Emma McBride (Dobell, Australian Labor Party, Shadow Assistant Minister for Mental Health) Share this | Hansard source

I rise to speak on the Therapeutic Goods Amendment (2020 Measures No. 2) Bill 2020 and to support the amendment moved by the member for Hindmarsh, and I'm pleased to follow the member for Fenner and many of my other colleagues who have spoken on this legislation.

Labor supports this bill, which amends the Therapeutic Goods Act to make a number of changes to the regulation of medicines and medical devices in Australia. There are a number of provisions in the bill, and I'll go to the main provisions. The first is designed to facilitate the importation of COVID-19 vaccines to Australia. The act currently requires therapies that are imported or supplied in Australia to display their Australian Register of Therapeutic Goods number, or ARTG number. This may not be possible, as others have spoken about, for some COVID-19 vaccines because suppliers are manufacturing doses in batches for more than one country. In some cases, it's because labels can't be affixed to vaccines that must be kept at minus 70 degrees. This bill allows the Secretary of the Department of Health to waive the requirement to display the ARTG registration on certain therapies, while making sure that that information is freely available elsewhere.

The bill will also facilitate a unique device identification, or UDI, database for medical devices. Right now—and I know this is a concern to many—there is limited collection of data on medical devices that have been implanted in patients. This has occurred where patients can't be contacted, let alone treated, in the event of safety issues arising. Many will remember that a Labor-led inquiry called for the creation of a central database or registry to address this issue, and a review of medicines and medical devices regulation released back in 2015 noted:

The Panel supports the Australian NRA in pursuing the adoption of the UDI, in alignment with international practice …

Now, some six years later, the government have made a first step. They are acting but are only introducing legislation which allows regulations to be made to establish a database. I call on the government to act more quickly. It shouldn't take years to act on recommendations to improve public safety and reduce the risk of harm.

I'd like to turn to another main provision of this bill which is of particular interest to me as a pharmacist. It will allow pharmacists to substitute medicines when certain shortages arise. Many people have experienced or have heard in their local community that medicine shortages are becoming increasingly common. It will be no surprise that around 150 shortages are now reported to the TGA each month. Increasingly this is for very commonly prescribed medications. People may remember that in February or March last year medicines like Ventolin or infant Panadol were in short supply or were not available in many communities.

The Society of Hospital Pharmacists of Australia has pointed out, 'The most commonly used antidepressant in Australia, sertraline, which ranks No. 9 in usage across Australia, had five brands listed on the website as out of stock.' They say, 'At the coalface we know from our members even more brands are unavailable for order from their wholesaler.' Having worked as a mental health pharmacist for many years in acute adult in-patient units, I understand the very real impact that shortages of antidepressants and other commonly prescribed medicines can have on patient care. When someone has finally found a medication that works for them, that is effective, whose side effects they can tolerate and that gives them good results and benefits it is very distressing to patients and their families and carers when that medication isn't available and there is a risk of disruption to their care.

The Pharmaceutical Society of Australia has also raised concerns about the impact of medication shortages. They go to what I have just mentioned, the impact on patients and their carers: 'Medicine shortages unfortunately occur regularly for a variety of reasons. Pharmacists deal with them every day, communicating with patients who are affected, liaising with prescribers regarding alternative medicines, working through logistics with wholesalers and suppliers.' They go on: 'Depending on the nature and duration of a shortage, as well as the availability of a clinically equivalent alternative medicine, it can be confusing and stressful for patients and carers, particularly when continuity of chronic therapy is disrupted, not to mention the risk of adverse health consequences. It's also really time consuming for the health professionals involved.' It must be pointed out that these medicine shortages are not new. They pre-date COVID and have only been exacerbated by the disruptions to global supply chains that we've seen over the past 12 months.

The Society of Hospital Pharmacists of Australia has noted: 'Hospital pharmacists already supply different strengths for in-patient medicines when required. They do so in a safe manner and have been doing so for years. They are acutely aware of medicine shortages, are uniquely positioned to best manage shortages and are ready to enact further alleviation measures based on their skills and experiences at the coalface.' Currently when shortages arise, pharmacists are allowed to substitute a different brand of the same medicine. However, they're generally not allowed to substitute a different medicine, although there are some ad hoc arrangements in different jurisdictions. This bill will allow the minister to declare a serious shortage of a particular medicine, what medicine or medicines are able to be dispensed instead and the circumstances in which substitution is able to occur. This is a commonsense change and has been welcomed. The PSA 'welcomes the willingness and efforts of regulators to implement solutions to help address medicine shortages for patients and to implement changes to allow pharmacists to substitute a medicine in a shortage without prior approval from the prescriber. This was originally proposed by the PSA and other industry bodies and advocated for by the profession,' and this commonsense change has been welcomed.

I'd now like to turn to the vaccine rollout. This will be the largest public health effort by a federal government, working with the states and other jurisdictions, in Australia's public health history. The Australian community expects Labor to work constructively with the government in the pandemic response. That's what we've consistently done, and that's our approach to this bill. However, we're conscious—and it's not just us; others are as well—of the danger of overpromising, especially in what will be, as I mentioned, the largest public health effort in Australian history. We were told last year and we were relieved that Australia was at the front of the queue in the global vaccine rollout. But today we know otherwise. We've seen tens of millions of people in the US and Canada, the UK, the EU and other countries already receive their vaccinations, and still not a single Australian has received a vaccination. It's important—and I know the Australian public are relying on this—that the Prime Minister delivers on his promise to have four million Australians vaccinated by the end of March and the entire country by the end of October. There are important questions that go to these commitments. What is the situation with the vaccine suppliers? There's been a lot of conjecture about this that's been reported. I'm sure most Australians would like to see that settled. When will we receive details about this single entry point, the online data entry point, which people will be required to use to make an appointment to receive their vaccination?

It's also of concern that Australia has only three direct vaccine deals, when most equivalent health systems have between five and six. The deals in Australia were made late and are seen by some to be weak. Now it appears that the rollout, from the original time frame that the government set, is delayed. As I mentioned, it's not just Labor that have concerns about this. Clinicians have been kept out of the process, and doctors were only formally invited to participate and register their practices on 12 January. In the middle of January, the New South Wales AMA President said that it was difficult to plan for the vaccine rollout because the schedule for the timing and number of vaccines was still not clear. It's concerning that the peak body in New South Wales doesn't have those details. Earlier in January, the RACGP national president said:

… what I haven't seen too much of is the detail that we need to do that logistics planning. … we need the logistics because we've got to provide for our staff, for our existing patients and for the huge undertaking we're about to go through.

She also made further comments in relation to residential aged-care vaccinations. She said it:

… doesn't sound like the GPs are involved, which is a bit challenging because GPs know these patients and could probably do it quickly—

adding:

… there wasn't any clarity around who it would be.

I now turn to the local concern—residents contacted me immediately about this—that no hospital on the Central Coast, in the region that I represent, has been announced as part of the rollout. This is in a community where one in five residents are aged over 65 and with a very high prevalence of COPD and other respiratory conditions. There is also very little detail with this hub model about outreach of vaccines from hubs to residential aged care or disability care—we know that's where we've seen, sadly, the biggest impacts of COVID-19 in Australia—or whether frontline workers, say, in a community like mine, will have to travel an hour to either Hornsby or Newcastle for their vaccines in the first phase of the rollout. These are really important questions and details that the government needs to make available to the community and also to those who will be providing this care.

As a pharmacist, I'd now like to turn to the involvement of pharmacists in the rollout. Over the weekend, I and many others were pleased to see the government commit $200 million to supporting the administration of COVID-19 vaccines by community pharmacists. I've undergone the training myself to be an immuniser, as have thousands of other pharmacists who are trained, prepared and ready to be part of this big nationwide effort. Community pharmacists, at this stage, are expected to administer the AstraZeneca vaccine in phase 2, subject to approval, and it's possible further vaccines will be approved for administration later in the year. While this is very welcome and I'm really pleased to see it, industry representative bodies have noted the clear recommendation from the King review that indicated the need to ensure adequate funding for services that pharmacists provide outside PBS expenditure. Pharmacists, like general practitioners and other medical professionals, are required to adhere to the strict protocols to administer the vaccine to the community. GPs are concerned around the level of remuneration, and, intuitively, pharmacists are concerned as well, particularly given that they must adhere to the same criteria and, as it stands currently, for less remuneration.

In my final remarks, I want to turn now more broadly to medicine supply shortages. Labor supports the measures in this bill to help address medication shortages, but, clearly, much more needs to be done. Pharmacists like myself are all too familiar with medicine shortages, and they face these problems, as I mentioned, day to day—even before COVID-19. I have firsthand experience dealing with shortages in both community pharmacies and in our local hospital. I mentioned before the example of sertraline, one of the most commonly prescribed medications—an antidepressant. At one point, multiple brands were just not available for people. As a specialist mental health pharmacist, I was involved in securing medicines through the TGA Special Access Scheme for patients at high risk if they were forced to discontinue or change medications. As a former chief pharmacist, I sat on the local Drug and Therapeutics Committee of Central Coast health, and we would deal with problems of this nature. Now, as a local MP, I'm hearing again the problems faced through COVID of people not being able to get infant Panadol or their ventolin inhaler. Medicine and medical device shortages represent a growing and potentially life-threatening risk.

This risk we have seen is real, and has only been heightened through COVID-19. When I spoke on bill No. 1 last year, I spoke about Australian manufacturing. The recent news concerning the European Union's plan to tighten rules on exports of coronavirus vaccines highlights a current and real risk that Australia faces. We need to be in a position so that supply shocks like this announcement don't risk the lives of vulnerable Australians. As I've mentioned, this issue of shortages of medicines and medical supplies is not new, but the COVID-19 pandemic has brought it into sharp relief. Where there is a sudden spike in global demand for particular medicines and vaccines combined with a disruption to global supply chains, Australia is suddenly even more exposed and often finds itself at the end of the queue. Medical supply shortages may occur more frequently in a global economy with consolidation of manufacturing and less products made in Australia. If more production occurs in fewer sites, especially overseas, there may be less spare capacity and more risks of disruption. That's why Labor firmly believes that, as part of the COVID-19 response, Australia should adopt policies to promote stronger domestic capabilities for the manufacturing and delivery of critical medical supplies.

As Labor leader Anthony Albanese said: 'Australia can and should be a country that makes things. If we get it right, a strong local manufacturing sector can deliver world-class products, incorporate the best technology and provide the good and secure jobs that our workers need and deserve.' We know Australian manufacturers are capable of world-class performance. It's been shown recently by the announcement from the US Department of Defense to grant contract work, worth over $300 million, to Brisbane based biotech firm Ellume to ramp up production of COVID-19 home test kits. We would really like to see, as part of this economic recovery, much stronger investment in Australian manufacturing, particularly in the regions. It's a win-win: a win for our economy and a win for local jobs, providing more security and certainty for Australians.

In the time I have left I would like to recognise the many frontline health workers who have worked to protect Australians through COVID-19. While there are many, in the context of this bill I would like to acknowledge my fellow pharmacists, who have made a considerable contribution on the front line, staying open and offering critical services when many other primary care providers were closed—hospital pharmacists managing supply and aged-care pharmacists providing telehealth services. For many of our most vulnerable Australians who have been forced into isolation, pharmacists have often been the only health professional they've had contact with.

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