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Wednesday, 4 December 2002
Page: 7190


Senator MURPHY (5:48 PM) —I will begin my response to Senator Collins's amendment by reading part of an answer given to a question I asked yesterday, which was incorporated by Senator Minchin today. The answer stated:

In Australia, biotechnology inventions are patentable, provided the invention meets the requirements of the Patents Act. The raw data obtained from the mapping of the human genome, that is the total human DNA, is not patentable. However, patents may be granted for inventions involving human DNA and gene fragments or human cell lines that are new, inventive and useful. Not all inventions in the field of biotechnology are patentable. Subsection 18(2) of the Patents Act expressly excludes the patenting of human beings and the biological processes for their generation.

The Government recognises that patenting in the human biotechnology area is both a sensitive and important issue, raising fundamental concerns that include moral and ethical issues, the impact on freedom of research in Australia and ensuring Australians have access to the latest health technology and health care. Without patent protection, neither foreign nor Australian enterprises will be encouraged to manufacture medical innovations and make them available in Australia.

In light of recent concerns regarding patenting in the human biotechnology area the Government is giving active consideration to a review of this issue. The Government is currently considering the Terms of Reference for a review to be conducted by the Australian Law Reform Commission on gene patenting.

The Minister for Health and Ageing, Senator Patterson, did raise that by saying that the terms of reference have now been issued to the Australian Law Reform Commission, and I am pleased about that.

With respect to my own amendment, I had given some thought to going down the same line that Senator Collins has proposed in her amendment, but I had some concerns that amending this legislation in that way would create some difficulties. That is one of the reasons why I suggested that the effective date of operation of this legislation be delayed until the Patents Act is amended. The Patents Act is the legislation that must ultimately be amended to give the type of protection that we need for potential investors in this areas and in order to ensure that any therapeutic, medical or remedial findings that come about as a result of stem cell research, particularly embryonic stem cell research, are going to remain affordable to Australians who are in need of them from a health point of view.

The government's vision for biotechnology—and this in the explanatory memorandum which I circulated with my amendment—states:

... consistent with safeguarding human health and ensuring environmental protection, Australia captures the benefits of biotechnology for the Australian community, industry and the environment.

That is an admirable goal, but what I cannot understand is that, given that the biotechnology age has been around for a little while, we have not proceeded to deal with one of the fundamental issues.


Senator Stott Despoja —Are you really surprised?


Senator MURPHY —I should not respond, because this is a very serious issue, but I am not really surprised. I take that interjection from Senator Stott Despoja. I know why she made it, and I think it was justified. But we are now proceeding with a piece of legislation that is going to allow more research that will offer up opportunities for patents to be claimed. Let us look at what has happened thus far in respect of patents in this area. Most of them have been claimed by overseas companies. How is that really going to assist Australian industry?

Why should it be the case that, at some point down the track, as a result of patents claimed now, patents which have been claimed previously or patents which are likely to be claimed in the future by overseas companies, particularly large pharmaceutical companies, Australians get to pay through the neck for the medical remedies and therapeutic services that might be provided to them through medical findings? Why should it be the case? I know we have all heard the minister in respect of the cost of the PBS. By way of an example in terms of the types of cost, a UK hospital received demands for $US6,000 to use a gene for cystic fibrosis which was employed to screen patients for that disorder. Is that the sort of process that we want to allow ourselves to be caught in? I would think not. I think that at the least we ought to be setting down some rules in respect of patentability. We ought to put them in place before we allow more research to be considered.

I have heard Senator Patterson say, `This is all about stopping the bill.' This is not about stopping the bill. That simply is not the case. The Patents Act could be amended very quickly, and it could be amended by next February next year. There will not be any significant advances, given that nothing has really happened in respect of embryonic stem cell research anyway, but we should proceed to put in place the rules of the game first. Would such an amendment—be it mine or even Senator Collins's—have any impact on investment? Yes, it would. It would actually assist it.

The same sorts of rules apply in the UK, in France and in Germany as I have proposed in my amendment. They are exactly the same. The only difference is this: they apply across the board. They do not choose between embryonic stem cells, for instance, and adult stem cells. I am happy for that to be the case, because I think ultimately the Patents Act should probably be amended to take account of that. It should have that broad coverage. But there is a difference— and I think Senator Collins has referred to this difference—when you look at it from an ethical point of view. The ethical issue is that you actually have to destroy the embryo to extract the stem cells. That is why I restricted my proposal to embryonic stem cells. I think it is fundamentally important, given what has happened with the National Stem Cell Centre and given the evidence that has been drawn out in the course of the committee hearings in respect of who is in which position with which company, located where, et cetera.

It is of fundamental importance that we make sure with this type of research that we have got the laws in place to ensure, as I said and as the government said, that, consistent with safeguarding human health and ensuring environmental protection, Australia captures the benefits of biotechnology for the Australian community. That is what this has to be consistent with, and that is what we should be doing. If we do not do that, we will be back here saying, `Woe is us; the PBS is confronted with another massive blow-out,' because all the things that we have discovered—and in part publicly funded, I might add—have been patented somewhere else in the world. If you look at the patenting that is happening around the world, there is a trend towards more patenting of upstream research. That is the basic research area. In terms of the issues that I was looking at in the US, for instance, it has been estimated that over 90 per cent of current US patents—and I think I put this in the explanatory memorandum—are never exploited. That tends to suggest one thing—that is, that they are to block other people from using them.

In the US they have what is known as the Bayh-Dole Act, which deals with licences on a case by case basis and which sets down very substantial restrictions and intellectual property sharing requirements. I do not think that we want to do that but, if you look at what has happened in the US with regard to the restrictions that they have alone and the type of investment that has occurred since those things have been in place, you can see it has not hindered it; in fact, it has enhanced it. I am suggesting a very simple, straightforward approach. It is consistent with the WTO requirements on the TRIPS agreement. It is consistent in part with what happens with the US, only it is a different approach. It is consistent with those laws in the UK, France and Germany. The UK act states:

An invention of a method of treatment of the human or animal body by surgery or therapy or of diagnosis practised on the human or animal body shall not be taken to be capable of industrial application.

The Patents Office manual sets out the definitions of surgery, therapy, diagnosis et cetera. In France, the Intellectual Property Code says:

Methods for treatment of the human or animal body by surgery or therapy and diagnostic methods practiced on the human or animal body shall not be regarded as inventions susceptible of industrial application within the meaning of Article L. 611-10. This provision shall not apply to products, in particular substances or compositions, for use in any of these methods.

I am talking about something that is already in place in other countries in the world. It is as straightforward as that. I do not want to take up any more of the committee's time, because I know we have our backs to the wall in terms of time. But I want to say that this is imperative; we do not have time for an Australian Law Reform Commission review that could take 12 months or longer. Then it could take another six months to begin developing legislation or amendments to the Patents Act. These things can be done very quickly. If they had any effect on the timing and operation of this act it would be very minimal. As I said, I am sure, given the legislation that exists around the world, that a legislative draftsperson could come up with a proposition that would be more than adequate to deal with these issues so that this parliament could pass the legislation in the first two weeks of next year. That would have no effect on the research that is proposed to be allowed under this particular bill.