Melissa Parke (Fremantle, Australian Labor Party) Share this | Link to this | Hansard source

I move:

That this House:

(1)

notes that:

(a)

on 6 September 2010 the ABC’s Four Corners program screened a story entitled ‘Body Corporate’, highlighting growing community and scientific concern regarding gene patents;

(b)

in particular, Four Corners discussed the case of five year old Liam who needed to have a genetic test to see if he had gene mutations to the SCN1A human gene linked to a specific form of epilepsy called Dravet Syndrome;

(c)

Bionomics, a South Australian company which had received a specific grant of around $1 000 000 from AusIndustry to develop a SCN1A gene test:

(i)

took out an Australian patent over the SCN1A human gene; and

(ii)

subsequently exclusively licensed the patent to Genetic Technologies, a Melbourne company that charges $2000 for the SCN1A gene test in Australia;

(d)

Liam was being treated at the Westmead Hospital—a publicly funded institution that is part of NSW Health—which could not afford to pay Genetic Technologies $2000 for each SCN1A gene test;

(e)

Liam’s doctors sent a sample of his DNA to be tested in Scotland where the charge was just one third of the price charged by Genetic Technologies; and

(f)

the option to send the DNA sample overseas for testing not only took more time, leaving the young boy and his family waiting in distress, but highlights how Australian taxpayers providing research funds to (i) Australian universities to identify the SCN1A genetic mutations; and (ii) an Australian company to develop a genetic test, have been deprived of the benefits of that very research;

(2)

notes that:

(a)

in July 2008, Genetic Technologies, as the exclusive licensee of Myriad Genetics, a United States company granted Australian patents over the BRCA 1 and 2 gene mutations linked to breast and ovarian cancers, demanded via a lawyer’s letter sent to all Australian hospitals and clinical laboratories (including the Peter MacCallum Cancer Centre) that they stop all testing for breast cancer, claiming such testing infringed Myriad Genetics’ Australian BRCA patents;

(b)

in 2009 in the United States, eleven plaintiffs, including Lisbeth Ceriani, a 43 year old single mother diagnosed with breast cancer, and professional medical and clinical associations such as the American Society for Clinical Pathology, launched a legal challenge to seven of Myriad Genetics’ United States BRCA patents, where: and

(i)

Ms Ceriani found that she was unable to get a second opinion on a positive genetic test for ovarian cancer because in the United States there is only one test, owned by only one company, Myriad Genetics, which charges over US$3000 per test;

(ii)

in March 2010 a United States Federal Court agreed with the plaintiffs and declared all seven United States patents invalid on the ground that under United States patent law, patents can only be granted over inventions, not for the discovery of natural phenomena; and

(iii)

the Court so held because, first, despite being removed from the human body and thus ‘isolated’, the BRCA genes were ‘not markedly different from native DNA as it exists in nature’ and second, the analysis of these two human genes by way of a genetic test was ‘merely data-gathering to obtain clinical data’;

(3)

notes that:

(a)

at the official commemoration of the decoding of the human genome in March 2000, United States President Bill Clinton and British Prime Minister Tony Blair said that ‘raw fundamental data on the human genome, including the human DNA sequence and its variations, should be made freely available to scientists everywhere’, yet by 2005, according to a survey published in Science, more than 20 per cent (probably now much higher) of the human genome was the subject of Untied States intellectual property;

(b)

President Clinton and Prime Minister Blair also said that ‘unencumbered access to this information will promote discoveries that will reduce the burden of disease, improve health around the world, and enhance the quality of life of all humankind.’;

(c)

unencumbered access to genetic information cannot be achieved when patents over human genes are being used to suppress competition, innovation, research and testing;

(d)

Professor Ian Frazer, the inventor of the cervical cancer vaccine, has joined other cancer researchers in calling for a revision of Australian patent law, stating that researchers need to be able to proceed with their work without having to consult the companies whose patents the work might infringe: ‘restricting the research use of a gene sequence could delay the development and testing of truly inventive and practical uses of the gene and its protein product for diagnosis and therapy.’; and

(e)

other groups opposed to the granting of gene patents include the Cancer Council Australia, the Breast Cancer Foundation of Australia, the Royal Australian College of Pathologists, the Human Genetics Society of Australia and the Australian Medical Association; and

(4)

calls for amendment of the Patents Act 1990 to ensure that patents cannot be granted over any biological materials which are identical or substantially identical to what exists in nature. (Notice given 28 September 2010.

Sharon Bird (Cunningham, Australian Labor Party) Share this | Link to this | Hansard source

Is the motion seconded?

Janelle Saffin (Page, Australian Labor Party) Share this | Link to this | Hansard source

I second the motion and reserve my right to speak.

Melissa Parke (Fremantle, Australian Labor Party) Share this | Link to this | Hansard source

I will try to set out at the outset what is involved in this issue. First, it is a fundamental principle of patent law that there must be an invention; however, it is clear that human genes are not inventions but naturally occurring phenomena. Second, in my opinion it is wrong from the point of view of public policy to allow genetic and biological material to be privately owned and controlled and for that control to be wielded in the interests of profit-making rather than in the interests of the public good. Lastly, when the companies that would be affected by the proposal to ban gene patents stir into the predictable frenzy of lobbying and public relations warfare to protect their interests, as is starting to happen right now, let us remember that their one argument—that is, that gene patents provide an incentive for companies to fund medical research—is both exaggerated and based on a false premise. The vast majority of research is publicly funded. Some of the 20th century’s greatest medical breakthroughs were not made in pursuit of a patent—penicillin and the polio vaccine, to mention just two. It is likely that banning gene patents will actually accelerate innovative competition in the biotechnology sector because the raw materials for new diagnostics treatments and medicines will be freely available and unencumbered.

I acknowledge the presence in the gallery tonight of Dr Luigi Palombi, who has dedicated much of his professional life and his passion to this issue. Since lodging my notice of motion about this issue a couple of weeks ago, I have been inundated with emails from around the country sent by people who cannot believe that we would permit genetic material to be controlled by patent. One of those emails was from a doctor at Westmead Hospital who each year cares for over 500 new families with a genetic history of breast and other cancers. On 30 September, Cancer Council Australia and the Clinical Oncological Society of Australia issued a press release welcoming my notice of motion. As I noted on 22 June 2009 in my last parliamentary speech on this issue, in 2008 a Melbourne company, Genetic Technologies, ordered Australian hospitals and clinical laboratories to stop testing for breast cancer, claiming it had the exclusive right to control access to the relevant gene under the licence it had obtained from US company Myriad Genetics.

In the US, public attention was drawn to the issue last year when two women, Genae Girard and Lisbeth Ciriani, who had sought second opinions on positive genetic tests for ovarian cancer, could not get those opinions because there is only one test, owned by only one company, Myriad Genetics. Ms Girard and Ms Ciriani, together with other patients and medical associations, participated in a legal challenge to Myriad’s US patents over the breast and ovarian cancer genes. In a landmark decision, the US Federal Court in New York held earlier this year that the patents were improperly granted to Myriad and were invalid under US patent law. In a subsequent article entitled The case against gene patents written for the Wall Street Journal in April by Nobel Prize winners Professor Joseph Stiglitz and Professor John Sulston, it was noted:

The court held that genes and human genetic sequences are naturally occurring things, not inventions. They are a part of all of our bodies and contain the most fundamental information about humanity—information that should be available to everyone. The researchers and private companies that applied for these gene patents did not invent the genes; they only identified what was already there.

Myriad is appealing the decision and it may take years for the matter to be definitively resolved in the US courts. In the meantime, Myriad has jacked up the price for its genetic test for ovarian and breast cancer from US$3,000 to $US4,000 per test. Americans cannot typically recover this cost under health insurance. A test case was launched by Cancer Voices Australia against Myriad’s Australian breast cancer gene patents in the Australian Federal Court earlier this year. Significantly, rather than having the principle determined by an Australian court, Myriad has chosen to surrender the entire patent in an attempt to avoid this happening.

There is no objection to corporations that have invested in research to develop a new diagnostic test or vaccine or medicine being granted patents. However, there is a very large objection to corporations being granted patents over the underlying biological materials—that is, genes and proteins—because, although the biological materials have not been invented, by having the patent on them corporations prevent others from carrying out clinical tests or undertaking research using those biological materials. In the Wall Street Journal article I referred to earlier, Professors Stiglitz and Sulston wrote:

Proponents of gene patents argue that private companies will not engage in genetic research unless they have the economic incentives created by the patent system. We believe that a deeper understanding of the economics and science of innovation leads to exactly the opposite conclusion.

Patents … not only prevent the use of knowledge in ways that would most benefit society, they may even impede scientific progress. Every scientific advance is built on those that came before it. There is still a great deal to learn about our genes, particularly how they contribute to disease. Gene patents inhibit access to the most basic information.

This motion calls for an amendment to Australia’s patent law to impose a ban on patents over biological materials such as human genes. Genetics technology companies argue that such a change will mean the end of medical research—the end of discovery. In fact, the exact opposite will happen. By liberating these naturally occurring materials from patents, the process of discovery and invention will be improved significantly. Everyone knows that human genes are not inventions but products of nature. They belong to everyone. This is why, when the human genome was decoded 10 years ago, US President Clinton and British Prime Minister Blair issued a joint statement which said that to ‘realise the full promise of this research, raw fundamental data on the human genome, including the human DNA sequence and its variations, should be made freely available to scientists everywhere’. Why did they say that? Because they believed that:

Unencumbered access to this information will promote discoveries that will reduce the burden of disease, improve health around the world, and enhance the quality of life for all humankind.

How are scientists supposed to make new discoveries and inventions to cure cancer if they have to seek permission and pay thousands if not millions of dollars to companies like Myriad who own patents over human genes? Publicly funded R&D is crucial, and these kinds of patents cause unnecessary delay and make research much more costly. During the Senate’s inquiry into gene patents, Australian scientists at the Peter MacCallum Cancer Centre told of how their research into breast and ovarian cancer was delayed by two years and ended up costing three times as much as it otherwise might have because Genetic Technologies refused to grant permission to use the patented genes.

Let us remember that nearly all of the primary research which has led to the discovery of human genes which are linked to cancers and diseases has been publicly funded by taxpayers or by philanthropic organisations. Is it right that Myriad should own patents over the BRCA1 gene mutations which cause breast and ovarian cancers, when it was Professor Mary-Claire King, a publicly funded researcher at the University of California who, after spending 16 years looking for the BRCA1 gene, found it on human chromosome 17q? That Myriad’s scientists were able to see a little further and sequence the BRCA1 gene is only because they stood, borrowing the words of Sir Isaac Newton, on the shoulders of Professor King, a true scientific giant.

Is it right that Australian taxpayers, who have provided research funds to universities to identify the epilepsy gene and have provided a $l million AusIndustry grant to the Bionomics company to develop a genetic test for epilepsy, have now been deprived of the benefits of that funding and research to the point where doctors at Westmead Hospital are sending children’s DNA samples to Scotland rather than pay the fees and royalties demanded by Genetic Technologies? We now know that we are merely at the beginning of a long and complex story about how genes work. To grant patents to those that make the initial link will impede the necessary work which must be done in order to turn science fiction into science fact.

As Professor Bowtell from the Peter MacCallum Cancer Centre said to the Senate inquiry:

We are coming into an era where lots of genes are actually being identified that work in concert to actually cause an outcome, like the risk of developing breast cancer, diabetes, stroke … If the patents for each of those genes are held by different companies then it is going to be extremely difficult to assemble a practical test to test for a particular condition.

Finally, a bedrock principle of the patent system which has stood for more than 500 years is that there must be an invention. Without an invention there is no reward. The proposed ban on gene patents will not prevent Myriad and other companies from seeking patents for new and inventive diagnostics, treatments, medicines and cures which make use of human genes. After all, that is what the patent system is about, rewarding those who invent such things. But the gene itself is not something that anyone has invented.

Professor Ian Frazer, inventor of the cervical cancer vaccine, President of Cancer Council Australia and former Australian of the Year, has said:

… there is no more invention in isolating and characterising biological materials that exist in our bodies … than in collecting and arranging a set of postage stamps.

Further, he said that ‘if we allow patenting of genes we’re allowing patenting of ourselves’. These are some of the reasons the Cancer Council of Australia, the National Breast Cancer Foundation, the Royal College of Pathologists of Australasia, the Royal Australasian College of Surgeons, the Clinical Oncological Society, the Human Genetics Society and many ordinary Australians are calling for an amendment to the Patents Act to ban gene patents.

Mal Washer (Moore, Liberal Party) Share this | Link to this | Hansard source

I wish to thank the member for Fremantle for moving this motion on gene patents and to let her know that Senator Bill Heffernan is very passionate and agrees with you, and so do I. Systems for protecting commercial rights stretch back for centuries, with patents being recorded in Britain under the Statute of Monopolies of 1623. In Australia an invention may be patented under the Patents Act 1990, if the invention is a manner of manufacture, is novel, involves an inventive step and is useful. Inventions which are patented give the patent holder an exclusive right to sell their invention for a standard term of 20 years. A mere discovery or bare principle is not a manner of manufacture.

In Australia the Patent Office manual refers to the distinction between discovery and invention. A chemical substance which is discovered in nature without any practical application is a ‘mere chemical curiosity’ and not patentable. However, if the isolated gene has some practicable application it is potentially patentable. IP Australia has also indicated that ‘the building blocks of living matter, such as DNA and genes which have for the first time been identified and copied from their natural source and then manufactured synthetically as unique materials with a definite industrial use’ are not discoveries and are therefore patentable. In June 2004 the Australian Law Reform Commission stated that a new approach to the patentability of genetic materials was not warranted. One of the reasons provided was that it would represent a departure from accepted international practice and may adversely affect investment in the Australian biotechnology industry.

Currently in the EU, isolated genetic sequences are patentable following the Biotechnology Directive in 1998; and in the US the Patent and Trademark Office has issued patents on genes and other DNA sequences covering up to 40 per cent of the human genome. But there are real concerns over the correctness of this policy. Apart from US President Clinton and Prime Minister Blair issuing a joint statement some 10 years ago saying that the human genome should be made freely available to scientists everywhere, recent decisions of both UK and US courts have cast a shadow over the legality of this policy.

In October 2004 the Judicial Committee of the House of Lords, sitting as the final court of appeal in the UK, invalidated the patent claims over a synthetically made human protein because the protein was identical in its genetic structure and function to the protein as it existed naturally in the human body. According to their lordships the protein was not ‘new’.

In March this year the US Federal Court ruled that seven US patents on the BRCA1 and BRCA2 human genes and the genetic mutations to those genes, which are causative of breast and ovarian cancers, are invalid. These patents have allowed Myriad to secure a near monopoly on diagnostic tests for BRCA gene mutations in the US. It is interesting to note that one of Myriad’s patents on BRCA1 was found to be so broad that it covered genetic sequences found in 80 per cent of all human genes. What is important to note is what the judge said: because the claimed isolated DNA is not markedly different from the native DNA as it exists in nature, it constitutes unpatentable subject matter under US patent law.

Applied properly, patents protect investors’ rights to be rewarded for their hard work and investment, whilst enabling others to improve on their innovations. Without patents there would be little incentive for researchers to invest their time, money and effort. Pharmaceutical and medical device manufacturers can legitimately argue that the patent system is crucial for stimulating research and development which leads to new products to improve medical care.

The problem with gene patents is that there are legitimate arguments that, rather than promoting biomedical innovation, they actually inhibit it. The process of determining which relevant patents are important to a research project, and the negotiations for access to them, can delay or even kill innovation. Unfortunately, IP Australia has told the Senate Standing Committee on Community Affairs, which has been conducting an inquiry into the impact of gene patents for nearly two years, that, unless directed by an Australian court to do otherwise, it will continue to grant patents over naturally occurring biological materials. And although the Federal Court of Australia has finally been given an opportunity to review this policy—thanks to Cancer Voices Australia and Mrs Yvonne D’Arcy, a woman suffering from breast cancer—Myriad has responded by surrendering its patents over BRCA1 gene mutations. This move, if it is successful, will bring that opportunity to a premature end. So it is now a matter of critical importance that this parliament consider this motion and take this subject seriously.

Janelle Saffin (Page, Australian Labor Party) Share this | Link to this | Hansard source

I commend the honourable member for Fremantle for moving this private member’s motion, which I support. This is an issue which has long concerned me, and I was so pleased to see that the member had it listed for debate. I have had so many positive messages from people all around Australia asking me to support this motion. I told them that I do support the motion and will be speaking on it. The support for some action in this area comes not just from women but from a whole range of groups covering the political spectrum—not partisan political but across ideologies.

Some months ago a law graduate from Southern Cross University, Keda Ley, did some research for me on this issue, for which I thank her. I will speak on some of the research she did for me. She said that, from a women’s rights and human rights perspective, the Women’s Network of the United States argues that ‘isolated DNA constitutes an unpatentable product of nature whose patenting harms women by stifling innovation and interfering with patient access to medical testing and treatment’. I agree. She also said proponents of the patenting of isolated human genes argue that an overall abolition of such patents would result in the stifling of genetic research because the incentive to invest in such research would be gone. I disagree. We heard the honourable member for Fremantle talk about people who know far more about this than I do—especially Professor Joseph Stiglitz—and they disagree.

There are also arguments against patents on human genes, which is clearly unethical because genetic material is the common heritage of humanity and it should not be subject to private ownership and exploited for profit by private owners. Furthermore, patenting such material may also hinder further development. I argue that human genetic material and isolated human genes should remain in the public domain.

As we know, the current position in Australia is that patents may be granted over selected genetic material or other methods or products used in testing for mutations in a gene or genetic sequence. For example, a United States company which we know of, Myriad Genetics Inc., holds patents internationally on isolated genetic materials associated with breast and ovarian cancer. Myriad’s patents also cover methods for predictive testing and products and processes involved in its breast cancer predisposition test, which is called ‘BRACAnalysis’. And we know about BRCA1 and BRCA2. There was a High Court case dealing with this, but it was in 1959. I think we have moved on a bit since 1959. If it were tested in the courts, it would be interesting to see what they say. But we can actually deal with this here. In its discussion paper No. 68 on gene patenting and human health, the Australian Law Reform Commission says, among other things, that there are many existing mechanisms through which problems might be addressed. These include the use of the compulsory licensing and Crown use provisions of the Patents Act and laws dealing with anticompetitive conduct and prices surveillance.

There are also ways in which the Commonwealth, state and territory governments, as funders and purchasers of healthcare services, may be able to influence the way in which patent holders exploit or enforce patent rights. Mandatory licensing, as suggested by the ALRC, is one way to go, but it would involve the Commonwealth having to pay just-terms compensation. I do not want more public money paid out in just-terms compensation on this issue, and it does not solve the ethically problematic issue of the private ownership of human genes.

The legal argument as to why genes are not patentable under the Patents Act is that, for subject matter to be patentable, it has to be an invention, not merely a discovery of something pre-existing in nature. The discovery of genes and gene sequences is just that—a discovery. Hence, in my view, it is not an invention and should fall outside the patents system. Explicit exclusion of human genetic material from the Patents Act would lay to rest any argument that human genes are patentable.

The policy argument about the incentive role of patenting is that it ensures innovation continues. But patenting can also hamper research, innovation and scientific progress by giving private owners too much power to name the price for the use of genes in research or experimentation—at an unjustifiable cost to society.

John Forrest (Mallee, National Party) Share this | Link to this | Hansard source

I am pleased to support the member for Fremantle’s motion. I commend her for bringing this matter to the attention of the House. This is an issue that was obviously going to go under the radar until she raised it in the House some time ago, and I support the motion’s direction. This is one of the longest private member’s motions I have seen in a long time. It calls on the parliament to note various things. I will start where it finishes. It says:

That this House:

       …         …         …

(4) calls for amendment of the Patents Act 1990 to ensure that patents cannot be granted over any biological materials which are identical or substantially identical to what exists in nature.

I note that the member for Fremantle adopts a compassionate, humanitarian approach. The member for Moore adopts a medical approach. Mine is just a simple pragmatic and scientific approach. It seems to me an oxymoron that the discovery of a human gene brings with it the entitlement to patent it. If anybody owned the gene, it would be nature itself. I think we have seen examples now in two great societies: the United States, which the resolution refers to, in legal cases; and Great Britain as well, which the member for Moore mentioned. I think it is time that we grew up and had that patent law amended to ensure that, particularly, cancer sufferers are not denied an opportunity to have access to the best medical testing at an affordable rate.

The member for Fremantle’s resolution draws attention to one particular case which was funded by taxpayers, by AusIndustry, with a sizeable grant. For that particular company to take advantage of taxpayer funded research is not, in my view, a patent or legitimate. I am disturbed that such an event has occurred, and I support the member for Fremantle in her call. It is true that many would argue that scientific investigation and experimentation costs an enormous amount of money, with the laboratory time and the patient time, and that therefore there is an entitlement for that level of investment to be returned. Opportunity exists for that in the charging of fees for service, but not at the extortionate amounts that are described in this resolution.

The call that the member for Fremantle brings to our attention is supported by a large number of significant groups in Australia: Cancer Council Australia, the Breast Cancer Foundation of Australia, the Royal College of Pathologists of Australasia, the Human Genetics Society of Australasia and the Australian Medical Association. I think it is fitting and suitable that this parliament takes up this cause, and I look forward to the ongoing opportunity—and I have no doubt that the member for Fremantle will continue to agitate until this revised legislation is brought to the attention of this place to ensure that people who suffer from cancer are not denied an opportunity to access their cure.

On Friday night, I was in my home town of Swan Hill, participating in the walkathon. I was thinking of three people I knew who we lost to cancer just in one year. One of them was Albert Heslop, who was my mentor when I was first elected as a rookie to the Swan Hill Rural City Council, and he followed my career from there. He was a great man. Sadly, he left his visit to the doctor till too late, and from diagnosis to his passing from prostate cancer was only a matter of weeks. I said to the group, ‘We’ve got to find this one last cure for what is one of the nation’s most debilitating diseases.’ (Time expired)

Michelle Rowland (Greenway, Australian Labor Party) Share this | Link to this | Hansard source

I rise in support of the motion. I thank the member for Fremantle for bringing this important issue to the attention of the House. This motion calls for an amendment to the Patents Act 1990 to expressly prohibit the granting of patents over ‘biological materials which are identical or substantially identical to what exists in nature’, such as gene sequences. I believe this makes sense legally, and from my understanding of the scientific commentary on this issue it also appears to me to make sense scientifically. It also makes sense to me as a matter of good public policy.

Currently, sections 18(2) and 18(3) of the Patents Act state:

(2)

Human beings, and the biological processes for their generation, are not patentable inventions.

…            …            …

(3)

For the purposes of an innovation patent, plants and animals, and the biological processes for the generation of plants and animals, are not patentable inventions.This is qualified by section 18(4), which states that this definition:

… does not apply if the invention is a microbiological process or a product of such a process.

It may appear as though the practice of issuing gene patents is justified because gene sequences are subjected to a microbiological process. The process of isolating the gene, removing it from the human body, removing the extraneous materials and inserting it into another cell constitutes an ‘invention’.

However, in reality there is no difference between an isolated cell and a cell that occurs naturally in the human body. This is a view supported by scientists who worked on the genome project. For instance, Nobel Prize-winning biologist Sir John Sulston has said, ‘The idea that genes can be isolated from the human body is simply absurd, because the essence of a gene is the information that it contains.’ Sir Sulston is essentially saying that nothing new is being created—no invention is taking place. And, if no invention is taking place, it makes it problematic to argue that a patent should be granted. This is a view supported by Cancer Council Australia, which recently said:

… human genetic material is not an invention and should not be patented.

Personally, I think it is important that the Cancer Council supports the prohibition of granting patents over genes.

In my first speech to this House, I gave a special commitment to support cancer research. I am concerned by reports that gene patents have the potential to hinder cancer research and medical research more broadly. Cancer researchers and support organisations across the country share these concerns and are opposed to the granting of patents over human genes. This includes the founder of the cervical cancer vaccine, Professor Ian Frazer; Breast Cancer Network Australia; the Peter MacCallum Cancer Centre; the Breast Cancer Action Group NSW; and Cancer Voices NSW.

Professor Ian Olver, from the Cancer Council, has warned that gene patents could curtail the development of cancer treatments. He has stated:

If you can patent a gene, a company could monopolise it for 20 years and that would preclude anyone else from doing research and that would slow up any discoveries of new treatments …

I find this perplexing, considering that approximately 20 per cent of human genes are patented in Australia.

I also note the disturbing instance to which this motion makes reference, as pointed out by the member for Fremantle—the BRCA 1 and BRCA 2 tests. These tests are used to determine whether women have a high risk of developing breast and ovarian cancer. The demand that public hospitals cease performing the tests on the ground of patent infringement would have made the BRCA 1 and BRCA 2 tests out of reach for many women across Australia. As members of this House we have an important responsibility to help, not hinder, cancer research. That is why I am speaking in support of this motion. It makes sense to me to prohibit the granting of patents over human genes if such perverse consequences would be the result.

In light of all these things, it appears to me that there is a statutory solution to the legitimate concerns noted by the member for Fremantle in this motion. It would be consistent with the legislative intent of the Patents Act to enact amending legislation which clarifies that gene patents cannot be the subject of a patent grant under law.

I note that there is an ongoing inquiry into gene patents by the Senate Community Affairs References Committee, which is considering this question. I will be closely examining the committee’s report, which is due to be released on the last parliamentary sitting day of this year. I understand that, for a variety of reasons, this committee was originally scheduled to report on the last day of the 2009 sittings. I am particularly interested to see whether the committee concludes that there exist valid grounds against legislative amendment.

I have been made aware of counterarguments to the need for legislative change, including the argument that researchers may be unwilling to undertake research for fear of infringing a patent. I am yet to be compelled by those assertions. As it stands, and in light of the reputable support for the sentiments expressed therein, I am very pleased to support the motion by the member for Fremantle.

Malcolm Turnbull (Wentworth, Liberal Party, Shadow Minister for Communications and Broadband) Share this | Link to this | Hansard source

I congratulate the member for Fremantle in bringing forward this motion tonight and thank the members from both sides, the members for Greenway and Page on the government side, and the members for Moore and Mallee on the opposition side, who have spoken in support of this motion. I too am very strongly in support of this motion. It is a very long time since I practiced in the patent area, and I do not claim to retain any particular knowledge or expertise of patent law, but my dim recollection is that a patent needed to be an invention, there needed to be novelty. I struggle to see, as indeed honourable members have struggled to see tonight, how the discovery or identification and isolation of something which is existing in nature can be regarded as an invention. It is something that is part of us. As so many people have said—as Ian Fraser in particular said, very eloquently not so long ago—by allowing patents of this kind to continue we are in effect allowing corporations to acquire a patent on ourselves and on a part of humanity.

The honourable member for Greenway referred to the controversy that attended the litigation over the breast cancer susceptibility genes 1 and 2—BRCA 1 and 2. This is worth dwelling on. It is a matter that really goes to the vital health and the ability of so many people to deal with and resist cancer, to have cancer treated. While the names of these genes would imply that they are largely related to cancers in women, in particular breast cancer and ovarian cancer, these genes are also associated with an increased risk of cancer in men. These genes are known as tumour suppressors, and mutations of them are found to be associated with an increased risk of cancer. These mutated genes are found in women of Ashkenazi Jewish descent, for example, more often than in the wider community. Naturally, if you have a chance of having these genes, whether by reason of family history or ethnic background, or both, you would wish to be tested.

Recently, as we know, an Australian company bought the rights to these genes from an American company, Myriad, and were proposing to stop laboratories in Australia from testing for these genes without payment. They backed off, thankfully and appropriately, because of public pressure; and in the United States the Federal Court has ruled against Myriad on the basis that I outlined at the very outset of my remarks—that this is not a patentable invention; this is a discovery, an isolation of something that is part of nature and it is not in the nature of an invention. A novel test for identifying the presence of these genes may well be patentable. A modification may well be patentable. A treatment may well be patentable. But the problem is the vice of allowing the patent to subsist in respect of these genes is that it discourages and locks up research on that gene. You can tie up a gene with one of these patents and nobody else will then have the ability, let alone the incentive, to find a treatment for it or a test for it. It is vital for the interests of all Australians—indeed, for all mankind—that we have the maximum amount of research being directed at cancer. And we know that the whole of cancer diagnosis is going to be based on the study of genes and their products. Targeting genes is critical. We need to have the greatest openness and encouragement for the widest possible research. For those reasons the motion should be supported. (Time expired)

Graham Perrett (Moreton, Australian Labor Party) Share this | Link to this | Hansard source

I rise to support the motion put forward by the member for Fremantle. In April 2003 scientists announced that they had mapped around 20,000 genes in the human genome, a truly great endeavour for humankind—up there with Galileo Galilei’s heliocentric solar system, Florey’s penicillin and the Wright brothers’ first flight. With this achievement came a lot of hope that there would be new opportunities for the treatment and diagnoses of many diseases—hope also that, through genetic testing, families facing recurrent unexplained illnesses might finally have some answers. But this hope has not yet turned into reality. Our grasp has not quite matched our reach.

It is troubling, then, that we are now hearing reports that gene patents are in fact stifling research and making access to genetic testing more difficult and more expensive for patients. More surprising still that companies like South Australian-based Bionomics should use $1 million of taxpayers’ money to fund their research and then through Genetic Technologies charge $2,000 for the genetic test—a cost far out of reach of many Australians. They are denying taxpayers the benefit of the research that taxpayers themselves funded.

A similar company in the US, Myriad Genetics, charges $3,000 per test. In March this year a New York court ruled that Myriad Genetics did not have the right to patent genes linked to breast cancer and ovarian cancer as they were a ‘product of nature’.

The Australian Cancer Council is one body among many in Australia who believe that natural biological materials should be freely available for research and public health. The patent system has created a monopoly for the companies who ‘own the gene’, consequently driving up the cost of tests for patients and all but prohibiting the sharing of important medical knowledge. Back in 2008, the Australian licensee for the genes BRCA1 and BRCA2 demanded that public laboratories stop conducting diagnostic tests. And there was nothing to stop them from doing so. These are diagnostic tests, as other speakers have mentioned, that are connected with breast cancer. I should declare that my mum had breast cancer and aunts both on my mother’s side and my father’s side and my sister have all had breast cancer. But this is not the hereditary gene type of breast cancer, fortunately, I guess.

President Bill Clinton and Prime Minister Tony Blair believe that genetic information should be used for the greater good, not for the profit of the patent holders. They mentioned this at the official commemoration of the decoding back in March 2000. But while the patenting of genes continues, there seems to be no way to stop corporate overreaching overwhelming the public interest. I know the balance is hard. We want scientific endeavour to continue and this needs funds, and funds flow from protecting intellectual property rights. I understand it is a balance. But the Cancer Council points to a commonsense way forward. In their submission to the Senate inquiry on 5 August 2009 they made a compelling argument for reform and they continue to push for an overhaul of gene patents. This is happening as the Gillard government facilitates a review of the patent system. The Cancer Council said:

As we sit on the cusp of a huge surge in the use of genes in diagnostics, treatments and cures for major illnesses, it is clear that the patent law system has not involved adequately to handle sophisticated substances such as human genes and needs to be overhauled to exclude genes.

If we allow patenting of genes, we are basically allowing patenting of ourselves. The patent system should be about protecting true inventions, such as medicines developed from genetic data, but not the data itself.

Australia should set a global precedent and put public interest at the forefront of genetic science by invalidating the patenting of genes.

I echo the sentiments of the Cancer Council and call for reform of gene patents because medical research should not be just about the bottom line, particularly taxpayer funded research. I am not against the profit motive or smarter industries—Queensland has a new but already proud record in this area. Professor Ian Frazer has been mentioned by a few, working out of the PA hospital and the University of Queensland. However, the human genome project and its offspring are supposed to be about better understanding for humanity of who we are and creating a healthier future for all of us, not just the well-heeled.

I thank the member for Fremantle for bringing this matter before the House and acknowledge her efforts to support the basic human rights of all people, both here in Australia and all around the world. I commend the motion.

Deborah O'Neill (Robertson, Australian Labor Party) Share this | Link to this | Hansard source

I too want to thank the member for Fremantle for raising this issue of great importance and the motion for debate in this place today. Advances in gene therapy will be the 21st century health breakthrough. Isolating one of 20,000 genes found in every human that carries breast cancer or hereditary genetic disorder and replacing it with a functional gene will mean longer lives, less pain and less suffering.

Innovation and invention are inherent in such breakthroughs, and are very much the drivers behind economic growth, productivity and general progress. Innovation certainly needs to be nurtured, encouraged and safeguarded to ensure that the spirit of creativity is instilled in our society. We need innovation to continue to strive for the betterment of our fellow community members. However, when we are protecting not what is invented but what already exists, and when we are prohibited from accessing medical advancements because of protections, we must consider our values carefully. Gene patents limit usage of an estimated 20 per cent of all human genes. This puts a stranglehold on a clinical institution’s ability to carry out their most important work.

It is not just that private organisations, the sole owners of genes, can compel medical groups to stop using what is, under law, private property—even for research or testing purposes. The problem of restricting gene use to only those who hold the patent serves to restrict the growth of educational and research possibilities for the Australian medical industry. The Peter MacCallum Cancer Centre—Australia’s only public hospital solely dedicated to cancer treatment, research and education—articulates the worry that day-to-day screening work, commonly done by public laboratories, will be severely reduced as more and more genes are made off limits through private intervention. The centre has raised specific concerns about the potential to skew research into genes BRCA1 and BRCA2, whose mutation commonly results in breast cancer. While testing might be available, albeit at an inflated price, occasional testing of more obscure gene mutations would not be accessible, as the commercial need would mean private sector development of testing practices.

This kind of testing environment would leave Australian researchers and clinicians unskilled in detection, and would put patients at risk due to a lack of testing availability. So a fundamental issue in gene patenting is that of access—access to affordable health care, access to best practice treatment, access to world leading research and development. This fear of a lack of access is also held by the Association of Genetic Support of Australasia, a charitable support group for many families and their children. The association deals with genetic disorders on a daily basis and fears the worst if genetic patenting is to continue unhindered.

I am not comfortable allowing the Australian experience of universal access to health-enhancing and potentially life-saving testing services to mirror that of the United States, where too often we hear that only those who can afford it are assured of care. We cannot let a situation develop that would require an Australian patient to travel overseas to have a test performed there because it is cheaper than having it done locally. We must work to ensure that we sufficiently skill and enable our medical personnel to perform tests quickly, cheaply, and locally, so that patients are not forced to send samples overseas to get results in a less timely fashion than would be the case if testing occurred in Australia.

There is another critical aspect to this debate. As gene therapy progresses, so will the issues of privacy related to it. Australia’s current insurance industry maintains fair and balanced membership standards where the presumption, even with existing medical conditions, is that cover will be granted to those who apply without prejudicial knowledge of what may occur to the applicant 10, 20 or 30 years down the line. However, as our knowledge of this area increases and we are able to link genes to specific medical conditions in later life, we must ensure that patents are not used to prejudice the hopes or chances of fairness in the future.

It is the responsibility of this government, and all governments, to ensure that their people have unencumbered access to the best standard of health care, and while gene patents are restricting development of medical advancements that cannot occur. As such, I support the call from the member for Fremantle to amend the Patents Act 1990 to ensure that patents cannot be granted over any biological materials which are identical or substantially identical to that which exists in nature.

Ms Anna Burke (Chisholm, Deputy-Speaker) Share this | Link to this | Hansard source

Order! The time allotted for this debate has expired. The debate is adjourned and the resumption of the debate will be made an order of the day for the next sitting.