Shayne Neumann (Blair, Australian Labor Party, Parliamentary Secretary for Health and Ageing) Share this | Hansard source

I would like to thank the member for Boothby for his contribution and also thank my predecessor, the member for Ballarat, in her former capacity as Parliamentary Secretary for Health and Ageing. As the member for Boothby correctly stated, the measures contained in the Therapeutic Goods Amendment (2013 Measures No. 1) Bill 2013 will streamline and improve the regulatory scheme for therapeutic goods. A number of regulatory requirements currently in the Therapeutic Goods Act are being standardised, replicated or clarified so that, where appropriate, common regulatory rules and processes under the act will apply to all classes of therapeutic goods, including medicines, biologicals and medical devices.

These changes will benefit the sponsors of therapeutic goods by providing greater clarity about their obligations under the act and provide the Therapeutic Goods Administration with improved mechanisms for its monitoring and compliance functions that are so essential to an effective therapeutic goods regulatory scheme. Additionally, the amendments will reinforce the main focus of the act, which is directed at the regulation of those goods for diagnosing, treating or alleviating disease, injuries or disabilities or that are used to replace or modify parts of the anatomy. It is a fact of modern life that health and therapeutic claims are increasingly being made on a range of goods, including food, jewellery and even some forms of household appliances—and, in fact, furniture, such as mattresses, as the member for Boothby correctly pointed out.

Because the definition of therapeutic goods under the act is so wide, goods that were perhaps not in contemplation when the legislation was enacted more than 20 years ago may now inadvertently be caught by the regulatory scheme. By enabling the minister, by disallowable instrument, to exclude these products from the operation of the act we can achieve greater certainty for those who wish to supply such products in Australia. I say to the member for Boothby—through you, Mr Deputy Speaker—that I wrote to the Scrutiny of Bills Committee in respect of its query in relation to that, and I am very pleased to provide the member for Boothby with a copy of my correspondence to the committee to satisfy the concerns he raised in relation to this issue. I also refer him to the second reading speech of the former Parliamentary Secretary for Health and Ageing in relation to some of the criteria and the basis on which the decision will be made. I would like to reiterate that any products moved from the therapeutic goods regulatory regime would still be subject to consumer protection provisions in the Commonwealth Competition and Consumer Act 2010.

In summary, the amendments in this bill will create greater regulatory harmonisation between the different classes of therapeutic goods and thus provide a more efficient regulatory scheme that will benefit consumers as well as the therapeutic goods industry.

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