Concetta Fierravanti-Wells (NSW, Liberal Party, Minister for International Development and the Pacific) Share 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.