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

I want to place on record my gratitude to those members who spoke in support of my motion relating to gene patents that was debated on Monday, 18 October: the members for Moore, Page, Moreton, Mallee, Greenway, Robertson and Wentworth. We spoke of how patents over human genes are preventing Australian doctors and scientific researchers from carrying out testing for disease and research for treatments because these patents prevent access to the underlying genes causing disease. We also spoke of our collective bewilderment as to how patents could even be granted over genes, given that they are naturally occurring phenomena and not inventions.

Tonight I wish to speak to a related aspect of the gene patents debate, and that is the direct link between the granting of gene patents and the cost to the PBS in the supply of essential biomedicines to the Australian people. I will illustrate this with the specific case of erythropoietin. Two decades ago a 22-year patent entitled ‘Polypeptides of erythropoietin’ was granted by IP Australia to Kirin-Amgen, a US biotechnology giant. Amgen is the world’s largest biotechnology company, and it is easy to understand why once you know of the billions of dollars it has received on the back of this one patent. Erythropoietin, also known as EPO, is a naturally occurring human protein. It controls the production of red blood cells in the human body, a function it has performed as humans have evolved. EPO is given to patients on chemotherapy and kidney dialysis.

In 1983 one of Amgen’s scientists, Dr Lin, identified the human gene that regulates the production of EPO in the body. He was only able to do this because Amgen was given exclusive access to samples of this substance extracted from human urine by a US academic scientist. That scientist, Dr Goldwasser, had received substantial amounts of US taxpayer research funds to undertake his research. But having gained a valuable biological sample he gave it exclusively to Amgen, which used it to identify the human gene which contains the genetic information for EPO.

The genetic sequence of the human gene was not invented by Amgen. In fact it is identical to the human gene as it exists in every human being. This is an undeniable fact, as a US court found in 1989. The court said:

… the overwhelming evidence, including Amgen’s own admissions, establishes that uEPO—

human EPO—

and rEPO—

synthetic EPO—

are the same product. The EPO gene used to produce rEPO is the same EPO gene as the human body uses to produce uEPO. The amino acid sequences of human uEPO and rEPO are identical.

But on the basis that Amgen had been the first to identify the gene and isolate it—that is, merely remove it from the human body—IP Australia decided that Amgen had met the patentability criteria provided by section 18(1)(a) of the Patents Act, namely that it had invented erythropoietin.

How can this be so? A human gene carries the genetic information common to all humans. It might be a chemical but its sole function is to store biological information, much as a DVD or CD stores digital information, so that when it is played by the human body the end result is a protein. But there is an important distinction. While the digital information stored on a DVD is the result of human creativity, a human gene and the information it contains is a product of nature.

As a result of the grant of this patent over the EPO gene to Amgen, the cost to the Australian taxpayer through the PBS has been over $1.5 billion. But the exorbitant cost of this biomedicine, which is little more than a synthetic form of a naturally occurring biological material, has been exacerbated because, during the time when Amgen held an exclusive 22-year monopoly, it was the exclusive supplier of this biomedicine under the PBS. Since their introduction on the PBS, EPO biomedicines have been No. 1 in the PBS Highly Specialised Drugs list. In 2006, the last year of Amgen’s patent, the cost of EPO to the PBS was nearly $100 million.

What this has also meant is that Australian companies were unable to manufacture EPO in Australia. Nor were they able to supply it in competition to Amgen. Not only did this mean that the cost of EPO to the PBS was much higher than it needed to be, but it meant the loss of Australian jobs in Australia’s generic medicines industry. Furthermore it has prevented Australian R&D into EPO biomedicines.

In the long term we know that genetics is going to play an even greater role in the health of Australians and so it is critical that this parliament eradicate these morally offensive, legally unjustified and research-suppressing gene patents once and for all. We must return innovative competition to Australian scientists and to Australian manufacturers of generic biomedicine so that they can work together to improve health outcomes, spark deeper and wider research and massively reduce the unnecessary impost on the Australian taxpayer.