Maxine McKew (Bennelong, Australian Labor Party, Parliamentary Secretary for Early Childhood Education and Child Care) Share this | Hansard source

In summing up on behalf of the Minister for Health and Ageing, I would like to thank the members who have contributed to this debate. This bill amends the Therapeutic Goods Act 1989 in a number of ways. Firstly, it incorporates into the act provisions allowing the stockpiling and supply of medical devices to deal with emergency situations. These provisions are based on similar provisions allowing medicines to be stockpiled and supplied in emergency situations which were added to the act in 2002. The amendments in schedule 1 to this bill allow the minister to exempt devices from the requirements of the act so that they can lawfully be stockpiled and made available in an emergency. These exemptions are not subject to parliamentary scrutiny. This follows advice, received by the then government in 2007, which recommended that the contents of the stockpile should be classified as confidential to ensure that would-be bioterrorists were not able to find out what preparations Australia had made for dealing with possible bioterrorist acts. For this reason, the bill also amends the act so that similar exemptions applying to medicines are not subject to disallowance. This bill also gives effect to a range of amendments which have been in contemplation for a number of years and which were to have been adopted as part of the proposed Australia New Zealand Therapeutic Products Authority, or ANZTPA.

The bill deals with the ‘fit and proper person’ test, default standards for medicines, information disclosure and the use of restricted representations in advertising. It also makes technical amendments to all offence provisions, to bring them into line with the latest policy on how these should be expressed, and these have been canvassed in the second reading speech. So the changes made by this bill do not encompass all of the reforms that the government intends to make to the therapeutic goods regulatory regime. The amendments in this bill are but the first instalment in an ongoing program of reform to the act. Australia has been well served by the TGA in the past, and it is important that the regulatory regime that the authority implements is kept up to date, so that the TGA and the industry it regulates can operate as efficiently as possible and so that Australian consumers can continue to have timely access to safe and effective therapeutic goods. I commend this bill to the House.

Question agreed to.

Bill read a second time.

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

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