Research

FSANZ Food Standards Australia New Zealand

FRST Foundation for Research, Science and Technology

GMO Genetically Modified Organism

GTAC Gene Technology Advisory Committee

HRC Health Research Council

HSNO Hazardous Substance and New Organisms Act 1996

HRCEC Health Research Council Ethics Committee

IBAC Independent Biotechnology Advisory Council (ceased existence in July 2002)

IBSC Institutional Biological Safety Committee

MAAC Medicines Assessment Advisory Committee

MED Ministry of Economic Development

MoRST Ministry of Research, Science and Technology

NECAHR National Ethics Committee on Assisted Human Reproduction

NERF New Economy Research Fund

RCGM Royal Commission on Genetic Modification

SCOTT HRC Standing Committee on Therapeutic Trials

VIF New Zealand Venture Investment Fund

Glossary


40

Angel Investment: Early, pre-seed funding for newstart-up businesses; this investment is usually inthe form of equity and involves ‘hands on’ businessadvice.

Biotechnology: Any technological application thatuses biological systems, living organisms orderivatives thereof, (whether genetically modified ornot) to make or modify products or processes forgeneral use.

Biodiversity, biological diversity: The existence of awide range of different types of species (e.g. plantand animal) at a given time.

Bioinformatics: A computer-based discipline thatorganises biological data from DNA and proteinsequencing and provides a technique for computerimaging and modelling of biological systems.

Bioprospecting: Examination of biological resources(e.g. plants, animals, micro-organisms) for featuresthat may be of value for commercial development.

Bioremediation: The use of biological systems toclean up pollution and other environmentalcontaminants.

Chromosome: Components in a cell that containgenetic information. Each chromosome containsnumerous genes.

Clone: An identical copy of something. The termmay be applied to a piece of DNA, a cell orindividual plants or animals such as identical twins.

Codex Alimentarius Commission: This Commissionwas created in 1963 by the Food and AgriculturalOrganisation (FAO) and the World HealthOrganisation (WHO) to develop world foodstandards, guidelines and related texts such ascodes of practice under the joint FAO/WHO FoodStandards Programme.

DNA: Deoxyribonucleic acid, the chemical at thecentre of the cells of all living things, which controlsthe structure and function of each cell and carriesgenetic information during reproduction.

Gene: A sequence of DNA on a chromosome thatcontains an instruction for a cellular function that isinherited.

Genetic modification: Altering the genetic material ofcells or organisms to make them capable of makingnew substances or performing new functions. Also referred to as genetic manipulation or geneticengineering.

Gene therapy: The process of introducing new genesinto cells to correct a genetic disease.

Horizontal gene transfer (HGT): Refers to themovement of a gene from one species to another.HGT is a naturally occurring process, especiallyamong bacteria. HGT between plants and bacteriamay occur, but only extremely rarely. It is distinctfrom the normal process of vertical gene transfer(from parent to offspring) which occurs inreproduction.

Intellectual property: The area of law involvingpatents, copyrights, trademarks, trade secrets andplant variety protection.

Nanotechnology: Sometimes called "molecularmanufacturing" or "micro-robotics". It involves thedevelopment and use of devices that have a smallsize (of only a few nanometers).

Nutraceutical: A food product that includesimproved nutritional characteristics and/orpharmaceutical properties.

Patent: The exclusive right to make use of aninvention for a fixed time.

Plant Variety Rights: The exclusive right to produce anew plant variety for sale and to sell propagatingmaterial.

Stem cells: Cells that have the ability to continuouslydivide and develop into various types of tissues.Can be sourced from early embryos, foetuses,umbilical cord blood and adult tissues (e.g. bonemarrow).

Technical Definitions


41

Therapeutic cloning: A technique whereby peoplecan provide their own somatic (adult cell) nuclei toreplace nuclei in their own or donated eggs, so thatindividual embryonic stem cells can be developed.The embryonic stem cells can then be used toreplace tissue that has been damaged by injury ordisease. This technique is being investigated for thetreatment of Parkinson’s and Alzheimer’s disease.

Transgenic: An organism that has been geneticallyengineered to contain genes from another species.

Wai 262: Claim to the Waitangi Tribunal from six iwiand one whanau, which claim exclusive andcomprehensive rights to indigenous flora, fauna andother ‘taonga’ such as traditional knowledge.

Xenotransplantation: Transplantation of cells, tissue ororgans between different species. A commonexample is the use of pig heart valves in humans.

For other useful technical definitions andinformation you can visit:

www.ibac.org.nz;

www.fao.org/biotech/glossary


42

Making a SubmissionIndividuals and organisations are invited to make written submissions on the Biotechnology StrategyDiscussion Paper. Your views will help inform the development of the Government’s Biotechnology Strategy.

To make a submission you can either;1 fill in online at www.morst.govt.nz2 Fill out the following form and post to:

Biotechnology Strategy GroupMinistry of Research, Science and TechnologyPO Box 5336Wellington

Please note that the Ministry’s policy on disclosure of submissions is to treat any written material given to usas being in the public domain and therefore available to any other person on request. You should thereforeindicate clearly if your comments are commercially sensitive, or if, for some other reason, you consider theyshould not be made public.

Personal contact details, gender and ethnicity data collected for validation and statistical purposes will not bedisclosed and are covered by MoRST’S privacy and security policy.

The Ministry of Research, Science and Technology will summarise submissions and make the summarypublicly available on its website and by hard copy on request. The Government intends to finalise theBiotechnology Strategy in early 2003, after analysing submissions and assessing policy options, includingthe work of the Biotechnology Sector Taskforce.


43

THE COMMUNITY AND BIOTECHNOLOGY -QUESTIONS FOR FEEDBACK

Q1 How can information on biotechnology be delivered in ways that are easily understood and trusted?

Personal Information

Name: Mr Miss Mrs Ms

Gender: Male Female

Ethnicity: NZ European NZ Maori Pacific Islander Asian Other

Address:

Organisation:

Number of members: 1-5 6-9 10-49 50-99 100+

Discussion process: I am responsible for the company view

Some discussion

Company policy

All staff discussed

Board mandate

Other

Organisational Information (if applicable)


44

THE COMMUNITY AND BIOTECHNOLOGY -QUESTIONS FOR FEEDBACK

Q3 Opportunities for public input into advice around biotechnology are incorporated into the work of theBioethics Council, as well as into HSNO Act processes. What other avenues for policy input do you think would be useful?

Q2 What role can the media, schools, universities, Crown Research Institutes, the biotechnology sector and government agencies play in increasing awareness and understanding of biotechnology?


45

Q5 How well does the current regulatory system support innovation while safeguarding health and the environment?

Q4 How can Maori perspectives and principles best be incorporated in decisions made on biotechnology?

EFFECTIVE REGULATION - QUESTIONS FOR FEEDBACK


46


Q7 What do you think are significant problems for the present system and why?

Q6 What do you think are significant strengths of the present system and why?


47


Q9 What are effective ways to provide information on biotechnology regulation to industry and thecommunity?

Q8 What is the appropriate way for Maori interests to be taken into account in the regulatory system?


48

Q11 What challenges do you regard as most significant for growing the sector?

Q10 What are effective ways to get better overview and co-ordination of the system?

GROWING THE SECTOR - QUESTIONS FOR FEEDBACK


49


Q13 What is needed to build successful clusters of biotechnology companies?

Q12 How can we ensure a research infrastructure that builds scientific capability and retains good scientists, given New Zealand’s small size and limited resources?


50


Q15 What are effective ways to foster Maori participation in biotechnology research and commercial development?

Q14 How can New Zealand attract and retain overseas investment without losing small biotechnologycompanies to offshore?


51


www.morst .govt .nz


new zealand biotechnology strategy - university of canterbury

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