Greg Hunt (Flinders, Liberal Party, Minister for Health) Share this | Link to this | Hansard source

I want to thank all of the members of the House for their contributions to the Therapeutic Goods Amendment (2017 Measures No. 1) Bill. In particular, the changes and amendments in this bill are about a simple concept, and that is firstly and most importantly supporting the availability of high-quality, safe and effective therapeutic goods and delivering them in the most timely way to the community—in other words, better medicines, better treatments and better devices, at the earliest possible time to the community. Secondly, it is about ensuring that there is a reduction in potential health risks to the public. Thirdly—something that I'm very pleased about—it is about streamlining and improving the regulatory environment, which is something I've endeavoured to assist with and to deliver across all of the different portfolios.

These amendments continue the implementation of the government's response to the Review of Medicines and Medical Device Regulation, and they establish a provisional approval scheme so that patients can have access to promising new medicines up to two years sooner. Other changes to the regulation of complementary medicines will allow indication as to pre-approved claims, all through a new pathway that will allow assessment of the efficacy or effectiveness for indications that fall outside the current permitted list. This will allow consumers to make more informed product choices.

In addition, there are significant reforms that will streamline the advertising framework for therapeutic goods. This will ensure that enhanced compliance and monitoring provisions will be in place to strengthen consumer protections. It will also increase post-market monitoring for listed products, leading to efficient reporting of any adverse effects. What that means is better protection for patients.

Medical devices will reach the market sooner through the greater use of comparable overseas regulator assessments afforded by this bill. In other words, this is the long-held objective of allowing us to adopt the best quality international regulatory findings and to bring them into the Australian system to help bring the devices into Australia earlier. Patients' lives will be prolonged, protected and improved through this process.

This bill in particular, coupled with the recent amendments already enacted, will strengthen Australia's therapeutic goods regulatory framework. It will ensure that it remains well positioned to respond effectively to global trends in the development, manufacture, marketing and regulation of therapeutic goods. It makes Australia a more desirable destination for clinical trials. It helps make Australia a more desirable destination for manufacture and development of medical devices. We will receive better health outcomes and better economic outcomes as a result of these changes. Ultimately, this is our opportunity to make significant reforms to the regulation of therapeutic goods in Australia that ensure better access to medicines, streamlined administrative processes and stronger consumer protections.

In addition, in addressing the Therapeutic Goods (Charges) Amendment Bill 2017, I would also like to thank members for their contribution to this debate. This bill amends the Therapeutic Goods (Charges) Act, enabling the imposition of annual charges on newly designated Australian conformity assessment bodies to undertake conformity of medical devices. Annual charges will be introduced on the sponsors who choose the new evaluation pathway of provisionally registering promising new prescription medicines up to two years earlier than the current framework. In other words, it's a fee for service which allows better and earlier access to new medicines. While these new provisions are important for timely availability of medical devices and for access to emerging medicines introduced through the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017, these are new regulatory functions for which the TGA must cost recover in accordance with the Australian Government Cost Recovery Guidelines.

Ultimately, and in particular, I want to thank Medicines Australia and I want to thank other medical bodies, such as the AMA, the Royal Australian College of GPs and the Pharmacy Guild, for their support. These developments will give Australians better access to medicines at an earlier date. I also want to acknowledge and appreciate the constructive work of the opposition. The opposition spokesperson, the member for Ballarat, has been a valued partner in this process, and I think it would be remiss of me not to acknowledge that. This is an example of the policy process, the engagement process with Medicines Australia and the magnificent TGA, led ably by Professor John Skerritt and his team, and the parliamentary process all working in tandem to produce a multipartisan result in the best possible way to produce better health outcomes for Australia. I thank everybody involved and I also want to acknowledge my adviser in this space, Alex Best, who has been remarkable in his work with Medicines Australia; the guild; the opposition; and all of the different players. I am delighted to commend this bill to the House.

I present for the information of members an addendum to the explanatory memorandum for the Therapeutic Goods Amendment (2017 Measures No. 1) Bill 2017 and an addendum to the explanatory memorandum for the Therapeutic Goods (Charges) Amendment Bill 2017.

Question agreed to.

Bill read a second time.

Message from the Governor-General recommending appropriation announced.

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