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Monday, 11 November 2002
Page: 5956

Senator NETTLE (6:01 PM) —In rising to speak to the Research Involving Embryos Bill 2002, like other senators before me I recognise the enormous amount of community interest that has been generated by this debate. For all of us, the volume and content of the letters and phone calls that we have received has made it very clear that many Australians feel very passionately about the subject of this bill. The Australian Greens' concerns with this bill focus around the privatisation and the commercialisation of the research involved. We believe that, if this type of research is to continue, it should be fully regulated, transparent and open to public scrutiny. We believe the bill in its current form fails to safeguard the public interest that we believe is so important.

Biotechnology companies lobbying for this bill have made much of the potential benefits of research using embryonic stem cells. We have been told that embryonic stem cells could hold the promise to cure Alzheimer's, Parkinson's, diabetes, and even allow people with paraplegia to walk again. People suffering serious illness and disability have been presented to support the case for this legislation. Understandably, some people with disabilities have been offended by this campaign. Some witnesses and authors of submissions to the inquiry into this bill questioned the claims of possible benefits and said the public has been misinformed about the potential of embryonic stem cell research. Even if we accept the claims of the advocates, this bill raises many serious issues, including how to guarantee that private companies do not gain a stranglehold on knowledge and developments that may save lives or improve the quality of life for people who are suffering serious debilitating diseases and conditions.

Part of the problem with this bill is that it does not actually regulate stem cell research, although the community could be forgiven for thinking otherwise, given the public debate. The House of Representatives Standing Committee on Legal and Constitutional Affairs, when it looked at the issue of human cloning last year, recommended that the government legislate to regulate human cloning and embryonic stem cell research. This legislation, however, sets out circumstances in which no licence is required to use a human embryo deemed excess to the needs of people undergoing assisted reproductive technology programs, and it leaves it to the National Health and Medical Research Council to decide for what other purposes researchers may have access to these embryos. Research involving embryonic stem cells will be subject to guidelines and the council's approval, but this is not regulation. Parliament does not even have the benefit of the new guidelines that will underpin this bill, as they are currently being revised.

This parliament should be legislating to regulate stem cell research to ensure as much accountability as possible and because of the ethical issues that such research raises. The public has a major stake in this matter. Government funding to IVF and assisted reproduction amounted to $2.9 million this year from the National Health and Medical Research Council alone. The excess embryos that may be provided for research under this bill have been created in part by public funding. But more significantly, the Australian public is ploughing millions of dollars into stem cell research, through Commonwealth government grants. The Australian public should be guaranteed a return on these grants, a guarantee that ensures profits go not only into private pockets but can also be used to ensure that any treatments or drugs derived from embryonic stem cell research will be widely available at a price that people can afford. Make no mistake: large sums of money are involved. Biotechnology Australia, a division of the Commonwealth Department of Industry, Tourism and Resources, told the committee that there were around 200 biotechnology companies in Australia and that the total market capitalisation of Australian biotechnology companies was greater than $US5 billion in February this year.

In its submission to the inquiry, the division gave one example of potential money to be made from stem cell research. If Australia could produce a single commercial cell therapy product for diabetes, with a conservative five per cent market share, annual sales revenue would be worth around $500 million in the year 2010. That is excluding royalties from third-party use of derived products based on Australian-owned embryonic stem cells. These sorts of figures explain the feverish lobbying from the private sector. State governments have been falling over themselves in the past few years throwing money at biotech companies, competing to be the hub for Australia's biotech industry. The federal government also has been keen to encourage this industry, not just in the area of stem cells—into which it has poured $43.5 million just this year for the National Stem Cell Centre—but also in other fields of biotechnology such as genetic engineering.

Earlier this year, the minister for industry addressed the AusBiotech 2002 dinner with news of 39 successful grants for $9 million from the Biotechnology Innovation Fund. The minister described himself as a `friend and a supporter of the industry in Canberra'. He told the audience that the industry's immediate future hinged in part on its relationship with individuals in the federal parliament, and he proceeded to dispense political advice on how to ensure a win for this bill before us. Without this legislation, the National Stem Cell Centre will be restricted in what it can do and will rely on human embryonic stem cells derived from overseas, with all the restraints on downstream benefits that that entails. The companies seeking the passage of this bill have told the parliament in no uncertain terms that failure to deliver will have them heading offshore, where some of them already have established operations.

The Australian Greens do not oppose research and development. We know it holds promise for alleviating human suffering and for developing techniques to reduce our environmental impacts and to improve the quality of life for all individuals. But we are concerned about transparency, public accountability, good decision making and equitable access to medical treatments and therapies. We also question some of the assumptions that others take for granted about the benefits of biotechnology—the focus on novel treatments and manipulations—especially when it is at the expense of addressing the causes of illness and disease. Is this the best use of public research moneys? We are concerned, also, about aspects of partnerships between public research institutions and commercial entities in which public moneys are being expended and can potentially be hidden behind claims of `commercial-in-confidence'.

Evidence to the committee about the National Stem Cell Centre supports our concerns. The Commonwealth has committed these funds before reaching a final agreement on commercialisation and intellectual property rights arising from the research that the centre conducts. One of the key research projects is planned to be embryonic stem cell research, even though the parliament has not yet determined whether this should be permitted. We note that negotiations on the deed of agreement are in abeyance, but we believe this sort of process is unsatisfactory. The Australian public ought to know what its money is buying, and I hope that in the deed of agreement the government has not pre-empted the parliament's consideration of this matter.

With so much profit at stake in this growing sector, we are right to be cautious. Market forces are not the most appropriate means for achieving the best outcomes, especially in an area as essential as health. They do not guarantee that people will receive the treatment that they need at a price they can afford. If governments are to be such a major player, with so much at stake financially, how can we be sure that the public good will outweigh the profit motive? Central to this issue is the quest for intellectual property rights over human stem cell discoveries. This appears to be one of the critical driving factors in the industry's push for this legislation. The committee heard from several witnesses that researchers cannot get free access to existing human embryonic stem cell lines and that private profit has a stranglehold on them. Will we end up with a situation where discoveries about how human cells work—how they grow, repair and renew themselves—will be locked up for decades in patents protecting intellectual property?

Traditionally, patents were sought and granted to protect an investment in innovation, the creation of something novel. But in recent years we have seen patents granted for simple discovery, as lengthy, challenging and commendable as the discovery may be. This trend to merge the line between what is novel and what is a discovery poses particular problems in the case of human biology, and it has grave implications in the field of health and medicine to which these discoveries may be applied. In the case of discovering how the complex and intricate processes of human biology work, this is a discovery of natural processes. The knowledge gained should be the common property of humankind, to be used for the benefit of all. To patent discovery of these processes is akin to patenting the discovery of a new species of plant or animal. It is completely absurd. More than this, it is bound to restrict access for researchers and eventually put access to any applications derived from these discoveries beyond the reach of many millions of people.

We have seen elsewhere the application and granting of patents for human stem cell lines, which has generated concern that scientists, including publicly funded ones, will be hampered in their research efforts in this field. These patents, and the conditions attached to any use of the stem cells they cover, have been used as an argument in support of this legislation: the need for Australian based researchers to have access to human embryos to derive their own stem cell lines. The Australian Research Council told the committee inquiry that the fastest rate of growth in Australian patenting is in biotechnology, and that this rate of growth is significantly faster than the world average. The committee heard that Australian biotech companies working in the stem cell field are keen to protect their discoveries with intellectual property patents. Will we be guilty of doing to others what we have complained of having done to us with regard to intellectual property patents? If all citizens are to benefit from the output of stem cell research involving human embryos, then government needs to moderate market forces and no-one should be permitted to patent stem cell lines.

To ensure this happens, the Greens propose that the Commonwealth government establish a national stem cell bank as a repository for stem cell lines from human embryos and adult stem cells. The United Kingdom is to have such a bank, to be established by the National Institute for Biological Standards and Control and to be overseen by the Medical Research Council. The British House of Lords Select Committee on Stem Cell Research this year endorsed such a proposal. We envisage that any holder of a licence issued under this legislation would be required to deposit stem cell lines into the national bank and that any researcher approved for conducting research using human tissue would be permitted to use stem cell lines from the bank. At the very least, a national stem cell bank ensures that all research institutions, in particular publicly funded institutions, will have access to the basic materials for developing applications from stem cell lines. As far as we can see, this is the best mechanism within the constraints of this legislation to safeguard the public interest. We note that Stem Cell Sciences Ltd supports such a proposal, as do a number of scientists who gave evidence to the inquiry.

Clearly, separate legislation would be required to establish a stem cell bank. Accordingly, we are proposing an amendment directing the Australian Health Ethics Committee of the National Health and Medical Research Council to investigate the establishment of a stem cell bank and report to parliament within six months of the act's commencement, and asking the government to bring forward a bill to establish the bank by the end of next year. We see no need to delay the stem cell bank by incorporating it into a review of the legislation, as the committee report suggested. This could lead to a long delay before a stem cell bank was established and, in the meantime, if the bill were passed, companies may be tempted to beat a possible future ban on the patenting of stem cell lines.

The Greens also support the suggestion in the committee report for a separate reference to the Australian Law Reform Commission and the Australian Health Ethics Committee to examine intellectual property rights in this area. However, as in the case of the stem cell bank, we are concerned that this matter not be delayed. We are calling on the government to issue such a reference immediately upon the passage of this legislation, and we will be moving a second reading amendment to this effect. I foreshadow that. It will be moved by my colleague Senator Brown. This reference should include an examination of intellectual property rights for human stem cell lines derived from embryos made available under this legislation. It should include all existing stem cell lines that are not subject to a patent and the ways to safeguard the public interest and guarantee equitable access to therapeutic applications and drugs developed from stem cell lines.

In the interim, we are calling on the federal government to commit to using its financial leverage as a partner in stem cell research to ensure that the Australian public secures a share of any intellectual property rights from derived products or applications. The revenue that would flow from such rights should be used to subsidise access to products and applications for disadvantaged Australians. The Australian Greens will be moving several other amendments that address the scope of the research permitted under this bill, looking at public disclosure and administrative arrangements. I look forward to support from a range of senators to ensure that, if this bill is passed, the public interest is protected.