Katie Allen (Higgins, Liberal Party) Share this | Link to this | Hansard source

Mr Speaker, it would be no surprise to you that the Morrison government is committed to keeping Australians healthy and safe. The Therapeutic Goods Amendment (2020 Measures No. 2) Bill 2020 builds on this objective by introducing to the Therapeutic Goods Act 1989 a suite of amendments that are fundamentally centred on promoting efficiency and flexibility in our healthcare system. This will be particularly critical as we turn attention to the swift and successful rollout of the COVID-19 vaccine over coming months.

This bill comprises five principal measures designed to ensure we continue to keep Australians healthy and safe. First, this bill helps guarantee the availability of prescription medicine. Throughout the COVID pandemic there have been major concerns about the availability of prescription medicines, and I take note of the hard work of the Minister for Health and Aged Care, Greg Hunt, with regard to supply of prescription medicines during what has been quite a difficult period in 2020. This is a reality that few Australians have ever faced or even contemplated. Many will recall that in March 2020 India, the world's main supplier of generic drugs, restricted the export of pharmaceutical ingredients and medicines, including paracetamol. This created a significant sovereign supply issue for many countries, including Australia.

In the case of a serious shortage of a prescribed medicine, this bill will allow pharmacists to substitute a different medicine from the one that has been prescribed for a person. This would not require the approval of the prescribing doctor, but could only occur when a safe alternative is available. This will be particularly helpful in regional and remote areas of Australia. Importantly, it would only be permitted under the act when the minister is satisfied there is a serious scarcity of a specified medicine. This will help improve the availability of prescription medication during medicine shortages, giving Australian families peace of mind that their loved ones will always have access to critical medicine. These legislative changes are very practical measures and are welcomed by patients and providers in the sector. Importantly, they build on legislative changes introduced in 2018. In 2018, our government introduced legislation to ensure medicine companies report shortages of important medicines as soon as they occur. In addition, if a critical drug is to be removed from the market, the Department of Health must be notified by the manufacturer at least 12 months in advance. This measure has been a really important step in giving comfort to patients who have life-saving drugs but can have their health put at risk at the whim of overseas manufacturers and suppliers.

The 2018 legislation followed on from a serious event that arose earlier that year when there was a critical shortage of medicines. Australia was one of several countries hit by a shortage of EpiPens, which provide life-saving adrenaline for people who've had an acute allergic response. As an allergist, I cannot tell you the chaos that was created in the lives of families whose children depend on the provision of EpiPens to keep their children safe from anaphylaxis. The phones were running hot across the country as literally thousands of families were concerned that, if their child were to eat a food that could be potentially life threatening, their child might die because they didn't have an EpiPen available. In this and a number of other cases the shortages were not reported in advance to the TGA within the Department of Health. Prior to 2018, medicine shortages had become an increasing problem, as medicine companies, manufacturers and importers had failed to comply with the previous voluntary reporting scheme. Mr Speaker, you'll be pleased to know that tough penalties, including fines of up to $210,000 for each infringement and the possibility of further court action, are now in place for companies that do not comply with these new laws.

The 2018 law protects patients who rely on vital medicines. It also gives the community, medicine companies and patients opportunities to take action to mitigate a medicine shortage. Responses to a shortage can include redirecting the available supplies to patients who need them most, nominating alternative treatments and providing PBS coverage for the alternatives. What the legislative amendments being debated today do is ensure that the alternatives, including formulation and dosage changes, can be provided by pharmacists if there is a serious shortage. For instance, a pharmacist can provide two 10 milligram tablets instead of a 20 milligram tablet, if that is not available. I have to say that a frequent occurrence in daily practice is a pharmacist having to resend a script because they have a short-term shortage of 20 milligram tablets instead of 10 milligram tablets. A pharmacist can now provide a capsule rather than a tablet, or a topical cream rather than a skin patch, if there is indeed a serious shortage of a vital medicine. These are practical and safe alternatives that help ensure vital medicines are supplied to patients in serious need.

Second, this bill will improve the traceability and monitoring of medical devices. Australians have become keenly aware of the importance and utility of accurate and up-to-date health data over the past year. This bill will provide a pathway to establishing a unique device identification, or UDI, database to improve the traceability and monitoring of medical devices post market. The current inability to trace medical devices once implanted or supplied has been a costly and timely constraint on clinical action on patient safety issues. Recent unfortunate examples include defective mesh devices and breast implants. The bill consolidates the work of many public and private hospitals that are in the process of making changes to their systems to enable the recording of devices implanted and supplied. As a previous member of the board of our local hospital, Cabrini, I know how important this change in process is in ensuring safety for our important patients. Establishing a UDI system also brings us into line with our international counterparts, including the European Union, the United States and Japan, who are undergoing various stages of implementation of the UDI system. These measures will also help prevent counterfeiting, helping keep Australian IP safe. This bill will enable faster responses to safety issues and more rapid and targeted recalls of defective devices, again, keeping Australians healthy and safe. This sort of market responsiveness to safety issues is something all Australians want and indeed deserve.

Third, this bill will provide protection to our TGA investigators so they can successfully fulfil their duties. In this place, we recognise the vital work of our TGA investigators and their role in keeping Australians healthy and safe. It is important we give our TGA investigators the scope and flexibility to carry out their duties effectively. This bill will allow TGA investigators to obtain illicit therapeutic goods to determine whether the act and regulations have been complied with. For example, a TGA investigator may order a test purchase of such products to examine the goods and determine whether they are being supplied legally or contain other potentially dangerous substances not declared to purchasers. This type of practice is becoming rampant online. For example, selective androgen receptor modulators, which have been used to assist in the gym and with bodybuilding, can now be more formally assessed. This will protect TGA investigators from being found criminally responsible under state or territory law for unlawfully obtaining and possessing these goods for the purpose of investigating their safety. By protecting the important work of TGA investigators, the Morrison government is helping protect Australians. These types of investigative powers enable our world-class TGA to be on the front foot to ensure the public is protected from potentially unsafe products making their way to our shores.

Fourth, this bill will protect Australians from internationally prohibited therapeutic goods. Just as we are committed to keeping Australians healthy and safe, the Morrison government is also committed to being a good global citizen. That is why the bill will allow for the making of regulations that prohibit the import, export, supply or manufacture of therapeutic goods that are prohibited under international agreements that Australia has ratified. For illustration, it is anticipated that the Minamata Convention on Mercury may potentially be ratified this year. This pertains to mercury-containing products which, in relation to therapeutic goods, would affect mercury-containing thermometers and sphygmomanometers as well as topical antiseptic, with the phasing out of mercury dental amalgams. This bill will allow regulators to give effect to Australian obligations under the Minamata Convention on Mercury. It is at the core of improving the safety—and, therefore, the safe health of Australians—of dangerous therapeutic goods.

Finally, and most importantly, this bill streamlines the rollout of COVID-19 vaccines. One of the most important aspects of the bill is enabling the secretary of Health to consent to the importation and supply of registered or listed therapeutic goods that do not have their registration or listing number on their label. This may seem like a small detail, but it's actually quite an important practical detail. This is primarily designed to address the potential impediment to the timely availability of COVID-19 vaccines, because, as we all know, some of these COVID vaccines, particularly the Pfizer one, have to be stored at very low temperatures. In the case of the Pfizer vaccine, this is minus 70 degrees. As a medical researcher myself, I know how difficult it is to store these minus-70 products, and it may not be possible to have the registration number affixed to the label. So this is a very pragmatic change that, in other circumstances, may result in the failure to have the registration or listing number on the label of the therapeutic good, and that could incur a maximum potential civil penalty of $440,000. This could be a major roadblock to the prompt and seamless rollout of the COVID-19 vaccine. I know it seems like a small change, but it's an incredibly important one. What it shows is a government that is very, very carefully thinking through all of the potential roadblocks so that we have a seamless rollout of the COVID-19 vaccine. It's a massive undertaking. It's an important undertaking—and it's one that I know Australians are waiting very carefully for—to make sure that all of the regulations, all of the policy and all of the potential practices that are going to be taking place do so for the safety of all Australians.

At the risk of sounding like a broken record, we are committed to keeping Australians healthy and safe. This bill supports the delivery of the highest quality health care for Australians, particularly as we look to the future rollout of the COVID-19 vaccine. Australians need to understand that the government has their back. This vaccine will be safe and it will be voluntary and, most importantly, we look forward to an effective rollout. The measures contained in the bill will provide efficiency and flexibility, meaning Australians can rest assured that our healthcare system will continue to deliver in these unprecedented times.

Mike Freelander (Macarthur, Australian Labor Party) Share this | Link to this | Hansard source

It is a great pleasure to follow the member for Higgins, although, like her government, she is perhaps a little loose with the truth regarding some aspects of this legislation. Whilst this legislation has been seen to be just routine and not of huge consequence, I believe that it is and that this government has once again been a little loose with the truth. I want to speak on the Therapeutic Goods Amendment (2020 Measures No. 2) Bill and on the amendments put forward by my colleague the member for Hindmarsh. Firstly, I would like to congratulate the member for Hindmarsh on his new appointment. I look forward to working closely with him over the coming months. It is great to have his very analytical and scientific approach to the Health portfolio.

I couldn't pass up the opportunity to speak on this legislation, because I do think it is very important in many respects. As a doctor, I believe in science. I wholeheartedly support the independent experts at the Therapeutic Goods Administration, which is a body that has a critical role in making evidence based decisions as well as keeping Australians safe when it comes to consuming pharmaceuticals, using devices, compliance and a whole number of therapeutic modalities. We are in the middle of a global pandemic, and the role of the TGA is of critical importance in our nation's ability to respond to this very challenging health crisis.

However, the greatest threat comes from the government benches, with some very unscientific, very polarising and very nasty information coming from some members opposite, whose names I won't mention. I would say that freedom of speech does not mean freedom of responsibility. I'd like those opposite to reflect on that. Disgracefully, members of the Liberal-National government continue to pedal misinformation and mistruths and to spread division and conspiracy theories without thinking about the consequences. I don't want to lay wanton blame where it is not due, because I do think much of our response to the pandemic has been good, but we need to face reality about some of the measures talked about in this bill. I know that many issues are being brought in under the cover of darkness, if you like. The issues regarding drug shortages, for example, have been many years in the making, and this government has failed to respond in any reasonable way to the supply chain difficulties, to the manufacturing difficulties and to the lack of local ability to respond when shortages occur.

The TGA is a very important organisation. It was formed in 1989. As I have mentioned, it regulates the quality, supply and advertising of a whole range of things, including medicines, pathology devices, medical devices, blood products, many other therapeutics and also some devices that enable therapeutic treatments. Anything that has a therapeutic effect or is used to administer a therapeutic effect must be approved by the TGA. For some years, the TGA has been led with great distinction by Professor John Skerritt, and it continues to do a wonderful job. On 25 January, the TGA provisionally approved the Pfizer-BioNTech COVID-19 vaccine, the first one approved in Australia, and I personally can't wait for the rollout of the vaccine. There's much we don't know about the future of COVID-19, but these new vaccines are very safe, and they will cover many of the mutations that are already appearing.

I cannot emphasise enough how important the TGA is in keeping Australians safe using their scientific ability to examine all the things that are used for medical treatments in Australia. I cannot emphasise enough their expertise, their approach to the science and their ability to make sure that vaccines, in particular, are very safe. Some of the information that's coming from the government benches is very, very bad in terms of public health and public confidence. I want to assure everyone that our TGA is the best medicine and device approval organisation in the world. Other countries envy it. We should be very glad that this is the organisation that is assessing and approving our new vaccines for COVID-19. It is keeping all Australians safe and is allowing us to access the novel treatments, the new treatments, that are now becoming available for a whole variety of diseases and illnesses, thanks to science, around the world. In particular, you may have read a recent Department of Health survey that demonstrated that, in the last 10 years, deaths from cancer have dropped pretty dramatically around Australia because of the new treatments that we have access to due to TGA assessment and approval.

This therapeutic goods amendment bill is described as non-controversial, but I do have significant concerns across a whole range of areas. This bill amends the Therapeutic Goods Act. Its main provisions are to facilitate the importation of COVID-19 vaccines to Australia. The member for Higgins and others have mentioned the difficulty with labelling, particularly labelling vials that have to be kept at minus 70 degrees Celsius. The bill also allows importation of the new vaccines, if they're approved to be used on Australians, without the TGA product number on them. As you can imagine, we need to be very nimble and very flexible in getting these safe vaccines into the country and distributed to all Australians. There are many vaccines in the development stage that will be becoming available. It's said now that the vaccines that we're getting will not be the best vaccines for COVID-19 in the future—and there are over 200 different vaccines still being examined and assessed around the world. This bill will allow us to get the vaccines to the Australian population as quickly and as nimbly as possible.

This new bill will also allow pharmacists to substitute medicines where certain shortages arise. It will allow the minister to declare a serious shortage of a particular medicine, and a substitute medicine can then be dispensed by pharmacists in circumstances in which substitution is permitted. As a prescribing doctor, I do have some concerns about this. I know that for many years the government has not adequately addressed shortages of medications around Australia. The member for Higgins mentioned EpiPens. At times there are still shortages of EpiPens. There are a number of reasons for this. There's only one manufacturer producing the autoinjector of adrenaline, which is the EpiPen. There's no alternative to the EpiPen listed for use on the PBS. I know that shortages can occur, and this is incredibly distressing for patients who have anaphylaxis. I myself have bee sting anaphylaxis. My granddaughter has nut anaphylaxis—true anaphylaxis, where she collapses and loses consciousness and her blood pressure drops if she has tree nuts and has no access to an adrenalin autoinjector. This is very troubling for parents. We know that these shortages have been present for years, and the government has failed to address this issue. We know there have been shortages for a number of different medications, including the antiepileptic Epilem, sodium valproate, which is the most common antiepileptic medication used in Australia.

A number of times, there have been shortages of appropriate strengths of Epilim. As you can imagine, for someone who has epilepsy, this can be very distressing. There've been shortages of common antibiotics. We, through CSL, used to manufacture most of our penicillin-derivative antibiotics, and others, in Australia. We no longer do that. The government has failed to address supply chains for the common antibiotics. There've been shortages of desmopressin—which is used for, amongst other things, a type of illness called diabetes insipidus and also for enuresis, or bedwetting—a number of times over the last three or four years. Again, this was not addressed, because of the supply-chain difficulties. We know that there've been shortages in a number of treatments for ADHD. It can be very distressing to families who have a child with ADHD if they can't get their medication. The government is, under cover of darkness, if you like—the pandemic—introducing this legislation and pretending the supply-chain difficulties are due to the pandemic. They are not. They are due to the fact that this government has failed to address pharmaceutical supply-chain difficulties for a number of years.

This legislation will also facilitate the development of a device identification database. Labor has been calling for this for years and years and years. This means that people who have implantable devices—for example, those used in orthopaedic surgery, for hip replacements and knee replacements et cetera—can be identified and they can be recalled if required. You may remember there was a problem with some hip-joint replacements some years ago. The metal was leaching from these devices, causing a number of medical problems. It was very difficult to follow up these patients and recall them, as they couldn't be adequately identified because of the lack of a national database. Labor called for the introduction of a database some years ago. The government has been so slow to respond to this. It's been years since this has been called for. It's only now coming into effect. It also means that patients who have things like pacemakers, some cardiac valves or a number of different implantable devices for neurological surgery can be easily tracked and easily followed.We've been calling for this for years. It's so late in the day that the government is introducing this, but at least it's happening at last.

I have a number of concerns about the database. The government are very prone—and the future in health is in the data—to selling off our health data to private organisations. I would mention that, when I came into parliament in 2016, the government very surreptitiously sold off, without any appropriate public discussion, our breast cancer registry to Telstra Health, putting that data all in the hands of a private organisation. We have a Medicare platform that could be easily used to access and collect this data. The government sold off that very important health information, that health data, to a private company and is doing it even as we speak. Can you believe this—they announced on the evening of Christmas Eve that Accenture, a huge data company, was the data partner for the COVID-19 vaccine rollout. There's only one reason why you would introduce that announcement on Christmas Eve: you want to keep it secret, because you're again selling off our health data to a private organisation. Under cover of darkness, that's what the government are doing. Will they be doing that with our device register? They won't tell us, but I think they will. That's what they'll want to do—sell it off to private enterprise, removing it from public access and removing it from our research organisations et cetera, probably unless they pay a fee. So that's one aspect of this legislation that I think is a major concern.

Even though we agree with the spirit of this legislation, I have major concerns about some aspects of it. There are no details about how pharmacists are going to be able to change medications, and unless this government does something about the supply chains there will be shortages in the future; that's for sure. Yes, we agree with this legislation and the amendment moved by the member for Hindmarsh, but I do have major concerns about this government's response to health care in general and about its ability to maintain good health care for all Australians.

Tim Watts (Gellibrand, Australian Labor Party, Shadow Assistant Minister for Communications and Cyber Security) Share this | Link to this | Hansard source

While Australians are rightly proud of the way that we as a nation have responded to the COVID-19 pandemic, all of us have a role to play in responding to this great challenge of our time. In large part, Australia's institutions have responded well. When I look at what has been successful in the Australian response, I look with great pride at the success of our governments, our public servants, our independent regulators and, indeed, our parliament and our political system. These institutions have served us well in the face of this extraordinary challenge. One of the institutions that Australians trust and rely on to protect them is the Therapeutic Goods Administration. This bill, the Therapeutic Goods Amendment (2020 Measures No. 2) Bill 2020, is designed to assist the delivery of the COVID-19 vaccine throughout the nation and the role of the TGA in doing that.

The Australian community rightly expects opposition parties around the country to work constructively with governments to do all that they can to respond to this COVID-19 pandemic, and that's exactly what Labor is doing with this bill. There are some aspects of this bill that we have some concerns with, but overall the urgency of facilitating the COVID-19 vaccination campaign militates in favour of the quick passage of this bill.

This bill does a number of things. It facilitates the importation of COVID-19 vaccines to Australia. There are a number of regulatory requirements, particularly those relating to the display of Australian Register of Therapeutic Goods numbers on vaccines, that are difficult to implement with the COVID-19 vaccines. In some cases manufacturers can't put those individual numbers on because they are making doses for multiple countries. In other cases it's because the labels with these numbers can't be affixed to vaccines that must be kept at a supercold, minus-70-degree, temperature. This bill enables the Secretary of the Department of Health to waive the requirements to display the ARTG registration on certain therapies while making sure the information is still available freely elsewhere, particularly online. That's a good thing. The bill does a number of other things. It allows pharmacists to substitute medicines if certain shortages arise and it facilitates unique device identification databases for medical devices, as the member for Macarthur discussed earlier.

As I said, we might have some quibbles with aspects of this bill, but this is an important bill for the nation and the opposition is approaching it constructively. The constructive role played by the opposition in the COVID-19 pandemic doesn't mean biting our tongue when we think that the government has dropped the ball. In particular, we will hold the government to its word. When the Prime Minister says something about the way the nation is combating COVID-19, the Australian public expects that he will honour his word. As to the rollout of the COVID-19 vaccine in particular, we want to see the Prime Minister live up to his promise, his commitment to the Australian people, that Australia is 'at the front of the queue' in the global vaccine rollout. I had a look online just before coming into the chamber today. We're at not quite 100 million doses—about 99 million doses of the vaccine have been administered worldwide—yet not a single Australian has received a vaccination. So 'at the front of the line but actually behind 100 million people' is where we are at the moment. It will be some time yet before the vaccine is actually rolled out in the Australian community. We will see then how far back in the queue we actually are, and we can compare the Prime Minister's words to his delivery.

The other thing that we will be very clear on is demanding that what has worked in Australia's response to COVID-19 is maintained by the government. What has worked is that our response in this pandemic has been based on science, and it requires political leaders to defend the science and it requires every one with a voice in our society to counter disinformation campaigns that undermine the primacy of science in our response to COVID-19.

It is particularly crucial that in the COVID-19 campaign all members of this House defend the institutions that Australians trust and rely on to protect them, particularly the TGA. Outrageously, the TGA has been the subject of a completely baseless campaign of abuse by the member for Hughes—an ongoing campaign of abuse of one of Australia's most important institutions in the middle of a global pandemic. It is outrageous, and it is not something that can be merely dismissed as the ravings of a Facebook comments guy come to life. Yes, this is happening on Facebook, but guess what? Facebook is very influential on people's decision-making in a modern world. The posts on the member for Hughes's Facebook page have been shared 10 times more than the posts of the Commonwealth Department of Health during this pandemic. They are 10 times as influential.

A particular problem is the member for Hughes's influence on the interaction and debate on Facebook—comments, shares and interactions. He regularly constitutes fully a quarter of Australian political debate on Facebook—a quarter of the total interactions Australia-wide are on the member for Hughes's Facebook page. This is not a trivial thing that can be dismissed. The member for Hughes is a one-man COVID-19 misinformation superspreader. It is extraordinary how he has enough time in the day to post the crap that goes through his Facebook page. I just had a look online. It's hard to actually keep up with it, but just in the last five days he has had 15 posts of COVID-19 misinformation. I was trying to keep count, because I did see that the Prime Minister had counselled the member for Hughes. It was reported in the media that the Prime Minister's spin doctors have been out there saying that he's had a word with the member for Hughes and he's counselled him—not sanctioned him, counselled him—and said privately, 'Please pull your head in.' Since that counselling—we saw it on 7News last night—the member for Hughes has done an interview with The Guardian; he's done an extended interview with Andrew Bolt on Sky News; he did a doorstop in the press gallery, where he accosted the member for Sydney in the middle of her doorstop; and, most tellingly, all of the member for Hughes's COVID-19 misinformation posts on his Facebook page are still up there. If the Prime Minister were serious about dealing with this COVID-19 misinformation superspreader he'd be saying to the member for Hughes: 'Take those misleading posts down. Take down the attacks that you are making on Australia's medical institutions, on our health and scientific institutions. Stop allowing this toxic, damaging garbage to be shared from your page.' But, of course, the Prime Minister is only concerned about the political problem here, not the substantive problem. He called the member for Hughes yesterday because the member for Hughes is starting to become a political embarrassment. He's not concerned about the substantive problem here of COVID-19 misinformation; he's concerned about the political problem. We know that, because you can hear the comments of the Prime Minister leading up to today, leading up to the absurd degree that the debate has gotten up to this week, enabling the member for Hughes. When asked about it previously, the Prime Minister has said, 'There's such a thing as freedom of speech in this country, and that will continue,' allowing the member for Hughes to continue his medical misinformation during the COVID-19 pandemic and dismissing it laughingly, saying, 'I am not going to get into what people are talking about on Facebook,' despite Facebook being the most influential medium in that demographic, in the cohort of people that are most—

Luke Howarth (Petrie, Liberal Party, Assistant Minister for Youth and Employment Services) Share this | Link to this | Hansard source

A point of order, Mr Deputy Speaker.

Rob Mitchell (McEwen, Australian Labor Party) Share this | Link to this | Hansard source

The member for Petrie.

Luke Howarth (Petrie, Liberal Party, Assistant Minister for Youth and Employment Services) Share this | Link to this | Hansard source

The member for Gellibrand just reflected terribly on the member for Hughes when he used the word 'accosted' and he should withdraw.

Rob Mitchell (McEwen, Australian Labor Party) Share this | Link to this | Hansard source

No, he didn't. There's no point of order.

Luke Howarth (Petrie, Liberal Party, Assistant Minister for Youth and Employment Services) Share this | Link to this | Hansard source

When you look up the work 'accosted' he should withdraw.

Rob Mitchell (McEwen, Australian Labor Party) Share this | Link to this | Hansard source

The member for Petrie will resume his seat.

Luke Howarth (Petrie, Liberal Party, Assistant Minister for Youth and Employment Services) Share this | Link to this | Hansard source

It's a bloody disgrace!

Rob Mitchell (McEwen, Australian Labor Party) Share this | Link to this | Hansard source

The member will withdraw that remark—you won't use that language in the chamber—and then you'll leave under 94(a).

Luke Howarth (Petrie, Liberal Party, Assistant Minister for Youth and Employment Services) Share this | Link to this | Hansard source

I withdraw.

The member for Petrie then left the chamber.

Rob Mitchell (McEwen, Australian Labor Party) Share this | Link to this | Hansard source

The member for Gellibrand in continuation.

Tim Watts (Gellibrand, Australian Labor Party, Shadow Assistant Minister for Communications and Cyber Security) Share this | Link to this | Hansard source

Thank you, Mr Deputy Speaker. We see the protection racket by those opposite for the member for Hughes. This man is leading a one-man medical misinformation campaign during a global pandemic, and we see a protection racket by those opposite. We see the Prime Minister continuing to refuse to do what is in his power to do to stop the member for Hughes from spreading medical misinformation in the COVID-19 pandemic. He could take his committee assignment. The member for Hughes is currently, at the behest of the Prime Minister, a member of the House Standing Committee on Industry, Innovation, Science and Resources. The member for Hughes is still an endorsed member of the Liberal Party. You would think that, during a global pandemic, a real leader, a real Prime Minister, would say, 'I do not want anything to do with someone who is undermining the vaccination campaign for COVID-19 during a global pandemic, someone who is undermining the work of our frontline doctors, nurses, epidemiologists and scientists.'

This Prime Minister is proud to stand next to the member for Hughes. Indeed, the Prime Minister has said that the member for Hughes is doing 'a great job'. Whose side is he on? Is this Prime Minister on the side of those doctors and nurses who have been so heroic in the COVID-19 pandemic? Is he on the side of the epidemiologists and the scientists? They're the ones who have been getting us through this. They're the ones giving us advice to help us through this crisis. It's the scientists who have developed these vaccines. You would call them miracles, but they are not miracles. The vaccines to protect us from this pandemic, which has cost so many lives around the world, are the product of scientific endeavour, of investment in research and of hard work. We need to be standing with these people. We need to be defending the TGA. We need to be calling out medical misinformation wherever we see it. We have seen what happened in the United States when peddlers of conspiracy theories and baseless extremism online were indulged. Those extremists and conspiracy theorists became emboldened. They started ramping up their fantasies, and they have real-world consequences.

We saw this week extraordinary degradation in the debate when the member for Hughes appeared on the podcast of Pete Evans. This man has been fined by the TGA for peddling quack COVID-19 cures during a global pandemic. This snake-oil salesman was peddling a $15,000 light machine to people who are scared in a global pandemic. He was fined $25,000 by the TGA for exploiting the fear of Australians in the middle of a pandemic. This is a man that the member for Hughes thought was a good idea to share a platform with. This is a man that the member for Hughes thought was a good idea to elevate in our public debate. This is a disgrace.

There have been no sanctions from the Prime Minister. The Prime Minister has not lifted a finger in the face of this COVID-19 medical misinformation superspreader. He has said not a public word about sanctions against this individual. He has taken not a single action that is within his control to stop this. It has real consequences. There is nothing more important in this country at the moment than the rollout of the COVID-19 vaccine. It is what will get us through the health crisis. It will be what will enable our economy to go back to something resembling normal.

Australians on the whole are sensible in the face of this. Newspoll today shows that 75 per cent of Australians have said that they will get a vaccine. But there are some reasons for concern and some reasons to think that all of us in this chamber have a special obligation to ensure public support for this vaccination campaign. About 29 per cent of Australians said, yes, they would probably get the vaccine. That 'probably' is a cause for concern. What is in that 'probably'? When you delve into the cross-tabs and look at who is most likely to have a concern you see that it is people in the 39-to-49-years-of-age demographic. This is the prime Facebook demographic. Roy Morgan stats confirm that that age demographic are the most prolific users of Facebook. They have some concerns and they're not being helped by the member for Hughes controlling 25 per cent—25 per cent—of Facebook political debate in this country.

It is time that the Prime Minister showed that he is on the side of Australian doctors, Australian nurses, Australian epidemiologists and Australian scientists—all of those Australian frontline workers who have risked their health to get us through this pandemic—because it is only by being on the side of these heroes of the pandemic that you can show that you're on the side of the Australian public. It's about time the Prime Minister showed that he's not on the side of the lunatic fringe; he's on the side of the Australian people.

Ged Kearney (Cooper, Australian Labor Party, Shadow Assistant Minister for Health and Ageing) Share this | Link to this | Hansard source

I rise to speak on the Therapeutic Goods Amendment (2020 Measures No. 2) Bill 2020. This bill amends the Therapeutic Goods Act to make a number of changes to the regulation of medicines and medical devices in Australia, especially during a pandemic. Before I get into the detail of the bill I want to take a moment to thank all the health professionals who have worked, and continue to work, so hard as we deal with the COVID pandemic. To the doctors, the nurses, the pharmacists, the carers: you stood in pouring rain, blistering heat and fume-filled car parks testing hundreds of thousands, if not millions, of Australians for COVID. To the pathologists who worked around the clock to get those tests out and to those wonderful people at the TGA who've been working incredibly hard as well: you are the reason that Australia has fared so well.

The bill's main provisions are to facilitate the importation of COVID-19 vaccines to Australia. This is the most pressing matter in the bill, as it deals with the labels that will be affixed to the bottles of the different COVID-19 vaccines.

The bill will also allow pharmacists to substitute medicines where certain shortages arise. Medicine shortages, as we heard from my good friend the member for Macarthur, are increasingly common. Around 150 a month are now reported to the Therapeutic Goods Administration. This bill would allow the minister to declare a serious shortage of a particular medicine, the medicines that can be dispensed instead and the circumstances in which substitution is permitted. As the member for Macarthur has pointed out, medical shortages have been happening since long before COVID, and this is a well-overdue measure.

Finally, the bill will facilitate a unique device identification database for medical devices. Under the status quo, there is limited collection of data on medical devices that have been implanted in patients. This means patients can't be contacted, let alone treated, in the event of safety issues down the track. There have long been calls for the creation of an essential database or registry to address this issue, including by a Labor-led Senate inquiry in the last parliamentary term. The bill allows the making of regulations to establish such a system but it doesn't directly establish one.

Labor will be supporting this bill. But, as the member for Hindmarsh has noted, there is no bigger task for 2021 than the COVID-19 vaccine rollout. The enormity of the logistical challenge involved in undertaking as many as 50 million to 60 million vaccinations over the coming months is really something. Labor wants this to work. We need a successful vaccine rollout that allows people to get back to work, not have to worry about border closures and see an end to the lockdowns, but we're worried that the Prime Minister has already fallen into his old trap of overpromising and underdelivering. The PM's track record isn't pretty. Throughout the pandemic the Prime Minister has failed in the two areas the federal government is responsible for: aged care and quarantine. The rest of the time he has hidden behind the incredibly good work of state premiers, taking credit when it goes well and getting his attack dogs out when things get tough. As a Victorian I was outraged to sit in this House and listen to the attacks on the Victorian Premier. In our state we worked so hard—so hard—to control the outbreak of COVID and we were successful. We were actually the envy of the world with regard to how we managed that, yet here in this House, my state—the people of Victoria and our Premier—was heartily attacked. And I find it galling when the Minister for Health and Aged Care stands here in this House and takes credit for the incredibly good outcomes from exactly the same measures that earlier were being attacked in this House.

There are three clear paths to delivering a successful vaccine rollout, and Labor will be putting some questions to the government on these points. There's the issue of vaccine supply—that is, getting enough vaccines to Australia to cover the whole population. There are the logistics of the rollout, and there's ensuring that Australians get clear, fact based information that is scientific and backed in by the experts. As an opposition member and as a nurse—and I'm proud to say that I'm still registered as a nurse—it's obvious to me that we already need clearer answers from the government on some of these points. These are important issues. The community needs to have confidence that the vaccine rollout is going to operate in a smooth, timely and effective fashion.

On the first point—the supply of the vaccine—the Prime Minister has already overpromised and underdelivered. Despite his promises that we were right at the front of the queue, Australia signed our first deal a full six months after other countries started securing theirs. We understand that there are emergencies, particularly in the Northern Hemisphere, at levels that, luckily, we're not experiencing here in Australia. But tens of millions of people around the world have already been vaccinated—in countries like Israel, which has vaccinated one-third of its whole population.

The Prime Minister has promised to vaccinate four million Australians by the end of April and all Australians by the end of October. Despite these promises, though, it's unlikely that we will see even half the number of doses required to do that in this country by the end of March. We're still not clear when the Pfizer vaccine and the importation of the AstraZeneca vaccine will be delivered.

We also need more information about whether the government should be pursuing more vaccine deals to diversify the supply of vaccines. Currently, Australia has secured three vaccine deals—far fewer than other countries. To quote Steven Hamilton, an assistant professor of economics at George Washington University, and Richard Holden, a professor of economics at the University of New South Wales Business School:

You could be forgiven for thinking that three or four vaccines would be sufficient. But amid a pandemic that has claimed millions of lives and trillions of dollars of global economic output, you'd be wrong. By a lot.

They go on to say:

We recently failed to reach an agreement with Moderna. It's hard to conceive of any terms they might demand that we shouldn't be willing to accept—

given the stakes. And, they say:

… we seemingly haven't tried to secure any agreement with Johnson and Johnson.

Meanwhile, the US government recently secured an additional 100 million Pfizer and Moderna vaccines.

So I ask those who sit opposite: please, do more to secure enough vaccines, and soon.

As a nurse, I am particularly focused on the logistics of the rollout. I know what has to happen on the ground. It is a huge challenge. While I know our wonderful public healthcare experts are up to the job, I hope the government is putting every effort into working with them and listening to them—hearing what they need on the ground to make this work.

Two early signs worry me. Firstly, there's the proposed single entry point—the online data entry point which will be required for people to make an appointment to receive their vaccinations. That is an online booking tool for people to secure their jab. Three weeks out from the launch of the vaccine rollout, we are yet to see any details of this tool. Is this going to be another COVIDSafe app debacle? We hope not. And can you imagine our elderly having to use a computer to book their vaccine? Under the government's current plans, not every GP will be participating in the vaccine rollout, and it would be a natural assumption for many, especially our elderly and vulnerable, that, to get that vaccine, they'd just ring their GP and book in. But for many, of course, this won't work. General practitioners have already raised this as an early issue.

We're also incredibly concerned about the plans to vaccinate residents in our aged-care facilities. After watching the federal government's failures in aged care during the pandemic, I hope they're putting every effort into ensuring the rollout goes well and that they know exactly what they're dealing with. It has to be thoroughly thought through. There are key issues like informed consent, especially for people with dementia.

Can we trust the government with this kind of complexity? We want to work with the government to make sure that they are covering off every single angle necessary, because we support this bill and we want the vaccine rollout to go well. But the government's broader pandemic response needs to not only be based on science; it has to defend the science and actively counter those disinformation campaigns, including against the TGA, that risk public health and that are emanating from the government's own ranks.

It's why the whole member for Hughes debacle is just so disappointing and worrying. Yesterday I was gagged in this House for calling him 'a dangerous fool', but I stand by that term and I stand by my comments that a real leader would have dealt with him by now. He's a menace to this vaccination program and, as a direct consequence, a menace to the health of all Australians—

Rob Mitchell (McEwen, Australian Labor Party) Share this | Link to this | Hansard source

The minister, on a point of order?

Stuart Robert (Fadden, Liberal Party, Minister for the National Disability Insurance Scheme) Share this | Link to this | Hansard source

It is inappropriate to call another member a 'fool' in the House.

Rob Mitchell (McEwen, Australian Labor Party) Share this | Link to this | Hansard source

I'll refer you to the Speaker's ruling yesterday. There is no point of order. The member for Cooper can continue.

Ged Kearney (Cooper, Australian Labor Party, Shadow Assistant Minister for Health and Ageing) Share this | Link to this | Hansard source

So it's utterly irresponsible for the Prime Minister to refuse to condemn Craig Kelly outright.

Rob Mitchell (McEwen, Australian Labor Party) Share this | Link to this | Hansard source

I will remind the member for Cooper to refer to members by their correct title.

Ged Kearney (Cooper, Australian Labor Party, Shadow Assistant Minister for Health and Ageing) Share this | Link to this | Hansard source

Sorry, I apologise. What did I say? I said Craig Kelly. I apologise—the member for Hughes. In fact, the PM said the member was doing a fantastic job. But he is undermining the advice of our public health experts, including the Chief Medical Officer, and he's undermining confidence in the vaccine campaign. He's engaging in systematically undermining confidence in our medical and scientific institutions. He's accused the Chief Medical Officer and chief health officers of 'crimes against humanity'. He's engaged in conspiracy theories about big pharma, and we heard the member for Gellibrand express his concern about the member for Hughes's Facebook page and the quantity of misinformation on there—that it's all a conspiracy and the vaccine is merely there to make money for big pharma. He pushes on about his remedies, like hydroxychloroquine.

We also saw the polling research out yesterday, from both Newspoll and Essential, reminding us of the challenge in making sure that as many Australians as possible are willing to take up this voluntary vaccine. Newspoll, for example, showed that only 75 per cent of Australians intend to take up the vaccine, and that rate is lower among some groups, as we heard—the 36 to 45 age group. That's why Labor has supported the government's information campaign, but it makes no sense that the Prime Minister would refuse to pull the member for Hughes into line for undoing all the good work they are trying to put into that information campaign.

The Australian community expects the opposition to work as constructively as we can with this government, and we will and we have consistently done so throughout the pandemic, and our approach to this bill and to the vaccine rollout will be no different. We want it to be the best rollout possible, so we will continue to push the government in areas where we have concerns, we will continue to push the government on issues of accountability and we will make sure that we can give Australians confidence in the vaccine and its rollout program.

Andrew Leigh (Fenner, Australian Labor Party, Shadow Assistant Minister for Treasury) Share this | Link to this | Hansard source

According to this morning's email update from the Johns Hopkins Center for Health Security, there are now 103 million cases of COVID globally and there have been 2.2 million deaths. The weekly global incidence, thankfully, is down to just 3.6 million new cases. Weekly global mortality is down a little but is still at the staggering figure of 93,803 deaths.

The vaccine is coming, but in Australia's case it's coming too slowly. Globally, there have been over 100 million vaccine doses administered; in the United States, 32 million doses administered. If you look at the Our World in Data site, it has figures on the share of people vaccinated per 100. In Israel, that figure is at 36 per cent; in the United Kingdom, 13 per cent; and, in the United States, eight per cent. So other countries are getting on with the rollout. But what is the share in Australia? Well, it's zero per cent. We are yet to begin the vaccination rollout, and, far from the Prime Minister saying that Australia is 'at the front of the queue', we find ourselves behind most advanced nations when it comes to rolling out the vaccine. That is not the fault of the Therapeutic Goods Administration, which has now approved the vaccine for administration in Australia; it is the fault of the Morrison government for failing to strike a sufficient number of vaccine deals.

Australia only has three direct vaccine deals; most equivalent health systems have five or six. It took us a full six months after other countries started signing vaccine deals in March before we secured our first vaccine deals. We signed vaccine deals with Oxford-AstraZeneca and UQ-CSL on 7 September 2020. The early access agreement was to have provided 3.8 million doses of Oxford-AstraZeneca vaccine in January and February 2021. On 7 September 2020, the health minister said on Twitter that the vaccine would be available progressively throughout 2021 in Australia, commencing in January. The government failed to meet that test. In part, that's due to AstraZeneca reneging on the promise to provide 3.8 million early doses from overseas, now only sending 1.2 million by March. Australia then signed a deal with Pfizer for 10 million doses and Novovax for 40 million doses on 5 November. But it took Pfizer proactively reaching out to the government in July for the government to even commence discussions on a vaccine deal. By the time Australia signed to get doses of the Pfizer vaccine, Pfizer had already signed away one billion doses to 34 countries, including those in the European Union. So Australia has too few vaccine deals in place.

As the rollout happens, it will be critical that we tackle vaccine misinformation. We've already seen the challenge this can pose overseas. On Saturday, Dodger Stadium in Los Angeles, one of the largest mass vaccination sites in the United States, was temporarily shut down when antivaxxer protesters blocked the entrance to the stadium. Thankfully it didn't result in the cancellation of any appointments, but it did represent an attempt to intimidate those in charge of the vaccine rollout.

Here in Australia, we should have a situation in which the entire federal parliament is standing in unity with the chief medical officers. But unfortunately, the Liberal and National parties have allowed the vocal antivaxxer statements of the member for Hughes to have their head. The member for Hughes has been vocal in his support for hydroxychloroquine. He stated it was safe and effective, and has referenced studies that allegedly found that hydroxychloroquine is associated with substantially reducing both death and hospitalisation in COVID-19 patients. The truth is a different matter. Hydroxychloroquine looked good in observational studies, but, once high-quality randomised controls were in place, it became clear it was not a desirable treatment. Its use is strongly discouraged by the Therapeutic Goods Administration, which cites the results of several large-scale studies conducted by the World Health Organization, the US National Institutes of Health and Oxford University. The National COVID Clinical Evidence Taskforce recommended against the use of hydroxychloroquine.

The member for Hughes has questioned the effectiveness of masks to stop the spread of COVID-19. He has also stated that forcing children to wear masks is causing massive physical and psychological harm and that forcing children to wear masks is 'child abuse'. There are two mistruths there. Firstly, children under 12 aren't required to wear masks in any state or territory. Secondly, there are multiple studies supporting the effectiveness of masks. One study of people who had the common cold found wearing a surgical mask reduced the amount of the respiratory viruses admitted in droplets and aerosols. Another study compared the coronavirus growth rate before and after mask mandates in 15 US states and found that mask mandates led to a slowdown in the daily growth rate of COVID. In the first five days after a mask mandate, the daily growth rate slowed by 0.9 of a percentage point compared to the five days prior to the mandate. At three weeks, the daily growth rate had slowed by two percentage points.

Then there are his attacks on the Victorian government, as the previous contributor to this debate has noted. When the Andrews government put in place measures to help stop the spread of coronavirus, the member for Hughes compared them to Nazi Germany and stated that 'tens of thousands of medical professionals around the world' had signed a declaration urging coronavirus restrictions to be lifted for non-vulnerable populations. Again, the truth is far more complicated. News organisations found that anyone could sign that declaration by claiming to be a medical professional and the list of signatories contained dozens of fake names including 'Dr IP Freely' and 'Dr Person Fakename'. Other so-called medical professionals included homeopaths, massage therapists and hypnotherapists—hardly infectious disease specialists.

We need ER, but this government is giving us The Twilight Zone. With the wild conspiracy theories spreading online, the member for Hughes could get his own gig writing a Netflix special. But his antics are anything but entertaining. His spreading of dangerous misinformation has been called out by the Chief Medical Officer, Paul Kelly. Dr Karen Price, the President of the Royal Australian College of General Practitioners has said it's unacceptable. But the Prime Minister has failed to act. He hasn't condemned the member for Hughes for spreading misinformation in the midst of a pandemic. He's just said people should listen to doctors.

But the simple truth is that so-called viral posts have an ability to catch fire in a way in which basic truths by medical professionals simply don't. Over the past six months, in the midst of the pandemic, Facebook posts made by the member for Hughes have been shared more than 10 times more than those posted by the Australian Department of Health. The member for Hughes's shares of misinformation amount to 847,000, compared to 79,000 from the official source. The member for Hughes is a superspreader of misinformation. Misinformation, as we well know, spreads like wildfire. It's a simple truth about the way in which social media operates. The point is that the Prime Minister should call him out, not just pick up the phone when he's having an interview with Mark Riley but actually publicly denounce the views of the member for Hughes.

The government itself is now spending $24 million promoting the COVID-19 vaccination campaign, and that campaign is itself being undermined by one of the government's own backbenchers. What do they do? Do they remove him from his committee assignments, including his position on the Standing Committee on Industry, Innovation, Science and Resources? No, nothing of the sort. Taxpayers are paying for vaccine information, and the government's own backbencher is spreading vaccine misinformation. The member for Hughes has claimed that hydroxychloroquine was being banned by our regulators as part of some anti-Donald Trump conspiracy and that it would be approved after the US election. He's supporting the view that any government that bans hydroxychloroquine is deep-state freemason controlled. He's accused Australia's chief medical officers of crimes against humanity, ominously stating 'the day of reckoning is coming', the sort of language that is used by QAnon supporters in the United States, by those who stormed the US Capitol on 6 January. When the World Economic Forum unveiled its post-COVID reconstruction plan, the member for Hughes compared it to Pol Pot's Cambodian genocide.

On Monday the Prime Minister laughed off criticism of the member for Hughes and said the member for Hughes was doing 'a great job'. Doing a great job of what exactly? Is it discouraging his constituents from listening to the Chief Medical Officer? Is it encouraging his constituents to use a dangerous and unproven drug, in hydroxychloroquine? Is it encouraging his constituents not to use masks, which we know save lives? Is this the kind of 'great job' the Prime Minister thinks the member for Hughes is doing? On Tuesday, when the member for Hindmarsh tried to call out the member for Hughes's irresponsible and dangerous behaviour, he was gagged by the votes of every Liberal and National party member opposite. When the member for Cooper tried to condemn the Prime Minister for not protecting the Australian people from misinformation, she too was gagged by every Liberal and National member in this House. When the member for Corio spoke out against the dangerous misinformation and spoke up for science, as he so often does in this place, he was gagged.

The Prime Minister is happy to gag those speaking out for truth, but he doesn't have the guts to gag his own backbencher from spreading medical mistruths in the face of the most dangerous pandemic Australia has seen in a century. And it's not just the member for Hughes. Make no mistake: if the Prime Minister were to take him on, he would also need to take on the member for Dawson, who co-authored a letter to the Queensland Chief Health Officer, Jeannette Young, criticising her stance on hydroxychloroquine, a letter which turned up in Queensland mailboxes spread house to house. The member for Hughes says that there are at least a dozen of his parliamentary colleagues that support his antiscience stance. That means that, like climate change denialism, vaccine denialism and the spreading of misinformation is rampant on the coalition back bench.

I haven't attempted in this speech to persuade the member for Hughes. I think he's a lost cause. But it is important that, as all of us in this parliament and people in the broader community speak about the importance of vaccines with those who are sceptical, we do draw on the best science. I draw the House's attention to a terrific piece by organisational psychologist Adam Grant, from the Wharton School, in The New York Times on 31 January 2021. It's called 'The science of reasoning with unreasonable people'. He says:

Several decades ago, when treating substance abuse problems, psychologists developed a technique called motivational interviewing. The central premise: Instead of trying to force other people to change, you're better off helping them find their own intrinsic motivation to change. You do that by interviewing them—asking open-ended questions and listening carefully—and holding up a mirror so they can see their own thoughts more clearly. If they express a desire to change, you guide them toward a plan.

He goes on to write:

In controlled trials, motivational interviewing has helped people to stop smoking, abusing drugs and alcohol, and gambling; to improve their diets and exercise; to overcome eating disorders; and to lose weight. The approach has also motivated students to get a good night's sleep; voters to reconsider their prejudices; and divorcing parents to reach settlements.

Recently, thanks to a vaccine whisperer, it has been applied to immunization. Arnaud Gagneur is a pediatrician in Quebec who encourages reluctant parents to immunize their children. In his experiments, a motivational interview in the maternity ward after birth increased the number of mothers willing to vaccinate their children from 72 percent to 87 percent; the number of children who were fully vaccinated two years later rose by 9 percent. A single conversation was enough to change behavior over the next 24 months.

It's incumbent on every member of this House to work with our chief medical experts to ensure that as many Australians as possible are vaccinated against COVID-19.

Emma McBride (Dobell, Australian Labor Party, Shadow Assistant Minister for Mental Health) Share this | Link to 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.

Josh Burns (Macnamara, Australian Labor Party) Share this | Link to this | Hansard source

I am very pleased to follow the member for Dobell. I can't promise that I'll cover as much ground as the member for Dobell. It was a fine contribution, and I thank her for that. I rise to speak on the Therapeutic Goods Amendment (2020 Measures No. 2) Bill 2020. Labor, as the previous speakers have already mentioned, will be supporting this bill. We reiterate our support for the member for Hindmarsh, who has moved the second reading amendment. We, of course, will be supporting that second reading amendment, which I will talk to a little bit later in my contribution.

I also want to take this opportunity while speaking on this bill to acknowledge the member for McMahon, who, until last week, was Labor's shadow minister for health. He has done an outstanding job of leading not just the Federal Parliamentary Labor Party but in many ways the national response to coronavirus—working with the government, working with the minister—and has put forward the guiding principle that we will listen to the health advice, listen to the health experts and put that before politics. It has been our North Star throughout this entire pandemic that we have been committed to listening and respecting the views of our health experts, our scientists and our experts on this awful disease. As such, they have led us into the enviable position that Australia now finds itself.

The Therapeutic Goods Amendment (2020 Measures No. 2) Bill 2020 covers three main provisions. I'll go over them very quickly and then I'll talk to one particular part of it in more detail. The first part goes to the labels on vaccines. At the moment there are, for good reason, requirements for vaccines to have labels to display their Australian registration and therapeutic goods number. We have never had mRNA vaccines before—they will be the first—and we have never had to administer these sorts of vaccines in Australia. The very nature of this technology means that they need to be stored at very low temperatures. It is a volatile substance and, as such, it makes the simple task of putting labels on these sorts of vials impossible, so this is a sensible measure that allows for this new technology to be administered in Australia and, of course, Labor supports it.

This bill will also allow pharmacists to substitute medicines where certain shortages arise. The member for Dobell very adequately went to issues pharmacists and pharmacies often face in some detail. Labor, again, supports that in principle. Finally, this bill will help facilitate a unique device identification database for medical devices that have been inserted into patients or implanted into patients and that will help the coordination of that particular medicine.

In my contribution to the debate on this bill today, I want to touch on the rollout of this vaccine, because it is obviously on all Australian's minds. It is encouraging that we are starting from this in a place where Australians broadly do have a trust in science and they do have an excellent vaccination record. I was pleased to work in the Victorian government when they introduced their No Jab, No Play legislation, which helped bring up the immunisation rates of children in Victoria to above the 95 per cent threshold, which in turn helped achieve herd immunity. It was an outstanding achievement led by the then health minister Jill Hennessy. I would say we are starting from a strong base when it comes to the rollout. We have outstanding health professionals around the country. We have outstanding resources and hospital systems that can successfully roll out the really mammoth logistical tasks required of this vaccine.

When we were here last year in this place, I was sitting with my colleagues and, like the sunrise in the morning, in every question time the Minister for Health would confidently stroll up to the dispatch box and parrot his lines about how Australia is at the head of the queue and how wonderful a job he and the Prime Minister had done to roll out a vaccine strategy in this country. On 19 August, the minister even put out a press release saying, 'Australians will be among the first in the world to receive a COVID-19 vaccine, if it proves successful, through an agreement between the Australian government and UK-based drug company AstraZeneca.' On 5 November, another press release from the minister boasted:

… our Strategy puts Australia at the front of the queue, if our medical experts give the vaccines the green light.

Well, our medical experts have given a vaccine the green light. They have given the Pfizer vaccine the green light. They gave that on 25 January. It has now been almost 10 days since that vaccine was given approval in this country, and how many vaccines have we had rolled out in this country? None.

The TGA have done their job. The TGA didn't get up at the dispatch box and boast about how good a job they have done; they just got on and did it. We saw from the Minister for Health and the Prime Minister constant patting on the back—the self-congratulations that they like to do—and self-aggrandising. They said that Australia was going to be among the first in the world to receive vaccines. There have been 99 million coronavirus vaccines administered around the world and not one of those 99 million has been administered here in Australia.

While I understand that there are supply chain difficulties, while I understand that there is obviously huge demand and while I absolutely think that Australia needs to be doing its part in ensuring the rollout of a vaccine happens not just in our country but also in our region—we have a responsibility to ensure that our friends and family in the Pacific also have access to a vaccine—it is simply not true to say that Australians are at the head of the queue and it is simply not true to say that the Minister for Health and the Prime Minister have done a great job in acquiring the vaccines, because, if they had, we would have already acquired them and they would have already started to be rolled out, like they have in almost 100 million cases around the world.

Things were made a little more frustrating for us on this side of the House, and the member for Fenner mentioned this—articulately, as always—in his contribution. At this stage the government has obviously put a lot of money into the various vaccines. I think it's safe to say that we have good vaccines that are coming to Australia and we should all be confident in receiving a vaccine as soon as the TGA approves the various vaccines. We have got only one approved, but, hopefully, in the not-too-distant future we'll have others approved as well. It's fair to say that the government is spending tens of millions of dollars rolling out an advertising campaign in order to build up the confidence of Australians to get vaccinated. Australians should know that, if a vaccine is available in Australia, it is safe. It has gone through some of the most rigorous testing and scientific analysis by some of the best experts in the world. Australia's Therapeutic Goods Administration is one of the best in the world, and we can and should have confidence in it. But we don't need government members undermining the health response throughout this pandemic.

We have seen throughout this entire pandemic the member for Hughes spouting ridiculous claims around hydroxychloroquine in a sort of politicised fantasy around former US President Donald Trump. They are completely unscientific and ignorant comments around treatments. Quite frankly, he has absolutely no qualification and no right to be making those comments in this country. They are dangerous and false, but then they obviously extended to attacks on the health authorities. He even compared the Victorian health authorities to Nazi Germany. It was offensive.

What was even more difficult to stomach was the Prime Minister doing absolutely nothing to stop him, to call him out or to intervene. He sat idly by and—wink-wink, nudge-nudge—said: 'Off you go, Member for Hughes. Keep going. We want those votes that you're acquiring on the far Right extremes of society. We want those people to support the Liberal-National party, so you're free to go out and peddle your dangerous conspiracy theories.' Instead of actually showing responsibility, the Prime Minister let him continually rain his false and dangerous conspiracies. It's hardly surprising that the member for Hughes then turned his false and dangerous claims about the coronavirus pandemic to the vaccines.

We need people to be vaccinated. We need them to be vaccinated with safe vaccines. We've already seen the University of Queensland program, sadly, shut down because it was deemed to not qualify to the high standards that we require. Australians won't be offered vaccines if they are not safe. The determination of the safety will be done by the world's best experts. The determination of the efficacy and safety for Australians is being done by people whom we should all have confidence in. It is completely outrageous that members opposite sit in the same party room and quietly do media interview after media interview after media interview but say nothing of the dangerous and false conspiracies being peddled by the member for Hughes.

'We are all in this together' was a comment that the Prime Minister made, and, throughout this pandemic, I would agree. In fact, it doesn't just extend to Australia. What we are seeing now is that countries that allow it to replicate are allowing it to mutate—countries like South Africa, Brazil and the United Kingdom. The more virus there is, the more chances it has to mutate into a virus that may reduce the efficacy of a vaccine. Even with these vaccines, we are still potentially months away from being in front of this coronavirus pandemic. Australia may yet see the worst of this pandemic, and I really hope that I have never been more wrong. I really hope that I have never been more wrong.

But we cannot have members of the Australian government undermining our health authorities. We cannot have members of the Australian government attacking the very thing that will help bring Australia back to increased levels of normality. We cannot have members of the government make unscientific claims and we cannot have members of Scott Morrison's government attacking the very health experts that we need to be listening to to guide us through this pandemic. It is not good enough to allow the member for Hughes to continue his false peddling of conspiracies. It needs to stop.

On this bill, we say, the more safe vaccines that are available to Australians, the better. But the government shouldn't stop now and rest on its laurels. As this virus evolves, so should our vaccine strategy, and the government should be doing more deals with companies that potentially will be able to tackle the different variants of this virus. We will be dealing with vaccines long into the future. The different generations of vaccines that we will be seeing and that we will be required to get will require ongoing management long into the future.

But getting a vaccine will make a difference. We need to have full confidence, and Australians should have full confidence, in the rigour and high standards that Australian scientists and experts are making vaccine producers achieve in order for Australians to receive one of the coronavirus vaccines. At the moment, we have the Pfizer vaccine; that has been approved. It would nice if we had the Pfizer vaccine being rolled out in this country. We are still waiting for them and the delays are concerning. Nonetheless, we on this side of House will keep pushing for a commitment to science, a commitment to our health experts and a commitment to vaccinations that will help save lives. In the meantime, we hope that those opposite find it within themselves to have enough guts to call out those who are working against the health strategy and attacking our health authorities.

Tony Zappia (Makin, Australian Labor Party) Share this | Link to this | Hansard source

I welcome the opportunity to make a contribution to this debate on the Therapeutic Goods Amendment (2020 Measures No. 2) Bill. As the approval body for the release of medicines, biologicals and medical devices, the Therapeutic Goods Administration, more commonly known as the TGA, serves a critical role in the wellbeing of the nation through the provision of safe, affordable and effective medical products. The TGA has an enormous responsibility because its work and its decisions can have a profound effect on the health of the Australian people. A wrong decision can be devastating. Similarly, delays in the approval process that gets products to market, or making flawed assessments, can cause additional or prolonged suffering. We saw that with the pelvic mesh implants, which resulted in not only an adverse court ruling against Johnson & Johnson but, even worse, years of pain and struggle for so many women who had the implants. I note that Johnson & Johnson are now appealing the case.

Notwithstanding the TGA's role in that matter, I believe that there is widespread agreement that the TGA is rating very highly both here in Australia and overseas. Because of its professionalism and its thoroughness, it is one of the most reputable and trusted federal government agencies. Whilst that thoroughness is, of course, time consuming, the TGA approval process nevertheless compares very well with its overseas counterparts in the US, the UK, Canada and Europe. The TGA median approval times in 2019-20 was, I understand, around 162 days, having fallen from around 182 days in the previous year. Of course, the TGA approval is not the final step, as most medical products are still not accessible to consumers without government subsidies provided through the Pharmaceutical Benefits Scheme, otherwise referred to as the PBS. In regard to the PBS process, Australia does not rate so well. It lags behind many of the comparable countries that I referred to earlier. Acknowledging the importance of getting medical products to market quickly and safely, the Standing Committee on Health, Aged Care and Sport is currently inquiring into the TGA and PBS approval processes. As a member of that committee, I have to say that it has been an interesting journey so far and I look forward to the conclusion of the work of the committee and its report to this parliament.

As we know, medical science is moving at a rapid pace, and the TGA process needs to keep up with the innovations that occur almost daily across the word. However, if the TGA is to improve any of its processes, it will need to be adequately staffed, adequately funded and free from political interference. Since most of its funding comes from industry fees—I believe that over 90 per cent of its funding comes from industry fees—there is no reason for its work to be constrained by staff or other necessary resources. This legislation arose because of the urgency to roll out a COVID-19 vaccine and, therefore, the need to remove technical administrative barriers.

The legislation also deals with medicine shortages and with the establishment of a database of where medical devices have been used. Currently there is no database kept, which makes it difficult to track recipients of failed or faulty medical devices. As we saw with the pelvic mesh implants, it can sometimes be several years before a product fault is identified. It therefore is crucial that we have some sort of tracking system so that, when a fault is identified, we can then go back to those people who need to be supported and give them the support they need. Regrettably, however, the legislation doesn't go far enough and only provides for the making of regulations that will create a database. In essence, what we're doing is simply agreeing to a process that might establish a database, but we're not actually establishing a database. This is something that is long overdue and, as other contributors to the debate have pointed out, is something that Labor not only supports but has been calling for for some time.

My view is that, if we're going to make regulations, we should also go to the next step of establishing the database. However, there is no commitment to do so and, even more concerning, there is no information as to how that will be done, how the database will be established, who will administer it and how secure it will be. Securing personal information, particularly medical information, is increasingly becoming a problem for government departments, even more so when that information is held by a private sector entity, as the Morrison government is inclined to do. These are serious matters and, quite frankly, I believe the public have a right to know the details of how the database will be established.

Here in Australia and throughout the world, COVID-19 has indeed been devastating. The urgency in developing and rolling out a vaccine is well understood: every day matters. So, if the TGA process can be sped up without compromising the vaccine's safety and effectiveness, then that is what must be done. This legislation makes it possible to roll out the vaccine sooner by exempting administrative requirements relating to vaccine labels. The vaccine labels are of course important, but ultimately it's the product itself that is the most important. If we have confidence in the product, I think it will be quite reasonable to have a proposition whereby the labelling can be dispensed with if that means that their product can be rolled out even faster. So Labor, because of the current circumstances and the urgency required, will be supporting that exemption to the process.

On Monday the Prime Minister made an announcement in his Press Club speech about his government's commitment to a rapid national rollout of the COVID vaccine. However, like so many of the government's program announcements, I hope that this one is delivered much more timely than most others have been, because the whole nation depends on it. I hope this is not simply another announcement that the Prime Minister is not able to live up to. Labor will of course support the rollout, just as we have been constructive with all other COVID measures that the government has announced, but also, importantly, because we know that bipartisanship is crucial in building public confidence in the vaccine rollout.

This is particularly the case in light of the widespread antivaxxers' campaign that I'm sure we in this place are all aware of—the COVID-19 conspiracy theories that are rife on social media, both here and throughout the world, and comments from political leaders questioning the effectiveness of the vaccines and competency of the TGA and other comparable global agencies. All of that makes the rollout much more difficult. I'm aware, through the studies that have been carried out, and I've read reports of them, that most Australians—I believe in the order of three-quarters of all Australians—support the vaccine rollout, but many are also understandably cautious because of other comments that they are hearing and reading. Their caution may mean that they will not have the vaccine even when it is available in the early stages. That is not in the nation's interest. My concern is that, unless we have bipartisanship and unless we have a strategy whereby the Australian people are absolutely confident in the vaccine, not all of them—not because they're antivaxxers—will take up the opportunity to become vaccinated. That, in turn, will mean that the problem will be with us for much longer. So it is important that we not only have bipartisanship on this issue but we also have a common message right through to the Australian people.

We know that COVID-19 has devastated communities. Whilst here in Australia—and other speakers have made this point and used the Prime Minister's own words—we are in fact one of the world leaders with respect to the way we've managed COVID-19, the reality is there are still many, many people doing it tough because of COVID-19 and indeed will continue to do it tough for many, many months to come. It's in the national interest, and it's in the individual interests of those people and their families to ensure that we get on top of the COVID pandemic. The best way to do that is through the rollout of the vaccine, and therefore it's important we do so as quickly as possible.

Can I say, even with respect to the rollout itself—again, I don't have the details of how that is going to be done—that I hope the government has a carefully thought through strategy to do so because it's a huge task. In fact, I'm not aware of a similar challenge being placed on the Australian government ever before. Whether it's going to be rolled out under the direction of the federal government or the individual states, I don't know, but it is something that needs to be managed very, very carefully.

The third matter I will refer to in respect of this legislation relates to medical shortages. Other speakers have made the point that this is something that's not new and has not been caused solely by COVID-19. COVID-19 might have added to the problem but, quite frankly, medical shortages have been with us for some time. This highlights of the issues that I and others in this place have been talking about for some time now—that is, our reliance on other countries for many of the essential products that we need here in Australia. Whilst in the past we might have had liberal trade and easy access to many of those products, COVID-19 has highlighted that when there's a crisis of some sort our access to essential products can be severely disrupted. It was disrupted with COVID-19 and it might be disrupted again if there's another crisis in the future. We need to stop relying on overseas countries for the things that we need to have at all times in Australia.

I believe that here in Australia we have the ability to improve our production of pharmaceuticals. In my own electorate, Mayne Pharma has a major production facility. I've been through it on more than one occasion; it's an impressive facility. Mayne Pharma also has facilities overseas. I know that it's a very competent organisation, and I believe there are others like them. We should be supporting Australian companies to manufacture products here in Australia just as we are with CSL's facilities producing the vaccine in Victoria. We should be doing that because medicines and medicinal products and medicinal goods are essential items; they are not something that we choose to have from time to time. If they are needed they become an essential product.

To simply say, as this legislation does, that doctors and pharmacists will be able to dispense a substitute product is nothing more than a bandaid measure. That shouldn't be the answer. That already exists if there is agreement between the doctor, the pharmacist and the patient. It already occurs. The real answer to the problem of medicine shortages is to ensure that we have adequate stocks in Australia at all times. That's done through the reporting process—which has been shown to be flawed from time to time—but, more importantly, it can be done by manufacturing medicines and medical products here in Australia. It is no good having a great reporting system or the ability to dispense an alternative product if we cannot access the products from overseas because there is a shortage for whatever reason or because supply lines have been cut off. When that happens people whose health is entirely reliant on the medicines they take will be placed at serious risk. At a time when we're looking to rebuild our nation, it's an opportunity to invest in the manufacture of medicines and medical products.

Labor will be supporting this legislation because it is the right thing to do right now. During the COVID pandemic that we are all experiencing it is in the national interest to do so. As I said in the course of my remarks, I hope that the rollout is carried out as smoothly and as quickly as possible.

Susan Templeman (Macquarie, Australian Labor Party) Share this | Link to this | Hansard source

It is a pleasure to speak on the amendment to the Therapeutic Goods Amendment (2020 Measures No. 2) Bill 2020, which was moved by the member for Hindmarsh. I very much look forward to working with him as our health and aged care shadow minister. I note his comments about the Therapeutic Goods Administration. It's an agency that we and the community need to have confidence in, and we need to defend its independence and make sure that it is able to stay independent and separate from political influences. I'll come to that mater later in my contribution. Of course, we have said that we'll support this bill, but there are some matters I'd like to speak about. I want to start with the COVID-19 vaccine, one of the measures in this bill.

Australians can be very proud of how they have responded to the pandemic. Their discipline and their willingness to comply have made it possible for us to be guided by science, knowing that people will, by and large, be willing to take the steps that are needed. There's no doubt that the majority of people I speak to have a huge desire to see the vaccination rollout get underway. It is vital that this rollout is done efficiently and fairly. I think we all recognise the absolute challenge of rolling out a vaccination program such as this on such a huge scale. We're not alone in facing this challenge; we're watching countries all around the world grapple with it. We are talking about 50 to 60 million vaccinations over the next six to eight months, depending on how quickly this can be done. This will obviously be made more challenging because you will need to have two doses of the Pfizer vaccine—and we need to see what other vaccines ultimately become available—so it's not going to be just one visit to a nurse, a doctor or a pharmacy; it's going to be two. And it will happen at the same time that the flu vaccinations are administered as usual, which in itself is already a major logistical undertaking. Certainly, I know from talking to my local GPs that that is a really busy time for them.

We have never before seen anything on this scale in Australia. I think we are right to be asking questions about the logistics of how it will happen and asking the government to clarify things and share their plans about it or identify the issues they haven't been able to find solutions for. One of the key things we're all aware of is that the Pfizer vaccine needs to be kept extremely cold, at minus 70 degrees Celsius, which is colder than winter in Antarctica. That is an extraordinary logistical challenge, when you think of it being rolled out around the country. There are other vaccines that have different requirements, and the different needs of vaccines, again, will be one of the things we have to adapt to. I'm told the Moderna vaccine, which we don't have access to, also needs to be frozen, but only at minus 20 degrees Celsius, more like a regular freezer.

I'm really conscious that the community wants this vaccination rollout to succeed and GPs want to be on board. GPs in my electorate have put up their hands to be part of it and I'm sure pharmacies also are going to put up their hands to be part of it. But they need to have confidence that the processes to support them in doing so are in place. We know the vaccine we have access to and which, hopefully, will begin being rolled out soon arrives in packs of 10. Having packs of 10 means our normal labelling processes don't apply, nor will the labels stick to something being stored at minus 70 degrees Celsius. That's one of the measures in this legislation, and we're very happy to support it and help expedite the rollout. Let's keep in mind that the community are deeply unsettled at the moment. They know that outbreaks can occur, as we saw only this week. What we need is confidence in the way the rollout occurs. That will flow through to consumer confidence, which in turn will impact on business confidence. Health is our No. 1 priority, but the way the rollout happens will have its own effects.

I want to note that, at a local level in my electorate, no hub has been identified for a local rollout, although I know that GPs have offered to be part of it. The Nepean Hospital has been identified as a second-phase hub, but it isn't clear exactly where people who are eligible for phase 1a in the far west of the city and in my electorate of Macquarie but outside the electorate of Lindsay will be able to get access to the vaccine. I know that if you're in Lindsay it's obvious where you go, but once you move further west or north-west there are much longer distances to travel. I'm really hoping that we see as much local access as possible for my frontline people so they can have the vaccine that they so urgently want to have to reduce the risk that they're facing every single day when they go to work.

I think that we can't talk about this issue without looking at the supply of the vaccine. It's been interesting hearing the claims that we are at the front of the queue to access supplies of the vaccine when I think the evidence shows that we clearly are not. We weren't even at the front of the queue in signing deals for the vaccine. There's been, from what I can see, just under 100 million doses of the vaccine administered worldwide. Israel has reached around a 35 per cent vaccination rate. They are about half the size of us, but that is a very impressive vaccination rate. We have had precisely zero vaccinations. We understand that the TGA needed to go through the processes thoroughly, and it is good to see they did that in a very timely way, but, some weeks on, we're still not seeing any exact start dates for the vaccine rollout. So I do look forward to seeing those soon.

My community is conscious every time they read about some sort of tightening of supplies, as we read about with the EU in the last little while. That's another factor that we in this place and our communities are aware of. No-one can ignore the fact that it heightens our inability to produce the volumes of vaccine in our own country to look after our own people. I do hope that this lesson is something not just being learned. It's all very well to learn a lesson, but we then need to see actions in place, because it has highlighted how much we need to be able to make things here, in Australia. If you can't make the things in your own country that are needed to protect the health of your own people, you really are failing your community. I think we have a responsibility to act on that, and I look forward to seeing action.

The other issue that I would like more clarity from the government on is the online booking system. There is meant to be a single point of entry. When I talk to my GPs about the rollout of flu vaccinations, they are very clear on who needs to have a flu shot fast. They know their patients. They know who's on the list. They reach out to them. Sometimes it takes more than one phone call to organise to have them in. The process they use to make sure that the flu vaccination is effectively rolled out is very intensive. I want to understand how a single point of entry into a system, what GPs are used to doing and how effective that is in getting good rates of flu vaccination coverage, is going to be supported. How is an elderly person going to use that single point of entry? Will people in my electorate, for instance, pop in a postcode and be advised that their nearest place is maybe some 60 or 70 kilometres away? How is it all going to work? We know the challenges, but what we haven't heard from the government is what the solutions are.

There is no doubt that there are some people who are hesitant about being vaccinated. We need to give them confidence. I welcome the government's campaign. I think it's something like a $24 million dollar campaign to promote vaccination; that's a good thing. But then, to have that effort undermined by people like the member for Hughes, who has continued to peddle his views and spread misinformation on Facebook, on social media, on TV and today in the corridors, undermines any efforts being made with a huge portion of the population who are willing to listen to those words.

It's reported today that the Prime Minister has spoken with the member for Hughes and not only advised him that he isn't his doctor but apparently asked him to change his sort of communication. I'll believe it when I see it. The fact that it's come now—the member for Hughes has been peddling this misinformation about COVID from almost the day COVID was identified as a pandemic. Only this morning he was haranguing the member for Sydney in the corridors about it, all because she had the audacity to say that she believed the Minister for Health and the Chief Medical Officer of this country. He's been peddling these dangerous views for such a long time, and the Prime Minister has failed to do anything other than turn a blind eye. He's failed to take any responsibility for the things that a member of his government is doing—things that were contradictory to what the minister for health and the Chief Medical Officer were saying.

In case people need to be reminded of what some of those things are, there has been a systematic undermining of confidence in all our medical and scientific institutions where they've spoken on COVID, not least the TGA. He went so far as accusing the chief medical and health officers of 'crimes against humanity'. There have been conspiracy theories about big pharma from the member for Hughes. He has planted so much doubt about a range of therapeutic practices. He's promoted so-called therapeutic practices that have no medical basis. He jumped on the Donald Trump bandwagon on a whole lot of things to do with this issue and thrived on being controversial about it. He was promoting things to people who were apt to believe. He didn't do it just once; he didn't do it twice. He did it every day. He did repeatedly. He did it over days, weeks and months.

For the Prime Minister to speak with him today is far too little, too late. We have asked the Prime Minister to speak publicly about the member for Hughes's views, and to my knowledge that is yet to happen. It's extraordinary that nobody on the other side has really had the guts to call him out. He must be an embarrassment to those opposite. They really should speak out in droves about what he is saying and how he is undermining the very things that their government is standing for and we are supporting them on—that is, to encourage people to be part of the vaccination rollout so that we can really start to tackle the consequences of COVID and recover from the impacts that it has had, not least being able to keep our people safe.

In the time remaining to me, I will touch briefly on the other measures in this bill. One aspect of the bill deals with medicine shortages. These are not new. They are pre-COVID issues and they've been further exacerbated by COVID. There have been serious medicine shortages. This bill is good in as much as, if a serious shortage is declared by a minister, it allows for a pharmacist to substitute a different medicine, not just a different brand of the same medicine. But this really doesn't address the underlying supply chain issues, and that's what we need to see this government do. I will give you one example that's been raised with me. The acid reflux drug Famotidine can be ordered by mail from the US—it's available over the counter from Costco in the US—but you can't buy it for love or money in Australia. Pharmacists are raising this issue about a range of medications, such as for thyroid treatments and even for anaesthetics in surgery. So we need to see more than this.

The last thing I will mention is the medical devices register. Many people have said that it is easier to track a car part than it is a medical device, so I welcome the fact that this is a register, but I note there is a long way to go before it is in place.

Helen Haines (Indi, Independent) Share this | Link to this | Hansard source

I rise to support the bill before the House, the Therapeutic Goods Amendment (2020 Measures No. 2) Bill 2020. This bill makes an important step towards the smooth rollout of Australia's very, very important vaccination program. Right now, drugs imported into Australia are required to have registration or a listing number on their label. With the COVID-19 vaccine, this may not always be possible—for instance, if those vaccines must be stored at extremely low temperatures, like the Pfizer vaccine. This bill amends the Therapeutic Goods Act to allow the secretary of the health department to waive this obligation so that we can import these critical life-saving vaccines and start the process of getting our lives back to normal. The removal of this impediment to the import of COVID-19 vaccines is a sensible and practical measure that puts public health and safety first.

The vaccine rollout in Australia will be delivered through hospitals, GP clinics, pharmacies and community health centres. But, if the rollout is to be successful, regional Australia will need additional support. We already have significantly fewer GPs per head of population than the cities, and these GPs are already overworked. Many people will have to travel significant distances to get to hospitals or other distribution points. Small clinics will need additional resourcing to cope with the millions of people across the nation who need to be vaccinated. This bill is important, but our vaccine rollout will need a dedicated regional focus if the promise of free and universal access to this vaccine is to be realised.

I have a deeper concern around the success of the vaccine rollout. My concern is that the government is not currently providing a clear and consistent evidence based public health message about COVID-19, largely due to the ongoing behaviour of the member for Hughes, behaviour that I believe is directly relevant to the bill before us. I was reluctant to make the following remarks today, because I have no wish to draw attention to this dangerous behaviour. But, with my background in clinical care and public health research, I felt it was my professional duty to intervene in this public debate. As a former nurse and midwife, over the years I've had many hundreds of conversations with new parents who hold concerns about vaccines. I know that in normal times many people harbour anxieties and reservations about vaccines; it's not unusual. If anyone out there listening feels hesitation about the vaccine, it's okay to feel some hesitation, but it's important to ask the right questions of the right people.

I know from my clinical and research experience that addressing people's concerns about their health and the health of their kids requires empathy, understanding and information that comes from evidence based medicine. That's why the member for Hughes is so heinous in doing what he's been doing. He's exploiting and aggravating legitimate concerns and anxieties of Australians just to big himself up. That is not on. In place of scientific, medically sound information, he's putting out serious misinformation. It's appalling in a pandemic—when millions overseas have died, when the entire world has been turned upside down, when people's lives have been disrupted so completely—to throw fuel onto the fire of people's anxieties about their health and security, and, in the process, endanger them.

I will not waste time countering each of the spurious claims that the member for Hughes has spouted over the last year. Instead, I am asking the government to stop this dangerous behaviour. I believe that there was a private conversation this morning between the Prime Minister and the member for Hughes. Apparently, that has been released in a media release. But a private conversation and a media release are not enough; this needs to be stated publicly. If the member for Hughes is allowed to continue, then all of the good work being done—for instance, through this really important bill—will be undermined.

The government has so much to be proud of in its response to the COVID-19 pandemic: shutting down the international borders early; establishing the national cabinet; and creating economic measures, like JobKeeper, JobSeeker and the coronavirus supplement, which were critical public health measures in allowing people not to have to choose between complying with public health advice and keeping an income. All of that good work is being undermined from the inside. Yet the government is refusing to do something publicly about it.

No person in this building has worked harder over the past year than the minister for health. I have much respect for his tireless and effective work in leading our national response. That's why I was so powerfully disappointed that, when asked to condemn the lies from the member for Hughes, the health minister only said, 'There will be different views from different people.' It's why I was so shocked when, as Acting Prime Minister, the Deputy Prime Minister was asked about the member for Hughes's dangerous fabrications and he told people to 'toughen up', because 'facts are sometimes contentious'. That's not good enough. It's why I was scandalised on Monday, when the Prime Minister was asked to reject the arguments put forward by the member for Hughes and he instead said that he was doing a 'great job' in his electorate. From three of the most senior members of the government, this is reprehensible. This is not what being captain of 'team Australia' looks like—no, it's not. This is capitulation to idiocy that does not befit a government which has otherwise overseen such a successful response to the COVID-19 pandemic and is presenting a good bill to us right now. This is a government that called COVID-19 our 'Dunkirk moment', and yet, when its most senior members were called upon to show leadership, they squibbed it. They've the spine of a jellyfish when it comes to the member for Hughes!

Even the member for Higgins, a decorated doctor in her past life and highly respected, when asked about the member for Hughes said that debate is fine and that she doesn't follow the member for Hughes on Facebook so hadn't seen what he'd said. I understand that she's probably working very hard—she's told me she has been, inside the tent—with her colleague. But it's not enough. You need to say this publicly and give confidence to the people out there who are listening. If the most experienced medical professional in the government claims to have not even read the dangerous anti-science nonsense being churned out several times a day by one of her own colleagues, that's not something of which to be proud. The member for Higgins stood up in this place just this morning highlighting, legitimately, her expertise as a medical researcher and declaring that the government is removing all roadblocks to an effective rollout of the vaccine, but, really, all of them accept the enormous roadblock that sits in the party room.

This government has started pushing the line that the grand solution for all of this business with the member for Hughes is just to stop using Facebook for health information. The member for Hughes, though, has 90,000 followers on Facebook—50 per cent more than the Treasurer of Australia. He's had 3.9 million interactions with his Facebook page since August. By contrast, the Australian government Department of Health has had just 605,000. There has not been a single week since August of last year where the Department of Health has had more interactions than the Facebook page of the member for Hughes. So the idea that you shouldn't go to Facebook for your health advice is ludicrous, because in fact it's one which all of us here—and, indeed, the government, most profoundly—subscribe to. Right now, the pinned Facebook post for the member for Higgins is a video about how the vaccine will be rolled out—a post that she has hashtagged 'DrKatie' and 'health'. So that's a curious way not to share medical advice on Facebook! When the TGA approved the Pfizer vaccine on 25 January, the Prime Minister was really quick to post a celebratory note on Facebook, as was the Treasurer, as was the Deputy Prime Minister and as was the health minister. The obvious truth is that the government do use Facebook and social media to spread health advice because they know that that's where people get a lot of their information. This idea that Australians could just delete their Facebook accounts is a fig leaf for an inability to rein in their own renegade colleagues.

As far as I can see, the only member of the government who has even remotely called out this tommyrot is the member for Reid, one of the newest and youngest members of our parliament. She said correctly:

Freedom of speech does not equal freedom of responsibility. In a political environment shaped by COVID, the responsibility of every MP is to safeguard democracy by rejecting disinformation and fake news. We have a duty to our nation to follow the evidence and facts.

I applaud the member for Reid and thoroughly agree with her. In a single tweet, she's shown more courage than the entire government ministry put together, and she's shamed the Prime Minister who, instead of leadership, has prioritised political expediency above public health—because you cannot claim to kneel at the altar of medical science and yet allow a bonfire of lies to blaze on the internet, lit by the self-appointed minister for conspiracy theories, the member for Hughes. You just cannot. It is simply unacceptable. It has to be called out—it has to be called out publicly, not just in a private conversation—and it has to stop, because people are being lied to and they are being misled.

Research from the ANU in November found that just 58 per cent of Australians will 'definitely' get the vaccine, but almost 30 per cent—30 per cent!—are hesitant, with 13 per cent actively resistant to it. Polling published by Newspoll yesterday showed a similar result, with just 46 per cent of Australians saying they would 'definitely' get the vaccine, a third saying 'probably', 17 per cent saying they won't and eight per cent being unsure. This is why it's so important that we get the logistics and communication right.

The vaccine will not itself be a silver bullet to get us back to normal, but it is our only pathway back to normal. To really get to the other side of this crisis, we need something like 70 per cent to 90 per cent of the Australian population to get vaccinated. The fact that we are only at around half of Australians saying they will definitely get the vaccine is a public policy failure that needs to be addressed urgently, and it is a failure that falls directly at the feet of those who spew lies and those too afraid to stop them.

The Prime Minister is spending $24 million of public money on a vaccine information campaign and yet his own backbencher is rowing in the other direction. The greatest challenge our nation will face this year, God willing, is to convince tens of millions of Australians of the truth that these vaccines are safe and effective. A clear and consistent message from our leaders is more important than ever. That's the one thing this government appears unable right now to give Australians while the member for Hughes is allowed to run riot.

The President of the AMA, Omar Khorshid, said:

It's really disappointing to see people who should know better getting out there and putting out just crackpot ideas on health issues.

And the vice president, Dr Chris Moy, said the member for Hughes and others are 'torching the foundation of community health and science'. There's now a push by organisations like the Doherty institute and the Immunisation Foundation of Australia for the parliament to pass legislation forcing social media companies to crack down on COVID-19 misinformation circulating online. So at a time when our vaccinologists and our public health experts should be focusing on the vaccine rollout they are instead mobilising to counter the dangerous behaviour coming from, of all places, the government party room. It beggars belief. What a disgrace.

I am not a firebrand MP. I came here to be a good local representative. I have no interest in stoking political drama just for the sake of it. My remarks on this bill today are absolutely motivated by a desire for the government to succeed on this, to protect public health with the same vigour with which it's approached the COVID-19 pandemic in general. I want to be extremely clear: if you are out there right now listening to all of this, getting confused about what vaccine works, what the side effects are or if you are feeling anxious, that's okay. It's not wrong to have questions. It's not wrong to feel anxious.

Before I was a public health researcher I spent 35 years as a nurse and a midwife. I have sat with thousands of new mothers and fathers and talked with them about how to care for their babies. Many hundreds of these new parents over the years have been reluctant or anxious to get their children vaccinated. When the measles-mumps- rubella vaccine was a big issue, I had many discussions with parents to reassure them about this. The research tells us that the best way to encourage people to get vaccinated is to recognise their concerns and answer their questions. Nobody refuses a vaccine because they are trying to harm themselves or other people; they do it because they are honestly worried about the health of themselves or their family. We are all driven by the same impulse here—to protect our families and our community. But it is important to be clear: the vaccines being rolled out in Australia have been rigorously tested. These approval processes have not been rushed. They are safe. They are effective. Australia's vaccine rollout will be voluntary, universal and free. The government is not making this mandatory. This means it is up to all Australians to choose vaccination. If we, as a country, can rally around this vaccination program and get vaccinated when we can then that is the way back to normal life.

I commend this bill to the House, but it would be absurd to do so without noting that the greatest tool we have for a successful vaccine rollout is not legislation but communication. If the government is to succeed in this challenge, a challenge that the Prime Minister on Monday said was his No. 1 priority, then it has to step up and show leadership that Australians deserve and publicly call out misinformation.

Paul Fletcher (Bradfield, Liberal Party, Minister for Communications, Urban Infrastructure, Cities and the Arts) Share this | Link to this | Hansard source

The Therapeutic Goods Amendment (2020 Measures No. 2) Bill 2020 amends the Therapeutic Goods Act to implement a range of measures to support the delivery of the highest quality health care for Australians and to promote the health and wellbeing of Australians. In particular, the bill removes a potential impediment to the Australian government's response to the COVID-19 pandemic in relation to the importation and supply of COVID-19 vaccines in Australia. It also introduces measures to improve access to therapeutic goods for Australians and to enhance patient safety.

The bill supports continued access to medicine where there is a serious scarcity of a medicine in Australia, improves the safety of therapeutic goods in Australia by providing for the introduction of a unique device identification database and related requirements to trace medical devices, and enables the ratification of international agreements that protect human health relating to therapeutic goods.

The bill supports Australian Public Service employees to lawfully obtain, possess and convey goods, licit or illicit, for the purpose of determining compliance with the therapeutic goods regulatory scheme, clarifies aspects of the data protection scheme for assessed listed medicines and makes other minor amendments. I thank members of the House for their contributions to debate on this bill.

Tony Smith (Speaker) Share this | Link to this | Hansard source

The original question was that this bill be now read a second time. To this the honourable member for Hindmarsh has moved as an amendment that all words after 'That' be omitted with a view to substituting other words. The immediate question is that the words proposed to be omitted stand part of the question.