Nigel Scullion (NT, Country Liberal Party, Minister for Indigenous Affairs) Share this | Hansard source

I thank the senator for his question. Patient safety is the Australian government's highest priority. Before any medicines or medical devices can be supplied in Australia, irrespective of whether they've been certified or otherwise in other countries, they have to go through an extensive assessment and meet the highest levels of safety and quality. They're also monitored once they're on the market. The Therapeutic Goods Administration is regarded as one of the most thorough of all agencies around the world and has the highest standards of assessment for both medicines and medical devices. But there is always a level of risk associated with any medical procedure or device. Companies are required by law to report safety issues and adverse events to the TGA. The TGA will monitor ongoing safety and performance of devices that are on the market, and if issues arise the TGA will issue safety alerts, mandate changes to the product or recall the product from the market.

I acknowledge the recent media, and I have read much of it. The Minister for Health has tasked the head of the TGA, Professor John Skerritt, to review all of the claims made in the media regarding the regulation of medical devices and to provide advice to government on whether further safety measures are necessary.

As I indicated earlier in my answer, we have to go through an extensive assessment to ensure we're meeting the highest levels. We don't provide a rubber-stamp approval for any medical device for use in Australia just because it has been approved overseas. Part of your question was: 'It hasn't been approved in the United States, and it's now being used here.' I'll certainly check that, because I don't understand that to be the case. It's a question I asked earlier today. Our regulatory framework— (Time expired)