Therapeutic Goods Amendment (Medicines Shortages and Other Measures) Bill 2026, Therapeutic Goods (Charges) Amendment Bill 2026

Ms MASCARENHAS (Swan) (18:37): Most Australians never think twice about whether their medicine will be available when they need it; they simply expect it to be there. If you come down with the flu, you expect to walk into a pharmacy and find cold and flu medication on the shelf. If you have an infected wound, you expect to be able to pick up your antibiotics when your doctor prescribes them.

If you live with ADHD, you expect your medication to be there month after month, not subject to a lottery of which pharmacy will happen to have it in stock. If you're going through menopause, you expect your hormone replacement therapy to be there when you need it, not rationed or unavailable for months at a time. During the COVID-19 pandemic, we saw the vulnerability of supply chains across our country.

In particular, this was heightened when it came to medications. What we saw was pharmacy visits become a real source of anxiety for Australians who depended on certain types of daily medication. I remember during that time that my son, who was two years old, was diagnosed with asthma.

If I look at my husband's family, my father-in-law had asthma as a young man and was one of the first people to try Ventolin. I'm going to say that that was indeed a life changing medicine for him. Of course, my husband has asthma, so when my son was diagnosed it was not a surprise.

However, what was a surprise was in relation to that diagnosis happening during the pandemic. When the doctor prescribed Ventolin, of course, I went to the pharmacy next door and assumed that I'd be able to buy Ventolin there and then, but that was not possible. I went home and I called another five pharmacies, and none of the pharmacies within my neighbourhood had this medicine in stock.

As a mother, the fear starts to rise of 'I don't have this really important medication for my two-year-old, who isn't necessarily the best communicator'. I then took to Facebook and had a note, asking, 'Does anybody know where I can get children's Ventolin from?' And my dear old friend Liam Ducey said, 'I know where you can get it,' so I drove about 30 minutes out to the Midland Pharmacy and Compounding Centre and was able to pick up the medication that I needed.

But it shouldn't be through persistence or lottery that you get access to the medications. The additional thing that I saw during the pandemic was that there were particular shortages out in regional communities. I remember seeing people needing medication and basically asking on Buy Nothing, 'Does anyone have access to this medication for my father, who doesn't have access to this in the regional communities?' We saw that happen and we said that was absolutely unacceptable.

But the shortages of medicines aren't just an inconvenience felt at the chemist counter. They can happen in other places as well, such as our hospitals. Even treatments as essential as IV fluids have, at times, been in short supply.

They can affect the very systems that our hospitals rely on to keep people alive and well. From the chemist counter to the hospital wards, Australians expect medicines to be there when they need it. They should be able to count on it, and that is something that this government is determined to protect.

That's exactly what the Therapeutic Goods Amendment (Medicines Shortages and Other Measures) Bill 2026 sets out to do. This bill amends the Therapeutic Goods Act 1989 to implement a series of practical public health measures that strengthen the way that Australia identifies, manages and responds to medicine shortages and discontinuations so that Australians can have confidence in the ongoing supply of medicines that they rely on from everyday treatments right through to life-saving therapies.

Global supply chains are complex. A shortage in Australia can be triggered by a manufacturing problem on the other side of the world, a shipping delay, a spike in global demand or even a regulatory issue in another country. Some disruptions are simply unavoidable, but how we prepare for them, how we monitor them and how we respond to them is absolutely within our control, and this bill is strategically changing our ability to do that.

Since 2019, Australia has had a mandatory reporting scheme requiring pharmaceutical sponsors and the companies responsible for supplying medicines here to notify governments when a reportable medicine is in short demand or is being discontinued. That scheme set out a good framework for communication, but stakeholder consultation over the past two years—including extensive engagement with patients, health practitioners and industry—has identified where it can be improved.

The Albanese Labor government has listened, and this bill responds to that feedback. At the centre of this bill is a change to how far in advance sponsors must notify the government of a permanent discontinuation. Under the current law, sponsors only have to give 12 months notice when a discontinuation is likely to have a critical impact.

For other medicines, the requirement is just six months. That's a six-month gap, and that gap matters. It means that, for a whole category of medicines, patients and their doctors have historically had half the warning time to prepare simply because a discontinuation was not classified as critical, even though, for the person relying on that medicine, the disruption is critical to how they live their lives every day.

This bill lifts that requirement so that all reportable medicine discontinuations must be notified at least 12 months in advance or as soon as practicable after the decision is made, where unforeseen circumstances such as a sudden manufacturing issue make that impossible. This matters because predicting in advance whether the discontinuation will turn out to be critical is not always straightforward, and patients and health practitioners deserve as much notice as possible, regardless of the classification.

Twelve months gives doctors, pharmacists, patients and the community more time to plan and prepare for these potential shortages. The bill also requires sponsors to keep government updated if their plans change—for instance, if the discontinuation is delayed, brought forward or called off altogether. This closes a gap in the current framework and ensures the information government and health practitioners are working from stays accurate.

Alongside this, the bill expands the power of the Secretary of the Department of Health, Disability and Ageing to request information about availability, shortages and discontinuations from all sponsors of approved medicine, not just those on the reportable list. We saw with IV fluids just how significant a shortage of non-reportable medicines can be. This shortage affected all three of Australia's IV fluid suppliers, with the Therapeutic Goods Administration warning that global disruptions were likely to continue well into 2025.

In response to that shortage, our government acted. We invested $20 million, matched by Baxter health care, to expand the only onshore IV-fluid manufacturing facility in the country. That investment set out a boost of local production by 20 million units in a year, taking our onshore production to 80 million units annually from 2027 and reducing our reliance on overseas supply chains, which are vulnerable to the exact type of disruption that we saw in 2024.

That is the kind of practical, decisive response Australians expect when a shortage puts pressure on our hospitals. This bill means the government has more time to gather the information it needs to respond, no matter what medicine is affected. This bill also makes a practical change for sponsors of biological products, such as tissue based treatments, cell based therapies and blood derived products.

Under current law, therapeutic goods with common characteristics can already be grouped under a single register entry, but there is no equivalent power for biological products. This means sponsors are currently forced to maintain separate register entries and pay separate annual fees for products that are essentially the same thing, differing only in minor ways such as formulation or approved uses.

This bill allows the secretary to determine common biological groups so that similar biologicals can share a single entry on the Australian Register of Therapeutic Goods. It's a sensible change that reduces duplication and cuts unnecessary costs and administrative burden for industry without compromising safety or oversight. The bill also strengthens the legal footing behind the inspection regime, which is already keeping trial participants safe.

Through the Therapeutic Goods Association Good Clinical Practice Inspection Program, authorised inspectors visit clinical trial sites. This is really important and it's something that we need to make sure we continue to do. The thing that I'd say is that, with this bill, what we're trying to do is ensure that Australians have the medicines they need, when they need them.

This bill continues to ensure that we do this in a methodical way. We're strengthening the regime to make sure that we do this in a really appropriate manner. I commend the bill to the House.