Therapeutic Goods Amendment (Medicines Shortages and Other Measures) Bill 2026, Therapeutic Goods (Charges) Amendment Bill 2026
Ms CAMPBELL (Moreton) (17:45): When you walk into the urgent care clinic in Oxley, in my electorate, on Brisbane's south side, you'll be greeted with a smile. Whether you've got a cut, whether you've got a burn or whether you've got a fracture, they'll treat it with just your Medicare card. And when you're sick and you get to the counter at one of the 28 fully bulk-billed GP practices in my community, all you'll need is that little green card.
And when you ask John, the pharmacist at the Eight Mile Plains Discount Drug Store, for a PBS medicine, all you'll ever pay is 25 bucks. That's because Labor governments, and this Labor government, believe that health care should be accessible and that it should be affordable, because Australia's public healthcare system was conceived and planned by Labor governments.
It was legislated and implemented by Labor governments. It's been supported and strengthened by Labor governments. And it is one of our most valued public institutions.
This system is based on Labor's commitment to the principle of universal health care, and its foundation has supported the growth of our healthcare system—one that is built on reliability, is built on accessibility and fundamentally is built on trust. At the end of this week I turn 40. Luckily I am not as old as Medicare, which is 42.
For more than four decades Australians have had confidence when they need care that the healthcare system is ready to support them. We trust that we will be able to access medical help from a GP when we need it. We expect that Medicare will help make that care affordable.
We have faith that healthcare professionals will provide quality and timely treatment. We depend on our hospitals in times of emergency and crisis. And we count on our local pharmacy to have the medicines we need when we need them, whether it is a course of antibiotics for a sudden illness or an ongoing prescription that helps manage a chronic condition.
We count on them. In recent years, however, Australians have had to cope with medicine shortages, and this is not merely an inconvenience. Medicine shortages decrease the confidence Australians have in our healthcare system.
They cause uncertainty and anxiety in patients. They affect pharmacists, who have to explain supply disruptions which are out of their control. They create additional work for doctors, who may be required to adjust treatment plans or find substitute medicines.
For vulnerable Australians, such as those living with chronic conditions or those in rural and remote communities, it can be particularly damaging. The Therapeutic Goods Administration Act provides up-to-date information on medicine shortages, explaining that they may be due to issues with manufacturing, challenges with supply chains, regulatory barriers, trade constraints or an unanticipated increase in demand for specific medicines.
Pharmaceutical supply chains are complex. You only have to walk into Symbion, in Acacia Ridge in my electorate, and look up at the thousands of different medicines being moved by robotic arms with enormous security to understand that. While many of the medicine shortages that have affected Australians arise from global factors beyond our control, it is our responsibility to ensure that our healthcare system can respond effectively That's where the Therapeutic Goods Amendment (Medicine Shortages and Other Measures) Bill 2026 comes in.
The bill amends the Therapeutic Goods Act 1989 to improve key elements of Australia's medicine shortage management framework. This will ensure that we are better equipped to respond when supplies of essential medicines come under pressure—because when those supplies come under pressure, it affects people's lives, it affects their livelihoods, and it affects their families, and we believe that we need to do something about that.
The bill will achieve this through three specific measures. Firstly, it focuses on improving Australia's preparedness for the withdrawal of essential medicines from the market. Basically, it legislates the ability for us to plan going forward.
Pharmaceutical companies will be required to provide early notification when they decide to permanently discontinue the supply of a reportable medicine in Australia, and this information must be provided to the Secretary of the Department of Health, Disability and Ageing at least 12 months before the discontinuation takes effect, where possible. If that timeframe is not possible, advice must be received as soon as practicable after the decision is made.
The second measure adds transparency to those decisions by requiring pharmaceutical companies to provide ongoing updates if their intended course of action changes. It's about saying to these companies, 'Tell us what you're doing, and tell us if it changes.' Decisions to discontinue medicines are not always irrevocable, and implementation timeframes can shift in response to market conditions, manufacturing considerations or supply chain developments.
This bill requires companies to notify the secretary if a proposed discontinuation is delayed, if it's brought forward or if it's cancelled. These measures will ensure that government, healthcare professionals and patients are working from the most current information available, enabling better preparation and reducing the likelihood of unexpected disruptions to access to essential medicines.
Australians, quite frankly, deserve to know, and they deserve to know as soon as possible. Thirdly, the bill also enhances the government's ability to monitor and respond to emerging supply risks. It empowers the secretary to require sponsors of approved medicines to provide information about the availability of their products in Australia.
This includes information relating to actual or anticipated shortages as well as any plans to discontinue supply. Access to this information will support earlier identification of potential problems and enable more proactive management of risks to medicine availability. This bill also contains a couple of technical and regulatory amendments.
It streamlines regulatory arrangements for biological medicines by allowing the secretary to establish common biological groups. This will enable closely related biological products to be recorded under a single entry on the Australian Register of Therapeutic Goods, rather than requiring multiple separate entries. By reducing unnecessary duplication, these changes will simplify administrative processes, lower compliance costs for sponsors and reduce regulatory burden while maintaining the necessary oversight of the safety and quality of medication.
The bill includes an important technical amendment to strengthen the operation of Australia's clinical trial regulatory framework as well. The amendment provides clear legislative authority for authorised officers to inspect and assess clinical trial sites to ensure that unapproved therapeutic goods being supplied or used as part of clinical research are complying with all relevant conditions and requirements.
This is an important safeguard that supports the protection of trial participants and helps ensure the integrity of Australia's clinical research system. By placing these powers on a clearer statutory footing, the bill strengthens oversight arrangements while supporting the continued safe and effective conduct of clinical trials in this country. This bill sits within a wider landscape of the Albanese Labor government's commitment to the Pharmaceutical Benefits Scheme, which is another institution that Labor is justly proud of and which is an important key component of our healthcare system.
The PBS ensures that Australians can access at an affordable price—regardless of their income, their circumstances and their bank balance. Access to medicine should never be determined by a person's capacity to pay. The Albanese government remains firmly committed to strengthening both the PBS and Medicare and ensuring that all Australians can access high-quality, affordable health care.
That's what we believe. That's what's in our DNA, and that's what we do every single day. At a time when many households continue to face cost-of-living pressures, we have taken significant steps to reduce the cost of medicines and ease pressure on family budgets.
The Albanese Labor government has reduced the maximum cost of a PBS medicine to $25—the lowest in two decades. We've also frozen the cost of PBS medicines for concession cardholders at $7.70. This helps pensioners, concession cardholders and other vulnerable Australians continue to access the medicines they rely upon without facing additional financial pressure.
These measures are making a real difference. They're helping Australians fill their prescriptions, continue their treatment plans and better manage their health while delivering meaningful cost-of-living relief. However, affordable medicines are of little use if they are unavailable.
That is why this government is focused on both strengthening the framework for managing medicine shortages and building a healthcare system that is more resilient, and that resilience is something that Australians deserve. I think we would all agree that, ultimately, the strength of a healthcare system is measured by both the quality of care it provides and the reliability in which that care is delivered.
The amendments in this bill are an important step towards ensuring that Australia's healthcare system remains worthy of the trust that millions of Australians place in it every single day. Labor governments will always stand up for Medicare and the Pharmaceutical Benefits Scheme. We will continue to protect those institutions and strengthen them for future generations and we will ensure that Australians can access the health care and the medicines that they need, most importantly, when they need them.