I don't know about the situation in Australia, but in the US the FDA is way too slow and arbitrary, and it's costing lives every year, including, soon, mine: https://jakeseliger.com/2023/07/22/i-am-dying-of-squamous-ce... (HN discussion: https://news.ycombinator.com/item?id=36827438).

People with what I have—recurrent/metastatic squamous cell carcinomas—are in effect already dead. We should be able to try novel drugs faster, and, if they don't work or have serious side effects, fine, the end result is the same. If they do work, they may prolong everyone else's lives.