Australasian Biotechnology (backfiles) AusBiotech ISSN: 1036-7128 Vol. 9, Num. 1, 1999

ISSUES

29 November - 1 December 1998, Adelaide

This three day meeting was relatively little publicised in the national press, but had an impressive line-up of speakers. Dr John Saunders of the Linden Group, Sydney was Chairman. Speakers at the opening afternoon session, which set the scene were politician, Senator Natasha Stott-Despoja on privacy rights, Professor Grant Sutherland on the human genome project, Professor Phillip Morris on the future of DNA diagnosis and Sir John Maddox on the new genetics. The following 8 sessions were filled with an impressive array of speakers, covering the broad areas of bioethics and genetics very comprehensively.

Gene Technology and Food - 31 March, 1999

This was the 59th meeting of the National Science and Industry Forum, held annually by the Academy, at the National Maritime Museum in Sydney on 31 March.

The subject of the meeting is, of course, very topical at present. In particular, it followed the Consensus Conference on Gene Technology in the Food Chain, held earlier in March. The participants and audience, however, were very different, largely drawn from food companies and/or the scientific community and so well informed on gene technology and its applications. Perhaps this is why there was relatively little contention at this meeting.

Genetically-Modified Foods and Crops

There is a good deal of public interest at present in issues surrounding genetically-modified (GM) foods and crops. Some people have called for a ban on GM foods. Others have called for a moratorium on growing GM crops in this country. Colleagues may find it helpful if we set out the main facts, and the Government's position on them.

Briefing Paper No. 8 of the Task Group on Public Perceptions of Biotechnologyby Prof. Dr Richard Braun, BIOLINK, Switzerland - rdbraun@bluewin.ch

On June 7, 1998, Switzerland voted by a 2:1 majority not to ban genetic engineering. The popular initiative, called the "Gene Protection Initiative (GPI)", had as goals the prohibition of all transgenic animals, the banning of all field releases of transgenic crops and the prevention of patenting certain inventions of biotechnology. Before the popular vote took place, Parliament committed itself to enact a strict regulatory framework, but no bans.

A Roadmap for Commercialisation of Australian Biotechnology Research

This symposium was held in the sumptuous surrounds of the hotel, which forms the centrepiece of Melbourne's casino. Against a backdrop of black marble, chandeliers and the distant swirl of roulette wheels, the most telling comment heard during the lunch break was "that with the turnover of one day's gambling, we could run CSIRO for a year". If that is so, then it was an ideal site for a conference on "A Roadmap for Commercialisation of Australian Biotechnology Research". The conference was supported generously by the government's Biotechnology Task Force (ISR) and Florigene Ltd. There were 13 speakers, a concluding panel session, and a seemingly endless cocktail reception afterwards!

The Company

BresaGen is a South Australian biotechnology company committed to the discovery and commercial development of products derived from recombinant protein technologies. BresaGen's quest for innovation is driven by an integrated network of research laboratories which trace their roots back to the University of Adelaide, where in 1982, the company was created as BRESA (Biotechnology Research Enterprises of South Australia). That strategic core has been carefully nurtured into today's team of 46 employees, 19 with post-doctoral experience. BresaGen has specialists in the fields of biochemistry, molecular biology, embryology, cell biology, chemical engineering and bioprocessing. Its science is supported by a management team whose years of expertise in biotechnology, manufacturing, finance and general management supports the company's mission.

The Battle for Scientific Journals

The April editorial for "Chemistry in Australia" follows. It is reproduced here with the kind permission of the author/editor, Dr Paul Savage, of CSIRO Molecular Science.

"Think about the journals you regularly read or scan in your library. Now choose five you could do without. Now choose another five to cross off your list. Getting difficult yet? Academic and company libraries around the world are cancelling thousands of dollars worth of journal subscriptions in an effort to stay within their budgets. Faced with spiraling journal costs, the proliferation of new journals, and electronic journal formats, most librarians have little choice but to cancel subscriptions to journals deemed dispensable in order to protect key journals.

29 November - 1 December 1998, Adelaide

This three day meeting was relatively little publicised in the national press, but had an impressive line-up of speakers. Dr John Saunders of the Linden Group, Sydney was Chairman. Speakers at the opening afternoon session, which set the scene were politician, Senator Natasha Stott-Despoja on privacy rights, Professor Grant Sutherland on the human genome project, Professor Phillip Morris on the future of DNA diagnosis and Sir John Maddox on the new genetics. The following 8 sessions were filled with an impressive array of speakers, covering the broad areas of bioethics and genetics very comprehensively.

The conference was attended by some 150 people at most sessions. Interestingly, the conference organisers had chosen a `set book' for the conference week for study by the delegates (see page 53 for our book review). "Engineering Genesis - The Ethics of Genetic Engineering in Non-Human Species" by the Working Group of the Society, Religion and Technology Project of The Church of Scotland.

This is an excellent idea, and presumably was included in the registration fees. The conference provided an excellent fore-runner for the Consensus Conference reported elsewhere in this issue. The next Gene Com conference GeneCom '99 is scheduled for September 1999 at the Mosoni Centre in San Francisco.

Further information: genecom@gryphen.com.au

Gene Technology and Food - 31 March, 1999

This was the 59th meeting of the National Science and Industry Forum, held annually by the Academy, at the National Maritime Museum in Sydney on 31 March.

The subject of the meeting is, of course, very topical at present. In particular, it followed the Consensus Conference on Gene Technology in the Food Chain, held earlier in March. The participants and audience, however, were very different, largely drawn from food companies and/or the scientific community and so well informed on gene technology and its applications. Perhaps this is why there was relatively little contention at this meeting.

Appropriately, the initial session covered industry perspectives, starting with Mitch Hooke (Australian Food and Grocery Council) who gave an impassioned address on the opportunities presented by gene technology. Interestingly, he and Bruce Bevan (Australian Supermarket Institute) in the afternoon session were perhaps more aggressively supportive of the use of gene technologies in food than the scientific presenters! Their view was that scientific assessment that a food is safe should be sufficient. Chris Hudson (Goodman Fielder) described how the food industry adopts new technology, often against initial consumer resistance (for example towards food preservation or microwave cooking). He identified three phases for application of gene technology, the first benefiting mainly the producer, the second benefiting the consumer, and the third being the industrial application of plant or animal products.

The scientific overviews were then ably presented by T.J. Higgins (CSIRO: plants), Oliver Mayo (CSIRO: animals) and Noel Dunn (CRC Food Industry Innovation: microorganisms). Although plants are leading the way into the market, advances in all three fields are impressive, as readers of this journal will already be aware. In the afternoon Richard Head's (CSIRO) thoughtful present- ation pointed out that our increased understanding of human nutrition and biochemistry and the role of nutrients in protecting against disease, is making it feasible to predict desirable improvements that gene technology could make to foods.

In a session chaired by Robyn Williams (ABC), Regulation and the Consumer were discussed. Paul Wellings (DISR) reported on progress towards a Gene Technology Office, which continues to be painfully slow. The urgent need for this and for a single food regulatory authority (GMAC, ANZFA, AQIS, NRA and State Departments of Agriculture all currently have a role) are frustrated by the complex bureaucratic decisions necessary and government's apparent incapability of making these.

Consumer attitudes were addressed by Carole Renouf (Australian Consumers Association) who gave a factual report of the outcome of the Consensus Conference, and Katrine Baghurst (CSIRO) who presented extensive and informative statistics from a recent consumer survey covering the use of gene technology in foods. Both reports reinforced the view that consumers would prefer application of gene technology to food to be slower and more cautious that some food companies and scientists would like, and that public education in this area is sorely required. Both the government and scientists need to pay more attention to the latter: as Mitch Hooke observed, "perception is reality", and all scientists should accept their responsibility to communicate their science to consumers, regulators and politicians.

For more detail, refer to the Australian Academy of Science (email: ac@science.org.au) which is preparing a twelve-page summary of the forum.

Genetically-Modified Foods and Crops

1. There is a good deal of public interest at present in issues surrounding genetically-modified (GM) foods and crops. Some people have called for a ban on GM foods. Others have called for a moratorium on growing GM crops in this country. Colleagues may find it helpful if we set out the main facts, and the Government's position on them.
2. The Government's first responsibility is to protect consumers and the environment. The BSE crisis demonstrated how vital it is for Government to act swiftly and effectively on the best scientific advice to ensure that food is safe. That is why we are setting up the Food Standards Agency, and why we have a comprehensive framework in place to regulate and advise on biotechnology, and to assess new products rigorously before they are approved for use. In operating this framework, we take advice from eminent independent scientists. The Government also understands and takes seriously concerns about the impact which GM crops may have on biodiversity. Our responsibility is to ensure that the cultivation of GM crops in this country does not harm our countryside and its wildlife.

Modern Biotechnology

3. Modern biotechnology is an exciting area of scientific advance in which the United Kingdom is a world leader. It offers enormous opportunities for improving our quality of life. In terms of healthcare, biotechnology has already helped to develop better treatments for diseases such as multiple sclerosis, heart disease and diabetes. Biotechnology also has important environmental applications. For example, it is helping traditional industries to clean up their processes to reduce emissions of pollutants.
4. Genetic modification has a significant contribution to make to agriculture. By allowing scientists to alter the genetic make-up of plants by adding or removing specific genes, it has the potential to produce food more efficiently, which is more nutritious, and which tastes better. It also enables the development of crops that benefit the environment because they need fewer pesticides to thrive.

Genetically-modified foods

5. Only a very few GM food products are currently on sale in this country. They are a tomato paste, a type of soya and a type of maize. Although the genetically-modified soya and maize are used in a wide range of processed foods, it is the same two products that are used in each of these foods. Some cheeses and other products are made using enzymes produced from genetically-modified material but the foods themselves do not contain any such material. All of these products have been through a rigorous assessment procedure by the United Kingdom's independent Advisory Committee on Novel Foods and Processes (ACNFP). Although the regulatory procedures governing this area are now determined at EU level this is a relatively recent development. The GM tomato and soya were approved in 1995, and the GM maize in 1996, under what were then national rules. They have also been approved by other member states.
6. The Government's primary duty is to protect people and the environment. That is why we have a comprehensive framework in place to regulate and advise on biotechnology at EU and national level, and to assess new products rigorously before they are approved for use. We are confident that the GM products currently on sale are safe. No new product would be allowed onto the market unless and until it went through this safety assessment, which is set out in EU legislation. If our scientific assessment raises doubts about a product, we will oppose its approval at EU level.
7. All member states, including the UK, must respect final decisions taken at EU level on whether or not to approve a product. Once a food has been granted a licence, it can be marketed in each member state. However, if new information comes to light which calls into question the original approval, a member state can halt the sale of a product while the new information is evaluated.
8. There has been a lot of publicity in recent days about one specific experiment in which potatoes were modified to have pesticidal properties. The debate within the scientific community on the validity and significance of this experiment is continuing. The Government welcomed the decision by the Rowett Research Institute on 16 February to publish additional information on the research, including a report by Dr Pusztai who conducted the experiment. The Government also welcomes the fact that the Royal Societies of London and Edinburgh have been asked to conduct an independent analysis of the research. We must not, however, lose sight of the fact that there are no GM potatoes on the market. And any potatoes (or other foods) which had the effects which those who conducted the experiments believe they had would never be allowed on to the market. It would in any case be scientifically wrong to draw general conclusions about GM foods from this set of experiments.

Labelling of genetically-modified foods

9. The Government accepts that, however safe it is, some people will choose not to eat foods which contain genetically-modified ingredients. We are committed to a full labelling regime that gives people this right. Responsibility for legislating in this area rests with the EU. But we have fought hard in Europe to achieve a comprehensive labelling regime. New rules came into force last September which require all products containing genetically-modified soya and maize ingredients to be labelled. At the moment, foods which contain additives which are genetically modified (such as lecithin which is derived from GM soya) do not need to be labelled. We are pushing in Europe for labelling requirements to be extended to these too. Any genetically-modified foods approved in the future must also be properly labelled. We are now seeking to extend the labelling requirements to cover restaurants and other catering establishments too. We expect these new rules to be in place by May.

Animal feed containing genetically-modified material

10. The Government also understands the concern that any animal feed which contains genetically-modified material should be properly labelled. The decision on this must be taken in Europe. We are pressing hard for it. We are also setting up an Advisory Committee on Animal Feedingstuffs. We plan to announce its chairperson in March.

Genetically-modified crops

11. There have been calls for a moratorium on cultivating genetically-modified crops in this country. No such crops are yet grown here commercially. Some carefully controlled, limited-scale trials are taking place. The Government believes that there is no evidence to justify demands for these to be stopped on environmental grounds - before they proceed they are subject to a rigorous scientific evaluation in this country. Only if we have carefully controlled experiments to give us data can we judge the potential impact which a crop might have on our countryside and wildlife.
12. Like GM foods, before GM crops can be planted commercially, they must be assessed at EU level, on the basis of their impact on the environment and on human health. Any such crops must also be registered under EU legislation governing new crop varieties. There is also a requirement to gain specific approval before using herbicides or pesticides on any crops, including those which have been genetically modified.
13. Should the hurdles all be passed, limited and monitored commercial planting of GM crops may start in the UK next year. We will not allow commercial plantings until all the regulatory hurdles have been passed. When they do, we believe it is important that they are carefully managed and that any impact on the environment is closely monitored. That is why we have reached agreement with the industry on a voluntary code of practice which will strictly limit the first farm-scale plantings of GM crops, and ensure the necessary environmental monitoring. Full-scale commercialisation will not take place until the Government has assessed these studies.
14. Some people have demanded a moratorium on the commercial planting of GM crops. We do not think this is justified. Nor could it be sustained under EU law. If, however, our trials show that some GM crops may have a damaging effect on the environment, we have powers to ban their cultivation in this country.
15. It has been reported that English Nature have advised us to impose a general moratorium on GM crops. This is not the case. Like us, English Nature are concerned to ensure that commercial plantings of GM herbicide-tolerant crops do not harm the environment. They agree that the only way to find out precisely what effects these crops will have is through farm-scale trials. We agree that farm scale trials are essential which is why we have a four year programme of trials. But we believe that the case for permitting commercial plantings should also be considered each year, based on the evidence available to date. We believe it would be appropriate to allow a move to limited and carefully monitored commercial production after, say, one year of farm-scale trials if the evidence was sufficient to demonstrate clearly that the crop would not have a damaging effect on the environment. English Nature would prefer us to set a minimum three-year period for the trials before any crops are commercially cultivated. We believe our approach offers sufficient safeguards to ensure that large-scale plantings do not proceed until we have sufficient evidence that the particular GM crop does not harm the environment. Other EU member states have agreed that in future consents granted by the EU should require companies to follow the approach we have agreed with the industry.

The regulatory framework and consultation

16. The Government recognises that there is public concern about genetic modification. It is a fast-moving science, and we accept we do not always have all the answers. We want to understand people's views. That is why the Prime Minister set up a Ministerial Group last year to oversee developments. And it is why, as a first step, this Ministerial Group commissioned in December 1998 a thorough examination of our regulatory framework for biotechnology. The Government is also carrying out a major public consultation right now on biotechnology.
17. Throughout history, new scientific advances have raised new fears. Some of these have proved irrational; others have proved well-judged. The Government's first priorities are to protect people and the environment. But we must do so in ways that do not deny to our people the healthcare, environmental, economic and other benefits that flow from technological advances. That would be an abdication of the responsibility placed on us.

John Prescott
Jack Cunningham
Frank Dobson
Nick Brown
Stephen Byers

(The signatories above comprise the Deputy Prime Minister and Secretary of State for the Environment, Transport and the Regions; Minister for the Cabinet Office; Secretary of State for Health; Minister of Agriculture, Fisheries and Food; and Secretary of State for Trade and Industry.)

Briefing Paper No. 8 of the Task Group on Public Perceptions of Biotechnologyby Prof. Dr Richard Braun, BIOLINK, Switzerland - rdbraun@bluewin.ch

On June 7, 1998, Switzerland voted by a 2:1 majority not to ban genetic engineering. The popular initiative, called the "Gene Protection Initiative (GPI)", had as goals the prohibition of all transgenic animals, the banning of all field releases of transgenic crops and the prevention of patenting certain inventions of biotechnology. Before the popular vote took place, Parliament committed itself to enact a strict regulatory framework, but no bans.

This was one of the most intense campaigns the country had ever seen for a referendum. Over the last two and a half years the media's intense reporting on biotechnology resulted in a marked increase in public understanding. In a thorough survey, general opposition to genetic engineering decreased from 62% to 33% and acceptance increased from 25% to 39%. Depending on the type of application, the level of acceptance still varied widely at the end of the campaign, with 66% acceptance in favour of medical research and 82% opposition to increasing productivity of farm animals.

The Swiss experience shows that given time, money and ideas, complex societal issues raised by new technologies can be brought to the public's attention allowing informed democratic decisions to be reached. For biotechnology the following lessons can be learned:

• Scientists, government and industry need to collaborate closely and together with other major groups involved such as the medical profession, farmers, food retailers, teachers etc;
• The public is capable of differentiating issues, even if they do not understand the technical details;
• Scientists need to engage in dialogue with different groups of the public in their own language. This needs to be in clear, non-technical terms, including about benefits and costs and also about the public's worries;
• The public has the right to know what the aims of publicly funded research are.

Following the referendum it was suggested by members of the EFB Task Group that it would be useful to analyse this recent debate and draw conclusions from it for the broader European context. This text was authored by the Vice-Chairman of the Task Group, Professor Richard Braun. He was directly involved in the Swiss debate as President of the "Gen Suisse" Foundation, whose aim is to promote science-based public debate on biotechnology.

Legal Background

The Swiss constitution provides various possibilities for citizens to intervene directly in the political process. Proposals for constitutional amendments carrying the signatures of at least 100,000 citizens have to be voted on by the general public. The outcome of a referendum is legally binding and cannot be reversed by parliament or the government. The launching of a popular initiative inevitably leads to public debate on a controversial subject. In this way the GPI contributed to the public's knowledge of this complex subject and the debate clearly had an educational effect.

The Contents of the GPI

The collection of signatures for the GPI was started on May 12, 1992 and completed with about 111,000 names on October 25, 1993. Far more signatures came from Basel and Zürich than from Geneva and Lausanne. The central features of the proposal were three specific bans and a reversal of the burden of proof of usefulness and safety.

The bans included:

1. No transgenic animals should be allowed, not even for biomedical research.
2. The release of all transgenic organisms should be banned, including transgenic crops for farms.
3. The patenting of transgenic plants and animals should be forbidden, also products and processes derived from them. This would have included human therapeutic proteins produced in plants or animals.

Researchers or producers employing methods of genetic engineering would have been required to prove the safety and usefulness of their products or processes, and would have had to demonstrate that no alternative procedure, other than gene technology, could have been used to achieve a specific goal.

Supporters of the GPI and their Arguments

The main supporters of the GPI were diverse environmental groups ranging from Pro Natura to Greenpeace to WWF and to a group called Medical Doctors for Environmental Protection. Further supporters were animal welfare organisations, organic farmers, one consumer group and some NGOs for developing countries. Religious organisations officially had little impact, although two church-affiliated women's groups were active. In the political arena the Green Party and the Social Democrats supported the GPI, although a faction of the Social Democrats were active in the opposing camp. In all, the supporters of the GPI were thought to have had 70 organisations with around 800,000 people on their side from a total Swiss population of 7.2 million (1995).

The arguments for the GPI were based primarily on perceived risks and on ethical grounds. The risks mentioned concerned both human health and the environment. Food produced from transgenic plants was claimed to be a new risk, with the possibility of new toxins or allergens arising through genetic engineering. It was suggested that the environment could be damaged by the release of transgenic plants, which could become weeds, or because of horizontal gene transfer to non-transgenic plants. On the ethical level, it was claimed that intrusions into an animal's genome violated its intrinsic dignity and that patenting of plants and animals was unethical, because they were products of nature. It was claimed that medical research would hardly be affected by the GPI and that the import of gene food such as transgenic maize and soya would be blocked. For some people, who are highly critical of the power of large multinational companies, the GPI was a welcome opportunity to vent their fears. Much of the imagery was based on romantic pictures of farming and the countryside.

Opponents of the Initiative and their Arguments

Early on, opposition to the initiative came from those using genetic engineering as their daily tools, namely researchers in the life sciences.

This led to an alliance of university researchers with the pharmaceutical industry and opened the path for such organisations as the "Gen Suisse" foundation, which started its operation in 1991. Later on, the lobby organisation for the promotion of Swiss industry (Wirtschaftsförderung) led the campaign. All major political parties of the right joined, including the Christian Democrats. Other important partners were the academies, professional associations of scientists and medical doctors, the universities and the National Farmers' Association.

The argument cited most often against the GPI was that its ban on transgenic animals would stop a great deal of medical research. A survey had shown that some 400 projects in Swiss universities involving 2000 scientists were using transgenic mice. The ban was therefore expected to lead to a loss of jobs and a situation where no new jobs would be created by discouraging start-ups and spin-offs, which had become so important in other industrialised countries. It was claimed that pharmaceutical companies would move not only experiments using transgenic animals, but entire research programmes out of the country. The third argument revolved around the quality of university teaching, claiming that Swiss universities would be less able to attract highly qualified researchers who could then not use the everyday tools available to their competitors in other countries. Finally, a further intellectual isolation of Switzerland was feared. The imagery of the opponents of the GPI focused heavily on illnesses and sick people, implying a blow to medical research if the initiative were to be accepted.

Position of the Government and Parliament

Every popular initiative is debated by government and parliament before it is voted on by the public. Both bodies express an opinion and have the right to elaborate a counter-proposal, but they cannot prevent the initiative from being voted on by the public in its original form. The government came out clearly against the GPI without putting forward a counterproposal. In the parliamentary debate, which took place in 1996 and 1997, the left formulated a counterproposal with less severe bans, but still with a clause preventing the patenting of inventions of biotechnology. It wanted to maintain a ban on the release of transgenic bacteria. In the parliamentary debate the counterproposal was turned down, the majority expressing its opposition to the GPI. Parliament therefore recommended the voters to reject the initiative.

Switzerland already has legislation covering genetic engineering, with a framework similar to the directives 90/219 and 90/220 of the European Union. Labelling of food from transgenic crops is mandatory. In the parliamentary debate on the GPI it was decided to look for possible gaps in the existing legislation and fill these in the next two years with a package called "Gen Lex".

In February 1998 the government decided that the vote would take place on June 7, 1998. The time span of the whole process from the collection of signatures to the final vote was six years, a remarkably long period.

The Campaign

The first five months of 1998 may be considered the period of the actual campaign. From January to March the five major German language newspapers each carried on average one article per day on the subject and this figure gradually went up to two articles per day by the end of May (1). In these newspapers there was a shift of the topics away from plants and animals to the impact on medicine and education. Many observers felt during the first half of the campaign that the GPI was going to be accepted. The initiative lost ground mainly in the last two months.

There were many reasons for this change. The proponents of the GPI claim their financial resources became scarce. On the other side, three events initiated by the proponents of modern biotechnology received considerable media coverage, particularly on television. First was a press conference of all Swiss Nobel Prize laureates, even those not working in biology. They decried the loss of research potential, pointing to a probable lowering of standards in the universities. Then came a televised interview with three of the seven federal councillors, explaining why the government unanimously opposed the GPI. Two of these three Federal Councillors actually belong to the Social Democratic Party, which as a party supported the GPI, against their own representatives in the government. Even in the peculiar Swiss political system this kind of split within a party is quite rare. Finally scientists organised their own demonstrations in the streets of Zürich and Geneva: in both cities around 2,000 researchers took to the streets, mostly young people. In all three events industry was not at all in the foreground, although in the final televised debate shortly before the vote the two lead opponents were a parliamentarian of the Green Party and a top executive from Novartis.

The Results and their Analysis

With 41% of registered voters taking part in the decision-making process, 67% were opposed to the GPI and 33% for it. The level of acceptance of the GPI was very low in the French speaking areas of the country, with only 16% to 28% "yes" votes. The highest levels of acceptance were in the mountainous, German speaking cantons with a maximum at 44% "yes". There was not a single canton where the initiative secured a majority of votes (2). However, it is still worth bearing in mind that one in three Swiss is heavily opposed to genetic engineering.

The GFS Research Institute (3) followed the campaign with its own surveys. Some of the highlights have been published in July 1998 and show that public opinion on gene technology changed very considerably over the last 21/2 years.

Figure 1 shows that whereas initially 62% opposed genetic engineering, only 33% opponents remained, while those with a basically positive attitude towards the technology rose from 25% to 39%. (Note that the time scales in Figures 1 and 3 are broken.) Those in favour of general bans decreased from 22% to 12% (Figure 2). The attitude towards the genetic modification of plants and animals varied considerably depending on what the aim was (Table 1). The number of those who say they would not eat genetically modified food has gone down from 62% to 48% (Figure 3). This is remarkable since the proponents of modern biotechnology did not bring food pro-actively into the debate, in contrast to the GPI proponents. It is worth recalling that in this same period the first few food items made from transgenic crops ap peared in the supermarkets, pointing to the actual existence of these materials. The GFS analysis found a positive correlation between optimism for biotechnology and both educational and economic status. To give an example, only 22% of the highest income group voted for the GPI, whilst 49% of the lowest income bracket favoured it. Finally, the credibility of medical doctors, scientists, the government and industry went up in the course of the campaign and that of environmentalists and animal protectionists went down correspondingly.

What are the Lessons?

Whilst the preceding paragraphs attempt to give an objective picture of the events, an interpretation is necessarily biased. It may be noted that the author was involved on the side opposing the GPI.

One may wonder whether the experience gained in one country debating the pros and cons of a new technology will help understand or predict the process in another. Although every country in Europe has its own social and political traditions, secular changes like individualism, the spread of democracy and liberalism took place everywhere. In addition, in the case of Switzerland with its mixed cultures, both Latin and Germanic elements of tradition come into the debate. So some generalisations, applicable to other countries, would therefore appear justified.

Knowledge of modern biology is an important basis for accepting modern biotechnology. Many studies have shown that optimism towards biotechnology increases with factual knowledge (4). The more different sources spread the same reliable information, the more credible it becomes. In this campaign quite similar factual information was transmitted by the academies, universities, lobby groups, industry etc., always from a different source.

Claims of dangers by those opposing biotechnology were immediately followed up by scientists and their findings published as "shoot-backs". It was found important to have a network with quick information exchange: to this end a closed e-mail circle was found efficient. One good example is the debate on allergies. The opponents of biotechnology (ie the proponents of the GPI) initially claimed that transgenic crops raised specific risks of new allergies: by following the scientific literature it became clear that this claim was ambiguous and misleading, and that some allergens were even removed from plants by genetic engineering. After this, the proponents of the GPI no longer brought up allergenicity as an argument against genetic modification of crops. In fact they moved more and more from concrete, scientific arguments to fuzzy, quasi-ethical arguments, for example that it was against the nature of an animal to have its DNA interfered with (although this is done all the time with traditional breeding).

Coalitions are essential for bringing about political changes. The same holds for making people change their mind about costs and benefits of new technologies. It helped the opponents of the GPI to have a majority of medical, patient and farming organisations on their side, in addition to virtually all laboratory scientists as well as the government and its agencies. Other public organisations were divided in their views, such as consumer groups, environmental and women's organisations. A strong leadership in the coalition proved important. The opponents of the initiative appeared to be more of a coherent group with well orchestrated, complementary messages and they had considerable financial backing. The opponents of the GPI managed to shift the emphasis of public perception from protection of Man and his environment to prohibition of research and medical progress.

Decisions on complex issues are made at different levels by people. Scientists tend to feel that rational thinking is the main or even decisive factor. As both sides realised during the campaign, emotional factors are important too. For this reason proponents and opponents both used emotional images, a beautiful picture-book countryside or a sick child sitting on a hospital bed. Scientists may be reluctant to use advertising techniques, but in order to be successful this is essential. The problem in using emotional strategies is how far to go: an excess of emotionality may be damaging to credibility.

Finally, acceptance and understanding need time to develop along with familiarity of products and services. The small increase in acceptance of food from transgenic crops, as described above, may come in part from the fact that last year the National Health Service authorised the sale of soya and maize from transgenic crops. This and the appearance of GMO-products on the shelves of supermarkets will presumably lead consumers to consider these products "normal". It must also be said that this state of "normality" will be reached more quickly if producers bring products onto the market that have obvious added value to the consumer.

In conclusion, understanding and acceptance of modern biotechnology can be promoted by a well-orchestrated public campaign, using very different carriers to convey the message. Scientists need to acknowledge their obligation to the general public and be willing to debate the broader issues of science and society. The dialogue has to be based on solid science and must not shy away from discussing both costs and benefits as well as pointing out what would happen if the new technology were not used.

Popular Initiative "for the Protection of Life and the Environment from Genetic Manipulation (Gene Protection Initiative)". On June 7, 1998, Swiss voters could say "yes" or "no" to the following text:

The Federal Constitution will be amended as follows: Article 24 decies (new)

1. The Confederation issues regulations against abuses and dangers arising from genetic modification of animals, plants and other organisms. It thereby takes into account the dignity and integrity of living beings, the conservation and utilisation of genetic diversity as well as the safety of human beings, animals and the environment.

2. It is forbidden to

1. Produce, purchase and transfer genetically modified animals;
2. Release genetically modified organisms into the environment;
3. Patent genetically modified animals and plants, as well as their constituents, the procedures employed thereby and the products obtained.

3. The legislation specifically regulates

1. Production, purchase and transfer of genetically modified plants:
2. The industrial production of compounds using genetically modified organisms;
3. Research on genetically modified organisms which may constitute a risk to human health or the environment.

4. Legislation specifically requires from an applicant the proof of usefulness and safety, the lack of alternatives as well as an explanation of ethical responsibility.

(Translated from the German text by Richard Braun, 28.7.1997)

Table 1: Percentage of those in favour of using genetic engineering for specified purposes in animals and plants (May 1998):

References

1. Press release, 1 July 1998, Institute for Sociology, ETHZ, Prof. Christian Sutter, Dr Christophe Glauser, Dr Thomas Oertli (Fax: +41 1 632 1054)
2. Neue Zürcher Zeitung, 8 June 1998
3. GFS Forschungsinstitut, Claude Longchamps, Hirschengraben 5, CH-3001 Bern, Fax +41 31 0819, http://www.gfs.ch
4. Eurobarometer 46.1, The Europeans and Modern Biotechnology, European Commission DGXII, 1997

For further information please contact:
Prof Dr Richard Braun, Bio-Link, Enggisteinstraße 19, CH-3076 Worb, Switzerland Tel: +41 31 8320000; fax: +41 31 8320000; email: rdbraun@bluewin.ch
Dr Françoise Bieri, BICS, Clarastraße 13, CH-4058 Basel, Switzerland Tel: +41 61 6909321; fax: +41 61 6909315; email: bierif@ubaclu.unibas.ch

Reproduced by kind permission of the author.

A Roadmap for Commercialisation of Australian Biotechnology Research

This symposium was held in the sumptuous surrounds of the hotel, which forms the centrepiece of Melbourne's casino. Against a backdrop of black marble, chandeliers and the distant swirl of roulette wheels, the most telling comment heard during the lunch break was "that with the turnover of one day's gambling, we could run CSIRO for a year". If that is so, then it was an ideal site for a conference on "A Roadmap for Commercialisation of Australian Biotechnology Research". The conference was supported generously by the government's Biotechnology Task Force (ISR) and Florigene Ltd. There were 13 speakers, a concluding panel session, and a seemingly endless cocktail reception afterwards!

The first morning session was devoted to the constraints in commercialisation experienced by universities. Papers were presented from Monash University (Peter Darvall) and from the University of Queensland. David Evans (from Uniquest) spoke of the Queensland experience, and likened it to "kissing more frogs more often", both on the demand side (the research workers or the princes) and on the supply side (the entrepreneurs, financiers, companies or the princesses). The University had now linked several different offices together and ensured cooperation. Technology transfer now involved :

• Office of Research Services
• Uniquest Ltd (IP and R&D management)
• Executive Deans' Offices
• University Corporate Office

These worked in unison, ensuring that, for example, student IP and its assignment was granted correctly, and that the future research pool size was large enough.

Evans emphasised the need to nurture both the supply side and the demand side, and then marry them up.

His talk was followed by Fiona Nicholson, from a Scottish law firm, who discussed the protection of university IP from a British perspective. She raised a number of real difficulties facing university staff when they became involved in commercialisation, eg. who is going to teach, when a lecturer starts a spin-off company? She also emphasised the importance of considering the IP rights of postgraduate students, and not just those of the lecturing staff. Nicholson described an LES survey on "the ownership of IP in academia and research" and showed preliminary international data on this which is emerging.

Cathryn Campbell, partner in a Californian patent firm, illustrated her talk with two examples. The Stanform University patenting of the Cohen Bayer invention of transfecting a cell with an exogenous gene (US Patent 4 470 470). Stanford did the licensing of this process by offering early sign-up incentives worldwide, and avoided litigation by keeping fees really low. This patent resulted in $200M royalties, and demonstrated that it is possible to get a really big royalty payment.

Her second example was Labner (US Patent 5 233 409) held by Diax concerned a library of transfected cells. She showed that it was possible to benefit from "using a method which is licensed".

George Jessup (Startup Australia) concluded the morning session with a talk on venture funding for start-ups. He discussed the different types of early stage agreements and their advantages and disadvantages ie. Research Agreement, Licence, or Company Formation. He went on to describe very clearly the role of a venture capital company in seed funding, in start-ups and to existing companies. He provided a very clear guide to the audience on factors involved. He concluded that the broad aim was to retain the value in Australia, rather than lose that value by multi-national licensing (the easy path).

The afternoon session was started by John Raff, who described three start-ups with which he had been intimately involved in the agro food area - Starpharma, Dovuro and Nutrihealth. His two key points were that personal agreement is exceedingly important, and overrides any legal agreement between parties, and that farmers should avoid getting entangled in trendy biotechnology stuff. Rather, they should go towards being farmers with an exclusive supply contract to a firm.

Ralph Nixon from Technico Ltd, who supply potato tubers to the breeders market, spoke about the absolute need to provide a reliable supply of quality product to market on time.

Technico basically held technology which reduced the time taken for new potato breeds to reach the supermarket from 7 years to 3 years. He described how the company had linked itself to other groups oversease in China, Thailand, India and USA in a very strategic way with the major partner being Fritoley (USA and Mexico).

Edwina Cornish, from Florigene Ltd and an earlier ABA Director, spoke of the development of Florigene in the cut flower business, and of its niche in the flower trade being to provide specific colours in flowers by genetic manipulation. Florigene's story includes its links with a subsidiary in The Netherlands, and a joint venture with Suntory in Japan. The world cut flower market is about $40 billion retail with over $40 per capita per annum being spent in Japan, USA and Europe. Cornish described the lessons learnt so far as being:

• no substitute for being in the market
• commercial partnerships
• internationally competitive research bases
• shared ownership of goals/horses for courses
• importance of people in the company, and the need for succession in leadership as the company evolves.

Joe Hlubucek, of the Biotechnology Task Force, ISR, then described the activities and aims of the taskforce so far.

• Australian Biotechnology Report (due for release October 1999) (a joint Ernst and Young and BTF effort)
• Public awareness program
• A strong presence at Bio's Californian meetings this May
• Plans for Biotechnica 99 Hanover _ October 1999
• The new Australian biotechnology directory, ready for release in May 1999 on line and as a CD-ROM
• The formation of Biotech Action Agenda (to report by December 1999)
• A Biotechnology Issues Paper, to be distributed in May 1999 in draft form for stakeholder consultations. It has been prepared in consultation with the newly-formed Biotechnology Consultative group and all Commonwealth departments.

He noted that readers can see the proceedings of the biotech venture capital forum held on 14 December 1998 (in conjunction with ABA and AVCA) on the internet at www.isr.gov.au/biotaskforce

David Wyatt (Novogenesis) described the formation in Southern Queensland of the QBIO cluster, which he likened to the Silicon Valley cluster for the electronics industry. The bioindustries emerging in SE Queensland have the support of the development authorities and also the Premier. This is leading to good support for :

• Institute for Molecular Biosciences, UQ ($100M centre being built)
• Queensland Pharmaceutical Research Institute (QPRI) (a joint venture of Astra Pharmaceuticals and Griffith University)
• Several new medical research centres.

Wyatt emphasised the need for such a vision, if we are to succeed in Australia in the future.

Ian Lowe was the final speaker for the day, and his role was to place biotechnology commercialisation in a broader economic/innovation future context. He lambasted the vision of our leaders, their attitude to innovation, to proper reward of scientists, and their old-fashioned backward looking views. This needed to be changed, he said, if we are to maintain our independence, and our integrity in the future. However, for change to occur, it requires :

• Discontent (eg reward structures, tax policies)
• Vision (sell the vision of science)
• Viable path (practical alternatives proposed)
• Commitment to the change.

Finally, he emphasised the need to interpret the science for the news reporters, and for all scientists to be active in getting their message across. The Conference closed with this optimistic and futuristic view of biotechnology in the next century.

The Conference was chaired by Drs Graham Mitchell and Shirley Lanning. The organising committee was led by Elane Zelcer and did a great job in procuring such a well balanced mix of good speakers, and a full house of delegates.

The Company

BresaGen is a South Australian biotechnology company committed to the discovery and commercial development of products derived from recombinant protein technologies. BresaGen's quest for innovation is driven by an integrated network of research laboratories which trace their roots back to the University of Adelaide, where in 1982, the company was created as BRESA (Biotechnology Research Enterprises of South Australia). That strategic core has been carefully nurtured into today's team of 46 employees, 19 with post-doctoral experience. BresaGen has specialists in the fields of biochemistry, molecular biology, embryology, cell biology, chemical engineering and bioprocessing. Its science is supported by a management team whose years of expertise in biotechnology, manufacturing, finance and general management supports the company's mission.

In parallel with its core scientific strengths, BresaGen continues to build a manufacturing base for the production of recombinant proteins. This base is strengthened by a growing expertise in regulatory compliance with Good Manufacturing Practice. From its earliest days, the company recognised the benefits of establishing external links to complement its core capabilities and streamline the development process and successful partnerships have been set up with industry, as well as with groups in Universities and Research Institutes, in Australia and abroad.

The company is structured around two divisions, Protein Pharmaceuticals and Transgenics. The Protein Pharmaceutical division has established cost-effective technology to express and purify recombinant proteins on a large scale, using a proprietary bacterial expression system. The division's aim is to develop and manufacture novel human and veterinary biotherapeutics for sale in the Asia-Pacific region, and to sell into additional territories in collaboration with other biopharm-aceutical companies. The Transgenics division focuses on research in the field of mammalian transgenic and cloning technologies. This division's efforts have resulted in a proof of concept demonstration of genetically enhancing growth rates and carcass quality in pigs through the introduction of additional copies of the pig growth hormone gene. The division operates at the leading edge of the application of molecular biology and cell and reproductive biology.

Human Therapeutics

BresaGen's lead product candidate, a recombinant GM-CSF antagonist is currently in Phase I trials at the Royal Adelaide Hospital. The drug is being evaluated as a therapeutic for myeloid leukemia and as adjuvant therapy in the treatment of some solid tumours such as breast cancer. It also has the potential to act as a therapeutic in the treatment of other diseases involving cells that express the GM-CSF receptor, including rheumatoid arthritis and asthma.

Other products at various stages of research and development include human growth hormone, for adult growth hormone deficiency, and an IL-5 antagonist, which has the potential to treat allergic diseases such as asthma.

Veterinary Therapeutics

The company's lead animal product, EquiGen Injection, was registered in Australia in May 1998 and has been enthusiastically received by the veterinary community both in Australia and in several South East Asian countries where it is currently being marketed. EquiGenTM is registered as a prescription animal remedy for improving nitrogen balance in aged horses and contains as its active ingredient equine somatotropin (eST), commonly known as equine growth hormone. It is a synthetic copy of the naturally-occurring equine growth hormone molecule produced using recombinant DNA technology. BresaGen first produced eST in 1993 and have undertaken several key clinical trials to examine its safety and efficacy in horses.

Clinical studies conducted so far with leading equine scientists in Australia and overseas indicate that eST is a safe, naturally-acting anabolic /anti-catabolic agent. One series of clinical trials undertaken in collaboration with Rutgers University (New Jersey, USA) investigated the effectiveness of eST as an anabolic for aged horses.

The data from these studies, used to support the Australian registration submission, demonstrated that nitrogen balance, food digestibility and nutrient utilisation were all improved. Plasma urea nitrogen was decreased by eST treatment indicating an anti-catabolic effect on nitrogen metabolism. Musculation was clearly enhanced as was overall body condition and animal well-being.

Based on the published effects of somatotropins in a number of other species, it is predicted that EquiGen may have a range of potential therapeutic applications. Some of these are currently under investigation, including accelerated and improved soft tissue healing, assisted recovery from musculoskeletal injuries, improved body condition in debilitated horses and improved mare fertility.

Veterinary product development continues with studies on the use of canine somatotropin for improved healing of fractures and lactation promotion.

Research

The Transgenic Division conducts research which currently centres around the production of genetically modified pigs whose organs, e.g. hearts and kidneys, are suitable for transplant into humans (xenotransplantation). BresaGen's current xenotransplantation program is conducted in collaboration with St. Vincent's Hospital, Melbourne, and is funded through an R & D syndicate. As part of this program, cloning technology is being developed which will also enable genetic manipulation of pigs by eliminating, or `knocking out' genes in the pig genome. The development of cloning technology in pigs could also have agricultural applications. It would allow pig producers to obtain large numbers of identical individual pigs derived from current best stock. Availability of cloned animals will substantially speed up the process of transmitting their current best genetics from breeding herds into production herds.

The Battle for Scientific Journals

The April editorial for "Chemistry in Australia" follows. It is reproduced here with the kind permission of the author/editor, Dr Paul Savage, of CSIRO Molecular Science.

"Think about the journals you regularly read or scan in your library. Now choose five you could do without. Now choose another five to cross off your list. Getting difficult yet? Academic and company libraries around the world are cancelling thousands of dollars worth of journal subscriptions in an effort to stay within their budgets. Faced with spiraling journal costs, the proliferation of new journals, and electronic journal formats, most librarians have little choice but to cancel subscriptions to journals deemed dispensable in order to protect key journals.

The force driving journal price increases is of course profit, a relatively new phenomenon in academic publishing. Traditionally, most academic journals were published by scholarly societies and university presses. However, during the past 10 to 15 years, while scholarly societies have retained editorial control and peer review most journal production has been turned over to commercial publishers. Like all commercial companies, these publishers have a duty to their shareholders to increase profits. Libraries are obliged to pay the price the publishers ask for the journals that their patrons demand. To compensate, libraries cancel subscriptions to non-key journals and try to rely on interlibrary loans to remain within budget. Publishers see their subscriber numbers fall and, to maintain or increase their revenues, they raise the subscription prices still higher.

The irony in this scenario is that nearly every element in the creation and publication of research information is highly subsidised. The research is often supported with government grants from taxpayer dollars. The papers are written in university offices and manuscripts sent off using institutional mail services. Researchers use their employers telephones, fax machines, e-mail accounts, and time to participate in the peer review process, which they do at no charge. Commercial publishers exploit this almost-free source of material and then turn around and gouge the hand that feeds them. Amazingly, some journals even *charge* the author to publish their research, while almost none pay.

Will the advent of electronic journals fix this problem? Probably not. Indeed, libraries are now often faced with paying twice for the same literature: once for immediate access in electronic format, and once for the archival record in print. Forgoing the print version, a direction in which some of the premier research organisations in Australia are heading, is a disaster in waiting for chemistry since the archival electronic record will surely be inaccessible to future generations (hands up who still has a microfiche reader). Chemistry literature, perhaps more than any of the scientific displines, retains its value forever. A procedure published in 1920 still works just as well today.

One attempted solution to this gloomy scenario is the formation of the Scholarly Publishing and Academic Resources Coalition (SPARC), a collaboration designed to produce a series of peer-reviewed, competitively-priced journals. For example SPARC and the Royal Society of Chemistry will jointly publish a physical chemistry journal called PhysChemComm, which will cost $353 and will compete directly with Chemical Physics Letters, an Elsevier Science journal priced at more than $8000.

Tenure and merit pay decisions frequently hinge on publishing. Scientists usually decide where to publish a research paper based on the perceived prestige of the journal rather than the publisher or the subscription price of the journal. Perhaps it's time, in the interests of preserving our own long-term access to the chemical literature, that we become more discriminating in where we choose to publish our research. Next time you are deciding where to submit your paper consider whether your best interests are served by giving your work to a commercial publishing house or supporting a learned society journal such as ACS and Royal Society journals, or better still, Aust.J.Chem."

Copyright 1999 Australian Biotechnology Association Ltd.