Therapeutic Goods Amendment (Medicines Shortages and Other Measures) Bill 2026, Therapeutic Goods (Charges) Amendment Bill 2026
Mr FRENCH (Moore) (18:14): 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.