Current Issues Brief 16 1998-99

Rod Panter
Science, Technology, Environment and Resources Group
8 June 1999

Contents

Major Issues

Introduction

Size of biotechnology sector

Pros and cons of biotechnology

Community attitudes

Some Concluding Points

Endnotes

Major Issues

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.

Introduction

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.

Size of biotechnology sector

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:

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.

Pros and cons of biotechnology

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.

Community attitudes

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.

Some Concluding Points

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.

 

Endnotes

2. 'Profiting From the Biotechnology Revolution', Prime Minister's Science, Engineering and Innovation Council, 29 May 1998.

3. Peter Spinks, 'Hopes Rise for Healthier Crops', The Age, 6 January 1999, p. 5.

4. Ann Thayer, 'Transforming Agriculture', Chemical and Engineering News, 19 April 1999, p. 21.

5. David Rotman, 'The Next Biotech Harvest', Technology Review, September/October 1998, p. 34.

6. 'NZ Approves Bid to Breed Genetically Altered Sheep', The Canberra Times, 24 March 1999, p. 10.

7. Martin Brookes, 'Running Wild', New Scientist, 31 October 1998, p. 38.

8. Josie Glausiusz, 'The Great Gene Escape', Discover, May 1998, p. 91.

9. Martin Brookes, op. cit.

10. Nigel Williams, 'Agricultural Biotech Faces Backlash in Europe', Science, 7 August 1998, p. 768.

11. 'Dimming Outlook for GM Crops as Member States Go it Alone', ENDS Report, October 1998, p. 46.

12. ibid.

13. Nigel Williams, op. cit.

14. 'New Measures on Biotechnology Announced', (UK Cabinet) CAB 109/99, 21 May 1999.

15. Janet Norton, Geoffrey Lawrence and Graham Wood, 'Consumer Misgivings over Genetically Engineered Foods', Australasian Science, October 1998, p. 23.

 

 

---