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

Ms PENFOLD (Lyne) (17:31): 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.