Mr McCORMACK (Riverina—Parliamentary Secretary to the Minister for Finance) (18:11): I am pleased to support the Therapeutic Goods Amendment (2013 Measures No.1) Bill in the chamber today. This bill amends the Therapeutic Goods Administration Act 1989 to reduce regulation, to simplify and to streamline the listing of therapeutic goods whilst also ensuring that the highest standards of public health and consumer protection are met. I note that the majority of these minor but important changes were undertaken under the former government, and the coalition government obviously supports these measures. The Therapeutic Goods Administration is responsible for ensuring that any product claiming to have a therapeutic benefit is fully evaluated before being supplied for use in Australia. The TGA regulates products via the Australian Register of Therapeutic Goods. The TGA is a world-class agency which performs its important functions competently and diligently. The changes proposed in this bill today, I believe, will further strengthen the TGA's role in regulating therapeutic goods and protecting the public. One of the significant changes in this bill, and one which we should all particularly welcome, relates to better regulating what types of products should be listed with or fall under the operations of the TGA. The bill will now more clearly define what constitutes a 'therapeutic good' and therefore whether a certain product would be required to be listed on the register. This amendment is particularly important as the current definition contained in the act has a wide meaning, and over recent years we have all witnessed a whole variety of products listed on the TGA register but that have been found to have no demonstrable therapeutic value. For example, we have seen the proliferation of jewellery products such as magical wrist bands embedded with silicone which purport to enhance a person's strength, flexibility and balance; household items such as bedding underlays containing bacterial spores which apparently fight dust mites; weight loss belts—and the list goes on. Some of these products may have no impact on public health yet could still be potentially registered with the TGA. Such listings may give health-conscious consumers the false impression that a TGA listing of a product may be an endorsement of the various claims being made. Schedule 3 of the bill therefore confers the power on the minister to remove products from operation of the act if it is determined that a product has no health purpose or where TGA regulation is simply not justified. This will also ensure that the TGA is not unduly regulating products which do not require further oversight. These amendments provide for new criteria that the minister must consider in excluding a product from the TGA register, which he or she can do by disallowable instrument. The bill also provides for a consultation process for sponsors where the minister has made a decision to exclude a product. All advertising and marketing claims made with respect to any excluded product of course must still comply with relevant consumer protection law, and the Australian Competition and Consumer Commission will continue to regulate such matters as is deemed appropriate. Schedule 6 of the bill will amend the number of days the TGA is required to audit new listings from the current 20 working days. This amendment is necessary to support the up-classification of hip, knee and shoulder joint implants from class IIb medical devices to class III. The government intends for this transition to be completed by 1 July this year, and this amendment will give the TGA adequate time to review new applications by sponsors of current IIb devices seeking to up-classify. It is important to note that no current products will be adversely affected by this change, provided that sponsors submit their class III applications by 30 June. The bill will provide new powers to the TGA to cancel products on two additional grounds, the first being on public health grounds, as set out in schedule 7, if a product's presentation is considered unacceptable. This amendment places an obligation on the sponsor to ensure the presentation of a good is not misleading to either health professionals or consumers and that the presentation of a product is maintained to this standard for as long as it is listed on the register. There are new civil and criminal penalties prescribed in this section associated with the false or misleading presentation of a product. The second ground, contained in schedule 15, relates to a failure by a sponsor to provide information, when requested by the TGA, within the time provided. Schedule 10 of the bill expands the scope of the definition of a kit. This will allow a greater range of products to be subject to a simpler regulatory approval process. Schedule 11 of the bill provides for new penalties with respect to giving false or misleading information where a sponsor or licence holder makes a request to the TGA to vary an approved therapeutic product. This provision seeks to ensure that the TGA is provided with only the most accurate information by sponsors and is particularly important where only the sponsor has access to certain product information that the TGA is unable to verify—for example, due to commercial-in-confidence. Schedule 16 of the bill provides for the reversal of cancellation decisions done at the request of sponsors and holders of licences, thus avoiding review procedures or the need to seek new marketing approval or licences. The provision allows sponsors 90 days to lodge their request to revoke a self-initiated listing and also refunds their cancellation fee. Finally, amendments under the bill will also require the TGA to publish details of cancellations of medicines on the TGA's website or in the Gazette. I note there was broad support for these changes from a number of stakeholder groups, including the Australian Commission on Safety and Quality in Health Care and Medicines Australia, the peak organisation representing pharmaceuticals. I do note, however, that the Australian Medical Association expressed a desire for there to be an additional classification that identified products that were not therapeutic goods. In closing, I strongly support this bill and the very necessary public health measures contained in it. I believe that Australia's health consumers will be better served by these important changes. I commend the bill to the House.