Dr GILLESPIE (Lyne) (19:01): I also rise to speak on the Therapeutic Goods Amendment (2013 Measures No. 1) Bill 2013. Our government made a commitment at the election that we would continue to work towards reducing red tape and regulation across government through a common-sense approach in the way we do things. These amendments that are being made are common-sense amendments. This bill passed through the House of Representatives in June 2013 and was before the Senate when the parliament was prorogued. The changes that have been made are to address issues and concerns raised by the coalition and by industry and other stakeholders in response to the bill, as well as to reflect the views of the Senate Standing Committee for the Scrutiny of Bills, the Parliamentary Joint Committee on Human Rights, the Senate Community Affairs Legislation Committee, and several submissions to the community affairs committee's inquiry into the previous versions of the bill. I view these amendments from the perspective of my past medical background of 33 years, in which I have had to rely on numerous product information statements and assurances to me and my colleagues that the TGA has indeed thoroughly assessed medicines and other therapeutic goods. Overall, with these changes we see not only a reduction in regulatory burden but also a reduction in health risks to the public and an improvement in the transparency of the regulatory process. First and foremost, we see an up-classification of implantable joint medical devices—such as for hip, knee, ankle and shoulder joints—that were on the register as of July 2012. The measures up-classify them from class IIb to the much higher and more rigorous level of class III. A two-year transition period, up until July 2014, has been allowed for the proponents to put themselves in for this up-classification, and an allowance of time has been made in regulations for the departmental audit of selected applicants. Second, the definition of a therapeutic good is very broad and has led to many inappropriate classifications, including of some household products that have been mentioned earlier this evening, like the magnet power band bracelets and mattresses that purport to have health benefits against dust mites. These are more appropriately regulated under consumer protection legislation. Schedule 3 of the bill allows the minister to remove products that are deemed not to be therapeutic goods from the register by making a disallowable legislative instrument. There are criteria which the minister would be required to consider before making such a legislative instrument to exclude products from the definition of therapeutic goods. This is particularly important for medicines that came in under section 26A. The bill also clarifies processes for dealing with and approving the product information statement. It allows the minister to suspend or cancel registration if the presentation of goods is not acceptable or if the sponsor does not respond to requests for information. There is, however, retention of a right to internal review and to review by the Administrative Appeals Tribunal of any decision to approve the product information for prescription medicines. This is very important, because the product information is the critical thing that medical practitioners and pharmacists rely on when they are making their advice to patients and consumers. The former bill had proposed that such decisions not be subjected to a separate right to merits review, principally because of the concern that the product information might become inconsistent with the decision to approve the medicine. These queries were raised before the Parliamentary Joint Committee on Human Rights. However, another way of addressing this concern has been found, and the bill maintains a right to merits review for product information decisions. Transparencies improve for consumers by the inclusion of an obligation to publish either in the Gazette or on the TGA's website the particulars of any decision of the TGA under the proposed new section 9F that facilitates removal of these non-therapeutic goods from the register. It also requires the TGA to publish the particulars of any overturning by the minister on review of a decision by the TGA to cancel or suspend a product from the register or to cancel or suspend a manufacturing licence or a conformity assessment certificate. This was in response to stakeholders in submissions to the Senate Community Affairs Legislation Committee. Most importantly, it also introduces an offence and a civil penalty if a sponsor provides false or misleading information in the product information. It also clarifies the definition of a kit, even if the kit contains only one therapeutic good or biological compound among many products in the so-called kit. All these are common-sense amendments. Certainly they simplify and clarify the TGA processes. Most importantly, they do not have financial impact on the Commonwealth. The government has assessed the regulatory impact of the former bill and removed selected amendments that would have imposed an unnecessary regulatory burden on Australian businesses. They are common sense, they increase transparency and they increase safety to consumers. I commend this bill to the House.