Monique Ryan (Kooyong, Independent) Share this | Hansard source

The Health Legislation Amendment (Improved Medicare Integrity and Other Measures) Bill 2025 proposes amendments to improve enforcement of several integrity measures for Medicare, some minor amendments to the Therapeutic Goods Act 1989 and amendments related to the government's tobacco and vaping reforms. I'd like to speak to the changes to the Therapeutic Goods Act 1989, which the government hopes will enhance its capacity to manage and alleviate the consequences of therapeutic goods shortages in Australia.

Medication shortages have been a significant and ongoing issue in this country for a number of years. I have drawn attention to this issue in question time on several occasions and in questions on notice to the minister. The fact is that we lack appropriate mechanisms in this country for anticipating or dealing appropriately with medication shortages. Today, the TGA lists 416 medication shortages and 67 anticipated shortages on its website. It receives an average of 120 notifications of new medical shortages every month, at least 10 per cent of which are critical. Last year, we had a national shortage of intravenous fluids for months. This was a shortage which the health minister himself admitted he did not see coming. It was a shortage which necessitated postponement of hundreds of elective surgeries and which prolonged inpatient stays in hospitals around Australia. Medication shortages are a global problem. The WHO recently reported 300 essential drugs in shortage worldwide. This longstanding problem was exacerbated by the COVID-19 pandemic, sequelae of which included increased production costs and increasingly complex logistic challenges. But these issues are and remain compounded by a lack of Australian domestic manufacturers. More than 90 per cent of the medications that we prescribe in this country are imported, most commonly from India and from China.

There is already an existing mechanism in the Therapeutic Goods Act to allow the secretary of the department to approve the importation or supply of substitutable unapproved products from overseas where the secretary is satisfied that the approved medicine or biological or medical device is already unavailable or is in short supply. The amendment before the House today gives similar powers to the secretary where there is an anticipated shortage of these registered goods. It's important to note that substitutable overseas goods are often in limited supply overseas, and they are often the subject of significant competition between countries which are seeking to secure supplies for their citizens. So this amendment will enable the secretary to try to secure and ensure ongoing supplies of necessary medications for Australians ahead of time, before we get to the situation where the medications are already in short supply.

The fact is that the government lacks a comprehensive strategy addressing these medication shortages and how to manage them better when they do occur. We have a medicines supply security guarantee. It was launched in July 2023, and it requires manufacturers to hold at least four to six months of key medications in Australia. However, it has not been enforced. All we are being given with this legislation is a minimal increase in our degree of preparedness for what we seem to be accepting as an inevitable occurrence. It's just not good enough. There are clearly no easy answers to this issue, but there are a number of things which the government could do and yet has not yet done to address the problem. A recent report, Understanding the impact of medicine shortages in Australia, found that many Australian patients have to wait a month or more to purchase medicines which are in shortage or they end up having to buy a second medication. As a result of that, 20 per cent of Australians ration their medicines to make them last longer. Clearly, this can result in adverse outcomes for patients. Fourteen per cent of patients who try to find a medication and can't find it end up not buying it at all. Four per cent purchase a non-prescription medicine, and two per cent of them end up in hospital. I'll repeat that—one in 50 Australians affected by medication shortages ends up in our hospital system.

These shortages and discontinuations disproportionately impact certain population groups, including First Nations people and Australians living in rural and regional settings. We know that Australians with higher incidences of chronic and complex diseases are those who are more likely to require specialist care. They are more vulnerable to shortages and to discontinuations. They may also have diminished capacity to advocate for alternative scripts, to find the remaining supplies of medications and to source them privately.

Medication shortages don't just cause inconvenience. For doctors, they result in a need for extra consultations, to identify alternative management options, to write additional or new scripts, to educate patients about the new medications and provide those patients with psychological support around the change, to organise collection or dispensation of new pharmacotherapies and to call pharmacies or the TGA for more information. These activities are made more time consuming when physicians are unfamiliar with alternative preparations or when those new agents require either authority scripts or access via the Special Access Scheme, the paperwork for which is considerable.

For patients and for pharmacists, uneven and inadequate distribution of medicines is a health equity problem. Delays in accessing or inability to access the best possible medication affects patients negatively. Withdrawal from medications causes side effects that affect patients negatively. Changes in medications can well result in inadvertent overdoses or unexpected side effects. Where alternative medications have to be sourced, that increases the workload of pharmacists. Patients often experience the extra cost associated with these new drugs, but they also have to pay to go back and see their GP when they have to get a second prescription because they can't access the first-choice medication.

The medications affected are often those which are in common use: medications for ADHD and antibiotics. Hormone replacement therapy transdermal patches have been in chronic supply for some years. I have explained to the health minister on a number of occasions that it is a very brave man who gets between a menopausal woman and her HRT, yet the TGA has now advised doctors to limit starting new patients on HRT patches, accepting that this will help preserve available supplies for those people who are already on them. This is what our health system is reduced to.

Similarly, copper IUDs have been in critical shortage for months at a time. Patients themselves have had to arrange to get them delivered from interstate. The HIV prevention drug PrEP has been in shortage for long periods. We have people at risk of developing HIV because we are not providing them with the medication that they need. Last year there were persistent shortages of the diabetes medication Mounjaro. The long-term national shortage of semaglutide is likely to persist until at least 31 December this year, and that is impacting patients with type 2 diabetes across this country. Finding it and accessing semaglutide, or Ozempic, has been described as being like winning the lottery. I've also heard from a constituent in Kooyong about their anxiety and fear relating to the shortage of cholestyramine powder sachets. These are used as a last-line therapy for people who have undergone an ileal resection and are at risk of severe diarrhoea related to that. There are very limited alternatives for people with that condition.

We have a duty to guarantee vulnerable Australians appropriate treatment for their serious medical conditions. At the same time, the recent discontinuation of lomustine capsules sparked a lot of concern in the Australian oncology community. There are very limited alternatives for treatment of glioblastoma, a rare and aggressive form of brain cancer. Taking away one of those alternatives just causes incredible distress to vulnerable Australians.

Worst of all, I want to draw the parliament's attention to the ongoing critical shortages of medications for palliative care in this country. Liquid morphine has been in shortage for months. I'll give you a few examples of the impact of that shortage on constituents from Kooyong. These are examples provided by my constituents. An 88-year-old gentleman had prostate cancer. He was stable on oral liquid morphine for breathlessness due to his metastatic disease. He was unable to source that medication in the community. He had to go to the emergency department with uncontrolled breathlessness. He was admitted to hospital, where he died. A 56-year-old woman with metastatic lung cancer who was stable on long-acting hydromorphone for pain was forced to change to methadone because the hydromorphone was no longer available. She required a two-week hospital admission to titrate her medications to safety. An 85-year-old man with metastatic bowel cancer was admitted to hospital for three weeks due to the need for slow titration onto methadone in lieu of long-acting hydromorphone. A 73-year-old man with end-stage cardiac disease had to attend a hospital palliative care clinic in person for the ongoing prescription and supply of his MS Contin granules because he was unable to source them in the community.

Communication around medication shortages is often poor. Many GPs find out that medications are in shortage from their patients. The frustration relating to medication shortages reduces consumer credibility and trust in healthcare professionals. Many have reported higher rates of physical and verbal abuse when their patients are unable to source the medications that they need. GPs would benefit from collaborative efforts of the TGA, medication suppliers and practice management software producers, who could together relatively easily provide online advice in practice management software regarding discontinuations and supply of the medications that the GPs are prescribing. But the government has not as yet made an effort to put that in place.

Pharmacists know when medications are in short supply in their own facilities, but they don't know which nearby stores will have the medication that might be able to help them. They tell me that they spend hours sometimes calling out to try and help their patients. Some time ago I suggested to the government that it look to establishing a central information point for pharmacists so that they could know what medications are in supply in what sites and save themselves time. Clearly, there are some commercial sensitivities around knowing which pharmacies have what medications, but we could get around these. As far as I know, there has been no progress on this issue from the government to date.

The legislation in front of the House addresses one part of one aspect of an issue, but it doesn't get to the underlying problem, which is the persisting deficits in the supply chain for many medications in this country; the lack of transparency around those shortages for consumers, doctors and pharmacists; and the inconvenience, the expense and the harm which result from those shortages. We need a better process to identify impending shortages of medications, biologics and devices. Doctors and pharmacists need to know about these shortages and discontinuations sooner. They need greater transparency about the reasons for medication shortages and consistent, location-specific information about stock availability. I'm particularly concerned by the cost of the medication shortages for consumers and the fact that Australians often have to pay more for a second-line or third-line agent.

I call on the government to act on this issue: to develop effective stockpiles of critical medicines; to mandate that medication manufacturers advise the TGA of shortages well in advance; and to ensure that we have duplication of registration by the TGA for those medicines which are critical to public health and safety. I call for the government to use Future Made in Australia or other funding to invest in incentives for the development of a domestic manufacturing industry for critical medicines; to introduce taxation or fiscal incentives to ensure supply of critical medications which might not otherwise be financially viable to introduce into the small Australian market; to review the system of statutory price reductions for older medications so as to temper the price reductions that often lead to PBS delisting; to simplify the special access scheme for unapproved medicines and therapeutic goods; and to enhance the regulatory powers of the TGA to enable it to redistribute scarce medicines to priority patient groups who are at risk of poorer health outcomes.

Deputy Speaker, Assistant Minister, we have to do better to protect vulnerable Australians and to ensure that they receive the very best practice care in our country. At the very least, as a show of good faith in the face of our apparent inability to guarantee access to the optimal medications for these patients' conditions, we have to ensure that Australian patients don't have to pay more to receive lesser medical care.

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