Therapeutic Goods Amendment (Medicines Shortages and Other Measures) Bill 2026, Therapeutic Goods (Charges) Amendment Bill 2026
Ms SPENDER (Wentworth) (18:29): I rise to speak in support of this bill. This bill strengthens the existing mandatory reporting scheme for medicine shortages. Sponsors will now be required to notify the secretary of the Department of Health, Disability and Ageing of a discontinuation at least 12 months in advance, rather than the currently tiered system where only discontinuations likely to have a critical impact require 12 months notice, and all others just require six.
This will give patients, clinicians and the health system more consistent advance warning about incoming medicine discontinuations regardless of severity. The bill would also streamline listing requirements by allowing the secretary to determine 'common biological groups', letting similar biologicals share a single entry in the Australian Register of Therapeutic Goods, ARTG, rather than requiring a separately charged entry for each.
This bill also fixes a technical gap in the Medicines Watch List, which tracks medicines with a critical impact. This list already incorporates documents like the National Immunisation Program—NIP—Schedule to identify medicines considered critical if they fall into shortage or are discontinued. Currently, the list can only reference these documents as they stood at a fixed point in time, meaning it can quickly fall out of step with the updates to the NIP Schedule, which changes several times a year.
The bill allows the list to instead track such documents 'as in force from time to time', so it automatically reflects the current version. This ensures that any medicine on the NIP Schedule is properly captured by the watch list's critical impact protections without the risk of a lag. A number of other minor technical and consequential amendments are also included.
These are not radical changes, but they are excellent steps to ensure that those who rely on life-saving, life-changing or just necessary medications are informed well in advance that they may no longer have access. This matters. However, there are many things that this bill doesn't do which I think are important to talk to.
In particular, it doesn't solve some of the challenges of how to make sure that the medicines that people rely on or that people need are on the PBS and are available. I particularly want to talk about the recent experience of some medicines being removed from the PBS, which has affected and concerned many people in my community. The recent reports that Ocrevus and Kesimpta may be removed from the PBS as a result of a pricing dispute deeply disturbed many people in my community of Wentworth.
Many wrote in to share their concerns. They told me about the impact these drugs have had on their ability to operate as a member of society, to leave the house and to participate in employment and education. These are massive impacts which I know are appreciated by this government.
These are two of the most widely used high-efficacy, disease-modifying therapies for multiple sclerosis in Australia, used by approximately half of the patients being treated for relapsing forms of the disease. The minister recently announced that these drugs will stay on the PBS, but this dispute did not occur without causing significant concern and grief to the community members who relied on this drug.
People wrote to me. People also approached me on the street and told me about their lives and their decisions and the difference that these drugs made to their lives. I remember a young woman telling me she had tried other drugs and they hadn't worked.
These drugs had been life changing in her case, and she was desperately worried about these drugs being potentially removed from the PBS. One constituent wrote to me to tell me that the only two options she faced were a 725 per cent increase in cost, from $4,000 to $33,000, or a medication delivered only through infusion at a hospital, which she had already tried and had stopped working for her.
This was a significant worry for this young woman, as she waited for the announcement from the minister. I know it worried many Australians across the country. I am very glad that the government was able to negotiate that these items remained on the Pharmaceutical Benefits Scheme, but this isn't a solitary example.
It followed the recent temporary delisting of the Zoladex 3.6-milligram monthly implant, which is used in the treatment of endometriosis and hormone receptor-positive breast cancer, while the equivalent higher dose implant, used for prostate cancer, remained on the PBS. Constituents have raised the pattern that this creates. They were particularly concerned that some of the recent medicines that were removed were those that had been shown to have greater impact on women, because both Zoladex and the MS drugs treat conditions that disproportionately impact women.
I wrote to the health minister about all these issues, and I know there was significant community pressure. This community pressure created real outcomes. Zoladex is now being offered free to breast cancer and endometriosis patients, and the life-changing MS drugs have remained on the PBS.
These are great outcomes, but, while these negotiations were ultimately successful, the uncertainty and fear that was experienced by patients reliant on these medications were sufficient to disrupt their sense of safety and security. That is not acceptable. I think it indicates that we have some broader issues going on with the PBS, and we do not want to see the same pattern emerge, as we have just had in this case, with other drugs.
We can't have medicines coming on, then being removed, then being back under negotiations. This is very destabilising, particularly for medicines that deal with chronic diseases and chronic conditions that people rely on. Again, this is where I want to raise things that this bill doesn't completely address, because it is likely that this bill will not even address expanding the notification period in instances where there are pricing disputes, as there were in these cases and as we expect there may be.
It only applies at the point where there is discontinuation and shortage of medicines, not to disputes and negotiations. The notification framework that this bill touches upon should be expanded with this in mind, as has been proposed by the member for Kooyong in detailed amendments, because these negotiations have occurred against a backdrop of broader pressure on the Pharmaceutical Benefits Scheme, as identified in the 2021 Health Technology Assessment review.
The ramifications of the United States's most-favoured nation pricing policy, combined with Australia's diminishing attractiveness in pharmaceutical companies as a market owing to comparatively low pricing and slow approval times, means that innovative medicines are increasingly failing to reach the PBS at all or are at heightened risk of removal once listed.
Discontinuation of a drug is not the only reason for their risk of disappearing from our shelves, and the requirement to notify our patients should reflect changing dynamics, such as the increasingly prevalent pricing disputes. Australia's lack of manufacturing capability also means that, while we're not only left waiting for the most innovative medicines, we also are not able to make them ourselves, especially in times of crisis, like a pandemic, when there are disrupted supply chains or worse.
I know that the minister and the department will be considering these concerns closely, but legislation like this is an opportunity to make a real difference in the lives of people who've been waiting in limbo while reports of discontinuation and negotiations occur and to further increase accountability mechanisms. That's why I do support the member for Kooyong's amendments today.
They seek to provide further safeguards and notification procedures where pharmaceutical companies provide less than 12 months notice, as well as expanding the notification requirements when they apply beyond discontinuation and/or shortage and require a national medicine security review. I support this bill. It will improve the notification process for pharmaceutical companies forced to discontinue medicines for reasons outside of their control, giving patients who rely on those drugs more advance warning and, as a result, improving their lives.
However, this bill could go further in addressing Australia's medicine shortages. The risk that this problem grows is significant. I hope the government will consider strengthening the bill in these regards and adopt some of those amendments that have been put forward.