Ms PARKE (Fremantle) (18:03): I rise to speak in broad support of the Therapeutic Goods Amendment (2013 Measures No. 1) Bill 2013 but with reservations which I will outline in due course. To a large degree, this legislation is the same as the bill prepared and listed by the Labor government during the 43rd Parliament. So to a large degree we support the changes it contains. There are, however, two key areas of difference in the present form of the bill as introduced by the government, and while we can support one of those changes we cannot support the other. The first area of difference relates to the issue of the up-classification of various joint implants from class IIb medical devices to the higher risk class III—a process put in train by the previous government. As the minister noted in his second reading speech, this process was delivered as an outcome of the 2011 inquiry by the Senate Standing Committee on Community Affairs and the consequent transition arrangements required that sponsors of relevant medical devices apply and achieve the approval for the class III classification by 1 July 2014. Unfortunately, there are many relevant devices on the register for which the up-classification process has not commenced, let alone been determined. It is in recognition of those circumstances that the changes in this bill allow for devices to remain on the register beyond 1 July 2014 provided the application for up-classification is lodged by that date. While, of course, it would have been more satisfactory for the up-classification to have occurred within the transition period, we accept that there are still a significant number of registered knee, hip and shoulder implants for which an application is yet to be made. This amendment allows a pragmatic leeway during which those devices can be reclassified as appropriate. It also, sensibly, extends the time limit within which the TGA would ordinarily need to initiate an audit in relation to a particular application. This is really a provision of corresponding leeway on the regulatory side in light of what is likely to be a substantial number of applications arriving on the TGA's desk in the last few months of what was a two-year transition period. The opposition does not have an issue with the aspects of the bill that I have just described. As I have said, it would have been preferable, both administratively and from a public health point of view, if the applications could have been received and determined in the window provided. But these processes do not always conform to the expected timetable, and the government's additional amendments in this area to the form of the bill that lapsed under the 43rd Parliament are supported. There is a second area of change that we do not and cannot support; namely, the removal of what was schedule 14 of the bill in its initial form, containing amendments to the notification and recovery provisions of the Therapeutic Goods Act. Those amendments, which have been omitted in the government's bill that we debate here today, were framed in order to improve the scope and flexibility of the secretary's powers when it comes to ensuring the proper communication of health risks or concerns and, in some cases, the issuing of recalls in relation to goods, biologicals and medical devices. It goes without saying that these powers are an incredibly important part of the good and proper oversight and regulation by the TGA of medicines and medical devices such as implants, which can have devastating health consequences when problems occur, as we have seen in recent years with faulty breast and hip implants. The amendments contained in the bill, as it was listed during the 43rd Parliament, essentially did three things: firstly, in relation to medical devices there was the inclusion of the additional power to require publication by the sponsor of the device of relevant information, which matched the equivalent provision that already exists in that act for therapeutic goods and for biologicals; secondly, in relation to each of the three categories there was to be added the additional power for the secretary to require from the sponsor of a particular therapeutic good, biological or medical device the details of patients who had received or been treated with such a good or device; and, thirdly, the bill gave the secretary the power to require the sponsor of goods or devices to provide information to the public or to a specified class of persons. As the relevant bullet point in the explanatory memorandum for the bill in the form in which it was listed during the 43rd Parliament stated, these amendments would give the secretary: … the power to require in particular circumstances (for instance where therapeutic goods have been suspended or cancelled from the Register, or where the Secretary has come to the view that the safety, quality, efficacy/performance, or presentation of therapeutic goods, is unacceptable), the sponsor of those therapeutic goods to provide information about the goods to the public or to a class of persons such as health care professionals or patients, and to give to the Secretary information about persons to whom the goods have been supplied; It further stated: It is also important that the Secretary have the ability to require the sponsor or supplier (e.g. where the goods are counterfeit) of goods to provide her with information about who relevant goods have been supplied to, so that patients who may be at risk can be quickly identified and contacted. I think the average Australian would understand the enormous value in having the Therapeutic Goods Administration, TGA, which regulates this critical area of health for the safety of all Australians, put in a position where it can ensure that people who may have been affected by a health product with legitimate safety and quality concerns are properly notified, and notified in a timely fashion. For that reason, it is really hard to fathom why those amendments have been omitted from this bill. We would hope that the government could consider reinstating those amendments and I will be moving that way in due course. I find it interesting that the minister made no mention of this significant change in his second reading speech. While there was text in the explanatory memorandum explaining the addition of the amendments I spoke about earlier in relation to the up-classification process, there was no text explaining why the amendments to empower the secretary of the TGA to better notify and protect Australian health consumers had disappeared. I guess if you are seeking to obstruct the provision of greater transparency and greater health consumer protection, the last thing you would do is be up-front about it, but I think that is a great shame. The amendments proposed in the first version of this bill in relation to the notification and recovery provisions of the Therapeutic Goods Act cannot be characterised as placing any regulatory or compliance burden on pharmaceutical companies or medical device manufacturers. They simply allow the TGA to do its job more effectively in response to evidence of a health product which may not be effective or of acceptable quality or in some cases may be harmful. It is for those reasons that we will move to amend the bill to reinstate the provisions that strengthen the TGA's role when it comes to notification and recovery.