Therapeutic Goods Amendment (Medicines Shortages and Other Measures) Bill 2026, Therapeutic Goods (Charges) Amendment Bill 2026
Ms COFFEY (Griffith) (17:17): 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.