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Thursday, 13 October 2005
Page: 114


Ms HALL (10:17 AM) —I rise to support the Therapeutic Goods Amendment Bill (No. 2) 2005. The Labor Party supports the bill because it enables the removal of obligations from parts of the industry which should not have had these obligations placed on them in the first place. The purpose of the bill is to amend the Therapeutic Goods Act 1989 by creating an exemption to the current certification requirements for registering or listing therapeutic goods on the Australian Register of Therapeutic Goods.

The amendments are in response to concerns raised by representatives of the complementary medicines industry, the over-the-counter medicines sector and the Australian biotechnology industry that the current patent certification requirements are more onerous and broad than they need to be. I know that all members of this House do not want that to be the case. We want to ensure that Australian people are able to obtain over-the-counter medicines and alternative medicines without the current onerous requirement. The bill proposes to exempt the complementary medicines industry and the over-the-counter medicines industry from the Australia-US Free Trade Agreement, which imposes an obligation on producers to prove that the products that they propose to list on the register do not infringe on existing patents. This generally involves expensive global patent searches.

The government has admitted that this bill is to correct an anomaly resulting from the Australia-US Free Trade Agreement. It has captured a sector that should not have been caught. I see that the Parliamentary Secretary to the Minister for Health and Ageing is at the table. I know that he has described this bill as being needed to address an unintended drafting error. We on this side of the House believe that that should be accommodated. We do not need to put in place requirements that are not needed.

The bill will effectively alter the way these products are brought into the market in Australia by restricting the patent certification requirements for particular products such as those that do not require manufacturers to submit safety or efficacy data in their application. The practical implication of this is that the majority of complementary and OTC products will no longer be subject to certification requirements. That is very laudable.

This error has added considerably to compliance costs and undue delay in applications to have products approved. That is the unintended nature of this drafting error. I know that the government would not want that to occur, and nor would we on this side of the House. We believe that you should streamline legislation so that you can get around these unintended errors that occur from time to time. Perhaps there should be more care taken in the drafting initially. This is an opportunity for us to see how there can be unintended consequences from the US free trade agreement. My contribution to this debate is only a small one. I join with the shadow minister in recommending that we support the legislation.