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

Ms STEGGALL (Warringah) (18:48): 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.