Tania Lawrence (Hasluck, Australian Labor Party) | Link to this | Hansard source

Before the debate is resumed on this bill, I advise the Federation Chamber that in the House it has been agreed that a general debate be allowed covering this bill and the Therapeutic Goods (Charges) Amendment Bill 2026.

Renee Coffey (Griffith, Australian Labor Party) | Link to this | Hansard source

I want to begin by sharing the experience of a young man from West End in my community of Griffith. In January last year, he spent an entire weekend searching for somewhere to fill his script of quetiapine. Quetiapine is an atypical antipsychotic medicine used to treat conditions including psychosis, schizophrenia and bipolar disorder. For this young man, it was the medicine that helped him manage psychotic symptoms and stay well. He and his psychiatrist had spent months adjusting his treatment. They had found the dose that worked for him, and he had seen real improvement in his health. Then he tried to fill his prescription. One pharmacy had no stock, nor did the next, nor the next. He kept searching across the entire weekend.

After visiting 12 pharmacies, he finally secured enough tablets to last another week. But the only tablets available were 100 milligrams. To get the dosage right, he had no choice but to break tablets into two. The problem was that the extended release tablets are not supposed to be split. The 100 milligram tablets he had finally secured were not scored and could not be divided accurately. Even after finding a week's supply, he could not be sure he was taking the right dose. His remaining supply had already run so low that he had begun rationing his medication to try and make it last. His psychiatrist had not changed his treatment. His health needs had not changed. He had a valid prescription and had followed every part of his care plan. The medicine simply was not there.

For a person managing symptoms, missed or reduced doses can have serious consequences. They can cause withdrawal effects, the return of symptoms and the risk of relapse. Searching for stock can be hard for anyone. It can be even harder for someone whose mental health is already under strain. This happened in West End in Brisbane within one of Australia's largest health and medical precincts. I've heard similar experiences from people trying to find ADHD medication. Some people have called pharmacy after pharmacy searching for stock while others have returned to their doctor and changed medicine purely due to what was available. That is a difficult way to make a treatment decision.

ADHD medicines can have different doses, release patterns and effects across the day. Changing medicine may mean another appointment, another prescription and another period of adjustment. For children, an unplanned change can affect learning, behaviour and family routines. For adults, it can affect work, study, driving and everyday tasks. The Therapeutic Goods Administration, the TGA, recorded shortages across several methylphenidate products during 2024 and 2025. While most have been resolved, some remain in short supply. These experiences show us why the Therapeutic Goods Amendment (Medicines Shortages and Other Measures) Bill 2026 is needed. The response to a medicine shortage should begin before a patient reaches their final tablets. Patients need clear information. Pharmacists and doctors need time to plan. Hospitals need enough warning to protect people whose treatment cannot safely be interrupted. This bill implements several important public health measures in relation to the management of medicine shortages and discontinuations.

Most people do not think about how their medicine reaches the local pharmacy, but pharmacies are often faced with long supply chains. A quality control problem at a factory, a delayed shipment or a shortage of an ingredient can affect patients thousands of kilometres away. Demand can rise quickly. A company can decide to stop supplying a product. While no government can prevent every factory fault or shipping delay, government can demand earlier warning and make sure information reaches the people planning the response. For a patient, a shortage may mean hours of calling pharmacies, extra travel and time away from work. It may mean paying for another appointment to obtain a new prescription. For a parent, it may mean searching for medicine needed by a child before school starts on Monday. For an older person, it may mean trying to navigate a change across several medicines and several doctors. A replacement medicine is not always a simple swap. A different strength may need new instructions. A different formulation may change how and when the medicine is taken. Another medicine may bring side effects or fail to control symptoms in the same way. Shortages place pressure on health workers too. Pharmacists spend hours contacting wholesalers and nearby stores. Doctors need to review treatment plans. A shortage of one brand can quickly increase demand for another. The alternative can then run short as well. Health workers need to see those pressures early before one supply problem spreads.

Australia has required companies to report medicine shortages and permanent discontinuations since 2019. Companies must alert the TGA when certain prescription, controlled and non-prescription medicines are in short supply. A shortage with a critical impact must be reported within two working days. Other reportable shortages must be notified within 10 days. The TGA publishes shortage information and works with health professionals, companies and government on alternative supply. That work depends on accurate and timely information. Under this bill, pharmaceutical companies must give at least 12 months notice when they decide to permanently stop supplying a reportable medicine in Australia. If the decision is made less than 12 months before supply ends, the company must notify the TGA as soon as practicable. It must provide an update if the date changes or it decides to continue supply. Accurate information cannot be a one-off exercise. If a supply date changes, hospitals, wholesalers, pharmacists and doctors need to adjust their plans. That notice gives doctors time to review treatment and explain the options. Pharmacists can check stock, identify alternatives and contact affected patients. Hospitals can assess demand, secure available supply and prepare clinical advice. The extra time lets the TGA and governments examine alternative sources of supply before the remaining sources of stock are exhausted. For patients, it creates time for a planned and monitored change in treatment rather than an urgent search after a prescription cannot be filled.

This bill gives the Secretary of the Department of Health, Disability and Ageing stronger powers to ask companies about medicines supply. Mandatory reporting currently covers certain medicines. Under this bill, the secretary can seek information from the company responsible for any approved medicine. The TGA can ask how much stock is available, how long it will last and when new supply may arrive. If one shortage increases demand for another product, the regulator can ask whether its supplier can meet that demand. The bill also updates the Medicines Watch List under section 30EJ of the Therapeutic Goods Act, which covers medicines whose shortage could put people at risk of death or serious illness with no suitable alternative. They are used in ambulances, emergency departments, maternity wards, clinics and homes. The list includes intravenous morphine and diazepam for emergency and critical care. It includes antivenenes for snakes, funnel-web spiders, box jellyfish and other venomous animals. It includes naloxone injections and nasal spray, which can temporarily reverse an opioid overdose. The list covers adrenaline autoinjectors, salbutamol inhalers, key antibiotics, vaccines and medicines used in obstetric emergencies. These medicines protect health and save lives across Australia. A break in supply could leave a paramedic, doctor, midwife or family without the treatment needed in a critical moment. The bill lets the watch list draw on source documents as they are updated, so it can keep pace with the changes in medicine name standards and clinical guidance.

Griffith is home to one of Australia's leading health and medical precincts. Within a few kilometres, we have the Princess Alexandra Hospital, the Mater, the Queensland Children's Hospital, private hospitals, specialist clinics, universities and the Translational Research Institute. Around 17,000 people in Griffith work in health care and social assistance. That is about 11 per cent of our local workforce, the fourth-highest share of any electorate in the country.

These workers see medicine shortages from every side. Our community pharmacists know which patient has been stable on the same medicines for years. They are often the person explaining that the usual brand or strength is unavailable. Our GPs and specialists know that changing treatment can bring uncertainty. They need time to speak with patients, consider their medical history and monitor any new medicine. Our hospital pharmacists manage medicines for some of the sickest patients in Queensland. A shortage can affect emergency care, surgery, cancer treatment and the management of complex conditions. Earlier information gives each of them more room to act. A hospital pharmacist can identify the patients at greatest risk. A specialist can decide whether a safe alternative exists. A GP can explain a different dose or formulation. A community pharmacist can contact patients before their supply runs out.

The bill also places clear inspection powers for clinical trial sites in the Therapeutic Goods Act. Authorised officers can examine consent processes, clinical records, facilities and the way unapproved products are stored and used. These checks protect people who volunteer for trials and support confidence in the research taking place across Australia and in my community in Griffith. Clinical trials provide the evidence needed to assess new treatments, diagnostic tools and medical devices. They can give patients another option when existing treatments have not met their needs.

In Griffith, I am so fortunate to have some of the world's leading medical research centres. The Translational Research Institute's Clinical Research Facility on the Princess Alexandra Hospital campus supports researcher led and commercially sponsored trials. It provides specialist facilities, staff and equipment to test new medicines, treatments and diagnostic tools. On the Queensland Children's Hospital campus, a purpose built facility within the Centre for Children's Health Research supports studies involving children, including low-risk research and phase 3 and phase 4 trials. Mater Research has more than 200 active clinical trials across nine areas of health care. These include studies of new medicines and medical devices, along with research led by the Mater, the University of Queensland and other institutions.

Last week I was delighted to join with researchers at Mater and celebrate their work. Earlier this year the Australian government provided $2 million for seven research projects to improve care for some of our nation's smallest and most vulnerable babies. These projects show how research moves from an idea to better care in a hospital and why strong protections for every participant are so important.

I'll just go through a few of the recipients of that funding. Dr Julie Wixey is advancing the Tiny Baby initiative, and its study will involve 2,400 extremely premature babies across eight countries to identify the safest oxygen levels in the first moments after birth. Dr Elizabeth Hurrion is preparing a trial for intravenous sodium sulfate that could help protect premature babies from cerebral palsy. And Professor Sailesh Kumar is developing a screening tool to identify babies affected by undetected placental problems. These projects and many more rely on babies, parents and families volunteering during a vulnerable time. The inspection powers in this bill help protect them and uphold the standards expected at every trial site. These checks protect participants and support the high standard of research taking place in Griffith and across Australia.

Medicine needs to be affordable, and it needs to be available when a patient presents their prescription. The Albanese Labor government is working on both. From the first of this year, we cut the maximum PBS co-payment for general patients from $31.60 to $25. We froze the concessional co-payment at $7.70 until 2030. The PBS provides subsidised access to more than 900 medicines. These treatments support people living with cancer, diabetes, heart disease, asthma, mental ill health and many other conditions. We have introduced 60-day prescriptions for eligible medicines. This saves patients time and money and reduces the number of trips needed to renew regular medicines.

Since July 2022, people in Griffith have saved more than $19.1 million across more than 2.1 million PBS prescriptions. Those savings are practical. They leave more in the household budget for rent, groceries, electricity and other bills. Lower prices help people fill their prescriptions. Better shortage information improves the chance that their medicine will be available when they arrive at the pharmacy. A cheaper prescription offers little comfort if the shelves are empty. Supply and cost need to be addressed together.

Access to health care is central to the work of the Albanese Labor government. Labor created Medicare, and we continue to strengthen Medicare and the PBS for every Australian who relies on them. This bill gives pharmacists, doctors, hospitals and the TGA more time to respond when medicine supply is at risk. It requires earlier notice, provides better information and keeps the Medicines Watch List current. These changes will help health professionals plan ahead and support patients through any change in treatment. They reflect Labor's commitment to a health system that is prepared, dependable and centred on the needs of patients.

Labor will continue to invest in Medicare, strengthen the PBS and improve access to medicines Australians rely on every day. That is important for the healthcare workers who live in my community of Griffith—the thousands of healthcare workers. It's important for the hospitals, the GPs, the pharmacies and all of the other allied health professionals in our community. Most importantly, it's important for the residents of Griffith, all of whom are so reliant on receiving good quality, affordable health care close to home. That is what we are committed to providing, and that is exactly what the Albanese Labor government is providing.

Alison Penfold (Lyne, National Party) | Link to this | Hansard source

For most Australians, medicine shortages are not an abstract problem about international supply chains or regulatory systems. They become very real when you walk into your local pharmacy with a prescription and the pharmacist tells you, 'I'm sorry; we can't get it.' That is particularly important in my electorate of Lyne. Lyne has the oldest population of any federal electorate in Australia. At the last census, the median age was 51, compared with 38 nationally. It is also a community where household incomes are considerably below the national average. That combination matters when we talk about medicines.

In regional Australia, a medicine shortage can be particularly difficult. If you live in Sydney and your local pharmacy doesn't have something, there may be another pharmacy a few kilometres away. But, if you live in Gloucester or Dungog or Stroud or one of the smaller communities across Lyne, that is not necessarily the case. Finding another pharmacy with stock might mean a substantial drive. For someone who is 80 years old, doesn't drive, is living on the pension and has limited mobility, that is a real problem. So I approach the Therapeutic Goods Amendment (Medicines Shortages and Other Measures) Bill 2026 and the accompanying Therapeutic Goods (Charges) Amendment Bill 2026 from a very practical perspective.

There are worthwhile measures in these bills; that is why the coalition will not oppose them in the House. But there is an important distinction between managing a medicine shortage better and preventing that shortage from occurring in the first place, and that is where the government still has a lot more work to do.

The main bill updates key aspects of Australia's therapeutic goods system, focusing on medicine shortages, biological medicines, clinical trials and related regulatory charges. A major focus is on strengthening requirements for reporting medicine shortages and discontinuations. Sponsors of reportable medicines must notify the Therapeutic Goods Administration of shortages and permanent discontinuations. This bill makes those requirements stricter. Pharmaceutical companies will generally need to give 12 months notice before discontinuing a reportable medicine in Australia. If 12 months notice isn't possible, notice must be given as soon as practicable. That is a sensible change. Earlier notice gives stakeholders more time to prepare, it gives regulators more opportunity to identify alternative products, it gives clinicians more time to work out whether patients need to be transitioned to another medicine and, hopefully, it means fewer patients finding out about a discontinuation when they arrive at the pharmacy counter.

The legislation recognises that circumstances can change. If a sponsor changes its decision or timeline, it must update the secretary accordingly. Again, that is sensible. The information held by the regulator should reflect what is actually happening in the market. The bill also gives the secretary broader information-gathering powers to require sponsors to provide availability and shortage information. The secretary will be able to require sponsors of approved medicines to provide information about the availability of their products and about any shortage or discontinuation. This helps government act before a crisis develops.

The legislation also updates the Medicines Watch List to keep it current as medicines and clinical circumstances change. The list covers medicines where a shortage could have a critical impact on patients. The amendments are intended to make it easier to keep that instrument current as medicines and clinical circumstances change.

These are all reasonable reforms, and they build on changes made by the former coalition government in 2018, when mandatory reporting of shortages of important medicines was introduced together with stronger penalties for noncompliance.

We should understand what these latest changes actually achieve. They improve information, they improve warning and they improve the government's visibility of a shortage. What they do not necessarily do is stop a shortage from occurring, and that distinction matters. That distinction matters because the difference between being able to access a critical medicine and not being able to access it is significant.

Medication is life saving. Constituents often write to me about how certain medications have changed their lives for the better. Anna from Killabakh, who has relapsing-remitting multiple sclerosis, says that, for over 10 years, she's had to live with fatigue, balance issues, cognitive challenges and the constant uncertainty of what tomorrow might bring. Two years ago, she started a new treatment, a new medication, which she says gave her something she hadn't felt for a long time—'confidence that my disease was finally being controlled and hope that I could continue living the life I'd worked so hard to build'. Now, Anna faces the prospect of losing access to life-changing medication because of government pricing negotiations. Anna says:

… being forced to change medications is frightening. To now face the possibility of losing the treatment that is keeping us stable has created enormous fear and distress among thousands of Australians living with this disease.

It's stories like this that remind us just how important access to medicine is. It is stories like this that highlight how this bill falls short in achieving that.

The bill also contains reforms relating to biological medicines, allowing closely related biological products from the same sponsor to be grouped under a single registration where the legislative requirements are satisfied. In plain English, if a company has essentially the same biological medicine in several closely related forms, we should not necessarily require the company to duplicate the entire regulatory process for every minor variation. That is something I support. Regulation has to protect patients—that is non-negotiable—but regulation should not create paperwork for the sake of paperwork. And, at a time when we are concerned about the availability and commercial viability of medicines in a relatively small Australian market, unnecessary regulatory cost matters.

The Therapeutic Goods (Charges) Amendment Bill 2026 accompanies these changes. Because the main bill changes the way certain biological products can be grouped on the Australian Register of Therapeutic Goods, the charging legislation also needs to be changed so that the charging arrangements work properly with the new structure. It is largely machinery legislation, but it illustrates something important: when we remove unnecessary regulatory duplication, we should also make sure businesses are not continuing to pay duplicated regulatory charges for processes that no longer need to occur separately.

All of that explains why the coalition is not opposing these bills, but it also brings us to their fundamental weakness. These bills are principally about how Australia manages shortages once the risk has emerged, but they do not answer the bigger question: why is Australia experiencing so many medicine shortages in the first place? Throughout 2025, more than 400 medicine shortages were listed on the TGA's medicine shortage reports database. Australia imports around 90 per cent of the medicines we rely upon, yet we account for barely two per cent of the global pharmaceutical market. That makes us vulnerable. When there is a global shortage, Australia is a small customer competing against the United States, Europe and other much larger markets.

There is another figure that should concern this parliament. When a medicine is unavailable in Australia, the TGA can use special arrangements to allow substitute overseas products to be supplied. Since mandatory shortage and discontinuation reporting was introduced, the number of these substitution approvals has more than doubled, from 99 in 2018-19 to more than 200 in 2024-25. That tells us something. Our system is increasingly having to find workarounds when normal supply fails, and a workaround is not the same thing as having a resilient system.

There is another extraordinary statistic: a Royal Australian College of General Practitioners poll in 2025 found that nearly three-quarters of GPs said their patients were the most common way they learned about medicine shortages. Think about that. The patient goes to the pharmacy, the pharmacist cannot fill the prescription, the patient goes back to the doctor and the patient effectively becomes the doctor's warning system. According to that polling, the TGA accounted for just two per cent of GPs first learning about shortages and for just one per cent of manufacturers. That is not good enough.

Perhaps the clearest demonstration of Australia's vulnerability was the shortage of intravenous fluids beginning in 2024. IV fluids are among the most basic products used in a hospital. Saline is not some obscure experimental medicine; it's fundamental to the operation of a modern health system. Yet Australia experienced a critical shortage. What makes this example particularly frustrating is that Australia actually has domestic manufacturing capability. The government had been warned of supply concerns well before the shortage reached its most serious point. Yet a national monitoring group was not established until August 2024, after the shortage had become critical. Then, in 2025, the government announced a $40 million joint investment to expand domestic manufacturing capacity. That investment is welcome, but why did Australia have to reach a critical shortage before government acted? My colleague the shadow minister for health, Senator Anne Ruston, put the question well at the time: what does a future made in Australia actually mean if the government cannot guarantee something as basic as saline? That question remains relevant.

The Albanese government is prepared to spend billions of dollars under its Future Made in Australia agenda, but sovereign capability should not mean politicians in Canberra cherry-picking fashionable industries and pet projects. It should start with identifying the things Australians genuinely cannot afford to be without: fuel, food, defence capability, critical infrastructure and essential medicines. Medicine security is national resilience. The COVID pandemic should have taught us that. The increasing instability in international shipping and global supply chains should reinforce it. Australia cannot manufacture every medicine we consume, but there is a very large distance between manufacturing everything and being dangerously dependent on everyone else.

We need a serious assessment of where Australia is vulnerable: which essential medicines have only one supplier, which rely upon active ingredients from a single country or manufacturer, which medicines have no practical substitute, which medicines would have the greatest consequences if supply stopped, what strategic stockpiles should Australia maintain, where should we diversify our overseas suppliers, and where does it make economic and strategic sense to maintain Australian manufacturing capability? Those are the questions a genuine medicine security strategy should answer.

The government also needs to be prepared to look at an uncomfortable part of this debate. Australia must make sure its regulatory and pricing systems do not inadvertently make the supply of essential medicines commercially unviable. Australians rightly expect medicines to be safe and taxpayers rightly expect value for money through the Pharmaceutical Benefits Scheme, but the cheapest theoretical price is not much use if nobody wants to supply the medicine. Government needs to understand where low margins, small market size, regulatory costs and reliance on single manufacturers are creating vulnerabilities, and it needs to identify those risks before the manufacturer tells us it is leaving the market. That is another reason the 12-month discontinuation requirement in this legislation is useful. But, again, receiving 12 months notice that a medicine is disappearing gives the government time to respond; it does not automatically give Australia another supplier.

The coalition, as I've said, will not oppose these bills in the House. The Senate has referred them to the Community Affairs Legislation Committee so stakeholders can be heard and the legislation examined in greater detail. The coalition reserves its position on changes to the bills following that inquiry. The measures before us are sensible, but parliament should not confuse improving the administration of medicine shortages with solving medicine shortages. The real test is not whether the TGA receives a notification 12 months earlier. The real test is whether the 80-year-old in Tea Gardens can get the medicine their doctor prescribed, whether the pensioner in Forster can fill a prescription without visiting three pharmacies, whether our doctors know about shortages before their patients tell them, and whether Manning Base Hospital or one of the other regional country hospitals in my electorate have the essential medicines and supplies available to them when patients need them. That is what medicine security looks like outside Canberra.

Australia needs a comprehensive medicine security strategy. We need to identify our critical medicines. We need to understand where there are single points of failure. We need diversified supply chains. We need appropriate strategic reserves. We need to examine the commercial viability of essential medicines in the Australian market. And, where the strategic case stacks up, we need sovereign manufacturing capacity. These bills improve the warning system, and that is certainly worthwhile. But, after four years in government, Labor needs to do more than tell Australians earlier that there is a problem. It needs a plan to reduce the likelihood of the problem occurring in the first place.

Julie-Ann Campbell (Moreton, Australian Labor Party) | Link to this | Hansard source

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.

Monique Ryan (Kooyong, Independent) | Link to this | Hansard source

Since its inception in 1948, Australia's Pharmaceutical Benefits Scheme has been one of our great public policy achievements and has given Australians access to essential medicines at a fraction of what people pay in comparable countries. But our PBS is under real pressure, and the events of the last few months should worry all Australians. Patients living with multiple sclerosis, cancer, opioid dependence, inflammatory bowel disease and other serious conditions have faced growing uncertainty about whether the medications keeping them healthy, independent and engaged in their communities will remain available to them. Supply of four medications across different therapeutic areas has been thrown into doubt in the space of three months. It's not a coincidence; it's a warning sign.

Zoladex, which is for breast cancer and endometriosis treatment, is being taken off the PBS by AstraZeneca for commercial reasons. Sublocade, which is used by thousands of Australians for opioid dependence treatment, is being withdrawn from our market by its sponsor Indivior for commercial reasons. Until recently over 13,000 Australians living with multiple sclerosis—roughly half of all of the Australians with multiple sclerosis, who are disproportionately women—faced the very real prospect of losing subsidised access to Ocrevus and Kesimpta. That risk arose not because the medicines stopped working for those patients or because of a supply chain issue but because the medications' sponsors, Roche and Novartis, rejected proposed price cuts of up to 50 per cent, triggering a fortnight of significant anxiety and uncertainty for Australians living with MS and their clinicians. The Minister for Health and Ageing has since confirmed that the MS medications will remain listed for the moment, but only after thousands of patients spent weeks unsure whether or not the medicines that they needed would still be there for them at the end of that month.

It seems inevitable, given the government's current struggles with the PBAC and TGA, that more such battles will follow. I've heard directly from many constituents in Kooyong about how these changes and these uncertainties make them feel. They feel anxious. They feel afraid. They feel like unwilling and helpless pawns in a struggle between their government and multinational drug companies. I spoke with Lucy, a gorgeous, very brave woman who lives in Prahran. She says that her breast cancer is still the main character in her life. At a time when she's dealing with recovery and difficulty with work, losing access to Zoladex is the last thing that she needs, and she knows scores of young women from across Kooyong and Melbourne who are in the same boat. Kate, a single mum with two children from Hawthorn, said:

It absolutely terrifies me that this drug will no longer be available to me and others that need it.

Australians should not be made to feel this way. This bill addresses some—but only some—of the issues. It strengthens the mandatory reporting framework under the Therapeutic Goods Act, requiring sponsors of all reportable medicines to give the Secretary of the Department of Health, Disability and Ageing at least 12 months notice of a decision to permanently discontinue supply and to update the TGA if their plans change. That is a very small improvement on the status quo, where only discontinuations that are likely to be of critical impact require 12 months notification, with other reportable medicines requiring only six months notice. A stronger notification regime means better planning, fewer rushed clinical decisions and less anxiety, but this modest enhancement to Australia's medicines notification regime does not go nearly far enough. There's much more to do on notifications, on continuity of care and on patient protections. This bill requires 12 months notice of discontinuation, but it also allows the sponsor to notify only 'as soon as practicable' when earlier notice is not available, with no obligation to explain why, no requirement to tell the secretary when they first knew trouble was coming and no obligation to tell the secretary what they've done to avoid it and what mitigation strategies might be in place.

Secondly, the bill's critical impact test asks only whether a registered substitute exists in sufficient quantity. That ignores the fact that stability of therapy is sometimes a clinical goal—that, for those individuals who need treatment with anticonvulsants, antipsychotics or immunosuppressants and for other conditions in which continuity and stability of care is vital, substitutes are often inadequate alternatives. The bill also applies only to discontinuation or shortages of supply. It wouldn't apply to sponsors' commercial decisions to cease supplying agents like Ocrevus, Kesimpta and Zoladex under the PBS. Where medications remain registered, manufactured and, theoretically at least, physically available, patients will not be informed that they are no longer funded under our PBS. This bill's notification framework is silent on this critical issue. The strongest and most airtight notification regime cannot safeguard our system against the scale of Australia's medicines vulnerability.

The TGA's database currently lists close to 400 medicines in shortage with a further 79 in anticipated shortage. About 40 of those are rated critical. They include blood thinners, antibiotics and hormone replacement therapy. As many as 120 new shortages are notified every month. It's not easy to keep track of those numbers. These are ongoing supply issues which preceded the pandemic but have since worsened. Every one of those shortages represents a supply failure and converts into a cost which is borne by patients—in money, time, inconvenience and stress.

If this bill was a serious attempt to address continuity of care, it would create cost and access protections for those patients who are forced onto second-line therapies during declared shortages so that these supply chain failures—which are not their own fault, let us remember—don't result in increased out-of-pocket costs for patients.

The reality is that Australia shouldn't be experiencing all these shortages. But we are too slow, too cautious and too stingy in how we assess and price new medicines. TGA approval typically takes about a year, PBAC listing takes an average of 466 days, and MSAC assessment takes one to two years. Only about 27 per cent of innovative medicines available globally ever reach our PBS. A report released just this month found that only 25 per cent of medicines launched over the last decade globally have been listed here. That's against 88 per cent in the United States and 46 per cent in the United Kingdom.

Net investment in Australia in innovative medicines has fallen from 6.2 per cent to 4.1 per cent of the health budget since 2015-16. We pay about a third less than Canada for innovative medicines while we take almost four years longer than Spain or the UK to fund first-in-class treatments once they have actually been proven safe and effective. Layer onto that the United States' most favoured nation pricing policy—which is pushing global companies to treat the lowest price that they accept anywhere as a floor for what they can charge in the much larger American market—and it's little wonder that the health minister himself has warned of the chilling effect on companies' willingness to bring us any new medicines at all.

Other countries have read these signs, and they've acted. The UK has struck a pricing deal with the US and it's listed its cost-effectiveness threshold for the first time in 20 years. Ireland has locked in faster reimbursements and new means of funding. South Korea has overhauled its system for the first time in 13 years. Australia's response so far has been yet another round of consultation.

The government accepted in full the 50 recommendations of its own 2021 Health Technology Assessment Policy and Methods Review. But, more than two years later, the recommendations remain almost entirely unimplemented, including the reforms to comparator selection and to discount rates that sat at the heart of the recent MS medication pricing dispute. The Health Technology Assessment Review Implementation Advisory Group delivered its final report and road map to the minister in December 2025, yet, eight months later, that report has still not been made public. I call on the government to publish that final report and road map, to allocate funding for its implementation in the 2026-27 MYEFO and to use the next five-year strategic agreement with Medicines Australia, which has to be negotiated in the next year, to deliver on those HTA reforms.

Our vulnerabilities with medicine are not just a health issue. They're a question of supply chain resilience and of sovereign risk. We can survive fuel disruptions, but many Australians will not survive an extended breakdown in our medicine supply. So it's not simply a health issue.

Australia manufactures very little of what it consumes. We have almost no capacity to produce active pharmaceutical ingredients for most products on the WHO's essential medicines list. When supply chains are disrupted by shipping delays, by demand spikes in larger markets or by sponsors' commercial decisions, Australia has a very limited ability to respond. We could manufacture many off-patent medications onshore more cheaply than what we pay to import them now, but our aggressive PBS price settings for out-of-patent medications, of which we're so proud, have squeezed margins to the point where the local manufacturer of many generic products has become commercially unviable. As a result, production has been pushed offshore to lower cost markets like India and China at the cost of sovereign capacity.

The best case for sovereign manufacturing is not that Australia could produce these medicines more cheaply tomorrow. It's that a modest premium for locally manufactured essential and off-patent medicines would cost taxpayers much less than the economic and clinical cost of repeated shortages and far less than the sovereign risk of leaving ourselves exposed to complete supply chain disruption. There's been too little movement on this front by this government. There has been some, but it's been patchy, opaque and non-competitive.

The government has invested in expanding onshore IV fluids production in partnership with Baxter, in Moderna's onshore mRNA manufacturing capacity and in the Future Made in Australia package, which includes funding for locally produced medicines and the National Medical Stockpile. We have the Medical Science Co-investment Plan for building up manufacturing capacities. Private investment has followed: Vitex Pharmaceuticals has opened a manufacturing facility in Western Sydney, and Noumed's new Adelaide facility should add significant onshore tablet and liquid-formulation capacity. They're encouraging, but these investments are very piecemeal and almost entirely reactive.

Australia's medicine supply chain deserves the same systemic national resilience treatment that we apply to our defence industrial capacity. An expanded sovereign manufacturing capacity would strengthen our role as a health security partner across the Pacific. Pacific island nations have little or no domestic medicines manufacturing capacity of their own, and they're even more exposed than us to global supply chain disruptions. A more substantial, dedicated Australian manufacturing base would enable us to extend our existing health security role from aid funding into onshore supply capacity. This would be analogous and complementary to the sovereign defence industrial capacity that we're already building now with our regional partners.

In view of that, I'm moving detailed amendments proposing a national medicines security review, including a specific assessment of Australia's thin stockholding of essential and critical medicines and of whether the National Medical Stockpile has the right settings to protect us through the next global disruption. We need this before the next five-year strategic agreement with Medicines Australia, which contains Australia's Medicines Supply Security Guarantee, is renegotiated next year. I'm moving these amendments because, while I support the very modest measures in this bill, they are insufficient. Sublocade, Zoladex, Ocrevus and Kesimpta are not the last medicines on the chopping block. They're the start of a broader trend.

Australians built our PBS so that we don't have to choose between our health and our finances. It's our responsibility to ensure that that promise holds, not just against ordinary supply shortages but also in the face of the increasing cost and complexity of the global pharmaceutical market, inadequate funding, slow approvals and licensing, and increasing sovereign risk. I commend the somewhat milquetoast measures in this bill to the House, but I urge the government to act with greater urgency and vision to secure the future of our PBS and our medicine sovereignty. In doing so, I move the amendment as circulated in my name:

That the following words be added after paragraph (2):

"(3) further calls on the Government to:

(a) release the Health Technology Assessment (HTA) Implementation Advisory Group's final report and roadmap, that were provided to the Government in December 2025;

(b) allocate funding in 2026-27 MYEFO to fund implementation of the HTA Methods and Policy Review; and

(c) commission a National Medicines Security Review before negotiation of the next five-year strategic agreement with Medicines Australia, to assess Australia's dependence on imported medicines, lack of domestic manufacturing capability, thin medicines stockholding arrangements and vulnerabilities in our supply-chain".

Andrew Wilkie (Clark, Independent) | Link to this | Hansard source

Is the member for Kooyong's second reading amendment seconded?

Sophie Scamps (Mackellar, Independent) | Link to this | Hansard source

I second the amendment and reserve my right to speak.

Tom French (Moore, Australian Labor Party) | Link to this | Hansard source

I rise to speak in support of the Therapeutic Goods Amendment (Medicines Shortages and Other Measures) Bill 2026 and the Therapeutic Goods (Charges) Amendment Bill 2026. These bills deal with a basic part of our health system: making sure Australians can get the medicines they need when they need them.

For most people, the supply of medicines is something they do not think about until something goes wrong. You go to the doctor, you get a prescription, you go to the pharmacy and you expect the medicine to be there, and most of the time that is exactly what happens. But behind that simple process is a large and complex supply chain. Medicines can be made overseas. Ingredients come from several countries. Products can pass through manufacturers, ports, warehouses and distributors before they arrive at the local pharmacy. A problem anywhere in that chain can affect patients here in Australia. A factory can close, there can be a shortage of raw ingredients, a natural disaster can interrupt production, conflict can disrupt shipping, demand can suddenly rise, or a manufacturer can decide it will no longer supply a particular medicine in Australia. Some of those events cannot be prevented, but we can make sure Australia is better prepared when they do happen.

For me this is not simply an issue I have read about in a briefing paper. At 25 I was diagnosed with chronic kidney disease, and in 2020 I received a kidney transplant from my brother Joe. A transplant changes your life in plenty of ways, and one of them is that medicines become part of your daily routine. For people who have had an organ transplant, the medicines we take are not optional. They help stop our immune systems from attacking the transplanted organ. You do not simply decide to miss a few doses and hope for the best. So when we debate medicine shortages, I think about what that means from the other side of the pharmacy counter. I think about the person in Moore who has had a transplant. I think about the parent managing a child's serious health condition. I think about someone receiving cancer treatment or managing epilepsy, diabetes or another long-term illness.

For those people, the words 'medicine shortage' have a very different meaning. A shortage can mean uncertainty about whether the treatment that has kept you well will still be available next month. It can mean changing treatment. It can mean going back to your specialist. It can mean trying different medicine that may not work in exactly the same way. For pharmacists, it can mean hours spent looking at stock or speaking with doctors about alternatives. For doctors, it can mean changing treatment plans and explaining those changes to patients. And across the health system it creates pressure that could have been reduced if there had been earlier warning.

That is why information is so important. When medicine is going to disappear from the Australian market, doctors, pharmacists, patients and government need as much warning as possible. This bill strengthens the existing reporting system. Under these changes, a pharmaceutical company that decides to permanently discontinue a reportable medicine in Australia will generally have to notify the Department of Health, Disability and Ageing at least 12 months before supply ends. That is an important qualification. Sometimes a company simply will not know. 12 months ahead. A factory may suddenly close, a supplier may fail or an international company may make a commercial decision quickly. The bill recognises that reality.

But, where 12 months notice cannot be provided, the sponsor must notify the secretary as soon as practicable after the decision has been made. That is a sensible balance. It sets a clear expectation that government should be told early, while recognising that global medicine supply chains cannot always be predicted a year in advance. The value of earlier notice is straightforward. If we know that an important medicine will disappear, we will have more time to respond. Health professionals can consider alternatives. Government can examine other supply options. Other suppliers may have time to increase production or imports. Patients can receive clear information and work with their doctors, rather than discovering the problem when they arrive at the pharmacy.

For someone like me, that distinction is important. If one of the medicines I rely on was going to be withdrawn, I would much rather have my specialist, my pharmacist and the health system know about it 12 months beforehand than find out about it when I'm at the pharmacy trying to fill my script. I suspect that every Australian who depends on regular medicine would say the same thing. And the bill recognises that plans change. A company might tell the government that it intends to stop supplying medicine and later decide to continue. Or the date when supply is expected to end may change. Under the bill, sponsors will have to update the secretary when those plans change. For medicines where a discontinuation could have a critical impact, the reporting timeframes are much faster. That is appropriate. If there is no reasonable substitute for the medicine, if there may not be enough of the substitute available or if losing access could seriously affect the health of patients, the government needs to know quickly. This is not paperwork for paperwork's sake. There is little value in requiring early notification if the information becomes wrong six months later, and nobody has to correct it. The goal is accurate information that can be acted upon.

The bill also strengthens the secretary's ability to ask medicine sponsors for information about supply. At present, those powers are more limited and focus on medicines covered by the reportable medicines framework. The amendments will allow information about any approved medicine to be requested. That is important because a shortage does not become serious only because a medicine happens to appear on a particular list. If the Therapeutic Goods Administration becomes aware that supply of an approved medicine may be under pressure, it should be able to ask some pretty basic questions: How much medicine is available? Is there a shortage? How long is that shortage expected to last? Has a decision been made to stop supplying the medicine in Australia? Those are reasonable questions for our national medicines regulator to ask.

These reforms have been shaped by consultation. The TGA consulted consumers, health professionals, the pharmaceutical industry and governments about medicine shortages and discontinuations. In 2024, more than 200 responses were received through public consultation alongside research involving consumers, pharmacists and prescribers. Further consultation was then undertaken on the proposed reforms. One concern was clear: people need earlier and more reliable information when medicine supply is at risk. These amendments respond to that concern.

The bill also improves the Medicines Watch List. The watch list identifies medicines of which a shortage or discontinuation could have a critical impact on Australia. The bill will allow the list to incorporate other documents as they are updated from time to time. Again, that sounds technical, but the purpose is practical. Our understanding of medicine supply risks changes. A system designed to identify critical medicines has to be capable of keeping up.

The legislation also reforms the regulation of biologicals. Biologicals are therapeutic products that can contain, consist of or be derived from human cells or tissues. They can be used to treat or prevent disease, diagnose conditions or change parts or processes of the human body. These products must be carefully regulated, but careful regulation does not require unnecessary duplication. Under the present arrangements, closely related biological products can require separate entries on the Australian Register of Therapeutic Goods. That can mean separate administrations, separate entries and separate annual charges, even where the products are essentially similar. The bill allows the secretary to establish common biological groups. The similar biologicals can then share a single entry on the register. That reduces unnecessary duplication and regulation costs without weakening the standards applying to therapeutic goods. That reform works together with the Therapeutic Goods (Charges) Amendment Bill. The charges bill amends the Therapeutic Goods (Charges) Act so that the annual charge can be prescribed for grouped biologicals held under that single entry. Instead of sponsors maintaining several entries and paying several annual charges for closely related products, the system can recognise a single grouped entry. The two bills therefore need to work together. The first creates the ability to group these biologicals. The second makes sure that the charging arrangements fit the new system.

The TGA operates largely through cost recovery. Annual charges support activities such as postmarket monitoring and compliance. The reforms do not remove that responsibility. They simply make the charging system fit a more efficient registration system. Consultation with around 40 stakeholders on the biologicals changes showed broad support for reducing duplication and improving efficiency, and that is sensible regulatory reform.

Good regulation should protect Australians. It should set strong standards where safety is involved. But where government can remove duplication without reducing protection, we should do that too. The Therapeutic Goods Amendment Bill also clarifies inspection powers at clinical trial sites. Clinical trials are essential to medical progress. My own life is evidence of what decades of medical research can achieve. Kidney transplantation was once experimental medicine. Today, because generations of researchers, clinicians, donors and patients, people like me can receive a transplant, return to work, raise a family and stand in this chamber. But medical progress depends on public confidence. People who volunteer to participate in clinical trials must know that their safety is protected. The bill therefore gives authorised officers clear legal powers to enter, search and inspect clinical trial sites where unapproved therapeutic goods are being used.

These powers already exist through delegated legislation. The bill moves them into primary legislation so their legal basis is clear. It is a technical legal change, but it serves an important purpose: protecting the people whose participation makes future medical advances possible. The bill also contains smaller changes to improve consistency, remove outdated provisions and correct errors. Taken together, these bills strengthen Australia's therapeutic goods system.

But there is also a wider issue here. Access to medicine is both about affordability and availability. This government has cut the maximum price of general PBS medicine prescriptions to $25 and frozen concessional prescriptions at $7.70. I know personally how important the Pharmaceutical Benefits Scheme is after a kidney transplant. There is no point in receiving world-class surgery if the medicines required afterwards are beyond reach. The transplant is one day; the medication continues every day after that. That is why the PBS is one of Australia's great public institutions. It means serious illness does not automatically come with a choice between your health and your household budget. For people across Moore, whether they are retirees in Beldon, families in Craigie, workers in Joondalup or patients anywhere across our northern suburbs, access to medicine has to mean more than having a prescription in your hand. It means the medicine has to be affordable, it has to be safe, and it has to be available at the pharmacy.

The same is true in every community across Australia: an affordable medicine that cannot be supplied does not help a patient. A medicine that is available but unaffordable does not deliver a health system Australians deserve. We need to address both sides, and that is why these bills sit alongside our broader commitment to cheaper medicines, Medicare and the PBS.

Most Australians will never read the Australian Register of Therapeutic Goods, and they will not study the medicines watchlist. I doubt many people in Moore are waiting eagerly for an explanation of the annual charging arrangements for grouped biologicals, but they rely on these systems whether they know their names or not. They rely on them when they take the tablet in the morning, they rely on them when their children need medicine, they rely on them when a parent begins cancer treatment, and I rely on them when they take the medicines that continue to protect the kidney my brother gave me. That is what sits behind the technical language in these bills: earlier warnings about medicine supply, better information when shortages occur, a stronger ability for the regulator to respond and less unnecessary duplication, clear safeguards for clinical trials and a health system better prepared to keep essential medicines in the hands of Australians who need them.

No law can stop every medicine shortage. Australia is part of the global market, and supply disruptions will continue to happen. But, if we build a system that sees problems earlier and responds faster, for patients, that extra time can be extremely important. These are practical reforms which help the way Australia manages medicines while supporting an efficient and strong regulatory system. They protect patients, they support health professionals, they improve accountability from medicine suppliers, and they strengthen the wider system that Australians depend on every day.

For me, there is nothing academic about access to medicine. I have been fortunate enough to benefit from extraordinary Australian health care, from medical science, from the PBS and, above all, from my brother, who was willing to give me a kidney. I want every Australian who depends on medicine to have confidence that the system behind them is doing everything reasonable to keep their treatment available. These bills help us do that. I commend the bills to the House.

Allegra Spender (Wentworth, Independent) | Link to this | Hansard source

I rise to speak in support of this bill. This bill strengthens the existing mandatory reporting scheme for medicine shortages. Sponsors will now be required to notify the secretary of the Department of Health, Disability and Ageing of a discontinuation at least 12 months in advance, rather than the currently tiered system where only discontinuations likely to have a critical impact require 12 months notice, and all others just require six. This will give patients, clinicians and the health system more consistent advance warning about incoming medicine discontinuations regardless of severity. The bill would also streamline listing requirements by allowing the secretary to determine 'common biological groups', letting similar biologicals share a single entry in the Australian Register of Therapeutic Goods, ARTG, rather than requiring a separately charged entry for each.

This bill also fixes a technical gap in the Medicines Watch List, which tracks medicines with a critical impact. This list already incorporates documents like the National Immunisation Program—NIP—Schedule to identify medicines considered critical if they fall into shortage or are discontinued. Currently, the list can only reference these documents as they stood at a fixed point in time, meaning it can quickly fall out of step with the updates to the NIP Schedule, which changes several times a year. The bill allows the list to instead track such documents 'as in force from time to time', so it automatically reflects the current version. This ensures that any medicine on the NIP Schedule is properly captured by the watch list's critical impact protections without the risk of a lag. A number of other minor technical and consequential amendments are also included. These are not radical changes, but they are excellent steps to ensure that those who rely on life-saving, life-changing or just necessary medications are informed well in advance that they may no longer have access. This matters.

However, there are many things that this bill doesn't do which I think are important to talk to. In particular, it doesn't solve some of the challenges of how to make sure that the medicines that people rely on or that people need are on the PBS and are available. I particularly want to talk about the recent experience of some medicines being removed from the PBS, which has affected and concerned many people in my community. The recent reports that Ocrevus and Kesimpta may be removed from the PBS as a result of a pricing dispute deeply disturbed many people in my community of Wentworth. Many wrote in to share their concerns. They told me about the impact these drugs have had on their ability to operate as a member of society, to leave the house and to participate in employment and education. These are massive impacts which I know are appreciated by this government. These are two of the most widely used high-efficacy, disease-modifying therapies for multiple sclerosis in Australia, used by approximately half of the patients being treated for relapsing forms of the disease. The minister recently announced that these drugs will stay on the PBS, but this dispute did not occur without causing significant concern and grief to the community members who relied on this drug. People wrote to me. People also approached me on the street and told me about their lives and their decisions and the difference that these drugs made to their lives. I remember a young woman telling me she had tried other drugs and they hadn't worked. These drugs had been life changing in her case, and she was desperately worried about these drugs being potentially removed from the PBS. One constituent wrote to me to tell me that the only two options she faced were a 725 per cent increase in cost, from $4,000 to $33,000, or a medication delivered only through infusion at a hospital, which she had already tried and had stopped working for her. This was a significant worry for this young woman, as she waited for the announcement from the minister. I know it worried many Australians across the country.

I am very glad that the government was able to negotiate that these items remained on the Pharmaceutical Benefits Scheme, but this isn't a solitary example. It followed the recent temporary delisting of the Zoladex 3.6-milligram monthly implant, which is used in the treatment of endometriosis and hormone receptor-positive breast cancer, while the equivalent higher dose implant, used for prostate cancer, remained on the PBS. Constituents have raised the pattern that this creates. They were particularly concerned that some of the recent medicines that were removed were those that had been shown to have greater impact on women, because both Zoladex and the MS drugs treat conditions that disproportionately impact women. I wrote to the health minister about all these issues, and I know there was significant community pressure. This community pressure created real outcomes. Zoladex is now being offered free to breast cancer and endometriosis patients, and the life-changing MS drugs have remained on the PBS. These are great outcomes, but, while these negotiations were ultimately successful, the uncertainty and fear that was experienced by patients reliant on these medications were sufficient to disrupt their sense of safety and security. That is not acceptable. I think it indicates that we have some broader issues going on with the PBS, and we do not want to see the same pattern emerge, as we have just had in this case, with other drugs. We can't have medicines coming on, then being removed, then being back under negotiations. This is very destabilising, particularly for medicines that deal with chronic diseases and chronic conditions that people rely on.

Again, this is where I want to raise things that this bill doesn't completely address, because it is likely that this bill will not even address expanding the notification period in instances where there are pricing disputes, as there were in these cases and as we expect there may be. It only applies at the point where there is discontinuation and shortage of medicines, not to disputes and negotiations. The notification framework that this bill touches upon should be expanded with this in mind, as has been proposed by the member for Kooyong in detailed amendments, because these negotiations have occurred against a backdrop of broader pressure on the Pharmaceutical Benefits Scheme, as identified in the 2021 Health Technology Assessment review. The ramifications of the United States's most-favoured nation pricing policy, combined with Australia's diminishing attractiveness in pharmaceutical companies as a market owing to comparatively low pricing and slow approval times, means that innovative medicines are increasingly failing to reach the PBS at all or are at heightened risk of removal once listed.

Discontinuation of a drug is not the only reason for their risk of disappearing from our shelves, and the requirement to notify our patients should reflect changing dynamics, such as the increasingly prevalent pricing disputes. Australia's lack of manufacturing capability also means that, while we're not only left waiting for the most innovative medicines, we also are not able to make them ourselves, especially in times of crisis, like a pandemic, when there are disrupted supply chains or worse. I know that the minister and the department will be considering these concerns closely, but legislation like this is an opportunity to make a real difference in the lives of people who've been waiting in limbo while reports of discontinuation and negotiations occur and to further increase accountability mechanisms. That's why I do support the member for Kooyong's amendments today. They seek to provide further safeguards and notification procedures where pharmaceutical companies provide less than 12 months notice, as well as expanding the notification requirements when they apply beyond discontinuation and/or shortage and require a national medicine security review.

I support this bill. It will improve the notification process for pharmaceutical companies forced to discontinue medicines for reasons outside of their control, giving patients who rely on those drugs more advance warning and, as a result, improving their lives. However, this bill could go further in addressing Australia's medicine shortages. The risk that this problem grows is significant. I hope the government will consider strengthening the bill in these regards and adopt some of those amendments that have been put forward.

Zaneta Mascarenhas (Swan, Australian Labor Party) | Link to this | Hansard source

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.

Zali Steggall (Warringah, Independent) | Link to this | Hansard source

I rise to speak on the Therapeutic Goods Amendment (Medicines Shortages and Other Measures) Bill. This is crucially important because Australians need to have confidence that those medicines are there when they are needed and that this is well managed. So I support the measures in this bill to strengthen the monitoring and management of medicine shortages in Australia. At its heart, this bill is based on a simple principle: when the supply of an important medicine is going to change, patients, doctors and pharmacists should have as much warning as possible. Disruption to Australia's medicines supply chain affect people managing very serious illnesses, including cancer, chronic illness and serious health conditions. Disruptions affect doctors trying to maintain continuity of treatment and pharmacists trying to find alternatives—and, of course, shortages create enormous stress for patients, who simply need to know that the medicine they rely on will be there when they need it.

The bill strengthens the existing mandatory reporting framework by requiring sponsors to provide, where possible, at least 12 months notice of a decision to permanently discontinue a reportable medicine. It also requires sponsors to update the TGA where those plans change and expands the TGA's ability to require information about the availability, shortage and discontinuation of any of the approved medicines. These are sensible and practical reforms. They will give the TGA, clinicians, patients and the broader community more time to anticipate problems and to respond before a shortage becomes a crisis.

The importance of these reforms has been brought home recently in our community and around Australia, and was referred to me by constituents who were contacting my office concerned about the future availability of Zoladex. Zoladex, or goserelin—I won't be able to pronounce that properly!—is a hormone treatment. In particular, the monthly 3.6-milligram implant is used in the treatment of conditions including hormone-receptor-positive breast cancer and endometriosis. Earlier this year, AstraZeneca announced that the 3.6-milligram form would be removed from the Pharmaceutical Benefits Scheme from 1 November 2026 for commercial reasons. These are companies that have made substantial profits throughout recent years—in particular after COVID and during COVID.

This decision caused incredible stress and concern. I wrote to the Minister for Health and Ageing, Mark Butler, advocating on behalf of affected constituents who wrote to me fearing the essential medication that they rely on would be cut off. The department of health has said that it attempted to retain the medicine on the PBS. I welcome the arrangements that AstraZeneca has now put in place to maintain access to Zoladex 3.6 milligrams at no cost for existing and future eligible patients. That provides important reassurance, but it doesn't resolve the underlying issue. The medicine is still being removed from the PBS for commercial reasons, and Breast Cancer Network Australia has made clear that the continuity program is not a long-term solution.

This experience demonstrates why Australia needs earlier warning of discontinuations. Patients should never find themselves suddenly wondering whether a treatment that is working for them will still be available in six months time. Advance warning is necessary, but advance warning alone does not guarantee access. We also need a medicine system capable of responding when a commercially driven decision leaves a genuine clinical need behind.

That brings me to a broader issue which I believe the government should address alongside these reforms. For Australians living with rare, rapidly progressive and life-limiting conditions, the challenge can be the opposite of a shortage. Instead of losing access to a medicine already available here, they can wait far too long for access to a therapy that exists and may already have been assessed and approved by a trusted overseas regulator but has not entered the Australian system. This issue is particularly acute for rare diseases, including some of the conditions that cause childhood dementia. For those families, time has a very different meaning. When a disease is rapidly progressive, a delay of months or years in relation to access to medicines can mean irreversible deterioration while a family watches a potential treatment remain beyond reach.

Australia does not have a mechanism designed to accelerate access. These mechanisms are important and must be maintained. There are fundamental limitations in the system. To register a prescription medicine on the Australian Register of Therapeutic Goods, a sponsoring company must make the application. For an extremely rare condition affecting a very small number of Australians, our relatively small patient populations can mean that there is insufficient commercial incentive for a sponsor to pursue Australian registration and reimbursement, potentially then delaying or preventing routine access to therapies for patients of rare diseases whilst those medicines or therapies are available overseas. Medicines, therefore, may not be readily listed and available. A therapy might be scientifically promising and it might have been approved by a comparable regulator overseas. Australian clinicians and families may want to have access to it. But, if the Australian market is too small to justify the expense and administrative burden for a commercial sponsor, there may simply never be an application for the TGA to assess. So that is, I would argue, a system or market failure.

In 2021, a bipartisan House inquiry into the approval of new medicines specifically recommended that the Commonwealth establish a fund to enable patients, clinicians and non-profit organisations to sponsor registrations and reimbursement applications where there is no realistic prospect of a pharmaceutical company doing so. I therefore call on the government to establish a faster, clearer and more transparent pathway for therapies that address high, unmet clinical needs to be listed—or for an application to be made. The precise mechanism should be developed with the TGA, clinicians, patient groups and industry. Doing nothing effectively allows market size and commercial prospects to determine whether or not a sponsored application is made and whether some Australian patients even get the opportunity for therapy to be assessed.

I support these bills because medicine shortages and discontinuations need to be identified early and managed better. The experience with Zoladex demonstrates, in real time, the importance of that work. But medicine security is about more than knowing a shortage is coming; it is about ensuring patients have a clear and reliable pathway to what comes next. We need a system that anticipates gaps, secures alternatives and protects continuity of care.

Rowan Holzberger (Forde, Australian Labor Party) | Link to this | Hansard source

While I never thought that I would be talking about soybeans and sweet potatoes in the context of a bill effectively about medicine shortages, I'll flag that as something that I'll return to later in my speech—as a bit of a page turner, perhaps. Meanwhile, I rise in support of the Therapeutic Goods Amendment (Medicines Shortages and Other Measures) Bill 2026 and the Therapeutic Goods (Charges) Amendment Bill 2026. In doing so, I recognise the really quite incredible work of the Minister for Health and Ageing in leading the government's strategy for health and also the work of the health and social services committee of the caucus which, in many ways, takes the aspirations and the dreams of Labor Party members across the country and of the communities from which those members come.

Ultimately, this piece of legislation sits within Labor's core mission—it sits within Labor's DNA—to provide a quality and universal health system. When you look at the work that has been done through this government and through the Labor Party in general, remembering that it was the Labor Party that created the PBS almost 80 years ago under the prime ministership of Ben Chifley—the work that this Labor government is doing to build on the PBS includes cheaper medicines, bulk-billing, tackling specialist fees and making urgent care clinics a central part of our health system.

It just goes to show that the Labor Party very much believes in universal and quality healthcare, while the Liberal Party, we learned today, is still trying to figure out what exactly Medicare means and still trying to work out a definition of Medicare. It is hardly surprising from a party that was led by Prime Minister John Howard, who believed that Medicare was a rort; by Prime Minister Tony Abbott, who tried to kill Medicare—literally by a thousand cuts—by imposing a co-payment on doctor visits; and by Turnbull and Morrison, who tried to throttle Medicare when none of those other things worked by keeping the rebate which was paid to doctors at the same rate in the time that they were in government.

Universal health care very much sits within Labor's mission. While the Labor Party and the labour movement exist to advance the economic interests of working-class Australians, there are some things that you can achieve on the shop floor. Wages and conditions at an enterprise level are the sorts of things that you can achieve on the shop floor, but what you can't achieve on the shop floor is universal and quality health care. That can only be achieved by having control of chambers and parliaments like this. You need governments and parliaments to make the laws and provide the resources for services such as universal health care. That's why the Labor Party exists. It exists to take up those things that you can't achieve on the shop floor but are so important to the economic interests of working-class Australians. This legislation is sitting within that general work.

'Universal' and 'quality' are, I think, what Medicare means to us. This bill deals with the quality of our health system. While medicine shortages have not necessarily been something new to the Australian experience, I think COVID really showed us what it means to be a country at the end of supply chains. Before I got elected to this place, I remember trying to help a friend look for Ozempic. I think the first big shock to our health system and to health consumers was when there was suddenly a massive shortage of Ozempic. This woman really needed it for diabetes treatment, and she couldn't get it anywhere. I want to give a shout-out to the Pharmacy Guild, who I was able to get a hold of and who did a ring around for us to find a pharmacist who was able to supply Ozempic at the beginning of that crisis. Even though it involved a logistical exercise in getting it delivered from the other side of Brisbane, it did alleviate the worry that my friend had in trying to get something which was really life-changing for her to manage her diabetes.

Medicine shortages are becoming much more acute post COVID. Last September, a constituent came to me, as a member of parliament. She was looking for some help because she couldn't get the hormone replacement treatment Estradot, which is a patch which deals with perimenopause and menopause. Again, while we were able to help her through the Pharmacy Guild, who provided a solution for that, it did show to me at that real-world level what it means when somebody is having trouble getting the medicine that they need.

In preparation for this speech, I was looking at some media and came across a story by the ABC's health reporter Lauren Roberts. She talks about what the shortage of Estradot means. She really does sum it up well. This story is from May this year, so this is happening right now. Lauren Roberts says:

Australian women are cutting their menopause patches in half, travelling interstate to fill scripts and going without amid ongoing supply shortages.

It's an issue Rachel, who didn't want to use her surname for privacy reasons, knows all too well.

"Whenever you can't find [your medication], you kind of go into a bit of a mild panic," she said.

"It's like, 'Oh, my quality of life is going to tumble, there's nothing [available].'"

Over the years, Rachel has 'spent hours calling pharmacies to check what they have on hand before travelling long distances to get the right medication'.

I feel this is a story that all of us as elected members and community representatives come across all too often. It goes on:

Pharmacist and nutritionist Sarah Gray, who specialises in perimenopause, said these patches weren't "cosmetic or optional".

"They are prescribed to manage hot flushes, sleep disruption, mood instability, cognitive symptoms and overall daily functioning," she said.

"For many women, they are the difference between coping and not coping at work, at home and in leadership roles.

"These medications can be life-changing."

Lauren Roberts, the journalist, said:

In 2023, the local market grew tighter after one brand of HRT patch approved for use in Australia was discontinued, putting an increased demand on those still available.

She goes on:

Ada Cheung, an endocrinologist at the University of Melbourne, said it wasn't just Australia experiencing shortages, with the United States and United Kingdom also impacted.

Here we get to the bit about soybeans and sweet potatoes.

Professor Cheung said the first issue along the supply chain was at the start, with soya beans and sweet potatoes—the raw ingredients used in most patches—in high demand and short supply globally.

Who would have thought that something as basic as those two things could have such profound ramifications?

Lauren Roberts goes on to say that there are reports of some patients: 'cutting patches in half, sharing medication, spacing out doses or going without to cope with the scarcity of supply. And in Brisbane, community pharmacist Tahnee Simpson said patients would drive "in search of a unicorn" looking for their preferred brand.' Tahnee Simpson, the pharmacist, said:

There may be one box sitting in a far-off pharmacy, a long way away and they will drive for it…

And for me, my heart sinks because it also means that I can't provide care to that patient …

I'm sure that all of our hearts sink when a constituent comes to us and can't get the life-changing and life-saving medication that they rely on.

By the way, I just thought it was interesting and relevant to talk about perimenopause and menopause because, as I say, this legislation sits in the broader government strategy of universal and quality healthcare. When it comes to perimenopause, the government has introduced a new item number for GPs to conduct menopause and perimenopause assessments on patients. We've also listed three new menopause hormone treatments for the first time in two decades. These are treatments which are already being used by 150,000 women across Australia. That's potentially 1,000 women in each of our electorates who, at the moment, are spending $580 a year on those menopause hormone treatments. They will now be getting them at the PBS rate. This legislation, while technical and slightly complex in its nature, sits at the very heart of the Labor Party's mission and this government's mission to make quality healthcare universal.

These shortages in medications and in medical products are not new, but they've been exacerbated by COVID and by the supply chain pressure that we feel on all sorts of products all around the world. And so, while mentioning soybeans and sweet potatoes in a speech on medicine shortages, I suppose it shouldn't be any surprise that I could also mention copper and steel and aluminium, because those three things are also examples of what the Albanese Labor government is doing when it comes to addressing the issues of national sovereignty. By protecting our foundational industries of steel in Whyalla, of copper in Mount Isa and aluminium in Gladstone, we are recognising that for too many years we have become too reliant—and that's probably a nice way to put it—on overseas suppliers to look after us.

Now we know that when the crunch is on we need to look after ourselves, which by the way seems to be a fundamental difference in philosophy between the Labor Party and, certainly, the Liberal Party and One Nation. I'm still not always sure where the National Party, the agrarian socialists, land on this. But when you get an opportunity to drill down into what One Nation stands for, it's no surprise that, when you see who backs her, they are actually a party that are economic rationalism on steroids, neoliberalism on steroids. So it is only the Labor Party that takes this approach to national sovereignty.

Earlier, the member for Swan mentioned the Albanese government's approach to the IV shortage back in 2023. If surgeries weren't being delayed they were being this close to being delayed, and patients who needed—we are not talking about niche products. When you talk about IV fluid, you're talking about sugar and salt water. Patients' recoveries were being compromised because there was a shortage. It took the Albanese Labor government to invest $20 million—with Baxter, as the member for Swan said—to bring back that sovereign capability and to try and head off those problems in the future. Of course, it invested in not just Baxter but Moderna—and through the Future Made in Australia package, through funding for locally produced medicines and through the national medicine stockpile. This shows that this government's and this party's great project for what are the Australian values of quality—which sits at the heart of why universal and quality health care is important.

Debate adjourned.

Federation Chamber adjourned at 19 : 12