Therapeutic Goods Amendment (2020 Measures No. 2) Bill 2020

18 February 2021

This bill makes a number of practical and sensible amendments to the Therapeutic Goods Act 1989. Some of these amendments respond to the challenges COVID-19 has created, including the ongoing, secure supply of certain medicines. The bill also ensures Australia is able to ratify international treaties, such as the Minamata Convention on Mercury, and, importantly it allows for the establishment of a medical device identification database to track and monitor all implanted medical devices in Australia.

In 2018, the collective efforts of the International Consortium of Investigative Journalists highlighted how little protection was offered to patients globally from poorly manufactured and tested medical implants. Whilst the series of stories, dubbed the 'Implant Files', showed problems globally with the industry and with regulatory environments, they also raised a number of questions about Australia's responsiveness and its approach to quality assurance. The Implant Files showed that at least 170 Australians had died in the decade to 2018 due to unsafe medical devices, though the real number of deaths was certainly higher than this, given some adverse events that actually led to deaths had, instead, been classified as injuries and malfunctions by manufacturers.

Unsafe implants are not only potentially deadly; they can cause devastating harm and ongoing pain to patients. We saw this with the vaginal mesh, and we've also seen it with malfunctioning defibrillators and pumps. We've seen it with breast implants and also with joint implants. There have been many thousands of lives ruined by devices that were meant to make lives better. In late 2018 and early 2019, when various European authorities withdrew an Allergan textured breast implant from their markets, Australia, unbelievably, continued to make it available. I asked the TGA at subsequent estimates how many women have been implanted with that particular device after France and other nations had acted on it, and the TGA responded: 'The TGA does not hold information about the number of devices implanted.' I found that response most incredible.

Why do we have such a glaring hole in our regulatory system? Australia has a couple of individual medical device registries, funded and run either by colleges or by the Commonwealth, such as the voluntary Australian Breast Device Registry. There is no unified and mandatory national system. So I'm glad to see this is being addressed through the planned Australian Unique Device Identification Database. The database will allow more accurate recording and analysis of adverse events, it will allow faster and more accurate identification of problems with devices and more effective management of recalls and, most importantly, it will improve the TGA's ability to trace which medical device a particular patient has been implanted with or supplied. This database is well and truly long overdue.

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