Mr LAMING (Bowman) (18:39): This therapeutic goods amendment bill carries out some small but fairly important amendments that started last year but did not manage to find their way through the parliament before the election. The purpose of the bill is to make some minor but important changes and to streamline and improve the functions of the Therapeutic Goods Administration. This has been an incredibly burdensome task for this agency to monitor the safety and efficacy of health products in the Australian market. The bill will be including amendments to provide support for the management of the TGA, which is greatly welcomed in this transitional up-classification period of hip, knee and shoulder joint implantable medical devices in the lead-up to the June 2014 transition. There are also, importantly, amendments to allow the Minister for Health to make legislative instruments the effect of which would be to exclude certain identified products from the definition of therapeutic goods in the act. This ensures that the focus of the act is not overly displaced onto goods that are unlikely to have any public health impact. The current definition of therapeutic goods can sometimes capture some household items that one normally would not expect to be caught up in that legislation. The regulatory impact of all of these proposed amendments I really welcome. The fact is that they aim to either be completely neutral in regulatory burden, to deliver a reduction in that burden or at least to set us up and facilitate future reduction in regulatory burden, such as allowing the minister to make legislative instruments that declare that products that are currently regulated that do not need to be can be seamlessly removed from the act. There will be questions about whether these amendments, particularly in schedule 1 relating to advertising, do broaden the TGA's powers. We would like it really clear that these changes where regulatory action can be taken under the act by reference to compliance with advertising requirements include compliance with the code. Regulatory action includes approval of therapeutic goods asking a sponsor of therapeutic goods for information about those goods and the cancellation of goods from the register for any form of breach of those advertising requirements. This is a classification that will reflect that longstanding approach that has been taken by the TGA on the provisions of the act which refer to compliance and noncompliance with applicable advertising requirements. It also contains an amendment that gives the TGA the power to acquire information relating to the compliance of registered medicines with applicable standards. That power I really think is vitally necessary. Why is this power necessary? In essence the TGA can only approve a prescription medicine or an over-the-counter medicine or a biological if its presentation is deemed acceptable. So the main purpose of these amendments is to ensure that the obligation is on the sponsor to ensure that their presentation of a therapeutic good is acceptable and is not misleading to healthcare professionals or to consumers. That continues for as long as those products are entered on the register. Thirdly, do these amendments as set out in schedule 7 relate to or pre-empt the outcomes of the TGA's review of labelling and packaging? The answer is a definitive no, because the TGA is considering some of these issues and potential reforms in the area of packaging but the bill does not pre-empt any of those processes, what they may be, and any of the measures that are associated with that reform process. That is encouraging. With the issues of consent to import, to supply or the export of goods, currently under the act the TGA can consent to importing into, supplying in or exporting from Australia registered and listed products that do not comply with a particular applicable standard. The TGA can give this consent unconditionally, subject to conditions. However, a decision of the TGA not to give consent is subject to merits review by the minister and the AAT. A decision to impose a condition such as a consent is not currently subject to any of those review processes, and this is an improvement that this bill delivers. These amendments address that anomaly. They provide sponsors with a right of merits review in relation to the imposition of these conditions by the TGA in areas such as consent, including the right of appeal, which I think is also vital for people taking a commercial risk to introduce therapeutic goods to this country. What is not retained in the bill I know is of key concern to the opposition. A small number of measures were removed from the former bill and I know that they received some focus from opposition speakers. The amendments that have been removed include allowing the TGA to require sponsors or suppliers of therapeutic goods to provide a wider range of information to the TGA or to the public about goods and the circumstances in which a recall could be ordered. But the omission of this particular amendment will not adversely affect the safety of the public because there are provisions in the act already under which the TGA can require sponsors, or even former sponsors, to provide that information about therapeutic goods for which there might be safety issues or potential recall. Also, information can be published on the TGA website about any matter relating to safe use of therapeutic goods or about a decision that is made under the act. Secondly, the power of the TGA was removed to cancel medical devices from the register for failing to comply with advertising requirements in order to align with the TGA's power to cancel registered and listed goods and biologicals. The omission of that element from the bill will not adversely affect patient safety because the TGA already possesses the power to cancel medical devices if the sponsor's certification—which is made when they apply for marketing approval, that their devices comply with applicable advertising requirements—is no longer correct. Thirdly, the TGA no longer has to impose conditions when permitting the use by sponsors of restricted or prohibited representation in advertisements. The omission of this from the bill will not adversely affect public safety either as the TGA retains discretion on whether to give permission for the use of such representations. Lastly, there is the extension of power to prescribe in regulations pharmacovigilance reporting requirements for registered or listed therapeutic goods. The omission of that from the bill will also not impact public safety because it was a minor technical amendment which would only have allowed TGA's pharmacovigilance guidelines to be carried out. In conclusion, the two main changes as a result of passing this bill will be to reduce regulation, which of course is quite a daunting prospect when one sees the expansive work that is performed under the Therapeutic Goods Act 1989, and provide the minister in particular with the power to remove low-risk products from the operation of this act even though the products may fall within the definition of a therapeutic good. That measure is necessary because of the increasing tendency of claims to be made for a range of goods that suggest that they can influence the health, wellbeing or mood of individuals. This power will facilitate a reduction in regulation, particularly where there are already consumer protection laws in place. The minister must, though, have regard to the criteria when exercising this power, including whether it is likely that specified goods not regulated under the act might harm the health of members of the public, and that will be a pre-eminent consideration for the minister in that case. There is the new power for the secretary to remove products that have been wrongfully included on the ARTG, the register, that are not in fact therapeutic goods at all. By doing so, they exclude them from the regulatory requirements of the regime. The other encouraging element that I want to emphasise is that we are, as a result of these amendments, contributing to a reduction in potential health risks to members of the public. Firstly, there are the amendments that support the current transitioning of the reclassification of hip and knee joints, which is coming up midway through this year. This follows the November 2011 inquiry by the Senate Community Affairs References Committee into regulatory standards, where they were looking at the approval of medical devices. These changes will allow for 20 working days for the secretary to decide whether to audit an application for marketing approval for a class IIb device that is seeking classification to class III. This simply allows more time for the TGA to determine whether an audit should be conducted. It allows the TGA to more efficiently manage the expected rush of applications towards the end of the transition period without affecting the sponsors, in having to wait longer, or tying up resources or diverting those resources from other evaluations or reviews that have to be carried out by the TGA. In conclusion, there are two measures that support ongoing compliance with regulatory requirements. It provides the power to cancel products from the register, which until now has not been available and has been cause for great frustration for those working in the approvals process. By doing this, there will be a power to cancel products including how they are labelled or packaged and any advertising or information that is associated with those goods when they seek approval for marketing. It is no longer acceptable that a sponsor fails to respond to a requirement to provide information that the TGA might require about a good in order to determine whether it should remain on the register or whether there is a safety issue requiring regulatory action. A number of elements that were included in the bill have been omitted, with some concern expressed by the opposition. The key thing to remember is that the focus is 100 per cent on patient health, demonstrating efficacy, demonstrating safety and demonstrating that, where we can monitor Australian therapeutic products, we can do it with as little regulation as possible.