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.