Mathias Cormann (WA, Liberal Party, Shadow Parliamentary Secretary for Health Administration) Share this | Link to this | Hansard source

The opposition supports the Therapeutic Goods Amendment (2009 Measures No. 1) Bill 2009, which is part of the ongoing reform of the Therapeutic Goods Act introduced under the Howard government and delayed by the withdrawal of New Zealand from the development of a joint regulatory arrangement in 2007. There has been general support by industry for the principles underlying this bill, however with the proviso that the support is conditional upon thorough and ongoing industry consultation moving forward. That seems to be a little bit of a theme coming through in relation to these sorts of bills.

The bill makes a number of amendments to the Therapeutic Goods Act, including in relation to the ability to suspend goods from the register, the individual licensing of manufacturing sites, increased monitoring for safety and quality and also changes to the treatment of homeopathic and anthroposophic preparations. As I have already mentioned, the opposition supports this bill as part of the ongoing reform process in relation to the Therapeutic Goods Act.

Ursula Stephens (NSW, Australian Labor Party, Parliamentary Secretary for Social Inclusion and the Voluntary Sector) Share this | Link to this | Hansard source

in reply—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.