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Thursday, 12 August 2004
Page: 26395


Senator ALLISON (7:46 PM) —Minister, there are cases right now on this very subject in our courts. As I referred to earlier, the Clayton Utz paper—which was circulated to most senators a few days ago—demonstrates that this is precisely what the current arguments are. To suggest that there is no so-called `evergreening' in this country already is quite false. It has already been established that these are the kinds of cases that are currently out there. I do not think you are able to assure us at all that this is not simply going to make it easier for those pharmaceutical companies to keep generics out of the scene. I would have to say that it is not very convincing. The reference in this document says:

Most of the Australian patent action in 2003—

and there has been quite a lot—

has been in connection with the introduction of bio-equivalent generic pharmaceuticals in challenge to the monopolies which are guarded jealously by the innovator pharmaceutical companies. In this regard, the Federal Court currently has litigation before it concerning omeprazole, paroxetine, epirubasin and other products. The 'generic v big pharma' battles are very interesting because it remains to be seen whether Australian courts will follow the very firm lead given by the UK courts which are now effectively obliging generics entering the market to obtain declarations of non-infringement and/or challenge the big pharma patents before launching their products.

That last sentence seems to be precisely what this legislation is doing—to oblige the generics entering the market to obtain declarations of non-infringement. That seems to me to be going down the path of accommodating big pharmaceutical companies. The report goes on to say:

The power of the big pharmas is seen as well in the current free trade agreement negotiations between Australia and the US which involve the US seeking major concessions from Australia with respect to access to the Australian market ...

I repeat: major concessions with respect to access to the Australian market for US pharmaceutical companies. The report continues:

The US wants Australia to modify its PBS reimbursement scheme so as to ensure that US pharmaceutical companies are able to charge higher prices for their products in Australia, the increase being funded by an increased PBS subsidy.

This is not some radical lobby group. This report was prepared by Clayton Utz, who do a great deal of work in intellectual property law and who did this analysis last year. That is what they say; I am not making it up. It is not as if the Democrats or the Greens or anyone else are imagining that this is a possibility. It is coming from academics, as we have already said. It is coming from lawyers and people who work in this field. It is certainly coming from advocacy groups, who are very worried about it. It is not coming so much from the generic manufacturers because, as we all know, they are mostly owned by the pharmaceutical companies. I think it is a real concern, Minister, and I do not know that you have satisfied us that it is not a problem.