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Thursday, 12 August 2004
Page: 26392


Senator ALLISON (7:30 PM) —The Democrats oppose schedule 7 in the following terms:

(13) Schedule 7, page 80 (line 2) to page 83 (line 12), to be opposed.

Amendment (13) effectively takes out schedule 7. Schedule 7, as we know, brings in a new certification scheme in which generic manufacturers must either certify that they will not infringe a patent or certify that they have notified the patent holder of their intention to market a drug. While this does not in and of itself delay the introduction of generic medications, we argue that it is likely to do so by deterring generic manufacturers from bringing the drug onto the market until all potential litigations have been dealt with. Our amendment simply strikes out all of the changes being proposed by the government and maintains the status quo.

We are essentially arguing with this amendment that we do not want to see any changes put in place as a result of the free trade agreement. Overall there are about 50 provisions within the legislation, not all of which are caught up with this legislation, that we say undermine the capacity of the Australian government to determine which drugs will be put on the PBS and which drugs can come off patent and be replaced by generics, and that undermine the capacity to promote affordability in drugs that are on the Pharmaceutical Benefits Scheme. So we see no reason whatsoever for this schedule. There are some arguments for transparency for this and that but we see no arguments at all that suggest that this is in our interests. We maintain the argument that changes to the PBS have been used as a trade-off for other changes under the free trade agreement, which may or may not be beneficial. Of course, there is certainly no agreement one way or the other on that.

We would rather not be dealing with any legislation relating to the PBS in this environment. There are unknown implications for our health system. The PBS should never have been on the table as part of a trade deal. The government promised us it would not be. It turned out to be. This amendment would effectively remove that important provision, as I said, which requires generic manufacturers to certify that they will not infringe a patent or certify that they have notified the patent holder of their intention to market a drug.

It is pretty obvious that the pharmaceutical manufacturers very much want this. They have been talking about these kinds of amendments for a long time. It is obvious that they will put in place measures to try to delay so-called evergreening—to try to delay the generic brand coming on stream. It must be the case that this provision would give the pharmaceutical companies some advantage. I would be really appreciative of the minister giving us assurances that there will be absolutely no disadvantage to Australia from this provision. But I doubt he can do that. Until we are satisfied that this is the case, the Democrats are not interested in supporting schedule 7.