Andrew Southcott (Boothby, Liberal Party, Shadow Parliamentary Secretary for Primary Healthcare) Share this | Link to this | Hansard source

I rise to speak on the Therapeutic Goods Amendment (2013 Measures No. 1) Bill 2013. The Therapeutic Goods Administration is the regime responsible for regulating Australia's medicines, medical devices, blood and blood products. Under the act, all products which make a therapeutic claim must be listed on the Register of Therapeutic Goods before they can be suppled in Australia. It is a high bar to get over. It is very important for consumer safety that we do have the TGA and we do have the Register of Therapeutic Goods, though there is one amendment relating to products which seem to inadvertently be covered on the register. The bill also makes a number of minor technical amendments to ensure the consistent regulatory treatment of different types of therapeutic goods. These minor changes would also streamline the operation of a number of provisions under the act. Many of these amendments address anomalies that have arisen from previous amendments made to the act. But there is one amendment I would like to cover in more detail.

The main amendment contained within this bill would give the minister, via legislative instrument, the power to exclude goods from the scope of the regulatory scheme under the TGA. These legislative instruments are required to be tabled in parliament and would be disallowable should the parliament decide that any decision made by the minister is not appropriate. Currently, any product that falls within the regulatory scheme because a therapeutic claim is made may be subject to burdensome regulation under the act, even if no public health risk is likely. This new power would be allowed only in the cases where it is clear that the goods in question have little to do with managing public health and safety, but, due to a therapeutic claim made by the manufacturer, fall within the very broad definition of 'therapeutic goods' within the act. Increasingly, more and more health and wellbeing claims are being made in relation to products where public health considerations are not likely to be an issue. Some examples of these types of products include 'power bands'—holographic wristbands that are claimed to improve balance, strength and flexibility—and mattresses which contain bacteria designed to reduce the effects of dust mites. While these products would be excluded from the TGA regulatory regime, they will still be regulated under consumer protection laws.

In speaking to this amendment, I note the response from the Senate Standing Committee for the Scrutiny of Bills regarding this change, in that the legislation sets out no requirements that the minister would consider in making a determination to exclude something from the definition of 'therapeutic goods'. The Scrutiny of Bills Committee in their digest stated:

The committee therefore seeks the Minister's advice as to whether consideration has been given as to specifying the purposes for which this power may be exercised or to other ways to confine this power …

The opposition would echo the calls of the Scrutiny of Bills Committee and ask the minister to explain whether this—that is, specifying the purposes for which the power may be exercised—has been considered and why it has not been included.

The second major change would provide a specific power to the Secretary of the Department of Health and Ageing to remove goods that are not therapeutic goods from the Australian Register of Therapeutic Goods. There are occasions when products are on the register when they should not be. Either they were a therapeutic good but are no longer a therapeutic good or they never were a therapeutic good. And there is currently no mechanism to remove these products from the Register of Therapeutic Goods. This power can be used only after the product sponsor has been notified, and any decision made by the secretary will be reviewable internally and externally by the Administrative Appeals Tribunal. The coalition will not be opposing this bill, but I do seek a response from the parliamentary secretary as to the circumstances and purposes for which the power may be exercised in deciding to not have a product listed on the Register of Therapeutic Goods.

Shayne Neumann (Blair, Australian Labor Party, Parliamentary Secretary for Health and Ageing) Share this | Link to 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.

Bruce Scott (Maranoa, Deputy-Speaker) Share this | Link to this | Hansard source

The question is that this bill be now read a second time.

Question agreed to.

Bill read a second time.

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