Therapeutic Goods Amendment (Medicines Shortages and Other Measures) Bill 2026, Therapeutic Goods (Charges) Amendment Bill 2026
Dr RYAN (Kooyong) (17:58): 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 Sublocade, which is used by thousands of Australians for opioid dependence treatment, is being withdrawn from our market by its sponsor Indivior for commercial reasons.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".
The DEPUTY SPEAKER ( Mr Wilkie ): Is the member for Kooyong's second reading amendment seconded? Dr Scamps: I second the amendment and reserve my right to speak.