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

I commend the member for Shortland for her motion and I am very happy to speak in support of the motion and to be one of many people trying to help raise awareness about this terribly damaging disease on Pink Ribbon Day and World Breast Cancer Day.

In Australia, breast cancer afflicts tens of thousands of women and also a smaller number of men every year. It is the leading cause of cancer deaths for women and one in nine women will be diagnosed with breast cancer before age 85. It is a cancer that can occur spontaneously, but some people are genetically predisposed to this form of cancer. We know that for women and men with certain mutations to the human genes known as BRCA1 and BRCA2 the chance of suffering from breast cancer is much higher. These particular genes, present in all people, actually function to provide some kind of protection against cancer, but unfortunately there are inheritable genetic mutations that for some reason spoil that function. In people whose natural genetic safety mechanism has this flaw the susceptibility to breast cancer can run as high as 80 per cent.

Family history of breast cancer has always been recognised as a strong indicator of susceptibility to the disease, but for a long time medical science could not say exactly why. That all changed in 1990 when, after 16 years of dedicated publicly funded research and the goodwill of hundreds of women who provided DNA samples, a team headed by Professor Mary-Claire King at the University of California in San Francisco made the breakthrough discovery that linked hereditary breast cancer to the human gene BRCA1. It was found to be on human chromosome 17q.

Each of us carries a genome in every cell in our bodies, a complex code that makes us who and what we are. The genome contains 46 chromosomes, and the chromosomes in turn are the repository of some 25,000 protein-coding genes. It is these genes that constitute the blueprint of our inherited genetic information. At the beginning of the 21st century, in a time that is likely to be regarded as an era of great progress in our understanding and use of genetic information, those 46 chromosomes and the 25,000 protein-coding genes they contain are humanity’s most precious common wealth. Our collective ownership of the genetic material we all share is surely one of the indisputable limits to the extent of what can be privately owned. I believe the vast majority of people would certainly think so.

In 1993, only three years after Professor King’s discovery that human chromosome 17q was the location of the BRCA gene and that the gene was linked to hereditary breast cancer, scientists at Myriad Genetics made a further discovery. This US company, formed jointly by Dr Mark Skolnick, a research scientist at the University of Utah, and Mr Peter Meldrum, a venture capitalist, took Professor King’s work a bit further and identified some of the genetic mutations that predisposed people to breast cancer. It is not hard to see how Myriad’s discovery, however valuable, was really only the tip of Professor King’s research iceberg. Myriad was formed in 1991 for the specific purpose of patenting the genetic mutations it hoped to identify as being linked to breast cancer. Dr Skolnick was one of the many US genetic researchers who had become half-scientist and half-entrepreneur. These people were part of a new breed of gene hunters hoping to become rich by first discovering and then owning the genes they identified. This is where the patent system comes in. In Dr Skolnick’s own words, the patent monopoly was ‘the real fruit’ in his company’s research effort, because only with a patent could Myriad control both the information coded within the relevant gene and any medical technique or treatment extrapolated from that information. Myriad realised that the best way to maximise profits for its investors was to prevent any other company or organisation from providing BRCA gene testing in the United States, Europe, Australia, and elsewhere. Today, in the US, the cost of Myriad’s BRCA test is US$4,000. The problem is this: Myriad’s scientific team did not invent the BRCA gene mutations which make people susceptible to breast cancer. They merely discovered them. And they were only able to do so within three years of their research program because of Professor King’s 16 years of work, the results of which she disclosed to the world without any conditions or encumbrances.

That, however, is only part of the story because at the same time, in the UK, another research group was also working towards identifying the BRCA mutations. As so often happens in the course of human endeavour, Professor King’s breakthrough—her eureka moment—had opened up a new branch of competitive scientific research. Unfortunately, from the time that Myriad achieved its patent over the BRCA gene, that research stopped dead. It is a great shame that Dr Skolnick and Myriad were not prepared to be as generous with their incremental insight into our genetic code as Professor King had been with her much more fundamental discovery, because today thousands of women with a predisposition to breast cancer are denied cheaper and potentially better treatment as a result of the private ownership by Myriad of these women’s own genetic information. That might sound like the plot of an evil science fiction film, but it is true.

The greatest cost and the greatest shame is not the price of Myriad’s monopoly over the BRCA diagnostic test, although US$4,000 is a very high price. The real cost is in the obstruction that the patent has represented in terms of further advances in medical science to identify and prevent breast cancer. We know that in Australia research scientists at the Peter MacCallum Cancer Centre had their work into breast cancer delayed by two years and their costs ballooned 300 per cent because of Myriad’s Australia-held patents on the BRCA genes. Former Australian diplomat and expert on international intellectual property development Anna George has written that ‘patents on human gene sequences that are awarded by IP Australia can at any time be traded as commodities on the global stock exchanges and the stock package can include rights to the samples of DNA harvested from Australian citizens’.

When one considers the affront to common sense that gene patents represent—and, what is more, the affront to the basic legal concept of what is patentable—it is, unfortunately, a poor reflection on our current system of regulating intellectual property in Australia. Both public health and the public purse demand that we reconsider the patent system in Australia and the role of the regulator, IP Australia. And it is for these reasons that I have spoken a number of times in this place recently about the moral and public health policy imperative of amending the Patents Act to make sure that genetic information cannot be monopolised for private gain. If our scientists are to be in a position to deliver the new and wonderful medicines, tests, treatments and cures which we know are possible, then we need to give them free and uninhibited access to the human genome and other biological materials that exist or are derived from nature. If inventions are to be encouraged and technological innovation stimulated by the patent system, then it is essential that the distinction between invention and discovery be properly applied. Granting patents over discoveries of what exists in nature will only leave us in the genetic dark-age because it will inevitably thwart and hinder the progress of medical science and therefore the struggle to win the battle against diseases like breast cancer.

According to Anna George:

The patent bureaucracy and the patent industry, particularly the patent lawyers through a series of legally untested bureaucratic decisions managed to extrapolate from patent decisions made over 30 years ago (which allowed patenting of chemical substances) and to use this rationale to justify awarding patents on human gene sequences. It could be described as incremental ‘patent creep’. A better description might be regulatory capture based on arguments similar to the ‘too big to fail’ arguments used by other industries who demand that governments provide unquestioning support for their operations … This is about awarding monopoly power over the basic scientific tools for health research, it is about the costs of health services paid by the Australian public and it is about the efficiency and the ethical underpinnings of the Australian patent system and who it is supposed to serve.

This Labor government has shown its resolve to advance the fight against breast cancer. The 2009 budget committed a record $2 billion to create a world-class cancer care system, and this included $120 million to upgrade BreastScreen Australia services nationally with digital mammography technology and $168 million to fund the Herceptin program for the treatment of metastatic or advanced breast cancer. The government’s initiatives include support for the training of specialist breast care nurses, better services for women with breast cancer in rural communities and the reimbursement of costs associated with breast prostheses. As part of that effort, it is important that we enable scientific and medical researchers in Australia to forge new and better tests and treatments for breast cancer and other diseases. This will require amending the legislative and regulatory framework that currently allows private companies to own and control, by patent, genetic information which should be incapable of private ownership. Such reform is strongly supported by the National Breast Cancer Foundation and the Cancer Council of Australia, among others. In the words of Ms Heather Drum from the Breast Cancer Network Australia, in her evidence to the Senate committee inquiry into gene patents last year:

If you discover a cure or a treatment, patent it but not the gene. Surely if the genes are available to everyone to research, they can all come up with some sort of treatment. The competition will still be there. Women are still being diagnosed with breast cancer every day. So let us have the competition about the research on how to find a cure then patent the cure.

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Patent the cure, not the gene.

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