Stirling Griff (SA, Nick Xenophon Team) Share this | Link to this | Hansard source

My question is to Senator Fierravanti-Wells, representing the Minister for Health. I refer the minister to the prostheses pricing agreement with the Medical Technology Association of Australia, which took effect from last month. In this agreement the government committed to reduce the time to market for implantable devices by removing the current requirement for clinical evidence with two years of follow-up data for some devices. Is there a reason that the government is exposing consumers to increased risks from prostheses that have not been demonstrated via two years of safety data?

Concetta Fierravanti-Wells (NSW, Liberal Party, Minister for International Development and the Pacific) Share this | Link to this | Hansard source

I thank Senator Griff for the question and for advanced warning of the question. There are two key components that underpin the safety of medical devices in Australia. Firstly, the Therapeutic Goods Administration operates a risk based system for the assessment of the safety of regulatory devices, where the highest threshold of evidence is required for the highest risk products. Changes to the Prostheses List will not alter this rigorous approach. The requirement for clinical evidence with two years of follow-up data does not apply to application for all devices on the Prostheses List. It is important to note that, within the government's agreement with the Medical Technology Association of Australia, the commitment to remove the current requirement for clinical evidence with two years of follow-up data for some devices will only occur where this is appropriate by 1 August 2018. This is designed to deliver new medical devices to Australians while maintaining strict clinical evidentiary rules.

Secondly, the Prostheses List Advisory Committee, known as PLAC, works with its clinical subcommittees to develop guidance for applicants on appropriate evidence to support listing devices on the list. There is a wide range of devices listed on the list, from simple fixation devices to complex cardiac devices. They require different levels of evidence and follow-up data to be able to determine whether they are clinically effective and cost effective. The PLAC will still require evidence demonstrating that devices are at least as clinically effective as devices on the prostheses list or other alternative treatments. The type of evidence and length of follow-up will differ depending on the type of device.

Scott Ryan (President, Special Minister of State) Share this | Link to this | Hansard source

Senator Griff, a supplementary question.

Stirling Griff (SA, Nick Xenophon Team) Share this | Link to this | Hansard source

Is the minister aware of failures using a fit-for-purpose assessment for new prosthesis applications? For instance, is the minister aware that the Johnson & Johnson ASR hip replacement, the cause of the largest recall in Australia to date, which I believe was a class action in Australia alone of in excess of $250 million, was initially approved as a comparative device before failing spectacularly? How will the government avoid the repeat of such a disaster?

Concetta Fierravanti-Wells (NSW, Liberal Party, Minister for International Development and the Pacific) Share this | Link to this | Hansard source

Currently, all applications to list devices on the prostheses list are subject to the processes outlined in the Prostheses List: Guide to listing and setting benefits for prostheses. The list advisory committee intends to review and strengthen the arrangements and processes to ensure that medical devices are assessed for comparative health outcomes that will inform private health insurance listing and benefits. The PLAC is also working cooperatively with the Therapeutic Goods Administration to look at use of post-market surveillance to inform review of device listings.

As I said, this is a two-pronged process. It is the TGA, not the PLAC, that assesses whether devices are safe to use. The TGA is informed by the independent Advisory Committee on Medical Devices, established under regulation 38 of the Therapeutic Goods Regulations 1990. The PLAC, on the other hand, assesses devices to determine what benefit levels private health insurers should be required to pay for the device. (Time expired)

Scott Ryan (President, Special Minister of State) Share this | Link to this | Hansard source

Senator Griff, a final supplementary question.

Stirling Griff (SA, Nick Xenophon Team) Share this | Link to this | Hansard source

The Australian Orthopaedic Association National Joint Replacement Registry is held up internationally as the benchmark for best practice in providing quality information on joint replacement. Can the minister confirm that joint replacement and long-life prostheses will not be listed unless they have a minimum of two years of clinical data?

Concetta Fierravanti-Wells (NSW, Liberal Party, Minister for International Development and the Pacific) Share this | Link to this | Hansard source

As I outlined in my first answer, Senator Griff, the Prostheses List Advisory Committee has asked its clinical subcommittees to advise on the appropriate level of evidence in order to set appropriate private health insurance benefits for devices. All devices approved in Australia must go through a rigorous assessment through the TGA. Changes to the prostheses list will not alter this rigorous process. As I've said, the TGA is informed by its independent Advisory Committee on Medical Devices and the PLAC, on the other hand, assesses devices to determine what benefit levels private health insurers should be required to pay for the device.