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Biotechnology in Australia
Rod Panter
Science, Technology, Environment and Resources Group
8 June 1999
Contents
Major Issues
Introduction
Size of biotechnology sector
Pros and cons of biotechnology
The science of genetic manipulation
Pro arguments
Arguments against
Morals, ethics, etc
Allergies
Genetic breakout
Community attitudes
International
Australia
Some Concluding Points
Endnotes
The term biotechnology can be taken to mean any commercial
exploitation of biological processes but usually refers to research and
development of the newer aspects of biology such as genetic engineering.
The best known products of biotechnology are new drugs, vaccines and genetically
engineered crops or animals.
The Treasurer's Budget Speech this year was unusual because
it included a six-paragraph section on science and technology. In most
years, the subject of science and technology would hardly rate a single
mention. The Treasurer stated that biotechnology would have a major commercial
impact and had the potential to improve living standards through advances
in medicine, food production and environmental protection. In his Reply,
the Leader of the Opposition also emphasised knowledge-intensive industries
such as biotechnology. The Budget has placed high priority on medical
research and has set up regulatory and policy machinery for the development
of biotechnology in Australia.
At present, the home-grown biotechnology industry is
quite small, the sector being dominated by large multinational drug companies.
Most of the Australian firms are based in Melbourne or Sydney but a recent
$200 million package committed to biotechnology in Queensland is a boost
to that State. Whereas Australia has a good record in research, the costs
and risks associated with development and government approval of products
such as a new drug are formidable. It is this huge gap which has to be
bridged, and is a greater problem than research funding.
However promising biotechnology may be, its acceptance
by the community is vital to its continued support by governments. There
is currently a vigorous worldwide debate, rather belatedly joined by Australia,
over the acceptability of genetically engineered foods. In the US, gene
crops are starting to dominate their conventional counterparts. The two
versions of, say, soybeans or maize are mixed in shipments but many European
consumers want to be able to distinguish between them through labelling.
There is evidence that Australians also are strong supporters of labelling
and regulation.
Biotechnology is in a high growth phase worldwide. It
has been estimated by Monsanto, a leading biotechnology company, that
the total area sown to genetically manipulated crops worldwide expanded
from 2.8 million hectares in 1996 to 26.2 million hectares in 1998. Forty-eight
transgenic crops have now been approved for commercial use.
What is biotechnology? Strictly speaking, it means the
technical exploitation of any biological structure or process, that is,
deriving from living organisms. Thus, one should include in the definition
such age-old technologies as cheese, bread and beer-making since these
require the help of microorganisms. However, in common usage biotechnology
is taken to mean a set of techniques relying on biological discoveries
of the last, say, 50 years. One of the most important branches of
biotechnology is the manipulation of genes, the molecular
blueprints for proteins in living cells.
Other branches are drug and vaccine development, biological
machines and so on. One possible future scenario is the convergence of
several 'high technologies' such as nano- (highly miniaturised) technology,
information technology and biotechnology. Needless to say, the process
of applying the 'pure' biological research of the last half-century has
only just begun; the potential usefulness of our new knowledge seems boundless.
In economic terms, it has often been suggested that Australia
cannot continue to rely on commodities, thereby leaving the development
of 'clever' industries such as biotechnology to other countries. Much
of Australia's current balance of payments problem can be traced to imports
of knowledge-intensive products such as specialty chemicals, computing
and communications equipment. If the present imbalances are compounded
in future by a huge growth in overseas payments for our use of intellectual
property, new medical drugs and procedures, genetically manipulated crops
and the like, Australian standards of living must fall. While Australia
will never be able to discover and develop all of the technology it needs,
our aim should be to balance imports with at least some successful lines
of high technology-based exports. To do this, we need several global-scale
companies in the biotechnology sector. In other words, some of the Australian
minnows will have to become sharks.
How big is Australia's biotechnology sector? This is
a difficult question to answer precisely but it is thought that up to
170 biotechnology companies are based here. There is a high proportion
of private companies (about two-thirds), they are generally of small size
(less than 25 employees on average) and a high proportion (three-quarters)
have their headquarters in Sydney or Melbourne. Many of the companies
are spinoffs from universities or CSIRO and are managed by working scientists.
While some companies are interested in manufacturing, the shortage of
venture capital in Australia means that many of our biotechnology companies
are earning only licensing fees from multinationals for intellectual property.
Sometimes the scientists/managers are really only seeking support for
their favourite activity-research.
The stranglehold of large international pharmaceutical
and agrochemical companies on world markets was highlighted in a report
of a working group of the Prime Minister's Science, Engineering and Innovation
Council last year. The report stated:
As well as doing their own research, the large (international)
companies are keenly interested in the activities of these small (biotechnology)
companies. The usual strategy is to wait until they fail, in which
case the large companies can buy key patents and staff cheaply, or
if they succeed, to buy them out quickly before they become too successful
and expensive.1
Royalties and the like being received by Australia represent
but a fraction of the return which would accrue from manufacturing, marketing
and distribution by Australian companies.
There is an Australian Biotechnology Association with
its own home page at http://www.aba.asn.au/.
The Association puts out Australasian Biotechnology, a bi-monthly
journal recently added to the Parliamentary Library's serials collection.
There is also a Directory of Australian Biotechnology Companies. While
undoubtedly useful, the Directory does not list sales data for the various
companies, so it is not possible to arrive at their combined economic
contribution. However, at present the biotechnology sector (disregarding
the traditional branches such as breadmaking) would hardly register as
a percentage of national GDP.
The recent announcement of a $200 million financing deal
for a new Institute for Molecular Bioscience at the University of Queensland
is a boost to the sector. The Institute is planned to employ 700 staff
by 2003, working in a range of biotechnology fields such as genomic research,
developmental biology, molecular design and bioinformatics. As always
in Australia, the challenge will be to develop products as well as make
discoveries. Unfortunately the cost of bringing biotechnology to the marketplace
is huge. The Australian influenza drug Relenza was worked on for about
20 years but it is yet to gain approval from the US Food and Drug Administration.
Some branches of biotechnology are relatively free of
controversy. Pharmaceuticals, for example, are generally perceived as
trying to improve people's health (but note discussion on Prozac, Ritalin
and Viagra). By far the most debate is generated by gene manipulation,
which has invaded medicine (via gene therapy), agriculture, horticulture,
pest control, and many other fields. It is therefore worthwhile to cover
this aspect of biotechnology in more detail.
The science of genetic manipulation
Before summarising each side of the biotechnology debate,
it is best to have some understanding of genetic manipulation. There
are thousands of genes in an organism which together make up what is known
as the genome situated in the chromosomes of the cell nucleus.
Genes are molecular blueprints for thousands of proteins which are needed
by the organism for building structures such as cell membranes, and as
biological catalysts (enzymes) for the handling of a myriad of small molecule
types such as sugars, fats, vitamins, hormones and so on.
In genetic manipulation, the usual idea is to introduce
a foreign gene or genes to a plant or animal (or patient) using a special
'vector' such as a virus which infects the host with new genetic material.
Alternatively, the added gene or genes can be forced into host cells with
a type of 'gun'. While the failure rate is very high, a small proportion
of host cells respond by taking up and using the new genetic blueprint
(DNA or RNA segment) to make one or more proteins which are new to the
host. These then are designed to assist the patient or improve the crop
or animal in some way. Gene manipulation in animals and plants is usually
directed towards germ cells (embryos) so that generations of transgenic
organisms will follow. In the case of gene therapy, the focus is on differentiated
cells. That is, the therapy is being directed at an individual patient,
not future generations.
Apart from adding one or more genes, genetic manipulation
may alternatively involve (i) cancelling or (ii) augmenting the action
of an existing gene. Also, the genome has special on/off/volume control
'switches' which can be activated artificially, for example, by spraying
a crop with a specific chemical or feeding special supplements to farm
animals. Thus not only the action but also the timing and level of gene
action can be manipulated. A recent report2 highlighted an
Australian/European discovery of a new gene switch found in a banana virus.
Genetic manipulation does not yet extend to artificial
genes leading to human-designed proteins; instead the process involves
transfer of more or less natural genes between species and even kingdoms
(animal/plant). Nor are there many genes transferred in one operation.
This is technically important, because a string of proteins have to act
together to produce many of the organism's 'bread and butter' molecules
such as sugars. For example, at the moment we cannot confer the whole
process of photosynthesis on an animal merely through conventional gene
manipulation-there are too many genes involved. For now, the ratio of
genes transferred or altered to the total number of natural genes in the
transformed organism is very low indeed. But while the percentage change
to protein makeup is small, the newly generated protein or proteins are
designed to make a significant difference, e.g., kill insects, slow rotting
processes, resist herbicides, increase growth rates, and so on.
Pro arguments
The research and medical communities, industry groups
and farmers are strongly in favour of biotechnology and its growth in
Australia. These groups perceive not only the advantages of existing genetically
engineered products but recognise the very great future potential of the
sector as a worldwide trend. They argue that, in many cases, biotechnology
offers a subtle 'biological' approach to an industry or medical problem
which brings reduced dependence on harmful synthetic chemicals such as
pesticides or harsh drugs. The improvements can be spectacular-using Ingard
cotton reduces the need to spray pesticide because it contains a bacterial
gene for an insecticide-and the economic advantages to the grower can
be so clearcut that genetically manipulated seeds can quickly dominate
the market. This year, genetically engineered soybean will make up half
of the total area planted to soybean in the US while more than half of
the canola planted in Canada will be genetically manipulated.3
A public relations problem for genetic engineering in
particular is that, for the general public, the technology has not yet
matched the promise with the potential. Development of products such as
the blue rose has been painfully slow with many setbacks. The first consumer-oriented
gene product, Calgene's slow-rotting Flavr-Savr tomato, was a flop4
because its higher cost did not justify its marginal benefits. As
far as consumers are concerned, genetic engineering has scarcely touched
their lives so far except through reading highly speculative magazine
and newspaper articles. Most of the real benefits such as savings on pesticides
have accrued to agricultural producers who are not perceived as having
passed them on. Human gene therapy is still largely a concept in the making.
Whatever risks are seen as inherent in gene manipulation (see below),
the community is in effect being asked to accept them without enjoying
any obvious benefits. Future benefits are almost certain and the growth
of biotechnology seems to be unstoppable, but there still is that insufficiency
of runs on the board at the moment.
Arguments against
Morals, ethics, etc
Arguments against genetic manipulation may be centred
on morals, ethics, religion, worry over new allergens in food, lack of
consumer choice and concern for the environment. Some people (famously,
the Prince of Wales) are troubled by the moral, ethical and religious
implications of what appear to be human 'acts of creation'. Even though
we have been manipulating the genetic makeup of domesticated plants and
animals for thousands of years through conventional breeding, the 'instant'
effects of genetic manipulation-such as making plants glow with firefly
genes-can be disturbing. This may be particularly so if gene donors and
recipients are unrelated and therefore 'unnatural' partners: plant genes
to an animal, bacterial genes to a plant and so on. Of course the reality
is that, in their biochemistry, the plant and animal kingdoms are broadly
similar; otherwise such genetic exchange could not take place.
Biotechnology over the years has had the capability of
challenging firmly established human customs, beliefs and taboos concerning
childbirth and sexuality. One need only mention the birth control pill
and in vitro fertilisation in this regard. Science is clearly capable
of moving far ahead of community acceptance of, say, eugenics at the embryo
stage, creation of a totally synthetic living organism, targeted war on
ethnic groups, 'spare parts' from foetal tissue and cloning. The very
weirdness of these and other biotechnology ideas, for example the notion
of making plastics from potatoes, is enough to 'turn people off'.
Only slightly less sensitive are customs, beliefs and
taboos surrounding food. Some vegetarians, probably most, will not want
the inclusion of animal-derived genes in their meatless diet. Religious
groups can be expected to extend their traditional customs, say of not
eating pork or beef, to avoiding any foods where genes from the key animals
(pig or cow) have been added. Transfer of human genes to food would be
seen by many as immoral in the extreme, yet in biochemical terms a single
human gene may be quite similar to genes in other species. It was reported
last February5 that New Zealand scientists have been given
approval to place human genes in cows so that their milk will more closely
resemble human milk.
Allergies
Since allergies are commonly caused by foreign proteins
(such as in grass pollen) overstimulating the body's immune defences,
many commentators have invoked the possibility of genetically modified
foods leading to new, possibly fatal allergies in susceptible people.
The argument is that genetic engineering creates new and-for the consumer-unexpected
proteins in foods which are being released for sale overseas without extensive
testing or labelling. An oft-repeated example is the mid-nineties case
of seven out of nine people allergic to Brazil nuts who were claimed also
to be allergic to modified soybeans, now discontinued, containing a Brazil
nut protein. If this is the only known evidence, however, the fear of
allergies may be more for the future than the present.
Genetic breakout
The most important concern about genetically modified
organisms reared or grown commercially away from the laboratory is the
possible spread of unnatural genes from the organisms to the natural environment.
Once again, there is little direct evidence that this is happening in
a harmful way. However, there is a Danish claim of a herbicide-resisting
gene of a transgenic canola variety escaping by cross-pollination to a
closely related plant, wild mustard. In France the same gene was found
to transfer to a wild radish. The world's crops are sometimes, but not
often, grown alongside their wild equivalents or relatives. If herbicide
resistance escaped from a crop to a serious weed, then the weed would
be selectively advantaged by spraying. This could be a severe problem
if the weed-infested crop were a food staple. Even worse would be a weed
with acquired resistance to several herbicides. One way to manage the
problem would be to spray before the weeds came into flower.
Some scientists fear that resistance genes for insect,
virus and fungal crop pests might escape from crops to weeds or certain
native flora species, enabling them to outgrow unaffected wild plants.6,7
Damage might also be done in the homeplaces of important foods like maize
and potato where the priceless original varieties could be genetically
transformed.
On the more positive side, regulators are conscious of
the advantages of restricting genetically manipulated crops to regions
where there are no wild relatives. The majority of transgenic crops grown
in the US are exotic and have no near relations in the wild. Secondly,
it should be noted that conventional breeding techniques have led to seemingly
harmless genetic exchange between crop varieties and wild varieties. For
example, in Switzerland, cultivated alfalfa is reported to have largely
displaced pure forms of sickle medic through hybridisation.8
Thirdly, it appears that weeds with acquired herbicide resistance are
less hardy than ordinary weeds in the wild. This phenomenon has been frequently
observed in the past with transformed bacteria.
To sum up, there is very little evidence so far to justify
fears of a disastrous 'genetic breakout'. Yet the very nature of the genes
being manipulated: herbicide-resistant, pest resistant, sterility genes
and so on will continue to invite scenarios of 'something going wrong'.
Research on animal rather than plant gene transfers to the wild, for example
inducing sterility in foxes with transformed viruses, may generate even
more alarm in the community. Could the virus infect wildlife or even people?
While gene manipulation was not involved, the unexpected escape of rabbit
calicivirus from Wardang Island in SA was not a good advertisement for
biotechnology.
International
Whereas strong industry lobbying and investment has made
the US a haven for genetic engineering, regulator and consumer attitudes
are much harder in Europe. This is despite Europe's strong support for
its powerful pharmaceutical industries. A poll held in the UK last year
(1998) revealed9 that 77 per cent of respondents wanted genetically
modified crops banned, while 61 per cent declared they did not want to
try genetically engineered foods. Even though heavy US importer and government
pressure has achieved some results for the Americans in Europe, for example
in securing patents for genetic material, many European countries are
questioning even conservative EU guidelines on crop approvals10.
For example, France last year suspended an authorisation for planting
transgenic maize even though the EU had given this crop marketing approval.11
Norway prohibits any products from transgenic crops containing antibiotic
marker genes.12 Food scares such as the BSE (bovine spongiform
encephalopathy) scandal; the reminders for some countries of Nazi abuses
of genetic science; the Danish research mentioned above; objections of
organic growers; imports of unlabelled genetic soy products from the US;
and the neglect of safety barriers in the UK by Monsanto have all played
a part in Europe's present antagonism.
The UK Government has recently come under intense pressure
to declare a moratorium on commercial planting of transgenic crops, partly
on the advice of its own wildlife advisers within the organisation English
Nature. Although Prime Minister Tony Blair has rejected the advisers'
call for a 3-5 year moratorium, the Government through its Environment
Minister (Mr Michael Meacher) has stated that commercial plantings will
not proceed until the Government is satisfied that farmland wildlife would
be safe. Two new bodies are to be set up in Britain: the Human Genetics
Commission to advise on healthcare biotechnology and human genetics, and
the Agricultural and Environment Biotechnology Commission to advise on
biotechnology in agriculture and its environmental effects .13
Meanwhile, there has been a recent unsuccessful attempt
to regulate trade in genetically modified commodities. In February of
this year, Australia, the US and four other producer countries opposed
a biosafety protocol which would have required labelling for all such
commodities.
Australia
The October 1998 issue of the journal Australasian
Science14 described a survey on Australian attitudes
to genetic manipulation. Briefly, the survey found that 66 per cent, or
two-thirds of the nearly 1000 respondents accepted the idea of transgenic
plants; but only 40 per cent stated that transgenic animals were acceptable.
The use of human genes in other organisms was approved of by 32 per cent.
This indicates that the type of genetic engineering skews opinion,
with plants being the most acceptable in this survey. The need for government
control of genetically engineered foods was maintained by 93 per cent
of respondents. Only about 5 per cent thought that labelling transgenic
food was unimportant. On the key question comparing risks with benefits,
52 per cent felt the risks of the technology were greater. And 56 per
cent agreed with a statement that transgenic food will have long-term
health consequences. Transgenic products which were not foods, particularly
plants (the blue rose), drew strong support.
These results, if indicative of wider attitudes, would
suggest that Australian opinion varies greatly according to the genetically
engineered product, but there is more wariness over animal manipulation.
Overwhelming support for government control indicated by the survey seems
to favour the individual approval process of transgenic foods entrusted
to ANZFA (Australia New Zealand Food Authority) and ANZFSC (Australia
New Zealand Food Standards Council), as well as supporting the creation
of the Office of the Gene Technology Regulator as set out in the Budget.
Although Australia has a good record in biological research,
as evidenced for example by our Nobel Prize winners in biology, the nation's
biotechnology sector hardly rates as an economic force. Whereas small
companies are essential for innovation, they need to be 'clustered' geographically
and have healthy client relationships with larger Australian companies
in order to grow. Government policies should be directed towards encouraging
investment in the sector, with the aim of developing biotechnology companies
beyond the very small scientist-oriented entities we now have. The rare
large Australian biotechnology companies such as Fauldings and CSL should
be groomed by government to become even larger, global-oriented companies.
Merely winning payment for intellectual property or research will never
be sufficient to balance the cost of massive future imports of biotechnology.
Only value-added production within our own biotechnology sector will be
enough.
Community support for biotechnology is reasonably good
at this stage, especially towards the pharmaceutical industry. However,
there will have to be more obvious benefits to consumers before genetic
manipulation in food crops becomes widely acceptable. In the 1999-2000
Budget the Federal Government is clearly trying to get to grips with biotechnology,
both in building community support for the sector and in regulation.
- 'Profiting From the Biotechnology Revolution', Prime Minister's Science,
Engineering and Innovation Council, 29 May 1998.
- Peter Spinks, 'Hopes Rise for Healthier Crops', The Age, 6
January 1999, p. 5.
- Ann Thayer, 'Transforming Agriculture', Chemical and Engineering
News, 19 April 1999, p. 21.
- David Rotman, 'The Next Biotech Harvest', Technology Review,
September/October 1998, p. 34.
- 'NZ Approves Bid to Breed Genetically Altered Sheep', The Canberra
Times, 24 March 1999, p. 10.
- Martin Brookes, 'Running Wild', New Scientist, 31 October 1998,
p. 38.
- Josie Glausiusz, 'The Great Gene Escape', Discover, May 1998,
p. 91.
- Martin Brookes, op. cit.
- Nigel Williams, 'Agricultural Biotech Faces Backlash in Europe', Science,
7 August 1998, p. 768.
- 'Dimming Outlook for GM Crops as Member States Go it Alone', ENDS
Report, October 1998, p. 46.
- ibid.
- Nigel Williams, op. cit.
- 'New Measures on Biotechnology Announced', (UK Cabinet) CAB 109/99,
21 May 1999.
- Janet Norton, Geoffrey Lawrence and Graham Wood, 'Consumer Misgivings
over Genetically Engineered Foods', Australasian Science, October
1998, p. 23.
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