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Thursday, 13 August 2009
Page: 4869

Senator STEPHENS (Parliamentary Secretary for Social Inclusion and the Voluntary Sector and Parliamentary Secretary Assisting the Prime Minister for Social Inclusion) (12:53 PM) —In concluding this debate can I say that, as mentioned in the second reading speech for this bill, this bill amends the Therapeutic Goods Act 1989 in a number of ways. Schedule 1 enables medicines to be suspended from being made available in Australia where there are concerns that are able to be corrected in the period of the suspension. This complements the suspension provisions, which are currently available under the act, for medical devices.

The second set of changes will clarify the issuing of manufacturing licences so that they cover only one site and will enable licences to be varied and transferred to another manufacturer, which is currently not possible. The bill also enhances the existing monitoring powers in the act to ensure that full inspection of premises can occur, and that any relevant samples and recordings can be taken to support the maintenance of high standards for therapeutic goods in Australia.

Schedule 4 of the bill sets out a new framework for the regulation of homeopathic and anthroposophic medicines. The new framework will commence in July 2011 to allow time for this industry sector to prepare to comply with the requirements and to ensure further consultation can occur to inform the necessary changes to the regulations giving effect to the details of the framework.

Schedule 5 of the bill enables the minister to determine ingredients that are permitted and those that are prohibited, from being included in listed medicines. Schedule 6 makes amendments to references in the act to orders published in the Gazette and disallowable instruments, to clarify that these are legislative instruments for the purposes of the Legislative Instruments Act 2003.

Finally, Schedule 7 makes a number of minor amendments to improve and clarify the operation of the act. Most significantly this schedule provides more transparent arrangements for the setting of conditions on therapeutic goods. The schedule also makes other improvements, including ensuring the ongoing quality of medicines that are manufactured overseas. The government intends to make further amendments to the regulatory regime for therapeutic goods, later in the year, particularly to establish a new regulatory framework for biological therapeutic products. The government is committed to ensuring that the regulatory arrangements for therapeutic goods in Australia continue to meet the needs of Australians to have access to safe and effective therapeutic goods. This bill continues that commitment, and I commend the bill to the Senate.

Question agreed to.

Bill read a second time.