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Wednesday, 4 December 2002
Page: 7186

Senator PATTERSON (Minister for Health and Ageing) (5:33 PM) —I will obviously take some time to respond because this is an important issue. Senator Collins has moved an amendment to clause 26 of the bill which would require the NHMRC Licensing Committee to revoke automatically a licence if the licence holder applies for a patent under the Patents Act 1990 `for any unmodified stem cells from human embryos'. I think we could all agree that the patenting of biological lines raises difficult political, ethical and commercial issues. We discussed some of these matters last night, but I want to put them back together on the record.

Patents law is a complex matter which cannot be addressed in an ad hoc way through this legislation. Any possible amendments should only be contemplated after very careful and detailed consideration to ensure that they do what is intended. This is a matter, as I have indicated before, much better dealt with in the context of a separate review process. The legislation was never intended to regulate stem cells; it only regulates the use of embryos. Any move beyond that would take the legislation far beyond the original intent of COAG. It is not absolutely clear to me what Senator Collins means by using the term `unmodified stem cells'. My understanding is that patents will be granted if inventions meet the statutory patentability requirements such as novelty, inventive merit, industrial application and adequate disclosure of the invention in the patents specification.

The amendments only catch a very limited class of people and therefore lead to inconsistencies and an unequal playing field. For example, what would be the impact on people who are not licence holders under the bill? Making amendments to this bill will not stop people who are not licence holders from seeking a patent. If these amendments were supported, we could have the situation where a licence holder had completed their initial research on embryos, the licence period had expired and the researcher would then be free to apply for a patent. It would also not stop people overseas registering patents in Australia.

A number of years ago, the US issued a patent known as the Thomson patent through the Wisconsin Alumni Research Foundation for the commercial application of certain stem lines. WARF also filed for a patent in Australia but subsequently allowed the application to lapse. The point is that any amendments restricting what licence holders can do and what they cannot seek a patent for would have absolutely no impact at all on this scenario and the capacity of a US organisation to seek a patent in Australia. This reinforces the need to avoid ad hoc changes to this legislation and to address the matter at the source, as I said, through Australian IP legislation. In a similar vein, Senator Collins's amendments do not appear to deal with existing patents but rather only revoke licences from those who apply for new patents. This seems to be rather anomalous. Licence holders who make new patent applications will have their licence revoked and will be unable to continue the research. However, licence holders with existing patents will not be affected.

Further, under the amendments, a company that is a licence holder would still be able to grant IP rights under a patent—for example, an exclusive licence to another company to continue the work started by the original licence holder. There is nothing to prevent the company to whom the IP rights have been transferred from being granted a licence from the licensing committee, provided, of course, that it meets the criteria in the legislation. I would add that IP licensing arrangements such as these are extremely common. I am aware of a number of Australian companies that hold licences from organisations who have patented certain processes overseas and it would appear that they would not be affected by the amendments. All of the issues regarding the patenting of biological material apply equally to embryonic stem cells, adult stem cells and all other cells and tissues.

During the debate on this bill there has been much discussion about the developments that have occurred as a result of the use of adult stem cells. The therapies which were developed as a result of the use of adult stem cells would not have been possible without commercial investment and accompanying IP protections providing the capacity for companies to market the therapies. The same opportunities should be considered in relation to embryonic stem cell research.

On the basis of the debate in the Senate it is clear that we all want to see the potential of stem cells being turned into therapeutic products which can help people—we might have a disagreement about whether they are embryonic or adult stem cells—but this must be done properly. To do this properly, to undertake extensive studies and trials and properly test the efficacy and safety of the therapies, takes significant investment. The size of the investment required simply cannot be met solely by governments and academic institutions, and therefore it must be supplemented by private investors. The fact is that private investors will not invest unless they stand to make a return on their investment, and they can do that only with proper intellectual property arrangements.

Senator Collins has attempted to include a sunset clause to repeal the operation of her amendment if the review under clause 47 is completed and parliament enacts legislation regarding commercial interests. It is ambiguous as to what type of amendments would need to be passed to give effect to the sunset clause. The term `commercial interests' is very broad and it would be difficult to know as a matter of legal interpretation whether or not the sunset clause has become operative. It is very unusual to repeal a provision, and I am sure that lawyers would have to exercise their minds about that.

I want to add an important development that has occurred, but it has not just happened as a result of the bill; it has been under way for some time. I announce that today the Prime Minister has agreed to a proposal by the Attorney-General for the Australian Law Reform Commission to undertake an inquiry into intellectual property. This is very important for those people who have a concern about the patenting issue. I would like senators who are listening in their rooms to take heed of what I am saying. For those of you who have half an ear on the debate, I would like you to really concentrate at this point because some people have a concern about the patenting issue.

I reiterate that today the Prime Minister has agreed to a proposal by the Attorney-General for the Australian Law Reform Commission to undertake an inquiry into intellectual property issues raised by genetic information. The proposal arose out of a joint Australian Law Reform Commission and Australian Health Ethics Committee reference on the protection of human genetic information. The inquiry will focus on human health issues, including the impact of current patenting laws and practices relating to genes and genetic and related technologies, the conduct of research, and the Australian biotechnology sector. The inquiry will also focus on any problems with current laws and practices, with the aim of encouraging the use of intellectual property to further the health benefits of genetic research. Biotechnology Australia advised that stem cells would be in the scope of the review.

As I argue now and have argued earlier, it is vital that this be dealt with not in an ad hoc way but in an overall way, taking into account the fact that this bill is about embryos and not stem cells, and the fact that it does not cover adult stem cells. Therefore, I will be opposing the amendment, because I consider that it would pre-empt the outcome of the review. The government has already made a commitment to review the patenting arrangements of genetic material in Australia. To act on this bill in an ad hoc, knee-jerk way is simply not appropriate. I will be opposing Senator Collins's amendment.