Bill Heffernan (NSW, Liberal Party) Share this | Hansard source

I rise to thank the Senate for its generosity in agreeing to an inquiry into the impact of gene patents on the provision of health care in Australia. I rise also to promote public debate and thought on this issue and to explore a few of the possibly unintended consequences of this, and to acknowledge the work done by several authors, including Rohan Hardcastle, Luigi Palombi and others.

I realise that the world is concerned with the financial meltdown at the present time. I have often said that, in public life, if you have got an inquiring mind, the more you know the worse you feel. I feel really bad about what I am about to talk about. The world financial crisis was probably caused by the extension to 40 times their capital base of some of the merchant banks in America such as Lehman Brothers, whereas in Australia they have been confined to an extension of less than 10 times their the credit base. The global financial instruments market has fallen into a heap and it is going to have serious consequences. This time next year we will really be starting to feel it. But the world moves on. The carbon market will become a river of gold for all the same people who play pass the parcel with financial instruments—and so will the gene patenting market.

In March 2000, when the genome was mapped, President Clinton and Prime Minister Blair argued that raw data of this nature should be free. Patents are placing controls on this raw data. The fiction argued by proponents of gene patents is that once they remove the gene from its natural environment—that is, the human body—they have an invention. Of course this is a complete nonsense. Most people are alarmed when you talk to them about it. The joint press release that come out of the White House in March 2000 said:

In the last decade of the twentieth century, scientists from around the world initiated one of the most significant scientific projects of all time: to determine the DNA sequence of the entire human genome, the human genetic blueprint. Progressing ahead of schedule, human genome research is rapidly advancing our understanding of the causes of human disease and will serve as the foundation for development of a new generation of effective treatments, preventions, and cures.

To realize 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. 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. Intellectual property protection for gene-based inventions will also play an important role in stimulating the development of important new health care products.

In 2003 a company called Myriad Genetics took out four patents in America. So there is no confusion about what those patents are—and there is at present lobbying around this building that I have got this wrong, but I have not got it wrong—there are three Australian BRCA1 patents, 686004, 691331 and 691958, and one BRCA2 patent, 773601, that have been granted by IP Australia. The owners of these patents vary, but Myriad Genetics USA is a part owner of all patents. All four patents expire. The BRCA1 patents expire in 2015, BRCA2 in 2016. Two BRCA1 and BRCA2 patents define the primary invention to be an isolated nucleic acid—that is, DNA that has been removed from the human body. The BRCA1 patent 691331 defines the primary invention to be any method of detecting in a human being the DNA or a biological derivative of the human gene that codes for the mutant protein BRCA1.

In October 2002, Genetic Technologies Ltd, an Australian company, became the exclusive licensee of all four patents. The Patents Act 1990 provides in section 18(1) that IP Australia is permitted to grant a 20-year patent monopoly for an invention that is novel, involves an inventive step or is industrially applicable. No Australian court has ruled on whether an isolated biological material that is identical or substantially identical to a naturally-occurring substance or material such as a human gene is a proper subject of letters patent in Australia. I am pleased that the Senate inquiry, which has broad-ranging terms of reference, will be able to investigate this matter. Genetic Technologies’s job—I have spoken to their gentleman this morning—is to get a quid for their shareholders and, the more patents they can accumulate, the more their share are going to be worth.

I will give you the tone of what is done around Australia to a whole body of research in a whole lot of public laboratories with great people in them. This is a typical application of the financial instrument from Gene Technologies:

I am writing to notify you that Genetic Technologies Limited (Genetic Technologies) is seeking to enforce its intellectual property rights with regard to offering diagnostic testing of the BRCA1 and BRCA2 genes for suspected cases of hereditary breast and ovarian cancer syndrome in Australia and New Zealand. In the interests of avoiding costly and time consuming litigation, Genetic Technologies proposes a commercial solution whereby Genetic Technologies will perform all of Peter MacCallum Cancer Institute’s future BRCA1 and BRCA2 testing requirements as settlement of all Peter MacCallum Cancer Institute’s past and prospective infringement of our exclusive patent rights.

What an insult to the public health system! Where are we going? They continue:

Gene Technologies has invested millions of dollars to both procure and be in a position to exploit these exclusive rights.

They conclude with a threat:

However, in the event the Peter MacCallum Institute is not prepared to provide the requested undertaking by the given date in this particular letter, of 14 July 2008—

which has been deferred—

… Genetic Technologies will then immediately proceed with legal action without further notice. Our lawyers have prepared a detailed statement of claim and are ready to file an application with the Federal Court if necessary.

That created great alarm across Australia. I am so pleased and privileged to stand in a parliament that has agreed to look at this. This is as big a question for the human race as coming to terms with some of the disgusting things that have appeared in our history in the past, such as the status of slaves in the Roman Empire, who for hundreds of years were determined to be chattel in the household. They had the same status as the chair or the table, and it took hundreds of years to fix. We look back now and say, ‘How could we have done that?’ I am wondering whether we are going to look back in years to come and say, ‘How can we have allowed this to happen?’

With their permission, I want to briefly read parts of a letter. I have a heap of other material, which I will run out of time for but no doubt will use at the inquiry. This is from two sisters who have written to me. They are seen by Professor Judith Kirk, the director of the Familial Cancer Service at Westmead Hospital in Sydney. They are beside themselves. They say:

My sister and I, as above, are writing to you to express our deep concern and dismay at the prospect of Genetic Technologies Ltd having the sole control of testing for familial breast cancer genes, in particular BRCA1 and BRCA2.

By the way, one of these genes is now discovered to be crossing over into the precursor for prostate cancer. The letter goes on:

This affects us and our families personally. Our brief histories are as follows.

One of the sisters—I will not name them—now aged 62:

… was diagnosed with breast cancer at the age of 33 and received treatment in 1979—total mastectomy. There was no lymphatic involvement. Further treatment was considered unnecessary.

Sister 2, now aged 66:

… was first diagnosed with breast cancer at the age of 52 in 1994. This was treated with a surgical lumpectomy and, as there was lymph node involvement, chemotherapy and radiotherapy. Following the treatment there was adjuvant therapy for seven years until a second primary cancer in the other breast was diagnosed and treated with surgery. As a result of these three cancers, together with family history going back generations, we qualified for familial genetic testing under Associate Professor Judy Kirk at Westmead Hospital in July 2002. From the very first telephone contact to the present time, we have been treated with the utmost respect, care and compassion by all the staff of the unit. Associate Professor Kirk clearly explained that we were in fact risk patients for further cancers, both breast and ovarian, and therefore blood samples were obtained for testing—

for the first sister—

… as her cancer had presented at a younger age. There was no cost for this service. We were happy to wait until 2003 for our results on this basis, having been offered faster and expensive alternates. Unfortunately the results were inconclusive, although the team at Westmead strongly believe that we do carry the faulty gene. On that basis we were counselled that surgical removal of our ovaries should be undertaken to reduce but not eliminate our ovarian cancer risk. We both understand the possibility of further breast cancer in the future. Professor Kirk advised us that the blood sample would be kept on file and continued testing would occur as technology improved. It is her understanding that this will not occur in a private laboratory.

The letter goes on:

Senator Heffernan, the diagnosis and subsequent urgent treatment for breast cancer is a major life-changing event. Then to discover that this insidious disease may in fact be passed on to our precious family members is an emotional burden. The support of the caring environment at the Westmead familial cancer centre has sustained us over six years and given us hope that a conclusive result will eventuate in the fullness of time. Should this genetic material be transferred to a profit-making business, possibly tested once or twice and then discarded with the costs incurred, our peace of mind would be destroyed along with the blood samples. We thank you for your being instrumental in being presenting this issue to the Senate. The importance of personal counselling information cannot be underestimated.

That is typical of the response from thousands of people who are now aware that what we are doing is turning years and years of public research into a financial instrument for financial gain.

I will just give a little history. There are current clinical services and testing in public laboratories on these particular genes. The bigger question for the Senate committee is: should we, under the Patents Act, be allowing patents to be taken on naturally occurring body parts? Current clinical services and testings have been in place since 1994. In 2003, GT made a statement to the Australian Stock Exchange that, although GT would be offering testing, the IP rights from Myriad would not be enforced, as a donation to the people of Australia—and New Zealand, I might say. Public labs and infrastructure have been further developed since then on this basis, using a cooperative team of expert Australian senior scientists in NATA-accredited public laboratories in most states.

GT now demands that all these labs now cease testing. Samples sent to a private lab are lost to the public good for the future and become the property of the private lab. Samples held in public laboratories can be used to test new genes not patented that may be identified in research or to apply new, improved technology for gene mutation tests. What happens when all these samples disappear out of the system? At Westmead Hospital they have samples from the early 1990s which they can go back to and test when new technology comes along, to get some understanding.

As Bill Clinton and Prime Minister Blair said, this ought to be public property. Einstein made discoveries for the betterment of mankind and did not take patents out on them. This is something everyone in Australia needs to become alert to. Australia, with the patent complexity under what is proposed, will do the testing here in Australia due to Genetic Technologies having a variable litigation prospect with the American company. Genetic Technologies discovered Myriad in America was breaching one of their patents so there was a settlement. But everywhere else in the world—places like Japan—when a test is taken from a distressed family, under the patent the test has to be sent to America to be tested. It will occur in Australia, if we allow this to go on, that governments will have to make decisions on who gets the test and on the break-up of the public health dollar. We are going down a very dangerous path. I am very grateful for this time to talk about it. (Time expired)