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Thursday, 12 May 2011
Page: 3938


Ms KING (BallaratParliamentary Secretary for Infrastructure and Transport and Parliamentary Secretary for Health and Ageing) (11:21): I would first like to thank members for their contributions to the debate on the Therapeutic Goods Amendment (2011 Measures No. 1) Bill 2011. I thank the member for Ryan, who is still here in the chamber and is obviously a great advocate for some of the research that is happening in her own electorate, the member for Boothby and also the member for Blair. The member for Boothby, in his contribution, raised questions around the measures in this bill. These measures will create some efficiencies and we are obviously hoping that those efficiencies will be passed on to industry. As to whether the potential savings will be passed on to industry, I can advise that the Therapeutic Goods Administration consults with industry annually about their fees and charges, and obviously the measures contained in this bill will form part of that annual consultation process. The member for Boothby also highlighted that the coalition will be watching for the efficiencies that these measures put in place. I am pretty sure that industry are watching that as well; they are in my ear, and that of the TGA, pretty quickly as those sorts of things start to make their way through the system.

The amendments in this bill are designed to improve processes for the evaluation of prescription medicines, the collection of evaluation fees payable for prescription medicines and the imposition of standard conditions on registered and listed therapeutic goods by way of a legislative instrument. New streamlined procedures for processing applications involving the evaluation of prescription medicines are being adopted by the TGA to significantly shorten the time taken to complete evaluations from 500 calendar days to 300.

To enable the TGA to meet the shortened time frame, an amendment has been included to require companies applying to make changes to the entry of their prescription medicines on the Australian Register of Therapeutic Goods where the changes involve an evaluation of clinical, preclinical or bioequivalence data to include adequate information in an approved form before the application is taken to be effective. Adequate data lodged at the appropriate time is necessary to allow an evaluation to be completed by the TGA in a timely fashion. Applications not accompanied by the required information in an approved form and accompanied by the application fee will not be evaluated. The full amount of evaluation fees payable for the registration of prescription medicines will now be required to be paid when applications are accepted for evaluation. The practice of sponsors paying the final quarter of the full evaluation fee, owing only after the completion of the evaluation by the TGA within the prescribed deadlines, will be replaced with a system of refunds at a quarter of the full evaluation fee paid if the TGA fails to complete an evaluation on time.

The bill also contains amendments to ensure that, where new standard conditions are for the first time imposed by means of a legislative instrument on registered or listed therapeutic goods already included in the register, any standard conditions in place in relation to those goods can be removed at the same time. This will avoid an overlap between the old standard conditions and the new standard conditions imposed by the instrument. Standard conditions imposed by the minister will generally apply to registered and listed therapeutic goods irrespective of when they were included in the register. However, an amendment will enable the minister to impose conditions only on goods that are entered in the register after an estimate has been made. This amendment will provide additional flexibility to ensure that changes in conditions do not apply to existing entries where it is not appropriate that they do so. These measures will help ensure that TGA processes keep up with the changing environment in which it undertakes its regulatory functions.

I commend the bill to the House.

Question agreed to.

Bill read a second time.

Message from the Governor-General recommending appropriation announced.

Ordered that the bill be reported to the House without amendment.