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Monday, 28 August 2000
Page: 19449

Mr GRIFFIN (6:25 PM) —The Gene Technology Bill 2000 will establish the Commonwealth component of a national scheme designed to regulate dealings with genetically modified organisms. It is expected that, following the passage of this bill, the states and territories will pass complementary legislation. I welcome this bill. It has been a long time coming. Aside from the fact that this type of regulation was first discussed in 1992 as part of a major inquiry into genetic manipulation, we have recently seen two examples of GM breaches that illustrate why legislation rather than administration is the only way to instil public confidence in this technology. I will say more about these later. Gene technology promises much. As a result of this technology, we have new, improved vaccines and for diabetics we have human insulin. In the future, doctors will be able to tailor drug therapy to the individual, leading to fewer adverse events and better outcomes. Pharmaceutical companies are working together with specialist genetic technology companies to identify genes that cause diseases, tests to identify those diseases at an early stage and, finally, drugs to treat those diseases. In agriculture, the public benefits of this technology are unfortunately a little less obvious, although much of the early agricultural technology has shown some benefit for producers and it is expected that developments such as golden rice, which has been enriched with vitamin A, will start to come on the market in the next few years.

Despite these potential benefits, the Australian public remains wary of this new technology, and with good reason. There is no better example of this concern than the recent debate about labelling of genetically modified foods. Poll after poll has shown that the vast majority of Australians want all genetically modified food labelled. This does not indicate that they do not or will not eat the food. The same polls show that there is a minority who would not. But they want to make an informed choice about what they eat and when. Yet, despite this public view, the Prime Minister has tried on several occasions to pressure the group responsible for setting the labelling standards, the Australia New Zealand Foods Standards Council, into watering down the labelling regime. Considering that our Prime Minister is well known for delivering poll driven policy, this behaviour is somewhat puzzling. Given his recent attacks on the United Nations for commenting on Australian issues, I would be interested to know why international views on how we label our foods are any different and require his misguided intervention. Luckily, as we know, the Prime Minister and the Commonwealth were rolled at the last ANZFSC meeting, and Australia will now have the regime that the public demanded—comprehensive and mandatory labelling.

To understand the genesis of this public reticence towards things genetic, we need to go back to the early 1990s and look at how the issue relating to the contamination of British beef by mad cow disease was handled by regulators and scientists in that country. Mad cow disease, better known as bovine spongiform encephalopathy, is a prion disease that affects cattle. It is a slow, progressive neurological disorder that is ultimately fatal. There is no treatment for BSE. In the early 1990s, it emerged that 0.3 per cent of British cattle were infected by BSE as a result of eating feed containing sheep offal that was infected by scrapie—also a prion disease. The early advice from government regulators and leading scientists was that there was no risk to human health from eating infected meat and that although the disease could move from sheep to cattle it could not be spread to humans. Over the next few years it was revealed that a number of farmers and workers exposed to the infected meat developed Creutzfeldt-Jakob disease—CJD—the human variant of BSE. It was not until 1996 that the CJD surveillance unit identified a previously unrecognised and consistent disease pattern amongst the growing number of people diagnosed with CJD. Even then, the committee concluded that:

Although there is no direct evidence of a link, the most likely explanation is that those cases are linked to the exposure to BSE.

There are now at least 69 people in Britain with CJD and, as symptoms of this disease often do not show for 20 years, there may be many more living with this death sentence. Is it surprising, then, that when scientists, academics and government bodies insist something is safe the public are sceptical? After the BSE disaster, who can blame them?

While this example is probably the most recent and the most high profile, the history of such breaches in trust is a long one—remember when doctors told us smoking was safe. The solution to this problem is a complex one. Science is not always right and there are no absolutes, but there are ways of identifying and minimising the risks that new technology brings in order to obtain the potential benefits that are also attached. This involves including the public in the evaluation process and educating them to understand both the risks and benefits of new technology. Most importantly, the government must ensure that this new technology is studied, regulated and monitored rigorously. Finally, the public must know that their health and safety and the safety of the environment are paramount and will not be compromised for economic or national interests. The Gene Technology Bill 2000 will, at least in theory, address the last two points. It provides for a national regulatory framework.

Sitting suspended from 6.30 p.m. to 8.00 p.m.

Mr GRIFFIN —As I was saying, the bill provides for a national regulatory framework through which all GMOs will be assessed for risk and, if the benefit outweighs the risk, they will be released under conditions designed to manage any risk. I do not believe, however, that this legislation or the processes currently in place address adequately the need for public involvement and public education. While the bill before us is certainly a vast improvement on the administrative process currently in place to deal with GMOs, it is by no means the best legislation we could have. In the past 18 months my colleagues and I have spent time talking to as many of the stakeholders who will be affected by this legislation as possible—from organic farmers, genetic researchers and environmental groups to multinational companies, ethicists and constituents. It was as a result of concerns raised by all of these groups that Labor successfully moved to have this bill referred to a Senate references inquiry, which is expected to report in the next few weeks.

Labor believe this inquiry is crucial to addressing some of the serious issues that have arisen as a result of this bill. Many of these issues, which I will expand on presently, could not have been addressed by a legislation committee. Some are ethical, some are legal and some are administrative but Labor believe that all of them are important enough for the public to have their say and to present their views on them. The inquiry process will also allow Labor to better understand many of the complex issues raised by gene technology. As a result, that will enable us to make more informed decisions about amendments to improve this legislation.

Briefly, the major areas of concern identified by Labor are: whether, following the decision by the government not to introduce its Environment Protection and Biodiversity Conservation Act amendments, there will be sufficient protection of our unique environment; whether there needs to be an explicit statement within the bill that requires the regulator to take a cautious approach to his or her decision making; whether the model outlined within the bill is robust enough to ensure that the objectives of the bill are met and that there can be no way that any GMO release applications could slip through the net; whether there is a sufficient role for public input into the process specifically in relation to the operation and influence of the Gene Technology Community Consultation Committee and the right of third parties to apply for reviews of decisions made by the gene technology regulator; whether there should be some provision within the bill for state, territory or local governments to create GM-free zones and/or approve releases on a case by case basis; how accidental contamination of either GM or non-GM crops will be dealt with from a compensation viewpoint; and, last but by no means least, the issue of cost recovery.

I would like to deal with this issue and one other in a little more depth as they have so far proven to be two of the most widely discussed concerns to arise during the Senate inquiry. Firstly, I would like to cover cost recovery and then look a little more closely at how the current administrative system responsible for overseeing GMOs has operated to date and what implications its performance has for the new regulator. In line with the Howard government's user-pays policy, it is proposed that the Office of the Gene Technology Regulator be resourced through 100 per cent cost recovery. What this means is that all those who have to use the office have to pay not only for the services required to assess their application but for all the costs associated with the running of the office, including those services that may have no benefit for the customer. This may include general policy advice to the minister or, as we have seen previously in this government, the provision of media clips and stock-market advice.

The main concerns raised by the proposed 100 per cent cost recovery policy fall into two areas: the integrity of the OGTR, and the effect on the future of research and development in the biotechnology area in Australia. In relation to the first point, there is widespread concern amongst environmental, consumer and industry groups that a body charged with protecting human health and environmental safety would be seriously compromised if it were funded entirely by the groups it is supposed to be monitoring. The general feeling is that spending priorities within such a body would be skewed towards supporting the needs of the payer and not towards the needs of the community. Currently, the only such body with true 100 per cent cost recovery is the Therapeutic Goods Administration, and this has recently occurred only following a phase-in of several years. It is interesting to note that a recent Auditor-General's follow-up report into a 1997 inquiry into the TGA found that, of the 12 areas identified as being of concern, 11 had been resolved to the satisfaction of the auditor and only one was still of some concern. The area of continued concern related to problems with the recording and monitoring of adverse drug events. Perhaps not surprisingly, this was the only area that related directly to consumer safety; the others were, in the main, efficiency improvements that would benefit the payer—a long bow perhaps but even so the issue of human safety is such that issues like this require close and continued scrutiny.

It is also worth noting that there is much that the OGTR will do that will be of direct benefit to the Australian public. This also needs to be taken into account when considering how the OGTR will be funded. Australia is well known for the world-class calibre of its researchers and scientists and for the standard of its research. Unfortunately, it is also well known for not being able to keep these people or much of the intellectual property that arises from their research in Australia. We are a training ground for the rest of the world and as a nation we are all the poorer for that. Labor has at the centre of its new policy platform a commitment to ensuring that Australia becomes a leading knowledge nation. A major plank of this policy is to grow industries such as gene technology in this country and to ensure that our researchers and their ideas stay here and that we attract the rest of the world to our shores to commercialise our ideas. Over the past week the Senate inquiry has heard much evidence to suggest that 100 per cent cost recovery will be a major barrier to R&D in this country. At the sharp end, PhD researchers, who usually work in the rather obscure and complex discovery research area, are already struggling for funds to continue this crucial groundwork. It is a fact that this is the sort of research that informs and directs more traditional research, which in turn leads to commercial discoveries and finally to some level of payback. Forcing these researchers and their institutions to pay for the services of a regulator that they will now have to use could have an enormous effect on the amount and quality of discovery research that can be continued in this country. This is the start of a domino effect that could see a decline in commercial research and in the royalties, employment and industries flowing from that.

At the big end of town, there is a concern that, in order to protect smaller researchers and companies from the cost of using the regulator, they will have to bear most of the new costs. Their response to that will be to look to other countries where it is cheaper to research and develop their products, and they will come to Australia only to sell these products. Both ways, Australia will lose. This is certainly an area requiring close consideration—which, by the way, will be rather challenging, considering that there is currently no information available as to what it will cost to run the OGTR and how the fee schedule might work. According to the Interim Office of the Gene Technology Regulator, this information will not be available until some time in September, which makes any sensible discussion and debate about this issue difficult, to say the least. Apparently, these calculations and structures are being developed by KPMG, which was awarded the contract as part of a competitive tender. Those of you who followed the GM labelling debate will no doubt remember that this is the company responsible for the initial, and widely discredited, report on the cost of the preferred labelling regime. If my memory serves me correctly, its first estimates were 10 times greater than those in the subsequent report and they provided the basis from which the Prime Minister launched his attack on the ANZFSC.

I would now like to move on to look at how GMOs and, in particular, genetically modified crops are being administered in the lead-up to the introduction of this new legislation. Despite the best intentions of those responsible for this important task, the ongoing cock-ups by the Interim Office of the Gene Technology Regulator are one of the most pressing reasons to have this new legislation up and running as soon as possible. The body responsible for the administration and monitoring of GMOs in Australia is the Interim Office of the Gene Technology Regulator. The IOGTR was established in 1999 to work with the Genetic Manipulation Advisory Committee until the OGTR is up and running. Unfortunately, as an administrative body the IOGTR has no real powers, and it relies on the companies and organisations it monitors to comply voluntarily with recommendations made by GMAC. It also relies heavily on companies to self-report and on third parties to report any breaches, alleged or otherwise, for investigation. Its own monitoring strategy came into effect only from June 2000—as you will see, just a bit late to be of any use in the two highly publicised breaches that I will be discussing. According to what we heard at the Senate inquiry last week, the IOGTR's record for spot checks is rivalled only by that of the Department of Health and Aged Care in its monitoring of nursing homes. Again, because of a lack of legislative underpinning, there is no capacity for the IOGTR to force companies or organisations to comply with risk management plans or to fine or penalise those who do not comply.

The first test of the IOGTR—and, as such, the first major case study into how new regulations might be tested—was brought to the public's attention on 25 March this year in the form of a newspaper article published in the Age. The article reported the dumping of GM canola plants in a manner contrary to GMAC recommendations and what seemed to be a problem with the size of buffer zones. An unconnected but even more worrying allegation was also made in the article about the existence of a black market in GM seeds. It has been subsequently shown that the IOGTR was made aware of the allegations in relation to the GM canola crops 11 days before the Age report and yet it did not contact the company involved, Aventis Cropscience, for further information until the day after the news broke publicly.

There are also unresolved questions about how the investigation was conducted. While Aventis Cropscience was told to supply a statutory declaration to support its evidence, no such request was made of the journalist who broke the story nor of the private individual who initially raised the issue with the IOGTR. In addition, the journalist involved has not been asked to provide the physical evidence—samples of the GM crops found in the open tip and some of the black market seeds—to the regulator. In fact, no real attempts were made to seek further evidence from the journalist after the initial conversation with the IOGTR that occurred the day before the article was published. I find that unbelievable.

The final report of the investigation into this specific incident was released only a week ago and only after Labor's continued pressure on the government. The report found that there had been five breaches of the GMAC recommendations by Aventis Cropscience, involving 81 per cent of the field trials that were under investigation. In its submission to the Senate inquiry and in its public evidence, Aventis continues to dispute the legitimacy of the IOGTR findings, claiming that while it ignored GMAC's recommendations it did so on the basis of its own scientific evidence. That is like saying that, on past evidence of never having had a car accident, a person can break the recommended speed limit with impunity. The point is that recommendations were made by GMAC to minimise the potential risk to the environment of these canola field trials and the company chose to ignore them. There are no excuses.

Aventis has also made some allegations of its own as part of its submission to the Senate inquiry, claiming that GMAC was aware of breaches the company had made in the past and that it had not acted on them. The company further alleges that the only reason GMAC and the IOGTR chose to act this time was because the issue had been made public. These are serious allegations, and while the IOGTR denied them during the Senate grilling last Friday it is unfortunate, to say the least, that the integrity of GMAC and the IOGTR has been called into question. The flagrant disregard for GMAC's recommendations by Aventis Cropscience, together with questions about the integrity of the watchdog, further supports Labor's calls for a full audit of all GM field trials currently being undertaken in Australia. This is the only way in which the Australian public can be sure that any other breaches are identified and dealt with appropriately. It is the only way that the Howard government can regain some level of public confidence in this technology and the bodies responsible for regulating and monitoring it.

Since Labor made this request last week, there has been a deafening silence from Dr Wooldridge, the minister who is—at least in writing—responsible for overseeing gene technology regulation and safety issues in Australia. I know that may come as a surprise to many in the House, given that much of the government's rhetoric on gene technology related issues can be attributed to the Prime Minister, the Minister for Agriculture, Fisheries and Forestry, Senator Hill, Senator Minchin and an assortment of other front- and backbenchers, but it does indeed come within Dr Wooldridge's sphere of responsibility.

There needs to be a full audit of GM trials, and this must occur as a matter of urgency. Before I move on to the most recent publicised GMO breach, I would like to refer back to the second allegation made in the Age article on 25 March relating to the existence of a black market in GM seeds. It is interesting to note that at no stage since the publication of this article has the government or indeed the IOGTR made any public reference to whether or not these claims have been investigated. I would not have been surprised if no further reference to it was ever made, had it not been for the issue being raised during the questioning of the IOGTR by the Senate inquiry last Friday. When asked about what had been done in relation to these serious claims, the IOGTR tried to dodge the issue by saying that the incident, while linked to the canola issue through the media, had nothing to do with the current inquiry and therefore should not be the subject of further scrutiny by the Senate committee. Unfortunately for the IOGTR, the committee chair stated that the way in which the interim regulator conducted itself and its inquiries was crucial in informing the committee on how the new legislation may or may not deal with future investigations.

According to evidence supplied, rather unwillingly, by the regulator, there has been an investigation into the allegations and the IOGTR has been asked on notice to provide the relevant report to the committee. We wait with interest to see what this report contains and to find out why there has been a lack of public information and transparency about the investigation process.

Friday's public hearing was also a useful way of finding out how yet another investigation into a GM breach was proceeding. This breach, which resulted in 69 tonnes of traditional cottonseed being mixed with GM cottonseed, first came to the public's attention on 25 July. Again, it was the media, in this case the Sydney Morning Herald, not the regulator or the company responsible, that revealed the incident. According to the media report, Monsanto informed the regulator on 21 June that the incident had occurred. When asked by the inquiry why the public was again dependent on the media for this information, the IOGTR stated that it had in fact posted information about the breach on its public web site, although it could not remember exactly when that occurred. Having looked up the web site, I can let the House know that the information, which is contained in an IOGTR bulletin, was posted on 9 August—two weeks after the Sydney Morning Herald report.

What this bulletin does not tell the public, though, is that the contaminated seed may have already found its way into the Australian food chain. It took Friday's Senate inquiry to uncover the fact that Monsanto does not know if the contaminated seed is currently in stockfeed used for Australian cattle but if it has made it directly into our food chain, says Monsanto, it would be in the form of cotton oil. According to the IOGTR's bulletin, the findings of its investigation into the breach will be made available on the IOGTR web site by 15 September. Of course, if the public wants to get a preview of the findings, they should keep their eyes on the Age or the Sydney Morning Herald for the two weeks prior to that date.

I think you will agree that these two examples seriously call into question the fitness of the IOGTR to do the job it was established to do. The lack of speed with which these breaches have been investigated, together with the lack of transparency and the media driven action, does nothing whatsoever to inspire public confidence in the current system. It also raises serious concerns about the resourcing of the IOGTR to do the job. All I can say is that, instead of complaining about Labor's ongoing criticism of the IOGTR, the government needs to make sure that all the weaknesses identified by these incidents will not and cannot be repeated under the proposed regulatory regime. I cannot emphasise enough that the future of gene technology in Australia, its potential benefits in terms of health, employment, science, technology, research and development, depend entirely on how much confidence Australians have in the OGTR. This is the message that has come out loudly and clearly during the Senate inquiry, and it is a message that industry as well as the government must heed. While Labor is aware of the additional financial and time burdens that strict regulation has on these industries, to try to water them down will bring only short-term financial benefits and will in the longer term lead to this technology carving out niche markets at best.

To understand why this will be the case, you need only to look at the fact that consumers both here and internationally have by and large accepted medical and pharmaceutical innovations produced through gene technology. On the other hand, there has been much less support for the agricultural applications. There are a number of reasons put forward for this. Firstly, the public has over the years developed confidence in the regulatory bodies responsible for overseeing the release of pharmaceuticals and medicines onto the Australian market. The Therapeutic Goods Administration has an enviable reputation for being a thorough and tough investigator and is considered to represent the gold standard for world drug regulation. Secondly, in order to access pharmaceuticals, consumers must get a prescription from a health professional. This gives the impression that in addition to the TGA there is a second gatekeeper for these products and therefore a further level of protection. In order for GM products to gain the same acceptance, the public needs time to develop the same level of confidence it has in the TGA. In the short term that means tough regulation, but in the long term, if the benefits of this technology are realised, it means a healthy and growing market for these products. In other words, the tougher the OGTR is, the more likely Australians will be to embrace this new technology and the greater the benefits to our nation.

It is for these reasons that Labor, while acknowledging the necessity for this bill and commending the IOGTR for its broad stakeholder consultation in the drafting of it, will be exercising its right to amend this legislation in the Senate once it has had time to consider the findings of the Senate inquiry. As we have said to the government and all stakeholders throughout the drafting and development process of this bill, Labor wants to ensure that legislation is in place as soon as possible, but we will not be pushed into rushing it through. The implications of this legislation are huge and long-lasting—it must not only meet the needs of industry and the scientific community in terms of providing certainty but also inspire trust and confidence amongst the Australian public.

This legislation is just the very tip of the iceberg when it comes to the regulation of gene technology. In the last month alone, we have seen public discussion, debate and concern about the insurance implications of genetic testing. Months after Labor supported a motion in the Senate to have an inquiry into the broader ethical, social, medical and legal ramifications of genetic testing, it took media and public pressure for the Howard government to act and call its own inquiry. The imminent negotiation of the GATT TRIPs agreement will reopen debate about the patentability of genetic material. Issues such as cloning, genetic data banks, and somatic cell therapy versus germ line therapy, issues of gene ownership, privacy and discrimination and the harvesting of stem cells—all of these issues—will confront and are confronting government. It was Labor who in 1992 held a House of Representatives inquiry into genetic manipulation. In his introduction, the chairman, Michael Lee, said:

The development of biotechnology, of which genetic manipulation techniques are a part, promises to generate a revolution in industrial techniques. Nations around the world are grappling with the legal and institutional changes which will be required to cope with this new technology.

Eight years on, the current government seems to take little interest in closing the gap between scientific advances and development of regulatory and ethical frameworks to deal with these advances. Labor continues to have these issues top of mind. At our national conference, Labor committed itself to a wide-ranging public consultation into the health, safety, ethical, environmental, legal and employment implications of new genetic technologies in the research, medical and agricultural sectors. Labor wants to ensure that the public's concerns are addressed and in doing so enable Australia to progress its research and development work as a means of establishing its position as a knowledge nation. As I have already said, Labor welcomes this long-awaited bill as a useful basis for regulation of genetically modified organisms. We await the results of the current Senate inquiry with interest and look forward to working constructively with the government and others to improve the legislation and provide the Australian public with an act that inspires trust and confidence.