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Monday, 2 December 2002
Page: 6918


Senator PATTERSON (Minister for Health and Ageing) —On 19 November 2002 (Hansard page 6451) Senator Stott Despoja asked me the following questions on Pharma-Foods:

My question is addressed to the Minister for Health and Ageing and continues on from my question yesterday about pharma-foods. Given there are several biopharmaceutic companies in Australia—including the federally funded CRC for bioproducts—that are actually conducting research on pharma-foods, can the Minister tell us if the Government has any protocols or measures in place in relation to biopharmaceutical research and the potential application, sale and use of those technologies and techniques? Specifically, can the Minister assure us as to what the Government is doing to make sure that the technologies and techniques are not used for illicit purposes, such as the production, sale and consumption of illicit drugs or drugs that would otherwise require a prescription? Also, can we find out what the Government is doing to ensure that the technologies that are being developed are not used by organisations for terrorism purposes?

I ask a supplementary question. I thank the Minister for the offer, again, to take it on notice. I ask when the Minister believes when she will have that information available for the Senate, and if she can include information as to what exact research is taking place in relation to biopharmaceuticals in Australia, particularly in relation to those that are receiving federal funds through the CRC. Can the minister also undertake to advise the Senate when protocols and measures will be in place, as well as her analysis as to whether the Gene Technology Act and the former ANZFA regulations are appropriate? I think that the Minister should have at least known by today what applications were available. I look forward to hearing from the Minister.

I will incorporate the answer to the senator's questions of 18 November 2002, into the answer to the questions of 19 November 2002.

There have been recent media reports highlighting concerns about so-called “Biopharming” in the United States. Biopharming is an outgrowth of genetic engineering where scientists insert genes that instruct a plant to make a specific chemical compound. By introducing novel genes, plants are in effect turned into pharmaceutical factories that express the desired drug in their leaves or seeds or fruit. This is seen as a potentially cheaper way of manufacturing vaccines and drugs.

In Australia, the Gene Technology Act 2000 (the Act) provides for the regulation of genetically modified products. The object of the Gene Technology Act 2000 is to protect the health and safety of people, and to protect the environment, by identifying risks posed by, or as a result of, gene technology and by managing those risks through regulating certain dealings with genetically modified organisms (GMOs). The Act commenced on 21 June 2001.

The term `deal with' a GMO is widely defined under the Act to mean: conduct of experiments; produce or manufacture; breed; propagate; manufacture, culture and includes the possession, supply, use, transport or disposal of a GMO. Thus, genetically modified (GM) biopharmaceutical research and associated activities involving GM plants and animals are subject to the Act.

Dealings with GM biopharmaceuticals that involve intentional release to the environment are prohibited under the Act unless they are licensed. No field trials involving a pharmaceutical-producing GM food crop have been approved in Australia. Any organisation that wishes to conduct a field trial or undertake a commercial release of a GM biopharmaceutical must apply to the Gene Technology Regulator (Regulator) for a Dealing involving Intentional Release licence for the genetically modified organism of concern. To be eligible to apply for a licence an organisation must first be accredited by the Regulator under the Act. A key criterion is having, or having access to, a properly constituted and resourced Institutional Biosafety Committee.

For every application, the Office of Gene Technology Regulator (OGTR) prepares a comprehensive risk assessment/risk management plan (RARMP). The preparation of this plan involves consultation with the States and Territories, the Environment Minister, prescribed other Commonwealth agencies, such as Food Standards Australia New Zealand, the Gene Technology Technical Advisory Committee, and relevant local councils. The RARMP, including draft licence provisions, is then released for public consultation. Industry and the public are invited to make submissions to the OGTR. Following consideration of all submissions, the Regulator makes a decision whether or not to grant the licence, with or without conditions.

A commercial release of a GM biopharmaceutical would not be contemplated unless there had been extensive field trials under limited and controlled Australian conditions. A key feature of the trials would be to demonstrate whether or not there are any risks posed to human health and safety and the environment could be managed in the Australian context.

To date, the Regulator has not received an intentional release (trial or commercial) licence application for a GM biopharmaceutical.

GM biopharmaceutical research that does not involve the intentional release of a GMO into the environment is required to be notified to the Regulator by the Institutional Biosafety Committee. Such research must be conducted in a physical containment facility (eg. laboratory or glasshouse) certified by the Regulator for that purpose under the Act.

There have been approximately 1700 notifications to the Regulator of which only a very small number involve GM biopharmaceutical research.

Some examples of contained research work currently underway include joint research by the Queensland Department of Primary Industries, the Queensland University of Technology and University of Southern Queensland who have been working on developing vaccines in plants for oral delivery in edible plants. The Bureau of Sugar Experimental Stations has been working on developing biodegradable plastics from sugarcane, and Murdoch University has been working on producing proteins to control rabbit infertility in grains and legumes. Also, Genetics Australia, Monash University and the Department Natural Resources and Environment have been working to produce GM calves with an extra bovine casein gene to produce more protein in milk at proof-of-concept stage with prospects to substitute other proteins.

The Co-operative Research Centre (CRC) for Bioproducts has a focus on developing commercially valuable materials produced by plants and other living organisms. The research includes a project “Biopharmaceuticals” which evaluates the potential of emerging biopharmaceutical technology based on plant cell culture. Further information in relation to biopharmaceuticals receiving funding through the CRC for Bioproducts would be available from the Department of Education, Science, and Training.

A dealing with a GM biopharmaceutical involving intentional release to the environment without, or in contravention of, a licence is a criminal offence. In the case of an aggravated offence, the penalty is 5 years prison or $1.1 million per day fine. For a lesser offence, the penalty is 2 years prison or $55,000 per day fine. In some instances the offences are based on strict liability.

In respect of gene technology being used for terrorism purposes, the Regulator has extensive enforcement powers under the Act. These powers relate to searches and seizures related to offences, to search premises and anything on the premises for evidential material, and emergency powers for dealing with dangerous situations. In addition, the Act empowers the Federal Court to issue injunctions, and also contains a forfeiture provision.

With regard to the approval of GM biopharmaceutical products for human consumption and sale, the Gene Technology Act only providesapprovals where no other statutory product approval authority exists. In regard to any Pharma-Food products wishing to make a medicinal claim such as a vaccine prevention or protection claim, such claims and the safety, quality and efficacy of the product would need to be evaluated by the Therapeutic Goods Administration to assess quality, safety and effectiveness, before they may be supplied or marketed in Australia.

If an organisation wished to market their products as foods they would be regulated under the Food Standards Australia New Zealand Act 1991. In relation to the safety of pharma-foods, both the modified animals and crops used to produce such foods and the foods thus produced, must be fully compliant with the requirements of the Food Standards Code, prior to being sold in Australia. The relevant standards include, not only all those applicable to conventional foods, but also the recently adopted Standards governing genetically modified foods and novel foods. The latter two Standards require that all genetically modified and novel foods undergo a rigorous scientific assessment and must be at least as safe as the conventional counterpart foods.