PO Box 155,

Kensington Park, SA, 5068

Australia

The Ethics of Safety

Submission
to the
Victorian Government
on
Ethical Principles to Guide Biotechnology

January, 2005

1. Introduction

The Institute of Health and Environmental Research Inc. (IHER) is a not-for-profit research institute with an interest in genetically modified (GM) organisms, particularly those destined for food. Its directors hold the following degrees: ordinary degrees in Medicine, Science and Agriculture, Honours Degrees in Agricultural Science and Organic Chemistry, a Master of Public Health, and PhDs in Plant Genetics and Medicine. The Directors have training and expertise in plant science, agriculture, medicine, chemistry, biochemistry, nutrition, epidemiology and biostatistics. Our website can be found at www.iher.org.au.

2. Background to this submission

Traditionally, scientists were generally free from commercial considerations of their work. They wrote their discoveries in scientific journals for others to see, repeat and extend. However, in the last few years in Australia, there has been a push from the Federal government to reduce funding to universities and other research institutions such as the CSIRO and to encourage these bodies to act like businesses. Consequently, such bodies now routinely seek funds from other sources, such as commercialising their research directly through in-house commercialisation bodies and by conducting research with or for corporations. Scientists and research organisations are encouraged to patent discoveries for commercial gain and scientists are encouraged to forge partnerships with corporations to further research and bring in more money. As a result, business interests strongly influence much of the research agenda in Australia. However, the prime responsibility of a business is to make a profit and hence to return money to its shareholders. If it doesn't do this, it doesn't survive. All other responsibilities necessarily come second, including wider social responsibilities. In summary, much of the research agenda in Australia is being driven by commercial, profit-making considerations ahead of wider scientific, environmental or social considerations. This is particularly the case in research areas where there is considerable money to be made, such as biotechnology.

For money to be made from a given biotechnology, a business plan needs to be drawn-up, including a marketing plan. Marketing involves selling the positives of the product while down-playing the negatives to the public, governments and regulatory bodies. Recent experience with several pharmaceutical drugs shows that this has included with-holding adverse findings, resulting in harm to the public. It is also in the interests of the business to argue for minimal regulation and to have affiliated people on regulatory bodies. These have already occurred with one form of biotechnology: GM foods. Consequently, governments and regulatory bodies are lobbied by vested interests with only the positives of a new technology. However, there is always an opposing point of view and for biotechnology, it often involves the safety of the new technology. This is an important view as one of the first considerations of science should be to first of all, do no harm. Yet this view usually takes years to be heard as volunteers take time to organise themselves and their position, by which time much of the regulatory framework has usually been established. In addition, any effective opposition to a science-based initiative generally requires scientists to publicly state their opposition. However, as most scientists now work for organisations that get funding from industries, they are increasingly reluctant to bite the hand that feeds them or their organisation. Some scientists that do speak out are warned-off continuing, or publicly ridiculed, as has happened in the GM food debate.

Biotechnology is potentially one of the most powerful tools we have used. It has the power to do immense good, but also immense harm. For example, a GM food released into the environment is a self-replicating organism that can never be recalled or completely removed from the food supply, even if it is later found to cause substantial ill-health. Thorough safety assessments of any biotechnology, done before commercialisation, are therefore profoundly important. Biotechnologists and biotechnology companies cannot be entrusted to do this, first, because they will always have a conflict of interest in assessing the safety of something they need to market to return their investment. Thorough safety assessments take time, money and may give unwanted results. Second, biotechnologists generally have little or no training or experience in public or environmental health and hence cannot properly assess the effects of their product on these. Safety assessments should be done by a panel of experts in health, public health and environmental health with no affiliations to biotechnology industries, taking a very long term view of the potential harm of these powerful new technologies. Procedures need to be put in place to do this.

3. Recommendations

• The first aim must be to do no harm to humans or other species. Given the power of biotechnology, a safety-first, or �better to be safe than sorry� approach should be used. The Precautionary Principle should be applied. Safety assessments should be conducted by a safety assessment advisory committee of experts in human, animal, public and environmental health who have no affiliations with biotechnology industries. This committee should have the power and financial resources to order or commission research to elucidate the safety of the biotechnology and to reject any it finds to be less than safe. For biotechnology destined to be used on or by humans, thorough animal safety testing should be done, followed by the four phases of a clinical trial. The clinical trial is the gold standard to determine efficacy and safety. Environmental assessments should use generally-accepted definitions of the environment, rather than the very limited definition used by the Office of the Gene Technology Regulator (OGTR). When assessing safety, broader and unintended effects should be assessed. If approved, the biotechnology should be monitored for effects to the health of humans and other species.


• Biotechnology must serve the public interest, not the agenda of scientists, corporations or commercial interests, nor be used for destructive, oppressive or aggressive ends. Strong guidelines should be established to ensure these. Scientists and corporations should be made legally liable for any negative consequences of their research or products. The safety assessment advisory committee should assess whether research and products derived from research are safe, ethical and contribute to the public and environmental good, as well as advancing science. Public money spent on biotechnology should be audited against these criteria.


• The touted benefits of a biotechnology should be assessed by a panel of independent experts to find the truth in the marketing material.


• As knowledge belongs to the community and cannot be privately owned, the knowledge that is gained from or during biotechnology research should be owned by the public rather than by private individuals or corporations. This includes knowledge obtained from indigenous peoples.


• Living organisms or their parts (including cells, cell lines and genes) should not be patented. Not only do many people have ethical difficulties with these patents, but they also tend to fuel a �gold rush� mentality in researchers to commercialise findings while often making the patented material too expensive for other researchers to freely use, hence slowing-down the rate of follow-on research.