Therapeutic Goods Amendment (Medicines Shortages and Other Measures) Bill 2026, Therapeutic Goods (Charges) Amendment Bill 2026
Mrs McINTOSH (Lindsay) (16:20): I rise to speak on the Therapeutic Goods Amendment (Medicines Shortages and Other Measures) Bill 2026 and the related Therapeutic Goods (Charges) Amendment Bill 2026, and I move: That all words after "That" be omitted with a view to substituting the following words: "whilst not declining to give the bill a second reading, the House: (1) notes that: (a) Australia imports around 90 per cent of the medicines the country requires, while making up barely two per cent of the global market, creating vulnerability to local supply due to overseas manufacturing issues, shipping delays and rerouting; (b) throughout 2025, there were more than 400 medicine shortages listed on the Therapeutic Goods Administration's (TGA) Medicine Shortage Reports Database, driven heavily by global manufacturing constraints, single-source active ingredients, and rising international demand; (c) the number of substitution approvals issued by the TGA in order to deal with shortages of medicines has more than doubled since 2018; and (d) the bill fails to deal with the underlying causes of medicine shortages; and (2) calls on the government to develop a comprehensive medicine shortage policy that boosts sovereign capability to ensure more essential medicines are made locally, and set targets to reduce the number of medicine shortages in Australia".
At its heart, this bill is about one thing: knowing sooner when a medicine is about to run short. It does a few sensible things to get there. It requires the pharmaceutical companies who supply our medicines to give at least 12 months notice before they permanently stop supplying one or as soon as they practically can.
It requires them to keep the secretary updated if that plan changes, and it lets the secretary ask any supplier whether their product is available, running short or being discontinued. It keeps the medicines watchlist—the list of medicines whose shortage would hit hardest—current and up to date. The bill makes a second change as well, a more technical one.
Right now, biologic medicines, things like hormones and immune treatments, which are made from living cells, are registered one by one, even when they are all but identical. A different bottle size means a separate listing. A different pack means more paperwork.
This bill lets very similar biologics from the same maker sit under a single listing, the same way we already treat ordinary medicines and medical devices, and the companion charges bill simply sets the fees that go with those group listings. It is a commonsense change. It cuts duplication and it cuts costs and red tape for the sector.
The bill does one more thing: it writes into primary law the power for authorised officers to enter and inspect clinical trial sites to make sure the goods used in those trials are safe for the patients taking part. The coalition will not oppose this bill in the House. The Senate has referred it to the Community Affairs Legislation Committee.
That is the right place to test the detail and to hear from the people this affects, and we reserve our position on any amendments until that inquiry work has been done. Here is the truth at the centre of this bill: earlier warning is welcome, but a warning is not a solution. This bill will tell a patient sooner that their medicine is about to disappear.
It does nothing to stop it disappearing in the first place. That's the problem this parliament should be reaching for, asking questions about and investigating deeper. Australia imports around 90 per cent of the medicines we depend on.
We make up barely two per cent of the global market, so, when a factory overseas has a problem or a shipment is delayed or supply is rerouted, we are at the very end of the queue. Right now, more than 400 medicines are listed on the TGA's database as being in shortage. Dozens of them are critical, and the warning system we already have is not reaching the people who need it.
A RACGP newsGP poll of nearly 1,500 GPs found that 73 per cent first hear about a shortage from their own patients; from the TGA, only two per cent; and from the manufacturer, only one per cent. The doctor is often the last to know. Since shortage reporting became mandatory, a reform this side of the House delivered in government, the number of substitute medicines the TGA has had to approve has more than doubled.
This is not a system getting healthier; this is a system under strain, and we have seen where this ends. In 2024, our public hospitals ran critically short of IV fluids, the saline that surgery and emergency care cannot run without. Operations were delayed.
Patients were put at risk. The government was warned it was coming, but the national response group was not stood up until August 2024, after the shortage had already turned critical, and it was only in 2025 that the government announced a $40 million deal to expand manufacturing here at home. It was a welcome step but a step taken after the horse had bolted, which, under this government, we see far too often.
As my colleague the shadow minister for health and aged care, Senator Anne Ruston, said at the time, what does 'a future made in Australia' actually mean if the Albanese government cannot even guarantee our supply of saline, which is essential to the operations in our health system? Australia can do better than lurching from one shortage to the next. We need to get ahead of this.
This needs to be done with a real strategy, one that builds our own capability, makes more essential medicines here at home and sets clear targets to bring the number of shortages down. Patients depend on it. Clinicians depend on it.
Our whole health system depends on it. That's why I've moved the second reading amendment. This bill will help Australians see the next shortage coming.
The job of this government, which they keep dodging, is to stop it arriving at all. Earlier warnings are welcome, but a warning is not a solution. I commend the amendment to the House.
The DEPUTY SPEAKER ( Ms Claydon ): Is the amendment seconded? Mr Thompson: I second the amendment and reserve my right to speak. Debate adjourned.